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Company Name Brand Name GMDN Term Name GMDN Term Status FDA Product Code Name FDA Product Code Device Packaged As Sterile Sterilization Prior To Use Issuing Agency Device Size Device Size Type Device Class Implantable

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e-vive II NMES System with Post-Op Brace; L/XL, Right (ITALIAN) - 00850022650017

e-vive II NMES System with Post-Op Brace; L/XL, Right (ITALIAN)
Motive Health, Inc.
CY-1000-308I
In Commercial Distribution

  • 00850022650017 ()

  • Length: 16 Inch
CY-1000-308I

  • Physical therapy transcutaneous neuromuscular electrical stimulation system

e-vive II NMES System with Post-Op Brace; S/M, Right (ITALIAN) - 00850022650000

e-vive II NMES System with Post-Op Brace; S/M, Right (ITALIAN)
Motive Health, Inc.
CY-1000-307I
In Commercial Distribution

  • 00850022650000 ()

  • Length: 16 Inch
CY-1000-307I

  • Physical therapy transcutaneous neuromuscular electrical stimulation system

NA - 05415067040756

Charger
Thoratec Corporation
16000
In Commercial Distribution

  • 05415067040756 ()
16000

  • Implant battery charger

NA - 05415067040749

Charger Kit, Lumbar
Thoratec Corporation
36000
In Commercial Distribution

  • 05415067040749 ()
36000

  • Implant battery charger

SJM™ - 05414734402477

No Description
ADVANCED NEUROMODULATION SYSTEMS, INC.
3701
In Commercial Distribution

  • 05414734402477 ()
3701

  • Noninvasive device battery charger

KOWA DR-1α - 04987646807728

The KOWA DR-1α is an ocular surface interferometer, which is an ophthalmic imaging device that is intended for use by physician in adult patients to observe and record a video image of specular (interferometric) observations of the tear film, which can be visually monitored and photographically documented.
KOWA COMPANY,LTD.
DE2K
Not in Commercial Distribution

  • 04987646807728 ()


  • Ophthalmic fundus camera

Optima View Video Laryngoscope for Single Use Blades - 05055382859840

Optima View Video Laryngoscope Handle and LCD Display 3.75'' For Single Use Blades
TIMESCO HEALTHCARE LIMITED
4000.310.50
In Commercial Distribution

  • 05055382859840 ()


  • Video intubation laryngoscope handle/monitor

MEDLINE - 10193489136241

OTO/OPH POCKET SET,2.5V LED,W/CASE
MEDLINE INDUSTRIES, INC.
MDSLS4SETL
In Commercial Distribution

  • 10193489136241 ()
MDSLS4SETL

  • Ophthalmic/otologic diagnostic set

MEDLINE - 10193489136210

OPHTHALMOSCOPE,POCKET,2.5V LED,W/POUCH
MEDLINE INDUSTRIES, INC.
MDSLS4LOP
In Commercial Distribution

  • 10193489136210 ()
MDSLS4LOP

  • Ophthalmic/otologic diagnostic set

WowGoHealth Pulse Oximeter GSH601 - 04719878124027

The pulse oximeter is a reusable device, and it’s intended for intermittent checks of oxygen saturation and pulse rate for adults in a home-use only. This device is not intended for continuous monitoring. The device is intended to use of Over-The-Counter.
GOLDEN SMART HOME TECHNOLOGY CORP.
GSH601
In Commercial Distribution

  • 04719878124027 ()
  • 14719878124024 ()
  • 54719878124022 ()

  • Weight: 50 Gram
  • Height: 58 Millimeter
  • Width: 34 Millimeter
  • Depth: 30 Millimeter
Orange

  • Pulse oximeter

WowGoHealth Pulse Oximeter GSH601 - 04719878124010

The pulse oximeter is a reusable device, and it’s intended for intermittent checks of oxygen saturation and pulse rate for adults in a home-use only. This device is not intended for continuous monitoring. The device is intended to use of Over-The-Counter.
GOLDEN SMART HOME TECHNOLOGY CORP.
GSH601
In Commercial Distribution

  • 04719878124010 ()
  • 14719878124017 ()
  • 54719878124015 ()

  • Weight: 50 Gram
  • Height: 58 Millimeter
  • Width: 34 Millimeter
  • Depth: 30 Millimeter
Gray

