11 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Human Lubricant
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
COSMEDICO
FDA UDI
JW NORTH AMERICA, INC.·G6192400810·Ultraviolet tanning device
NEUWAVE Microwave Ablation System and Accessories
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
PALOMAR LUXV HANDPIECE
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
Widex
FDA UDI
Widex A/S·05706069827743·WIDEX EVOKE EBB3D (Tan silk ) 440, Telecoil, RC...
Widex
FDA UDI
Widex A/S·05706069692051·Widex BEYOND B-F2 (Tan silk ) 440, Telecoil, RC...
DEKNATEL TEV TRI BR 2-0 KT-3 30"X9 PFM
FDA Adverse Event
Malfunction
·TELEFLEX MEDICAL·Product code OVN·November 4, 2014
FLO-GARD 6301 VOLUMETRIC INFUSION PUMP
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE·Product code FRN·November 24, 2008
ISOFLEX OPTIM LEAD
FDA Adverse Event
Injury
·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code DTB·September 9, 2011
Direct Drive Clip Applier CA090, indicated for ligation of tubular structures or vessels in laparoscopic and general surgical procedures. Distributed individually and in kits.
FDA Enforcement
Class II
·Terminated·Applied Medical Resources Corp·May 18, 2016
Model Number L111, ESSENTIO DR SL MRI Pacemaker
FDA Enforcement
Class I
·Ongoing·Boston Scientific Corporation·October 22, 2025