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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UPORAL D cup small CA
DFS - DIAMON GmbH
802010
In Commercial Distribution

  • 04057176161079 ()


  • Dental polishing brush
Carbide bone cutter CA L
DFS - DIAMON GmbH
111200
In Commercial Distribution

  • 04057176148483 ()
  • 04057176148490 ()


  • Carbide dental bur, reusable
Bone Cutter type 168 CA
DFS - DIAMON GmbH
111684
In Commercial Distribution

  • 04057176148261 ()
  • 04057176148278 ()


  • Steel dental bur, reusable
Bone Cutter type 167 CA
DFS - DIAMON GmbH
111674
In Commercial Distribution

  • 04057176148223 ()
  • 04057176148230 ()


  • Steel dental bur, reusable
Bone Cutter type 166 CA
DFS - DIAMON GmbH
111664
In Commercial Distribution

  • 04057176148186 ()
  • 04057176148193 ()


  • Steel dental bur, reusable
Bone Cutter type 165 CA
DFS - DIAMON GmbH
111654
In Commercial Distribution

  • 04057176148148 ()
  • 04057176148155 ()


  • Steel dental bur, reusable
Bone Cutter type 164 CA
DFS - DIAMON GmbH
111644
In Commercial Distribution

  • 04057176148100 ()
  • 04057176148117 ()


  • Steel dental bur, reusable
Bone Cutter type 163 CA
DFS - DIAMON GmbH
111634
In Commercial Distribution

  • 04057176148063 ()
  • 04057176148070 ()


  • Steel dental bur, reusable
Bone Cutter type 162 CA
DFS - DIAMON GmbH
111624
In Commercial Distribution

  • 04057176148025 ()
  • 04057176148032 ()


  • Steel dental bur, reusable
Bone Cutter type 161 CA
DFS - DIAMON GmbH
111614
In Commercial Distribution

  • 04057176147967 ()
  • 04057176147974 ()


  • Steel dental bur, reusable
O1/AD/OT/SFT/CA
BSN-Jobst GmbH
73539-00039-00
In Commercial Distribution

  • 04019702237467 ()

  • PRESSURE 18-21 MMHG


  • Compression/pressure sock/stocking, reusable
O1/AG/OT/FBIJ/CA
BSN-Jobst GmbH
73541-00020-00
In Commercial Distribution

  • 04019702237368 ()

  • Pressure 18-21 mmHg


  • Compression/pressure sock/stocking, reusable
O1/AF/OT/SOF/CA
BSN-Jobst GmbH
73540-00030-00
In Commercial Distribution

  • 04019702237108 ()

  • Pressure 18-21 mmHg


  • Compression/pressure sock/stocking, reusable
O2/AT/CT/FFM/CA
BSN-Jobst GmbH
73550-00015-00
In Commercial Distribution

  • 04019702243338 ()

  • Pressure 23-32 mmHg


  • Compression/pressure sock/stocking, reusable
O2/AT/OT/FFM-WB2,5/CA
BSN-Jobst GmbH
73550-00100-00
In Commercial Distribution

  • 04019702242812 ()

  • Pressure 23-32 mmHg


  • Compression/pressure sock/stocking, reusable
E2/AE/WOF-WT/OH/CA
BSN-Jobst GmbH
77359-00053-00
In Commercial Distribution

  • 04019702303421 ()

  • PRESSURE 23-32 MMHG


  • Compression/pressure sock/stocking, reusable
E1/AG1/WOF-WT/NOP2,5-T/CA
BSN-Jobst GmbH
77328-00053-00
In Commercial Distribution

  • 04019702299502 ()

  • Pressure 15-21 mmHg


  • Compression/pressure sock/stocking, reusable
CA 15-3 - CENTAUR - CAL - 2x2x2mL
Siemens Healthcare Diagnostics Inc.
10329796
In Commercial Distribution

  • 00630414461359 ()
128538

  • Cancer antigen 15-3 (CA15-3) IVD, calibrator
CA 125 CVM - IMMULITE - CONS
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
10373698
In Commercial Distribution