  • Pulse oximeter

Micro-X - 09357123000051

The device is designed to perform radiographic x-ray examinations on pediatric and adult patients, in all patient treatment areas
MICRO-X LIMITED
Rover
In Commercial Distribution

  • 09357123000051 ()
MXU-RV71

  • Mobile basic diagnostic x-ray system, digital

Micro-X - 09357123000044

The device is designed to perform radiographic x-ray examinations on pediatric and adult patients, in all patient treatment areas
MICRO-X LIMITED
Rover
In Commercial Distribution

  • 09357123000044 ()
MXU-RV60

  • Mobile basic diagnostic x-ray system, digital

Micro-X - 09357123000037

The device is designed to perform radiographic x-ray examinations on pediatric and adult patients, in all patient treatment areas
MICRO-X LIMITED
Rover
In Commercial Distribution

  • 09357123000037 ()
MXU-RV35

  • Mobile basic diagnostic x-ray system, digital

Micro-X - 09357123000013

The device is designed to perform radiographic x-ray examinations on pediatric and adult patients, in all patient treatment areas
MICRO-X LIMITED
Rover
In Commercial Distribution

  • 09357123000013 ()
MXU-RV19

  • Mobile basic diagnostic x-ray system, digital

Aerogen®Go - 04719873130191

The Aerogen®Go Vibrating Mesh Nebulizer is a small, handheld, internally powered general-purpose nebulizer which utilizes vibrating mesh technology to generate aerosol. The Aerogen®Go Vibrating Mesh Nebulizer is designed for a single patient, multiple uses, and mainly composed of a Main Unit and a Medication Reservoir. The Main Unit contains the control circuitry and the firmware to control the vibrating mesh module in the Medication Reservoir and is powered by 2 AA alkaline batteries or an AC adaptor. The Medication Reservoir contains the nebulizing module (mesh) where the liquid medication will be turned into aerosols. The prescribed medication is added into the reservoir with ten (10) ml of medication capacity, nebulized, and inhaled through the aerosol port. The Aerogen®Go Vibrating Mesh Nebulizer generates aerosol from liquid medication during turning on through pressing ON/OFF button and turning off when pressing ON/OFF button again, auto-turn off when no liquid detected, or 10-minute session completed. There are different LED lights to monitor the status and operating condition of the nebulizer: green indicates power on and normally working, yellow flash indicates low power caution, and constant yellow indicates shut-off due to too low power.
HCMED INNOVATIONS CO., LTD.
HCM-86C
In Commercial Distribution

  • 04719873130191 ()


  • Benchtop nebulizer, non-heated

Pulmogine - 04719873130030

The Pulmogine Vibrating Mesh Nebulizer is a small, handheld, internally powered general-purpose nebulizer which utilizes vibrating mesh technology to generate aerosol. The Pulmogine Vibrating Mesh Nebulizer is designed for a single patient, multiple uses, and mainly composed of a Main Unit and a Medication Reservoir. The Main Unit contains the control circuitry and the firmware to control the vibrating mesh module in the Medication Reservoir and is powered by 2 AA alkaline batteries or an AC adaptor. The Medication Reservoir contains the nebulizing module (mesh) where the liquid medication will be turned into aerosols. The prescribed medication is added into the reservoir with ten (10) ml of medication capacity, nebulized, and inhaled through the aerosol port. The Pulmogine Vibrating Mesh Nebulizer generates aerosol from liquid medication during turning on through pressing ON/OFF button and turning off when pressing ON/OFF button again, auto-turn off when no liquid detected, or 10-minute session completed. There are different LED lights to monitor the status and operating condition of the nebulizer: green indicates power on and normally working, yellow flash indicates low power caution, and constant yellow indicates shut-off due to too low power.
HCMED INNOVATIONS CO., LTD.
HCM-86C
In Commercial Distribution

  • 04719873130030 ()


  • Benchtop nebulizer, non-heated

PHILIPS - 10075020040319

An over the counter device intended for the removal of unwanted hair. Also intended for permanent reduction in hair regrowth, defined as the long-term, stable reduction in hair counts following a treatment regime.
HOME SKINOVATIONS LTD
Lumea Comfort SC1981
In Commercial Distribution

