10 results
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29ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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OSSIOfiber Cannulated Trimmable Fixation Nail, OSSIOfiber Trimmable Fixation Nail, OSSIOfiber Trimmable Fixation Nail, Cannulated Design
FDA 510(k)
FDA Class 2
·Orthopedic
Blade Scalpel
FDA UDI
KATENA PRODUCTS, INC.·00841668113486·MINIATURE BLADE #65 (BX/5)
BIOGX SARS-COV-2 OPEN SYSTEM REAGENTS FOR BD MAX SYSTEM
FDA Adverse Event
Malfunction
·BECTON, DICKINSON & CO. (SPARKS)·Product code QJR·October 8, 2020
SYNAPSE 3D CARDIAC TOOLS
FDA 510(k)
FDA Class 2
·Radiology
KENDRO HERACELL 240 INCUBATOR
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
FOOTED ATTACHMENT 2.4 MM LEGEND, AF02 (B-1)
FDA Adverse Event
Malfunction
·MEDTRONIC POWERED SURGICAL SOLUTIONS·Product code HBB·October 17, 2008
DA+ T SERIES DR
FDA Adverse Event
Malfunction
·MEDTRONIC S.A.·Product code NVZ·August 11, 2011
MECHANICAL (MANUAL) WHEELCHAIR
FDA Adverse Event
Malfunction
·INVACARE TAYLOR STREET·Product code IOR·July 2, 2013
Spacelabs Healthcare elance Vital Signs Monitor, Model 93300, with Option S. It is a patient monitor with arrhythmia detection or alarms.
FDA Enforcement
Class II
·Terminated·Spacelabs Healthcare, Llc·November 20, 2013
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