18 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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LensHooke X3 PRO Semen Quality Analyzer; LensHooke X3 PRO SE Semen Quality Analyzer
FDA 510(k)
FDA Class 2
·Hematology
KMEDIC
FDA UDI
TELEFLEX INCORPORATED·14026704920645·
KMEDIC
FDA UDI
TELEFLEX INCORPORATED·24026704266498·FRAZIER TUBE 12 FRENCH
devemed
FDA UDI
devemed GmbH·04061644032792·Suction cannula Ø 4mm | 17.0cm
with slot agains...
Yellowstone
FDA UDI
SUMMIT SPINE LLC·B587A24283080·24mm H x 28mm W x 30mm L x 8 degrees ALIF
Yellowstone
FDA UDI
SUMMIT SPINE LLC·B587A242830120·24mm H x 28mm W x 30mm L x 12 degrees ALIF
Yellowstone
FDA UDI
SUMMIT SPINE LLC·B587A242830150·24mm H x 28mm W x 30mm L x 15 degrees ALIF
Reicodent
FDA UDI
devemed GmbH·04061644061501·Suction cannula Ø 4mm | 17.0cm
with slot agains...
BD INSYTE¿ AUTOGUARD¿ SHIELDED IV CATHETER
FDA Adverse Event
Malfunction
·BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.·Product code FOZ·June 7, 2023
BD INSYTE¿ AUTOGUARD¿ SHIELDED IV CATHETER
FDA Adverse Event
Malfunction
·BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.·Product code FOZ·June 7, 2023
POWDER FREE VINYL SYNTHETIC EXAMINATION GLOVES
FDA 510(k)
FDA Class 1
·General Hospital
Ophthalmed Bending Laser Probes
FDA 510(k)
FDA Class 2
·Ophthalmic
CURRENT RF DR
FDA Adverse Event
Injury
·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code LWS·September 11, 2011
530G INSULIN PUMP MMT-751NAS
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OZO·November 11, 2014
ONETOUCHPING GLUCOSEMGMTSYSTEM
FDA Adverse Event
Injury
·ANIMAS CORPORATION·Product code LZG·July 23, 2013
Model Number L111, ESSENTIO DR SL MRI Pacemaker
FDA Enforcement
Class I
·Ongoing·Boston Scientific Corporation·October 22, 2025
ALLURA Xper FD20; System Code: (1) 722006, (2)722012, (3)722028;
FDA Enforcement
Class II
·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·April 8, 2026
Allura Xper FD20; Model Numbers: (1) 722006, (2) 722012, (3) 722028; Associated 510(k)s: K102005, K130638, K130842, K133292, K141979, K162859, K161563;
FDA Enforcement
Class II
·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·October 8, 2025