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
Cochlear Bone Anchored Solutions AB
95205
In Commercial Distribution

  • 09321502028745 ()
95205

  • Bone-conduction hearing implant system sound processor/vibrator
No Description
Cochlear Americas Corporation
P803255CD
In Commercial Distribution

  • 09321502074117 ()


  • Hearing aid wireless-fitting computer-aided set
No Description
Cochlear Bone Anchored Solutions AB
95475
In Commercial Distribution

  • 09321502034630 ()
95475

  • Bone-conduction hearing implant system sound processor/vibrator
No Description
Cochlear Bone Anchored Solutions AB
96002
In Commercial Distribution

  • 09321502033817 ()
96002

  • Bone-conduction hearing implant system sound processor/vibrator
No Description
Cochlear Bone Anchored Solutions AB
95330
In Commercial Distribution

  • 09321502033220 ()
  • 09321502039246 ()
95330

  • Bone-conduction hearing implant system sound processor/vibrator
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
SIGNATURE ORTHOPAEDICS PTY LTD
112-184-546
In Commercial Distribution

  • 09348215055677 ()


  • Surgical implant template, reusable
No Description
SIGNATURE ORTHOPAEDICS PTY LTD
122-16-0333
In Commercial Distribution

  • 09348215046323 ()


  • Surgical implant template, reusable
No Description
IT-V Medizintechnik GmbH
P10107-642
In Commercial Distribution

  • 09120074396425 ()


  • Radiological whole-body positioner
No Description
IT-V Medizintechnik GmbH
P10107-483
In Commercial Distribution

  • 09120074394834 ()


  • Radiological whole-body positioner
A reusable surgical instrument intended to be used during an orthopaedic surgical procedure
ENZTEC LIMITED
4252-2367
In Commercial Distribution

  • 09421028119900 ()
4252-2367

  • Orthopaedic implant impactor, reusable
No Description
SIGNATURE ORTHOPAEDICS PTY LTD
112-42-3005
In Commercial Distribution

  • 09348215083373 ()


  • Surgical implant template, reusable
Clip-on Loupe 5 Diopter (#715) Eyewear
HAGER WORLDWIDE, INC.
87021
In Commercial Distribution

  • D2488702100 ()


  • Eye splash shield, reusable
3% Bismuth Tribromophenate in a petrolatum blend, Sterile
Dynarex Corporation
3054
In Commercial Distribution

  • 00616784305417 ()
  • 00616784305424 ()
  • 00616784305431 ()


  • Wound hydrogel dressing, non-antimicrobial
No Description
Dynarex Corporation
1251
In Commercial Distribution

  • 00616784125114 ()
  • 00616784125121 ()
  • 00616784125138 ()


  • General-body orifice lubricant
No Description
Silipos Holding LLC
14455
In Commercial Distribution

  • 00614464144554 ()


  • External limb prosthesis socket liner
No Description
Silipos Holding LLC
13355
In Commercial Distribution

  • 00614464133558 ()


  • External limb prosthesis socket liner
No Description
Silipos Holding LLC
3610
In Commercial Distribution

  • 00614464036101 ()


  • Custom-made cushion
No Description
Silipos Holding LLC
1624
In Commercial Distribution

  • 00614464016240 ()


  • External limb prosthesis socket liner
No Description
Silipos Holding LLC
1614
In Commercial Distribution

  • 00614464016141 ()


  • External limb prosthesis socket liner
No Description
Silipos Holding LLC
1466
In Commercial Distribution

  • 00614464014666 ()


  • External limb prosthesis socket liner
No Description
Silipos Holding LLC
1462
In Commercial Distribution

  • 00614464014628 ()


  • External limb prosthesis socket liner
No Description
ATOM MEDICAL CORPORATION
60321
In Commercial Distribution

  • 04942962603218 ()
  • 84942962603214 ()
60321

  • Basic bed sheet, single-use
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
Noras MRI products GmbH
02
In Commercial Distribution

  • 04251269205347 ()
112996

  • MRI system coil, radio-frequency
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
This is a medical device.This is a medical device.
KaVo Dental GmbH
0.571.5171
In Commercial Distribution

  • EKAV057151710 ()
scaler Tip No 5

  • Ultrasonic dental scaling/debridement system
No Description
KaVo Dental GmbH
0.571.0472
In Commercial Distribution

  • EKAV057104720 ()
clean Brush No 5

  • Ultrasonic dental scaling/debridement system
No Description
Orasure Technologies, Inc.
1154IB
In Commercial Distribution

  • 00608337000726 ()


  • Phencyclidine (PCP) IVD, kit, enzyme immunoassay (EIA)
No Description
Orasure Technologies, Inc.
1150IB
In Commercial Distribution

  • 00608337000702 ()


  • Opiate/opiate metabolite IVD, kit, enzyme immunoassay (EIA)
No Description
Orasure Technologies, Inc.
1150EB
In Commercial Distribution

  • 00608337000689 ()


  • Opiate/opiate metabolite IVD, kit, enzyme immunoassay (EIA)
No Description
Orasure Technologies, Inc.
1124SB
In Commercial Distribution

  • 00608337000665 ()


  • Cotinine (nicotine metabolite) IVD, kit, enzyme immunoassay (EIA)
No Description
Orasure Technologies, Inc.
1122SB
In Commercial Distribution

  • 00608337000412 ()


  • Cocaine/cocaine metabolite 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.
1122IB
In Commercial Distribution

  • 00608337000290 ()


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

  • 00608337000269 ()


  • Cannabinoid/cannabinoid metabolite IVD, kit, enzyme immunoassay (EIA)
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