32 results · 23ms · Sources: EU EUDAMED, US FDA

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ALPHALOK Plating System

FDA 510(k)
FDA Class 2 ·Orthopedic

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

Ophthalmic Cannula

FDA UDI
KATENA PRODUCTS, INC.·00841668114162·ROBINS-KRATZ POLISHING CAN, 22GA PK/10

Stat Profile Prime Plus Analyzer System

FDA 510(k)
FDA Class 2 ·Hematology

Capsule Vitals Plus Patient Monitoring System

FDA 510(k)
FDA Class 2 ·Cardiovascular

T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY

FDA Adverse Event
Malfunction ·TANDEM DIABETES CARE·Product code QFG·April 3, 2023

COCHLEAR OSIA OSI300 IMPLANT

FDA Adverse Event
Injury ·COCHLEAR LTD·Product code PFO·March 8, 2026

COCHLEAR OSIA OSI300 IMPLANT

FDA Adverse Event
Injury ·COCHLEAR LTD·Product code PFO·January 15, 2024

UNSPECIFIED BD¿ NEEDLE

FDA Adverse Event
Malfunction ·BECTON DICKINSON, S.A.·Product code FMI·July 7, 2023

COCHLEAR OSIA OSI300 IMPLANT

FDA Adverse Event
Injury ·COCHLEAR LIMITED·Product code PFO·January 15, 2024

FREESTYLE LITE

FDA Adverse Event
Injury ·Product code NBW·September 1, 2011

GATEWAY PTA DILATION CATHETER

FDA Adverse Event
Malfunction ·NEUROVASCULAR DIV, BOSTON SCIENTIFIC CORP·Product code GBA·July 30, 2008

SYNERGY

FDA Adverse Event
Injury ·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code LGW·July 16, 2013

BD® BLUNT FILL NEEDLE

FDA Adverse Event
Malfunction ·BECTON DICKINSON, S.A.·Product code FMI·September 15, 2023

BD® BLUNT FILL NEEDLE

FDA Adverse Event
Malfunction ·BECTON DICKINSON, S.A.·Product code FMI·July 11, 2023

HERMETIC LUMBAR CATHETER, CLOSED TIP

FDA Adverse Event
Malfunction ·INTEGRA NEUROSCIENCES PR·Product code JXG·August 19, 2019

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