30 results
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36ms
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Sources: EU EUDAMED, US FDA
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Status: Terminated
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Ventana Image Analysis System (VIAS) - PATHWAY anti-HER-2/neu (4B5) primary antibody with software version 2.3.0.2, Model Number: VIAS-799-10000-00, Pathology Image Analysis System, Ventana Medical Systems, Inc., Tucson, AZ 85755
FDA Recall
Terminated
·Ventana Medical Systems Inc·Product code NQN·June 26, 2007
CryoCath Frost Byte CryoSurgical Clamp, Model 60FB1, Manufacturer CryoCath Technologies, Inc., Quebec, Canada. The product consists of a cryosurgical probe (SurgiFrost 7 cm) plus Clamp (FrostByte) packaged for use with Cryosurgical console.
FDA Recall
Terminated
·ATS Medical, Inc.·Product code GEH·May 5, 2006
ATS Open Pivot Mechanical Heart Valve
FDA Recall
Terminated
·ATS Medical, Inc.·Product code LWQ·February 18, 2004
Medtronic Open Pivot Aortic Valve Graft, REF 502AG25, SIZE 25 mm
FDA Recall
Terminated
·MEDTRONIC ATS MEDICAL, INC.·Product code LWQ·February 11, 2020
Cardioblate CryoFlex, Surgical Ablation Probe, Model Number 60SF7, PROBE 60SF7 CRYOFLEX 7CM 26L - is a single use, disposable cryoprobe that is designed for use with the CryoFlex Surgical Ablation System. The probe has an integrated thermocouple for monitoring temperature at its ablation segment.
FDA Recall
Terminated
·MEDTRONIC ATS MEDICAL, INC.·Product code OCL·October 12, 2020
Cardioblate CryoFlex, Surgical Ablation Probe, Model Number 60SF3, PROBE 60SF3 CRYOFLEX 10-S 26L - is a single use, disposable cryoprobe that is designed for use with the CryoFlex Surgical Ablation System. The probe has an integrated thermocouple for monitoring temperature at its ablation segment.
FDA Recall
Terminated
·MEDTRONIC ATS MEDICAL, INC.·Product code OCL·October 12, 2020
Cardioblate CryoFlex, Surgical Ablation Probe, Model Number 60CM1, CLAMP 60CM1 CRYOFLEX PROBE 26L - is a single use, disposable cryoprobe that is designed for use with the CryoFlex Surgical Ablation System. The probe has an integrated thermocouple for monitoring temperature at its ablation segment.
FDA Recall
Terminated
·MEDTRONIC ATS MEDICAL, INC.·Product code OCL·October 12, 2020
Cardioblate CryoFlex, Surgical Ablation Probe, Model Number 60SF2, PROBE 60SF2 CRYOFLEX 10CM 26L - Product Usage: is a single use, disposable cryoprobe that is designed for use with the CryoFlex Surgical Ablation System. The probe has an integrated thermocouple for monitoring temperature at its ablation segment.
FDA Recall
Terminated
·MEDTRONIC ATS MEDICAL, INC.·Product code OCL·October 12, 2020
Medtronic Open Pivot Aortic Valve Graft, REF 502AG25, SIZE 25 mm
FDA Enforcement
Class II
·Terminated·MEDTRONIC ATS MEDICAL, INC.·April 1, 2020
Cardioblate CryoFlex, Surgical Ablation Probe, Model Number 60SF3, PROBE 60SF3 CRYOFLEX 10-S 26L - is a single use, disposable cryoprobe that is designed for use with the CryoFlex Surgical Ablation System. The probe has an integrated thermocouple for monitoring temperature at its ablation segment.
FDA Enforcement
Class II
·Terminated·MEDTRONIC ATS MEDICAL, INC.·December 2, 2020
Cardioblate CryoFlex, Surgical Ablation Probe, Model Number 60SF7, PROBE 60SF7 CRYOFLEX 7CM 26L - is a single use, disposable cryoprobe that is designed for use with the CryoFlex Surgical Ablation System. The probe has an integrated thermocouple for monitoring temperature at its ablation segment.
FDA Enforcement
Class II
·Terminated·MEDTRONIC ATS MEDICAL, INC.·December 2, 2020
Cardioblate CryoFlex, Surgical Ablation Probe, Model Number 60SF2, PROBE 60SF2 CRYOFLEX 10CM 26L - Product Usage: is a single use, disposable cryoprobe that is designed for use with the CryoFlex Surgical Ablation System. The probe has an integrated thermocouple for monitoring temperature at its ablation segment.
FDA Enforcement
Class II
·Terminated·MEDTRONIC ATS MEDICAL, INC.·December 2, 2020
Cardioblate CryoFlex, Surgical Ablation Probe, Model Number 60CM1, CLAMP 60CM1 CRYOFLEX PROBE 26L - is a single use, disposable cryoprobe that is designed for use with the CryoFlex Surgical Ablation System. The probe has an integrated thermocouple for monitoring temperature at its ablation segment.
FDA Enforcement
Class II
·Terminated·MEDTRONIC ATS MEDICAL, INC.·December 2, 2020
Vial2BAG Transfer Device, REF 6070104, Single use only, Rx Only
FDA Recall
Terminated
·WEST PHARMA. SERVICES IL, LTD 4, Ha-Sheizaf Ra'Anana Israel·Product code LHI·December 26, 2018
Vial2BAG DC 13mm, REF 6070111, Single use only, Rx Only
FDA Recall
Terminated
·WEST PHARMA. SERVICES IL, LTD 4, Ha-Sheizaf Ra'Anana Israel·Product code LHI·December 26, 2018
Vial2BAG DC 20mm: 1) REF 6070112 & 2) REF 6070112C, Single use only, Rx Only
FDA Recall
Terminated
·WEST PHARMA. SERVICES IL, LTD 4, Ha-Sheizaf Ra'Anana Israel·Product code LHI·December 26, 2018
Autopen Classic Automatic insulin delivery pen, 3.0ml x 2 unit 2-42 units, AN3800, Lot 7JH, NDC 08470-3800-01, The product is a non-sterile automatic subcutaneous injection device which delivers insulin.
FDA Recall
Terminated
·Owen Mumford USA, Inc.·Product code FMF·December 11, 2014
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 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