9 results
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26ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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AUTO SUTURE(R) ENDOSCOPIC SCISSORS
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
Affinity J (Instruments for Microscope)
FDA UDI
MEDTRONIC SOFAMOR DANEK, INC.·00885074084411·SLEEVE 0903206 DBL GUIDE ASSY 6MM
ORTHOMAP 3D 1.1 MODULE
FDA 510(k)
FDA Class 2
·Neurology
GLIASITE RADIATION THERAPY SYSTEM (RTS), MODEL 1020,1030,1040,8150,9005
FDA 510(k)
FDA Class 2
·Radiology
BD SYRINGE S2 5ML
FDA Adverse Event
Malfunction
·BECTON DICKINSON, S.A.·Product code FMF·August 15, 2019
HOMECHOICE AUTOMATED PD SET WITH CASSETTE
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code FKX·June 30, 2014
EON MINI
FDA Adverse Event
Injury
·ST. JUDE MEDICAL -NEUROMODULATION DIV·Product code LGW·January 2, 2013
SERFAS ENERGY SUPER 90-S
FDA Adverse Event
Malfunction
·STRYKER ENDOSCOPY PUERTO RICO·Product code GEI·November 12, 2010
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