16 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Catalys Precision Laser System
FDA 510(k)
FDA Class 2
·Ophthalmic
CoRoent
FDA UDI
Nuvasive, Inc.·00887517731524·CoRoent XL+, 14x18x55mm 15°
CoRoent
FDA UDI
Nuvasive, Inc.·00887517292384·CoRoent® XLFW, 14x22x55mm
Yellowstone
FDA UDI
SUMMIT SPINE LLC·B587X1614550·16mm H x 14mm W x 55mm L x 0 degrees XLIF
TALOS® IBF
FDA UDI
MEDITECH SPINE, LLC·B16741614550·
Yellowstone
FDA UDI
SUMMIT SPINE LLC·B587X161455120·16mm H x 14mm W x 55mm L x 12 degrees XLIF
Yellowstone
FDA UDI
SUMMIT SPINE LLC·B587X16145580·16mm H x 14mm W x 55mm L x 8 degrees XLIF
TALOS® IBF
FDA UDI
MEDITECH SPINE, LLC·B1674161455060·
EKO 7 DIAGNOSTIC ULTRASOUND SYSTEM
FDA 510(k)
FDA Class 2
·Radiology
DORNIER MEDILAS H 20 LASER
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
UNKNOWN VANGUARD FEMORAL
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code JWH·August 4, 2025
LAMITRODE TRIPOLE 16C
FDA Adverse Event
Injury
·ST. JUDE MEDICAL - NEUROMODULATION·Product code LGW·June 5, 2013
ENTERPRISE VASCULAR RECONSTRUCTION DEVICE AND DELIVERY SYSTEM
FDA Adverse Event
Malfunction
·CORDIS NEUROVASCULAR, INC.·Product code NJE·July 14, 2011
CYPHER SIROLIMUS-ELUTING CORONARY STENT
FDA Adverse Event
Malfunction
·CORDIS DE MEXICO·Product code NIQ·September 12, 2008
COBAS AMPLIPREP / COBAS TAQMAN 48 ANALYZER
FDA Adverse Event
Malfunction
·ROCHE DIAGNSOTICS, LTD.·Product code JJF·October 4, 2010
Jackson-Pratt Hemaduct Cardiothoracic Silicone Round Drain,19FR. Sterile, Rx Only. For Single Use Only. Jackson-Pratt Wound Drainage Systems are sterile single use devices. The wound drainage system consist of a wound drain and a fluid collection reservoir. The wound drain is a radio-opaque section of tubing which has perforations or ducts. The wound drain is surgically placed in a surgical wound site using a trocar. Blood and fluids are collected through a wound drain into a fluid collection reservoir. Wound drains are used to remove exudates from wound sites. Trocars, drains and reservoirs are for a single patient use only and should be discarded after use
FDA Enforcement
Class II
·Terminated·Cardinal Health 200, LLC·May 31, 2017