29 results
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30ms
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Sources: EU EUDAMED, US FDA
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Status: Terminated
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Cosmedent's Etching Gel, 3g, 37% Phosphoric Acid, Rx only. Packaged in 3g Luer Lock syringes. Used for etching enamel and dentin.
FDA Recall
Terminated
·Cosmedent, Inc.·Product code KLE·September 28, 2017
Cosmedent's Etching Gel, 3g, 37% Phosphoric Acid, Rx only. Packaged in 3g Luer Lock syringes. Used for etching enamel and dentin.
FDA Enforcement
Class II
·Terminated·Cosmedent, Inc.·March 7, 2018
CASMED 500cc Unifusor with aneroid gauge and stopcock valve. Model: 803SGA. It is designed for use in rapid infusion,invasive pressure monitoring and with auto-transfusion devices.
FDA Recall
Terminated
·CAS Medical Systems, Inc.·Product code KZD·September 20, 2008
CASMED 500cc Unifusor Classic with piston gauge and stopcock valve Model: 903SGA. It is designed for use in rapid infusion,invasive pressure monitoring and with auto-transfusion devices.
FDA Recall
Terminated
·CAS Medical Systems, Inc.·Product code KZD·September 20, 2008
CASMED 500cc Unifusor Classic with piston gauge and thumbwheel valve. Model: 903TGA. It is designed for use in rapid infusion,invasive pressure monitoring and with auto-transfusion devices.
FDA Recall
Terminated
·CAS Medical Systems, Inc.·Product code KZD·September 20, 2008
CASMED 500cc Unifusor with aneroid gauge and thumbwheel valve Model: 803FGA. It is designed for use in rapid infusion,invasive pressure monitoring and with auto-transfusion devices.
FDA Recall
Terminated
·CAS Medical Systems, Inc.·Product code KZD·September 20, 2008
Casmed 500cc Unifusor II with aneroid gauge and thumbwheel valve Model: 2803SGA. It is designed for use in rapid infusion,invasive pressure monitoring and with auto-transfusion devices.
FDA Recall
Terminated
·CAS Medical Systems, Inc.·Product code KZD·September 20, 2008
CASMED 500cc Unifusor with a short tube. Private labeled for King Systems. Model: P500BAG. It is designed for use in rapid infusion,invasive pressure monitoring and with auto-transfusion devices.
FDA Recall
Terminated
·CAS Medical Systems, Inc.·Product code KZD·September 20, 2008
CASMED 500cc Unifusor II with aneroid gauge and thumbwheel valve. Private labeled for Transmed in Germany. Model: T2803SGA. It is designed for use in rapid infusion,invasive pressure monitoring and with auto-transfusion devices.
FDA Recall
Terminated
·CAS Medical Systems, Inc.·Product code KZD·September 20, 2008
CASMED 500cc Unifusor Classic with aneroid gauge and thumbwheel valve. Model: D803FGA. Private labeled for P.J. Dahlhausen in Germany. It is designed for use in rapid infusion,invasive pressure monitoring and with auto-transfusion devices.
FDA Recall
Terminated
·CAS Medical Systems, Inc.·Product code KZD·September 20, 2008
CASMED 500cc Unifusor Classic with aneroid gauge and thumbwheel valve Model:FN-803FGA. Private labeled for Femcare-Nikomed in the UK. It is designed for use in rapid infusion,invasive pressure monitoring and with auto-transfusion devices.
FDA Recall
Terminated
·CAS Medical Systems, Inc.·Product code KZD·September 20, 2008
CASMED 500cc Unifusor with aneroid gauge and stopcock valve. Model: A803SGA . The letter A refers to a special quantity designator for a particular customer. The product is designed for use in rapid infusion,invasive pressure monitoring and with auto-transfusion devices.
FDA Recall
Terminated
·CAS Medical Systems, Inc.·Product code KZD·September 20, 2008
CASMED 500cc Unifusor Classic with piston gauge and stopcock valve. Model : A903SGA. The letter A refers to a special quantity designator for a particular customer. It is designed for use in rapid infusion,invasive pressure monitoring and with auto-transfusion devices.
FDA Recall
Terminated
·CAS Medical Systems, Inc.·Product code KZD·September 20, 2008
Custom Perfusion System (CUSTOM PACK BB7W03R8 CCSM NEON). The Affinity Pixie Cardiotomy/Venous Reservoir (CVR) with Balance Biosurface is a single-use device designed to collect and store blood during extracorporeal circulation. Cardiotomy blood is collected, filtered, and defoamed before mixing with the venous blood, which is filtered. The primary blood-contacting surfaces of the CVR are coated with Balance Biosurface to reduce platelet activation and adhesion and preserve platelet function. (Generic Name: Cardiopulmonary bypass oxygenator).
FDA Recall
Terminated
·Medtronic Perfusion Systems·Product code DTN·February 4, 2021
740 Series Multiparameter Monitor Software Version 3.0 Model Numbers: 740-1, 740M-1, 740-2T, 740M-2T, 740-2MS, 740M-2MS, 740-2NL, 740M-2NL, 740-2NN, 740M-2NN, 740-3MS, 740M-3MS, 740-3NL, 740M-3NL, 740-3NN, and 740M-3NN CAS Medical Systems, Inc., Branford, Connecticut 06405 Indicated for use for non-invasive monitoring of blood pressure, oxygen saturation, pulse and temperature of adults, pediatric and neonatal patients, in the care of health professionals.
FDA Recall
Terminated
·CAS Medical Systems, Inc.·Product code MHX·June 24, 2008
TRINIAS for diagnostic imaging and interventional procedures in cardiac angiography, neurovascular angiography, abdominal angiography, peripheral angiography, rotational angiography, multi-purpose angiography and whole body radiographic/fluoroscopic procedures.
FDA Enforcement
Class II
·Terminated·Shimadzu Medical Systems Usa Com·February 27, 2019
SHIMADZU RADspeed Pro Catalog Number: RADspeed Pro; Stationary x-ray system
FDA Enforcement
Class II
·Terminated·Shimadzu Medical Systems Usa Com·July 5, 2017
TRINIAS Digital Angiographic System intended to be used for cardiac angiography, neurovascular angiography, abdominal angiography, peripheral angiography, rotational angiography, multi-purpose angiography and whole body radiographic/fluoroscopic procedures.
FDA Enforcement
Class II
·Terminated·Shimadzu Medical Systems Usa Com·October 31, 2018
SHIMADZU FDR Visionary Catalog Number: FDR Visionary Suite Stationary x-ray system for taking general radiographic and tomographic images of the whole body. The device is intended to be used in hospitals, clinics, imaging centers, and/or other healthcare facilities by qualified/trained professionals
FDA Enforcement
Class II
·Terminated·Shimadzu Medical Systems Usa Com·July 5, 2017
SHIMADZU Ceiling Type X-ray Tube Support CH-200/CH-200M Catalog Number: CH-200/CH-200M Holds an x-ray tube unit and collimator combined with an z-ray high voltage generator, radiographic stand, and table. It is designed to perform radiography of patients either in a standing or supine position
FDA Enforcement
Class II
·Terminated·Shimadzu Medical Systems Usa Com·July 5, 2017