17 results · 22ms · Sources: EU EUDAMED, US FDA

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LCCS Disposable RF Electrode, LCCS Reusable RF Electrode

FDA 510(k)
FDA Class 2 ·Neurology

Signature Femoral Head

FDA UDI
SIGNATURE ORTHOPAEDICS PTY LTD·09348215002015·

Paxeon Femoral Head

FDA UDI
PAXEON RECONSTRUCTION LLC·08177570200238·Paxeon Head, Ceramic Size 40mm M

OrthoMedFlex

FDA UDI
ORTHOMEDFLEX LLC·M7161111526420·Femoral Head, 40mm +0mm (M)

SONOSCAPE ULTRASOUND SYSTEM AND TRANSDUCERS MODEL SSI-8000, 2P1 PHASED ARRAY, 5P1 PHASED ARRAY MODEL 2P1, 5P1, 6V1 MICRO

FDA 510(k)
FDA Class 2 ·Radiology

SUTURING WASHER

FDA 510(k)
FDA Class 2 ·Cardiovascular

SIGNATURE Head - BIOLOX Delta

FDA UDI
AMPLITUDE SAS·03701089520843·

WALLSTENT RP ENDOPROSTHESIS

FDA Adverse Event
Malfunction ·BOSTON SCIENTIFIC CORPORATION·Product code JCT·March 21, 2025

AQUILEX FLUID CONTROL SYSTEM

FDA Adverse Event
Malfunction ·W.O.M. WORLD OF MEDICINE GMBH·Product code HIG·March 12, 2020

WALLSTENT ENDOPROSTHESIS

FDA Adverse Event
Malfunction ·BOSTON SCIENTIFIC CORPORATION·Product code MAF·December 22, 2025

WALLSTENT ENDOPROSTHESIS

FDA Adverse Event
Malfunction ·BOSTON SCIENTIFIC CORPORATION·Product code MAF·December 1, 2025

PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL)

FDA Adverse Event
Malfunction ·INVACARE FLORIDA OPERATIONS·Product code CAW·October 8, 2014

ACRYSOF RESTOR

FDA Adverse Event
Injury ·ALCON RESEARCH, LTD. / HUNTINGTON·Product code HQL·June 5, 2013

PENUMBRA SYSTEM REPERFUSION CATHETER 026

FDA Adverse Event
Malfunction ·PENUMBRA, INC.·Product code NRY·June 22, 2011

WALLSTENT? RP ENDOPROSTHESIS

FDA Adverse Event
Malfunction ·BOSTON SCIENTIFIC CORPORATION·Product code FGE·July 21, 2025

ELEKTA LIMITED Elekta Synergy Platform, REF MRT 8501, MRT 8511; 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