9 results
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19ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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KSEA MODEL 26012CH ELECTRONIC LAPAROFLATOR
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
Millennium
FDA UDI
Avalign Technologies, Inc.·00190776093488·Pacifico Suction Tube, Long
Volk Disposable Iridotomy Lens, Volk Disposable Capsulotomy Lens
FDA 510(k)
FDA Class 2
·Ophthalmic
WWMED, MODEL 401
FDA 510(k)
FDA Class 2
·Physical Medicine
ELECTRODE, PACEMAKER, PERMANENT
FDA Adverse Event
Injury
·MPRI·Product code DTB·February 9, 2013
SYNERGY
FDA Adverse Event
Malfunction
·MDT PUERTO RICO OPERATIONS CO., JUNCOS·Product code LGW·January 4, 2011
PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL)
FDA Adverse Event
Malfunction
·INVACARE FLORIDA OPERATIONS·Product code CAW·July 23, 2014
PDS II POLYDIOXANONE SUTURE UNKNOWN PRODUCT
FDA Adverse Event
Injury
·ETHICON INC.·Product code NEW·October 28, 2024
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