11 results · 28ms · Sources: EU EUDAMED, US FDA

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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