15 results
·
19ms
·
Sources: EU EUDAMED, US FDA
KUDO (POWERED ROTATION BED)
FDA 510(k)
FDA Class 2
·Physical Medicine
AURA CERAMIC DENTAL APPLIANCE
FDA 510(k)
FDA Class 1
·Dental
DMAC INDOLE REAGENT
FDA 510(k)
FDA Class 1
·Microbiology
TENDRIL ST
FDA Adverse Event
Injury
·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code NVN·January 9, 2013
UNKNOWN DEPUY ASR HIP
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDICS, INC.·Product code JDI·November 19, 2010
SWEET TIP
FDA Adverse Event
Malfunction
·CPI - DEL CARIBE·Product code NVN·July 1, 2014
COMP PRIMARY STEM 10MM MINI
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code KWS·August 6, 2019
COMP RVRS 25MM BSPLT HA+ADPTR
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code KWS·August 6, 2019
COMP RVSR SHLDR GLNSP +3 36MM
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code KWS·August 6, 2019
ARCOM XL 44-36 STD HMRL BRNG
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code KWS·August 6, 2019
COMPREHENSIVE REVERSE SHOULDER LK SCR 3.5HEX 4.75X45 ST
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code KWS·September 23, 2019
COMPREHENSIVE REVERSE SHOULDER LK SCR 3.5HEX 4.75X15 ST
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code HSD·September 23, 2019
COMPREHENSIVE REVERSE SHOULDER LK SCR 3.5HEX 4.75X20 ST
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code KWS·September 23, 2019
COMPREHENSIVE REVERSE SHOULDER LK SCR 3.5HEX 4.75X20 ST
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code HSD·September 23, 2019
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