33 results
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12ms
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Sources: EU EUDAMED, US FDA
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Classification: Class Iii
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CDI¿ H/S Cuvette The intended use for the CDI¿ H IS Cuvette is as follows: The CDI¿ H/S Cuvettes are intended for use with a CDI monitor during cardiopulmonary bypass procedures when continuous monitoring of blood hematocrit and oxygen saturation is desired.
FDA Enforcement
Class III
·Terminated·Terumo Cardiovascular Systems Corporation·October 12, 2016
CDI H/S Cuvette, non-sterile, Manufactured by Terumo Cardiovascular Group, Perfusion Pack or Smart Perfusion Pack. Product Usage: Heart/Lung Perfusion Pack is either a customized tubing pack built to user specifications or a stock tubing pack, designed for use during surgery requiring cardiopulmonary bypass. It is not designed for long-term use (greater than six hours). Perfusion Packs labeled as SMART¿ contain components that have an additive to improve blood compatibility. Non-SMART packs may contain some SMART tubing and/or connectors depending on the customer requirements.
FDA Enforcement
Class III
·Terminated·Sorin Group USA, Inc.·March 2, 2016
Mercury Spinal System DIA 5.5 x 70mm Straight Rod, Part Number: 60101-070. Intended to provide immobilization and stabilization of the spine in skeletally mature patients.
FDA Enforcement
Class III
·Terminated·Spinal Elements, Inc·May 15, 2013
Mercury Spinal System DIA 5.5 x 400mm Straight Rod, Part Number: 60101-400. Intended to provide immobilization and stabilization of the spine in skeletally mature patients.
FDA Enforcement
Class III
·Terminated·Spinal Elements, Inc·May 15, 2013
Mercury Spinal System DIA 5.5 x 100mm Straight Rod, Part Number: 60101-100. Intended to provide immobilization and stabilization of the spine in skeletally mature patients.
FDA Enforcement
Class III
·Terminated·Spinal Elements, Inc·May 15, 2013
Mercury Spinal System DIA 5.5 x 80mm Straight Rod, Part Number: 60101-080. Intended to provide immobilization and stabilization of the spine in skeletally mature patients.
FDA Enforcement
Class III
·Terminated·Spinal Elements, Inc·May 15, 2013
Mercury Spinal System DIA 5.5 x 110mm Straight Rod, Part Number: 60101-110. Intended to provide immobilization and stabilization of the spine in skeletally mature patients.
FDA Enforcement
Class III
·Terminated·Spinal Elements, Inc·May 15, 2013
Mercury Spinal System DIA 5.5 x 30mm Straight Rod, Part Number: 60101-030. Intended to provide immobilization and stabilization of the spine in skeletally mature patients.
FDA Enforcement
Class III
·Terminated·Spinal Elements, Inc·May 15, 2013
Mercury Spinal System DIA 5.5 x 90mm Straight Rod, Part Number: 60101-090. Intended to provide immobilization and stabilization of the spine in skeletally mature patients.
FDA Enforcement
Class III
·Terminated·Spinal Elements, Inc·May 15, 2013
Mercury Spinal System DIA 5.5 x 120mm Straight Rod, Part Number: 60101-120. Intended to provide immobilization and stabilization of the spine in skeletally mature patients.
FDA Enforcement
Class III
·Terminated·Spinal Elements, Inc·May 15, 2013
Mercury Spinal System DIA 5.5 x 50mm Straight Rod, Part Number: 60101-050. Intended to provide immobilization and stabilization of the spine in skeletally mature patients.
FDA Enforcement
Class III
·Terminated·Spinal Elements, Inc·May 15, 2013
Mercury Spinal System DIA 5.5 x 100mm Lordosed Rod, Part Number: 60100-100. Intended to provide immobilization and stabilization of the spine in skeletally mature patients.
FDA Enforcement
Class III
·Terminated·Spinal Elements, Inc·May 15, 2013
Mercury Spinal System DIA 5.5 x 60mm Straight Rod, Part Number: 60101-060. Intended to provide immobilization and stabilization of the spine in skeletally mature patients.
FDA Enforcement
Class III
·Terminated·Spinal Elements, Inc·May 15, 2013
Mercury Spinal System DIA 5.5 x 110mm Lordosed Rod, Part Number: 60100-110. Intended to provide immobilization and stabilization of the spine in skeletally mature patients.
FDA Enforcement
Class III
·Terminated·Spinal Elements, Inc·May 15, 2013
Mercury Spinal System DIA 5.5 x 40mm Straight Rod, Part Number: 60101-040. Intended to provide immobilization and stabilization of the spine in skeletally mature patients.
FDA Enforcement
Class III
·Terminated·Spinal Elements, Inc·May 15, 2013
Mercury Spinal System DIA 5.5 x 120mm Lordosed Rod, Part Number: 60100-120. Intended to provide immobilization and stabilization of the spine in skeletally mature patients.
FDA Enforcement
Class III
·Terminated·Spinal Elements, Inc·May 15, 2013
Mercury Spinal System DIA 5.5 x 40 MM Lordosed Rod, Part Number: 60100-040. Intended to provide immobilization and stabilization of the spine in skeletally mature patients.
FDA Enforcement
Class III
·Terminated·Spinal Elements, Inc·May 15, 2013
Mercury Spinal System DIA 5.5 x 30 MM Lordosed Rod, Part Number: 60100-030. Intended to provide immobilization and stabilization of the spine in skeletally mature patients.
FDA Enforcement
Class III
·Terminated·Spinal Elements, Inc·May 15, 2013
Mercury Spinal System DIA 5.5 x 80 MM Lordosed Rod, Part Number: 60100-080. Intended to provide immobilization and stabilization of the spine in skeletally mature patients.
FDA Enforcement
Class III
·Terminated·Spinal Elements, Inc·May 15, 2013
Mercury Spinal System DIA 5.5 x 70 MM Lordosed Rod, Part Number: 60100-070. Intended to provide immobilization and stabilization of the spine in skeletally mature patients.
FDA Enforcement
Class III
·Terminated·Spinal Elements, Inc·May 15, 2013