74 results
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27ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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LENSAR Laser System - fs 3D (LLS-fs 3D)
FDA 510(k)
FDA Class 2
·Ophthalmic
Millennium
FDA UDI
Avalign Technologies, Inc.·00190776179632·EYE SCISSORS WITH PROBE TIPS STRAIGHT
TALOS® IBF
FDA UDI
MEDITECH SPINE, LLC·B16741814300·
TALOS® IBF
FDA UDI
MEDITECH SPINE, LLC·B1674181430060·
Yellowstone
FDA UDI
SUMMIT SPINE LLC·B587X1814300·18mm H x 14mm W x 30mm L x 0 degrees XLIF
Integra® Miltex®
FDA UDI
INTEGRA LIFESCIENCES PRODUCTION CORPORATION·10381780361879·Integra® Miltex® Eye Scissors 4-1/8", Straight,...
Yellowstone
FDA UDI
SUMMIT SPINE LLC·B587L181430120·18mm H x 14mm W x 30mm L XLIF Trial 12 degree L...
Yellowstone
FDA UDI
SUMMIT SPINE LLC·B587X181430120·18mm H x 14mm W x 30mm L x 12 degrees XLIF
Yellowstone
FDA UDI
SUMMIT SPINE LLC·B587X18143080·18mm H x 14mm W x 30mm L x 8 degrees XLIF
ELEKTA NEUROMAG WITH MAXWELL FILTER WITH INTERNAL ACTIVE SHIELDING
FDA 510(k)
FDA Class 2
·Neurology
MLS-AC DERMA SCANNER
FDA 510(k)
FDA Class 2
·Physical Medicine
EVOLUTION® BILIARY CONTROLLED-RELEASE STENT - FULLY COVERED
FDA Adverse Event
Malfunction
·COOK IRELAND LTD·Product code FCG·January 3, 2017
EVOLUTION® BILIARY CONTROLLED-RELEASE STENT - FULLY COVERED
FDA Adverse Event
Malfunction
·COOK IRELAND LTD·Product code FGE·February 2, 2016
EVOLUTION® BILIARY CONTROLLED-RELEASE STENT - FULLY COVERED
FDA Adverse Event
Injury
·COOK IRELAND LTD·Product code FGE·September 27, 2016
FGE CATHETER, BILIARY, DIAGNOSTIC - BILIARY STENT - METAL
FDA Adverse Event
Injury
·COOK INC·Product code FGE·January 29, 2020
PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·October 17, 2014
ENDOPATH** XCEL* BLADELESS TROCAR
FDA Adverse Event
Malfunction
·ETHICON ENDO-SURGERY, LLC.·Product code GCJ·June 21, 2013
OCTRODE 60-CM LENGTH PERCUTANEOUS LEAD
FDA Adverse Event
Malfunction
·ST. JUDE MEDICAL - NEUROMODULATION·Product code LGW·July 6, 2011
MAGNETOM Vida (DE). Model Number: 11060815. 510(k): K170396, K173617, K181433, K183254, K192924, K203443, K213693, K213805, K220425, K231560.
FDA Recall
Open, Classified
·Siemens Medical Solutions USA, Inc·Product code LNH·August 28, 2025
MAGNETOM Vida (DE). Model Number: 11060815. 510(k): K170396, K173617, K181433, K183254, K192924, K203443, K213693, K213805, K220425, K231560.
FDA Enforcement
Class I
·Ongoing·Siemens Medical Solutions USA, Inc·October 8, 2025