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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S1090 810nm 200mW Acu Tip B/G
THOR PHOTOMEDICINE LIMITED
2.0
In Commercial Distribution

  • 05060494130176 ()


  • Red-light phototherapy unit, professional
S1160 810nm 1W Cluster (5x200mW)
THOR PHOTOMEDICINE LIMITED
2.0
In Commercial Distribution

  • 05060494130145 ()


  • Red-light phototherapy unit, professional
S2110 69 LED Cluster Probe Wavelength = 660nm & 850nm Power
THOR PHOTOMEDICINE LIMITED
2.3
In Commercial Distribution

  • 05060494130138 ()


  • Red-light phototherapy unit, professional
S2173 660nm 75mW Dental Probe
THOR PHOTOMEDICINE LIMITED
2.3
In Commercial Distribution

  • 05060494130114 ()


  • Red-light phototherapy unit, professional
S2042 660nm 30mW Standard Tip B/G
THOR PHOTOMEDICINE LIMITED
2.3
In Commercial Distribution

  • 05060494130091 ()


  • Red-light phototherapy unit, professional
S1042 660nm 30mW Standard Tip B/G
THOR PHOTOMEDICINE LIMITED
2.0
In Commercial Distribution

  • 05060494130084 ()


  • Red-light phototherapy unit, professional
S2040 660nm 30mW Acu Tip B/G
THOR PHOTOMEDICINE LIMITED
2.3
In Commercial Distribution

  • 05060494130077 ()


  • Red-light phototherapy unit, professional
S2062 660nm 200mW Standard Tip B/G
THOR PHOTOMEDICINE LIMITED
2.3
In Commercial Distribution

  • 05060494130053 ()


  • Red-light phototherapy unit, professional
S1175 660nm 100mW Acu Tip B/G
THOR PHOTOMEDICINE LIMITED
2.0
In Commercial Distribution

  • 05060494130039 ()


  • Red-light phototherapy unit, professional
Refill accessory for Gemini EVO laser
AZENA MEDICAL, LLC
9124
In Commercial Distribution

  • 00850010501109 ()
G2-5-008

  • Dental diode laser system
Refill accessory for Gemini EVO kit
AZENA MEDICAL, LLC
9123
In Commercial Distribution

  • 00850010501093 ()
G2-5-007

  • Dental diode laser system
Over the counter Red/IR LED Heating device for minor aches and pains, temporary increase in circulation.
Omm Imports Inc.
RX100
In Commercial Distribution

  • 00850001456357 ()


  • Musculoskeletal infrared phototherapy unit, non-wearable
OxyKnight Fingertip Oximeter CF-100
CMI HEALTH INC.
CF-100
In Commercial Distribution

  • 00850000967304 ()


  • Pulse oximeter
Pulse Oximeter for use with sporting and aviation activities. Intended to monitor heart rate during exercise.
BEURER NORTH AMERICA, L.P.
CMS50D
In Commercial Distribution

  • 10850003500994 ()
  • 00850003500997 ()


  • Pulse oximeter
No Description
EASY HEALTHCARE CORPORATION
EHP50D1
In Commercial Distribution

  • 00850003180199 ()
  • 10850003180196 ()


  • Pulse oximeter
Pediatric and Adult Pulse Oximeter
Gpd Health LLC
GPD-PO1GR01C
In Commercial Distribution

  • 00850022983023 ()


  • Pulse oximeter
FINGERTIP PULSE OXIMENTER
KONQUEST GROUP INC
KPO-1720
In Commercial Distribution

  • 00850021777005 ()


  • Pulse oximeter
Pulse Oximeter for use with sporting and aviation activities. Intended to monitor heart rate during exercise.
BEURER NORTH AMERICA, L.P.
PO50
In Commercial Distribution

  • 10850018808009 ()
  • 00850018808002 ()
453.76

  • Pulse oximeter
Disposable SP02 Sensor Comparable to Nellcor MAX-N - Neonatal/Adult - Use with PM100N Nellcor Monitor
SUNSET HEALTHCARE SOLUTIONS, INC.
RES7100
In Commercial Distribution

  • 00848530103842 ()


  • Pulse oximeter
Fingertip Pulse Oximeter with 6-way Display
SUNSET HEALTHCARE SOLUTIONS, INC.
RES5101
In Commercial Distribution

  • 10848530061170 ()
  • 00848530061173 ()
RES5101

  • Pulse oximeter
Sunset Fingertip Pulse Oximeter
SUNSET HEALTHCARE SOLUTIONS, INC.
RES5100
In Commercial Distribution

  • 10848530061163 ()
  • 00848530061166 ()
RES5100

  • Pulse oximeter
Sunset Fingertip Pulse Oximeter with OLED Display - 1/Each
SUNSET HEALTHCARE SOLUTIONS, INC.
RES5102
In Commercial Distribution

  • 10848530097650 ()
  • 00848530097653 ()


  • Pulse oximeter
S1110 69 LED Cluster Probe 660nm & 850nm 1390mW
THOR PHOTOMEDICINE LIMITED
2.0
In Commercial Distribution

  • 05060494130121 ()


  • Red-light phototherapy unit, professional
S1173 660nm 75mW Dental Probe
THOR PHOTOMEDICINE LIMITED
2.0
In Commercial Distribution

  • 05060494130107 ()


  • Red-light phototherapy unit, professional
S1040 660nm 30mW Acu Tip B/G
THOR PHOTOMEDICINE LIMITED
2.0
In Commercial Distribution

  • 05060494130060 ()


