11 results
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23ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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ACCUFRAME
FDA 510(k)
FDA Class 2
·Dental
SchureMed
FDA UDI
SCHUERCH CORPORATION·00810014609935·MIDMARK 2.25" SOFTCARE PLUS
COOK IVF CRYOPRESERVATION KIT AND THE COOK IVF THAW KIT
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
MONARCH II IOL DELIVERY SYSTEM
FDA 510(k)
FDA Class 1
·Ophthalmic
CADD MEDICATION CASSETTE
FDA Adverse Event
Malfunction
·NULL·Product code FPA·February 4, 2022
INFINION? CX
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC NEUROMODULATION CORPORATION·Product code LGW·August 26, 2025
XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM
FDA Adverse Event
Injury
·AV-TEMECULA-CT·Product code NIQ·April 26, 2013
KNIFE
FDA Adverse Event
Malfunction
·ALCON PRECISION DEVICE - SINKING SPRING·Product code HNN·April 14, 2011
HOLMIUM LASER FIBER
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC CORPORATION·Product code GEX·July 10, 2008
DAVINCI SI
FDA Adverse Event
Malfunction
·INTUITIVE SURGICAL, INC·Product code NAY·May 4, 2020
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