17 results
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30ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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XIA TITANIUM SPINAL SYSTEM AND XIA STAINLESS STEEL SPINAL SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
Henry Schein
FDA UDI
HENRY SCHEIN, INC.·00304040090947·THREAD ELASTOMERIC GREY .025
TOKUYAMA M-BOND
FDA 510(k)
FDA Class 2
·Dental
DFV CPG COLPOSCOPE
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
UNKNOWN
FDA Adverse Event
WILLIAM COOK EUROPE·Product code DTK·October 27, 2015
EQUINOXE
FDA Adverse Event
Injury
·EXACTECH, INC.·Product code KWT·March 26, 2019
LEAD MODEL 302
FDA Adverse Event
Malfunction
·CYBERONICS INC·Product code LYJ·April 16, 2013
COOK
FDA Adverse Event
Injury
·COOK UROLOGICAL, INC.·Product code DQO·June 17, 2008
PROGRAMMING SOFTWARE
FDA Adverse Event
Malfunction
·CYBERONICS, INC.·Product code LYJ·April 4, 2011
VASOPRESS DIGITAL MINI PUMP
FDA Adverse Event
Malfunction
·ZIMMER SURGICAL, INC.·Product code JOW·January 6, 2020
VASOPRESS DIGITAL MINI PUMP
FDA Adverse Event
Malfunction
·COMPRESSION THERAPY CONCEPTS, INC.·Product code JOW·February 18, 2020
VASOPRESS DIGITAL MINI PUMP
FDA Adverse Event
Malfunction
·COMPRESSION THERAPY CONCEPTS, INC.·Product code JOW·September 17, 2019
VASOPRESS DIGITAL MINI PUMP
FDA Adverse Event
Malfunction
·ZIMMER SURGICAL, INC.·Product code JOW·November 19, 2019
VASOPRESS DIGITAL MINI PUMP
FDA Adverse Event
Malfunction
·ZIMMER SURGICAL, INC.·Product code JOW·November 19, 2019
VASOPRESS DIGITAL MINI PUMP
FDA Adverse Event
Malfunction
·ZIMMER SURGICAL, INC.·Product code JOW·December 10, 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
CADD¿- Solis Ambulatory Infusion Pump, Model 2111 & 2112, Version 1.0, Version 2.0 and Version 3.0 & Model 2120, Version 1.0. Provide measured drug therapy to patients in hospital or outpatient settings.
FDA Enforcement
Class II
·Terminated·Smiths Medical ASD, Inc.·June 24, 2015