12 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: 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