11 results
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37ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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STERILS SINGLE-USE I/A HANDPIECES
FDA 510(k)
FDA Class 2
·Ophthalmic
SILCONE COATED I/A 45 HANDHELD INSTRUMENT
FDA Adverse Event
Injury
·BAUSCH + LOMB·Product code HQC·May 7, 2019
COBE HC 700 MIDI HEMOCONCENTRATOR
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
LIFESITE HEMODIALYSIS ACCESS SYSTEM, CANNULA EXCHANGE KIT, INSERTION KIT, ACCESS CANNILA
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
RECONSTRUCTION NAIL R2.0, TI, LEFT T2 RECON 11X340 MM X 125
FDA Adverse Event
Injury
·STRYKER TRAUMA KIEL·Product code HSB·September 24, 2020
OT ULTRALINK METER
FDA Adverse Event
Malfunction
·LIFESCAN INC.·Product code NBW·April 6, 2011
LIFEVEST WCD 4000 SYSTEM
FDA Adverse Event
Malfunction
·ZOLL LIFECOR CORPORATION·Product code MVK·April 8, 2013
PRIME 5TH WHEEL STRETCHER, 30"
FDA Adverse Event
Malfunction
·STRYKER MEDICAL·Product code FPO·April 21, 2011
CURRENT VR RF
FDA Adverse Event
Injury
·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code LWS·July 11, 2008
OT ULTRALINK METER
FDA Adverse Event
Malfunction
·LIFESCAN INC.·Product code NBW·February 18, 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