14 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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RELION ULTIMA BLOOD GLUCOSE MONITORING SYSTEM, MODELS 70055-50, STRIPS (20 COUNT): 70973-01
FDA 510(k)
FDA Class 2
·Clinical Chemistry
GEON DIGITAL CLINICAL THERMOMETER
FDA 510(k)
FDA Class 2
·General Hospital
PATIENT VENTILATION OXYGEN CONCENTRATING SYSTEM (PVOCS)
FDA 510(k)
FDA Class 2
·Anesthesiology
PLATE, FIXATION, BONE
FDA Adverse Event
Malfunction
·SYNTHES USA·Product code HRS·November 16, 2015
WAVEWRITER ALPHA PRIME 16
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC NEUROMODULATION·Product code LGW·August 6, 2021
4.0MM CANCELLOUS BONE SCREW PARTIALLY THREADED/45MM
FDA Adverse Event
Malfunction
·SYNTHES USA·Product code HWC·December 9, 2015
FLEXICAP
FDA Adverse Event
Injury
·BAXTER HEALTHCARE - SWINFORD·Product code KDJ·April 29, 2013
PRECISION XTRA
FDA Adverse Event
Malfunction
·Product code NBW·May 10, 2011
ENDOVIVE SAFETY PEG KITS PULL METHOD
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC CORPORATION·Product code KNT·July 24, 2008
BIODESIGN SURGISIS ANTERIOR PELVIC FLOOR GRAFT
FDA Adverse Event
Injury
·COOK BIOTECH, INC.·Product code PAJ·August 2, 2013
SCREW, FIXATION, BONE
FDA Adverse Event
Injury
·SYNTHES (USA)·Product code HWC·September 1, 2016
SCREW, FIXATION, BONE
FDA Adverse Event
Injury
·SYNTHES USA·Product code HWC·December 4, 2015
4.0MM CANCELLOUS BONE SCREW FULLY THREADED/45MM
FDA Adverse Event
Injury
·SYNTHES GRENCHEN·Product code HWC·December 18, 2015
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