18 results
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25ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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VANGUARD COMPLETE KNEE CRUCIATE RETAINING POROUS & HA FEMUR LEFT 75MM
FDA Adverse Event
Injury
·BIOMET UK LTD.·Product code MBH·December 16, 2016
VANGUARD PS OPEN BOX POROUS FEMORAL COMPONENTS
FDA 510(k)
FDA Class 2
·Orthopedic
PERMITE
FDA UDI
SDI LIMITED·DO3640603032·
Mini-Mono®
FDA UDI
Forestadent Bernhard Förster GmbH·EFOR70603031·Mini-Mono-Brackets Alexander 'S' .022" 100 Brac...
Rumor
FDA UDI
Ortho Organizers, Inc.·00190707003685·Rumor .018 UL2 8T 9A 0O
ROSA® Hip
FDA UDI
Orthosoft Inc·00887868518546·ROSA® Offset Cup Inserter Shaft
ARTSCAN CARTILAGE STIFFNESS TESTING DEVICE
FDA 510(k)
FDA Class 2
·Orthopedic
HEALTHCARE SERVICE AND SUPPLY ALP ALTERNATING LEG PRESSURE PUMP AND GARMENTS FOR THE LIMB
FDA 510(k)
FDA Class 2
·Cardiovascular
SOLITAIRE FR
FDA Adverse Event
Malfunction
·MICRO THERAPEUTICS, INC. DBA EV3·Product code NRY·April 3, 2026
G7 CURVED INSERTER THD SHAFT
FDA Adverse Event
Malfunction
·ZIMMER BIOMET, INC.·Product code PBI·September 20, 2023
G7 OSSEOTI MULTIHOLE 56MM F
FDA Adverse Event
Malfunction
·ZIMMER BIOMET, INC.·Product code LPH·September 20, 2023
9900
FDA Adverse Event
Malfunction
·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·April 11, 2013
GORE TAG THORACIC ENDOPROSTHESIS
FDA Adverse Event
Death
·W. L. GORE & ASSOCIATES, INC.·Product code MIH·June 12, 2008
PRECISION XTRA
FDA Adverse Event
Malfunction
·Product code NBW·April 15, 2011
Bard Orbiter PV Steerable Catheter Item #: 320100 (Marketed in Europe Only)
FDA Recall
Terminated
·C. R.Bard, Inc./Electrophysiology Division·January 8, 2003
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