8 results
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27ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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OLYMPUS LF-TP AND LF-DP TRACHEAL INTUBATION FIBERSCOPES, ACCESSORIES AND ANCILLARY EQUIPMENT
FDA 510(k)
FDA Class 2
·Ear, Nose, Throat
Polystar Selection EDITION
FDA UDI
Merz Dental GmbH·D7091981543·anteriors; shade A2 light; mould CM6
VITROS IMMUNODIAGNOSTIC PRODUCTS TSH REAGENT PACK AND CALIBRATORS, VITROS 5600 INTEGRATED SYSTEM
FDA 510(k)
FDA Class 2
·Clinical Chemistry
Cure OPEL-C Plate System
FDA 510(k)
FDA Class 2
·Orthopedic
INTERMATE
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - IRVINE·Product code FRN·February 27, 2013
9800
FDA Adverse Event
Malfunction
·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·January 31, 2011
ULTRAFLEX? ESOPHAGEAL NG
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC - GALWAY·Product code ESW·August 5, 2014
MENTOR 2" Tall Height TE With Sutures 450cc PN: 354-9313 The MENTOR CPX4 and CPX4 with Suture Tabs Breast Tissue Expanders are used for breast reconstruction following mastectomy and are intended for temporary subcutaneous or submuscular implantation and are not intended for use beyond six months.
FDA Enforcement
Class II
·Terminated·Mentor Texas, LP.·September 14, 2016