10 results
·
25ms
·
Sources: EU EUDAMED, US FDA
TELOS DISTAL TARGETING DEVICE
FDA 510(k)
FDA Class 1
·Orthopedic
DESS dental smart solutions
FDA UDI
TERRATS MEDICAL SL.·08435457210603·Internal Hex "Click"
Powder Free Vinyl Patient Examination Gloves
FDA 510(k)
FDA Class 1
·General Hospital
QUEST DIAGNOSTICS METHAMPHETAMINE MICRO-PLATE EIA
FDA 510(k)
FDA Class 2
·Clinical Toxicology
ESSURE
FDA Adverse Event
Injury
·BAYER·Product code HHS·June 13, 2014
LEAD MODEL 302
FDA Adverse Event
Malfunction
·CYBERONICS, INC.·Product code LYJ·October 15, 2010
ARTHROSCOPE
FDA Adverse Event
Malfunction
·MDT KYPHON NEUCHATEL MFG·Product code HRX·December 19, 2012
MENTOR MEMORYGEL BREAST IMPLANT
FDA Adverse Event
Injury
·MENTOR TEXAS·Product code FTR·May 19, 2026
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
Alaris Syringe Pump, Model No. 8110. Delivers fluids. Expansion of Affected Units: BOM Housing Assembly Service, Part No. 49000226, and Lower Housing/Carriage Block Assembly, Part No. 148188-100.
FDA Enforcement
Class I
·Terminated·CareFusion 303, Inc.·August 26, 2015