9 results
·
26ms
·
Sources: EU EUDAMED, US FDA
MULTI FORMAT VIDEO IMAGER 600 PLUS
FDA 510(k)
FDA Class 2
·Radiology
RP Low Margin Abutment Plastic Cylinder, 8.0 mm
FDA UDI
STERNGOLD DENTAL LLC·00841549111204·A prefabricated device intended to provide a pe...
NEOPHOR-MC
FDA 510(k)
FDA Class 2
·Physical Medicine
TOPOGRAPHIC MODELING SYSTEM
FDA 510(k)
FDA Class 1
·Ophthalmic
CORTEX SCREW
FDA Adverse Event
Injury
·SYNTHES (USA)·Product code HWC·January 9, 2013
OCTRODE LEAD KIT, 60CM LENGTH
FDA Adverse Event
Malfunction
·ADVANCED NEUROMODULATION SYSTEMS·Product code LGW·October 28, 2010
INGENIO
FDA Adverse Event
Injury
·GUIDANT CRM CLONMEL IRELAND·Product code LWP·July 1, 2014
CUP: MPACT 01.32.156MH ACETABULAR SHELL Ø56 MULTI-HOLE
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code LPH·February 21, 2022
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