10 results
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20ms
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Sources: EU EUDAMED, US FDA
SYVA MICROTRAK EIA ACCESSORY REAGENTS
FDA 510(k)
FDA Class 1
·Microbiology
ALLOFIT ACETABULAR SYSTEM
FDA 510(k)
FDA Class 3
·Orthopedic
BGM GALECTIN -3
FDA 510(k)
FDA Class 2
·Clinical Chemistry
ALLOFT-S ALLOCLASSIC SHL 52/II
FDA Adverse Event
Malfunction
·ZIMMER GMBH·Product code JDI·March 12, 2019
DURATA STS OPTIM ACTIVE FIXATION
FDA Adverse Event
Injury
·ST. JUDE MEDICAL, INC., CRMD·Product code NVY·June 30, 2014
LAP-BAND AP ADJUSTABLE GASTRIC BANDING SYSTEN (STANDARD)
FDA Adverse Event
Malfunction
·ALLERGAN·Product code LTI·January 4, 2013
HI-TORQUE PILOT GUIDE WIRE
FDA Adverse Event
Malfunction
·AV-MURRIETA·Product code DQX·November 20, 2010
ALLOFIT-S ALLOCLASSIC, SHELL WITH POLAR SCREW PLUG, UNCEMENTED, 52/II
FDA Adverse Event
Injury
·ZIMMER GMBH·Product code LZO·September 27, 2018
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
Alaris Syringe Pump, Model No. 8110. Delivers fluids. Expansion of Affected Units: BOM Housing Assembly Service, Part No. 49000226, and Lower Housing/Carriage Block Assembly, Part No. 148188-100.
FDA Enforcement
Class I
·Terminated·CareFusion 303, Inc.·August 26, 2015