13 results
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22ms
·
Sources: EU EUDAMED, US FDA
SYNERMED URIC ACID REAGENT KIT
FDA 510(k)
FDA Class 1
·Clinical Chemistry
POWDER FREE VINYL PATIENT EXAMINATION GLOVES, LIGHT YELLO COLOR
FDA 510(k)
FDA Class 1
·General Hospital
Harmony Latex Dam, Harmony Non-Latex Dam
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
QUADRA ASSURA DR CRT-D
FDA Adverse Event
Injury
·ST. JUDE MEDICAL, INC., CRMD·Product code NIK·June 30, 2014
PRIM SYM SET 2 CL
FDA Adverse Event
Malfunction
·HOSPIRA COSTA RICA LTD.·Product code FPA·January 4, 2013
INTEGRATED APD SET W/CASSETTE3-PRONG
FDA Adverse Event
Injury
·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code FKX·November 20, 2010
PROFEMUR PLASMA Z CLASSIC STEM SIZE 7 STANDARD SHORT NECK
FDA Enforcement
Class II
·Terminated·MicroPort Orthopedics Inc.·June 8, 2022
EVOLUTION® BILIARY CONTROLLED-RELEASE STENT - FULLY COVERED
FDA Adverse Event
Injury
·COOK IRELAND LTD·Product code FGE·December 22, 2015
EVOLUTION® BILIARY CONTROLLED-RELEASE STENT - FULLY COVERED
FDA Adverse Event
Injury
·COOK IRELAND LTD·Product code FGE·December 16, 2015
EVOLUTION® BILIARY CONTROLLED-RELEASE STENT - FULLY COVERED
FDA Adverse Event
Injury
·COOK IRELAND LTD·Product code FGE·December 21, 2015
30" (76 cm) Appx 3.6 ml, 20 Drop Admin Set w/ Integrated ChemoLock Port Drip Chamber, ChemoLock, Bag Hanger, Item No. 011-CL3511 sterile devices intended for the infusion and withdrawal of fluids.
FDA Enforcement
Class II
·Terminated·ICU Medical, Inc.·April 6, 2016
EVOLUTION® BILIARY CONTROLLED-RELEASE STENT - FULLY COVERED
FDA Adverse Event
Injury
·COOK IRELAND LTD·Product code FGE·April 4, 2016
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