12 results
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27ms
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Sources: EU EUDAMED, US FDA
HOT/COLD PACK HOLDERS
FDA 510(k)
FDA Class 1
·Physical Medicine
CODMAN® HAKIM®
FDA UDI
INTEGRA LIFESCIENCES PRODUCTION CORPORATION·10381780534914·CODMAN® HAKIM® Precision Fixed Pressure Valve, ...
HUMELOCK II CEMENTED SHOULDER SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
GRADIA DIRECT
FDA 510(k)
FDA Class 2
·Dental
DISTAL TARGETING DEVICE R1.5
FDA Adverse Event
Malfunction
·STRYKER OSTEOSYNTHESIS KIEL·Product code LXH·February 22, 2012
PV-INLINE W/SG [MH]
FDA Adverse Event
Malfunction
·CODMAN & SHURTLEFF·Product code JXG·July 23, 2014
LIFEVEST WCD 4000 SYSTEM
FDA Adverse Event
Malfunction
·ZOLL LIFECOR CORPORATION·Product code MVK·May 2, 2014
PROXIMATE HCS PROCEDURE FOR PROLAPSE AND HEMORRHOIDS (PPH)
FDA Adverse Event
Malfunction
·ETHICON ENDO-SURGERY, INC. (CINCINNATI)·Product code GDW·December 3, 2007
TOTALCARE
FDA Adverse Event
Malfunction
·HILL-ROM, INC.·Product code FNL·October 10, 2012
PV-INLINE W/SG [MH]
FDA Adverse Event
Malfunction
·CODMAN & SHURTLEFF, INC.·Product code JXG·February 25, 2015
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
Exactech Equinoxe REVERSE SHOULDER,42mm Humeral Liner, a) +0mm, Item number 320-42-00, b) +2.5mm, Item Number 320-42-03; Shoulder Arthroplasty
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·April 10, 2024