13 results
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29ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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SURGICRAFT SURGICAL MESH SYSTEM
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
Closed Wound Suction
FDA UDI
C. R. Bard, Inc.·00801741050015·100cc Silicone Closed Wound Suction Evacuator K...
NOBELACTIVE INTERNAL NP 3.5X11.5MM
FDA Adverse Event
Injury
·NOBEL BIOCARE AB·Product code DZE·August 13, 2020
NOBELACTIVE INTERNAL RP 4.3X10MM
FDA Adverse Event
Injury
·NOBEL BIOCARE USA INC·Product code DZE·September 8, 2020
NOBELACTIVE INTERNAL NP 3.5X11.5MM
FDA Adverse Event
Injury
·NOBEL BIOCARE AB·Product code DZE·August 13, 2020
SOLARA JR. MANUAL WHEELCHAIR
FDA 510(k)
FDA Class 1
·Physical Medicine
FRAMELOCK; FRAMELOCK ACCESSORIES
FDA 510(k)
FDA Class 2
·Neurology
SPECTRA WAVEWRITER
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC NEUROMODULATION·Product code LGW·December 1, 2020
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·March 27, 2025
HEARTMATE II LVAD
FDA Adverse Event
Injury
·THORATEC CORP.·Product code DSQ·April 19, 2013
ARCHITECT HAVAB IGM REAGENT
FDA Adverse Event
Malfunction
·ABBOTT·Product code LOL·April 29, 2011
CAPSUREFIX NOVUS
FDA Adverse Event
Injury
·MEDTRONIC PUERTO RICO, INC.·Product code DTB·July 10, 2008
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