17 results · 22ms · Sources: EU EUDAMED, US FDA

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TENOLIG

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

SECURMIX

FDA 510(k)
FDA Class 2 ·General Hospital

MODIFICATION TO TITANIUM TRI-LOCK HIPS STEM

FDA 510(k)
FDA Class 2 ·Orthopedic

XIA LP POLYAXIAL SCREW 6.5 X 40MM

FDA Adverse Event
Malfunction ·STRYKER SPINE BORDEAUX·Product code KWQ·September 20, 2011

XIA ROD DIA. 6 X 480

FDA Adverse Event
Malfunction ·STRYKER SPINE BORDEAUX·Product code KWQ·June 2, 2011

XIA BLOCKER

FDA Adverse Event
Malfunction ·STRYKER SPINE BORDEAUX·Product code KWQ·May 2, 2011

XIA SCREW 6, 5 X 40

FDA Adverse Event
Malfunction ·STRYKER SPINE BORDEAUX·Product code MNI·May 11, 2011

XIA LP POLYAXIAL SCREW 5.5 X 45MM

FDA Adverse Event
Injury ·STRYKER SPINE-SWITZERLAND·Product code KWP·September 7, 2016

XIA POLYAXIAL SCREW 8.5 X 40MM

FDA Adverse Event
Malfunction ·STRYKER SPINE BORDEAUX·Product code MNH·May 2, 2011

XIA BLOCKER

FDA Adverse Event
Injury ·STRYKER SPINE BORDEAUX·Product code KWP·May 11, 2011

7700

FDA Adverse Event
Malfunction ·GE OEC MEDICAL SYSTEMS GMBH·Product code JAA·April 10, 2013

STORZ SIMCO DOUBLE BARRELED I/A UNIT 23G

FDA Adverse Event
Malfunction ·BAUSCH & LOMB, INC.·Product code HNR·August 8, 2014

LASIK EYE SURGERY

FDA Adverse Event
*·Product code LZS·June 13, 2008

XIA LP POLYAXIAL SCREW 6.5 X 50MM

FDA Adverse Event
Malfunction ·STRYKER SPINE BORDEAUX·Product code KWQ·September 20, 2011

The PRM is intended to be used as part of the ZOOM LATITUDE Programming System to communicate with Boston Scientific implantable pulse generators. The software in use controls all communication functions for the pulse generator.

FDA Enforcement
Class II ·Ongoing·Boston Scientific Corporation·September 7, 2022

The Programmer/Recorder/Monitor (PRM) is intended to be used as part of the ZOOM LATITUDE Programming System to communicate with Boston Scientific implantable pulse generators. The software in use controls all communication functions for the pulse generator.

FDA Enforcement
Class II ·Ongoing·Boston Scientific Corporation·September 7, 2022

The PRM is intended to be used as part of the ZOOM LATITUDE Programming System to communicate with Boston Scientific implantable pulse generators. The software in use controls all communication functions for the pulse generator.

FDA Enforcement
Class II ·Ongoing·Boston Scientific Corporation·September 7, 2022