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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HIGH FLOW START KIT,7'*,10/CA
BOUND TREE MEDICAL, LLC
P3052EA
In Commercial Distribution

  • 00810071638015 ()
  • 00810071637292 ()
301-P3052EA

  • Non-heated respiratory humidifier
MASK,TRACH,ADULT,CURAPLEX,SPU,50/CA
BOUND TREE MEDICAL, LLC
301-184
In Commercial Distribution

  • 00810071630880 ()
  • 00810071631283 ()
301-184

  • Tracheostomy mask, oxygen
TEE,AEROSOL,22MX22MX15F 50/BG 100/CA
BOUND TREE MEDICAL, LLC
301-160EA
In Commercial Distribution

  • 00810071630767 ()
  • 00810071631160 ()
301-160EA

  • Non-rebreathing valve, single-use
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
Gs/Gw Drive Lock CA Long Wide
INTRA-LOCK INTERNATIONAL, INC.
SDLCALW
In Commercial Distribution

  • D742SDLCALW0 ()
SDLCALW

  • Dental implant system
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
Personal Use Kit OC-Auto, for Mather, CA
POLYMEDCO CANCER DIAGNOSTIC PRODUCTS LLC
OCPU-VA1 213264
In Commercial Distribution

  • 00816917021706 ()


  • Faecal occult blood IVD, reagent
E-Type K-Style CA 1:1 Latch Chuck
SIRONA Dental Systems GmbH
710430
In Commercial Distribution

  • E2767104300 ()


  • Dental power tool handpiece motorless component
227203 @VAPR WEDGE ELTD, W/INTEGRATED CA
MEDLINE INDUSTRIES, INC.
227203RH
In Commercial Distribution

  • 10888277386846 ()
227203RH

  • Endoscopic electrosurgical handpiece/electrode, bipolar, reprocessed
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
No Description
Roche Diagnostics GmbH
07027028190
Not in Commercial Distribution

  • 04015630939640 ()
07027028190

  • Cancer antigen 19-9 (CA19-9) IVD, kit, chemiluminescent immunoassay
Calcium Reagent Kit for use with EasyRA Analyzers
MEDICA CORPORATION
10210-4
In Commercial Distribution

  • 00386100002060 ()
10210-4

  • Calcium (Ca2+) IVD, kit, spectrophotometry
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
Tricalcium silicate-based cement for contact with vital pulp and periradicular tissues. This cement is supplied as a powder and gel for mixing prior to use. Cement is radiopaque.
Avalon Biomed Inc.
MN050
In Commercial Distribution

  • 00857570006167 ()

  • Weight: 0.5 Gram


  • Endodontic filling/sealing material
  • Dental pulp-capping material
Tricalcium silicate-based cement for contact with vital pulp and periradicular tissues. This cement is supplied as a powder and gel for mixing prior to use. Cement is radiopaque.
Avalon Biomed Inc.
MN200
In Commercial Distribution

  • 00857570006150 ()

  • Weight: 2.0 Gram


  • Dental pulp-capping material
  • Endodontic filling/sealing material
Tricalcium silicate-based cement for contact with vital pulp and periradicular tissues. This cement is supplied as a powder and gel for mixing prior to use. Cement is radiopaque.
Avalon Biomed Inc.
MN100
In Commercial Distribution

  • 00857570006143 ()

  • Weight: 1.0 Gram


  • Endodontic filling/sealing material
  • Dental pulp-capping material
Tricalcium silicate-based cement for contact with vital pulp and periradicular tissues. This cement is supplied as a powder and gel for mixing prior to use. Cement is radiopaque.
Avalon Biomed Inc.
MG200
In Commercial Distribution

  • 00857570006136 ()

  • Weight: 2.0 Gram


  • Dental pulp-capping material
  • Endodontic filling/sealing material
Tricalcium silicate-based cement for contact with vital pulp and periradicular tissues. This cement is supplied as a powder and gel for mixing prior to use. Cement is radiopaque.
Avalon Biomed Inc.
MG100
In Commercial Distribution

  • 00857570006129 ()

  • Weight: 1.0 Gram


  • Endodontic filling/sealing material
  • Dental pulp-capping material
Tricalcium silicate-based cement for contact with vital pulp and periradicular tissues. This cement is supplied as a powder and gel for mixing prior to use. Cement is radiopaque.
Avalon Biomed Inc.
N700
In Commercial Distribution

  • 00857570006112 ()

  • Weight: 7.0 Gram


  • Dental pulp-capping material
  • Endodontic filling/sealing material
Tricalcium silicate-based cement for contact with vital pulp and periradicular tissues. This cement is supplied as a powder and gel for mixing prior to use. Cement is radiopaque.
Avalon Biomed Inc.
N600
In Commercial Distribution

  • 00857570006105 ()

  • Weight: 6.0 Gram


  • Endodontic filling/sealing material
  • Dental pulp-capping material
Tricalcium silicate-based cement for contact with vital pulp and periradicular tissues. This cement is supplied as a powder and gel for mixing prior to use. Cement is radiopaque.
Avalon Biomed Inc.
N250
In Commercial Distribution

  • 00857570006099 ()

  • Weight: 2.5 Gram


  • Dental pulp-capping material
  • Endodontic filling/sealing material
Tricalcium silicate-based cement for contact with vital pulp and periradicular tissues. This cement is supplied as a powder and gel for mixing prior to use. Cement is radiopaque.
Avalon Biomed Inc.
N200
In Commercial Distribution

  • 00857570006082 ()

