8 results
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35ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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TRANSBOND SUPREME ADHESIVE
FDA 510(k)
FDA Class 2
·Dental
POWER LED
FDA 510(k)
FDA Class 2
·Dental
STERI-MATE STERILIZABLE HANDPIECE
FDA 510(k)
FDA Class 2
·Dental
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·March 28, 2025
PARADIGM REAL-TIME INSULIN INFUSION PUMP
FDA Adverse Event
Injury
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·April 23, 2013
NEXGEN COMPLETE KNEE SOLUTION ROTATING HINGE KNEE SCREW DRIVER
FDA Adverse Event
Malfunction
·ZIMMER, INC.·Product code HXX·July 1, 2008
PROGRAMMING SOFTWARE
FDA Adverse Event
Malfunction
·CYBERONICS INC·Product code LYJ·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