14 results
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20ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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Sony IP Converter NU-IP40S
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
Symmetry Rochester-Pean
FDA UDI
ASPEN SURGICAL PRODUCTS, INC.·00887482040317·Symmetry® Forceps, Rochester-Pean Hemostatic, C...
Sentry
FDA UDI
Life Spine, Inc.·00190837034269·
BOSS Instruments
FDA UDI
BOSS INSTRUMENTS, LTD., INC.·00888515023307·Forester Sponge Fcps, str, 18"
ZEUS-L
FDA UDI
SPINAL ELEMENTS·00840916141912·ZEUS®-L Dual Sided Zeus-L Rasp
BENZ-G 4X (HIOXIFILCON D) MULTIFOCAL LATHED LENS
FDA 510(k)
FDA Class 2
·Ophthalmic
NIGHT GUARD
FDA 510(k)
FDA Unclassified
·Unknown
SPRINT QUATTRO SECURE
FDA Adverse Event
Malfunction
·MPRI·Product code LWS·October 10, 2014
OT ULTRALINK METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·June 11, 2013
INFINITI VISION SYSTEM OZIL
FDA Adverse Event
Malfunction
·ALCON - IRVINE TECHNOLOGY CENTER·Product code HQC·June 17, 2011
BEACON TIP TORCON NB ADVANTAGE ANGIOGRAPHIC CATHETER
FDA Adverse Event
Injury
·COOK INC·Product code DQO·November 26, 2025
Glidesheath Slender Hydrophilic Coated Introducer Sheath, 6FR - 10CM (0.021), REF/Product Code RM*RS6F10PA, STERILE, Rx ONLY
FDA Enforcement
Class II
·Terminated·Terumo Medical Corp·December 20, 2017
Allura Xper FD20/20; Catalog numbers: 722038
FDA Enforcement
Class I
·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·February 26, 2025
Allura Xper FD20/20; Model Numbers: 722038; 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