72 results · 27ms · Sources: EU EUDAMED, US FDA

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GOODLIFE CS-200 (SINGLE PATIENT USE), CS-200 PROFESSIONAL (MULTIPLE PATIENT USE) BLOOD GLUCOSE MONITORING SYSTEMS

FDA 510(k)
FDA Class 2 ·Clinical Chemistry

SafeGuide®

FDA UDI
DIVERSATEK HEALTHCARE, INC.·00816734021095·Esophageal Dilator, 33 French

MaxFuse VBR, 10 (D) x 12 (W) x 49 (H)

FDA UDI
Pioneer Surgical Technology, Inc.·00846468055530·10 (D) x 12 (W) x 49 (H)

MODEL 415PH-64/42: PHASED ARRAY SHOULDER COIL

FDA 510(k)
FDA Class 2 ·Radiology

DEPUY ATTUNE KNEE SYSTEM

FDA 510(k)
FDA Class 2 ·Orthopedic

Matrixx System

FDA UDI
NEXXT SPINE, LLC·00889929064719·Corpectomy, 12Dx14Wx33H 0°

Matrixx System

FDA UDI
NEXXT SPINE, LLC·00889929038826·Corpectomy, 12Dx14Wx33H 6°

BD SYRINGE 10ML LL TIP BULK CONVENIENCE PAK

FDA Adverse Event
Malfunction ·BECTON DICKINSON MEDICAL SYSTEMS·Product code FMF·October 30, 2025

BD SYRINGE 10ML LL TIP BULK CONVENIENCE PAK

FDA Adverse Event
Malfunction ·BECTON DICKINSON MEDICAL SYSTEMS·Product code FMF·October 30, 2025

EVOLUTION® BILIARY CONTROLLED-RELEASE STENT - FULLY COVERED

FDA Adverse Event
Malfunction ·COOK IRELAND LTD·Product code FCG·January 3, 2017

EVOLUTION® BILIARY CONTROLLED-RELEASE STENT - FULLY COVERED

FDA Adverse Event
Malfunction ·COOK IRELAND LTD·Product code FGE·February 2, 2016

EVOLUTION® BILIARY CONTROLLED-RELEASE STENT - FULLY COVERED

FDA Adverse Event
Injury ·COOK IRELAND LTD·Product code FGE·September 27, 2016

FGE CATHETER, BILIARY, DIAGNOSTIC - BILIARY STENT - METAL

FDA Adverse Event
Injury ·COOK INC·Product code FGE·January 29, 2020

OT VERIO IQ METER

FDA Adverse Event
Malfunction ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·May 20, 2013

ONETOUCHPING GLUCOSEMGMTSYSTEM

FDA Adverse Event
Malfunction ·ANIMAS CORPORATION·Product code LZG·September 26, 2014

LIGASURE ATLAS HANDSWITCHING 37CM

FDA Adverse Event
Malfunction ·COVIDIEN LLC (SHANGHAI)·Product code GEI·May 5, 2011

MAGNETOM Vida (DE). Model Number: 11060815. 510(k): K170396, K173617, K181433, K183254, K192924, K203443, K213693, K213805, K220425, K231560.

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

MAGNETOM Vida (DE). Model Number: 11060815. 510(k): K170396, K173617, K181433, K183254, K192924, K203443, K213693, K213805, K220425, K231560.

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

EVOLUTION BILIARY CONTROLLED-RELEASE STENT-FULLY COVERED

FDA Adverse Event
Injury ·COOK IRELAND LTD·Product code FGE·March 25, 2015

EVOLUTION BILIARY CONTROLLED-RELEASE STENT - FULLY COVERED

FDA Adverse Event
Malfunction ·COOK IRELAND LTD·Product code FGE·April 24, 2015