Creo Medical, Ltd.

FDA Regulatory Profile

Summary

Total Recalls
0
510(k) Clearances
10
Inspections
1
Compliance Actions
0

Recent 510(k) Clearances

K-NumberDeviceDate
K242774SpydrBlade Flex Instrument (PRD-RG1-001)June 6, 2025
K242983CROMA Electrosurgical Generator (PRD-EMR-050)February 5, 2025
K242061Reusable Interface Cable 1.5 m (PRD-IFC-002)August 15, 2024
K230328Speedboat Flush SB1 InstrumentOctober 31, 2023
K223138AB1 Electrosurgical Instrument, Creo Electrosurgical SystemJune 26, 2023
K221672Creo Electrosurgical System with NP1 InstrumentFebruary 14, 2023
K200298ABI Instrument, Creo Electrosurgical SystemJanuary 5, 2021
K200003NP1 Instrument, Creo Electrosurgical SystemOctober 28, 2020
K192905Creo Electrosurgical System with HS1 Hemostasis AccessoryMarch 19, 2020
K171983Creo Medical Electrosurgical System including Speedboat RS2 Surgical AccessoryAugust 17, 2017