18 results
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36ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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VITROS CHEMISTRY PRODUCTS CAFFN REAGENT KIT AND TDM PERFORMANCE VERIFIERS I, II AND III
FDA 510(k)
FDA Class 2
·Clinical Toxicology
JOBST forMen
FDA UDI
BSN MEDICAL, INC.·04042809868524·FOR MEN 20-30 MM HG THIGH MICRO DOT BAND CLOSED...
Entuit Thrive LP
FDA UDI
XERIDIEM MEDICAL DEVICES, INC.·00827002356764·
ROVERS SPATULA
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
GYRO-TIP LARIAT DEFLECTABLE LOOP MAPPING CATHETER, MODEL GTL-20E
FDA 510(k)
FDA Class 2
·Cardiovascular
VERTEX RECONSTRUCTION SYSTEM
FDA Adverse Event
Malfunction
·WARSAW ORTHOPEDIC INC.·Product code KWP·November 2, 2010
MALLINCKRODT
FDA Adverse Event
Injury
·COVIDIEN, FORMERLY TYCOHEALTHCARE·Product code JOH·November 18, 2010
MALLINCKRODT
FDA Adverse Event
Injury
·COVIDIEN, FORMERLY TYCOHEALTHCARE·Product code BTR·December 9, 2010
VERTEX RECONSTRUCTION SYSTEM
FDA Adverse Event
Malfunction
·WARSAW ORTHOPEDIC INC.·Product code KWP·January 5, 2009
VERTEX RECONSTRUCTION SPINAL SYSTEM
FDA Adverse Event
Malfunction
·WARSAW ORTHOPEDIC INC.·Product code KWP·July 23, 2010
VERTEX RECONSTRUCTION SYSTEM
FDA Adverse Event
Injury
·WARSAW ORTHOPEDIC INC.·Product code KWP·April 2, 2010
MALLINCKRODT
FDA Adverse Event
Injury
·COVIDIEN, FORMERLY TYCOHEALTHCARE·Product code BTR·February 1, 2011
VERTEX RECONSTRUCTION SYSTEM
FDA Adverse Event
Malfunction
·WARSAW ORTHOPEDIC INC.·Product code KWP·November 20, 2009
PROMUS ELEMENT ?
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC - GALWAY·Product code NIQ·April 9, 2013
FINELINE II
FDA Adverse Event
Injury
·CARDIAC PACEMAKERS, INC·Product code DTB·May 8, 2008
TAXUS LIBERTE ATOM PACLITAXEL-ELUTING CORONARY STENT SYSTEM
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC - GALWAY·Product code NIQ·April 6, 2011
Medfusion Syringe Pump, Model 4000. The Model 4000 pump is a small, lightweight and portable syringe infusion pump. The pump offers a variety of delivery modes programmable to meet specific patient care needs.
FDA Enforcement
Class I
·Terminated·Smiths Medical ASD Inc.·December 18, 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