12 results
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32ms
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Sources: EU EUDAMED, US FDA
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Status: Terminated
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Chromovision High Definition (HD) Wireless Camera, Pt # CC-9715900. Visual recording of surgical procedures.
FDA Enforcement
Class III
·Terminated·Berchtold Corp.·August 15, 2012
Hand Controls for Operon D750, D752, D760, D820 and D850 The hand controls are used to operate OPERON surgical tables
FDA Enforcement
Class II
·Terminated·Berchtold Corp.·June 12, 2013
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 and variants can differ depending on the scope of the delivery.
FDA Enforcement
Class II
·Terminated·Berchtold Corp.·June 15, 2016
OPERON D850 Surgical Table Product Usage: Surgical Table
FDA Enforcement
Class II
·Terminated·Berchtold Corp.·September 18, 2013
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 ceiling mounted device to supply power, medical gases, and data-communication services. TELETOM is designed to be used in rooms that have been constructed to meet National Fire Protection Association.
FDA Enforcement
Class II
·Terminated·Berchtold Corp.·October 28, 2015
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 ceiling mounted device to supply power, medical gases, and data-communication services. TELETOM is designed to be used in rooms that have been constructed to meet National Fire Protection Association.
FDA Recall
Terminated
·Berchtold Corp.·Product code FQO·September 23, 2015
Chromovision High Definition (HD) Wireless Camera, Pt # CC-9715900. Visual recording of surgical procedures.
FDA Recall
Terminated
·Berchtold Corp.·Product code FWH·July 10, 2012
OPERON D850 Surgical Table Product Usage: Surgical Table
FDA Recall
Terminated
·Berchtold Corp.·Product code GDC·April 16, 2012
CHROMOPHARE Surgical Lighting System & CHROMOVIEW Flat Panel Monitor, Mechanical Spring Arms.
FDA Recall
Terminated
·Berchtold Corp.·Product code FTD·November 16, 2009
Hand Controls for Operon D750, D752, D760, D820 and D850 The hand controls are used to operate OPERON surgical tables
FDA Recall
Terminated
·Berchtold Corp.·Product code GDC·March 12, 2013
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 and variants can differ depending on the scope of the delivery.
FDA Recall
Terminated
·Berchtold Corp.·Product code LWG·April 19, 2016
Operon Electrical Operating Room Table. The device is used as an electrical operating room table.
FDA Recall
Terminated
·Berchtold Corp.·Product code GDC·February 2, 2009