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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D-Series Panel Pad, Left
SCHUERCH CORPORATION
508-0099
In Commercial Distribution

  • 00810014600208 ()
508-0099

  • Soft-rubber chair cushion
Triage Cardiac Panel (TnI)
QUIDEL CARDIOVASCULAR INC.
97021HS
In Commercial Distribution

  • 30014613337935 ()
97021HS

  • Troponin I IVD, kit, fluorescent immunoassay
Triage Cardiac Panel (OUS)
QUIDEL CARDIOVASCULAR INC.
97000HSEU
In Commercial Distribution

  • 30014613337928 ()
97000HSEU

  • Multiple cardiac marker IVD, kit, fluorescent immunoassay
Liver Enzyme Panel Kit
AERO-MED, LLC
AMM4350
In Commercial Distribution

  • 00810010893055 ()
AMM4350

  • Phlebotomy kit
ELR PANEL&HDW BLUE-PR
GF HEALTH PRODUCTS, INC.
90763132
In Commercial Distribution

  • M368907631321 ()
90763132

  • Wheelchair legrest pad
ELR PANEL&HDW BLACK-PR
GF HEALTH PRODUCTS, INC.
90763032A
In Commercial Distribution

  • M36890763032A1 ()
90763032A

  • Wheelchair legrest pad
RFBFLAT PANEL LCD 23
Smith & Nephew, Inc.
72201088F
Not in Commercial Distribution

  • 00885556571910 ()
72201088F

  • Image display unit, colour
FLAT PANEL LCD 26
Smith & Nephew, Inc.
72202591
In Commercial Distribution

  • 00885556541098 ()
72202591

  • Image display unit, colour
LEGION FEMORALTRIAL PANEL 7-8
Smith & Nephew, Inc.
71442167
In Commercial Distribution

  • 00885556613511 ()
71442167

  • Instrument tray, reusable
ULTRALIGN + LSO POSTERIOR PANEL
DEROYAL INDUSTRIES, INC.
UPP1302
In Commercial Distribution

  • 00749756569590 ()
UPP1302

  • Lumbar spine orthosis
Mano4343X Flat Panel Detector
iRay Group
Mano4343X
In Commercial Distribution

  • 06970569090443 ()


  • Indirect flat panel x-ray detector
Mano4343T Flat Panel Detector
iRay Group
Mano4343T
In Commercial Distribution

  • 06970569090436 ()


  • Indirect flat panel x-ray detector
Venu1717X Flat Panel Detector
iRay Group
Venu1717X
In Commercial Distribution

  • 06970569090429 ()


  • Indirect flat panel x-ray detector
ULTRALIGN + TLSO POSTERIOR PANEL
DEROYAL INDUSTRIES, INC.
UPP2302
In Commercial Distribution

  • 00749756569712 ()
UPP2302

  • Lumbar spine orthosis
ULTRALIGN + TLSO POSTERIOR PANEL
DEROYAL INDUSTRIES, INC.
UPP2701
In Commercial Distribution

  • 00749756569705 ()
UPP2701

  • Lumbar spine orthosis
ULTRALIGN + TLSO POSTERIOR PANEL
DEROYAL INDUSTRIES, INC.
UPP2601
In Commercial Distribution

  • 00749756569699 ()
UPP2601

  • Lumbar spine orthosis
ULTRALIGN + TLSO POSTERIOR PANEL
DEROYAL INDUSTRIES, INC.
UPP2401
In Commercial Distribution

  • 00749756569668 ()
UPP2401

  • Lumbar spine orthosis
ULTRALIGN + TLSO POSTERIOR PANEL
DEROYAL INDUSTRIES, INC.
UPP2301
In Commercial Distribution

  • 00749756569651 ()
UPP2301

  • Lumbar spine orthosis
ULTRALIGN + LSO POSTERIOR PANEL
DEROYAL INDUSTRIES, INC.
UPP1402
In Commercial Distribution

  • 00749756569606 ()
UPP1402

  • Lumbar spine orthosis
No Description
REPROCESSING PRODUCTS CORPORATION
D300-0110
In Commercial Distribution

  • 00858293006809 ()


  • Haemodialysis dialysate central supply system
No Description
REPROCESSING PRODUCTS CORPORATION
D300-0108
In Commercial Distribution

  • 00858293006793 ()


  • Haemodialysis dialysate central supply system
No Description
REPROCESSING PRODUCTS CORPORATION
D300-0106
In Commercial Distribution

  • 00858293006786 ()


  • Haemodialysis dialysate central supply system
No Description
REPROCESSING PRODUCTS CORPORATION
D300-0105
In Commercial Distribution

