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

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Bovie Disposable Bipolar Ablator

FDA 510(k)
FDA Class 2 ·General, Plastic Surgery

BD LUER-LOK

FDA Adverse Event
Malfunction ·BECTON DICKINSON MEDICAL SYSTEMS·Product code FMF·March 10, 2025

INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT, LUMBAR

FDA Adverse Event
Death ·MEDTRONIC SOFAMOR DANEK USA, INC.·Product code MAX·December 18, 2019

BD SYRINGE 1ML LL

FDA Adverse Event
Malfunction ·BECTON DICKINSON MEDICAL SYSTEMS·Product code FMF·April 22, 2025

BD LUER-LOK

FDA Adverse Event
Malfunction ·BECTON DICKINSON MEDICAL SYSTEMS·Product code FMF·February 22, 2025

LASEREX DUO FAMILY OF DUAL WAVELENGTH OPHTHALMIC LASERS INCLUDING MODELS INTEGRE DUO LP1RG-S, LP1RG-D

FDA 510(k)
FDA Class 2 ·General, Plastic Surgery

TWISTCUT ENDOSORB SCREWS

FDA 510(k)
FDA Class 2 ·Orthopedic

DREAMTOME? RX 44

FDA Adverse Event
Malfunction ·BOSTON SCIENTIFIC - SPENCER·Product code KNS·June 8, 2013

COLLEAGUE PRE P1.7

FDA Adverse Event
Malfunction ·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·July 7, 2011

VALIANT

FDA Adverse Event
Injury ·MEDTRONIC CARDIOVASCULAR·Product code MIH·October 8, 2014

ARTOURA BREAST TISSUE EXPANDER

FDA Adverse Event
Injury ·MENTOR TEXAS·Product code LCJ·August 21, 2023

Precise Treatment Table. To be used as part of radiation therapy treatment process.

FDA Enforcement
Class II ·Terminated·Elekta, Inc.·April 17, 2013

ELEKTA LIMITED Versa HD, REF XRT 2121, 2131; Medical Charged-Particle Radiation Therapy System Accelerator, Linear

FDA Enforcement
Class II ·Ongoing·Elekta, Inc.·December 13, 2023

Integrity 1.1. Integrity is the interface and control software for the Elekta range of medical digital linear accelerators and is intended to assist a licensed practitioner in the delivery of radiation to defined target volumes.

FDA Enforcement
Class II ·Terminated·Elekta, Inc.·April 9, 2014