17 results
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24ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: 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