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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Cross Connector / Multiaxial
SpineArt SA
ELL-CC MU 31-S
In Commercial Distribution

  • 07640151084042 ()

  • L31 to 33


  • Bone-screw internal spinal fixation system, sterile
Cross Connector / Multiaxial
SpineArt SA
ELL-CC MU 30-S
In Commercial Distribution

  • 07640151084035 ()

  • L30 to 31


  • Bone-screw internal spinal fixation system, sterile
Cross Connector / Multiaxial
SpineArt SA
ELL-CC MU 55-S
In Commercial Distribution

  • 07640151082512 ()

  • L55 to 80


  • Bone-screw internal spinal fixation system, sterile
Multi-unit Laboratory implant
MEDENTiKA GmbH
8515-30
In Commercial Distribution

  • 04251574835093 ()
  • EMKA8515309 ()

  • compatible to Multi-unit
8515-30

  • Dental implant analog
Multi-unit Laboratory implant
MEDENTiKA GmbH
8515-17
In Commercial Distribution

  • 04251574835086 ()
  • EMKA8515179 ()

  • compatible to Multi-unit
8515-17

  • Dental implant analog
Multi-unit Laboratory implant
MEDENTiKA GmbH
8514-30
In Commercial Distribution

  • 04251574805881 ()
  • EMKA8514309 ()

  • compatible to Multi-unit
8514-30

  • Dental implant analog
Multi-unit Laboratory implant
MEDENTiKA GmbH
8514-17
In Commercial Distribution

  • 04251574805874 ()
  • EMKA8514179 ()

  • compatible to Multi-unit
8514-17

  • Dental implant analog
Multi-unit Laboratory implant
MEDENTiKA GmbH
8510
In Commercial Distribution

  • 04251574805867 ()
  • EMKA85109 ()

  • compatible to Multi-unit
8510

  • Dental implant analog
Multi-unit Laboratory implant
MEDENTiKA GmbH
8509
In Commercial Distribution

  • 04251574835079 ()
  • EMKA85099 ()

  • compatible to Multi-unit
8509

  • Dental implant analog
Multi-unit Laboratory implant
MEDENTiKA GmbH
8504
In Commercial Distribution

  • 04251574805850 ()
  • EMKA85049 ()

  • compatible to Multi-unit
8504

  • Dental implant analog
MedentiBASE Laboratory implant
MEDENTiKA GmbH
80
In Commercial Distribution

  • 04251574837455 ()
  • EMKA809 ()

  • compatible to MedentiBase
80

  • Dental implant analog
Novaloc
MEDENTiKA GmbH
59
In Commercial Distribution

  • 04251574805836 ()
  • EMKA599 ()

  • compatible to Novaloc
59

  • Dental implant analog
Novaloc
MEDENTiKA GmbH
58
In Commercial Distribution

  • 04251574805829 ()
  • EMKA589 ()

  • compatible to Novaloc
58

  • Dental implant analog
MedentiLOC
MEDENTiKA GmbH
57
In Commercial Distribution

  • 04251574805812 ()
  • EMKA579 ()

  • compatible to MedentiLOC
57

  • Dental implant analog
MedentiLOC
MEDENTiKA GmbH
56
In Commercial Distribution

  • 04251574805805 ()
  • EMKA569 ()

  • compatible to MedentiLOC
56

  • Dental implant analog
MedentiBASE Laboratory implant
MEDENTiKA GmbH
4630
In Commercial Distribution

  • 04251574805768 ()
  • EMKA46309 ()

  • compatible to MedentiBase
4630

  • Dental implant analog
800 P37,JE,1L,POT WIPER TIED TO COMMON
CURBELL MEDICAL PRODUCTS, INC.
BIC-19C0-E03-8
In Commercial Distribution

  • 00840828123778 ()
3902

  • Electrical mains power extension cable
This is an application intended to be used by neurologists who are monitoring or reviewing EEGs. It is part of a larger system provided by Persyst.
Persyst Development Corp
App for Web
Not in Commercial Distribution

  • 00869732000142 ()


  • Bioelectrical signal analysis software
JUSTI- PAKTO POWDER 4 OZ TRANS. OVER
AMERICAN TOOTH INDUSTRIES
070-28-0003/TO
In Commercial Distribution

  • D772ATI280003TO0 ()


