11 results
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19ms
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Sources: EU EUDAMED, US FDA
BALDER FINESSE AND JUNIOR POWERED WHEELCHAIRS (WITH STAND-UP OPTION)
FDA 510(k)
FDA Class 2
·Physical Medicine
CAAS II QVA
FDA 510(k)
FDA Class 2
·Radiology
REPLACE TPS COATED IMPLANTS
FDA 510(k)
FDA Class 2
·Dental
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·March 27, 2025
VERCISE GEVIA?
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC NEUROMODULATION CORPORATION·Product code MHY·February 20, 2025
STONEBREAKER SINGLE USE PROBE
FDA Adverse Event
Malfunction
·COOK INC·Product code FFK·March 28, 2018
ARIS TRANS-OBTURATOR KIT
FDA Adverse Event
Injury
·COLOPLAST A/S·Product code FTL·April 23, 2013
LOW PROFILE SCREW, SS, 4.0 X 40MM, CANCELLOUS
FDA Adverse Event
Injury
·ARTHREX, INC.·Product code HRS·April 29, 2011
SPRINT FIDELIS
FDA Adverse Event
Injury
·MEDTRONIC PUERTO RICO, INC.·Product code LWS·July 10, 2008
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