5,223 results
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13ms
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Sources: EU EUDAMED, US FDA
Filters
Classification: Class Ii
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Tacy Medical, Inc PORT ACCESS TRAY, Sterile, QTY 20. Manufactured for Tracy Medical, Inc.
FDA Enforcement
Class II
·Ongoing·Stradis Healthcare·January 18, 2023
Tacy Medical, Inc Fluid Filter Transfer Kit, Sterile, 60 kits per bag, 5 bags per case. Manufactured for Tracy Medical, Inc.
FDA Enforcement
Class II
·Ongoing·Stradis Healthcare·January 18, 2023
Tacy Medical, Inc Syringe Convenience Pack, IML L/L, Sterile, 60 packs per bag, 5 bags per case. Manufactured for Tracy Medical, Inc.
FDA Enforcement
Class II
·Ongoing·Stradis Healthcare·January 18, 2023
POM Procedural Oxygen Masks, Endoscopic, Conscious Sedation, Bronchoscopy Mask, as follows: (1) POM Medical, LLC, REF 1001-MM, High/Med Concentrations, Distributed by POM Medical, LLC, Moorpark, CA; (2) curaplex, REF 301-0318LT, Medium Concentration, Distributed by Sarnova HC, LLC's family of companies: Bound Tree Medical, LLC, Cardio Partners, Inc., Emergency Medical Products, Inc. & Tri-anim Health Services, Inc., Dublin, OH; and (3) POM Medical, LLC REF 1001-MF, High/Med Concentrations, Distributed by POM Medical, LLC, Moorpark, CA. All are packaged 1 mask/plastic pouch, 30 masks/case.
FDA Enforcement
Class II
·Terminated·POM Medical LLC·November 6, 2019
Medical Action Industries Inc. Port Access Kit, REF #76511B (on case label), sterile; and Medical Action Industries Inc. IV Start Kit, REF #78019 (on kit label), sterile. Kit components are the Port Access Kit.
FDA Enforcement
Class II
·Terminated·Medical Action Industries, Inc. 306·December 14, 2022
Medical Action INDUSTRIES INC., Minor Procedure Tray, REF 61214
FDA Enforcement
Class II
·Terminated·Medical Action Industries, Inc. 306·June 30, 2021
Medical Action INDUSTRIES INC., General Purpose Instrument Tray, REF 61209
FDA Enforcement
Class II
·Terminated·Medical Action Industries, Inc. 306·June 30, 2021
Toshiba America Medical Systems, Inc Aquilion Lightning TSX-035A CT Scanner.
FDA Enforcement
Class II
·Terminated·Toshiba American Medical Systems Inc·October 12, 2016
Toshiba America Medical Systems, Inc . Celesteion PCA-9000A/2 CT Scanner
FDA Enforcement
Class II
·Terminated·Toshiba American Medical Systems Inc·October 12, 2016
Medical Action INDUSTRIES INC., Disposable Instrument Pack Curved Hemostat, REF 56224
FDA Enforcement
Class II
·Terminated·Medical Action Industries, Inc. 306·June 30, 2021
Medical Action INDUSTRIES INC., Disposable Instrument Pack Mosquito Hemostat, REF 56220
FDA Enforcement
Class II
·Terminated·Medical Action Industries, Inc. 306·June 30, 2021
Elcam Medical MANI 3G Plate BLS RAD B.BRAUN; Manifold for pressure monitoring and intravenous fluid administration. Manufactured by: Elcam Medical ACAL, Israel; Distributed by: Elcam Medical Inc., USA. Sterile
FDA Enforcement
Class II
·Terminated·Elcam Medical, Inc.·September 16, 2015
Toshiba America Medical Systems, Inc . Aquilion LB TSX-201A/2, 3 CT Scanner
FDA Enforcement
Class II
·Terminated·Toshiba American Medical Systems Inc·October 12, 2016
Ingenuity Core 128, Computed Tomography X-ray systems, Philips Medical Systems (Cleveland), Inc.
FDA Enforcement
Class II
·Terminated·Philips Medical Systems (Cleveland) Inc·April 23, 2014
Argon Medical Devices AHD Luer Lock Cap, REF 501303, Sterile, Rx. The firm name on the label is Argon Medical Devices, Inc., Athens, TX.
FDA Enforcement
Class II
·Terminated·Argon Medical Devices, Inc·November 13, 2019
Argon Medical Devices Double Male LL Adapter, REF 040184800A, bulk, non-sterile. The firm name on the label is Argon Medical Devices, Inc., Athens, TX.
FDA Enforcement
Class II
·Terminated·Argon Medical Devices, Inc·November 13, 2019
MVAP MEDICAL SUPPLIES INC, Mavidon CardioPrep Single, 24 use cups, Re order # MCP-24
FDA Enforcement
Class II
·Terminated·Carroll-Baccari, Inc.·April 1, 2020
Medical Action INDUSTRIES INC. Port a Cath Kit REF 58647D, cardiac catheter introduction kit
FDA Enforcement
Class II
·Terminated·Medical Action Industries, Inc. 306·December 28, 2022
Argon Medical Devices Septishield II, 80 cm, REF 497302, 25/box, Sterile, Rx. The firm name on the label is Argon Medical Devices, Inc., Athens, TX.
FDA Enforcement
Class II
·Terminated·Argon Medical Devices, Inc·November 13, 2019
Laceration Trays, Sterile Single Use, Latex Free, 20/case, Medical Action Industries, Inc., Arden, NC.
FDA Enforcement
Class II
·Terminated·Medical Action Industries Inc·July 9, 2014