56 results
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12ms
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Sources: EU EUDAMED, US FDA
Filters
Status: Terminated
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5.0mm Unit Rod 270mm 5.0mm Unit Rod 290mm 5.0mm Unit Rod 310mm 5.0mm Unit Rod 330mm 5.0mm Unit Rod 350mm 5.0mm Unit Rod 370mm 5.0mm Unit Rod 390mm 5.0mm Unit Rod 410mm 5.0mm Unit Rod 430mm 5.0mm Unit Rod 450mm pedicle screw spinal system; Intended to provide immobilization and stabilization of spinal segments in skeletally mature patients.
FDA Recall
Terminated
·Synthes USA HQ, Inc.·Product code MNI·June 5, 2013
Cardiopulmonary bypass connector; P/N: 321334-000 DESC: CONNECTOR, 3/8 X 3/8 X 1/2 CLEAR PAY LOT: 295424 STERILE Expiration May 2019 Manufacturing Date May 2014
FDA Enforcement
Class II
·Terminated·Dokitz NovoSci·November 12, 2014
Ingenuity Core 128 Computed Tomography X-ray system
FDA Recall
Terminated
·Philips Medical Systems (Cleveland) Inc·Product code JAK·October 29, 2015
Brilliance 64 Computed Tomography X-ray system
FDA Recall
Terminated
·Philips Medical Systems (Cleveland) Inc·Product code JAK·October 29, 2015
Ingenuity CT Computed Tomography X-ray system
FDA Recall
Terminated
·Philips Medical Systems (Cleveland) Inc·Product code JAK·October 29, 2015
Brilliance iCT SP Computed Tomography X-ray system
FDA Recall
Terminated
·Philips Medical Systems (Cleveland) Inc·Product code JAK·October 29, 2015
Ingenuity Core Computed Tomography X-ray system
FDA Recall
Terminated
·Philips Medical Systems (Cleveland) Inc·Product code JAK·October 29, 2015
Brilliance iCT Computed Tomography X-ray system
FDA Recall
Terminated
·Philips Medical Systems (Cleveland) Inc·Product code JAK·October 29, 2015
Sterling Diagnostics, Inc.Colorimetric SGOT for IN VITRO DIAGNOSTIC USE in the quantitative determination of analytes. These are CONSUMABLES - a customer buys another when kit is consumed.
FDA Enforcement
Class III
·Terminated·Sterling Diagnostics, Inc.·January 4, 2017
Sterling Diagnostics, Inc., Enzymatic Glucose for IN VITRO DIAGNOSTIC USE in the quantitative determination of analytes. These are CONSUMABLES - a customer buys another when kit is consumed.
FDA Enforcement
Class III
·Terminated·Sterling Diagnostics, Inc.·January 4, 2017
Sterling Diagnostics, Inc., SGPT Colorimetric for IN VITRO DIAGNOSTIC USE in the quantitative determination of analytes. These are CONSUMABLES - a customer buys another when kit is consumed.
FDA Enforcement
Class III
·Terminated·Sterling Diagnostics, Inc.·January 4, 2017
Enzymatic Cholesterol (Trinder/COD-CEH) for IN VITRO DIAGNOSTIC USE in the quantitative determination of analytes. These are CONSUMABLES - a customer buys another when kit is consumed.
FDA Enforcement
Class III
·Terminated·Sterling Diagnostics, Inc.·January 4, 2017
Urea Nitrogen/Color BUN (Enzymatic Berthelot) for IN VITRO DIAGNOSTIC USE in the quantitative determination of analytes. These are CONSUMABLES - a customer buys another when kit is consumed.
FDA Enforcement
Class III
·Terminated·Sterling Diagnostics, Inc.·January 4, 2017
Creatinine/Endpoint [Modified Heinegard-Tiderstrom] for IN VITRO DIAGNOSTIC USE in the quantitative determination of analytes. These are CONSUMABLES - a customer buys another when kit is consumed.
FDA Enforcement
Class III
·Terminated·Sterling Diagnostics, Inc.·January 4, 2017
Sterling Diagnostics, Inc., Enzymatic Uric Acid (Uricase Trinder) for IN VITRO DIAGNOSTIC USE in the quantitative determination of analytes. These are CONSUMABLES - a customer buys another when kit is consumed.
FDA Enforcement
Class III
·Terminated·Sterling Diagnostics, Inc.·January 4, 2017
Sterling Diagnostics, Inc., HDL Cholesterol (PEF Method) for IN VITRO DIAGNOSTIC USE in the quantitative determination of analytes. These are CONSUMABLES - a customer buys another when kit is consumed.
FDA Enforcement
Class III
·Terminated·Sterling Diagnostics, Inc.·January 4, 2017
Sterling Diagnostics, Inc. Serum Iron/IBC (Colorimetric) for IN VITRO DIAGNOSTIC USE in the quantitative determination of analytes. These are CONSUMABLES - a customer buys another when kit is consumed.
FDA Enforcement
Class III
·Terminated·Sterling Diagnostics, Inc.·January 4, 2017
Brilliance iCT SP Computed Tomography X-ray system
FDA Enforcement
Class II
·Terminated·Philips Medical Systems (Cleveland) Inc·December 30, 2015
Sterling Diagnostics, Inc.Colorimetric SGOT for IN VITRO DIAGNOSTIC USE in the quantitative determination of analytes. These are CONSUMABLES - a customer buys another when kit is consumed.
FDA Recall
Terminated
·Sterling Diagnostics, Inc.·Product code CIQ·July 20, 2016
Creatinine/Endpoint [Modified Heinegard-Tiderstrom] for IN VITRO DIAGNOSTIC USE in the quantitative determination of analytes. These are CONSUMABLES - a customer buys another when kit is consumed.
FDA Recall
Terminated
·Sterling Diagnostics, Inc.·Product code CGX·July 20, 2016