  • 00630414971308 ()
LOPCVM

  • Cancer antigen 125 (CA125) IVD, control
HYDROVEN 3 PUMP USA/CA
HUNTLEIGH HEALTHCARE LIMITED
510003
In Commercial Distribution

  • 05051968031907 ()
510003

  • Sequential venous compression system
MTO RHK CA PACIFIC MED
MEDLINE INDUSTRIES, INC.
63160615
In Commercial Distribution

  • 20193489085959 ()
  • 10193489085952 ()
63160615

  • Angiography kit
KENDALL 18X5 ULTRAMER 2-WAY CA
Cardinal Health 200, LLC
1619
In Commercial Distribution

  • 20192253026150 ()
  • 10192253026153 ()
  • 50192253026151 ()
1619

  • Indwelling urethral drainage balloon catheter, non-antimicrobial
"ASSY, CA, HANDSWITCH, EXTENDED (85276549)"
BAYER MEDICAL CARE INC.
ART 700 HS12
In Commercial Distribution

  • 00616258009384 ()
ART 700 HS12

  • Contrast medium injection system hand controller kit
"ASSY, CA, HAND SWITCH (85276522)"
BAYER MEDICAL CARE INC.
ART 700 HS6
In Commercial Distribution

  • 00616258009377 ()
ART 700 HS6

  • Contrast medium injection system hand controller kit
CA CAL S 3.0X3 (GCL-100A)
SYSMEX CORPORATION
01412714
In Commercial Distribution

  • 04987562205936 ()
  • 84987562205932 ()


  • Multiple coagulation factor IVD, calibrator
H.E.L.P. ACETATPUFFER HOT US / CA
B.Braun Avitum AG
4469
Not in Commercial Distribution

  • 04046964156731 ()
  • 04046964156724 ()

  • Volume : 4000.000 ML
  • Acidity (pH) : 4.850 PH
  • Acetic acid 99% : 6.820 GLI
  • Sodium acetate x 3 H2O : 27.220 GLI
4469

  • Apheresis kit
DVD,FSW,AUDIGY 2.1,CA
Gn Hearing A/S
20816721
In Commercial Distribution

  • 05708296099832 ()


  • Audiometric/hearing device software
3X15" REUSABLE IV ARMBOARD, CA
MORRISON MEDICAL, LTD
1041S-50
In Commercial Distribution

  • 00647921104167 ()
  • 00647921104181 ()
1041S-50

  • Armboard, reusable
Roth .022 NHK CA LRGTRAY
World Class Technology Corporation
905.2034-LRGTRAY
In Commercial Distribution

  • 00840273916758 ()
905.2034-LRGTRAY

  • Orthodontic bracket, metal
Roth .018 NHK CA LRGTRAY
World Class Technology Corporation
905.1034-LRGTRAY
In Commercial Distribution

  • 00840273915881 ()
905.1034-LRGTRAY

  • Orthodontic bracket, metal
VITROS Chemistry Products Ca Slides
ORTHO-CLINICAL DIAGNOSTICS, INC.
1450261
In Commercial Distribution

  • 10758750009114 ()
  • 20758750009111 ()
1450261

  • Calcium (Ca2+) IVD, reagent
MASK,OXY,ADL 50/CA
TRI-ANIM HEALTH SERVICES, INC.
301-180MO
In Commercial Distribution

  • 00818834022019 ()
  • 00818834020930 ()
301-180MO

  • Rebreathing oxygen face mask
LHK, CA, ST. MARY'S HOSPITAL
MEDLINE INDUSTRIES, INC.
VASC1479B
In Commercial Distribution

  • 40195327673575 ()
  • 10195327673574 ()
VASC1479B

  • General surgical procedure kit, non-medicated, single-use
LHK, CA, SUNNYBROOK HLTH MANIF
MEDLINE INDUSTRIES, INC.
VASC1512
In Commercial Distribution

  • 40195327697670 ()
  • 10195327697679 ()
VASC1512

  • General surgical procedure kit, non-medicated, single-use
LHK, CA, ST. MARY'S HOSPITAL
MEDLINE INDUSTRIES, INC.
VASC1479
In Commercial Distribution

