12 results
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28ms
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Sources: EU EUDAMED, US FDA
CAD 12, COLONOSCOPY ASSIST DEVICE
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
Bosworth Pit & Fissure
FDA UDI
Harry J Bosworth Company·H6680921561·Pit & Fissure LC Sealant w Fluoride
APPRAISE URINE MICROALBUMIN COLLECTION KIT
FDA 510(k)
FDA Class 2
·Clinical Chemistry
IMAGINE H.E.
FDA 510(k)
FDA Class 2
·Dental
LINEAR ST
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC NEUROMODULATION·Product code LGW·October 20, 2020
LINEAR ST
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC NEUROMODULATION·Product code LGW·June 26, 2020
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·April 18, 2025
RELION CONFIRM BLOOD GLUCOSE SYSTEM
FDA Adverse Event
Injury
·ARKRAY, INC.·Product code NBW·May 3, 2013
UNKNOWN - UNSPECIFIED BY THE COMPLAINANT
FDA Adverse Event
Injury
·COOK BIOTECH, INC.·Product code PAG·August 21, 2014
LEAD MODEL 302
FDA Adverse Event
Malfunction
·CYBERONICS, INC.·Product code LYJ·April 27, 2011
Belmont Rapid Infuser, a Fluid Management System, Model FMS2000.
FDA Enforcement
Class II
·Terminated·Belmont Instrument Corporation·October 24, 2012
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