88 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Exogenesis Hernia Mesh
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
CD HORIZON® Spinal System
FDA UDI
MEDTRONIC SOFAMOR DANEK, INC.·00885074465180·CDH 7191545 HA COATED 5.5X45
PIVOX™ Oblique Lateral Spinal System
FDA UDI
MEDTRONIC SOFAMOR DANEK, INC.·00643169595569·TRIAL 2191545 O25 IB 27MM 6 DEG 16X45
Axcess Percutaneous Introducer
FDA UDI
ARGON MEDICAL DEVICES, INC.·00886333206896·Axcess Percutaneous Introducer with Multi-Purpo...
DIGITAL RADIOGRAPHY CXDI-60C
FDA 510(k)
FDA Class 2
·Radiology
GENESIS IMPLANT SYSTEM
FDA 510(k)
FDA Class 2
·Dental
REZUM
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC CORPORATION·Product code KNS·October 6, 2025
REZUM
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC CORPORATION·Product code KNS·October 6, 2025
REZUM
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC CORPORATION·Product code KNS·January 7, 2026
ARCHITECT STAT HIGH SENSITIVE TROPONIN-I
FDA Adverse Event
Malfunction
·ABBOTT IRELAND DIAGNOSTICS DIVISION·Product code MMI·May 27, 2026
REZUM
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC CORPORATION·Product code KNS·November 18, 2025
REZUM
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC CORPORATION·Product code KNS·March 13, 2026
REZUM
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC CORPORATION·Product code KNS·November 18, 2025
REZUM
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC CORPORATION·Product code KNS·November 18, 2025
ARCHITECT STAT HIGH SENSITIVE TROPONIN-I
FDA Adverse Event
Malfunction
·ABBOTT IRELAND DIAGNOSTICS DIVISION·Product code MMI·May 27, 2026
RESTORE SENSOR
FDA Adverse Event
Injury
·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code LGW·June 26, 2013
COLLEAGUE PRE P1.7
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·August 4, 2011
917 DISK SYSTEM
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS·Product code JJE·September 26, 2008
ARCHITECT STAT HIGH SENSITIVE TROPONIN-I
FDA Adverse Event
Malfunction
·ABBOTT IRELAND DIAGNOSTICS DIVISION·Product code MMI·May 19, 2026
ARCHITECT STAT HIGH SENSITIVE TROPONIN-I
FDA Adverse Event
Malfunction
·ABBOTT IRELAND DIAGNOSTICS DIVISION·Product code MMI·April 8, 2026