  • 00858293006779 ()


  • Haemodialysis dialysate central supply system
No Description
REPROCESSING PRODUCTS CORPORATION
D300-0204
In Commercial Distribution

  • 10858293006769 ()
  • 00858293006762 ()


  • Haemodialysis dialysate central supply system
No Description
REPROCESSING PRODUCTS CORPORATION
D300-0203
In Commercial Distribution

  • 10858293006752 ()
  • 00858293006755 ()


  • Haemodialysis dialysate central supply system
SONOPRO is a limited pre-production run of Automated Disinfector Devices. It is classified by the FDA as a Class II medical device, product code MEC. It is intended for use in the critical care areas of the hospital clinical setting, disinfecting Spaulding category low-risk hand-held re-useable medical devices. Devices must be first pre-cleaned or free of visible bioburden.
Restec Solutions LLC
0002
In Commercial Distribution

  • 00860009496903 ()
SONO-0002

  • Atomized-chemical device disinfector
High Level Disinfection System
NANOSONICS LIMITED
N05000-1
In Commercial Distribution

  • 09350855000184 ()
  • 09350855000191 ()


  • Atomized-chemical device disinfector
Trophon US Refurbished
NANOSONICS LIMITED
N00010-US-RFB
In Commercial Distribution

  • 09350855000139 ()
  • 09350855000122 ()


  • Atomized-chemical device disinfector
Trophon EPR Nth America AHECC 8419.20.00 (NNA VARIANT)
NANOSONICS LIMITED
N00010-NNA
In Commercial Distribution

  • 09350855000115 ()
  • 09350855000016 ()


  • Atomized-chemical device disinfector
Trophon EPR USA Variant AHECC 8419.20.00 (GE VARIANT)
NANOSONICS LIMITED
N00010-US
In Commercial Distribution

  • 09350855000108 ()
  • 09350855000009 ()


  • Atomized-chemical device disinfector
PLATE DRY CLI GRAM+ ID AUTO A semi-quantitative test intended for the automated identification of Gram positive bacterial isolates based on biochemical reactions. Used in a diagnostic workflow to aid clinicians in determining potential treatment options for patients suspected of having a microbial infection, the device requires an automated system to produce a result and requires a pure, agar grown culture. This device is for professional use only and is not a companion diagnostic.
REMEL, INC.
GPID
In Commercial Distribution

  • 00848838074363 ()


  • Multiple aerobic gram positive bacteria species culture isolate identification IVD, kit
PLATE DRY CLI GRAM+ ID AUTO -A semi-quantitative test intended for the automated identification of Gram negative bacterial isolates based on biochemical reactions. Used in a diagnostic workflow to aid clinicians in determining potential treatment options for patients suspected of having a microbial infection, the device requires an automated system to produce a result and requires a pure, agar grown culture. This device is for professional use only and is not a companion diagnostic.
REMEL, INC.
GNID
In Commercial Distribution

  • 00848838074325 ()


  • Multiple aerobic gram positive bacteria species culture isolate identification IVD, kit
Codebook Crystal Rgp Manual
BECTON, DICKINSON AND COMPANY
245041
Not in Commercial Distribution

  • 00382902450412 ()
245041

  • Microorganism identification analyser IVD, manual
Codebook Crystal Gram-Positive Manual
BECTON, DICKINSON AND COMPANY
245037
Not in Commercial Distribution

  • 00382902450375 ()
245037

  • Microorganism identification analyser IVD, manual
BD BBL™ CRYSTAL™ Identification Systems Enteric / Nonfermenter
BECTON, DICKINSON AND COMPANY
245002
Not in Commercial Distribution

  • 00382902450023 ()
245002

  • Microorganism identification analyser IVD, manual
No Description
OXOID LIMITED
MB1588A
In Commercial Distribution

  • 05032384128013 ()


  • Multiple bacteria species culture isolate identification control IVD, kit
No Description
OXOID LIMITED
MB1561A
In Commercial Distribution

  • 05032384128006 ()


  • Multiple bacteria species culture isolate identification control IVD, kit
No Description
OXOID LIMITED
MB1133A
In Commercial Distribution

  • 05032384127979 ()


  • Multiple bacteria species culture isolate identification control IVD, kit
No Description
OXOID LIMITED
MB1132A
In Commercial Distribution

  • 05032384127962 ()


  • Multiple bacteria species culture isolate identification control IVD, kit
No Description
OXOID LIMITED
MB1131A
In Commercial Distribution

  • 05032384127955 ()


  • Multiple bacteria species culture isolate identification control IVD, kit
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