7 results
·
19ms
·
Sources: EU EUDAMED, US FDA
ARTERIAL BLOOD SAMPLING KIT
FDA 510(k)
FDA Class 2
·Cardiovascular
DYNA LOCKING IM NAIL
FDA 510(k)
FDA Class 2
·Orthopedic
BIOPSY HANDY, MRI BIOPSY HANDY
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
INRATIO2 PT/INR PROFESSIONAL TEST STRIPS
FDA Adverse Event
Malfunction
·ALERE SAN DIEGO, INC.·Product code GJS·May 9, 2014
OT VERIO IQ METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·January 9, 2013
PROX*ACCESS 55MM ART STAP THIC
FDA Adverse Event
Malfunction
·ETHICON ENDO-SURGERY, LLC.·Product code GDW·November 18, 2010
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