10 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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COOK INCORPORATED POLYVINYL ALCOHOL FOAM EMBOLIZATION PARTICLES
FDA 510(k)
FDA Class 2
·Cardiovascular
PVA FOAM EMBOLIZATION PARTICLES
FDA Adverse Event
Malfunction
·COOK INC·Product code KRD·March 26, 2018
OCCU-FLO PUNCTUM PLUGS
FDA 510(k)
FDA Unclassified
·Unknown
THERMO-THERAPY, MODELS TT-101, TT-201, AND TT-202
FDA 510(k)
FDA Class 2
·Physical Medicine
EVOLIS TIBIAL BASE PLATE TI PLASMA SPRAYED
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL, SA·Product code JWH·October 22, 2012
EVOLIS STD FEMUR TI PLASMA SPRAYED RIGHT SIZE 4
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code JWH·September 25, 2019
PARADIGM REAL-TIME INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·April 29, 2013
STRETCHER CHAIR
FDA Adverse Event
Malfunction
·STRYKER MEDICAL·Product code FPO·April 13, 2011
HOMECHOICE CYCLER-REFURBISHED
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE·Product code FKX·July 18, 2008
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