14 results
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20ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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MedCAD® AccuPlate® Patient-Specific Plate
FDA 510(k)
FDA Class 2
·Dental
CoRoent
FDA UDI
Nuvasive, Inc.·00887517568199·CoRoent Ant TLIF PEEK, 9x13x28mm 0°
CHIMAERA Hip Fracture System
FDA UDI
ORTHOFIX SRL·18056099649223·LAG SCREWDRIVER RETENTION ROD - SHORT
BHDENTAL IMPLANT SYSTEM
FDA 510(k)
FDA Class 2
·Dental
OPTI CCA-TS, B-LAC CASSETTE MODEL BP7561
FDA 510(k)
FDA Class 2
·Clinical Chemistry
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·August 5, 2024
EQUINOXE SHOULDER COMPONENTS
FDA Adverse Event
Injury
·EXACTECH, INC.·Product code KWT·January 17, 2024
MAVERICK2 MONORAIL PTCA CATHETER
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC·Product code LOX·October 7, 2008
RESTORE PRIME ADVANCED
FDA Adverse Event
Injury
·MEDTRONIC PUERTO RICO OPERATIONS CO., JUNCOS·Product code LGW·July 13, 2011
LCP RECOPL 3.5 STRAIGHT W/COMBINED HOLE
FDA Adverse Event
Injury
·SYNTHES GMBH·Product code KTT·June 27, 2013
Philips Azurion system; Software Version Number: R3.1;
FDA Enforcement
Class II
·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·January 28, 2026
Azurion 5 M20; System Code: (1)722228, (2)722232, (3) 722281 (OUS only);
FDA Enforcement
Class II
·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·April 8, 2026
Azurion 7 M12; Catalog numbers: (1) 722078, (2) 722223, (3) 722233 (OUS ONLY).
FDA Enforcement
Class I
·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·February 26, 2025
Azurion 7 M12; System Code: (1)722078, (2)722223, (3)722233;
FDA Enforcement
Class II
·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·April 8, 2026