10 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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AMS SMART SLING SYSTEM
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
ARM AUTOMATIC REPROCESSING MACHINE
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
SONOPREP IMPEDANCE DIAGNOSTICS (IDX) SYSTEM, MODEL D1000
FDA 510(k)
FDA Class 2
·Cardiovascular
SYNERGY II EVEROLIMUS-ELUTING PLATINUM CHROMIUM CORONARY STENT SYSTEM
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC - GALWAY·Product code NIQ·September 6, 2016
CONNECTA PLUS3 RED
FDA Adverse Event
Malfunction
·BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V.·Product code FPA·January 18, 2021
LIQUID INFANT HEEL WARMER
FDA Adverse Event
Malfunction
·COOPERSURGICAL, INC.·Product code MPO·April 12, 2013
3D KNEE SYSTEM
FDA Adverse Event
Other
·ENCORE MEDICAL, L.P.·Product code HSH·June 20, 2008
ZIMMER M/L TAPER FEMORAL STEM
FDA Adverse Event
Injury
·ZIMMER INC·Product code LPH·April 13, 2011
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