16 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Navagio
FDA UDI
Kalitec Direct LLC·B07330K0134120·Trial, TLIF, 27L OB STR 7Deg, 12mm
AT HOME DRUG TEST, MODEL 9069
FDA 510(k)
FDA Unclassified
·Unknown
Marienfeld Superior
FDA UDI
Paul Marienfeld GmbH & Co. KG·04250317319586·
BETSEY JOHNSON
FDA UDI
FGX INTERNATIONAL INC.·00193033484814·
Cosmolock
FDA UDI
Kalitec Direct LLC·B07311K0130120·Segmental Rod Reducer Driver
BETSEY JOHNSON
FDA UDI
FGX INTERNATIONAL INC.·00193033484838·
BETSEY JOHNSON
FDA UDI
FGX INTERNATIONAL INC.·00193033484821·
FLEXIBLE ENDOSCOPIC SCISSORS
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
ADVIA CENTAUR RUBELLA IGG ASSAY
FDA 510(k)
FDA Class 2
·Microbiology
SERIES 7000 SANDARD TIBIA
FDA Adverse Event
Injury
·STRYKER ORTHOPAEDICS MAHWAH·Product code JWH·August 13, 2012
TRAPEASE FILTER
FDA Adverse Event
Injury
·CORDIS CORPORATION·Product code DTK·June 26, 2015
INTERSTIM II
FDA Adverse Event
Injury
·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code EZW·March 20, 2013
ASAHI CONFIANZA PRO PTCA GUIDE WIRE
FDA Adverse Event
Malfunction
·AV-ASAHI·Product code DQX·March 10, 2011
INSYNC SENTRY
FDA Adverse Event
Injury
·MEDTRONIC MED REL, INC.·Product code NIK·March 10, 2008
Stryker MA204 Bed Model (FL25E) Beds are intended for medical purposes in both general patient care as well as critical care environments. Each uses built-in electric motors and controls which can be operated by the patient, or caregiver, to adjust the height and/or surface contour of the bed.The devices listed above also include movable and latchable side rails which can be lowered or raised to help prevent patient fall and subsequent injury. The Beds include an optional Scale (Models: FL20E, FL25E, FL28C, FL28EX) as well as an optional Bed Exit (1 Zone) or Chaperone
FDA Enforcement
Class II
·Terminated·Stryker Medical Division of Stryker Corporation·July 4, 2012
Ellipse Implantable Cardioverter Defibrillators (ICDs), Model No. CD1275, CD1311, CD2275, CD2311, CD1411, CD2411 Ellipse ST Implantable Cardioverter Defibrillators (ICDs), Model No. CD1273, CD1309, CD1409, CD2273, CD2309, CD2409.
FDA Enforcement
Class II
·Terminated·St Jude Medical Cardiac Rhythm Management Division·September 10, 2014