10 results
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23ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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ACON UTI URINARY TRACT INFECTION TEST STRIPS
FDA 510(k)
FDA Class 1
·Hematology
TIMX SPINAL SYSTEMS
FDA 510(k)
FDA Class 2
·Orthopedic
BUTLER NUCARE ROOT CONDITIONER WITH NOVAMIN
FDA 510(k)
FDA Class 2
·Dental
UNKNOWN STRYKER LONG GAMMA NAIL LOT#K0B4A9D
FDA Adverse Event
Injury
·STRYKER TRAUMA KIEL·Product code HSB·August 11, 2016
CP87170 DE MUENCHEN
FDA Adverse Event
Death
·SORIN GROUP ITALIA·Product code DTZ·July 15, 2011
LIBERTY CYCLER SET, SINGLE CONN./EXT DL
FDA Adverse Event
Malfunction
·ERIKA DE REYNOSA, S.A. DE C.V.·Product code FKX·April 11, 2013
PRECISE RX NITINOL STENT
FDA Adverse Event
Death
·CORDIS DE MEXICO·Product code NIM·June 17, 2008
SWAN-GANZ CCO/VIPTHERMODILUTION CATHETER WITH AMC THROMBOSHIELD
FDA Adverse Event
Malfunction
·EDWARDS LIFESCIENCES, PR·Product code KRA·April 19, 2011
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
CADD¿- Solis Ambulatory Infusion Pump, Model 2111 & 2112, Version 1.0, Version 2.0 and Version 3.0 & Model 2120, Version 1.0. Provide measured drug therapy to patients in hospital or outpatient settings.
FDA Enforcement
Class II
·Terminated·Smiths Medical ASD, Inc.·June 24, 2015