11 results
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28ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Catalyst EA Convertible Stemmed Shoulder
FDA 510(k)
FDA Class 2
·Orthopedic
HEALIX ADVANCE
FDA UDI
Medos International Sàrl·10886705022427·HEALIX ADVANCE Cortical Awl-Tap Package Contain...
Philips
FDA UDI
Sbo Hearing A/S·05714464011001·HEARLINK 9030 MNR T R BL
DANA DIABECARE II INSULIN PUMP & SUPERLINE-EASYRELEASE, SOFT-RELEASE-ST, & SOFT-RELEASE-R INFUSION SETS
FDA 510(k)
FDA Class 2
·General Hospital
TETRIS II
FDA 510(k)
FDA Class 2
·Orthopedic
Ambassador Cervical Plate System
FDA UDI
Choice Spine, LP·00840996161282·AMBASSADOR,DRILL,2.3x17
OT VERIO2 METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·June 28, 2018
HOMECHOICE AUTOMATED PD SET WITH CASSETTE
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - SINGAPORE·Product code FKX·November 3, 2014
COLLEAGUE
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·August 24, 2011
TAXUS® LIBERTÉ® LONG
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC - GALWAY·Product code NIQ·July 12, 2013
ARGENT SURGICAL SYSTEMS***BIOPSY Punches*** Disposable manual instrument for skin biopsy.
FDA Enforcement
Class II
·Terminated·Clorox Healthcare Holdings, LLC (dba HealthLink)·July 10, 2013