10 results
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34ms
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Sources: EU EUDAMED, US FDA
SYVA(R) ETS(R) PLUS SYSTEM
FDA 510(k)
FDA Class 1
·Clinical Chemistry
Brigade
FDA UDI
Nuvasive, Inc.·00887517961709·Brigade Lateral Trial, 8x34x24mm 30°
LIFEBRIDGE
FDA 510(k)
FDA Class 2
·Cardiovascular
DIAMOND MEDICA ISE MODULE CALIBRANT A MODEL ME-6370D, DIAMOND MEDICA ISE MODULE CALIBRANT B, MODEL ME-5410D
FDA 510(k)
FDA Class 2
·Clinical Chemistry
ACQSIM CT SCANNER
FDA Adverse Event
Malfunction
·PHILIPS·Product code JAK·August 12, 2014
SYRINGE 50ML LL CONVENIENCE TRAY EUROPE
FDA Adverse Event
Malfunction
·BECTON DICKINSON, S.A.·Product code FMF·August 16, 2019
INFUSOR
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - IRVINE·Product code MEB·June 30, 2014
HEARTMATE II LVAS
FDA Adverse Event
Death
·THORATEC CORPORATION·Product code DSQ·January 4, 2013
UNKNOWN DEPUY LINER
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDICS, INC.·Product code JDI·November 16, 2010
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