9 results
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25ms
·
Sources: EU EUDAMED, US FDA
KONE CALCIUM TEST
FDA 510(k)
FDA Class 2
·Clinical Chemistry
HeRO Symphony, HeRO ES, HeRO solo/duet
FDA 510(k)
FDA Class 2
·Cardiovascular
HEARTWAY POWER MOBILITY SCOOTER, PF7
FDA 510(k)
FDA Class 2
·Physical Medicine
TOTAL ASR ACET IMP SIZE 52
FDA Adverse Event
Injury
·DEPUY INTERNATIONAL LTD.·Product code KWA·December 19, 2012
SPECTRUM INFUSION PUMP
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE CORP·Product code FRN·January 30, 2014
EON 16-CHANNEL IPG
FDA Adverse Event
Injury
·ADVANCED NEUROMODULATION SYSTEMS, INC·Product code LGW·October 19, 2010
Male-Female Midsection with the following sizes and model numbers. a. Male-Female Midsection, 40mm, 1 EACH; Model Number: 25001040E b. Male-Female Midsection, 50mm, 1 EACH; Model Number: 25001050E c. Male-Female Midsection, 60mm, 1 EACH; Model Number: 25001060E d. Male-Female Midsection, 70mm, 1 EACH; Model Number: e. Male-Female Midsection, 90mm, 1 EACH; Model Number: 25001090E f. Male-Female Midsection, 110mm, 1 EACH; Model Number: 25001110E g. Male-Female Midsection, 140mm, 1 EACH. Model Number: 25001140E Component of ELEOS SEGMENTAL LIMB SALVAGE SYSTEM
FDA Enforcement
Class II
·Ongoing·Onkos Surgical, Inc.·June 4, 2025
SPRYSTEP VECTOR, Custom made device dynamic ankle-foot orthosis (AFO) , Reference numbers: 17V1030, 17V2030, 17V1031, 17V2031, 17V1032, 17V2032, 17V1033, 17V2033, 17V1035, 17V2035, 17V1036, 17V2036, 17V1037, 17V2037
FDA Enforcement
Class II
·Completed·Townsend Design·January 17, 2024
Alaris System PC Unit Model 8000, a modular infusion pump and monitoring system
FDA Enforcement
Class I
·Terminated·CareFusion 303, Inc.·August 12, 2020