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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Crown Cutter SOFTY-longlife CA
DFS - DIAMON GmbH
51145
In Commercial Distribution

  • 04057176149428 ()


  • Diamond dental bur, reusable
Crown Cutter SOFTY-longlife CA
DFS - DIAMON GmbH
51143
In Commercial Distribution

  • 04057176149381 ()


  • Diamond dental bur, reusable
Crown Cutter SOFTY-longlife CA
DFS - DIAMON GmbH
51141
In Commercial Distribution

  • 04057176149374 ()


  • Diamond dental bur, reusable
Carbide bone cutter CA
DFS - DIAMON GmbH
111414
In Commercial Distribution

  • 04057176149053 ()
  • 04057176149060 ()


  • Carbide dental bur, reusable
Carbide CA bone cutter
DFS - DIAMON GmbH
111513
In Commercial Distribution

  • 04057176148711 ()
  • 04057176148728 ()


  • Carbide dental bur, reusable
UPORAL D flame CA
DFS - DIAMON GmbH
801990
In Commercial Distribution

  • 04057176147370 ()


  • Dental polishing brush
UPORAL D cup CA
DFS - DIAMON GmbH
801980
In Commercial Distribution

  • 04057176147349 ()


  • Dental polishing brush
UPORAL C cup CA
DFS - DIAMON GmbH
80094
In Commercial Distribution

  • 04057176147165 ()


  • Dental polishing brush
UPORAL C wheel CA
DFS - DIAMON GmbH
80093
In Commercial Distribution

  • 04057176147158 ()


  • Dental polishing brush
DreamStation BiPAP autoSV, CA
Respironics, Inc.
DreamStation BiPAP autoSV, CA
In Commercial Distribution

  • 00606959040540 ()
CAX900S12

  • Portable electric ventilator
Maxima ELITE Electric CA
HENRY SCHEIN, INC.
1125681
In Commercial Distribution

  • 00304040058015 ()
1125681

  • Dental power tool converter attachment, rotary
E-Type Reduction CA Sheath
HENRY SCHEIN, INC.
1026953
In Commercial Distribution

  • 00304040057827 ()
1026953

  • Dental power tool system handpiece, pneumatic
Controller/Transport/ Excel Ca
Tridien Medical
ExcelCare Transport
In Commercial Distribution

  • 00841965101216 ()
23-SMMIL3TPHR06

  • Low-air-loss bed
Controller/Transport/ Excel Ca
Tridien Medical
ExcelCare Transport
In Commercial Distribution

  • 00841965101209 ()
23-SMMIL3TPHR02

  • Low-air-loss bed
Controller/Transport/ Excel Ca
Tridien Medical
ExcelCare Transport
In Commercial Distribution

  • 00841965101193 ()
23-SMMIL3TPHR01

  • Low-air-loss bed
BiPAP A40 Pro, CA
Respironics, Inc.
CAX3100S12
In Commercial Distribution

  • 00606959059405 ()
CAX3100S12

  • Portable electric ventilator
PROVIDENCE CA LAP CHOLE
MEDLINE INDUSTRIES, INC.
DYNJ35090I
In Commercial Distribution

  • 40195327358632 ()
  • 10195327358631 ()
DYNJ35090I

  • General surgical procedure kit, non-medicated, single-use
PROVIDENCE CA MINOR PACK-LF
MEDLINE INDUSTRIES, INC.
DYNJ35372G
In Commercial Distribution

  • 10193489332957 ()
DYNJ35372G

  • General surgical procedure kit, non-medicated, single-use
PROVIDENCE CA LAP CHOLE-LF
MEDLINE INDUSTRIES, INC.
DYNJ35090D
In Commercial Distribution

  • 10193489332940 ()
DYNJ35090D

  • General surgical procedure kit, non-medicated, single-use
PROVIDENCE CA MINOR PACK-LF
MEDLINE INDUSTRIES, INC.
DYNJ35372F
In Commercial Distribution

  • 10889942257003 ()
DYNJ35372F

  • General surgical procedure kit, non-medicated, single-use
PROVIDENCE CA LAP CHOLE-LF
MEDLINE INDUSTRIES, INC.
DYNJ35090C
In Commercial Distribution

  • 40889942256335 ()
  • 10889942256334 ()
DYNJ35090C

  • General surgical procedure kit, non-medicated, reusable
PROVIDENCE CA LAP CHOLE-LF
MEDLINE INDUSTRIES, INC.
DYNJ35090G
In Commercial Distribution

  • 40195327068524 ()
  • 10195327068523 ()
DYNJ35090G

  • General surgical procedure kit, non-medicated, single-use
USB,AUDIGY 2.1,CA
Gn Hearing A/S
20813321
In Commercial Distribution

  • 05708296099818 ()


  • Audiometric/hearing device software
USB,AUDIGY 2.4,CA
Gn Hearing A/S
21122700
In Commercial Distribution

  • 05708296169825 ()


  • Audiometric/hearing device software
USB,AUDIGY2.5#1,CA
Gn Hearing A/S
21381800
In Commercial Distribution

  • 05708296189342 ()


  • Audiometric/hearing device software
USB,AUDIGY 2.5,CA
Gn Hearing A/S
21316225
In Commercial Distribution

