8 results
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18ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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VITA OMEGA PORCELAIN
FDA 510(k)
FDA Class 2
·Dental
De Soutter Medical
FDA UDI
DE SOUTTER MEDICAL LIMITED·05051471123809·K-WIRE - DOUBLE TROCAR 1.4mm DIA x 100mm
PRIMUS Healthcare Sterilizer (Model PSS11-HC)
FDA 510(k)
FDA Class 2
·General Hospital
DISPOSABLE LINEAR STAPLER, DISPOSABLE LINEAR CUTTER
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
RUSCH EB ROBERTSHAW LEFT 39F
FDA Adverse Event
Malfunction
·TELEFLEX MEDICAL·Product code BTS·June 6, 2014
HOMECHOICE PRO
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - LARGO·Product code FKX·January 18, 2013
SPRINT QUATTRO SECURE
FDA Adverse Event
Injury
·MEDTRONIC PUERTO RICO, INC.·Product code LWS·December 13, 2010
TRULIANT Knee System including TRULIANT Tibial Inserts, also labeled as the following: a. TRULIANT CR Tibial Inserts; b. TRULIANT CR Slope + Tibial Inserts; c. TRULIANT CR Slope ++ Tibial Inserts; d. TRULIANT CRC Tibial Inserts; e. TRULIANT PS Tibial Inserts; f. TRULIANT PSC Tibial Inserts. NOTE: Information reflects Exactech recall expansion initiated on 02/07/2022.
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·October 13, 2021