148 results
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14ms
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Sources: EU EUDAMED, US FDA
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Status: Ongoing
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Brand Name: Disposable Mixing Bowls with Spatula Product Name: Mixing Bowl and Spatula Model/Catalog Number: 00-5049-011-00 Software Version: N/A Product Description: Mixing Bowl and Spatula Component: N/A
FDA Enforcement
Class II
·Ongoing·Zimmer, Inc.·May 6, 2026
stryker Blueprint Mixed Reality Glenoid Digitizer, Catalog Number MRUE201, packaged in stryker Blueprint Mixed Reality Instrument Kit, Catalog Number MRUEGLN; Total Shoulder Arthroplasty
FDA Enforcement
Class II
·Ongoing·Tornier S.A.S.·April 16, 2025
stryker Blueprint Mixed Reality Box Base, Catalog Number MRUE204, packaged in stryker Blueprint Mixed Reality Instrument Kit, Catalog Number MRUEGLN; Total Shoulder Arthroplasty
FDA Enforcement
Class II
·Ongoing·Tornier S.A.S.·April 16, 2025
stryker Blueprint Mixed Reality Coracoid Clamp, Catalog Number MRUE202, packaged in stryker Blueprint Mixed Reality Instrument Kit, Catalog Number MRUEGLN; Total Shoulder Arthroplasty
FDA Enforcement
Class II
·Ongoing·Tornier S.A.S.·April 16, 2025
stryker Blueprint Mixed Reality Glenoid Box Lid, Catalog Number MRUE205, packaged in stryker Blueprint Mixed Reality Instrument Kit, Catalog Number MRUEGLN; Total Shoulder Arthroplasty
FDA Enforcement
Class II
·Ongoing·Tornier S.A.S.·April 16, 2025
stryker Blueprint Mixed Reality Instrument Check Block, Catalog Number MRUE203, packaged in stryker Blueprint Mixed Reality Instrument Kit, Catalog Number MRUEGLN; Total Shoulder Arthroplasty
FDA Enforcement
Class II
·Ongoing·Tornier S.A.S.·April 16, 2025
stryker Blueprint Mixed Reality BP MxR Glenoid Pin Guide PPSU + Stainless Steel, Catalog Number MRUE200, packaged in stryker Blueprint Mixed Reality Instrument Kit, Catalog Number MRUEGLN; Total Shoulder Arthroplasty
FDA Enforcement
Class II
·Ongoing·Tornier S.A.S.·April 16, 2025
Stryker ACM (Advanced Cement Mixing) System: Break-Away Femoral Nozzle-, Allows the user to mix bone cement with a constant high vacuum through the process. Catalog number: 0206-512-000.
FDA Enforcement
Class II
·Ongoing·Stryker Corporation·September 27, 2023
Stryker ACM (Advanced Cement Mixing) System: ACM Kit w/ Femoral Breakaway Nozzle-Allows the user to mix bone cement witha constant high vacuum through the process Catalog Number: 0306-563-000
FDA Enforcement
Class II
·Ongoing·Stryker Corporation·September 27, 2023
Stryker ACM (Advanced Cement Mixing): 180-Gram Cement Cartridge with Breakaway Femoral Nozzle-Allows the user to mix bone cement with a constant high vacuum through the process Catalog Number: 0206-530-000
FDA Enforcement
Class II
·Ongoing·Stryker Corporation·September 27, 2023
Stryker ACM (Advanced Cement Mixing) System: ACM Kit w/ Femoral Breakaway Nozzle & Solid Blades-Allows the user to mix bone cement with a constant high vacuum through the process Catalog Number: 0306-564-000
FDA Enforcement
Class II
·Ongoing·Stryker Corporation·September 27, 2023
Stryker ACM (Advanced Cement Mixing) System: ACM Kit w/ Femoral Breakaway Nozzle & Prox. Med. Press-Allows the user to mix bone cement with a constant high vacuum through the process Catalog Number: 0306-573-000
FDA Enforcement
Class II
·Ongoing·Stryker Corporation·September 27, 2023
Stryker ACM (Advanced Cement Mixing)System: ACM Kit w/ Femoral Breakaway Nozzle, Restrictors & Prox. Press-Allows the user to mix bone cement with a constant high vacuum through the process Catalog Number: 0306-703-000
FDA Enforcement
Class II
·Ongoing·Stryker Corporation·September 27, 2023
Stryker ACM (Advanced Cement Mixing)System: ACM Kit w/ Femoral Breakaway Nozzle, Restrictors & Prox. Med. Press- Allows the user to mix bone cement with a constant high vacuum through the process. Catalog Number: 0306-705-000
FDA Enforcement
Class II
·Ongoing·Stryker Corporation·September 27, 2023
Unifine Pentips Plus, hypodermic needle - Product Usage: Pen needles with built in pen needle remover.
FDA Enforcement
Class II
·Ongoing·Owen Mumford USA, Inc.·July 21, 2021
Heraeus, PALAMIX duo. Material Number: 66057897.
FDA Enforcement
Class III
·Ongoing·Heraeus Medical GmbH (Dental Division)·May 6, 2026
Heraeus, PALAMIX uno. Material Number: 66057893.
FDA Enforcement
Class III
·Ongoing·Heraeus Medical GmbH (Dental Division)·May 6, 2026
Simplexa Flu A/B & RSV Direct Gen II, REF: MOL2655; including Reaction Mix REF: MOL2656; with previous assay definition v5.
FDA Enforcement
Class II
·Ongoing·DiaSorin Molecular LLC·March 15, 2023
Stryker Blueprint Mixed Reality BP MxR Glenoid Pin Guide, REF MRUE200. Indicated for use during Total Shoulder Arthroplasty.
FDA Enforcement
Class II
·Ongoing·Tornier S.A.S.·January 22, 2025
Isopure Sodium Bicarbonate Mixing and Distribution System (IsoMix PRO)
FDA Enforcement
Class II
·Ongoing·Isopure Corp·July 20, 2022