10 results
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17ms
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Sources: EU EUDAMED, US FDA
VARIOUS SUPPORTS AND SPLINTS
FDA 510(k)
FDA Class 1
·Physical Medicine
CODMAN® HAKIM®
FDA UDI
INTEGRA LIFESCIENCES PRODUCTION CORPORATION·10381780534891·CODMAN® HAKIM® Precision Fixed Pressure Valve, ...
Obtura Spartan
FDA UDI
Young Innovations, Inc.·00843471100288·Obtura Max Plunger Shaft Assy.
NESSY (OMEGA) DISPOSABLE SPLIT RETURN ELECTRODES, MODELS P/N: 20193-084 AND P/N: 20193-085
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
COHERENCE RT THERAPIST CONNECT WORKSPACE, V2.3, ARIA CONNECTIVITY OPTION FOR SIEMENS NON-IMAGING SYSTEMS, ARIA CONNECTIV
FDA 510(k)
FDA Class 2
·Radiology
UNIVERSAL MODULAR ELECTRIC/BATTERY DOUBLE
FDA Adverse Event
Malfunction
·ZIMMER SURGICAL S.A.·Product code GEY·February 20, 2014
HARMONIC ACE 36 CM
FDA Adverse Event
Malfunction
·ETHICON ENDO-SURGERY, INC. (CINCINNATI)·Product code LFL·December 3, 2007
TOTALCARE
FDA Adverse Event
Malfunction
·HILL-ROM, INC.·Product code FNL·October 10, 2012
PSS Select medical products***Biopsy Punches*** Disposable manual instrument for skin biopsy.
FDA Enforcement
Class II
·Terminated·Clorox Healthcare Holdings, LLC (dba HealthLink)·July 10, 2013
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