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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PrimePlus Bariatric Bed, 750 lb. Wgt Ca
Drive Devilbiss Healthcare
P1752
Not in Commercial Distribution

  • 00822383550626 ()


  • Bariatric bed
TEE,AEROSOL,22MX22MX15F 50/BG 100/CA
TRI-ANIM HEALTH SERVICES, INC.
301-160EA
In Commercial Distribution

  • 00818834021432 ()
  • 00818834020893 ()
  • 00818834021975 ()
301-160EA

  • Oxygen administration tubing
E-Type K-Style CA 1:1 Latch Chuck
SIRONA Dental Systems GmbH
710430
In Commercial Distribution

  • E2767104300 ()


  • Dental power tool handpiece motorless component
EXTRA SHORT RETENTIVE CA DRIVER OUTLINK2-GLOBAL MOUNTER
SWEDEN & MARTINA SPA
E2-AVV3-MOUC-CA
In Commercial Distribution

  • D7701107403 ()
E2-AVV3-MOUC-CA

  • Dental implant/prosthesis surgical procedure kit
EASY MOUNTER PREMIUM ONE CA, SLEEVE 550
SWEDEN & MARTINA SPA
GS-EASY-AS-550-CA
In Commercial Distribution

  • D7701515563 ()
GS-EASY-AS-550-CA

  • Surgical screwdriver, reusable
EASY MOUNTER PREMIUM ONE CA, SLEEVE 415
SWEDEN & MARTINA SPA
GS-EASY-AS-415-CA
In Commercial Distribution

  • D7701515553 ()
GS-EASY-AS-415-CA

  • Surgical screwdriver, reusable
Gs/Gw Drive Lock CA Long Wide
INTRA-LOCK INTERNATIONAL, INC.
SDLCALW
In Commercial Distribution

  • D742SDLCALW0 ()
SDLCALW

  • Dental implant system
TAG-72/CA 72-4, Clone B72.3, 6ml (Manual)
Slmp, LLC
(BTO) Manual TAG-72/CA 72-4 (B72.3) Antibody (6ml)
In Commercial Distribution

  • 00810170550683 ()
MM137-6

  • Tumour-associated glycoprotein-72 (TAG72) IVD, antibody
CS7600 Imaging System for US, CA, Brazil
CARESTREAM HEALTH, INC.
CS 7600
In Commercial Distribution

  • 60889971068408 ()
1068402

  • Dental computed radiography digital imaging scanner
CA OF MI #11642 ILR IMPLANT PACK
DEROYAL INDUSTRIES, INC.
89-10714
In Commercial Distribution

  • 50749756374366 ()
  • 00749756374361 ()
89-10714

  • General surgical procedure kit, non-medicated, single-use
FOREFOOT/ MIDFOOT WIRES. DRILLS. & DRILL GUIDE CA
Smith & Nephew, Inc.
CSA-1001-10
In Commercial Distribution

  • 00885556839614 ()
CSA-1001-10

  • Instrument tray, reusable
KIT,HIMA TOTAL PBDS TOT HIP CA
Cardinal Health 200, LLC
PO30THHR8
In Commercial Distribution

  • 50197106124503 ()
  • 10197106124505 ()
PO30THHR8

  • Orthopaedic surgical procedure kit, medicated
25g x 7/8" Lasik Irrig Ca
STERIMEDIX LIMITED
M2822-02/10
In Commercial Distribution

  • 25056030400296 ()
  • 35056030400477 ()
M2822

  • Ophthalmic irrigation/infusion/aspiration cannula, non-illuminating, single-use
Calcium Reagent Kit for use with EasyRA Analyzers
MEDICA CORPORATION
10210-4
In Commercial Distribution

  • 00386100002060 ()
10210-4

  • Calcium (Ca2+) IVD, kit, spectrophotometry
No Description
Roche Diagnostics GmbH
07027028190
Not in Commercial Distribution

