89 results
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14ms
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Sources: EU EUDAMED, US FDA
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Classification: Class I
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ShapeMatch Cutting Guides Product Usage: The ShapeMatch Cutting Guides are intended to be used as patient-specific surgical instrumentation to assist in the positioning of total knee arthroplasty components intraoperatively and in guiding the marking of bone before cutting.
FDA Enforcement
Class I
·Terminated·Stryker Howmedica Osteonics Corp.·April 24, 2013
Astral 100 and Astral 150 ventilators
FDA Enforcement
Class I
·Ongoing·ResMed Ltd.·November 1, 2023
Outlook ES pump is intended for use with B. Braun Medical Inc. Horizon Pump IV Sets. Used to regulate the flow of primary and secondary fluids when positive pressure is required. The infusion system is capable of delivering fluid from a negative head height (when the IV fluid container is lower than the pump), and provides clinically accepted volumetric accuracy for all standard IV fluids, including blood, lipid, and Total Parenteral Nutrition (TPN). Model number: 621-300ES and 621-400ES. To deliver a broad range of drugs with use with the B. Braun Medical Inc. Horizon Pump IV Sets.
FDA Enforcement
Class I
·Terminated·B Braun Medical, Inc.·September 25, 2013
Celltrion DiaTrust COVID-19 Ag Rapid Test, Reference No. CT-P60 D-2 02
FDA Enforcement
Class I
·Terminated·CELLTRION USA INC·March 9, 2022
Hillrom Hospital Bed Accessory, Watch Care Incontinence Management System for Progressa Bed, Product Code/Part Number P00697903.
FDA Enforcement
Class I
·Ongoing·Baxter Healthcare Corporation·November 9, 2022
Hillrom Hospital Bed Accessory, Watch Care Incontinence Management System for Centrella Bed, Product Code/Part Number P00697905
FDA Enforcement
Class I
·Ongoing·Baxter Healthcare Corporation·November 9, 2022
Hillrom Hospital Bed Accessory, WatchCare Incontinence Management System for VersaCare Bed Rev. K, Product Code/Part Number P00697902
FDA Enforcement
Class I
·Ongoing·Baxter Healthcare Corporation·November 9, 2022
ANGIOGUARD RX / XP Emboli Capture Guidewire System, REF 801814RMC
FDA Enforcement
Class I
·Ongoing·Cordis US Corp·May 17, 2023
ANGIOGUARD RX / XP Emboli Capture Guidewire System, REF 701814RMC
FDA Enforcement
Class I
·Ongoing·Cordis US Corp·May 17, 2023
Hillrom Hospital Bed Accessory, Watch Care Incontinence Management System for VersaCare Bed Rev. A-J, Product Code/Part Number P00697901
FDA Enforcement
Class I
·Ongoing·Baxter Healthcare Corporation·November 9, 2022
ANGIOGUARD RX / XP Emboli Capture Guidewire System, REF 401814RM
FDA Enforcement
Class I
·Ongoing·Cordis US Corp·May 17, 2023
ANGIOGUARD RX / XP Emboli Capture Guidewire System, REF 501814RM
FDA Enforcement
Class I
·Ongoing·Cordis US Corp·May 17, 2023
ANGIOGUARD RX / XP Emboli Capture Guidewire System, REF 603014MC
FDA Enforcement
Class I
·Ongoing·Cordis US Corp·May 17, 2023
ANGIOGUARD RX / XP Emboli Capture Guidewire System, REF 801814RE
FDA Enforcement
Class I
·Ongoing·Cordis US Corp·May 17, 2023
ANGIOGUARD RX / XP Emboli Capture Guidewire System, REF 501814REC
FDA Enforcement
Class I
·Ongoing·Cordis US Corp·May 17, 2023
ANGIOGUARD RX / XP Emboli Capture Guidewire System, REF 501814RMC
FDA Enforcement
Class I
·Ongoing·Cordis US Corp·May 17, 2023
ANGIOGUARD RX / XP Emboli Capture Guidewire System, REF 701814RE
FDA Enforcement
Class I
·Ongoing·Cordis US Corp·May 17, 2023
ANGIOGUARD RX / XP Emboli Capture Guidewire System, REF 601814RM
FDA Enforcement
Class I
·Ongoing·Cordis US Corp·May 17, 2023
ANGIOGUARD RX / XP Emboli Capture Guidewire System, REF 401814RMC
FDA Enforcement
Class I
·Ongoing·Cordis US Corp·May 17, 2023
ANGIOGUARD RX / XP Emboli Capture Guidewire System, REF 601814RMC
FDA Enforcement
Class I
·Ongoing·Cordis US Corp·May 17, 2023