23 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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HEPAFAT SCAN
FDA 510(k)
FDA Class 2
·Radiology
MSI Precision Specialty Instruments
FDA UDI
Med Saver, Inc.·00194613017699·K-Wire, Double Ended, Trocar Point, Diameter Si...
Yellowstone
FDA UDI
SUMMIT SPINE LLC·B587X1220350·12mm H x 20mm W x 35mm L x 0 degrees XLIF
75V - Class A BMD 21 - 3 Shelf Cabinet
FDA UDI
Certified Safety Manufacturing, Inc.·00766588620350·75V - Class A BMD 21 - 3 Shelf Cabinet
TALOS® IBF
FDA UDI
MEDITECH SPINE, LLC·B16741220350·
Yellowstone
FDA UDI
SUMMIT SPINE LLC·B587X122035120·12mm H x 20mm W x 35mm L x 12 degrees XLIF
Yellowstone
FDA UDI
SUMMIT SPINE LLC·B587L122035120·12mm H x 20mm W x 35mm L XLIF Trial 12 degree L...
Yellowstone
FDA UDI
SUMMIT SPINE LLC·B587X12203580·12mm H x 20mm W x 35mm L x 8 degrees XLIF
TALOS® IBF
FDA UDI
MEDITECH SPINE, LLC·B1674122035060·
SLEEK OTW PTA CATHETERS
FDA 510(k)
FDA Class 2
·Cardiovascular
OSTEOMEDICS RESORBABLE SMALL FIXATION SYSTEM, OSTEOSORB
FDA 510(k)
FDA Class 2
·Dental
HAHN TAPERED IMPLANT Ø4.3 X 10 MM
FDA Adverse Event
Injury
·PRISMATIK DENTALCRAFT, INC.·Product code DZE·January 12, 2024
ABSORB BIORESORBABLE VASCULAR SCAFFOLD SYSTEM
FDA Adverse Event
Malfunction
·AV-TEMECULA-CT·Product code PNY·February 21, 2019
ALLEGRETTO WAVE EYE-Q
FDA Adverse Event
Injury
·WAVELIGHT GMBH·Product code LZS·May 16, 2013
ASR UNI FEMORAL IMPL SIZE 49
FDA Adverse Event
Injury
·DEPUY INTL. LTD.·Product code KWA·June 9, 2011
LIGAMAX-5MM ENDO CLIP APPLIER
FDA Adverse Event
Malfunction
·ETHICON ENDO-SURGERY, LLC·Product code FZP·August 14, 2008
ABSORB BIORESORBABLE VASCULAR SCAFFOLD SYSTEM
FDA Adverse Event
Death
·AV-TEMECULA-CT·Product code PNY·February 21, 2019
SLEEK OTW PTA CATHETER
FDA Adverse Event
Injury
·CLEARSTREAM TECHNOLOGIES LTD.·Product code DQY·December 13, 2023
SOMATOM Edge Plus-Computed tomography system Model 1026700
FDA Enforcement
Class II
·Ongoing·Siemens Medical Solutions USA, Inc·January 19, 2022
SOMATOM Edge Plus with software syngo.CT VB20 Model #10267000
FDA Enforcement
Class II
·Terminated·Siemens Medical Solutions USA, Inc·December 1, 2021