Berchtold Corp.
FDA Regulatory Profile
Berchtold Corp. appears in FDA public data with 5 recalls, 1 510(k) clearance, 2 FDA inspections, and 0 compliance actions on record. Its most recent recall (Z-1925-2016, Class II) was initiated on April 19, 2016. Its most recent 510(k) clearance was granted on February 4, 2002.
Summary
- Total Recalls
- 5
- 510(k) Clearances
- 1
- Inspections
- 2
- Compliance Actions
- 0
Recent Recalls
| Number | Class | Product | Date |
|---|
| Z-1925-2016 | Class II | Surgical Table Cushion (HybriGel Pads) HybrGel Pads are an optional accessory to the Operon Surgica | April 19, 2016 |
| Z-0154-2016 | Class II | TELETOM EQUIPMENT MANAGEMENT SYSTEM 4 and 6 series TELETOM is designed for use in operating rooms, | September 23, 2015 |
| Z-1488-2013 | Class II | Hand Controls for Operon D750, D752, D760, D820 and D850 The hand controls are used to operate OP | March 12, 2013 |
| Z-2148-2012 | Class III | Chromovision High Definition (HD) Wireless Camera, Pt # CC-9715900. Visual recording of surgical | July 10, 2012 |
| Z-2168-2013 | Class II | OPERON D850 Surgical Table Product Usage: Surgical Table | April 16, 2012 |
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|
| K013668 | BERCHTOLD ELEKTROTOM 106 HITT | February 4, 2002 |