21 results
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25ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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BD VACUTAINER SAFETY COAGULATION TUBE
FDA 510(k)
FDA Class 2
·Clinical Chemistry
BD VACUTAINER® PLUS CITRATE TUBE 2.7ML WITH LIGHT BLUE HEMOGARD CLOSURE
FDA Adverse Event
Malfunction
·BECTON, DICKINSON AND COMPANY (BD)·Product code JKA·December 5, 2017
BD VACUTAINER® PLUS CITRATE TUBE
FDA Adverse Event
Malfunction
·BECTON, DICKINSON AND COMPANY (BD)·Product code JKA·December 1, 2017
BD VACUTAINER® PLUS CITRATE TUBE
FDA Adverse Event
Malfunction
·BECTON, DICKINSON AND COMPANY (BD)·Product code JKA·December 6, 2017
BD VACUTAINER® CITRATE TUBES 4.5 13X75 NA CITRATE (0.105M = 3.2%)
FDA Adverse Event
Malfunction
·BECTON, DICKINSON AND COMPANY (BD)·Product code JKA·November 10, 2017
BD VACUTAINER® PLUS CITRATE TUBE
FDA Adverse Event
Malfunction
·BECTON, DICKINSON AND COMPANY (BD)·Product code JKA·December 14, 2017
BD VACUTAINER® PLUS CITRATE TUBE
FDA Adverse Event
Malfunction
·BECTON, DICKINSON AND COMPANY (BD)·Product code JKA·December 8, 2017
CITRATE TUBE
FDA Adverse Event
Malfunction
·BECTON, DICKINSON AND COMPANY (BD)·Product code JKA·November 27, 2017
BD VACUTAINER® BUFFERED SODIUM CITRATE (9NC) BLOOD COLLECTION TUBES
FDA Adverse Event
Malfunction
·BECTON, DICKINSON & CO. (BROKEN BOW)·Product code JKA·May 24, 2019
UNSPECIFIED BD BLOOD COLLECTION TUBE
FDA Adverse Event
Malfunction
·BECTON, DICKINSON & CO. (BROKEN BOW)·Product code JKA·June 19, 2019
UNIVERSAL THREAD
FDA UDI
FGX INTERNATIONAL INC.·00196365849436·
UNIVERSAL THREAD
FDA UDI
FGX INTERNATIONAL INC.·00193033574980·
AXYA MEDICAL, INC. MODEL 1000 AXYALOOP BONE ANCHOR
FDA 510(k)
FDA Class 2
·Orthopedic
NAVIGUS TRAJECTORY GUIDE BIOPSY KIT, MODELS BK-7000 AND 8000
FDA 510(k)
FDA Class 2
·Neurology
OT PING METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·March 21, 2013
PASSIVE PLUS DX
FDA Adverse Event
Injury
·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code DTB·March 10, 2011
INRATIO
FDA Adverse Event
Malfunction
·HEMOSENSE SJ·Product code JPA·March 14, 2008
RICH-MAR WINNER CM2
FDA Adverse Event
Injury
·RICH-MAR·Product code IPF·March 1, 2012
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
Medfusion Syringe Pump Model: Model 4000-0100-50, Model 4000-0101-249, Model 4000-0101-50, Model 4000-0101-51, Model 4000-0101-78, Model 4000-0105-249, Model 4000-0105-51, Model 4000-0105-78, Model 4000-0106-00, Model 4000-0106-01, Model 4000-0106-231
FDA Enforcement
Class I
·Ongoing·Smiths Medical ASD Inc.·June 29, 2022