  • 00075020040312 ()
  • 20075020040316 ()
  • 10075020040319 ()
075020040312

  • Cosmetic red-light phototherapy system, home-use

Remington - 10074590550860

An over the counter device intended for the removal of unwanted hair. Also intended for permanent reduction in hair regrowth, defined as the long-term, stable reduction in hair counts following a treatment regime.
HOME SKINOVATIONS LTD
IPL3500
In Commercial Distribution

  • 00074590550863 ()
  • 10074590550860 ()
  • 20074590550867 ()
0074590550863

  • Cosmetic red-light phototherapy system, home-use

TekCare Touch Free Infrared Thermometer - 04710953421512

The NT17 THERMO DISTANCE thermometer is designed for the intermittent measurement of the human body's temperature in the domestic environment and can be used upon people of all ages
AVITA CORPORATION
NT17
In Commercial Distribution

  • 04710953421529 ()
  • 04710953421512 ()


  • Infrared patient thermometer, ear

TekCare Blood Pressure Monitor - 04710953421338

BPM19 Series Blood Pressure Monitor applies the Oscillometric method to measure human systolic / diastolic blood pressure and heart rate. All values are shown on the LCD monitor. This device is designed only for adults.
AVITA CORPORATION
BPM19
In Commercial Distribution

  • 04710953421345 ()
  • 04710953421338 ()


  • Automatic-inflation electronic sphygmomanometer, non-portable

TekCare Touch Free Infrared Thermometer - 04710953421291

The NT11 THERMO DISTANCE thermometer is designed for the intermittent measurement of the human body's temperature in a domestic environment, and can be used upon people of all ages.
AVITA CORPORATION
NT11
In Commercial Distribution

  • 04710953421307 ()
  • 04710953421291 ()


  • Infrared patient thermometer, ear

Blood pressure monitor - 04710953421161

The device is a arm type blood pressure monitor intended for automatically measures systolic and diastolic blood pressure and pulse rate by the oscillometric method. The measurement position is at the arm.The cuff circumference is limited to 220 mm - 420 mm (approx.:9 - 17 inches).The device is intended for home use. When the device detects irregular heart beats during measurement, an irregular heartbeat symbol will appear along with the measured readings
AVITA CORPORATION
BPA-O300
In Commercial Distribution

  • 04710953421161 ()
  • 04710953421192 ()


  • Automatic-inflation electronic sphygmomanometer, non-portable

Blood pressure monitor - 04710953420942

The device is a wrist type blood pressure monitor intended for automatically measures systolic and diastolic blood pressure and pulse rate by the oscillometric method. The measurement position is at the wrist. The device is intended to be used by adults with a wrist circumference ranging from 125mm to 210mm (approx. 4.9 to 8.3 inches). The device is intended for home use. When the device detects irregular heartbeats during measurement, an irregular heartbeat symbol will appear along with the measured readings.
AVITA CORPORATION
62220
In Commercial Distribution

  • 04710953420942 ()


  • Automatic-inflation electronic sphygmomanometer, non-portable

TekCare Non-Contact Infrared Thermometer - 04710953421598

The NT19 thermometer is designed for the intermittent measurement of the human body's temperature in the domestic environment and can be used upon people of all ages
AVITA CORPORATION
NT19
In Commercial Distribution

  • 04710953421604 ()
  • 04710953421598 ()


  • Infrared patient thermometer, ear

TekCare Infrared Thermometer - 04710953421314

The device is an infrared thermometer intended for the intermittent measurement of human body temperature in people of all ages.
AVITA CORPORATION
TS46
In Commercial Distribution

  • 04710953421321 ()
  • 04710953421314 ()


  • Infrared patient thermometer, ear

KG-2-SET koplight light handle set (infrared cut-off model) - 04562231093597

-koplight Cordless Lighted Retractor is a medical device consisting of two main parts; koplight S blade/koplight HT S blade and koplight light handle. -koplight S blade/koplight HT S blade is a surgical retractor, and it retracts incisions and/or wounds to provide access to the operative field. koplight S blade/koplight HT S blade is sterilized single-use. -koplight light handle is an auxiliary surgical light, and it illuminates the operative field with LED light. -KG-2-SET koplight light handle set is packed with KG-2 koplight light handle (Infrared cut-off model), KY-1 koplight light handle finger hook, KP-1 koplight light handle O-ring and KD-1 koplight battery inserter.
YASUI CO.,LTD.
KG-2-SET
In Commercial Distribution

  • 04562231093597 ()

