Smart Medical Systems , Ltd.

FDA Regulatory Profile

Smart Medical Systems , Ltd. appears in FDA public data with 0 recalls, 9 510(k) clearances, 0 FDA inspections, and 0 compliance actions on record. Its most recent 510(k) clearance was granted on April 11, 2022.

Summary

Total Recalls
0
510(k) Clearances
9
Inspections
0
Compliance Actions
0

Recent 510(k) Clearances

K-NumberDeviceDate
K220158G-EYE SystemApril 11, 2022
K202469G-EYE SystemOctober 26, 2020
K192588G-EYE SystemApril 15, 2020
K112106NAVIAID ICVI-F,S,B,R DEVICEFebruary 6, 2012
K111760NAVIAID(TM) BGC DEVICEAugust 9, 2011
K110291NAVIAID ICVI-F DEVICE, NAVIAID ICVI-S DEVICE, NAVIAID ICVI-B DEVICEJune 17, 2011
K102616NAVIAID BALLOON GUIDED COLONOSCOPY (BGC) DEVICEDecember 30, 2010
K101191NAVIAID ICVI DEVICEJuly 27, 2010
K060923NAVIAID BGE DEVICE, MODEL 21-001August 15, 2006