Kalitec Direct, LLC Doing Business AS Kalitec Medical

FDA Regulatory Profile

Kalitec Direct, LLC Doing Business AS Kalitec Medical appears in FDA public data with 0 recalls, 1 510(k) clearance, 0 FDA inspections, and 0 compliance actions on record. Its most recent 510(k) clearance was granted on Dec 13, 2023.

Reviewing Kalitec Direct, LLC Doing Business AS Kalitec Medical as a supplier? Request a free FDA snapshot: name up to five suppliers and get a PDF of their public FDA record, with sources and dates. You do not need an API connection. Each snapshot is prepared by hand.

Request a free FDA snapshot

Or get Kalitec Direct, LLC Doing Business AS Kalitec Medical's full FDA risk summary, with inspections, warning letters, Form 483s and import alerts by site, in Claude, Cursor or ChatGPT.

Get a free API key

Summary

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

Recent 510(k) Clearances

K-NumberDeviceDate
K232572Kalitec Navigated Instrument SystemDec 13, 2023