19 results
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21ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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LENSTEC INTRAOCULAR LENS (IOL) INJECTION SYSTEM FOR TETRAFLEX INTRAOCULAR LENSES
FDA 510(k)
FDA Class 1
·Ophthalmic
RESPONDER 3000
FDA 510(k)
FDA Class 3
·Cardiovascular
NEUROPLUS, MODEL A10040, A10041, A10042, A10043
FDA 510(k)
FDA Class 2
·Neurology
ZILVER 518 BILIARY SELF-EXPANDING STENT
FDA Adverse Event
Malfunction
·COOK IRELAND LTD·Product code FGE·September 21, 2017
CART 9734056 S7 STAFF SHRT 100-120V INTL
FDA Adverse Event
Malfunction
·MEDTRONIC NAVIGATION, INC·Product code HAW·June 14, 2019
CART 9733856 S7 STAFF ASSEMBLED 110V
FDA Adverse Event
Malfunction
·MEDTRONIC NAVIGATION, INC·Product code HAW·June 4, 2019
NAVLOCK UNIVERSAL GREEN TRACKER
FDA Adverse Event
Malfunction
·MEDTRONIC NAVIGATION, INC. (LOUISVILLE)·Product code HAW·October 30, 2015
SCREW DRIVER
FDA Adverse Event
Malfunction
·MEDTRONIC NAVIGATION, INC·Product code HAW·August 5, 2019
ENDURANT
FDA Adverse Event
Injury
·MEDTRONIC IRELAND·Product code MIH·April 10, 2013
X7000 XENON LIGHTSOURCE
FDA Adverse Event
Malfunction
·STRYKER ENDOSCOPY SAN JOSE·Product code FCW·March 14, 2011
TENDRIL ST
FDA Adverse Event
Injury
·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code DTB·May 27, 2008
CART 9734056 S7 STAFF SHRT 100-120V INTL
FDA Adverse Event
Malfunction
·MEDTRONIC NAVIGATION, INC·Product code HAW·June 18, 2019
CART 9734056 S7 STAFF SHRT 100-120V INTL
FDA Adverse Event
Malfunction
·MEDTRONIC NAVIGATION, INC. (LOUISVILLE)·Product code HAW·May 18, 2018
TI MATRIXNEURO CONTOUR MESH 200MM X 200MM/0.6MM RIGID
FDA Adverse Event
Injury
·SYNTHES MONUMENT·Product code JEY·May 21, 2014
NAV THORACIC PROBE TIP
FDA Adverse Event
Injury
·MEDTRONIC NAVIGATION, INC.·Product code OLO·August 27, 2014
ZILVER 518 SELF-EXPANDING STENT
FDA Adverse Event
Malfunction
·COOK IRELAND LTD·Product code FGE·October 26, 2012
NEUROLOGICAL STEREOTAXIC INSTRUMENT
FDA Adverse Event
Injury
·MEDTRONIC NAVIGATION, INC. (LOUISVILLE)·Product code HAW·October 26, 2015
Belmont Rapid Infuser, a Fluid Management System, Model FMS2000.
FDA Enforcement
Class II
·Terminated·Belmont Instrument Corporation·October 24, 2012
cobas 6000 Modular Series system; Part Numbers: 1. 04745914001 cobas c 501 module; 2. 05036453001 cobas 6000 UL c 501 + Core Fix configuration; 3. 05036453692 - cobas 6000 UL + CORE CU; and 4. 05860636001 cobas 6000 c 501 (UL) V
FDA Enforcement
Class II
·Terminated·Roche Diagnostics Corporation·March 14, 2018