12 results
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27ms
·
Sources: EU EUDAMED, US FDA
TTU-100THERMAL THERAPY UNIT
FDA 510(k)
FDA Class 2
·Physical Medicine
EBERLE
FDA UDI
Eberle GmbH & Co. KG·04050052023508·Wire driver adapter, 1.8-3.2mm
NA
FDA UDI
Stryker Leibinger GmbH & Co. KG·04546540695048·UNIVERSAL MANDIBLE INSTRUMENT TRAY
WARMTOUCH COMPACT WARMING UNIT
FDA Adverse Event
Malfunction
·COVIDIEN/FORMERLY TYCO·Product code DWJ·December 23, 2010
POWDERED LATEX EXAMINATION GLOVES
FDA 510(k)
FDA Class 1
·General Hospital
Visera Elite II Video System Center, Visera Elite II Endoeye 3D
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
WARM TOUCH II COMPACT WARMING UNIT
FDA Adverse Event
Malfunction
·COVIDIEN, FORMERLY TYCO HEALTHCARE·Product code DWJ·September 24, 2010
ICY HOT SMART RELIEF TENS THERAPY (SMART RELIEF TENS THERAPY)
FDA Adverse Event
Injury
·CHATTEM, INC.·Product code NUH·June 11, 2014
LRG TAP PRI MOD NCK 0DEG 30MM
FDA Adverse Event
Injury
·STRYKER ORTHOPAEDICS-MAHWAH·Product code LZO·January 14, 2013
LIFEVEST WCD 4000 SYSTEM
FDA Adverse Event
Malfunction
·ZOLL LIFECOR CORPORATION·Product code MVK·November 18, 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
Exactech Equinoxe CAGE GLENOID, CEMENTED, alpha curvature, Mates with: a) 38, 41, 44 head, Small, Item Number 314-13-02, b) 38, 41, 44 head, Medium, Item Number 314-13-03, c) 38, 41, 44 head, Large, Item Number 314-13-04; Shoulder Arthroplasty
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·April 10, 2024