18 results · 26ms · Sources: EU EUDAMED, US FDA

Get notified when this changes

We'll email you when new records match this search — new devices, new clearances, certificate changes, or withdrawals.

InFill Graft Delivery System

FDA 510(k)
FDA Class 2 ·General Hospital

CONCORDE BULLET CAGE SYSTEM

FDA 510(k)
FDA Class 2 ·Orthopedic

MODIFICATION TO CD HORIZON SPINAL SYSTEM

FDA 510(k)
FDA Class 2 ·Orthopedic

INTELLAMAP ORION

FDA Adverse Event
Injury ·BOSTON SCIENTIFIC CORPORATION·Product code DRF·April 15, 2025

CD HORIZON SPINAL SYSTEM

FDA Adverse Event
Malfunction ·WARSAW ORTHOPEDICS·Product code NKB·November 11, 2020

CD HORIZON SPINAL SYSTEM

FDA Adverse Event
Malfunction ·WARSAW ORTHOPEDICS·Product code NKB·November 11, 2020

CD HORIZON SPINAL SYSTEM

FDA Adverse Event
Malfunction ·WARSAW ORTHOPEDICS·Product code NKB·October 8, 2020

BATTERY REAMER/DRILL

FDA Adverse Event
Malfunction ·SYNTHES GMBH·Product code MOQ·October 6, 2014

MECHANICAL (MANUAL) WHEELCHAIR

FDA Adverse Event
Malfunction ·UNKNOWN·Product code IOR·June 3, 2013

TROCHANTERIC GRIP PLATE WITH 2

FDA Adverse Event
Malfunction ·STRYKER ORTHOPAEDICS CORK·Product code HRS·June 2, 2011

CD HORIZON SPINAL SYSTEM

FDA Adverse Event
Malfunction ·WARSAW ORTHOPEDICS·Product code NKB·November 12, 2020

INTELLAMAP ORION?

FDA Adverse Event
Injury ·BOSTON SCIENTIFIC CORPORATION·Product code DRF·January 30, 2026

CD HORIZON SPINAL SYSTEM

FDA Adverse Event
Malfunction ·WARSAW ORTHOPEDICS·Product code NKB·November 25, 2020

INTELLAMAP ORION

FDA Adverse Event
Injury ·BOSTON SCIENTIFIC CORPORATION·Product code DRF·November 21, 2024

INTELLAMAP ORION?

FDA Adverse Event
Injury ·BOSTON SCIENTIFIC CORPORATION·Product code DRF·February 26, 2026

INTELLAMAP ORION

FDA Adverse Event
Malfunction ·BOSTON SCIENTIFIC CORPORATION·Product code DRF·December 12, 2024

SOLARICE RX

FDA Adverse Event
Malfunction ·MEDTRONIC MEXICO·Product code LOX·August 26, 2019

Allura Exper FD Series. System codes 722003 722010 722022 722005 722011 722019 722001 722002 722006 722012 722008 722013 722020 722025 722015 722023 722038 889006 889016 889009 722005 The device is an X-Ray Generator.

FDA Enforcement
Class II ·Terminated·Philips North America, LLC·March 25, 2020