171 results · 23ms · 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.

Surface Applicator Set

FDA 510(k)
FDA Class 2 ·Radiology

MSI Precision Specialty Instruments

FDA UDI
Med Saver, Inc.·00194613122928·Vented Instrument Guards, Clear, 1/16" x 5/8" x...

Straight Pin with Shoulder 3.2x70

FDA UDI
SIGNATURE ORTHOPAEDICS PTY LTD·09348215061920·

Avalign

FDA UDI
Avalign Technologies, Inc.·00190776020293·Keyhole Bracket

Millennium

FDA UDI
Avalign Technologies, Inc.·00190776116194·Keyhole Bracket

SMART READ EZTEST STEAM

FDA 510(k)
FDA Class 2 ·General Hospital

NORIAN REINFORCED, NORIAN REINFORCED FAST SET PUTTY

FDA 510(k)
FDA Class 2 ·Neurology

MAGNETOM Verio Dot Upgrade. Model Number: 10684334.

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

UNKNOWN STRATA VALVE/SHUNT

FDA Adverse Event
Injury ·MEDTRONIC NEUROSURGERY·Product code JXG·July 5, 2018

PARADIGM REAL-TIME INSULIN INFUSION PUMP

FDA Adverse Event
Injury ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·October 10, 2014

RX BILIARY

FDA Adverse Event
Injury ·BOSTON SCIENTIFIC - SPENCER·Product code FGE·July 14, 2011

IMPAX CV REPORTING

FDA Adverse Event
Malfunction ·AGFA HEALTHCARE CORP.·Product code LLZ·June 11, 2013

UNKNOWN_SPINE_PRODUCT

FDA Adverse Event
Injury ·STRYKER SPINE-US·Product code MQP·June 29, 2021

PROLENE POLYPROPYLENE MESH UNKNOWN PRODUCT

FDA Adverse Event
Death ·ETHICON INC.·Product code FTL·April 23, 2021

PROLENE POLYPROPYLENE MESH UNKNOWN PRODUCT

FDA Adverse Event
Injury ·ETHICON INC.·Product code FTL·April 23, 2021

OSCOR ADELANTE BREEZEWAY 8F C90¿ S79CM D84CM Catalog # AB081046 Is designed to facilitate the introduction of catheters to any of the heart chambers, including the left atrium via a transseptal puncture.

FDA Enforcement
Class II ·Terminated·Oscor, Inc.·December 28, 2016

MEDTRONIC ARRIVE BRAIDED TRANSSEPTAL SHEATH 10F C70¿ S61CM D66CM GLOBAL Catalog # 990061-070-000 Is designed to facilitate the introduction of catheters to any of the heart chambers, including the left atrium via a transseptal puncture.

FDA Enforcement
Class II ·Terminated·Oscor, Inc.·December 28, 2016

OSCOR ADELANTE BREEZEWAY 10F C55¿ S79CM D84CM Catalog # AB101076 Is designed to facilitate the introduction of catheters to any of the heart chambers, including the left atrium via a transseptal puncture.

FDA Enforcement
Class II ·Terminated·Oscor, Inc.·December 28, 2016

MEDTRONIC ARRIVE BRAIDED TRANSSEPTAL SHEATH 10F C70¿ S79CM D84CM GLOBAL Catalog # 990079-070-000 Is designed to facilitate the introduction of catheters to any of the heart chambers, including the left atrium via a transseptal puncture.

FDA Enforcement
Class II ·Terminated·Oscor, Inc.·December 28, 2016

OSCOR ADELANTE BREEZEWAY 8F C70¿ S61CM D66CM Catalog # AB081041 Is designed to facilitate the introduction of catheters to any of the heart chambers, including the left atrium via a transseptal puncture.

FDA Enforcement
Class II ·Terminated·Oscor, Inc.·December 28, 2016