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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No Description
SIGNATURE ORTHOPAEDICS PTY LTD
111-59-0105
In Commercial Distribution

  • 09348215134693 ()


  • Coated hip femur prosthesis, modular
No Description
SIGNATURE ORTHOPAEDICS PTY LTD
111-59-0005
In Commercial Distribution

  • 09348215134563 ()


  • Coated hip femur prosthesis, modular
No Description
LIFE TECHNOLOGIES CORPORATION
180267
Not in Commercial Distribution

  • 10190302007993 ()


  • Multiple solid tumour differentiation marker IVD, kit, enzyme immunoassay (EIA)
No Description
DRAEGER MEDICAL SYSTEMS, INC.
MS16232
In Commercial Distribution

  • 04049098005418 ()


  • Electrocardiographic lead set, reusable
No Description
DRAEGER MEDICAL SYSTEMS, INC.
3368391
In Commercial Distribution

  • 04049098009546 ()


  • Electrical-only medical device connection cable, reusable
No Description
DRAEGER MEDICAL SYSTEMS, INC.
5950196
In Commercial Distribution

  • 04049098007993 ()


  • Electrical-only medical device connection cable, reusable
No Description
DRAEGER MEDICAL SYSTEMS, INC.
5956367
In Commercial Distribution

  • 04049098007863 ()


  • Electrocardiographic lead set, reusable
No Description
DRAEGER MEDICAL SYSTEMS, INC.
MS14560
In Commercial Distribution

  • 04049098006217 ()


  • Electrocardiographic lead set, reusable
No Description
DRAEGER MEDICAL SYSTEMS, INC.
MS14679
In Commercial Distribution

  • 04049098006118 ()


  • Electrosurgical cable adaptor
ERA® Standard 5° Female. ERA abutments provide a resilient attachment with universal hinge movement. Available as one piece straight abutment-screwed into implant and as a two-piece angled abutment (angled attachment cemented into abutment base, and base screed into implant).
STERNGOLD DENTAL LLC
811601
In Commercial Distribution

  • 00841549102189 ()


  • Resilient dental precision attachment
No Description
Drägerwerk AG & Co. KGaA
8418539
In Commercial Distribution

  • 04048675016526 ()
  • 04048675429111 ()


  • Nasal oxygen cannula, CPAP
No Description
Drägerwerk AG & Co. KGaA
MP05132
In Commercial Distribution

  • 04048675634713 ()


  • Electrocardiographic lead set, reusable
No Description
Drägerwerk AG & Co. KGaA
MP05122
In Commercial Distribution

  • 04048675634096 ()


  • Electrocardiographic lead set, reusable
No Description
Drägerwerk AG & Co. KGaA
MP02741
Not in Commercial Distribution

  • 04048675412120 ()


  • Anaesthesia breathing circuit, single-use
No Description
Drägerwerk AG & Co. KGaA
MP00944
Not in Commercial Distribution

  • 04048675395515 ()


  • Pin-indexed adaptor, reusable
No Description
Drägerwerk AG & Co. KGaA
8418609
In Commercial Distribution

  • 04048675250470 ()
  • 04048675429050 ()


  • Nasal oxygen cannula, CPAP
No Description
IT-V Medizintechnik GmbH
P10107-483
In Commercial Distribution

  • 09120074394834 ()


  • Radiological whole-body positioner
No Description
Orasure Technologies, Inc.
1154IB
In Commercial Distribution

  • 00608337000726 ()


  • Phencyclidine (PCP) IVD, kit, enzyme immunoassay (EIA)
No Description
Orasure Technologies, Inc.
1124EB
In Commercial Distribution

  • 00608337000399 ()


  • Cotinine (nicotine metabolite) IVD, kit, enzyme immunoassay (EIA)
No Description
Orasure Technologies, Inc.
1142IB
In Commercial Distribution

  • 00608337000320 ()


  • Methadone IVD, kit, enzyme immunoassay (EIA)
No Description
Orasure Technologies, Inc.
1118IB
In Commercial Distribution

  • 00608337000269 ()


  • Cannabinoid/cannabinoid metabolite IVD, kit, enzyme immunoassay (EIA)
No Description
Orasure Technologies, Inc.
1110IB
In Commercial Distribution

  • 00608337000238 ()


  • Benzodiazepine group IVD, kit, enzyme immunoassay (EIA)
No Description
Orasure Technologies, Inc.
1108IB
In Commercial Distribution

  • 00608337000207 ()


  • Barbiturate IVD, kit, enzyme immunoassay (EIA)
No Description
Orasure Technologies, Inc.
1104IB
In Commercial Distribution

  • 00608337000184 ()


  • Methamphetamine-specific IVD, kit, enzyme immunoassay (EIA)
Surgical Instrument Tray
Med-El Elektromedizinische Geräte Gesellschaft m.b.H.
33509
In Commercial Distribution

  • 09008737335090 ()


  • Instrument tray, reusable
This pad is designed for use with the 5806 Radiolucent Imaging Top. Dimensions: 58x20x2 inches. Made with Tempur-Pedic® Medical materials
MIZUHO ORTHOPEDIC SYSTEMS, INC.
5806-7010
In Commercial Distribution

