19 results · 21ms · 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.

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