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

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LENSAR Laser System - fs 3D (LLS-fs 3D)

FDA 510(k)
FDA Class 2 ·Ophthalmic

Millennium

FDA UDI
Avalign Technologies, Inc.·00190776179632·EYE SCISSORS WITH PROBE TIPS STRAIGHT

TALOS® IBF

FDA UDI
MEDITECH SPINE, LLC·B16741814300·

TALOS® IBF

FDA UDI
MEDITECH SPINE, LLC·B1674181430060·

Yellowstone

FDA UDI
SUMMIT SPINE LLC·B587X1814300·18mm H x 14mm W x 30mm L x 0 degrees XLIF

Integra® Miltex®

FDA UDI
INTEGRA LIFESCIENCES PRODUCTION CORPORATION·10381780361879·Integra® Miltex® Eye Scissors 4-1/8", Straight,...

Yellowstone

FDA UDI
SUMMIT SPINE LLC·B587L181430120·18mm H x 14mm W x 30mm L XLIF Trial 12 degree L...

Yellowstone

FDA UDI
SUMMIT SPINE LLC·B587X181430120·18mm H x 14mm W x 30mm L x 12 degrees XLIF

Yellowstone

FDA UDI
SUMMIT SPINE LLC·B587X18143080·18mm H x 14mm W x 30mm L x 8 degrees XLIF

ELEKTA NEUROMAG WITH MAXWELL FILTER WITH INTERNAL ACTIVE SHIELDING

FDA 510(k)
FDA Class 2 ·Neurology

MLS-AC DERMA SCANNER

FDA 510(k)
FDA Class 2 ·Physical Medicine

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

PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

FDA Adverse Event
Malfunction ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·October 17, 2014

ENDOPATH** XCEL* BLADELESS TROCAR

FDA Adverse Event
Malfunction ·ETHICON ENDO-SURGERY, LLC.·Product code GCJ·June 21, 2013

OCTRODE 60-CM LENGTH PERCUTANEOUS LEAD

FDA Adverse Event
Malfunction ·ST. JUDE MEDICAL - NEUROMODULATION·Product code LGW·July 6, 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