ClearanceBrief
Company ยท US

Berchtold Corp.

FDA 510(k) clearances and medical device recalls filed under this name, 2002 to 2012. Name variants (Inc, Corp, punctuation) are merged.

3510(k) clearances (0 in 12 months)
7recalls (0 in 12 months)
1recalls that name a 510(k)

Product codes

CodeDeviceRecords
GDCTable, Operating-Room, Electrical3
FSYLight, Surgical, Ceiling Mounted2
FQOTable, Operating-Room, Ac-Powered1
FTDLamp, Surgical1
FWHCamera, Cine, Surgical, Without Audio1
GEIElectrosurgical, Cutting & Coagulation & Accessories1
LWGSurgical Table Cushion1

Latest 510(k) clearances

Decided510(k)Device and applicantCode
Feb 16, 2012K120392CHROMOPHARE F 628 AND F 528
Berchtold GmbH & Co. KG, DE
FSY
Feb 23, 2009K090378CHROMOPHARE E 668
Berchtold GmbH & Co. KG
FSY
Feb 4, 2002K013668BERCHTOLD ELEKTROTOM 106 HITT
Berchtold Corp.
GEI

Latest recalls

DateFirm and productCodeLinked 510(k)
Jun 7, 2016Berchtold Corp.
Surgical Table Cushion (HybriGel Pads) HybrGel Pads are an optional accessory to the Operon Surgical Table. The pads may be attached to the base section with a Velcro fastener. The HybriGel pad shapes
Terminated
LWGNone listed
Sep 23, 2015Berchtold Corp.
TELETOM EQUIPMENT MANAGEMENT SYSTEM 4 and 6 series TELETOM is designed for use in operating rooms, medical treatment rooms, intensive care units, or any area of a medical facility that requires a ceil
Terminated
FQONone listed
Sep 9, 2013Berchtold Corp.
OPERON D850 Surgical Table Product Usage: Surgical Table
Terminated
GDCNone listed
Jun 6, 2013Berchtold Corp.
Hand Controls for Operon D750, D752, D760, D820 and D850 The hand controls are used to operate OPERON surgical tables
Terminated
GDCNone listed
Aug 6, 2012Berchtold Corp.
Chromovision High Definition (HD) Wireless Camera, Pt # CC-9715900. Visual recording of surgical procedures.
Terminated
FWHNone listed
Dec 10, 2010Berchtold Corp.
CHROMOPHARE Surgical Lighting System & CHROMOVIEW Flat Panel Monitor, Mechanical Spring Arms.
Terminated
FTDK922836
Apr 27, 2009Berchtold Corp.
Operon Electrical Operating Room Table. The device is used as an electrical operating room table.
Terminated
GDCNone listed
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