14 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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LigaSure Impact Curved, Large Jaw, Open Sealer/Divider, Nano-coated
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
Avalign
FDA UDI
Avalign Technologies, Inc.·00190776020217·Slotted U Bracket
Millennium
FDA UDI
Avalign Technologies, Inc.·00190776115883·Slotted U Bracket
ADAPTABLE MONOPOLAR ADAPTABLE AND/OR RETRACTABLE ELECTRODES
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
LCI OPTION FOR INNOCOR
FDA 510(k)
FDA Class 2
·Anesthesiology
RIVA STAR SILVER DIAMINE FLUORIDE
FDA Adverse Event
Injury
·SDI LIMITED·Product code LBH·February 13, 2019
WEREWOLF RF 20000 CONTROLLER
FDA Adverse Event
Malfunction
·ARTHROCARE CORP.·Product code GEI·June 29, 2020
IMPACT
FDA Adverse Event
Other
·IMPACT INSTRUMENTATION, INC·Product code BTA·April 5, 2010
INTERSTIM II
FDA Adverse Event
Injury
·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code EZW·October 10, 2014
EX-PRESS MINI GLAUCOMA SHUNT
FDA Adverse Event
Malfunction
·OPTONOL, LTD·Product code KYF·June 6, 2013
MENISCAL CINCH
FDA Adverse Event
Injury
·ARTHREX INC.·Product code GAT·December 6, 2017
MENISCAL CINCH
FDA Adverse Event
Injury
·ARTHREX INC.·Product code GAT·December 6, 2017
MAGNETOM Verio Dot Upgrade. Model Number: 10684334.
FDA Enforcement
Class I
·Ongoing·Siemens Medical Solutions USA, Inc·October 8, 2025
Philips Ingenia Elition X with MR Elastography (MRE). 1. Model Number (REF): 781358. 2. Model Number (REF): 782107. 3. Model Number (REF): 782136. 510(k) Numbers: K213516, K223458, K230972, K232030, K251397, K251808
FDA Enforcement
Class II
·Ongoing·Philips North America·May 6, 2026