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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INTEGRATED PATIENT MONITORING SYSTEM
FDA 510(k)
FDA Class 2
·Cardiovascular
BD LUER-LOK SYRINGE BULK STERILE PHARMACY CONVENIENCE TRAY
FDA Adverse Event
Malfunction
·BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V.·Product code FMF·June 8, 2020
NIHON KOHDEN BSM-2300A SERIES BEDSIDE MONITOR AND ACCESSORIES, MODEL BSM-2300A SERIES
FDA 510(k)
FDA Class 2
·Cardiovascular
KSEA PERCUTANEOUS FORAMINOSCOPY SET
FDA 510(k)
FDA Class 2
·Orthopedic
OT ULTRALINK METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·April 8, 2013
ANGIO-SEAL DEVICE
FDA Adverse Event
Injury
·ST. JUDE MEDICAL·Product code MGB·March 30, 2011
PULSAR MAX DR
FDA Adverse Event
Malfunction
·CARDIAC PACEMAKERS, INC·Product code DXY·May 8, 2008
BD Q-SYTE¿ LUER ACCESS SPLIT-SEPTUM STAND-ALONE DEVICE
FDA Adverse Event
Malfunction
·BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.·Product code FPA·December 21, 2017
BD LUER-LOK SYRINGE BULK STERILE PHARMACY CONVENIENCE PAK
FDA Adverse Event
Malfunction
·BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V.·Product code FMF·November 26, 2020
PLATE, FIXATION, BONE
FDA Adverse Event
Injury
·SYNTHES USA·Product code HRS·September 22, 2016
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