13 results
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34ms
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Sources: EU EUDAMED, US FDA
LIQUID-STAT REAGENT FOR ASSAY OF CHOLES.
FDA 510(k)
FDA Class 1
·Clinical Chemistry
Baha
FDA UDI
Cochlear Bone Anchored Solutions AB·09321502036023·Baha® Fitting Software
Unimed
FDA UDI
Unimed Medical Supplies, Inc.·06936735454563·Reusable Multi-site Y-shape SpO2 Sensor M Tech ...
Unimed
FDA UDI
Unimed Medical Supplies, Inc.·06945664859967·Repetitive blood oxygen probe/Masimo/RD SET/Y-s...
CORTEZ NEEDLE FREE IV CONNECTOR, MODEL MMD-001
FDA 510(k)
FDA Class 2
·General Hospital
ALOKA PROUSOUND 2 DIAGNOSTIC ULTRASOUND SYSTEM
FDA 510(k)
FDA Class 2
·Radiology
BD PLASTIPAK¿ SYRINGE
FDA Adverse Event
Malfunction
·BECTON DICKINSON, S.A.·Product code FMF·June 28, 2018
NUCLEUS 24 CHANNEL COCHLEAR IMPLANT SYSTEM
FDA Adverse Event
Injury
·COCHLEAR LTD .·Product code MCM·May 9, 2014
INVACARE COMMODE
FDA Adverse Event
Injury
·INVACARE·Product code INB·November 8, 2007
FREESTYLE FLASH
FDA Adverse Event
Malfunction
·ABBOTT DIABETES CARE INC, USA·Product code LFR·September 27, 2007
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
Reamer / Irrigator / Aspirator (RIA): RIA Drive Shafts, RIA Tube Assemblies, sterile, RIA Reamer Head, sterile (12.0mm-19.0mm); intended to clear the medullary canal of bone marrow and debris and to effectively size the medullary canal for the acceptance of an intramedullary implant or prosthesis
FDA Enforcement
Class II
·Terminated·Synthes, Inc.·July 22, 2015
smiths medical Pneupac paraPAC plus 310 ventilator kit with PEEP and CPAP, REF P310NUS
FDA Enforcement
Class I
·Ongoing·Smiths Medical ASD Inc.·March 27, 2024