9 results
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36ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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6 CHANNEL BODY COIL
FDA 510(k)
FDA Class 2
·Radiology
SERONO FOR USE WITH GONAL-F 1200IU MULTI-DOSE ONLY AT 600IU/ML SYRINGE
FDA 510(k)
FDA Class 2
·General Hospital
MAGICFIL
FDA 510(k)
FDA Class 2
·Dental
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·January 28, 2025
ANIMAS VIBE
FDA Adverse Event
ANIMAS CORPORATION·Product code LZG·March 27, 2013
SILVER SOAKER 5 IN - 12.5 CM
FDA Adverse Event
Malfunction
·1 FLOW CORPORATION·Product code BSO·March 14, 2011
CARDIOCAP 5
FDA Adverse Event
Malfunction
·GE HEALTHCARE FINLAND OY·Product code MHX·April 2, 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
Exactech Equinoxe Humeral Liner: Item Numbers: a) 320-40-00, b) 320-40-03; Shoulder Arthroplasty
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·April 10, 2024