36 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Disposable Pre-calibrated Brain Biopsy Needle 2.0
FDA 510(k)
FDA Class 2
·Neurology
Vilex Guidewire
FDA UDI
VILEX IN TENNESSEE, INC.·00841731120670·Guide wire, 2.0x230mm Pt.Thrd.
Vilex Guidewire
FDA UDI
VILEX IN TENNESSEE, INC.·00841731120663·Guidewire 2.0x230mm Sgl Trocar
Vilex Guidewire
FDA UDI
VILEX IN TENNESSEE, INC.·00841731120656·Guidewire 2.0x230mm Drill Tip
MODIFICATION TO EXPORT ASPIRATION CATHETER
FDA 510(k)
FDA Class 2
·Cardiovascular
NYSTAGRAM VIDEO NYSTAGMOGRAPHY SYSTEM
FDA 510(k)
FDA Class 2
·Neurology
BD VACUTAINER® VENOUS BLOOD COLLECTION TUBE SERUM
FDA Adverse Event
Malfunction
·BECTON DICKINSON·Product code JKA·October 5, 2023
TROCHANTERIC NAIL KIT, TI GAMMA3 11X80MM X 125
FDA Adverse Event
Injury
·STRYKER OSTEOSYNTHESIS KIEL·Product code HSB·October 17, 2012
BD VACUTAINER® RAPID SERUM TUBE (RST) BLOOD COLLECTION TUBES THROMBIN
FDA Adverse Event
Malfunction
·BECTON DICKINSON·Product code JKA·April 26, 2023
CUSTOM PAK
FDA Adverse Event
Injury
·ALCON - HOUSTON·Product code KYG·November 13, 2008
ACCESS
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - MALTA·Product code FPA·September 1, 2011
THERMOCOOL® SF NAV UNI-DIRECTIONAL CATHETER
FDA Adverse Event
Malfunction
·BIOSENSE WEBSTER, INC. (JUAREZ)·Product code LPB·July 16, 2013
BD NDLE 18GA 1-1/2IN BLT FILL NC TW SHLD
FDA Adverse Event
Malfunction
·BECTON DICKINSON, S.A.·Product code FOZ·May 14, 2024
BD CONVENTIONAL NEEDLE
FDA Adverse Event
Malfunction
·BECTON DICKINSON, S.A.·Product code FMI·July 25, 2024
BD VACUTAINER® VENOUS BLOOD COLLECTION TUBE SERUM
FDA Adverse Event
Malfunction
·BECTON DICKINSON·Product code JKA·April 24, 2023
BD VACUTAINER® RAPID SERUM TUBE (RST) BLOOD COLLECTION TUBES THROMBIN
FDA Adverse Event
Malfunction
·BECTON DICKINSON·Product code JKA·May 31, 2023
Monoject" 35 mL Syringe Luer-Lock Tip Soft Pack
FDA Enforcement
Class I
·Ongoing·Cardinal Health 200, LLC·November 1, 2023
Monoject 1 mL Tuberculin Syringe Luer-Lock Tip Soft Pack
FDA Enforcement
Class I
·Ongoing·Cardinal Health 200, LLC·November 1, 2023
Monoject" 6 mL Syringe Luer-Lock Tip Soft Pack
FDA Enforcement
Class I
·Ongoing·Cardinal Health 200, LLC·November 1, 2023
Monoject 20 mL Syringe Luer-Lock Tip Soft Pack
FDA Enforcement
Class I
·Ongoing·Cardinal Health 200, LLC·November 1, 2023