7 results
·
25ms
·
Sources: EU EUDAMED, US FDA
TIP, RUBBER, PERFORATED
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
PIEZOTOME
FDA 510(k)
FDA Class 2
·Dental
Hi bebe plus
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
IVT DISPOSABLE
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - AIBONITO·Product code KPE·September 26, 2012
VASOVIEW HEMOPRO 2
FDA Adverse Event
Malfunction
·MAQUET CV·Product code GEI·June 29, 2016
LAMITRODE TRIPOLE 16 LEAD, 60 CM
FDA Adverse Event
Injury
·ST. JUDE MEDICAL - NEUROMODULATION·Product code GZB·May 8, 2015
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