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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Number One 12-Panel Drug Test Cup AMP/BZO/BUP/COC/MET/MTD/MDMA/OPI/OXY/PCP/BAR/THC
UCP BIOSCIENCES, INC.
N1T-1127-P
In Commercial Distribution

  • 20817038022188 ()
  • 10817038022181 ()
  • 00817038022184 ()
N1T-1127-P

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Number One 12-Panel Drug Test Cup AMP/BZO/BUP/COC/MET/MTD/MDMA/OPI/OXY/PCP/TCA/THC
UCP BIOSCIENCES, INC.
N1T-1126-P
In Commercial Distribution

  • 20817038022171 ()
  • 10817038022174 ()
  • 00817038022177 ()
N1T-1126-P

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
No Description
D.S.I DENTAL SOLUTIONS LTD
DSMTA-RC
In Commercial Distribution

  • D956DSMTARC0 ()


  • Calcium hydroxide dental cement
No Description
CANON MEDICAL SYSTEMS CORPORATION
TSX-308A
In Commercial Distribution

  • 04987670105579 ()


  • Full-body CT system
SCAN CONVERTER
PENTAX OF AMERICA, INC.
7138
In Commercial Distribution

  • 04961333245161 ()


  • Video cassette recorder
No Description
PROPHARMA-UK LTD
NA
In Commercial Distribution

  • 05060519180032 ()
  • 05060519180049 ()


  • Synovial fluid supplementation medium
Inject into the knee to relieve the pain from osteoarthritis.
ACRE PHARMA LIMITED
NA
In Commercial Distribution

  • 05060604130034 ()


  • Synovial fluid supplementation medium
No Description
ALLY MEDICAL SUPPLIES LTD
None
In Commercial Distribution

  • 05060459970021 ()


  • Synovial fluid supplementation medium
Dental mixer of Surefill one and Calibra Bio capsules, Brand Dentsply Sirona
Renfert GmbH
2770001000
In Commercial Distribution

  • J00927700010000 ()
2770001000

  • Dental amalgam mixer
Endodontic instrument for professionnal dental use only
MICRO MEGA
n25 9% L17 Classics sterile
In Commercial Distribution

  • J015209522011 ()
  • J015209522012 ()
  • J015209522010 ()
20952201

  • Rotary/reciprocating endodontic file/rasp, reusable
Endodontic instrument for professionnal dental use only
MICRO MEGA
n025 L21
In Commercial Distribution

  • J015209490011 ()
  • J015209490019 ()
  • J015209490010 ()
20949001

  • Rotary/reciprocating endodontic file/rasp, single-use
Endodontic instrument for professionnal dental use only
MICRO MEGA
n014 3% L29 Classics Sterile
In Commercial Distribution

  • J015209482030 ()
  • J015209482031 ()
  • J015209482039 ()
20948203

  • Rotary/reciprocating endodontic file/rasp, single-use
Endodontic instrument for professionnal dental use only
MICRO MEGA
n014 3% L25 Classics Sterile
In Commercial Distribution

  • J015209482029 ()
  • J015209482020 ()
  • J015209482021 ()
20948202

  • Rotary/reciprocating endodontic file/rasp, single-use
Endodontic instrument for professionnal dental use only
MICRO MEGA
n014 3% L21 Classics Sterile
In Commercial Distribution

  • J015209482010 ()
  • J015209482011 ()
  • J015209482019 ()
20948201

  • Rotary/reciprocating endodontic file/rasp, single-use
Endodontic instrument for professionnal dental use only
MICRO MEGA
n45 4% L31
In Commercial Distribution

  • J015201494589 ()
  • J015201494581 ()
  • J015201494580 ()
20149458

  • Rotary/reciprocating endodontic file/rasp, single-use
Endodontic instrument for professionnal dental use only
MICRO MEGA
n35 4% L31
In Commercial Distribution

  • J015201494579 ()
  • J015201494571 ()
  • J015201494570 ()
20149457

  • Rotary/reciprocating endodontic file/rasp, single-use
Endodontic instrument for professionnal dental use only
MICRO MEGA
n25 4% L31
In Commercial Distribution