  • 04015630939640 ()
07027028190

  • Cancer antigen 19-9 (CA19-9) IVD, kit, chemiluminescent immunoassay
CA and HP are intended to transmit and apply the mechanical energy produced by a dental air or electric micromotor. They contain the gearing necessary for maintaining, increasing or reducing the micromotor's speed
Bien-Air Dental SA
1600632-001
In Commercial Distribution

  • J00716006320011 ()
1600632-001

  • Dental power tool system handpiece, remotely-driven
CA and HP are intended to transmit and apply the mechanical energy produced by a dental air or electric micromotor. They contain the gearing necessary for maintaining, increasing or reducing the micromotor's speed
Bien-Air Dental SA
1600425-001
In Commercial Distribution

  • J00716004250011 ()
1600425-001

  • Dental power tool system handpiece, remotely-driven
CA and HP are intended to transmit and apply the mechanical energy produced by a dental air or electric micromotor. They contain the gearing necessary for maintaining, increasing or reducing the micromotor's speed
Bien-Air Dental SA
1600424-001
In Commercial Distribution

  • J00716004240011 ()
1600424-001

  • Dental power tool system handpiece, remotely-driven
CA and HP are intended to transmit and apply the mechanical energy produced by a dental air or electric micromotor. They contain the gearing necessary for maintaining, increasing or reducing the micromotor's speed
Bien-Air Dental SA
1600325-001
In Commercial Distribution

  • J00716003250011 ()
1600325-001

  • Dental power tool system handpiece, remotely-driven
The product is applied to calibrate the sensitivity of LEDs used for blood coagulation analyzer.
SYSMEX CORPORATION
014-1271-4
In Commercial Distribution

  • 14987562516794 ()
  • 04987562516797 ()


  • Multiple coagulation factor IVD, calibrator
Series 3, 500 DT, Single CA,N/A, Single CA, 850mm, 850mm, Gen 2, Sgl M SA, MH
Amico Clinical Solutions Corp
iCE30m
In Commercial Distribution

  • 00684706007732 ()
C35SBS2211

  • Operating room light
S3,300DT,Sgl CA,Dl CA,SgCA,1300 1150 1000 1300, SgMH Sony,(N3P, DY,3PLH) Sg MH S
Amico Clinical Solutions Corp
iCE30m
In Commercial Distribution

  • 00684706007671 ()
C33SDS5435N33N

  • Operating room light
S3 Sgl CA Dual CA 1300,1150,1000 9P SA DY 30M 9P SA DY 30M 3P SA DY 30M
Amico Clinical Solutions Corp
iCE30m
In Commercial Distribution

  • 00684706001051 ()
C33SDB543535

  • Operating room light
Custom Canal 64
HEARING LAB TECHNOLOGY, LLC
CA 64
In Commercial Distribution

  • 00812944022846 ()
HLT-CUSCA-64

  • Air-conduction hearing aid, in-the-ear
Custom Canal PLD 32
HEARING LAB TECHNOLOGY, LLC
CA 32
In Commercial Distribution

  • 00812944022792 ()
GWP-AHICUSCA

  • Air-conduction hearing aid, in-the-ear
Custom Canal 64
HEARING LAB TECHNOLOGY, LLC
CA 64
In Commercial Distribution

  • 00812944023898 ()
HLT-CUSCA-64

  • Air-conduction hearing aid, in-the-ear
Custom Canal PLD 32
HEARING LAB TECHNOLOGY, LLC
CA 32
In Commercial Distribution

  • 00812944023881 ()
GWP-AHICUSCA

  • Air-conduction hearing aid, in-the-ear
Custom Canal PLD 32
HEARING LAB TECHNOLOGY, LLC
CA 32
Not in Commercial Distribution

  • 00812944020781 ()
GWP-AHICUSCA

  • Air-conduction hearing aid, in-the-ear
Custom Canal 64
HEARING LAB TECHNOLOGY, LLC
CA 64
Not in Commercial Distribution

  • 00812944020606 ()
HLT-CUSCA-64

  • Air-conduction hearing aid, in-the-ear
Custom Canal PLD 32
HEARING LAB TECHNOLOGY, LLC
CA 32
In Commercial Distribution

