71 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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FDA 510(k)
FDA Class 2
·Radiology
Ophthalmic Knife
FDA UDI
KATENA PRODUCTS, INC.·00841668101148·TOOKE CORNEAL KNIFE
IdentiTi
FDA UDI
ALPHATEC SPINE, INC.·00190376517520·IDENTITi ALIF SA, 40° LATERAL AWL, 25mm
IdentiTi
FDA UDI
ALPHATEC SPINE, INC.·00190376517537·IDENTITi ALIF SA, 60° LATERAL AWL, 25mm
CAPSTONE SPINAL SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
ACUNAV 90/10 DIAGNOSTIC ULTRASOUND CATHETER
FDA 510(k)
FDA Class 2
·Cardiovascular
COOK CELECT® PLATINUM NAVALIGN UNISET VENA CAVA FILTER SET
FDA Adverse Event
Injury
·WILLIAM COOK EUROPE·Product code DTK·July 29, 2025
COOK CELECT® PLATINUM NAVALIGN JUGULAR VENA CAVA FILTER SET
FDA Adverse Event
Malfunction
·WILLIAM COOK EUROPE·Product code DTK·November 12, 2024
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·August 22, 2025
MONOCRYL (PROLIGLECAPRONE 25) SUTURE
FDA Adverse Event
Injury
·ETHICON, INC.·Product code GAN·November 14, 2008
ACCESS® 2 IMMUNOASSAY SYSTEM
FDA Adverse Event
Malfunction
·BECKMAN COULTER, INC.·Product code JJE·September 2, 2011
OT VERIO PRO METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·July 18, 2013
COOK CELECT® PLATINUM NAVALIGN FEMORAL VENA CAVA FILTER SET
FDA Adverse Event
Malfunction
·WILLIAM COOK EUROPE·Product code DTK·May 20, 2026
COOK CELECT® PLATINUM NAVALIGN UNISET VENA CAVA FILTER SET
FDA Adverse Event
Malfunction
·WILLIAM COOK EUROPE·Product code DTK·April 20, 2026
COOK CELECT PLATINUM NAVALIGN UNISET VENA CAVA FILTER SET
FDA Adverse Event
Malfunction
·WILLIAM COOK EUROPE·Product code DTK·March 20, 2026
COOK CELECT® PLATINUM NAVALIGN UNISET VENA CAVA FILTER SET
FDA Adverse Event
Malfunction
·WILLIAM COOK EUROPE·Product code DTK·April 22, 2026
UNKNOWN
FDA Adverse Event
Injury
·WILLIAM COOK EUROPE·Product code DTK·January 9, 2025
COOK CELECT® PLATINUM NAVALIGN UNISET VENA CAVA FILTER SET
FDA Adverse Event
Injury
·WILLIAM COOK EUROPE·Product code DTK·March 20, 2026
COOK CELECT® PLATINUM NAVALIGN UNISET VENA CAVA FILTER SET
FDA Adverse Event
Malfunction
·WILLIAM COOK EUROPE·Product code DTK·May 12, 2026
UNKNOWN
FDA Adverse Event
Injury
·WILLIAM COOK EUROPE·Product code DTK·September 12, 2024