20 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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ProSun sunlamp products, Luxura sunlamp products
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
TALOS® IBF
FDA UDI
MEDITECH SPINE, LLC·B16741814550·
Millennium
FDA UDI
Avalign Technologies, Inc.·00190776186449·STEVENS TENOTOMY SCS CURVED
TALOS® IBF
FDA UDI
MEDITECH SPINE, LLC·B1674181455060·
Yellowstone
FDA UDI
SUMMIT SPINE LLC·B587X1814550·18mm H x 14mm W x 55mm L x 0 degrees XLIF
Integra® Miltex®
FDA UDI
INTEGRA LIFESCIENCES PRODUCTION CORPORATION·10381780361947·Integra® Miltex® Stevens Tenotomy Scissors, 5-3...
Yellowstone
FDA UDI
SUMMIT SPINE LLC·B587X181455120·18mm H x 14mm W x 55mm L x 12 degrees XLIF
Yellowstone
FDA UDI
SUMMIT SPINE LLC·B587X18145580·18mm H x 14mm W x 55mm L x 8 degrees XLIF
Regatta Lateral System
FDA UDI
Seaspine Orthopedics Corporation·10889981158545·Lateral Implant, 18mm x 14mm x 55mm, 10 Deg
Regatta Lateral System
FDA UDI
Seaspine Orthopedics Corporation·10889981158552·Lateral Implant, 18mm x 14mm x 55mm, 15 Deg
Regatta
FDA UDI
Seaspine Orthopedics Corporation·10889981158538·Lateral Implant, 18mm x 14mm x 55mm, 0 Deg
EKO 7 DIAGNOSTIC ULTRASOUND SYSTEM
FDA 510(k)
FDA Class 2
·Radiology
RAYNER SINGLE USE SMALL INCISION DISPOSABLE INJECTOR, MODEL R-INJ-06
FDA 510(k)
FDA Class 1
·Ophthalmic
LINEAR ST
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC NEUROMODULATION·Product code LGW·October 3, 2018
PARADIGM REAL-TIME INSULIN INFUSION PUMP
FDA Adverse Event
Injury
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·October 17, 2014
STYLE 20 SILICONE GEL FILLED BREAST IMPLANT
FDA Adverse Event
Injury
·ALLERGAN·Product code FTR·June 14, 2013
NC QUANTUM APEX PTCA DILATATION CATHETER
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC - MAPLE GROVE·Product code LOX·July 27, 2011
NUTRILINE
FDA Adverse Event
Malfunction
·VYGON USA·Product code LJS·October 15, 2025
EPIQ 7C ULTRASOUND CHINA LOCAL
FDA Adverse Event
Malfunction
·PHILIPS ULTRASOUND (SHANGHAI) CO., LTD·Product code IYN·June 2, 2023
Vantage Total Ankle System including a. Vantage Fixed-Bearing Polyethylene Liner Component (Product Line: 350-21-XX, 350-22-XX); b. Vantage Mobile-Bearing Polyethylene Liner Component (Product Line: 350-41-XX, 350-42-XX). NOTE: Information reflects Exactech recall expansion initiated on 02/07/2022.
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·October 13, 2021