  • 00812944024895 ()
GWP-AHICUSCA

  • Air-conduction hearing aid, in-the-ear
Custom Canal PLD 32
HEARING LAB TECHNOLOGY, LLC
CA 32
In Commercial Distribution

  • 00812944025250 ()
GWP-AHICUSCA

  • Air-conduction hearing aid, in-the-ear
MANI DIA-BURS
MANI, INC.
FO-25 CA
In Commercial Distribution

  • 74546951609589 ()
  • 04546951609580 ()


  • Diamond dental bur, reusable
MANI DIA-BURS
MANI, INC.
SF-21 CA
In Commercial Distribution

  • 74546951608650 ()
  • 04546951608651 ()


  • Diamond dental bur, reusable
MANI DIA-BURS
MANI, INC.
SF-24 CA
In Commercial Distribution

  • 74546951608612 ()
  • 04546951608613 ()


  • Diamond dental bur, reusable
MANI DIA-BURS
MANI, INC.
SF-41 CA
In Commercial Distribution

  • 74546951608513 ()
  • 04546951608514 ()


  • Diamond dental bur, reusable
MANI DIA-BURS
MANI, INC.
SF-82 CA
In Commercial Distribution

  • 74546951608391 ()
  • 04546951608392 ()


  • Diamond dental bur, reusable
MANI DIA-BURS
MANI, INC.
SF-83 CA
In Commercial Distribution

  • 74546951608384 ()
  • 04546951608385 ()


  • Diamond dental bur, reusable
MANI DIA-BURS
MANI, INC.
SI-147 CA
In Commercial Distribution

  • 74546951608346 ()
  • 04546951608347 ()


  • Diamond dental bur, reusable
MANI DIA-BURS
MANI, INC.
SI-46 CA
In Commercial Distribution

  • 74546951608230 ()
  • 04546951608231 ()


  • Diamond dental bur, reusable
MANI DIA-BURS
MANI, INC.
SI-49 CA
In Commercial Distribution

  • 74546951608155 ()
  • 04546951608156 ()


  • Diamond dental bur, reusable
MANI DIA-BURS
MANI, INC.
SO-20 CA
In Commercial Distribution

  • 74546951608056 ()
  • 04546951608057 ()


  • Diamond dental bur, reusable
MANI DIA-BURS
MANI, INC.
SO-21 CA
In Commercial Distribution

  • 74546951608025 ()
  • 04546951608026 ()


  • Diamond dental bur, reusable
MANI DIA-BURS
MANI, INC.
TC-11 CA
In Commercial Distribution

  • 74546951607783 ()
  • 04546951607784 ()


  • Diamond dental bur, reusable
MANI DIA-BURS
MANI, INC.
TF-11 CA
In Commercial Distribution

  • 74546951607455 ()
  • 04546951607456 ()


  • Diamond dental bur, reusable
MANI DIA-BURS
MANI, INC.
TF-138 CA
In Commercial Distribution

  • 74546951607370 ()
  • 04546951607371 ()


  • Diamond dental bur, reusable
MANI DIA-BURS
MANI, INC.
TF-165 CA
In Commercial Distribution

  • 74546951607318 ()
  • 04546951607319 ()


  • Diamond dental bur, reusable
MANI DIA-BURS
MANI, INC.
TF-41 CA
In Commercial Distribution

  • 74546951607134 ()
  • 04546951607135 ()


  • Diamond dental bur, reusable
MANI DIA-BURS
MANI, INC.
WR-13 CA
In Commercial Distribution

  • 74546951606267 ()
  • 04546951606268 ()


  • Diamond dental bur, reusable
MANI DIA-BURS
MANI, INC.
BR-141 CA
In Commercial Distribution

  • 74546951611155 ()
  • 04546951611156 ()


  • Diamond dental bur, reusable
MANI DIA-BURS
MANI, INC.
BR-45 CA
In Commercial Distribution

  • 74546951610929 ()
  • 04546951610920 ()


  • Diamond dental bur, reusable
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