16 results
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23ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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GMK Sphere
FDA 510(k)
FDA Class 2
·Orthopedic
MSI Precision Specialty Instruments
FDA UDI
Med Saver, Inc.·00194613017699·K-Wire, Double Ended, Trocar Point, Diameter Si...
Yellowstone
FDA UDI
SUMMIT SPINE LLC·B587X1620350·16mm H x 20mm W x 35mm L x 0 degrees XLIF
TALOS® IBF
FDA UDI
MEDITECH SPINE, LLC·B16741620350·
Epimed
FDA UDI
EPIMED INTERNATIONAL, INC·00818788022875·20g TW x 3.5" Blunt Nerve Block Needle
Yellowstone
FDA UDI
SUMMIT SPINE LLC·B587X162035120·16mm H x 20mm W x 35mm L x 12 degrees XLIF
Yellowstone
FDA UDI
SUMMIT SPINE LLC·B587X16203580·16mm H x 20mm W x 35mm L x 8 degrees XLIF
Yellowstone
FDA UDI
SUMMIT SPINE LLC·B587L162035120·16mm H x 20mm W x 35mm L XLIF Trial 12 degree L...
TALOS® IBF
FDA UDI
MEDITECH SPINE, LLC·B1674162035060·
MAGNETOM Verio Dot Upgrade. Model Number: 10684334.
FDA Enforcement
Class I
·Ongoing·Siemens Medical Solutions USA, Inc·October 8, 2025
SLEEK OTW PTA CATHETERS
FDA 510(k)
FDA Class 2
·Cardiovascular
DIMENSION VISTA RF FLEX REAGENT CARTRIDGE; PROTEIN 2 CALIBRATOR AND CONTROL
FDA 510(k)
FDA Class 2
·Clinical Chemistry
SD/PD LONG CURVED
FDA Adverse Event
Malfunction
·STRYKER INSTRUMENTS-KALAMAZOO·Product code ERL·October 10, 2014
9900
FDA Adverse Event
Malfunction
·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·June 6, 2013
MEDISENSE OPTIUM
FDA Adverse Event
Malfunction
·Product code NBW·July 14, 2011
SLEEK OTW PTA CATHETER
FDA Adverse Event
Injury
·CLEARSTREAM TECHNOLOGIES LTD.·Product code DQY·December 13, 2023