  • Outer Diameter: 15.0 Millimeter
  • Length: 155.0 Millimeter


  • Hand-held surgical retractor, single-use

KG-1-SET koplight light handle set - 04562231093580

-koplight Cordless Lighted Retractor is a medical device consisting of two main parts; koplight S blade/koplight HT S blade and koplight light handle. -koplight S blade/koplight HT S blade is a surgical retractor, and it retracts incisions and/or wounds to provide access to the operative field. koplight S blade/koplight HT S blade is sterilized single-use. -koplight light handle is an auxiliary surgical light, and it illuminates the operative field with LED light. -KG-1-SET koplight light handle set is packed with KG-1 koplight light handle, KY-1 koplight light handle finger hook, KP-1 koplight light handle O-ring and KD-1 koplight battery inserter.
YASUI CO.,LTD.
KG-1-SET
In Commercial Distribution

  • 04562231093580 ()

  • Outer Diameter: 15.0 Millimeter
  • Length: 155.0 Millimeter


  • Hand-held surgical retractor, single-use

KG-2 koplight light handle (Infrared cut-off model) - 04562231093368

-koplight Cordless Lighted Retractor is a medical device consisting of two main parts; koplight S blade/koplight HT S blade and koplight light handle. -koplight S blade/koplight HT S blade is a surgical retractor, and it retracts incisions and/or wounds to provide access to the operative field. koplight S blade/koplight HT S blade is sterilized single-use. -koplight light handle is an auxiliary surgical light, and it illuminates the operative field with LED light.
YASUI CO.,LTD.
KG-2
In Commercial Distribution

  • 04562231093368 ()

  • Outer Diameter: 15.0 Millimeter
  • Length: 155.0 Millimeter


  • Hand-held surgical retractor, single-use

KG-1 koplight light handle - 04562231091074

-koplight Cordless Lighted Retractor is a medical device consisting of two main parts; koplight S blade/koplight HT S blade and koplight light handle. -koplight S blade/koplight HT S blade is a surgical retractor, and it retracts incisions and/or wounds to provide access to the operative field. koplight S blade/koplight HT S blade is sterilized single-use. -koplight light handle is an auxiliary surgical light, and it illuminates the operative field with LED light.
YASUI CO.,LTD.
KG-1
In Commercial Distribution

  • 04562231091074 ()

  • Outer Diameter: 15.0 Millimeter
  • Length: 155.0 Millimeter


  • Hand-held surgical retractor, single-use

LED SLIT LAMP - 04562230698991

No Description
RIGHT MFG. CO., LTD.
MW50D
Not in Commercial Distribution

  • 04562230698991 ()

  • Width: 350 Millimeter
  • Depth: 387 Millimeter
  • Height: 678.5 Millimeter
  • Weight: 14 Kilogram


  • Ophthalmic examination slit lamp

LED SLIT LAMP - 04562230698984

No Description
RIGHT MFG. CO., LTD.
MW50D
Not in Commercial Distribution

  • 04562230698984 ()

  • Weight: 14 Kilogram
  • Height: 678.5 Millimeter
  • Depth: 387 Millimeter
  • Width: 350 Millimeter


  • Ophthalmic examination slit lamp

LED SLIT LAMP - 04562230698977

No Description
RIGHT MFG. CO., LTD.
MW50D
Not in Commercial Distribution

  • 04562230698977 ()

  • Weight: 14 Kilogram
  • Height: 678.5 Millimeter
  • Depth: 387 Millimeter
  • Width: 350 Millimeter


  • Ophthalmic examination slit lamp

LED SLIT LAMP - 04562230698960

No Description
RIGHT MFG. CO., LTD.
MW50D
Not in Commercial Distribution

  • 04562230698960 ()

  • Width: 350 Millimeter
  • Depth: 387 Millimeter
  • Height: 678.5 Millimeter
  • Weight: 14 Kilogram


  • Ophthalmic examination slit lamp

LED SLIT LAMP - 04562230698953

No Description
RIGHT MFG. CO., LTD.
MW50D
Not in Commercial Distribution

  • 04562230698953 ()

  • Width: 350 Millimeter
  • Depth: 387 Millimeter
  • Height: 678.5 Millimeter
  • Weight: 14 Kilogram


  • Ophthalmic examination slit lamp

LED SLIT LAMP - 04562230698946

No Description
RIGHT MFG. CO., LTD.
MW50D
Not in Commercial Distribution

  • 04562230698946 ()