  • J015201494569 ()
  • J015201494561 ()
  • J015201494560 ()
20149456

  • Rotary/reciprocating endodontic file/rasp, single-use
Endodontic instrument for professionnal dental use only
MICRO MEGA
n45 4% L31
In Commercial Distribution

  • J015201494539 ()
  • J015201494531 ()
  • J015201494530 ()
20149453

  • Rotary/reciprocating endodontic file/rasp, single-use
Endodontic instrument for professionnal dental use only
MICRO MEGA
n35 4% L31
In Commercial Distribution

  • J015201494529 ()
  • J015201494521 ()
  • J015201494520 ()
20149452

  • Rotary/reciprocating endodontic file/rasp, single-use
Endodontic instrument for professionnal dental use only
MICRO MEGA
n25 4% L31
In Commercial Distribution

  • J015201494519 ()
  • J015201494511 ()
  • J015201494510 ()
20149451

  • Rotary/reciprocating endodontic file/rasp, single-use
Endodontic instrument for professionnal dental use only
MICRO MEGA
n45 4% L25
In Commercial Distribution

  • J015201494489 ()
  • J015201494481 ()
  • J015201494480 ()
20149448

  • Rotary/reciprocating endodontic file/rasp, single-use
Endodontic instrument for professionnal dental use only
MICRO MEGA
n35 4% L25
In Commercial Distribution

  • J015201494479 ()
  • J015201494471 ()
  • J015201494470 ()
20149447

  • Rotary/reciprocating endodontic file/rasp, single-use
Endodontic instrument for professionnal dental use only
MICRO MEGA
n25 4% L25
In Commercial Distribution

  • J015201494469 ()
  • J015201494461 ()
  • J015201494460 ()
20149446

  • Rotary/reciprocating endodontic file/rasp, single-use
Endodontic instrument for professionnal dental use only
MICRO MEGA
n45 4% L25
In Commercial Distribution

  • J015201494439 ()
  • J015201494431 ()
  • J015201494430 ()
20149443

  • Rotary/reciprocating endodontic file/rasp, single-use
Endodontic instrument for professionnal dental use only
MICRO MEGA
n35 4% L25
In Commercial Distribution

  • J015201494429 ()
  • J015201494421 ()
  • J015201494420 ()
20149442

  • Rotary/reciprocating endodontic file/rasp, single-use
Endodontic instrument for professionnal dental use only
MICRO MEGA
n25 4% L25
In Commercial Distribution

  • J015201494419 ()
  • J015201494411 ()
  • J015201494410 ()
20149441

  • Rotary/reciprocating endodontic file/rasp, single-use
Endodontic instrument for professionnal dental use only
MICRO MEGA
n45 4% L21
In Commercial Distribution

  • J015201494389 ()
  • J015201494381 ()
  • J015201494380 ()
20149438

  • Rotary/reciprocating endodontic file/rasp, single-use
Endodontic instrument for professionnal dental use only
MICRO MEGA
n35 4% L21
In Commercial Distribution

  • J015201494379 ()
  • J015201494371 ()
  • J015201494370 ()
20149437

  • Rotary/reciprocating endodontic file/rasp, single-use
Endodontic instrument for professionnal dental use only
MICRO MEGA
n25 4% L21
In Commercial Distribution

  • J015201494369 ()
  • J015201494361 ()
  • J015201494360 ()
20149436

  • Rotary/reciprocating endodontic file/rasp, single-use
Endodontic instrument for professionnal dental use only
MICRO MEGA
n45 4% L21
In Commercial Distribution

  • J015201494339 ()
  • J015201494331 ()
  • J015201494330 ()
20149433

  • Rotary/reciprocating endodontic file/rasp, single-use
Endodontic instrument for professionnal dental use only
MICRO MEGA
n35 4% L21
In Commercial Distribution

  • J015201494329 ()
  • J015201494321 ()
  • J015201494320 ()
20149432

  • Rotary/reciprocating endodontic file/rasp, single-use
Endodontic instrument for professionnal dental use only
MICRO MEGA
n25 4% L21
In Commercial Distribution

  • J015201494319 ()
  • J015201494311 ()
  • J015201494310 ()
20149431

  • Rotary/reciprocating endodontic file/rasp, single-use
Endodontic instrument for professionnal dental use only
MICRO MEGA
n25 6% L31
In Commercial Distribution

