12 results · 22ms · Sources: EU EUDAMED, US FDA

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FIRST RESPONSE EARLY RESULT PREGNANCY TEST

FDA 510(k)
FDA Class 2 ·Clinical Chemistry

ACE ALKALINE PHOSPHATASE REAGENT, ACE AMYLASE REAGENT, ACE LDH-L REAGENT

FDA 510(k)
FDA Class 2 ·Clinical Chemistry

DAS MEDICAL EQUIPMENT DRAPES

FDA 510(k)
FDA Class 2 ·General, Plastic Surgery

CLARIUS ULTRASOUND SCANNER

FDA Adverse Event
Malfunction ·CLARIUS MOBILE HEALTH CORP.·Product code IYN·October 17, 2024

TRIATHLON P/A CR BEADED #5L

FDA Adverse Event
Injury ·STRYKER ORTHOPAEDICS-MAHWAH·Product code MBH·January 29, 2024

OT VERIO IQ METER

FDA Adverse Event
Malfunction ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·May 21, 2013

AUTOSONIX* ULTRA SHEARS* 5MM INSTRUMENT

FDA Adverse Event
Malfunction ·COVIDIEN, FORMERLY US SURGICAL A DIVISON·Product code LFL·September 26, 2014

JAGWIRE

FDA Adverse Event
Malfunction ·BOSTON SCIENTIFIC - COSTA RICA·Product code EZB·June 14, 2011

MINIBORE EXTENSION SET

FDA Adverse Event
Malfunction ·CAREFUSION·Product code FPA·May 19, 2015

TRIATHION

FDA Adverse Event
Injury ·HOWMEDICA OSTEONICS CORP.·Product code JWH·December 14, 2023

TRIATHION COMPONENT

FDA Adverse Event
Injury ·HOWMEDICA OSTEONICS CORP.·Product code JWH·December 14, 2023

The Merlin PCS 3650 programmer Model 3330 The Merlin PCS programmer model 3650 is a portable, dedicated programming system which operates using the Merlin PCS Model 3330 software and is designed to interrogate, program, display data from, and test Abbott Medical implantable devices and leads.

FDA Enforcement
Class II ·Ongoing·Abbott Medical·January 1, 2025