10 results
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31ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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TRAXCESS 14EX GUIDEWIRE AND TRAXCESS DOCKING WIRE
FDA 510(k)
FDA Class 2
·Cardiovascular
COLLES C SERIES FRAME STERILE PACK
FDA 510(k)
FDA Class 2
·Orthopedic
PACIFIC HEMOSTASIS REFERENCE EMULSION
FDA 510(k)
FDA Class 2
·Clinical Chemistry
FOOTPRINT ULTRA PK SUTURE ANCHOR, 4.5
FDA Adverse Event
Injury
·SMITH & NEPHEW, INC.·Product code MBI·August 4, 2015
FOOTPRINT ULTRA PK SUTURE ANCHOR, 4.5
FDA Adverse Event
Injury
·SMITH & NEPHEW, INC.·Product code MBI·July 28, 2015
25 G X 5/8 IN. BD ECLIPSE¿ NEEDLE
FDA Adverse Event
Malfunction
·BECTON DICKINSON, S.A.·Product code FMI·March 1, 2016
HEARTSTREAM FR2
FDA Adverse Event
Malfunction
·PHILIPS MEDICAL SYSTEMS·Product code MKJ·April 26, 2013
MECHANICAL WALKER, ROLLATOR
FDA Adverse Event
UNKNOWN·Product code ITJ·September 16, 2014
VASOVIEW HEMOPRO 2 EVH SYSTEM
FDA Adverse Event
Malfunction
·MAQUET CARDIOVASCULAR, LLC.·Product code GEI·April 12, 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