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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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ARCHITECT - 00380740170141

Apolipoprotein A1 243 Tests
ABBOTT IRELAND
09D9224
In Commercial Distribution

  • 00380740170141 ()
09D9224

  • Apolipoprotein A-I (Apo A1) IVD, reagent

Alinity - 00380740170134

Apolipoprotein A1 190 Tests
ABBOTT IRELAND
09P4624
In Commercial Distribution

  • 00380740170134 ()
09P4624

  • Apolipoprotein A-I (Apo A1) IVD, reagent

K-ASSAY® Apo AI Reagent - 00816426020016

For the quantitative determination of human apolipoprotein AI (Apo AI) in serum by immunoturbidimetric assay.
KAMIYA BIOMEDICAL COMPANY, LLC
KAI-002
In Commercial Distribution

  • 00816426020016 ()
KAI-002

  • Apolipoprotein A-I (Apo A1) IVD, reagent

Antiserum to Apolipoprotein A-1 - B1761500

No Description
KENT LABORATORIES INC
1
In Commercial Distribution

  • B1761500 ()
150002

  • Apolipoprotein A-I (Apo A1) IVD, reagent

BIOBASE - 06971674867753

No Description
Biobase Biodustry(Shandong)Co., Ltd.
Calibrator:1mL×1, 3mL×1
In Commercial Distribution

  • 06971674867753 ()


  • Apolipoprotein A-I (Apo A1) IVD, reagent

BIOBASE - 06971674860945

No Description
Biobase Biodustry(Shandong)Co., Ltd.
R1:48mL×2 R2:16mL×2
In Commercial Distribution

  • 06971674860945 ()


  • Apolipoprotein A-I (Apo A1) IVD, reagent

BIOBASE - 06971674860938

No Description
Biobase Biodustry(Shandong)Co., Ltd.
R1:48mL×2 R2:16mL×2
In Commercial Distribution

  • 06971674860938 ()


  • Apolipoprotein A-I (Apo A1) IVD, reagent

BIOBASE - 06971674860921

No Description
Biobase Biodustry(Shandong)Co., Ltd.
R1:48mL×2 R2:16mL×2
In Commercial Distribution

  • 06971674860921 ()


  • Apolipoprotein A-I (Apo A1) IVD, reagent

BIOBASE - 06971674860914

No Description
Biobase Biodustry(Shandong)Co., Ltd.
R1:48mL×2 R2:16mL×2
In Commercial Distribution

  • 06971674860914 ()


  • Apolipoprotein A-I (Apo A1) IVD, reagent

BIOBASE - 06971674860907

No Description
Biobase Biodustry(Shandong)Co., Ltd.
R1:18mL×4 R2:6mL×4
In Commercial Distribution

  • 06971674860907 ()


  • Apolipoprotein A-I (Apo A1) IVD, reagent

BIOBASE - 06971674860891

No Description
Biobase Biodustry(Shandong)Co., Ltd.
R1:60mL×6 R2:60mL×2
In Commercial Distribution

  • 06971674860891 ()


  • Apolipoprotein A-I (Apo A1) IVD, reagent

BIOBASE - 06971674860884

No Description
Biobase Biodustry(Shandong)Co., Ltd.
R1:48mL×2 R2:32mL×1
In Commercial Distribution

  • 06971674860884 ()


  • Apolipoprotein A-I (Apo A1) IVD, reagent

BIOBASE - 06971674860877

No Description
Biobase Biodustry(Shandong)Co., Ltd.
R1:48mL×2 R2:32mL×1
In Commercial Distribution

  • 06971674860877 ()


  • Apolipoprotein A-I (Apo A1) IVD, reagent

BIOBASE - 06971674860860

No Description
Biobase Biodustry(Shandong)Co., Ltd.
R1:48mL×2 R2:16mL×2
In Commercial Distribution

  • 06971674860860 ()


  • Apolipoprotein A-I (Apo A1) IVD, reagent

BIOBASE - 06971674860853

No Description
Biobase Biodustry(Shandong)Co., Ltd.
R1:90mL×1 R2:30mL×1
In Commercial Distribution

  • 06971674860853 ()


  • Apolipoprotein A-I (Apo A1) IVD, reagent

BIOBASE - 06971674860846

No Description
Biobase Biodustry(Shandong)Co., Ltd.
R1:18mL×4 R2:6mL×4
In Commercial Distribution

  • 06971674860846 ()


  • Apolipoprotein A-I (Apo A1) IVD, reagent

BIOBASE - 06971674860839

No Description
Biobase Biodustry(Shandong)Co., Ltd.
R1:60mL×2 R2:20mL×2
In Commercial Distribution

  • 06971674860839 ()


  • Apolipoprotein A-I (Apo A1) IVD, reagent

BIOBASE - 06971674860822

No Description
Biobase Biodustry(Shandong)Co., Ltd.
R1:48mL×2 R2:16mL×2
In Commercial Distribution

  • 06971674860822 ()


  • Apolipoprotein A-I (Apo A1) IVD, reagent

BIOBASE - 06971674860815

No Description
Biobase Biodustry(Shandong)Co., Ltd.
R1:40mL×3 R2:20mL×2
In Commercial Distribution

