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Healthtronics, Inc.

FDA Regulatory Profile

Summary

Total Recalls
1
510(k) Clearances
4
Inspections
1
Compliance Actions
0

Recent Recalls

NumberClassProductDate
Z-0825-2013Class IIHealthTronics Endocare 3.8mm RenalCryo Cryoprobe, R3.8L. The Endocare CryoProbe is an accessory prDecember 20, 2012

Recent 510(k) Clearances

K-NumberDeviceDate
K153489Cryocare CS Surgical SystemFebruary 5, 2016
K151968Cryocare CS-3 Surgical System version 5September 9, 2015
K141110CRYOCARE CS SURGICAL SYSTEMJune 25, 2015
K021775LTFS230December 23, 2002