11 results
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37ms
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Sources: EU EUDAMED, US FDA
VERIFY DRY HEAT LABEL
FDA 510(k)
FDA Class 2
·General Hospital
COMPLETE BRAND MULTI-PURPOSE SOLUTION
FDA 510(k)
FDA Class 2
·Ophthalmic
U-SYSTEMS ULTRASOUND SYSTEM USI-2000
FDA 510(k)
FDA Class 2
·Radiology
PRECISION NOVI
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC NEUROMODULATION·Product code LGW·February 1, 2023
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·January 20, 2026
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·March 6, 2025
RAD-57 PULSE CO-OXIMETER
FDA Adverse Event
Malfunction
·MASIMO - 15750 ALTON PKWY·Product code DQA·July 26, 2023
GOBED II MED/SURG BED
FDA Adverse Event
Malfunction
·STRYKER MEDICAL-KALAMAZOO·Product code FNL·April 11, 2013
FLUENCY PLUS TRACHEOBRONCHIAL STENT GRAFT
FDA Adverse Event
Malfunction
·ANGIOMED GMBH & CO. MEDIZINTE·Product code JCT·May 28, 2008
SYNCRA CRT-P
FDA Adverse Event
Malfunction
·MEDTRONIC S.A.·Product code NVZ·April 13, 2011
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