  • 00842430101793 ()
5806-7010

  • Operating table mattress, basic
No Description
MIZUHO ORTHOPEDIC SYSTEMS, INC.
3460S-5
In Commercial Distribution

  • 00842430115202 ()
  • 00842430112515 ()
3460S-5

  • Upper-limb traction wrap/trap, reusable
No Description
MIZUHO ORTHOPEDIC SYSTEMS, INC.
3460M-5
In Commercial Distribution

  • 00842430115196 ()
  • 00842430112508 ()
3460M-5

  • Upper-limb traction wrap/trap, reusable
No Description
MIZUHO ORTHOPEDIC SYSTEMS, INC.
3460L-5
In Commercial Distribution

  • 00842430115189 ()
  • 00842430112492 ()
3460L-5

  • Upper-limb traction wrap/trap, reusable
No Description
MIZUHO ORTHOPEDIC SYSTEMS, INC.
1937S
In Commercial Distribution

  • 10842430110112 ()
  • 00842430110115 ()
1937SDZ

  • Freestanding headrest, single-use
No Description
MIZUHO ORTHOPEDIC SYSTEMS, INC.
1941S
In Commercial Distribution

  • 10842430110099 ()
  • 00842430110092 ()
1941SDZ

  • Freestanding headrest, single-use
No Description
SIGNATURE ORTHOPAEDICS PTY LTD
112-42-3005
In Commercial Distribution

  • 09348215083373 ()


  • Surgical implant template, reusable
No Description
SIGNATURE ORTHOPAEDICS PTY LTD
122-15-0412
In Commercial Distribution

  • 09348215074487 ()


  • Orthopaedic prosthesis implantation positioning instrument, reusable
No Description
SIGNATURE ORTHOPAEDICS PTY LTD
122-15-0460
In Commercial Distribution

  • 09348215074401 ()


  • Orthopaedic implant aiming/guiding block, reusable
No Description
SIGNATURE ORTHOPAEDICS PTY LTD
122-15-0537
In Commercial Distribution

  • 09348215074357 ()


  • Orthopaedic implant aiming/guiding block, reusable
No Description
SIGNATURE ORTHOPAEDICS PTY LTD
122-15-0387
In Commercial Distribution

  • 09348215074265 ()


  • Medullary canal orthopaedic reamer, flexible
No Description
SIGNATURE ORTHOPAEDICS PTY LTD
122-15-0160
In Commercial Distribution

  • 09348215074104 ()


  • Surgical implant template, reusable
No Description
SIGNATURE ORTHOPAEDICS PTY LTD
122-15-0045
In Commercial Distribution

  • 09348215074050 ()


  • Orthopaedic implant aiming/guiding block, reusable
No Description
SIGNATURE ORTHOPAEDICS PTY LTD
122-15-0175
In Commercial Distribution

  • 09348215074012 ()


  • Orthopaedic prosthesis implantation positioning instrument, reusable
No Description
SIGNATURE ORTHOPAEDICS PTY LTD
111-201-605
In Commercial Distribution

  • 09348215056162 ()


  • Surgical implant template, reusable
No Description
SIGNATURE ORTHOPAEDICS PTY LTD
112-34-1005
In Commercial Distribution

  • 09348215056032 ()


  • Surgical implant template, reusable
No Description
Orasure Technologies, Inc.
1103IB
In Commercial Distribution

  • 00608337000146 ()


  • Amphetamine-specific IVD, kit, enzyme immunoassay (EIA)
No Description
Noras MRI products GmbH
02
In Commercial Distribution

  • 04251269205347 ()
112996

  • MRI system coil, radio-frequency
No Description
Cochlear Bone Anchored Solutions AB
95330
In Commercial Distribution

  • 09321502033220 ()
  • 09321502039246 ()
95330

  • Bone-conduction hearing implant system sound processor/vibrator
No Description
Cochlear Bone Anchored Solutions AB
95201
In Commercial Distribution

  • 09321502028783 ()
95201

  • Bone-conduction hearing implant system sound processor/vibrator
No Description
Cochlear Bone Anchored Solutions AB
95202
In Commercial Distribution

  • 09321502028776 ()
95202

  • Bone-conduction hearing implant system sound processor/vibrator
No Description
Cochlear Bone Anchored Solutions AB
95203
In Commercial Distribution

  • 09321502028769 ()
95203

  • Bone-conduction hearing implant system sound processor/vibrator
No Description
Cochlear Bone Anchored Solutions AB
95204
In Commercial Distribution

  • 09321502028752 ()
95204

  • Bone-conduction hearing implant system sound processor/vibrator
No Description
Cochlear Bone Anchored Solutions AB
95205
In Commercial Distribution

  • 09321502028745 ()
95205

  • Bone-conduction hearing implant system sound processor/vibrator
No Description
Noras MRI products GmbH
01
In Commercial Distribution

  • 04251269200755 ()
112996

  • MRI system coil, radio-frequency
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