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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Bedside Monitor
NIHON KOHDEN CORPORATION
BSM-2301A
In Commercial Distribution

  • 04931921101629 ()


  • General-purpose multi-parameter bedside monitor
No Description
PREVEST DENPRO LIMITED
Large Pack
In Commercial Distribution

  • D967300032 ()
30003-2

  • Dental composite resin kit
No Description
PREVEST DENPRO LIMITED
Regular Pack
In Commercial Distribution

  • D967300031 ()
30003-1

  • Dental composite resin kit
No Description
PREVEST DENPRO LIMITED
Economy Pack
In Commercial Distribution

  • D96730003 ()
30003

  • Dental composite resin kit
No Description
PREVEST DENPRO LIMITED
Trial Pack
In Commercial Distribution

  • D967300021 ()
30002-1

  • Dental composite resin kit
No Description
PREVEST DENPRO LIMITED
Intro Pack
In Commercial Distribution

  • D96730002 ()
30002

  • Dental composite resin kit
Home pregnancy test for early results
Immunostics Company, Inc
5050M2-3B
In Commercial Distribution

  • 00722355002859 ()
  • 80722355002855 ()


  • Total human chorionic gonadotropin IVD, kit, rapid ICT, clinical
Home pregnancy test for early results
Immunostics Company, Inc
5050M2-1B
In Commercial Distribution

  • 00722355002842 ()


  • Total human chorionic gonadotropin IVD, kit, rapid ICT, clinical
For use with the AutoDELFIA® and the DELFIA® kits for sample dilution.
Wallac Oy
B128-100
Not in Commercial Distribution

  • 06438147009756 ()
B128-100

  • Buffered sample diluent IVD
For use with the AutoDELFIA® and the DELFIA® kits for sample dilution.
Wallac Oy
B127-100
Not in Commercial Distribution

  • 06438147009749 ()
B127-100

  • Buffered sample diluent IVD
AeroTech I Shield, part of Radioaerosol Administration System
Mirion Technologies (capintec), Inc.
177-095
In Commercial Distribution

  • 00879942070101 ()
177-095

  • Radioaerosol administration set
No Description
Axiodent Inc.
24001
In Commercial Distribution

  • D161240010 ()


  • Glass ionomer dental cement
No Description
HANILMEDICAL CO.,LTD.
CGM ESA-SD1501
In Commercial Distribution

  • 08800132500025 ()


  • Freestanding electric massager
No Description
VITALSCIENTIFIC
ISCT-0046
In Commercial Distribution

  • 03661540214400 ()


  • Multiple-type clinical chemistry analyte profile IVD, control
A rapid, automated, molecular test for the qualitative detection of respiratory syncytial virus (RSV) nucleic acid in nasopharyngeal specimens.
Alere Scarborough, Inc.
435-000
Not in Commercial Distribution

  • 10811877010118 ()


  • Respiratory syncytial virus (RSV) nucleic acid IVD, kit, nucleic acid technique (NAT)
No Description
Hong Qiangxing (Shen Zhen) Electronics Limited
TENS
In Commercial Distribution

  • 00190119165001 ()
  • 25190119016012 ()


  • Physical therapy transcutaneous neuromuscular electrical stimulation system
The Simply Tranquil I utilizes advanced digital signal processing with broadband white noise integrated into a cosmetically appealing in the canal design. Designed for patients that suffer from Tinnitus
GENERAL HEARING INSTRUMENT, INC.
Simply Tranquil I,10A,Digital,Pair
In Commercial Distribution

  • 00089518000474 ()


  • Air-conduction tinnitus masker, in-the-ear
The Simply Tranquil I utilizes advanced digital signal processing with broadband white noise integrated into a cosmetically appealing in the canal design. Designed for patients that suffer from Tinnitus
GENERAL HEARING INSTRUMENT, INC.
Simply Tranquil I,10A,Digital,Right
In Commercial Distribution

  • 00089518000467 ()


  • Air-conduction tinnitus masker, in-the-ear
The Simply Tranquil I utilizes advanced digital signal processing with broadband white noise integrated into a cosmetically appealing in the canal design. Designed for patients that suffer from Tinnitus
GENERAL HEARING INSTRUMENT, INC.
Simply Tranquil I,10A,Digital,Left
In Commercial Distribution

  • 00089518000450 ()


