20 results · 21ms · 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.

RADIFORCE LARGE MONITOR SYSTEM

FDA 510(k)
FDA Class 2 ·Cardiovascular

MSI Precision Specialty Instruments

FDA UDI
Med Saver, Inc.·00194613017705·K-Wire, Double Ended, Trocar Point, Diameter Si...

PIVOX™ Oblique Lateral Spinal System

FDA UDI
MEDTRONIC SOFAMOR DANEK, INC.·00643169605343·SPACER 2112645 OLIF25 20MM 12 DEG 18X45

2810 3WAY SLIDE VALVE

FDA UDI
HANS RUDOLPH, INC.·00874750009336·2810C 3W SLDVL 1.375OD/1.125ID

TALOS® IBF

FDA UDI
MEDITECH SPINE, LLC·B16741126450·

Algovita®

FDA UDI
Greatbatch Ltd·00821329580222·Algovita® 12 Electrode Percutaneous Lead Kit - ...

Velocity™ Expandable Interbody System

FDA UDI
Spine Wave, Inc.·10840642106916·Expandable Implant, 25(L) X 10(W) X 8-14(H) 8 D...

TALOS® IBF

FDA UDI
MEDITECH SPINE, LLC·B1674112645060·

WILLOW/ELM PTA BALLOON DILATATION CATHETER

FDA 510(k)
FDA Class 2 ·Cardiovascular

REPROCESSED EBI EXTERNAL FIXATION DEVICES

FDA 510(k)
FDA Class 2 ·Orthopedic

WAVEWRITER ALPHA?

FDA Adverse Event
Injury ·BOSTON SCIENTIFIC NEUROMODULATION CORPORATION·Product code LGW·May 15, 2026

AQUILEX FLUID CONTROL SYSTEM

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

LINEAR? ST

FDA Adverse Event
Injury ·BOSTON SCIENTIFIC NEUROMODULATION CORPORATION·Product code LGW·April 20, 2025

U BY KOTEX SLEEK

FDA Adverse Event
Malfunction ·K-C AFC MANUFACTURING, S. DE R.L. DE C.V·Product code HEB·August 31, 2018

PARADIGM REAL-TIME INSULIN INFUSION PUMP

FDA Adverse Event
Malfunction ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·May 14, 2013

ASR ACETABULAR CUPS 54

FDA Adverse Event
Injury ·DEPUY INTERNATIONAL, LTD.·Product code KWA·May 19, 2011

PROXIMATE RELOADABLE LINEAR STAPLER

FDA Adverse Event
Malfunction ·ETHICON ENDO-SURGERY, LLC.·Product code GDW·August 11, 2008

U BY KOTEX SLEEK

FDA Adverse Event
Malfunction ·K-C AFC MANUFACTURING, S. DE R.L. DE C.V·Product code HEB·June 27, 2018

Eversense CGM SENSOR (FG-4200-00-301)-Continuous Glucose Monitor

FDA Enforcement
Class II ·Terminated·Senseonics, Inc.·November 6, 2019

INLIVEN CRT-P, Model Numbers: a) V284 b) V285 c) W274 d) W275 (added 7/15/2021)

FDA Enforcement
Class I ·Ongoing·Boston Scientific Corporation·July 21, 2021