17 results · 24ms · Sources: EU EUDAMED, US FDA

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PROLENE POLYPROPYLENE NONABSORBABLE SUTURE

FDA 510(k)
FDA Class 2 ·General, Plastic Surgery

AGXO

FDA UDI
Oticon A/S·05707131260413·H100, MINIBTE 312 WL 85 CNB AGXO

PRUITT CAROTID KIT

FDA 510(k)
FDA Class 2 ·Cardiovascular

VERASOFT ES

FDA 510(k)
FDA Class 2 ·Dental

PERIPHERAL NERVE BLOCK SUPPORT TRAY

FDA Adverse Event
Malfunction ·I-FLOW, LLC·Product code CAZ·October 1, 2014

PRECISION®

FDA Adverse Event
Injury ·BOSTON SCIENTIFIC NEUROMODULATION·Product code LGW·May 29, 2013

TALENT THORACIC STENT GRAFT SYSTEM

FDA Adverse Event
Death ·MEDTRONIC IRELAND·Product code MIH·June 14, 2011

PUMP MMT-722LNAB PRDGM INS BL EN ML

FDA Adverse Event
Injury ·MEDTRONIC MINIMED·Product code LZG·August 22, 2008

CONTINUOUS TRAY WITH 100MM NEEDLE, STIMULATING

FDA Adverse Event
Malfunction ·I-FLOW LLC·Product code CAZ·October 2, 2014

CONTINUOUS TRAY WITH 100MM NEEDLE 4IN ECHO NEE

FDA Adverse Event
Malfunction ·I-FLOW LLC·Product code CAZ·October 3, 2014

CONTINUOUS TRAY WITH 100MM NEEDLE, NON STIMULA

FDA Adverse Event
Malfunction ·I-FLOW LLC·Product code CAZ·October 1, 2014

PERIPHERAL NERVE BLOCK SUPPORT TRAY : CONTINUEOUS TRAY 100MM NEEDLE STIMULATING

FDA Adverse Event
Malfunction ·HALYARD - IRVINE·Product code CAZ·May 12, 2015

CONTINUOUS TRAY WITH 100MM NEEDLE STIMULATING & 61CM CATHETER

FDA Adverse Event
Malfunction ·HALYARD HEALTH - IRVINE·Product code CAZ·November 8, 2015

CONTINUOUS TRAY WITH 100MM NEEDLE STIMULATING

FDA Adverse Event
Malfunction ·HALYARD - IRVINE·Product code CAZ·July 1, 2015

ECHOBRIGHT T-BLOC TRAY 100MM NEEDLE, NON STIMU

FDA Adverse Event
Malfunction ·HALYARD·Product code CAZ·April 7, 2015

ECHOBRIGHT T-BLOC TRAY 100MM NEEDLE, NON STIMU

FDA Adverse Event
Malfunction ·HALYARD·Product code CAZ·April 7, 2015

Ultraview SL Command Modules, Model 91496, with the Masimo SpO2 PCBA, PN: 010-1636-02. The Spacelabs Multi-parameter Module is intended for use with the Patient Care Management System (PCMS) to acquire, monitor, and process various clinical parameters from an adult or neonate/infant populations in any type of clinical environment other than home use.

FDA Enforcement
Class II ·Terminated·Spacelabs Healthcare Inc·May 13, 2015