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

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Synaptive ImageDrive Pro

FDA 510(k)
FDA Class 2 ·Radiology

CoRoent

FDA UDI
Nuvasive, Inc.·00887517566492·CoRoent Ant TLIF PEEK, 15x13x28mm 4°

LAMINOPLASY PLATING SYSTEM

FDA 510(k)
FDA Class 2 ·Orthopedic

MAGBODY DT-600

FDA 510(k)
FDA Class 2 ·Neurology

LINEAR? ST

FDA Adverse Event
Injury ·BOSTON SCIENTIFIC NEUROMODULATION CORPORATION·Product code LGW·September 11, 2025

ELECTRODE, PACEMAKER, PERMANENT

FDA Adverse Event
Injury ·MPRI·Product code DTB·June 8, 2013

MEMBRAGEL

FDA Adverse Event
Injury ·INSTITUT STRAUMANN AG·Product code NPK·June 30, 2011

AUTOMATED PD SET W/CASSETTE4 PRONG

FDA Adverse Event
Injury ·BAXTER HEALTHCARE·Product code FKX·September 8, 2008

ENDOWRIST

FDA Adverse Event
Malfunction ·INTUITIVE SURGICAL, INC·Product code NAY·April 22, 2020

SCR BIORCI 7X25MM (8MM HEAD) STRL BX 1

FDA Adverse Event
Malfunction ·SMITH & NEPHEW, INC.·Product code HWC·August 17, 2017

SCR BIORCI 7X25MM (8MM HEAD) STRL BX 1

FDA Adverse Event
Malfunction ·SMITH & NEPHEW, INC.·Product code HWC·August 17, 2017

SCR BIORCI 7X25MM (8MM HEAD) STRL BX 1

FDA Adverse Event
Malfunction ·SMITH & NEPHEW, INC.·Product code HWC·August 17, 2017

SCR BIORCI 7X25MM (8MM HEAD) STRL BX 1

FDA Adverse Event
Malfunction ·SMITH & NEPHEW, INC.·Product code HWC·August 17, 2017

Allura Xper FD20/15; System Code: 722058;

FDA Enforcement
Class II ·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·April 8, 2026

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

Allura Xper FD20/15; Model Numbers: 722058; Associated 510(k)s: K102005, K130638, K130842, K133292, K141979, K162859, K161563;

FDA Enforcement
Class II ·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·October 8, 2025