Berchtold Corp.

FDA Regulatory Profile

Summary

Total Recalls
5
510(k) Clearances
1
Inspections
2
Compliance Actions
0

Recent Recalls

NumberClassProductDate
Z-1925-2016Class IISurgical Table Cushion (HybriGel Pads) HybrGel Pads are an optional accessory to the Operon SurgicaApril 19, 2016
Z-0154-2016Class IITELETOM EQUIPMENT MANAGEMENT SYSTEM 4 and 6 series TELETOM is designed for use in operating rooms, September 23, 2015
Z-1488-2013Class IIHand Controls for Operon D750, D752, D760, D820 and D850 The hand controls are used to operate OPMarch 12, 2013
Z-2148-2012Class IIIChromovision High Definition (HD) Wireless Camera, Pt # CC-9715900. Visual recording of surgical July 10, 2012
Z-2168-2013Class IIOPERON D850 Surgical Table Product Usage: Surgical TableApril 16, 2012

Recent 510(k) Clearances

K-NumberDeviceDate
K013668BERCHTOLD ELEKTROTOM 106 HITTFebruary 4, 2002