  • 05708296184811 ()


  • Audiometric/hearing device software
USB,AUDIGY2.6#1,CA
Gn Hearing A/S
21570900
In Commercial Distribution

  • 05708296195145 ()


  • Audiometric/hearing device software
USB,AUDIGY 2.6,CA
Gn Hearing A/S
21451200
In Commercial Distribution

  • 05708296191918 ()


  • Audiometric/hearing device software
USB,AUDIGY 2.8,CA
Gn Hearing A/S
21611628
In Commercial Distribution

  • 05708296198177 ()


  • Audiometric/hearing device software
USB,AUDIGY 2.7,CA
Gn Hearing A/S
21658027
In Commercial Distribution

  • 05708296208319 ()


  • Audiometric/hearing device software
PROVIDENCE CA MINOR PACK-LF
MEDLINE INDUSTRIES, INC.
DYNJ35372I
In Commercial Distribution

  • 10193489816990 ()
  • 40193489816991 ()
DYNJ35372I

  • General surgical procedure kit, non-medicated, single-use
PROVIDENCE CA LAP CHOLE-LF
MEDLINE INDUSTRIES, INC.
DYNJ35090F
In Commercial Distribution

  • 10193489816976 ()
  • 40193489816977 ()
DYNJ35090F

  • General surgical procedure kit, non-medicated, single-use
PROVIDENCE CA MINOR PACK-LF
MEDLINE INDUSTRIES, INC.
DYNJ35372J
In Commercial Distribution

  • 40195327101719 ()
  • 10195327101718 ()
DYNJ35372J

  • General surgical procedure kit, non-medicated, single-use
S1-500, CA, 1600, N3P-G2DY30M
Amico Clinical Solutions Corp
iCE30m
In Commercial Distribution

  • 00684706008326 ()
C15S73

  • Operating room light
CONN.TUBE,14'*,50/CA
TRI-ANIM HEALTH SERVICES, INC.
301-142
In Commercial Distribution

  • 00818834021937 ()
  • 00818834020855 ()
301-142

  • Oxygen administration tubing
CA GREENIE MINI-PT HG
SHOFU DENTAL CORPORATION
H404
In Commercial Distribution

  • E235H4040 ()
H404

  • Dental abrasive point, reusable
CA BROWNIE MINI-PT HG
SHOFU DENTAL CORPORATION
H403
In Commercial Distribution

  • E235H4030 ()
H403

  • Dental abrasive point, reusable
CA GREENIE CUP HG
SHOFU DENTAL CORPORATION
H402
In Commercial Distribution

  • E235H4020 ()
H402

  • Dental abrasive point, reusable
CA BROWNIE CUP HG
SHOFU DENTAL CORPORATION
H401
In Commercial Distribution

  • E235H4010 ()
H401

  • Dental abrasive point, reusable
Broken 4.0 CA Trephine
Acumed LLC
80-0215
In Commercial Distribution

  • 10806378040559 ()


  • General internal orthopaedic fixation system implantation kit
E1/CG-ARM/SFT/CA
BSN-Jobst GmbH
77330-00064-00
In Commercial Distribution

  • 04019702585711 ()

  • Pressure 15-21 mmHg


  • Compression/pressure sock/stocking, reusable
IRISpec CA/CB Twinset
IRIS INTERNATIONAL, INC.
CA/CB Twinset
Not in Commercial Distribution

  • 10837461001973 ()
800-7211

  • Multiple urine analyte IVD, control
E2/CG1/NOP2,5-T-ZI/CA
BSN-Jobst GmbH
77559-00030-00
In Commercial Distribution

  • 04019702288353 ()

  • Pressure 23-32 mmHg


  • Compression/pressure sock/stocking, reusable
E1/AH/BS-V-WOF-WT/CA
BSN-Jobst GmbH
77329-00045-00
In Commercial Distribution

  • 04019702298178 ()

  • PRESSURE 15-21 MMHG


  • Compression/pressure sock/stocking, reusable
E1/CG1/NOP-I-ZI/CA
BSN-Jobst GmbH
77331-00019-00
In Commercial Distribution

  • 04019702300598 ()

  • Pressure 15-21 mmHg


  • Compression/pressure sock/stocking, reusable
CA IMPLANTOLOGY DEPTH STOP
ETABLISSEMENTS ANTHOGYR
10401X
In Commercial Distribution

  • 03663394010894 ()


  • Dental power tool handpiece motorless component
IMPLANTOLOGY CA WITH LIGHT
ETABLISSEMENTS ANTHOGYR
10400XL
In Commercial Distribution

  • 03663394169929 ()


  • Dental power tool handpiece motorless component
ARCHITECT CA 15-3 Controls
Abbott GmbH
02K4411
In Commercial Distribution

  • 00380740145309 ()
02K4411

  • Cancer antigen 15-3 (CA15-3) IVD, control
ARCHITECT CA 15-3 Calibrators
Abbott GmbH
02K4402
In Commercial Distribution

  • 00380740145293 ()
02K4402

  • Cancer antigen 15-3 (CA15-3) IVD, calibrator
NOMAD Pro 2, CA
Dental Imaging Technologies Corporation
1.013.7788
In Commercial Distribution



  • Diagnostic x-ray system generator, hand-held
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