18 results · 21ms · Sources: EU EUDAMED, US FDA

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SurGuard3 Safety Hypodermic Needle

FDA 510(k)
FDA Class 2 ·General Hospital

LEONE SPA

FDA UDI
LEONE SPA·08033707039204·BOSTON DB BRACKET KIT

Hayden Medical

FDA UDI
Hayden Medical, Inc.·00840319753828·Varady Phlebectomy Hook 7" (17.5cm), large hook...

BIOGX SARS-COV-2 OPEN SYSTEM REAGENTS FOR BD MAX SYSTEM

FDA Adverse Event
Malfunction ·BECTON, DICKINSON & CO. (SPARKS)·Product code QJR·August 9, 2021

ACCULIF TL-PEEK IBF CAGE

FDA 510(k)
FDA Class 2 ·Orthopedic

THE LPS - CONTINUUM TM HYBRID TIBIA, MODELS 32-5886-2Y-XX (ZIMMER) AND 05-119-XXYY1-0 (IMPLEX)

FDA 510(k)
FDA Class 2 ·Orthopedic

ENDOWRIST

FDA Adverse Event
Malfunction ·INTUITIVE SURGICAL, INC·Product code NAY·January 30, 2026

EEA 28MM SINGLE-USE STAPLER

FDA Adverse Event
Injury ·NORTH HAVEN - USS·Product code GDW·October 24, 2008

U BY KOTEX CLICK TAMPONS

FDA Adverse Event
Malfunction ·AVENT S. DE R.L. DE C.V.·Product code HEB·July 8, 2011

MECHANICAL (MANUAL) WHEELCHAIR

FDA Adverse Event
Malfunction ·INVACARE TAYLOR STREET·Product code IOR·July 8, 2013

BD NANO¿ 2ND GEN PEN NEEDLE

FDA Adverse Event
Malfunction ·BECTON DICKINSON AND CO.·Product code FMI·November 22, 2022

ENDOWRIST

FDA Adverse Event
Malfunction ·INTUITIVE SURGICAL, INC·Product code NAY·May 30, 2025

BD NANO¿ 2ND GEN PEN NEEDLES 32G X 4MM (100 COUNT)

FDA Adverse Event
Malfunction ·BECTON DICKINSON AND CO.·Product code FMI·October 25, 2023

BD NANO¿ 2ND GEN PEN NEEDLE

FDA Adverse Event
Malfunction ·BECTON DICKINSON AND CO.·Product code FMI·February 14, 2022

Ingenuity TF PET/CT 882442

FDA Enforcement
Class II ·Terminated·Philips Medical Systems (Cleveland) Inc·July 4, 2018

Veradius Unity with Software Release 2.1- Amobile, diagnostic X-ray imaging and viewing system. . Model Number: 718132

FDA Enforcement
Class II ·Ongoing·Philips North America Llc·December 15, 2021

Model Number L211 PROPONENT DR SL MRI Pacemaker

FDA Enforcement
Class I ·Ongoing·Boston Scientific Corporation·October 22, 2025

BV Pulsera with Software Release 2.3-A mobile, diagnostic X-ray image acquisition and viewing system. Model Number: 718095

FDA Enforcement
Class II ·Ongoing·Philips North America Llc·December 15, 2021