16 results
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19ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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OMNIFIT II HIP PROSTHESES: CEMENT FIXATION
FDA 510(k)
FDA Class 2
·Orthopedic
Invictus
FDA UDI
ALPHATEC SPINE, INC.·00190376408514·Cross Connector, Rod to Rod, 3.5mm X 55mm
Invictus
FDA UDI
ALPHATEC SPINE, INC.·00190376408484·Cross Connector, Rod to Rod, 3.5mm X 40mm
Invictus
FDA UDI
ALPHATEC SPINE, INC.·00190376408507·Cross Connector, Rod to Rod, 3.5mm X 50mm
Invictus
FDA UDI
ALPHATEC SPINE, INC.·00190376408460·Cross Connector, Rod to Rod, 3.5mm X 30mm
Invictus
FDA UDI
ALPHATEC SPINE, INC.·00190376408477·Cross Connector, Rod to Rod, 3.5mm X 35mm
Invictus
FDA UDI
ALPHATEC SPINE, INC.·00190376408491·Cross Connector, Rod to Rod, 3.5mm X 45mm
Invictus
FDA UDI
ALPHATEC SPINE, INC.·00190376408453·Cross Connector, Rod to Rod, 3.5mm X 25mm
Lucent®
FDA 510(k)
FDA Class 2
·Orthopedic
BODYGUARD PAIN MANAGER INFUSION SYSTEM
FDA 510(k)
FDA Class 2
·General Hospital
G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code MDS·June 12, 2014
E SERIES DEFIBRILLATOR
FDA Adverse Event
Malfunction
·ZOLL MEDICAL CORPORATION·Product code MKJ·October 6, 2010
SCREW
FDA Adverse Event
Injury
·Product code HWC·December 12, 2012
Exactech Equinoxe REVERSE SHOULDER,36mm Humeral Liner: a) +0mm, Item Number 320-36-00, b) +2.5mm, Item Number 320-36-03; Shoulder Arthroplasty
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·April 10, 2024
ALLURA Xper FD20; System Code: (1) 722006, (2)722012, (3)722028;
FDA Enforcement
Class II
·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·April 8, 2026
Allura Xper FD20; Model Numbers: (1) 722006, (2) 722012, (3) 722028; Associated 510(k)s: K102005, K130638, K130842, K133292, K141979, K162859, K161563;
FDA Enforcement
Class II
·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·October 8, 2025