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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Blood storage refrigerator
B Medical Systems SARL
BR490G
In Commercial Distribution

  • 05450104495540 ()
991.6647.**

  • Blood refrigerator
Pharmacy refrigerator
B Medical Systems SARL
PR410G
In Commercial Distribution

  • 05450104494307 ()
991.6637.**

  • Pharmacy refrigerator
Laboratory refrigerator
B Medical Systems SARL
LR410G
In Commercial Distribution

  • 05450104494291 ()
991.6637.**

  • Laboratory refrigerator, basic
Blood storage refrigerator
B Medical Systems SARL
BR410G
In Commercial Distribution

  • 05450104494284 ()
991.6637.**

  • Blood refrigerator
Pharmacy refrigerator
B Medical Systems SARL
PR250G
In Commercial Distribution

  • 05450104493317 ()
991.6627.**

  • Pharmacy refrigerator
Laboratory refrigerator
B Medical Systems SARL
LR250G
In Commercial Distribution

  • 05450104493300 ()
991.6627.**

  • Laboratory refrigerator, basic
Blood storage refrigerator
B Medical Systems SARL
BR250G
In Commercial Distribution

  • 05450104493294 ()
991.6627.**

  • Blood refrigerator
Blood storage refrigerator
B Medical Systems SARL
MT100
In Commercial Distribution

  • 05450104061837 ()
991.2370.**

  • Blood refrigerator/incubator
No Description
NAKANISHI INC.
Perio Kit B
Not in Commercial Distribution

  • 04560264562660 ()


  • Ultrasonic dental scaling/debridement system handpiece tip, periodontal
No Description
KITAZATO CORPORATION
Cryotop US(B)
In Commercial Distribution

  • 14582231462923 ()
  • 04582231462926 ()
81174

  • Assisted reproduction vitrification carrier
No Description
W.H. Holden, Inc.
10-4535
In Commercial Distribution

  • D9281045350 ()


  • Dental elevator, tooth/root
No Description
EXACT SCIENCES CORPORATION
100310
In Commercial Distribution

  • 00858637005512 ()


  • Nucleic acid amplification mastermix kit IVD
CHANG Basal-450ml
FUJIFILM IRVINE SCIENTIFIC, INC.
C101-450mL
In Commercial Distribution

  • 00857515006108 ()

  • Total Volume: 450 Milliliter
C101

  • Amniotic fluid/chorionic villus sample (CVS) karyotype suspension IVD, reagent
Disposable single use prism for FMAT1 Device
FALCK MEDICAL INC
Prism B
In Commercial Distribution

  • 00867009000215 ()
  • 10867009000212 ()
  • 20867009000219 ()

  • Length: 35 Centimeter


  • Ophthalmic tonometer tip cover
No Description
LIGHTMED USA INC
US0000
In Commercial Distribution

  • 00853386006285 ()


  • Ophthalmic ultrasound imaging system
No Description
DIO Corporation
3DCNBF-1000D2
In Commercial Distribution

  • 08800049401538 ()


  • Dental prosthesis veneer resin
No Description
DIO Corporation
3DCNBF-1000C2
In Commercial Distribution

  • 08800049401521 ()


  • Dental prosthesis veneer resin
No Description
DIO Corporation
3DCNBF-1000B4
In Commercial Distribution

  • 08800049401514 ()


  • Dental prosthesis veneer resin
No Description
DIO Corporation
3DCNBF-1000B3
In Commercial Distribution

  • 08800049401507 ()


  • Dental prosthesis veneer resin
No Description
DIO Corporation
3DCNBF-1000B2
In Commercial Distribution

  • 08800049401491 ()


  • Dental prosthesis veneer resin
No Description
DIO Corporation
3DCNBF-1000A4
In Commercial Distribution

  • 08800049401484 ()


  • Dental prosthesis veneer resin
No Description
DIO Corporation
3DCNBF-1000A3.5
In Commercial Distribution

  • 08800049401477 ()


  • Dental prosthesis veneer resin
Accessories of LED Curing Light
Dentall co.,Ltd.
B&Lite S-Light Shield
In Commercial Distribution

  • 08800096902064 ()


  • Dental/surgical polymerization lamp
Accessories of LED Curing Light
Dentall co.,Ltd.
B&Lite S-Light probe
In Commercial Distribution

  • 08800096902057 ()


  • Dental/surgical polymerization lamp
Accessories of LED Curing Light
Dentall co.,Ltd.
B&Lite S-Battery pack
In Commercial Distribution

  • 08800096902040 ()


  • Dental/surgical polymerization lamp
Accessories of LED Curing Light
Dentall co.,Ltd.
B&Lite S-Charger
In Commercial Distribution

  • 08800096902033 ()


