3,128 results · 33ms · Sources: EU EUDAMED, US FDA

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Microthin Natural Rubber Latex Condom

FDA 510(k)
FDA Class 2 ·Obstetrics/Gynecology

TECO DIAGNOSTICS UTI DETECTION STRIPS

FDA 510(k)
FDA Class 1 ·Clinical Chemistry

The Parkinsons KinetiGraph (PKG) System

Basic UDI-DI
EU MDR · Eu Md Class 2a ·GKC Manufacturing Pty. Ltd.·3 devices

Ethyl Alcohol DAU Controls

FDA registration
LIN-ZHI INTERNATIONAL, INC.·3 products·🇺🇸 United States

60-EA0450 Pointe Ethyl Alcohol Level 2 Control (300 mg/dL)

FDA registration
HORIBA INSTRUMENTS INCORPORATED·3 products·🇺🇸 United States

Carolina Liquid Chemistries Corp.

FDA registration
Carolina Liquid Chemistries Corp.·3 products·🇺🇸 United States

Test, Hepatitis B (B Core, Be Antigen, Be Antibody, B Core Igm)

FDA Pre-Market Approval
FDA Class 3 ·ADVIA Centaur HBsAgII/Confirmatory Readypack Reagents and QC Material

KAY-PLUS & VARIOUS VANIA SANITARY LINERS & PADS

FDA 510(k)
FDA Class 2 ·Obstetrics/Gynecology

MKC-750UHD Type H

Basic UDI-DI
EU MDR · Eu Md Class 1 ·Ikegami Tsushinki Co.,Ltd.·1 device

ARCHITECT

FDA UDI
ABBOTT LABORATORIES·00380740005535·Ethanol 50 Control

ARCHITECT

FDA UDI
ABBOTT LABORATORIES·00380740005511·Ethanol Neg Calibrator

ARCHITECT

FDA UDI
ABBOTT LABORATORIES·00380740005528·Ethanol 100 Calibrator

ARCHITECT

FDA UDI
ABBOTT LABORATORIES·00380740005542·Ethanol 300 Control

DBEST ONE-STEP HCG SERUM/URINE TEST

FDA 510(k)
FDA Class 2 ·Clinical Chemistry

DBEST METHAMPHETAMINES TEST KIT

FDA 510(k)
FDA Class 2 ·Clinical Toxicology

KENEX RADIATION SHIELD (VARIOUS MODELS AS EXHIBITS #2 & 5)

FDA 510(k)
FDA Class 1 ·Radiology

ADDIQUIP DISPOSABLE ACUPUNCTURE NEEDLES

FDA 510(k)
FDA Class 2 ·General Hospital

DBEST OPIATES TEST KIT

FDA 510(k)
FDA Class 2 ·Clinical Toxicology

URINE REAGENT STRIPS-3 PARAMETERS (MODIFICATION)

FDA 510(k)
FDA Class 1 ·Clinical Chemistry

Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs and Fentanyl Citrate

FDA 510(k)
FDA Class 1 ·General Hospital