RanD S.r.l.

FDA Regulatory Profile

RanD S.r.l. appears in FDA public data with 2 recalls, 4 510(k) clearances, 2 FDA inspections, and 0 compliance actions on record. Its most recent recall (Z-2048-2021, Class II) was initiated on April 30, 2021. Its most recent 510(k) clearance was granted on December 28, 2016.

Summary

Total Recalls
2
510(k) Clearances
4
Inspections
2
Compliance Actions
0

Recent Recalls

NumberClassProductDate
Z-2048-2021Class IIHang&Go (kit for hyperthermic perfusion), Reference Code R9900120April 30, 2021
Z-2049-2021Class IICh24 round silicone catheter, Diameter: 8 mm, Perforated section: 230 mm, Total length: 600 mm, RefeApril 30, 2021

Recent 510(k) Clearances

K-NumberDeviceDate
K161613Hang&Go PACDecember 28, 2016
K120026PERFORMER HT/ HANG&GO HT BASICMay 8, 2012
K070213PERFORMER CBP SYSTEMMarch 21, 2007
K052555MEDTRONIC PERFORMER TM CPB, MODEL R51, PCPBMarch 15, 2006