34 results · 20ms · Sources: EU EUDAMED, US FDA

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UNIMAX SPECIMEN RETRIEVAL SYSTEM

FDA 510(k)
FDA Class 2 ·Gastroenterology, Urology

SURE LOCK,A34,10 PK,GRN LEVER,CAREFUSION

FDA UDI
CURBELL MEDICAL PRODUCTS, INC.·00840828149136·SURE LOCK,A34,10 PK,GRN LEVER,CAREFUSION

Atoll™

FDA UDI
Seaspine Orthopedics Corporation·10889981052102·3.5mm x 10mm Standard Screw. The Atoll OCT Spin...

Sochi

FDA UDI
Altus Spine, LLC·00843210166216·Standard Screw, 3.5mm x 10mm

Cortium Universal OCT Spinal Fixation System

FDA UDI
Ulrich Medical Usa, Inc.·00814386026338·Screw, Ø 3.5mm, length 10mm, high angulation

MINIMUM ESSENTIAL MEDIUM EAGLE NO. 210-3510

FDA 510(k)
FDA Class 1 ·Hematology

POINT 4 MODIFIED

FDA 510(k)
FDA Class 2 ·Dental

INSTATRAK SYSTEM WITH FLUOROCAT, MODEL IT3500

FDA 510(k)
FDA Class 2 ·Radiology

EVOLUTION® COLONIC CONTROLLED-RELEASE STENT - UNCOVERED

FDA Adverse Event
Malfunction ·COOK IRELAND LTD·Product code MQR·April 12, 2018

NC TREK CORONARY DILATATION CATHETER

FDA Adverse Event
Injury ·ABBOTT VASCULAR·Product code LOX·December 16, 2022

POWERED WHEELCHAIR

FDA Adverse Event
Malfunction ·INVACARE TAYLOR STREET·Product code ITI·May 9, 2013

SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE

FDA Adverse Event
Injury ·BAXTER HEALTHCARE CORPORATION·Product code KDJ·September 19, 2014

ANIMAS INSULIN INFUSION PUMP

FDA Adverse Event
Malfunction ·ANIMAS CORPORATION·Product code LZG·May 26, 2011

TREK¿

FDA Adverse Event
Malfunction ·ABBOTT VASCULAR INC.·Product code LOX·May 27, 2025

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

EVOLUTION® COLONIC CONTROLLED-RELEASE STENT - UNCOVERED

FDA Adverse Event
Injury ·COOK IRELAND LTD·Product code MQR·August 17, 2017

EVOLUTION BILIARY CONTROLLED-RELEASE STENT - FULLY COVERED

FDA Adverse Event
Malfunction ·COOK IRELAND LTD·Product code FAD·March 12, 2015

TREK¿

FDA Adverse Event
Malfunction ·ABBOTT VASCULAR INC.·Product code LOX·January 7, 2026

EVOLUTION® COLONIC CONTROLLED-RELEASE STENT - UNCOVERED

FDA Adverse Event
Malfunction ·COOK IRELAND LTD·Product code MQR·March 15, 2018

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