8 results
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20ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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LIGHTLAS 561 OPTHALMIC PHOTOCOAGULATOR
FDA 510(k)
FDA Class 2
·Ophthalmic
AIRCAST, MODEL #3011
FDA 510(k)
FDA Class 2
·Cardiovascular
MAMMOTOME HAND HELD PROBE, MODEL MHH8
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
OPTIFLUX 160NRE DIALYZER FINISHED ASSY.
FDA Adverse Event
Malfunction
·OGDEN MANUFACTURING·Product code FJI·March 1, 2013
COATED VICRYL (POLYGLACTIN 910) SUTURE
FDA Adverse Event
Injury
·ETHICON,INC·Product code GAM·April 19, 2011
TAXUS EXPRESS2 PACLITAXEL - ELUTING CORONARY STENT SYSTEM
FDA Adverse Event
Death
·BOSTON SCIENTIFIC·Product code NIQ·June 19, 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