  • Dental/surgical polymerization lamp
LED Curing Light
Dentall co.,Ltd.
B&Lite S-Handpiece
In Commercial Distribution

  • 08800096902026 ()


  • Dental/surgical polymerization lamp
LED Curing Light
Dentall co.,Ltd.
B&Lite S-Regular kit
In Commercial Distribution

  • 08800096902019 ()


  • Dental/surgical polymerization lamp
SOLCART B USA SOD.BIC.-CARTR. 760GR
B. BRAUN MEDICAL INC.
839
In Commercial Distribution

  • 04046955634811 ()
  • 04046955634828 ()

  • Weight : 760.000 G
839

  • Haemodialysis concentrate
SOLCART B USA SOD.BIC.-CARTR. 650GR
B. BRAUN MEDICAL INC.
838
In Commercial Distribution

  • 04046955634279 ()
  • 04046955634286 ()

  • Weight : 650.000 G
838

  • Haemodialysis concentrate
No Description
B& L Biotech, inc.
B&Lite S
In Commercial Distribution

  • 08800019116059 ()


  • Dental/surgical polymerization lamp
No Description
B& L Biotech, inc.
JX5
In Commercial Distribution

  • 08800019115038 ()


  • Dental mirror, reusable
No Description
B& L Biotech, inc.
WL-B1
In Commercial Distribution

  • 08800019101642 ()


  • Endodontic obturation system
No Description
B& L Biotech, inc.
WL-B1
In Commercial Distribution

  • 08800019101635 ()


  • Endodontic obturation system
No Description
B& L Biotech, inc.
WL-B1
In Commercial Distribution

  • 08800019101031 ()


  • Endodontic obturation system
No Description
B& L Biotech, inc.
WL-B1
In Commercial Distribution

  • 08800019101024 ()


  • Endodontic obturation system
No Description
B& L Biotech, inc.
CL-A1
In Commercial Distribution

  • 08800019100003 ()


  • Endodontic obturation system
Microfibrillar Collagen Dental Wound Dressing
COLLAGEN MATRIX, INC.
58499
In Commercial Distribution

  • 00813954023502 ()
  • 10813954023509 ()

  • Weight: 0.1 Gram


  • General oral wound dressing, animal-derived
No Description
ECENTIAL ROBOTICS
A00064
In Commercial Distribution

  • 03701311500872 ()


  • Surgical optical-tracking spatial marker, reusable
No Description
MAUNA KEA TECHNOLOGIES
211-0142
In Commercial Distribution

  • 03760187910130 ()
MP-0011-URF

  • Confocal endomicroscopy system probe
No Description
WALDEMAR LINK GmbH & Co. KG
198-828/05
In Commercial Distribution

  • 04026575133093 ()
198-828/05

  • Metallic femoral head prosthesis
Modular Prosthesis Head,CoCrMo
WALDEMAR LINK GmbH & Co. KG
128-756
In Commercial Distribution

  • 04026575028221 ()
128-756

  • Metallic femoral head prosthesis
Modular Prosthesis Head,CoCrMo
WALDEMAR LINK GmbH & Co. KG
128-755
In Commercial Distribution

  • 04026575028214 ()
128-755

  • Metallic femoral head prosthesis
Modular Prosthesis Head,CoCrMo
WALDEMAR LINK GmbH & Co. KG
128-754
In Commercial Distribution

  • 04026575028207 ()
128-754

  • Metallic femoral head prosthesis
Modular Prosthesis Head,CoCrMo
WALDEMAR LINK GmbH & Co. KG
128-752
In Commercial Distribution

  • 04026575028191 ()
128-752

  • Metallic femoral head prosthesis
Modular Prosthesis Head,CoCrMo
WALDEMAR LINK GmbH & Co. KG
128-751
In Commercial Distribution

  • 04026575028184 ()
128-751

  • Metallic femoral head prosthesis
Modular Prosthesis Head,CoCrMo
WALDEMAR LINK GmbH & Co. KG
128-750
In Commercial Distribution

  • 04026575028177 ()
128-750

  • Metallic femoral head prosthesis
Modular Prosthesis Head,CoCrMo
WALDEMAR LINK GmbH & Co. KG
128-748
In Commercial Distribution

  • 04026575028160 ()
128-748

  • Metallic femoral head prosthesis
Modular Prosthesis Head,CoCrMo
WALDEMAR LINK GmbH & Co. KG
128-747
In Commercial Distribution

  • 04026575028153 ()
128-747

  • Metallic femoral head prosthesis
Modular Prosthesis Head,CoCrMo
WALDEMAR LINK GmbH & Co. KG
128-746
In Commercial Distribution

  • 04026575028146 ()
128-746

  • Metallic femoral head prosthesis
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