9 results
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17ms
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Sources: EU EUDAMED, US FDA
GYNE-SHEAR CERVICAL BIOPSY INSTRUMENT W/DISPIS TIP
FDA 510(k)
FDA Class 1
·Obstetrics/Gynecology
NAR
FDA UDI
NORTH AMERICAN RESCUE, LLC·00842209118830·
Endo-Model SL Knee Prosthesis System
FDA UDI
WALDEMAR LINK GmbH & Co. KG·04026575384167·Modular Stem, with male taper for 6mm noses, ce...
PATHWAY - ATS/CHEPS
FDA 510(k)
FDA Class 2
·Neurology
MicroSTAAR Injector System Cartridges
FDA 510(k)
FDA Class 1
·Ophthalmic
ASR UNI FEMORAL IMPL SIZE 47
FDA Adverse Event
Injury
·DEPUY INTL., LTD - 8010379·Product code KWA·June 5, 2014
SPINBRUSH PRO WHITENING POWERED TOOTHBRUSH
FDA Adverse Event
Malfunction
·CHURCH & DWIGHT CO., INC.·Product code JEQ·November 13, 2012
LAMITRODE 44 LEAD
FDA Adverse Event
Injury
·ADVANCED NEUROMODULATION SYSTEMS, INC.·Product code LGW·September 29, 2010
Exactech Equinoxe CAGE GLENOID,POSTERIOR AUGMENT, CEMENTED, Left, Mates with: a) 38, 41, 44, 47 head, Small, Item Number 314-13-22, b) 41, 44, 47, 50, head, Medium, Item Number 314-13-23, c) 44, 47, 50, 53 head, Large, Item Number 314-13-24, d) 44, 47, 50, 53 head, Extra Large, Item Number 314-13-25; Shoulder Arthroplasty
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·April 10, 2024