  • Dental acrylic resin
JUSTI- PAKTO POWDER 1 OZ TRANS. OVER
AMERICAN TOOTH INDUSTRIES
070-28-0002/TO
In Commercial Distribution

  • D772ATI280002TO0 ()


  • Dental acrylic resin
PYROPLAST POWDER 4 OZ SHADE TRANS. OVER
AMERICAN TOOTH INDUSTRIES
070-10-0404/TO
In Commercial Distribution

  • D772ATI100404TO0 ()


  • Dental acrylic resin
PYROPLAST POWDER 1 OZ SHADE TRANS. OVER
AMERICAN TOOTH INDUSTRIES
070-10-0401/TO
In Commercial Distribution

  • D772ATI100401TO0 ()


  • Dental acrylic resin
Locate veins and assist with medical procedures Venipuncture and blood drawing are easier Suitable for children and elderly patients Solving the problem of difficulty in venous access Quickly respond to emergency situations and save lives
OPCOM INC.
CM3100FF6
In Commercial Distribution

  • 04711099370009 ()


  • Infrared-light vein locator
Disposable Dilators, Set of 2 Dilators (9-12 mm) 1) 9-10 mm Dilator 1) 11-12 mm Dilator
BOSTON SCIENTIFIC CORPORATION
720131-01
Not in Commercial Distribution

  • 00878953005379 ()

  • 9 to 10 mm
  • 11 to 12 mm
720131-01

  • Corpus cavernosum dilator, single-use
URINAL, MALE, SUSPENSORY GARMENT, URINE COLLECTION, COTTON, REUSABLE, LARGE 46" TO 54" (117CM TO 137CM) WAIST Replacement suspensory garment for Urocare Male Urinal systems & kits #94404 & #4404.
UROCARE PRODUCTS, INC.
4423
In Commercial Distribution

  • 00792293044235 ()

  • 117cm to 137cm Waist
  • 46" to 54" Wasit
  • Weight: 0.20 Pound
4423

  • Penis/scrotum wearable urinal
URINAL, MALE, SUSPENSORY GARMENT, URINE COLLECTION, COTTON, REUSABLE, UNIVERSAL 26" TO 46" (66CM TO 117CM) WAIST Replacement suspensory garment for Urocare Male Urinal systems & kits #94403, #94402, #4403 & #4402.
UROCARE PRODUCTS, INC.
4420
In Commercial Distribution

  • 00792293044228 ()

  • Weight: 0.20 Pound
  • 26" to 46" Wasit
  • 66cm to 117cm Waist
4420

  • Penis/scrotum wearable urinal
URINAL, MALE, SUSPENSORY GARMENT, URINE COLLECTION, COTTON, REUSABLE, LARGE 38" TO 46" (97CM TO 117CM) WAIST Replacement suspensory garment for Urocare Male Urinal systems & kits #94401 & #4401.
UROCARE PRODUCTS, INC.
4421
Not in Commercial Distribution

  • 00792293044211 ()

  • Weight: 0.18 Pound
  • 38" to 46" Wasit
  • 97cm to 117cm Waist
4421

  • Penis/scrotum wearable urinal
URINAL, MALE, SUSPENSORY GARMENT, URINE COLLECTION, COTTON, REUSABLE, SMALL 26" TO 38" (66CM TO 97CM) WAIST Replacement suspensory garment for Urocare Male Urinal systems & kits #94400, #4400 & #4399.
UROCARE PRODUCTS, INC.
4420
Not in Commercial Distribution

  • 00792293044204 ()

  • 66cm to 97cm Waist
  • 26" to 38" Wasit
  • Weight: 0.16 Pound
4420

  • Penis/scrotum wearable urinal
TG RATCHET ADAPTER
BIOMET 3I, LLC
MDR10H
Not in Commercial Distribution

  • 00844868010098 ()


  • Surgical screwdriver, reusable
myDigitalKnee mobile app is used with a Digital Knee sensor attached to a brace or orthosis and worn by a patient to collect motion data and assist with management of their condition.
OPUM TECHNOLOGIES SERVICES LIMITED
Mobile App Android
In Commercial Distribution

  • 09413000126273 ()


  • Electronic goniometer/kinesiology sensor
No Description
Phillips-Medisize A/S
Android (Mobile App)
Not in Commercial Distribution

  • 05713495000060 ()
84601063

  • Medication reminder application software
No Description
EMPATICA SRL
EpiMonitor App Android
In Commercial Distribution