  • Red-light phototherapy unit, professional
S2060 660nm 200mW Acu Tip B/G
THOR PHOTOMEDICINE LIMITED
2.3
In Commercial Distribution

  • 05060494130046 ()


  • Red-light phototherapy unit, professional
S1131 19 LED Cluster Probe 660nm & 850nm 370mW
THOR PHOTOMEDICINE LIMITED
2.0
In Commercial Distribution

  • 05060494130022 ()


  • Red-light phototherapy unit, professional
S2140 104 LED Cluster Probe 660nm & 850nm 2W
THOR PHOTOMEDICINE LIMITED
2.3
In Commercial Distribution

  • 05060494130015 ()


  • Red-light phototherapy unit, professional
S1140 104 LED Cluster Probe 660nm & 850nm 2W
THOR PHOTOMEDICINE LIMITED
2.0
In Commercial Distribution

  • 05060494130008 ()


  • Red-light phototherapy unit, professional
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
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
No Description
BLUBLOX PTY LTD
Red Light Face Wand
In Commercial Distribution

  • 09361725000081 ()


  • Cosmetic red-light phototherapy system, home-use
No Description
BLUBLOX PTY LTD
Mini Red Light Therapy Device
In Commercial Distribution

  • 09361725000074 ()


  • Cosmetic red-light phototherapy system, home-use
No Description
BLUBLOX PTY LTD
Red Light Therapy Blanket
In Commercial Distribution

  • 09361725000067 ()


  • Cosmetic red-light phototherapy system, home-use
No Description
BLUBLOX PTY LTD
Red Light Neck and Chest Mask
In Commercial Distribution

  • 09361725000050 ()


  • Cosmetic red-light phototherapy system, home-use
No Description
BLUBLOX PTY LTD
Red Light Face Mask
In Commercial Distribution

  • 09361725000043 ()


  • Cosmetic red-light phototherapy system, home-use
No Description
BLUBLOX PTY LTD
Super Max Red Light Therapy Device
In Commercial Distribution

  • 09361725000036 ()


  • Cosmetic red-light phototherapy system, home-use
No Description
BLUBLOX PTY LTD
Max Red Light Therapy Device
In Commercial Distribution

  • 09361725000029 ()


  • Cosmetic red-light phototherapy system, home-use
No Description
BLUBLOX PTY LTD
Demi Red Light Therapy Device
In Commercial Distribution

  • 09361725000012 ()


  • Cosmetic red-light phototherapy system, home-use
No Description
BLUBLOX PTY LTD
Bullet Red Light Therapy Device
In Commercial Distribution

  • 09361725000005 ()


  • Cosmetic red-light phototherapy system, home-use
a cosmetic outlook improved version if compare with the previous ABPT1003 device. so, this is a Mark II version with slight change to the machine outlook.
APPLIED BIOPHOTONICS LIMITED
ABPT1003-2
In Commercial Distribution

  • 04719873240029 ()


  • Red-light phototherapy unit, professional
  • Musculoskeletal infrared phototherapy unit, non-wearable
No Description
APPLIED BIOPHOTONICS LIMITED
ABPT1003
In Commercial Distribution

  • 04719873240012 ()


  • Red-light phototherapy unit, professional
  • Musculoskeletal infrared phototherapy unit, non-wearable
The WS Far-Infrared Therapy Unit, Model: KP-B210, is an infrared heating system which delivers 3~25 μm Far-infrared energy through Far Infrared (FIR) radiation plate. The device is a non-invasive physiology therapy device and emits topical heat to the human forearm and upper arm for therapeutic applications without direct contact. The model, KP-B210 is a single object without additional assembly which contains an emitter, a user control panel, a power switch and safety distance reminder.
WS FAR IR MEDICAL TECHNOLOGY CO., LTD.
KP-B210
In Commercial Distribution

  • 04719873220199 ()


  • Full-body radiant heating system
The WS Therapy Unit is an infrared heating system which emits topical heat to the human body for therapeutic applications. It consists of an IR emitter (Emission spectrum ranges from 3~25 microns.), a control box, a supporting arm to allow for adjustment of the emitter locations, and a protection net on the emitter to prevent fire or direct touch by the user. The entire unit is mounted on the base that is easy to move. The device uses 100V as the power source. It meets the related requirement of IEC60601-1 Electrical Safety.
WS FAR IR MEDICAL TECHNOLOGY CO., LTD.
TY-101F
In Commercial Distribution

  • 04719873220045 ()


  • Full-body radiant heating system
SmartHeart Talking Pulse Oximeter
VERIDIAN HEALTHCARE LLC
11-50L
In Commercial Distribution

  • 10845717006818 ()
  • 30845717006812 ()
  • 00845717006811 ()
11-50L

  • Pulse oximeter probe, reusable
Far Infrared Ray Healthful Lamp (or Medical FIR Radiator)
CHUNG CHENG ELECTRIC HEATING CO., LTD.
CH-8810
In Commercial Distribution

  • 04716171749018 ()


  • Musculoskeletal infrared phototherapy unit, non-wearable
No Description
MASIMO CORPORATION
9900
In Commercial Distribution

  • 00843997009379 ()
  • 00843997005111 ()


  • Pulse oximeter
No Description
MASIMO CORPORATION
9800
In Commercial Distribution

  • 00843997009362 ()


  • Pulse oximeter
No Description
MASIMO CORPORATION
9700
In Commercial Distribution

  • 00843997009355 ()


  • Pulse oximeter
No Description
MASIMO CORPORATION
9574
In Commercial Distribution

  • 00843997008310 ()


  • Patient monitoring system module, pulse oximetry
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