  • Weight: 2.0 Gram


  • Endodontic filling/sealing material
  • Dental pulp-capping material
Tricalcium silicate-based cement for contact with vital pulp and periradicular tissues. This cement is supplied as a powder and gel for mixing prior to use. Cement is radiopaque.
Avalon Biomed Inc.
N100
In Commercial Distribution

  • 00857570006075 ()

  • Weight: 1.0 Gram


  • Dental pulp-capping material
  • Endodontic filling/sealing material
Tricalcium silicate-based cement for contact with vital pulp and periradicular tissues. This cement is supplied as a powder and gel for mixing prior to use. Cement is radiopaque.
Avalon Biomed Inc.
N050
In Commercial Distribution

  • 00857570006068 ()

  • Weight: 0.5 Gram


  • Endodontic filling/sealing material
  • Dental pulp-capping material
Tricalcium silicate-based cement for contact with vital pulp and periradicular tissues. This cement is supplied as a powder and gel for mixing prior to use. Cement is radiopaque.
Avalon Biomed Inc.
G800
In Commercial Distribution

  • 00857570006051 ()

  • Weight: 8.0 Gram


  • Dental pulp-capping material
  • Endodontic filling/sealing material
Tricalcium silicate-based cement for contact with vital pulp and periradicular tissues. This cement is supplied as a powder and gel for mixing prior to use. Cement is radiopaque.
Avalon Biomed Inc.
G600
In Commercial Distribution

  • 00857570006044 ()

  • Weight: 6.0 Gram


  • Endodontic filling/sealing material
  • Dental pulp-capping material
Tricalcium silicate-based cement for contact with vital pulp and periradicular tissues. This cement is supplied as a powder and gel for mixing prior to use. Cement is radiopaque.
Avalon Biomed Inc.
G200
In Commercial Distribution

  • 00857570006020 ()

  • Weight: 2.0 Gram


  • Endodontic filling/sealing material
  • Dental pulp-capping material
S3 300DT 3x Sgl CA 1xDual CA 1300 1150 1000 1300 2x LCH 3P 1x9P LCH 1x Sgl MH
Amico Clinical Solutions Corp
iCE30m
In Commercial Distribution

  • 00684706003741 ()
C33SDS54354614

  • Operating room light
S3 300DT 2x Sgl 1x Dual CA 2x 1300 1150 1000 CA 3P 30M 9P 30M 2x Barco Monitor
Amico Clinical Solutions Corp
iCE30m
In Commercial Distribution

  • 00684706006438 ()
C33SDS554335KK

  • Operating room light
STAPLE 8698504 CDH M8 DUAL ROD LG CA
MEDTRONIC SOFAMOR DANEK, INC.
8698504
In Commercial Distribution

  • 00681490902700 ()

  • 25mm


  • Bone-screw internal spinal fixation system rod
STAPLE 8698502 CDH M8 DUAL ROD MD CA
MEDTRONIC SOFAMOR DANEK, INC.
8698502
In Commercial Distribution

  • 00681490902687 ()

  • 23mm


  • Bone-screw internal spinal fixation system rod
STAPLE 8698500 CDH M8 DUAL ROD SM CA
MEDTRONIC SOFAMOR DANEK, INC.
8698500
In Commercial Distribution

  • 00681490902656 ()

  • Length: 21.0 Millimeter


  • Bone-screw internal spinal fixation system rod
1081 Madsen A450, ANSI Cal., HB-8, Earphone (CA)
Natus Medical Denmark ApS
8-04-14562-CA
In Commercial Distribution

  • 05713315009228 ()
8-04-14562-CA

  • Speech audiometer
S1 300DT Sgl CA 2250 9P DY SL-30M
Amico Clinical Solutions Corp
iCE30m
In Commercial Distribution

  • 00684706003383 ()
C13S95

  • Operating room light
S1 500DT SGL CA 1300 LCH 3P SL-30M
Amico Clinical Solutions Corp
iCE30m
In Commercial Distribution

  • 00684706003284 ()
C15S54

  • Operating room light
S3 300DT 2xSgl 1000,1150 CA 2x Sgl MH
Amico Clinical Solutions Corp
iCE30m
In Commercial Distribution

  • 00684706003161 ()
C33BSS3411

  • Operating room light
S1 300DT Sgl CA 1000mm LCH 3P SL-30M
Amico Clinical Solutions Corp
iCE30M
In Commercial Distribution

  • 00684706001730 ()
C13S34

  • Operating room light
Series 1, 200 DT, Dual CA, 1000mm, 850mm
Amico Clinical Solutions Corp
iCE30m
In Commercial Distribution

  • 00684706009323 ()
C12D32V3

  • Operating room light
S1 500DT Single CA 2250 LCH 9P 30M
Amico Clinical Solutions Corp
iCE30m
In Commercial Distribution

  • 00684706006902 ()
C15S96

  • Operating room light
S1 500DT Sgl CA 2250 9P DY 30M
Amico Clinical Solutions Corp
iCE30m
In Commercial Distribution

  • 00684706006896 ()
C15S95

  • Operating room light
S1 300DT Sgl CA 8500 3P DY 30M
Amico Clinical Solutions Corp
iCE30m
In Commercial Distribution

  • 00684706006889 ()
C13S23

  • Operating room light
S1 200DT Sgl CA 850 LCH 3P 30M
Amico Clinical Solutions Corp
iCE30m
In Commercial Distribution

  • 00684706006773 ()
C12S24

  • Operating room light
Series 1 200DT Sgl CA 1150mm 3P SL-30M
Amico Clinical Solutions Corp
iCE30m
In Commercial Distribution

  • 00684706003604 ()
C12S43

  • Operating room light
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