10 results
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19ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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OTC TENS FOR LOW BACK PAIN RELIEF, MODEL WL-2407
FDA 510(k)
FDA Class 2
·Neurology
ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
FDA UDI
FX SOLUTIONS·03701037315040·Ø36 Centered Glenosphere with +6mm lateralized ...
GENETRA
FDA 510(k)
FDA Class 2
·Radiology
LEIBINGER NEURO CLIP SYSTEM
FDA 510(k)
FDA Class 2
·Dental
ATRICURE BIPOLAR SYSTEM
FDA Adverse Event
Injury
·ATRICURE, INC.·Product code GEI·July 28, 2010
GEM MICROVASCULAR ANASTOMOTIC COUPLER
FDA Adverse Event
Malfunction
·SYNOVIS SURGICAL INNOVATIONS·Product code MVR·April 12, 2013
HEATED OXYGEN THERAPY KIT
FDA Adverse Event
Malfunction
·FISHER & PAYKEL HEALTHCARE LTD·Product code BTT·April 20, 2011
PULSE GEN MODEL 102
FDA Adverse Event
Malfunction
·CYBERONICS, INC.·Product code LYJ·June 20, 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