Medicatech USA

FDA Regulatory Profile

Medicatech USA appears in FDA public data with 0 recalls, 10 510(k) clearances, 2 FDA inspections, and 0 compliance actions on record. Its most recent 510(k) clearance was granted on May 16, 2025.

Summary

Total Recalls
0
510(k) Clearances
10
Inspections
2
Compliance Actions
0

Recent 510(k) Clearances

K-NumberDeviceDate
K242731MasteRad MiniX Mobile Digital Imaging System (Mini-X)May 16, 2025
K230918MasterX 800 SeriesSep 1, 2023
K190601MasteRad MX30Apr 25, 2019
K143257KrystalRad 11000 and KrystalRad 3000 Digital Stationary Radiographic SystemFeb 6, 2015
K130377KRYSTALRAD NEW SERIESDIGITAL RADIOGRAPHIC PORTABLE RETROFIT SYSTEMMay 17, 2013
K112132KRYSTALRAD 660 DIGITAL RADIOGRAPHIC PORTABLE RETROFIT SYSTEMNov 18, 2011
K102284KRYSTALRAD 560 (FLAATZ 560)Jan 3, 2011
K102285KRYSTALRAD (ATAL8)Jan 3, 2011
K082798DIGITAL DIAGNOSTIC X-RAY SYSTEM, MODELS MAK 1500, MAK 2000 AND MAK 3000Oct 28, 2008
K080582MEDICATECH, MODEL DDR MAK-800, DDT MAK-1000 FS, DDR MAK-1100 FAMay 15, 2008