  • Weight: 14 Kilogram
  • Height: 678.5 Millimeter
  • Depth: 387 Millimeter
  • Width: 350 Millimeter


  • Ophthalmic examination slit lamp

LED SLIT LAMP - 04562230698939

No Description
RIGHT MFG. CO., LTD.
MW50D
Not in Commercial Distribution

  • 04562230698939 ()

  • Width: 350 Millimeter
  • Depth: 387 Millimeter
  • Height: 678.5 Millimeter
  • Weight: 14 Kilogram


  • Ophthalmic examination slit lamp

LED SLIT LAMP - 04562230698922

No Description
RIGHT MFG. CO., LTD.
MW50D
Not in Commercial Distribution

  • 04562230698922 ()

  • Weight: 14 Kilogram
  • Height: 678.5 Millimeter
  • Depth: 387 Millimeter
  • Width: 350 Millimeter


  • Ophthalmic examination slit lamp

LED SLIT LAMP - 04562230697192

No Description
RIGHT MFG. CO., LTD.
MW50D
Not in Commercial Distribution

  • 04562230697192 ()

  • Width: 350 Millimeter
  • Depth: 387 Millimeter
  • Height: 678.5 Millimeter
  • Weight: 14 Kilogram


  • Ophthalmic examination slit lamp

LED SLIT LAMP - 04562230697161

No Description
RIGHT MFG. CO., LTD.
MW50D
Not in Commercial Distribution

  • 04562230697161 ()

  • Width: 350 Millimeter
  • Depth: 387 Millimeter
  • Height: 678.5 Millimeter
  • Weight: 14 Kilogram


  • Ophthalmic examination slit lamp

LED SLIT LAMP - 04562230697123

No Description
RIGHT MFG. CO., LTD.
MW50D
Not in Commercial Distribution

  • 04562230697123 ()

  • Weight: 14 Kilogram
  • Height: 678.5 Millimeter
  • Depth: 387 Millimeter
  • Width: 350 Millimeter


  • Ophthalmic examination slit lamp

LED SLIT LAMP - 04562230697109

No Description
RIGHT MFG. CO., LTD.
MW50D
Not in Commercial Distribution

  • 04562230697109 ()

  • Weight: 14 Kilogram
  • Height: 678.5 Millimeter
  • Depth: 387 Millimeter
  • Width: 350 Millimeter


  • Ophthalmic examination slit lamp

LED SLIT LAMP - 04562230697062

No Description
RIGHT MFG. CO., LTD.
MW50D
Not in Commercial Distribution

  • 04562230697062 ()

  • Weight: 14 Kilogram
  • Height: 678.5 Millimeter
  • Depth: 387 Millimeter
  • Width: 350 Millimeter


  • Ophthalmic examination slit lamp

C23RV - 04562122959926

Probe
HITACHI, LTD.
C23RV
Not in Commercial Distribution

  • 04562122959926 ()


  • Extracorporeal ultrasound imaging transducer, hand-held

C23 - 04562122959919

Probe
HITACHI, LTD.
C23
Not in Commercial Distribution

  • 04562122959919 ()


  • Extracorporeal ultrasound imaging transducer, hand-held

Arietta 750 - 04562122959841

Diagnostic Ultrasound System
HITACHI, LTD.
ARIETTA 750
Not in Commercial Distribution

  • 04562122959841 ()


  • General-purpose ultrasound imaging system

HITACHI - 04562122959162

Probe
HITACHI, LTD.
MXS2ESLL1
Not in Commercial Distribution

  • 04562122959162 ()


  • Oesophageal ultrasound imaging transducer, reusable

HITACHI - 04562122959155

Probe
HITACHI, LTD.
VC35
Not in Commercial Distribution

  • 04562122959155 ()


  • Extracorporeal ultrasound imaging transducer, hand-held

HITACHI - 04562122959018

Probe
HITACHI, LTD.
SML44
Not in Commercial Distribution

  • 04562122959018 ()


  • Extracorporeal ultrasound imaging transducer, hand-held

HITACHI - 04562122958974

Diagnostic Ultrasound System
HITACHI, LTD.
Aloka Arietta 850
Not in Commercial Distribution

  • 04562122958974 ()


  • General-purpose ultrasound imaging system
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