116 results
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18ms
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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
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
1. Tech Medical Services Inc. Detachable Endo Retrieval Pouch, REF TM2001, 3" x 6", sterile; 2. Tech Medical Services Inc. Detachable Endo Retrieval Pouch, REF TM2000, 5" x 7", sterile; 3. Tech Medical Services, Inc. Detachable Endo Retrieval Pouch, REF TM2002, 8" x 10", sterile; 4. UNIMAX Detachable endo pocket, REF FEP936116, 3" x 6", sterile; 5. UNIMAX Detachable endo pocket, REF FEP979000, 8" x 10", sterile; 6. ConMed Corporation Detachable endo pocket, REF SB936, 3" x 6", sterile; 7. ConMed Corporation Detachable endo pocket, REF SB957, 5" x 7", sterile; 8. ConMed Corporation Detachable endo pocket, REF SB979, 7.5" x 9", sterile; 9. ConMed Corporation Detachable endo pocket, REF SB979-CA, 7.5 x 9", sterile; 10. ConMed Corporation Detachable endo pocket, REF SB936-CA, 3" x 6", sterile;
FDA Enforcement
Class II
·Ongoing·UNIMAX MEDICAL SYSTEMS INC·September 25, 2024
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
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
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
Safety Laceration Kit, 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
Laceration/Suture Removal, 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
Max Barrier Kit, 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
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
Laceration Kit: W/Needles, 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
ET-20 Anesthesia Extension Tubes, 2.5 ml approximately, Sterile and Disposable, Wall Medical Inc., Made in China
FDA Enforcement
Class II
·Terminated·Global Healthcare Inc·February 10, 2016
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
CADD(R) Medication Cassette Reservoir with clamp and female Luer. Non vented stopper included, REF 21-7002-24, Rx only, STERILE EO, Manufacturer Smiths Medical ASD, Inc.
FDA Enforcement
Class II
·Terminated·Smiths Medical ASD Inc.·September 6, 2017
Argon Medical Devices Plugs, Male/Female Luer Lock Plug, REF 041295000A, 50/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
MICROTEK(TM) MEDICAL BUR HOLE LATEX PROBE COVER WITH GEL, featuring IsoSilk(R), 13cm x 249 cm, REF 3688UK, STERILE EO, QTY 20, Microtek Medical, Inc., Columbus, MS 39702
FDA Enforcement
Class II
·Terminated·Ecolab Inc·February 19, 2014
Suture Set, Sterile Single Use, Stage Two: Clean Ready to Use, Latex Free, 20/case, Medical Action Industries, Inc, Arden, NC.
FDA Enforcement
Class II
·Terminated·Medical Action Industries Inc·July 9, 2014
Medical Action Industries Inc. Disposable Instrument Pack, Littauer Scissor, REF 56247, packaged 1/package, 20 packages/box, 12 boxes/case, sterile.
FDA Enforcement
Class II
·Terminated·Medical Action Industries, Inc. 306·December 28, 2022