18 results
·
27ms
·
Sources: EU EUDAMED, US FDA
PATELLAR TENDON GRAFT GUIDE
FDA 510(k)
FDA Class 1
·Orthopedic
Archon
FDA UDI
Nuvasive, Inc.·00887517303752·Archon Screw, 4.0x13mm S.T. Var Recon
R82
FDA UDI
R82 A/S·05707292603203·
DESS dental smart solutions
FDA UDI
TERRATS MEDICAL SL.·08435457210016·Internal Hex Conic
LinkSymphoKnee
FDA UDI
WALDEMAR LINK GmbH & Co. KG·04026575258741·Tibial Component, All-Poly PS
LinkSymphoKnee
FDA UDI
WALDEMAR LINK GmbH & Co. KG·04026575258703·Tibial Component, All-Poly PS
LinkSymphoKnee
FDA UDI
WALDEMAR LINK GmbH & Co. KG·04026575258734·Tibial Component, All-Poly PS
LinkSymphoKnee
FDA UDI
WALDEMAR LINK GmbH & Co. KG·04026575258727·Tibial Component, All-Poly PS
LinkSymphoKnee
FDA UDI
WALDEMAR LINK GmbH & Co. KG·04026575258710·Tibial Component, All-Poly PS
LinkSymphoKnee
FDA UDI
WALDEMAR LINK GmbH & Co. KG·04026575258697·Tibial Component, All-Poly PS
FERRIS MODIFIED DISP. IL STERNAL-ILIAC
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
LOW IIONIC STRENGTH SOLUTION
FDA 510(k)
FDA Class 2
·Hematology
LYNX SYSTEM
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC - MARLBOROUGH·Product code FTL·October 22, 2010
ONETOUCHPING GLUCOSEMGMTSYSTEM
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·December 19, 2012
GORE® HYBRID VASCULAR GRAFT
FDA Adverse Event
Death
·W.L. GORE & ASSOCIATES·Product code DSY·June 18, 2014
BARDEX® LUBRICATH® FOLEY CATHETER
FDA Adverse Event
Malfunction
·C.R. BARD, INC. (COVINGTON) -1018233·Product code EZC·May 27, 2025
Pressure Monitoring Tray, C-PMSY, G02854
FDA Enforcement
Class II
·Terminated·Cook Inc.·June 10, 2020
a. Segmental Stem, Cemented, Straight, 100MM, 1 EACH; Model Numbers: CS-09100-03M, CS-10100-03M. b. Segmental Stem, Cemented, Straight, 120MM, 1 EACH. Model Numbers: CS-11120-03M, CS-13120-03M, CS-15120-03M, CS-17120-03M. Component. of ELEOS LIMB SALVAGE SYSTEM
FDA Enforcement
Class II
·Ongoing·Onkos Surgical, Inc.·June 4, 2025