iScreen™

FDA UDI

Instant Technologies, Inc.·00817405022038·iScreen DOA Multi-Panel(Urine) 25T

Models 2200DR and 1600DR Digital Stationary Radiographic Systems

FDA 510(k)

FDA Class 2 ·Radiology

ACCUSIGN DOA 10, ACCUSIGN DOA 10 PANEL, ACUSIGN MET/OPI/COC/THC/PCP/BZO/BAR/MTD/TCA/AMP, BIOSIGN DOA10, BIOSIGN MET/OPI/

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

FDA Pre-Market Approval

MOSAIC PORCINE BIOPROSTHESIS

ACCUSIGN DOA 5 (THC/OPI/COC/MET OR AMP/PCP)

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

Epidermal Growth Factor Receptor (EGFR) - 31G7 - Mob461A,PDM226A

FDA registration

DIAGNOSTIC BIOSYSTEMS·1 product·🇺🇸 United States

Atlas Multi-Drugs Screening Test Cup, Atlas Multi-Drugs Screening Test Panel

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

Eon Aligner

FDA 510(k)

FDA Class 2 ·Dental

ATLAS HOME PREGNANCY TEST (MIDSTREAM FORMAT) MODEL 70172001

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

Evidence MultiSTAT Drugs of Abuse (DOA) ToxPlex Urine Array

Device

EU IVDR · Eu Ivd Class C ·Randox Laboratories Limited·On the market·1 country

Heart-Valve, Non-Allograft Tissue

FDA Pre-Market Approval

FDA Class 3 ·MEDTONIC FREESTYLE AORTIC BIOPROSTHESIS

MTG Pediatric Intermittent Catheter, Coude-tip with hydrophilic low-friction coa

FDA UDI

MEDICAL TECHNOLOGIES OF GEORGIA, INC.·00851593006302·Pediatric Intermittent Catheter, Coude-tip with...

MTG Female Intermittent Catheter, Straight-tip with hydrophilic low-friction coa

FDA UDI

MEDICAL TECHNOLOGIES OF GEORGIA, INC.·00851593006227·Female Intermittent Catheter, Straight-tip with...

Powder Free Nitrile Examination Gloves (Blue), Tested for Use with Chemotherapy Drugs and Fentanyl Citrate (XS,S,M,L,XL,XXL)

FDA 510(k)

FDA Class 1 ·General Hospital

Anti-Coa, for card method Coombs-reactive, polyclonal, human IgG

Device

EU IVDR · Eu Ivd Class C ·ANTITOXIN GmbH·On the market·2 countries

Flexible Sensor-Ureterorenoscopes BOA Vision EF, Flexible Sensor-Ureterorenoscopes COBRA Vision EF

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

ACCUSIGN DOA3, DOA, BAR/BZO/MTD, BIOSIGN DOA3, BIOSIGN BAR/BZO/MTD

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

GALEMED PEAK FLOW METER, MODELS 3751/3752

FDA 510(k)

FDA Class 2 ·Anesthesiology

DOA-XSE, LIQUID DRUGS OF ABUSE CONTROL LEVELS 2,3, AND 4 (SDOA- 202,303,404)

FDA 510(k)

FDA Class 1 ·Clinical Toxicology

SUPPORT, ARM

FDA registration

Good Time Health Care Products Co., Ltd.·1 product·🇻🇳 Vietnam