12 results
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24ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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ANEUROPLASTIC, MODEL 43-1290
FDA 510(k)
FDA Class 2
·Neurology
Key Surgical K-Wires and Steinmann Pins
FDA UDI
KEY SURGICAL, INC.·10849771045844·Steinmann Pins, Single trocar threaded, 7/64-in...
KMEDIC
FDA UDI
TELEFLEX INCORPORATED·24026704294163·
KSEA QUADRO SWITCH
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
MODIFICATION TO HP M2376A DEVICE LINK SYSTEM, MODEL M2376A
FDA 510(k)
FDA Class 2
·Cardiovascular
BD INSYTE¿ AUTOGUARD¿ BC SHIELDED IV CATHETER
FDA Adverse Event
Malfunction
·BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.·Product code FOZ·October 30, 2019
MAXIMO VR
FDA Adverse Event
Injury
·MEDTRONIC S.A. (SMO)·Product code LWS·April 22, 2013
GORE EXCLUDER AAA ENDOPROSTHESIS
FDA Adverse Event
Injury
·W. L. GORE & ASSOCIATES·Product code MIH·April 20, 2011
LIGASURE LAPAROSCOPIC SLR/DIV
FDA Adverse Event
Malfunction
·COVIDIEN LP (US SURGICAL)·Product code GEI·July 7, 2008
BD INSYTE¿ AUTOGUARD¿ BC SHIELDED IV CATHETER
FDA Adverse Event
Injury
·BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.·Product code FOZ·August 22, 2019
Equinoxe Reverse Shoulder Compression Screw/Locking Cap Kit 4.5 x 22 mm.
FDA Enforcement
Class II
·Terminated·Exactech, Inc.·October 7, 2020
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