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

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MAGNETOM Spectra

FDA 510(k)
FDA Class 2 ·Radiology

Sklar®

FDA UDI
SKLAR CORPORATION·10649111386367·SKLHN OP SCIS CVD BB SER 5 1/2

RISE SPACER

FDA 510(k)
FDA Class 2 ·Orthopedic

ARTHROCARE PERC-D SPINEWAND

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

CD HORIZON® SPINAL SYSTEM

FDA Adverse Event
Malfunction ·MEDTRONIC PUERTO RICO OPERATIONS CO., HU·Product code KWP·October 17, 2025

CD HORIZON BALLAST SPINAL SYSTEM

FDA Adverse Event
Injury ·MEDTRONIC SOFAMOR DANEK USA, INC·Product code NKB·December 9, 2019

ATTAIN ABILITY

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

HEARTSTREAM FR2

FDA Adverse Event
Malfunction ·PHILIPS MEDICAL SYSTEMS (HTST)·Product code MKJ·June 21, 2011

CYPHER SIROLIMUS-ELUTING CORONARY STENT

FDA Adverse Event
Injury ·CORDIS DE MEXICO·Product code NIQ·September 5, 2008

ASAHI CONQUEST PRO 9-40

FDA Adverse Event
Malfunction ·ASAHI INTECC CO., LTD.·Product code DQX·April 27, 2016

AXIUM

FDA Adverse Event
Malfunction ·MICRO THERAPEUTICS, INC. DBA EV3·Product code KRD·October 10, 2019

AXIUM

FDA Adverse Event
Malfunction ·MICRO THERAPEUTICS, INC. DBA EV3·Product code KRD·October 10, 2019

AXIUM

FDA Adverse Event
Malfunction ·MICRO THERAPEUTICS, INC. DBA EV3·Product code KRD·October 10, 2019

AXIUM

FDA Adverse Event
Malfunction ·MICRO THERAPEUTICS, INC. DBA EV3·Product code KRD·October 11, 2019

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