11 results
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25ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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OSTEOPORE PCL SCAFFOLD
FDA 510(k)
FDA Class 2
·Neurology
AGILENT INFORMATION CENTER SOFTWARE FOR M3150,M3151,M3153 AND M3154
FDA 510(k)
FDA Class 2
·Cardiovascular
CANDELA SPTL-1B PULSED DYE LASER
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·March 4, 2025
SPINEMED TABLE - FDA 510(K) K051013
FDA Adverse Event
Other
·CERT HEALTH SCIENCES, LLC·Product code ITH·July 16, 2007
SPRINT FIDELIS
FDA Adverse Event
Injury
·MPRI·Product code LWS·April 10, 2013
CAPSUREFIX
FDA Adverse Event
Injury
·MEDTRONIC PUERTO RICO, INC.·Product code DTB·April 12, 2011
SYNCHROMED II
FDA Adverse Event
Injury
·MEDTRONIC NEUROMODULATION·Product code LKK·May 22, 2008
INSYTE
FDA Adverse Event
Malfunction
·BECTON DICKINSON INDUSTRIAS CIRURGICAS, LTDA.·Product code FOZ·January 12, 2026
1093 OTOSCAN
FDA Adverse Event
Malfunction
·NATUS MEDICAL DENMARK APS·Product code ERA·October 20, 2022
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