7 results
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26ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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RM3 RENAL PRESERVATION SYSTEM--CONTROL UNIT
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
NexSite HD, Hemodialysis Step Tip Catheter (60cm)
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
SURGIQUEST AIRSEAL OPTICAL TROCAR & CANNULA SYSTEM
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
ASR TAP SLV ADAP 12/14 -1
FDA Adverse Event
Injury
·DEPUY INTERNATIONAL·Product code KWA·February 21, 2013
UNKNOWN SPINAL CORD STIMULATOR
FDA Adverse Event
Injury
·MEDTRONIC NEUROMODULATION·Product code LGW·January 25, 2011
HOMECHOICE AUTOMATED PD SET WITH CASSETTE
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code FKX·July 31, 2014
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