10 results
·
27ms
·
Sources: EU EUDAMED, US FDA
MASKA, OXYGEN VINYL D-SP. SINGLE USE
FDA 510(k)
FDA Class 1
·Anesthesiology
Ceramill® ZI
FDA UDI
Amann Girrbach AG·E4947602191·
The Orthodontic Store
FDA UDI
Young Innovations, Inc.·00843471178645·Anatomical Molar Bands, Upper Right 1St & 2Nd M...
Ophthalmic Cannula
FDA UDI
KATENA PRODUCTS, INC.·00841668110560·COAXIAL IRRIGAT-ASPIRAT TIP STR 0.4 PORT
Hilal Embolization MicroCoils
FDA 510(k)
FDA Class 2
·Cardiovascular
VACUUM TUBES, PEDIATRIC SIZES (J-VAC)
FDA 510(k)
FDA Class 2
·Clinical Chemistry
UNKNOWN DEPUY ASR ACETABULAR CUP
FDA Adverse Event
Injury
·DEPUY INTERNATIONAL·Product code KWA·September 26, 2012
SOLITAIRE FR REVASCULARIZATION DEVICE
FDA Adverse Event
Death
·COVIDIEN (IRVINE)·Product code NRY·May 8, 2015
TRANSTAR STRETCHER
FDA Adverse Event
Malfunction
·HILL-ROM, INC.·Product code FPO·July 12, 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