11 results
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36ms
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Sources: EU EUDAMED, US FDA
ZENIEVA
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
DATEX-OHMEDA S/5 NETWORK AND CENTRAL '01
FDA 510(k)
FDA Class 2
·Cardiovascular
SIEMENS MULTI VIEW WORKSTATION WITH VENT VIEWER OPTION
FDA 510(k)
FDA Class 2
·Cardiovascular
PRECISION SPECTRA
FDA Adverse Event
Injury
·Product code LGW·November 1, 2021
PRONOVA BLUE MONO POLY(HEXAFLUOROPROPYLENE)SUTURE
FDA Adverse Event
Malfunction
·ETHICON, INC.·Product code GAW·April 23, 2013
PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·MEDTRONIC MINIMED·Product code OYC·September 9, 2014
TENDRIL SDX
FDA Adverse Event
Injury
·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code DTB·July 11, 2008
EQUINOXE REVERSE SHOULDER COMPONENTS
FDA Adverse Event
Injury
·EXACTECH, INC.·Product code KWT·September 25, 2024
COOK TURBO-FLO HD HEMODIALYSIS CATHETER TRAY
FDA Adverse Event
Injury
·COOK INC·Product code MPB·May 24, 2019
COOK TURBO-FLO HD HEMODIALYSIS CATHETER TRAY
FDA Adverse Event
Injury
·COOK INC·Product code MPB·July 11, 2019
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