9 results
·
22ms
·
Sources: EU EUDAMED, US FDA
MitraPatch Mitral Valve Repair System
FDA 510(k)
FDA Class 2
·Cardiovascular
Tissue Holder
FDA UDI
KATENA PRODUCTS, INC.·00841668111192·STEEL BASE FOR BARRON AAC
ENDURANCE
FDA UDI
DEPUY ORTHOPAEDICS, INC.·10603295128113·ENDURANCE REVISION TRIAL SIZE 4 250mm
UST-5550-R; UST-5536-R; L43K
FDA 510(k)
FDA Class 2
·Radiology
Disposable Surgical Mask
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
INTERSTIM II
FDA Adverse Event
Injury
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code EZW·November 14, 2014
HOMECHOICE AUTOMATED PD SET WITH CASSETTE
FDA Adverse Event
Injury
·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code FKX·September 16, 2011
UNKNOWN BMD WOMEN'S HEALTH PRODUCT
FDA Adverse Event
Injury
·C.R. BARD, INC. (COVINGTON)·Product code FTM·July 25, 2013
Allura Exper FD Series. System codes 722003 722010 722022 722005 722011 722019 722001 722002 722006 722012 722008 722013 722020 722025 722015 722023 722038 889006 889016 889009 722005 The device is an X-Ray Generator.
FDA Enforcement
Class II
·Terminated·Philips North America, LLC·March 25, 2020