12 results
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20ms
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Sources: EU EUDAMED, US FDA
ISLAM STERNAL PUNCTURE NEEDLE, CAT #AG-598-OO-E
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
APK
FDA UDI
APK Technology Co.,Ltd.·06946725540367·Criticare Compatible Adult Clip SpO2 Sensor
Sklar®
FDA UDI
SKLAR CORPORATION·10649111220913·FREEWAY GRAVES SPEC OPNSIDE90
ECHELON MICRO CATHETER, MARATHON MICRO CATHETER, NAUTICA MICRO CATHETER ULTRAFLOW HPC FLOW DIRECTED MICRO CATHETER, REBA
FDA 510(k)
FDA Class 2
·Cardiovascular
NUVASIVE TRAVERSE PLATE SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
NV MICROCATHETER
FDA Adverse Event
Injury
·MICRO THERAPEUTICS, INC. DBA EV3·Product code KRA·July 9, 2020
MANIFOLD IN K09-03750 CONVENIENCE KIT
FDA Adverse Event
Malfunction
·MERIT MEDICAL SYSTEMS, INC.·Product code DTL·April 30, 2009
HIGH PRESSURE TUBING /K09-03750 CONVENIENCE KIT
FDA Adverse Event
Malfunction
·MERIT MEDICAL SYSTEMS, INC.·Product code FPK·April 30, 2009
DURATA STS OPTIM ACTIVE FIXATION
FDA Adverse Event
Malfunction
·ST. JUDE MEDICAL, INC., CRMD·Product code NVY·June 30, 2014
MAYFIELD 2000 BASE UNIT
FDA Adverse Event
Malfunction
·INTEGRA LIFESCIENCES CORPORATION OH/USA·Product code HBL·January 4, 2013
RENAL - DISPOSABLE
FDA Adverse Event
Injury
·Product code KDJ·November 20, 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