  • 06971674860815 ()


  • Apolipoprotein A-I (Apo A1) IVD, reagent

BIOBASE - 06971674860808

No Description
Biobase Biodustry(Shandong)Co., Ltd.
R1:60mL×1 R2:20mL×1
In Commercial Distribution

  • 06971674860808 ()


  • Apolipoprotein A-I (Apo A1) IVD, reagent

BIOBASE - 06971674860792

No Description
Biobase Biodustry(Shandong)Co., Ltd.
R1:18mL×1 R2:6mL×1
In Commercial Distribution

  • 06971674860792 ()


  • Apolipoprotein A-I (Apo A1) IVD, reagent

BIOBASE - 06971674860785

No Description
Biobase Biodustry(Shandong)Co., Ltd.
R1:18mL×4 R2:6mL×4
In Commercial Distribution

  • 06971674860785 ()


  • Apolipoprotein A-I (Apo A1) IVD, reagent

BIOBASE - 06971674860778

No Description
Biobase Biodustry(Shandong)Co., Ltd.
R1:60mL×2 R2:20mL×2
In Commercial Distribution

  • 06971674860778 ()


  • Apolipoprotein A-I (Apo A1) IVD, reagent

N/A - 00810047420156

Crypto Kinyoun Large Stain Set [250ml bottle x 3/pkg]
Scientific Device Laboratory, Inc.
379
In Commercial Distribution

  • 00810047420156 ()


  • Biological stain IVD

iQuest - 00850012642008

AI SaMD for prostate cancer.
Avenda Health, Inc.
V0.1.4
In Commercial Distribution

  • 00850012642008 ()


  • MRI image interpretive software

CEREC - E27665647070

CEREC AI Connect with Omnicam
SIRONA Dental Systems GmbH
6564707
In Commercial Distribution

  • E27665647070 ()


  • CAD/CAM software

CEREC - E27665429010

CEREC AI without CEREC Omnicam
SIRONA Dental Systems GmbH
6542901
In Commercial Distribution

  • E27665429010 ()


  • CAD/CAM software

CEREC - E27665347910

CEREC AI with CEREC Omnicam
SIRONA Dental Systems GmbH
6534791
In Commercial Distribution

  • E27665347910 ()


  • CAD/CAM software

Millennium - 00190776208462

Silastic Ring Applicator AI Style
Avalign Technologies, Inc.
72-52205501M
In Commercial Distribution

  • 00190776208462 ()


  • Rigid endoscopic tissue manipulation forceps, reusable

Millennium - 00190776191504

FiberOptic Adapter Storzympus to AI
Avalign Technologies, Inc.
72-9883
In Commercial Distribution

  • 00190776191504 ()


  • Fibreoptic retractor handle

AccuRhythm™ AI - 00763000504519

SW ZA400 ACCURHYTHM AI POST-PROCESSING
MEDTRONIC, INC.
ZA400
In Commercial Distribution

  • 00763000504519 ()


  • Implantable cardiac device management application software

Overjet Image Enhancement Assist - 00860005586370

No Description
Overjet, Inc.
v1
In Commercial Distribution

  • 00860005586370 ()


  • Dental x-ray image interpretive software

Overjet Charting Assist - 00860005586356

No Description
Overjet, Inc.
v1
In Commercial Distribution

  • 00860005586356 ()


  • Dental x-ray image interpretive software

Overjet Periapical Radiolucency Assist - 00860005586332

No Description
Overjet, Inc.
v1
In Commercial Distribution

  • 00860005586332 ()


  • Dental x-ray image interpretive software

Overjet Caries Assist - 00860005586318

No Description
Overjet, Inc.
v1
In Commercial Distribution

  • 00860005586318 ()


  • Dental x-ray image interpretive software

Overjet Caries Assist-Pediatric - 00860005586363

No Description
Overjet, Inc.
v1
In Commercial Distribution

  • 00860005586363 ()


  • Dental x-ray image interpretive software

Overjet Calculus Assist - 00860005586325

No Description
Overjet, Inc.
v1
In Commercial Distribution

  • 00860005586325 ()


  • Dental x-ray image interpretive software

Overjet Dental Assist - 00860005586301

No Description
Overjet, Inc.
v1
In Commercial Distribution

  • 00860005586301 ()


  • Dental x-ray image interpretive software

Velmeni for Dentists - 00860010893203

No Description
Velmeni Inc.
1.0
In Commercial Distribution

  • 00860010893203 ()
V4D

  • Dental x-ray image interpretive software

Videa Dental Assist - 00860009836822

Update: Now commercialized under the brand name 'Videa Dental AI'. Videa Dental AI is a computer-assisted detection (CADe) device that analyzes intraoral radiographs to identify and localize suspect dental finding, historical treatment and normal anatomy features. Videa Dental Assist is indicated for the review of bitewing, periapical, and panoramic radiographs acquired from patients aged 3 years or older.
Videahealth, Inc.
VDA01BPN
In Commercial Distribution

  • 00860009836822 ()


  • Dental x-ray image interpretive software
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