11 results
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28ms
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Sources: EU EUDAMED, US FDA
SAPCRILL THERMODETECT BREAST SCANNER DEV
FDA 510(k)
FDA Class 1
·General Hospital
Cochlear™ Slimline™ Coil
FDA UDI
COCHLEAR LIMITED·09321502040358·25cm (10") Sand
NAR
FDA UDI
NORTH AMERICAN RESCUE, LLC·00842209127511·
MEDTRONIC EXPORT AP CATHETER
FDA 510(k)
FDA Class 2
·Cardiovascular
SENSITITRE 18-24 HOURS SUSCEPTIBILITY PLATES
FDA 510(k)
FDA Class 2
·Microbiology
OT PING METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·May 9, 2014
FREESTYLE FLASH
FDA Adverse Event
Malfunction
·ABBOTT DIABETES CARE INC, USA·Product code LFR·October 16, 2007
XIENCE PRIME LL EVEROLIMUS ELUTING CORONARY STENT SYSTEM
FDA Adverse Event
Malfunction
·AV-TEMECULA-CT·Product code NIQ·October 23, 2012
AORTIC EXCLUDER AAA ENDOPROSTHESIS (LOW PROFILE)
FDA Adverse Event
Death
·W.L. GORE & ASSOCIATES·Product code MIH·October 31, 2018
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
Promote Quadra, Sterile EO, Model # / Part #: CD3221-36/100025054, 60019195; CD3223-36P/100013763; CD3239-40/100029115, 100029254, 100037181; CD3239-40Q/100029116, 100029244, 100037115
FDA Enforcement
Class II
·Terminated·St Jude Medical Inc.·July 4, 2018