37 results
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32ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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OMNICHROMA
FDA 510(k)
FDA Class 2
·Dental
CENTRONAIL TITANIUM UNIVERSAL FEMORAL NAILING SYSTEM
FDA UDI
ORTHOFIX SRL·18032937169238·RULER
AOS HUMERAL NAIL 9.0mm x 27.5cm
FDA UDI
ADVANCED ORTHOPAEDIC SOLUTIONS, INC.·00848665016987·
Cancellous Screw, Cannulated
FDA UDI
I.T.S. GmbH·09120034308161·Cancellous Screw, Cannulated, D=7,3mm, L=75mm,
Sklar®
FDA UDI
SKLAR CORPORATION·10649111051937·COLLER FCPS STR 7 1/2"
NUVASIVE HELIX MINI ACP SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
SPECIALTY COILS FOR MAGNETOM AERA 1.5T & MAGNETIM SKYRA 3T MR SYSTEMS
FDA 510(k)
FDA Class 2
·Radiology
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·July 7, 2025
OT ULTRALINK METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·October 15, 2014
COGNIS
FDA Adverse Event
Malfunction
·GUIDANT CRM CLONMEL IRELAND·Product code LWP·July 23, 2011
LIFEVEST WCD 4000 SYSTEM
FDA Adverse Event
Malfunction
·ZOLL LIFECOR CORPORATION·Product code MVK·June 7, 2013
MICROPUNCTURE TRANSITIONLESS ACCESS SET
FDA Adverse Event
Injury
·COOK INC·Product code DYB·June 19, 2019
MICROPUNCTURE TRANSITIONLESS STIFFENED CANNULA ACCESS SET
FDA Adverse Event
Injury
·COOK INC·Product code DYB·June 20, 2019
MICROPUNCTURE TRANSITIONLESS STIFFENED CANNULA ACCESS SET
FDA Adverse Event
Malfunction
·COOK INC·Product code DYB·January 2, 2020
MICROPUNCTURE TRANSITIONLESS ACCESS SET
FDA Adverse Event
Injury
·COOK INC·Product code DYB·February 10, 2020
MICROPUNCTURE TRANSITIONLESS ACCESS SET
FDA Adverse Event
Malfunction
·COOK INC·Product code DYB·March 12, 2020
MICROPUNCTURE TRANSITIONLESS STIFFENED CANNULA ACCESS SET
FDA Adverse Event
Injury
·COOK INC·Product code DYB·January 16, 2020
MICROPUNCTURE TRANSITIONLESS STIFFENED CANNULA ACCESS SET
FDA Adverse Event
Injury
·COOK INC·Product code DYB·February 3, 2020
MICROPUNCTURE TRANSITIONLESS STIFFENED CANNULA ACCESS SET
FDA Adverse Event
Malfunction
·COOK INC·Product code DYB·March 10, 2020
MICROPUNCTURE TRANSITIONLESS STIFFENED CANNULA ACCESS SET
FDA Adverse Event
Malfunction
·COOK INC·Product code DYB·March 24, 2020