11 results
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20ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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GENESIS II TOTAL KNEE SYSTEM, LEGION REVISION KNEE SYSTEM, JOURNEY BCS KNEE SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
MICROCRUISER PLUS INTRODUCER SET
FDA 510(k)
FDA Class 2
·Cardiovascular
SLIDE-ON ENDOSHEATH SYSTEM FOR SENSORY TESTING
FDA 510(k)
FDA Class 2
·Ear, Nose, Throat
INFINION CX
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC NEUROMODULATION·Product code LGW·October 19, 2021
LINEAR 3-6
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC NEUROMODULATION CORPORATION·Product code LGW·November 22, 2024
SPRINT QUATTRO
FDA Adverse Event
Malfunction
·MPRI·Product code LWS·April 22, 2013
PERIGEE
FDA Adverse Event
Injury
·AMERICAN MEDICAL SYSTEMS, INC.·Product code FTL·April 20, 2011
LIFEPAK 12 DEFIBRILLATOR/MONITOR SERIES
FDA Adverse Event
Malfunction
·PHYSIO-CONTROL, INC.·Product code MKJ·July 7, 2008
CORAIL2 LAT COXA VARA SIZE 13
FDA Adverse Event
Injury
·DEPUY FRANCE SAS 3003895575·Product code LZO·July 27, 2018
Equinoxe Reverse Shoulder Compression Screw/Locking Cap Kit 4.5 x 22 mm.
FDA Enforcement
Class II
·Terminated·Exactech, Inc.·October 7, 2020
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