15 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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TruMatch Graft Cage - Long Bone
FDA 510(k)
FDA Class 2
·Orthopedic
N/A
FDA UDI
Ortho Development Corporation·00822409129638·Uni Knee Keeled Tibial Tray Trial Size 2 Left
MICROCUFF PEDIATRIC ENDOTRACHEAL TUBE
FDA 510(k)
FDA Class 2
·Anesthesiology
PREVENA INCISION MANAGEMENT SYSTEM
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
LEAD MODEL 302
FDA Adverse Event
Malfunction
·CYBERONICS INC·Product code LYJ·June 20, 2013
DUAL COOLER/HEATER
FDA Adverse Event
Malfunction
·TERUMO CARDIOVASCULAR SYSTEMS CORP.·Product code DWC·July 1, 2011
COBAS 6000 CORE
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS·Product code CEM·September 23, 2008
PREVENA PLUS¿ INCISION MANAGEMENT SYSTEM
FDA Adverse Event
Injury
·KINETIC CONCEPTS, INC.·Product code OMP·July 19, 2019
OPTILENE 6/0 (0,7) 75CM 2XDRC13 CV2 RCP
FDA Adverse Event
Malfunction
·B. BRAUN SURGICAL, S.A.·Product code GAW·December 9, 2025
OPTILENE 7/0 (0,5) 60CM 2XDRC8 CV2 RCP
FDA Adverse Event
Malfunction
·B. BRAUN SURGICAL, S.A.·Product code GAW·December 9, 2025
CD HORIZON SPINAL SYSTEM
FDA Adverse Event
Injury
·WARSAW ORTHOPEDICS·Product code NKB·April 19, 2019
Cold Form Wrap: Back, REF: DP163CT03-BLK-L,XL, and Shoulder, REF: DP163CT02
FDA Enforcement
Class II
·Ongoing·DJO, LLC·December 3, 2025
FLEXCERA BASE -a Dental resins for the fabrication of artificial teeth
FDA Enforcement
Class II
·Ongoing·Envisiontec US Llc·February 23, 2022
FLEXCERA SMILE -a Dental resins for the fabrication of artificial teeth
FDA Enforcement
Class II
·Ongoing·Envisiontec US Llc·February 23, 2022
AquaC UNO H [120V, 60Hz, 1000VA, Fresenius US-Version: 24-10VA-1 Vivonic Part Number: G02000970-US
FDA Enforcement
Class II
·Ongoing·Fresenius Medical Care Holdings, Inc.·August 3, 2022