  • Air-conduction tinnitus masker, in-the-ear
The Tranquil I OTE utilizes advanced digital signal processing with broadband white noise integrated into a cosmetically appealing mini OTE case design. Designed for patients that suffer from Tinnitus
GENERAL HEARING INSTRUMENT, INC.
Tranquil I,OTE,10A,Digital,Grey,Pair
In Commercial Distribution

  • 00089518000320 ()


  • Air-conduction tinnitus masker, out-of-ear
The Tranquil I OTE utilizes advanced digital signal processing with broadband white noise integrated into a cosmetically appealing mini OTE case design. Designed for patients that suffer from Tinnitus
GENERAL HEARING INSTRUMENT, INC.
Tranquil I,OTE,10A,Digital,Grey,Right
In Commercial Distribution

  • 00089518000313 ()


  • Air-conduction tinnitus masker, out-of-ear
The Tranquil I OTE utilizes advanced digital signal processing with broadband white noise integrated into a cosmetically appealing mini OTE case design. Designed for patients that suffer from Tinnitus
GENERAL HEARING INSTRUMENT, INC.
Tranquil I,OTE,10A,Digital,Grey,Left
In Commercial Distribution

  • 00089518000306 ()


  • Air-conduction tinnitus masker, out-of-ear
The Tranquil I OTE utilizes advanced digital signal processing with broadband white noise integrated into a cosmetically appealing mini OTE case design. Designed for patients that suffer from Tinnitus
GENERAL HEARING INSTRUMENT, INC.
Tranquil I,OTE,10A,Digital,Black,Pair
In Commercial Distribution

  • 00089518000290 ()


  • Air-conduction tinnitus masker, out-of-ear
The Tranquil I OTE utilizes advanced digital signal processing with broadband white noise integrated into a cosmetically appealing mini OTE case design. Designed for patients that suffer from Tinnitus
GENERAL HEARING INSTRUMENT, INC.
Tranquil I,OTE,10A,Digital,Black,Right
In Commercial Distribution

  • 00089518000283 ()


  • Air-conduction tinnitus masker, out-of-ear
The Tranquil I OTE utilizes advanced digital signal processing with broadband white noise integrated into a cosmetically appealing mini OTE case design. Designed for patients that suffer from Tinnitus
GENERAL HEARING INSTRUMENT, INC.
Tranquil I,OTE,10A,Digital,Black,Left
In Commercial Distribution

  • 00089518000276 ()


  • Air-conduction tinnitus masker, out-of-ear
The Tranquil I OTE utilizes advanced digital signal processing with broadband white noise integrated into a cosmetically appealing mini OTE case design. Designed for patients that suffer from Tinnitus
GENERAL HEARING INSTRUMENT, INC.
Tranquil I,OTE,10A,Digital,Brown,Right
In Commercial Distribution

  • 00089518000252 ()


  • Air-conduction tinnitus masker, out-of-ear
The Tranquil I OTE utilizes advanced digital signal processing with broadband white noise integrated into a cosmetically appealing mini OTE case design. Designed for patients that suffer from Tinnitus
GENERAL HEARING INSTRUMENT, INC.
Tranquil I,OTE,10A,Digital,Beige,Pair
In Commercial Distribution

  • 00089518000238 ()


  • Air-conduction tinnitus masker, out-of-ear
The Tranquil I OTE utilizes advanced digital signal processing with broadband white noise integrated into a cosmetically appealing mini OTE case design. Designed for patients that suffer from Tinnitus
GENERAL HEARING INSTRUMENT, INC.
Tranquil I,OTE,10A,Digital,Beige,Left
In Commercial Distribution

  • 00089518000214 ()


  • Air-conduction tinnitus masker, out-of-ear
No Description
CLASSYS Inc.
VLMC02502R
In Commercial Distribution

  • 08800016905397 ()


  • Radio-frequency skin contouring system applicator tip
CERVICAL I/F CAGE FILLER BLOCK
DEPUY SPINE, LLC
273301400
In Commercial Distribution

  • 10705034187969 ()
273301400

  • Bone graft packing block
The Tranquil I OTE utilizes advanced digital signal processing with broadband white noise integrated into a cosmetically appealing mini OTE case design. Designed for patients that suffer from Tinnitus
GENERAL HEARING INSTRUMENT, INC.
Tranquil I,OTE,10A,Digital,Brown,Pair
In Commercial Distribution

