9 results
·
18ms
·
Sources: EU EUDAMED, US FDA
QUARTZ RETRACTOR/PROBE
FDA 510(k)
FDA Class 1
·Obstetrics/Gynecology
CALIBRATION PACK, MODELS A9100-101S AND A9100-103S
FDA 510(k)
FDA Class 2
·Clinical Chemistry
HORIZON XVU (FFR)
FDA 510(k)
FDA Class 2
·Cardiovascular
THERAPY ABLATION CATHETER
FDA Adverse Event
Malfunction
·IRVINE BIOMEDICAL, A ST. JUDE MEDICAL COMPANY·Product code OAD·August 25, 2010
AIR DERMATOME HANDPIECE
FDA Adverse Event
Malfunction
·ZIMMER SURGICAL·Product code GFD·February 20, 2014
VNGRD PS TIB BRNG 63/67X12
FDA Adverse Event
Injury
·BIOMET ORTHOPEDICS·Product code JWH·November 8, 2012
TRIATHLON-CR FEMORAL COMPONENT CEMEMTED #5 RIGHT
FDA Adverse Event
Other
·STRYKER ORTHOPAEDICS LIMERICK·Product code JWH·August 30, 2010
Exactech Equinoxe CAGE GLENOID, CEMENTED, beta curvature, Mates with: a) 47, 50, 53 head, Medium, Item Number 314-13-13, b) 47, 50, 53 head, Large, Item Number 314-13-14, c) 47, 50, 53 head, Extra Large, Item Number 314-13-15; Shoulder Arthroplasty
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·April 10, 2024
Zimmer, Cuff Tourniquet Dual Hose Single Bladder Maroon Reprocessed by Sterilmed, Sterile EO, Rx only.
FDA Enforcement
Class II
·Terminated·STERILMED, INC.·December 16, 2015