23 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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LUTZ NEEDLE
FDA 510(k)
FDA Class 2
·Anesthesiology
DESIGN OPTICS
FDA UDI
FGX INTERNATIONAL INC.·00193033540800·
DESIGN OPTICS
FDA UDI
FGX INTERNATIONAL INC.·00193033540817·
DESIGN OPTICS
FDA UDI
FGX INTERNATIONAL INC.·00193033540787·
DESIGN OPTICS
FDA UDI
FGX INTERNATIONAL INC.·00193033540831·
DESIGN OPTICS
FDA UDI
FGX INTERNATIONAL INC.·00193033540824·
DESIGN OPTICS
FDA UDI
FGX INTERNATIONAL INC.·00193033540794·
MODIFICATION HYBRID CAPTURE II CT-ID DNA TEST, MODEL 03M91-01
FDA 510(k)
FDA Class 1
·Microbiology
TOTAL BILIRUBIN REAGENT
FDA 510(k)
FDA Class 2
·Clinical Chemistry
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·January 15, 2025
ACCU-CHEK FLEXLINK
FDA Adverse Event
Injury
·DISETRONIC MEDICAL SYSTEMS, INC.·Product code FPA·July 20, 2007
ACCU-CHEK FLEXLINK
FDA Adverse Event
Injury
·DISETRONIC MEDICAL SYSTEMS, INC.·Product code FPA·March 29, 2007
ACCU-CHEK FLEXLINK
FDA Adverse Event
Injury
·DISETRONIC MEDICAL SYSTEMS, INC.·Product code FPA·July 20, 2007
ACCU-CHEK FLEXLINK
FDA Adverse Event
Injury
·DISETRONIC MEDICAL SYSTEMS, INC.·Product code FPA·March 29, 2007
PRECISION®
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC NEUROMODULATION·Product code LGW·March 20, 2013
TENDRIL ST
FDA Adverse Event
Injury
·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code DTB·March 10, 2011
POLYLOOP
FDA Adverse Event
Malfunction
·OLYMPUS AMERICA, INC.·Product code MND·March 7, 2008
BD INSYTE¿ AUTOGUARD¿ BC SHIELDED IV CATHETER
FDA Adverse Event
Malfunction
·BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.·Product code FOZ·June 1, 2018
BD INSYTE¿ AUTOGUARD¿ BC SHIELDED IV CATHETER
FDA Adverse Event
Malfunction
·BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.·Product code FOZ·June 12, 2018
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