19 results
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32ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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DENFIL
FDA 510(k)
FDA Class 2
·Dental
GALEMED PEAK FLOW METER, MODELS 3751/3752
FDA 510(k)
FDA Class 2
·Anesthesiology
MERSILK BLACK SILK BRAIDED NON-ABSORBABLE SUTURE, USP
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
VERTEX RECONSTRUCTION SYSTEM
FDA Adverse Event
Malfunction
·WARSAW ORTHOPEDIC INC.·Product code KWP·November 2, 2010
SPECTRUM INFUSION PUMP
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - MEDINA·Product code FRN·April 5, 2019
AISYS
FDA Adverse Event
Malfunction
·DATEX-OHMEDA, INC.·Product code BSZ·January 18, 2016
VERTEX RECONSTRUCTION SYSTEM
FDA Adverse Event
Malfunction
·WARSAW ORTHOPEDIC INC.·Product code KWP·January 5, 2009
VERTEX RECONSTRUCTION SPINAL SYSTEM
FDA Adverse Event
Malfunction
·WARSAW ORTHOPEDIC INC.·Product code KWP·July 23, 2010
SPECTRUM INFUSION PUMP
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - MEDINA·Product code FRN·April 5, 2019
SPECTRUM INFUSION PUMP
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - MEDINA·Product code FRN·April 5, 2019
SPECTRUM INFUSION PUMP
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - MEDINA·Product code FRN·April 5, 2019
SPECTRUM INFUSION PUMP
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - MEDINA·Product code FRN·April 4, 2019
AISYS
FDA Adverse Event
Malfunction
·DATEX-OHMEDA, INC.·Product code BSZ·January 15, 2016
VERTEX RECONSTRUCTION SYSTEM
FDA Adverse Event
Injury
·WARSAW ORTHOPEDIC INC.·Product code KWP·April 2, 2010
VERTEX RECONSTRUCTION SYSTEM
FDA Adverse Event
Malfunction
·WARSAW ORTHOPEDIC INC.·Product code KWP·November 20, 2009
QUATTRODE
FDA Adverse Event
Injury
·ST. JUDE MEDICAL - NEUROMODULATION·Product code GZB·April 4, 2013
VITALITY DS VR
FDA Adverse Event
Malfunction
·CARDIAC PACEMAKERS, INC·Product code LWS·May 8, 2008
SAGB QUICK CLOSE
FDA Adverse Event
Injury
·OBTECH MEDICAL SARL_·Product code LTI·April 6, 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