  • 00089518000269 ()


  • Air-conduction tinnitus masker, out-of-ear
The Tranquil I OTE utilizes advanced digital signal processing with broadband white noise integrated into a cosmetically appealing mini OTE case design. Designed for patients that suffer from Tinnitus
GENERAL HEARING INSTRUMENT, INC.
Tranquil I,OTE,10A,Digital,Brown,Left
In Commercial Distribution

  • 00089518000245 ()


  • Air-conduction tinnitus masker, out-of-ear
The Tranquil I OTE utilizes advanced digital signal processing with broadband white noise integrated into a cosmetically appealing mini OTE case design. Designed for patients that suffer from Tinnitus
GENERAL HEARING INSTRUMENT, INC.
Tranquil I,OTE,10A,Digital,Beige,Right
In Commercial Distribution

  • 00089518000221 ()


  • Air-conduction tinnitus masker, out-of-ear
No Description
Roche Diagnostics GmbH
3375790190
In Commercial Distribution

  • 04015630996964 ()
3375790190

  • Multiple drugs of abuse IVD, calibrator
No Description
Carl Zeiss Meditec AG
6633
In Commercial Distribution

  • 04049539066336 ()


  • Ophthalmic surgical microscope
No Description
EUROIMMUN Medizinische Labordiagnostika AG
YG 0014-0101
In Commercial Distribution

  • 04049016068792 ()


  • Enzyme immunoassay (EIA) analyser IVD
The med-kit I doctor`s case which contains high quality Riester products is an indispensable piece of basic equipment for every physican.
Rudolf Riester GmbH
5280-05
In Commercial Distribution

  • 04045396121959 ()
5280-05

  • Aneroid manual sphygmomanometer
The med-kit I doctor`s case which contains high quality Riester products is an indispensable piece of basic equipment for every physican.
Rudolf Riester GmbH
5280-04
In Commercial Distribution

  • 04045396121942 ()
5280-04

  • Aneroid manual sphygmomanometer
The med-kit I doctor`s case which contains high quality Riester products is an indispensable piece of basic equipment for every physican.
Rudolf Riester GmbH
5280-03
In Commercial Distribution

  • 04045396121935 ()
5280-03

  • Aneroid manual sphygmomanometer
No Description
ARUM DENTISTRY Co., Ltd.
NB16513SS
In Commercial Distribution

  • 08809917605290 ()


  • Screw endosteal dental implant, two-piece
No Description
ARUM DENTISTRY Co., Ltd.
NB16511SS
In Commercial Distribution

  • 08809917605283 ()


  • Screw endosteal dental implant, two-piece
No Description
ARUM DENTISTRY Co., Ltd.
NB15507SS
In Commercial Distribution

  • 08809917605139 ()


  • Screw endosteal dental implant, two-piece
No Description
ARUM DENTISTRY Co., Ltd.
NB15007SS
In Commercial Distribution

  • 08809917605115 ()


  • Screw endosteal dental implant, two-piece
No Description
ARUM DENTISTRY Co., Ltd.
NB14007SS
In Commercial Distribution

  • 08809917605092 ()


  • Screw endosteal dental implant, two-piece
No Description
ARUM DENTISTRY Co., Ltd.
NB16510SS
In Commercial Distribution

  • 08809917605276 ()


  • Screw endosteal dental implant, two-piece
No Description
ARUM DENTISTRY Co., Ltd.
NB16508SS
In Commercial Distribution

  • 08809917605269 ()


  • Screw endosteal dental implant, two-piece
No Description
ARUM DENTISTRY Co., Ltd.
NB16507SS
In Commercial Distribution

  • 08809917605252 ()


  • Screw endosteal dental implant, two-piece
No Description
ARUM DENTISTRY Co., Ltd.
NB16506SS
In Commercial Distribution

  • 08809917605245 ()


  • Screw endosteal dental implant, two-piece
No Description
ARUM DENTISTRY Co., Ltd.
NB16013SS
In Commercial Distribution

  • 08809917605238 ()


  • Screw endosteal dental implant, two-piece
No Description
ARUM DENTISTRY Co., Ltd.
NB16011SS
In Commercial Distribution

  • 08809917605221 ()


  • Screw endosteal dental implant, two-piece
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