8 results
·
17ms
·
Sources: EU EUDAMED, US FDA
INMAN IRRIGATION TAPERED PROBE
FDA 510(k)
FDA Class 1
·General Hospital
Nu-Edge Cobalt Chromium Brackets
FDA UDI
TP ORTHODONTICS INC·00192029047026·UR LAT
PF Keep; Cad Cam Keep Block
FDA 510(k)
FDA Class 2
·Dental
NSI HEXED AND NON-HEXED IMPLANT SYSTEM AND IMMEDIATE LOADING
FDA 510(k)
FDA Class 2
·Dental
CORE IMPACTION DRILL
FDA Adverse Event
Malfunction
·STRYKER INSTRUMENTS-KALAMAZOO·Product code DZJ·January 29, 2013
PUMP MMT-522WWP PRDGM INSULIN PL EN ML
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO OPERATIONS MED-REL·Product code MDS·December 14, 2010
PRECISION SPECTRA®
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC NEUROMODULATION·Product code LGW·July 14, 2014
OPTETRAK Comprehensive Knee System including OPTETRAK RBK PS Tibial Components. NOTE: Information reflects Exactech recall expansion initiated on 02/07/2022.
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·October 13, 2021