3,550 results
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26ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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IntelliSpace Portal Platform
FDA 510(k)
FDA Class 2
·Radiology
XENMATRIX
FDA UDI
Davol Inc.·00801741031465·XenMatrix Surgical Graft, 20 cm x 25 cm (7.9” x...
n.a.
FDA UDI
Karl Storz GmbH & Co. KG·04048551057964·Ear Forceps, Ø 2,5 mm, 8 cm
Yellowstone
FDA UDI
SUMMIT SPINE LLC·B587X1620250·16mm H x 20mm W x 25mm L x 0 degrees XLIF
Yellowstone
FDA UDI
SUMMIT SPINE LLC·B587X16202580·16mm H x 20mm W x 25mm L x 8 degrees XLIF
Yellowstone
FDA UDI
SUMMIT SPINE LLC·B587L162025120·16mm H x 20mm W x 25mm L XLIF Trial 12 degree L...
Yellowstone
FDA UDI
SUMMIT SPINE LLC·B587X162025120·16mm H x 20mm W x 25mm L x 12 degrees XLIF
TALOS° HA PEEK IBF
FDA UDI
MEDITECH SPINE, LLC·B167321620250·
Millennium
FDA UDI
Avalign Technologies, Inc.·00190776116101·Pass Thru Bracket
COMBAT READY CLAMP
FDA 510(k)
FDA Class 2
·Cardiovascular
ASPIRINWORKS TEST KIT (11-DEHYDRO THROMBOXANE B2), MODEL 12136
FDA 510(k)
FDA Class 2
·Hematology
NA
FDA UDI
Zimmer, Inc.·00889024084964·
MAGNETOM Verio Dot Upgrade. Model Number: 10684334.
FDA Enforcement
Class I
·Ongoing·Siemens Medical Solutions USA, Inc·October 8, 2025
CONTINUUM TM SHELL WITH CLUSTER HOLES
FDA Adverse Event
Injury
·ZIMMER INC·Product code JDI·July 12, 2011
MAXGUARD EXTENSION SET
FDA Adverse Event
Injury
·CAREFUSION CORPORATION·Product code FPA·May 29, 2013
530G INSULIN PUMP
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OZO·October 10, 2014
PUMP MMT-1884L MM780G BLE 3.0 MG/ML
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OZP·August 17, 2025
PUMP MMT-1884L MM780G BLE 3.0 MG/ML
FDA Adverse Event
Injury
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OZP·December 16, 2025
PUMP MMT-1780KPK 670G PATHWAY BLACK MG
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OZP·July 18, 2025
OsteoBridge Intremedullary Knee Arthrodesis (IKA) nails
FDA Enforcement
Class II
·Terminated·Merete Medical GmbH·November 18, 2020