641 results
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23ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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ARTHRO-SURGIMAT-A103
FDA 510(k)
FDA Class 2
·Orthopedic
StruXure
FDA UDI
Nuvasive, Inc.·00887517408433·StruXure Rod Holder, 5.5mm
Preat
FDA UDI
Preat Corporation·00842092182536·ASC Zimmer TSV 3.5mm/4.5mm/5.7mm-Compatible Tit...
K3Pro Konus Dental Implants
FDA UDI
Argon Medical Productions & Vertriebs Gesellschaft mbH & Co. KG·EAGNCS40001530·1.5mm Cerec Mill Abut w/ 3mm Post
LIFEPAK® 500 Automated External Defibrillator
FDA UDI
PHYSIO-CONTROL, INC.·00681490577557·FINAL ASSY-LP500,ENGLISHVOICE,3 BUTTON OP
GI Holter System
FDA UDI
GLOBAL INSTRUMENTATION, LLC·90815187020245·M3R L Holter Recorder
ACL 9000 SYSTEM
FDA 510(k)
FDA Class 2
·Hematology
AVL OPTI R ANALYZER
FDA 510(k)
FDA Class 2
·Clinical Chemistry
6000153-2016-00816
FDA Adverse Event
Malfunction
·NEURO - VILLALBA·Product code MHY·November 4, 2016
6000153-2007-04557
FDA Adverse Event
Injury
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code GZB·December 20, 2007
6000153-2008-00271
FDA Adverse Event
Injury
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code GZB·January 16, 2008
ACTIVA
FDA Adverse Event
Malfunction
·NEURO - VILLALBA·Product code MHY·July 23, 2012
ON-POINT
FDA Adverse Event
Injury
·MEDTRONIC NEUROMODULATION·Product code LGW·December 28, 2015
ACTIVA
FDA Adverse Event
Malfunction
·NEURO - VILLALBA·Product code MHY·July 23, 2012
PISCES-QUAD
FDA Adverse Event
Injury
·NEURO - VILLALBA·Product code LGW·December 28, 2015
ACTIVA
FDA Adverse Event
Malfunction
·NEURO - VILLALBA·Product code MHY·July 23, 2012
PISCES-QUAD
FDA Adverse Event
Injury
·NEURO - VILLALBA·Product code LGW·December 28, 2015
KINETRA
FDA Adverse Event
Death
·MDT PUERTO RICO OPERATIONS CO., JUNCOS·Product code MHY·August 12, 2010
DEEP BRAIN STIMULATION LEAD KIT
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code MHY·April 21, 2008
DEEP BRAIN STIMULATION LEAD KIT
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO OPERATIONS·Product code MHY·April 21, 2008