11 results
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20ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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CONMED ECG PATIENT CABLES AND LEADWIRES
FDA 510(k)
FDA Class 2
·Cardiovascular
HEPATIC VCAR
FDA 510(k)
FDA Class 2
·Radiology
ALGO Pro Newborn Hearing Screener (ALGO Pro)
FDA 510(k)
FDA Class 2
·Neurology
ASR ACETABULAR CUPS 54
FDA Adverse Event
Injury
·DEPUY INTERNATIONAL, LTD.·Product code KWA·December 17, 2010
SM104 MSERIES W5TH WHLOBS3/07
FDA Adverse Event
Malfunction
·STRYKER MEDICAL-KALAMAZOO·Product code FPO·January 29, 2013
OT VERIO IQ METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·July 15, 2014
MINMED QUICK SET
FDA Adverse Event
Malfunction
·UNOMEDICAL A/S·Product code FPA·August 8, 2024
MINMED QUICK SET
FDA Adverse Event
Malfunction
·UNOMEDICAL A/S·Product code FPA·August 8, 2024
MINMED QUICK SET
FDA Adverse Event
Malfunction
·UNOMEDICAL A/S·Product code FPA·August 8, 2024
MINMED QUICK SET
FDA Adverse Event
Malfunction
·UNOMEDICAL A/S·Product code FPA·August 8, 2024
OPTETRAK Comprehensive Knee System including OPTETRAK All-polyethylene UNI Tibial Components, Product Lines, 252-12-XX, 252-13-XX, 252-22-XX, 252-23-XX. NOTE: Information reflects Exactech recall expansion initiated on 02/07/2022.
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·October 13, 2021