12 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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LIGHTLAS 577 MEDICAL OPTICAL PUMPED SEMICONDUCTOR LASER
FDA 510(k)
FDA Class 2
·Ophthalmic
MHS 5000
FDA 510(k)
FDA Class 1
·Obstetrics/Gynecology
DIASTAT ANTI-CARDIOLIPIN IGA, MODEL FCAR 500
FDA 510(k)
FDA Class 2
·Immunology
VASOVIEW 6 ACCESSORY PACK
FDA Adverse Event
Malfunction
·MAQUET CV·Product code GCJ·January 10, 2019
VASOVIEW 6 ACCESSORY PACK
FDA Adverse Event
Malfunction
·MAQUET CV·Product code GCJ·January 10, 2019
VASOVIEW 6 ACCESSORY PACK
FDA Adverse Event
Malfunction
·MAQUET CV·Product code GCJ·January 10, 2019
FORTIFY VR, DF4 CONNECTOR
FDA Adverse Event
Malfunction
·ST. JUDE MEDICAL, INC. CRMD·Product code LWS·January 13, 2014
COAGUCHEK ® XS SYSTEM
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS·Product code GJS·May 3, 2013
SYSTEM, PERITONEAL, AUTOMATIC DELIVERY
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE·Product code FKX·May 18, 2011
SMARTNAIL
FDA Adverse Event
Injury
·CONMED CORPORATION·Product code MAI·July 29, 2019
EVOLUT FX PLUS VALVE
FDA Adverse Event
Malfunction
·MEDTRONIC HEART VALVES DIVISION·Product code NPT·May 6, 2025
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