  • 00853858006386 ()


  • Home seizure monitoring system
actiTENS is a transcutaneous electrical nerve stimulation (TENS) medical device designed to manage chronic pain in people. The compact design and flexible shape of the actiTENS electrical impulse generator allows to fix it for daily use directly to the body of the patient. The impulse generator is delivered with a separate cradle which allows safely recharging its non- removable battery. The actiTENS is compatible with a selection of disposable electrodes and compatible connector cables transmit the electrical stimulation impulses to the targeted nerves according to the selected therapy. The electrical stimulation waveforms are biphasic and asymmetric. The actiTENS is controlled via a downloadable mobile app which allows the comfortable and simple selection of the adequate stimulation program. The actiTENS is intended to be used by the patient at home and also for therapeutic application by medical professionals. It is available for prescription only.
SUBLIMED
actiTENS Android app
In Commercial Distribution

  • B786SBM2AA1100 ()
SBM2AA110

  • Analgesic transcutaneous electrical nerve stimulation system
Android
RESMED PTY LTD
22244
In Commercial Distribution

  • 00619498222445 ()


  • Ventilator application software
Universal slit-lamp imaging device.
Innovations Lightx Inc
BSI-14-UN
In Commercial Distribution

  • 00860012447145 ()


  • Smartphone camera ophthalmic imaging lens
Slit-Lamp imaging for HS BP900
Innovations Lightx Inc
BSI-14-HS-BP900
In Commercial Distribution

  • 00860012447138 ()


  • Smartphone camera ophthalmic imaging lens
Slit-Lamp imaging for HS BQ900
Innovations Lightx Inc
BSI-14-HS-BQ900
In Commercial Distribution

  • 00860012447121 ()


  • Smartphone camera ophthalmic imaging lens
Web application used by Healthcare Professionals to generate dose calculations
Takeda Pharmaceuticals U.S.A., Inc.
V3
In Commercial Distribution

  • 00850025688819 ()


  • Home pharmaceutical management support software
No Description
Biomet Orthopedics, LLC
478735
In Commercial Distribution

  • 00880304386952 ()
478735

  • Orthopaedic implant-instrument extension adaptor, reusable
Interbody, 9mm x 24mm x 16mm, 15 Deg, 3D
Seaspine Orthopedics Corporation
WO1-924165
In Commercial Distribution

  • 10889981234928 ()
WO1-924165

  • Metallic spinal interbody fusion cage
Interbody, 9mm x 24mm x 14mm, 15 Deg, 3D
Seaspine Orthopedics Corporation
WO1-924145
In Commercial Distribution

  • 10889981234843 ()
WO1-924145

  • Metallic spinal interbody fusion cage
Interbody, 9mm x 24mm x 12mm, 15 Deg, 3D
Seaspine Orthopedics Corporation
WO1-924125
In Commercial Distribution

  • 10889981234768 ()
WO1-924125

  • Metallic spinal interbody fusion cage
Interbody, 9mm x 24mm x 10mm, 15 Deg, 3D
Seaspine Orthopedics Corporation
WO1-924105
In Commercial Distribution

  • 10889981234683 ()
WO1-924105

  • Metallic spinal interbody fusion cage
No Description
FGX INTERNATIONAL INC.
1017658-350.FDR
In Commercial Distribution

  • 00193033149805 ()


  • Prescription spectacles
No Description
FGX INTERNATIONAL INC.
3865003.LTS
Not in Commercial Distribution

  • 00999999005977 ()


  • Prescription spectacles
No Description
FGX INTERNATIONAL INC.
DL4050/8.SDM
In Commercial Distribution

  • 00057800940401 ()


  • Tinted non-prescription spectacles
No Description
FGX INTERNATIONAL INC.
DL4049/41.SDM
In Commercial Distribution

  • 00057800940005 ()


  • Tinted non-prescription spectacles
No Description
FGX INTERNATIONAL INC.
DL4048/28.SDM
In Commercial Distribution

  • 00057800939993 ()


  • Tinted non-prescription spectacles
No Description
FGX INTERNATIONAL INC.
DL4047/24.SDM
In Commercial Distribution

  • 00057800939986 ()


  • Tinted non-prescription spectacles
No Description
FGX INTERNATIONAL INC.
DL4046/4.SDM
In Commercial Distribution

  • 00057800939979 ()


  • Tinted non-prescription spectacles
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