  • 40195327569922 ()
  • 10195327569921 ()
VASC1479

  • General surgical procedure kit, non-medicated, single-use
LHK, CA, ST. MARY'S HOSPITAL
MEDLINE INDUSTRIES, INC.
VASC1479A
In Commercial Distribution

  • 40195327609864 ()
  • 10195327609863 ()
VASC1479A

  • General surgical procedure kit, non-medicated, single-use
Gs/Gw Drive-Lock CA Short
INTRA-LOCK INTERNATIONAL, INC.
SDLCAS
In Commercial Distribution

  • D742SDLCAS0 ()
SDLCAS

  • Dental implant system
PRO TECHNOLOGY PUMP - US/CA
JOERNS HEALTHCARE, LLC
PMP-CU-01
In Commercial Distribution

  • 00810055880430 ()


  • Alternating-pressure bed mattress overlay system
Menu CA Cutoff +50%, 50mL
BIOCHEMICAL DIAGNOSTICS INC
18008464
In Commercial Distribution

  • 00810042683358 ()
18008464

  • Multiple drugs of abuse IVD, control
Menu CA Cutoff -50%, 50mL
BIOCHEMICAL DIAGNOSTICS INC
18008463
In Commercial Distribution

  • 00810042683334 ()
18008463

  • Multiple drugs of abuse IVD, control
HBSS, NO CA, NO MG
DIAGNOSTIC HYBRIDS, INC.
10-120500
In Commercial Distribution

  • 30014613331124 ()
10-120500

  • Cell culture medium IVD
HBSS, NO CA, NO MG
DIAGNOSTIC HYBRIDS, INC.
10-120100
In Commercial Distribution

  • 30014613331117 ()
10-120100

  • Cell culture medium IVD
CA 15-3, Clone DBMM1, 10ml
Slmp, LLC
(BTO) CA 15-3 (DBMM1) Antibody (10ml)
In Commercial Distribution

  • 00810170550522 ()
MM12-10

  • Cancer antigen 15-3 (CA15-3) IVD, antibody
KaVo NOMAD Pro 2, CA
Dental Imaging Technologies Corporation
1.013.7788
Not in Commercial Distribution

  • EKAV101377880 ()


  • Diagnostic x-ray system generator, hand-held
HUB CD320 CMDR FLEX - CA
Medtronic Care Management Services, LLC
101001-002
In Commercial Distribution

  • 00763000286989 ()


  • Multiple physiological parameter spot-check system, home-use
5R200 Mirror Magic 100/ca
DEROYAL INDUSTRIES, INC.
28-ZIRC
In Commercial Distribution

  • 50749756851928 ()
  • 00749756851923 ()


  • Endoscope antifog solution
AccuThrive #15 Surgical Blade SS MicroCoat Sterile 500BL/CA (100BL/CT 5CT/CA)
AccuTec, Inc.
Scalpel Blade
In Commercial Distribution

  • 10843382104259 ()
  • 00843382104252 ()
AVBL-1031-0000

  • Manual scalpel blade, single-use
AccuThrive #10 Surgical Blade SS MicroCoat Sterile 500BL/CA (100BL/CT 5CT/CA)
AccuTec, Inc.
Scalpel Blade
In Commercial Distribution

  • 10843382104235 ()
  • 00843382104238 ()
AVBL-1001-0000

  • Manual scalpel blade, single-use
AccuThrive #21 Surgical Blade SS Microcoat Sterile 500BL/CA (100BL/CT 5CT/CA)
AccuTec, Inc.
Scalpel Blade
In Commercial Distribution

  • 10843382105379 ()
  • 00843382105372 ()
AVBL-1061-0000

  • Manual scalpel blade, single-use
AccuThrive #23 Surgical Blade SS Microcoat Sterile 500BL/CA (100BL/CT 5CT/CA)
AccuTec, Inc.
Scalpel Blade
In Commercial Distribution

  • 10843382105225 ()
  • 00843382105228 ()
AVBL-1081-0000

  • Manual scalpel blade, single-use
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