  • J015201494139 ()
  • J015201494131 ()
  • J015201494130 ()
20149413

  • Rotary/reciprocating endodontic file/rasp, single-use
Endodontic instrument for professionnal dental use only
MICRO MEGA
n25 6% L25
In Commercial Distribution

  • J015201494129 ()
  • J015201494121 ()
  • J015201494120 ()
20149412

  • Rotary/reciprocating endodontic file/rasp, single-use
Endodontic instrument for professionnal dental use only
MICRO MEGA
n25 6% L21
In Commercial Distribution

  • J015201494119 ()
  • J015201494111 ()
  • J015201494110 ()
20149411

  • Rotary/reciprocating endodontic file/rasp, single-use
Endodontic instrument for professionnal dental use only
MICRO MEGA
n25 6% L31
In Commercial Distribution

  • J015201494039 ()
  • J015201494031 ()
  • J015201494030 ()
20149403

  • Rotary/reciprocating endodontic file/rasp, single-use
Endodontic instrument for professionnal dental use only
MICRO MEGA
n25 6% L25
In Commercial Distribution

  • J015201494029 ()
  • J015201494021 ()
  • J015201494020 ()
20149402

  • Rotary/reciprocating endodontic file/rasp, single-use
Endodontic instrument for professionnal dental use only
MICRO MEGA
n25 6% L21
In Commercial Distribution

  • J015201494019 ()
  • J015201494011 ()
  • J015201494010 ()
20149401

  • Rotary/reciprocating endodontic file/rasp, single-use
No Description
KEELER LIMITED
3010-P-2001
In Commercial Distribution

  • 05055272711777 ()


  • Ophthalmic examination slit lamp
No Description
NANTONG EGENS BIOLOGY TECHNIC CO., LTD.
HCG-U11
In Commercial Distribution

  • 05055718942376 ()


  • Human chorionic gonadotropin alpha-subunit IVD, calibrator
No Description
NANTONG EGENS BIOLOGY TECHNIC CO., LTD.
HCG-U23
In Commercial Distribution

  • 05055718942345 ()


  • Human chorionic gonadotropin alpha-subunit IVD, calibrator
No Description
NANTONG EGENS BIOLOGY TECHNIC CO., LTD.
HCG-U11
In Commercial Distribution

  • 05055718942314 ()


  • Human chorionic gonadotropin alpha-subunit IVD, calibrator
No Description
NANTONG EGENS BIOLOGY TECHNIC CO., LTD.
HCG-U11
In Commercial Distribution

  • 05055718942307 ()


  • Human chorionic gonadotropin alpha-subunit IVD, calibrator
No Description
NANTONG EGENS BIOLOGY TECHNIC CO., LTD.
HCG-U35
In Commercial Distribution

  • 05055718942284 ()


  • Human chorionic gonadotropin alpha-subunit IVD, calibrator
R07-B, C07, T01, I07H, A03*3, P01, ZeeBud
SOMNICS, INC.
Starter Kit
In Commercial Distribution

  • 04719878321105 ()


  • Intraoral negative-pressure sleep apnoea unit
R07-B, C07, T01, I07, A03*3, P01, ZeeBud
SOMNICS, INC.
Starter Kit
In Commercial Distribution

  • 04719878321099 ()


  • Intraoral negative-pressure sleep apnoea unit
iNAP One Quarterly Kit (with I07)
SOMNICS, INC.
Quarterly Kit
In Commercial Distribution

  • 04719878321075 ()


  • Intraoral negative-pressure sleep apnoea unit
iNAP One Quarterly Kit
SOMNICS, INC.
Quarterly Kit
In Commercial Distribution

  • 04719878320887 ()


  • Intraoral negative-pressure sleep apnoea unit
R07-B, C07, T01, I07S, A03*3, P01
SOMNICS, INC.
Quarterly Set w/I07S
In Commercial Distribution

  • 04719878320542 ()
91010-9S

  • Intraoral negative-pressure sleep apnoea unit
R07-B, C07, T01, I07H, A03*3, P01
SOMNICS, INC.
Quarterly Set w/I07H
In Commercial Distribution

  • 04719878320535 ()
91010-9H

  • Intraoral negative-pressure sleep apnoea unit
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