26 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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TMINI Miniature Robotic System
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
SKINTACT
FDA Adverse Event
Injury
·LEONHARD LANG GMBH·Product code DRX·July 24, 2023
BioWaveGO RX
FDA 510(k)
FDA Class 2
·Neurology
IRIS ANTERIOR CERVICAL PLATE
FDA 510(k)
FDA Class 2
·Orthopedic
PUMP MMT-1780KPK 670G PATHWAY BLACK MG
FDA Adverse Event
Injury
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OZP·June 1, 2018
RESERVOIR 3ML
FDA Adverse Event
Injury
·MEDTRONIC MINIMED·Product code FRN·June 11, 2018
ACRYSOF RESTOR
FDA Adverse Event
Injury
·ALCON RESEARCH, LTD/HUNTINGTON·Product code MFK·November 13, 2008
IVT DISPOSABLE
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - SHERBROOKE·Product code KPE·September 1, 2011
CARTO® 3 SYSTEM
FDA Adverse Event
Malfunction
·BIOSENSE WEBSTER, LTD (HAIFA, ISRAEL)·Product code DQK·July 16, 2013
BD BLUNT FILL NEEDLE 18G 1 1/2IN
FDA Adverse Event
Malfunction
·BECTON DICKINSON, S.A.·Product code FMI·July 27, 2023
BD® BLUNT FILL NEEDLE
FDA Adverse Event
Malfunction
·BECTON DICKINSON, S.A.·Product code FMI·June 27, 2023
BIOMET StageOne Select, Hip Stem Cement Spacer Mold w/Reinforcement Cement, 17 X 200 MM, Silicone, Sterile, Item 431199.
FDA Enforcement
Class II
·Terminated·Biomet, Inc.·April 15, 2020
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
Monoject(TM) 1 mL Tuberculin Syringe Luer-Lock Tip Soft Pack, Model Number/Product Code: 1180100777
FDA Enforcement
Class II
·Ongoing·Cardinal Health 200, LLC·October 25, 2023
Monoject U-100 1 mL Insulin Syringe Luer-Lock with Tip Cap Soft Pack, REF 1188100777
FDA Enforcement
Class I
·Ongoing·Cardinal Health 200, LLC·November 20, 2024