13 results · 51ms · Sources: EU EUDAMED, US FDA

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SUMMIT SWIVEL COLLIMATOR

FDA Adverse Event
Malfunction ·SUMMIT INDUSTRIES, INC.·Product code IZX·June 26, 2007

SUMMIT SWIVEL COLLIMATOR

FDA Adverse Event
Malfunction ·SUMMIT INDUSTRIES, INC.·Product code KPW·May 22, 2007

CHIROTECH MODULAR CHIROPRACTIC SYSTEM

FDA Adverse Event
Malfunction ·SUMMIT INDUSTRIES, INC.·Product code IXY·January 17, 2008

LX125V Swivel Collimator, Model E600; Manual Radiographic Collimator; Summit Industries, Inc., Chicago, Illinois

FDA Recall
Terminated ·Summit Industries Inc.·Product code IZX·August 10, 2007

PCS125 Swivel Collimator, Model F100; Manual Radiographic Collimator; Summit Industries, Inc., Chicago, Illinois

FDA Recall
Terminated ·Summit Industries Inc.·Product code IZX·August 10, 2007

LX125 Swivel Collimator, Model D800; Manual Radiographic Collimator; Summit Industries, Inc., Chicago, Illinois

FDA Recall
Terminated ·Summit Industries Inc.·Product code IZX·August 10, 2007

The J700 Floor Mounted Tube Stand (FMTS) is intended to support and position the diagnostic x-ray tube housing assembly for a medical radiographic procedure. The product consists of a vertical column (with counterbalanced vertical carriage, counterweight and pulley system), horizontal floor car and a floor mounted track to ride on.

FDA Recall
Terminated ·Summit Industries Inc.·Product code IYB·October 28, 2014

The J700 Floor Mounted Tube Stand (FMTS) is intended to support and position the diagnostic x-ray tube housing assembly for a medical radiographic procedure. The product consists of a vertical column (with counterbalanced vertical carriage, counterweight and pulley system), horizontal floor car and a floor mounted track to ride on.

FDA Enforcement
Class II ·Terminated·Summit Industries Inc.·December 3, 2014

mdi Europa GmbH

Authorized representative
🇩🇪 Germany·132 Manufacturers·4741 Devices

Medical Technology Promedt Consulting GmbH

Authorized representative
🇩🇪 Germany·194 Manufacturers·10009 Devices

MDSS GmbH

Authorized representative
🇩🇪 Germany·388 Manufacturers·16562 Devices

Duomed Belgium NV

Importer
🇧🇪 Belgium·62 Manufacturers

Lotus NL B.V.

Authorized representative
🇳🇱 Netherlands·584 Manufacturers·21427 Devices