Chrysalis Intelligence · Sponsors · Z-Medica, LLC

Z-Medica, LLC

Wallingford, CT, US · 2 510(k) clearances · 1 recalls

Total clearances
2
2020-04-23 → 2022-12-14
Last 12 months
0
Product codes
1
Most recent
2022-12-14
Trend

Clearance cadence by quarter

Portfolio

Product codes worked

Code Device name Class Specialty Clearances Most recent
POD 2 2022-12-14
Safety

Recalls (1)

Class I (serious)
0
Risk of injury / death
Total recalls
1
Currently ongoing
0
Most recent
2021-09-22
DateSeverityStatusRecall # ProductCodeReason
2021-09-22 Class II Terminated Z-0211-2022 QuikClot Combat Gauze-For Temporary External Use To Control Traumatic Bleeding Model / Part# 200 Lack of Packaging seal integrity may result in a sterile barrier breach.
Filings

All 510(k) clearances (2)

Date K-number Device Code Class Specialty
2022-12-14 K220971 QuikClot Control+ Hemostatic Dressing POD
2020-04-23 K200167 QuikClot Control+ POD