10 results
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26ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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EXPEDIUM MIS SPINE SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
SOLIDEA
FDA UDI
CALZIFICIO PINELLI SRL·08300496041801·CATHERINE CCL.1 OPEN TOE, SIZE XL, NATUR, GRADU...
FUTURA TOPCAP NON GAMMA-2
FDA 510(k)
FDA Class 2
·Dental
STEATHSTATION TREATMENT GUIDANCE PLATFORM
FDA 510(k)
FDA Class 2
·Neurology
CELL-DYN EMERALD CLEANER
FDA Adverse Event
Malfunction
·ABBOTT DIAGNOSTICS DIVISION·Product code GKZ·April 26, 2016
OT VERIO IQ METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·April 8, 2013
VENTAK PRIZM 2 VR
FDA Adverse Event
Malfunction
·CARDIAC PACEMAKERS, INC·Product code LWS·May 8, 2008
FINELINE II
FDA Adverse Event
Malfunction
·CPI - DEL CARIBE·Product code NVN·April 6, 2011
The Spirit Plus Bed, Model 5600 Spirit Plus /with high rail siderail option
FDA Enforcement
Class II
·Terminated·Stryker Medical Division of Stryker Corporation·November 21, 2018
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