12 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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SCALEMAN BODY FAT SCALES, MODEL: FS-148BW1 SERIES
FDA 510(k)
FDA Class 2
·Cardiovascular
KSEA CLEARVISION LENS IRRIGATION SYSTEM
FDA 510(k)
FDA Class 2
·Ear, Nose, Throat
LUNEAU STERILE TONOMETER SEPARATION PRISMS
FDA 510(k)
FDA Class 2
·Ophthalmic
TI MATRIXMIDFACE SCREW SELF-DRILLING 5MM
FDA Adverse Event
Malfunction
·SYNTHES MONUMENT·Product code JEY·March 3, 2017
WAVEWRITER ALPHA 16
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC NEUROMODULATION·Product code LGW·December 9, 2022
TI MATRIXMIDFACE SCREW SELF-TAPPING 6MM
FDA Adverse Event
Malfunction
·SYNTHES MONUMENT·Product code DZL·September 6, 2017
BD¿ VACUTAINER¿ MULTI-SAMPLE NEEDLES
FDA Adverse Event
Malfunction
·BECTON, DICKINSON AND COMPANY (BD)·Product code FMI·March 19, 2018
OT VERIO IQ METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·April 29, 2013
RIATA ACTIVE FIXATION
FDA Adverse Event
Malfunction
·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code NVY·May 10, 2011
GE OEC 9800
FDA Adverse Event
Malfunction
·GE OEC MEDICAL SYSTEMS INC.·Product code JAA·July 29, 2008
TI MATRIXMIDFACE SCREW SELF-DRILLING 5MM
FDA Adverse Event
Malfunction
·SYNTHES MONUMENT·Product code JEY·March 3, 2017
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