15 results · 19ms · Sources: EU EUDAMED, US FDA

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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