10 results
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28ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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KARL STORZ RETRACTORS, PROBES, DISSECTORS, HOOKD
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
APEX Knee System
FDA UDI
Omni Life Science, Inc.·00841690188254·NOTCHED POSTERIOR AUGMENT TRIAL REVISION FEMUR ...
APEX Knee System
FDA UDI
Omni Life Science, Inc.·00841690128953·Femoral Augment, Notched Posterior, Size 5+, 10mm
Guided Tissue Punch
FDA UDI
BICON, LLC·00813110026422·4.5mm Guided Tissue Punch
NEONATAL/STERILE/DISPOS/NONINVAS BLOOD PRESS CUFF
FDA 510(k)
FDA Class 2
·Cardiovascular
SYSTEMATE PLUS CALIBRATOR
FDA 510(k)
FDA Class 2
·Clinical Chemistry
LAP-BAND AP ADJUSTABLE GASTRIC BANDING SYSTEM (LARGE)
FDA Adverse Event
Malfunction
·ALLERGAN·Product code LTI·January 31, 2013
HEARTMATE II LVAS
FDA Adverse Event
Injury
·THORATEC CORPORATION·Product code DSQ·January 3, 2011
PINN MAR LIP LNR 32IDX54OD
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDICS, INC.1818910·Product code LPH·July 18, 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