14 results
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19ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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BILIRUBIN CONTROL
FDA 510(k)
FDA Class 1
·Clinical Chemistry
SureStep™ Foley Tray System Bard®Lubricath® Foley Catheter
FDA UDI
C. R. Bard, Inc.·00801741104633·SureStep® Foley Tray System
Bard Lubricath Fole...
Bard® Urine Meter Foley Tray with Bardex® Lubricath® Foley Catheter
FDA UDI
C. R. Bard, Inc.·00801741046087·Bard® Urine Meter Foley Tray with Bardex® Lubri...
ASCENT BOND UNIVERSAL ADHESIVE SYSTEM, MODELS 006-00029, 006-00030, 006-00044, 006-00045
FDA 510(k)
FDA Class 2
·Dental
ELECTRIC MOBILITY RASCAL AND CHAUFFER SCOOTERS
FDA 510(k)
FDA Class 2
·Physical Medicine
Catalog A902616, SureStep" Foley Tray, Bardex" I.C., Lubricath", Urine Meter
FDA Enforcement
Class II
·Ongoing·C.R. Bard Inc·September 29, 2021
PULSE GEN MODEL 101
FDA Adverse Event
Malfunction
·CYBERONICS INC·Product code LYJ·June 30, 2014
RIATA ST ACTIVE FIXATION
FDA Adverse Event
Malfunction
·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code NVY·January 8, 2013
COLLEAGUE CX VOLUMETRIC INFUSION PUMP SINGLE CHANNEL
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·November 18, 2010
Catalog A902616, SureStep" Foley Tray, Bardex" I.C., Lubricath", Urine Meter
FDA Recall
Open, Classified
·C.R. Bard Inc·Product code EZC·August 5, 2021
SureStep(TM) FOLEY TRAY SYSTEM, Preconnected Closed System Foley Tray, Product Codes: A119214M, A119216M, A119218M, A119416M, A153200, A300916A, A301216, A301216A, A303314A, A303316A, A303318A, A303414A, A303416A, A303418A, A304400A, A304714A, A304716A, A304718A, A304914, A304916, A304918, A307414A, A307416A, A319414AM, A319416A, A319416AM, A319418AM, A319514AM, A319516A, A319516AM, A333100A, A333416A, A339414AM, A339516AM, A339516AM, A344916, A800064, A800065, A800364, A800365, A800366, A900216, A900416, A901216, A902114, A902216, A902414, A902416, A902418, A902616, A902914, A902916, A902918, A903314A, A903316A, A903318A, A903416A, A904100, A904400A, A909116M, A909216M, A919416AM, A919516AM, A942206, A942208, A942210, A942212, A942214, A942216, A942218, A942616, A942618, A943214, A943216, A943218, MTA902416 Product Usage catheter
FDA Recall
Terminated
·Bard Medical Division·Product code MJC·December 13, 2018
SureStep(TM) FOLEY TRAY SYSTEM, Preconnected Closed System Foley Tray, Product Codes: A119214M, A119216M, A119218M, A119416M, A153200, A300916A, A301216, A301216A, A303314A, A303316A, A303318A, A303414A, A303416A, A303418A, A304400A, A304714A, A304716A, A304718A, A304914, A304916, A304918, A307414A, A307416A, A319414AM, A319416A, A319416AM, A319418AM, A319514AM, A319516A, A319516AM, A333100A, A333416A, A339414AM, A339516AM, A339516AM, A344916, A800064, A800065, A800364, A800365, A800366, A900216, A900416, A901216, A902114, A902216, A902414, A902416, A902418, A902616, A902914, A902916, A902918, A903314A, A903316A, A903318A, A903416A, A904100, A904400A, A909116M, A909216M, A919416AM, A919516AM, A942206, A942208, A942210, A942212, A942214, A942216, A942218, A942616, A942618, A943214, A943216, A943218, MTA902416 Product Usage catheter
FDA Enforcement
Class II
·Terminated·Bard Medical Division·February 13, 2019
UniCel DxI 600 Access Immunoassay Analyzer, Part Number A30260
FDA Enforcement
Class II
·Ongoing·Beckman Coulter, Inc.·August 13, 2025
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