9 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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1.9F X 20 CM VASCU-PICC, MODELS VP1.9S20 AND VP1.9S50
FDA 510(k)
FDA Class 2
·General Hospital
GUIDE WIRE, SMOOTH-TIPPED, STERILE T2 HUMERUS Ø2,2X800 MM
FDA Adverse Event
Malfunction
·STRYKER TRAUMA KIEL·Product code LXH·August 11, 2016
SURGITRON IEC II
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
SAFE-STEER GUIDE WIRE SYSTEM
FDA 510(k)
FDA Class 2
·Cardiovascular
ONETOUCHPING GLUCOSEMGMTSYSTEM
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·April 16, 2013
PULSE GEN MODEL 103
FDA Adverse Event
Malfunction
·CYBERONICS, INC.·Product code LYJ·April 6, 2011
PULSE GEN MODEL 101
FDA Adverse Event
Malfunction
·CYBERONICS, INC.·Product code LYJ·June 13, 2008
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
CADD¿- Solis Ambulatory Infusion Pump, Model 2111 & 2112, Version 1.0, Version 2.0 and Version 3.0 & Model 2120, Version 1.0. Provide measured drug therapy to patients in hospital or outpatient settings.
FDA Enforcement
Class II
·Terminated·Smiths Medical ASD, Inc.·June 24, 2015