19 results
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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THE AMO OPHTHALMIC SURGICAL SYSTEM
FDA 510(k)
FDA Class 2
·Ophthalmic
Marina Medical
FDA UDI
MARINA MEDICAL INSTRUMENTS, INC.·00840306801662·Magill Endotracheal Catheter Intro Forceps, 8"(...
FIXATION STYLETS, MODELS 335-287 AND 335-288
FDA 510(k)
FDA Class 2
·Cardiovascular
DISPOSABLE STORAGE CAP
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
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
PRECISION? MONTAGE? MRI
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC NEUROMODULATION CORPORATION·Product code LGW·September 3, 2025
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
IMPRESS ANGIOGRAPHIC CATHETERS
FDA Adverse Event
Injury
·MERIT MEDICAL SYSTEMS, INC.·Product code DQO·April 11, 2013
STORZ SIMCO DOUBLE BARRELED I/A UNIT 23G
FDA Adverse Event
Malfunction
·BAUSCH & LOMB, INC.·Product code HNR·August 8, 2014
ONE TOUCH ULTRAMINI METER
FDA Adverse Event
Injury
·LIFESCAN, INC.·Product code NBW·June 17, 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