26 results · 21ms · Sources: EU EUDAMED, 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