12 results
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28ms
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Sources: EU EUDAMED, US FDA
PREMIER-C. DIFFICILE TOXIN A
FDA 510(k)
FDA Class 1
·Microbiology
Brigade
FDA UDI
Nuvasive, Inc.·00887517962683·Brigade Lateral Trial, 8x34x32mm 15°
BBIG
FDA UDI
BBig B.V.·08719616011714·4903456
AUTOSOFT XC
FDA Adverse Event
Malfunction
·UNOMEDICAL A/S·Product code FPA·July 4, 2024
THE SENSITITRE AIM
FDA 510(k)
FDA Class 2
·Microbiology
JETSTREAM G3 SYSTEM
FDA 510(k)
FDA Class 2
·Cardiovascular
DURASUL, ALPHA INSERT, II/36
FDA Adverse Event
Malfunction
·ZIMMER GMBH·Product code JDI·July 27, 2017
MENTOR SMOOTH ROUND MODERATE PROFILE
FDA Adverse Event
Injury
·MENTOR TEXAS·Product code FWM·November 27, 2018
XIENCE XPEDITION EVEROLIMUS ELUTING CORONARY STENT SYSTEM
FDA Adverse Event
Injury
·AV-TEMECULA-CT·Product code NIQ·June 30, 2014
VENTRICULAR ASSIST DEVICE
FDA Adverse Event
Injury
·THORATEC CORP.·Product code DSQ·January 4, 2013
LP20
FDA Adverse Event
Malfunction
·PHYSIO-CONTROL, INC.·Product code MKJ·September 20, 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