13 results · 29ms · Sources: EU EUDAMED, US FDA

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ASAHI Astato XS 40

FDA 510(k)
FDA Class 2 ·Cardiovascular

ASAHI CONQUEST PRO 9-40

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

Sklar®

FDA UDI
SKLAR CORPORATION·10649111074820·SKLHN OP SCIS STR SB SER 5 1/2

BIOGEL ECLIPSE NON-PYROGENIC LATEX POWDER-FREE STERILE SURGEON'S GLOVE

FDA 510(k)
FDA Class 1 ·General, Plastic Surgery

21.3 INCH (54 CM) MONOCHROME LCD MONITOR MS23I2 (ML21023)

FDA 510(k)
FDA Class 2 ·Radiology

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

SPRINT QUATTRO SECURE

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

TELIGEN

FDA Adverse Event
Injury ·GUIDANT CRM CLONMEL IRELAND·Product code LWS·July 7, 2011

CYPHER SIROLIMUS-ELUTING CORONARY STENT

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

MAGNETOM Skyra (DE). Model Number: 10432915. 510(k) Numbers: K101347, K111242, K123510, K133435, K140253, K141977, K142515, K153343, K173592, K202014, K231560.

FDA Recall
Open, Classified ·Siemens Medical Solutions USA, Inc·Product code LNH·August 28, 2025

MAGNETOM Skyra (DE). Model Number: 10432915. 510(k) Numbers: K101347, K111242, K123510, K133435, K140253, K141977, K142515, K153343, K173592, K202014, K231560.

FDA Enforcement
Class I ·Ongoing·Siemens Medical Solutions USA, Inc·October 8, 2025

ELEKTA LIMITED Precise Digital Accelerator, REF MRT 6001, MRT 6011; Medical Charged-Particle Radiation Therapy System Accelerator, Linear

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