Calendar

Week of Apr 6, 2026

Apr 8, 2026recall144d agoK.C. Pharmaceuticals, Inc recall (Cls II)CNS Pharmaceuticals, Inc.

EYE DROPS Advanced Relief, (dextran 70 0.1%, polyethylene glycol 400 1% and tetrahydrozoline HCl 0.05%), 0.5 FL OZ (15 mL) bottles, Sterile; a) Walgreens, DISTRIBUTED BY: WALGREEN CO., DEERFIELD, IL 60015; UPC 3 11917 20074 3; b) Kroger, DISTRIBUTED BY THE KROGER CO., CINCINNATI, OHIO 45202; c) CVS Health, Distributed by :CVS Pharmacy, Inc., Woonsocket, RI 02895, UPC 0 50428 43544 1; d) QC-Quality Choice, Distributed by: CDMA, Inc., Novi, MI 48375, NDC 83324-191-14; e) Discount drug mart, Discount Drug Mart Food Fair, Medina, OH 44256, UPC 0 93351 01155 9; f) Foster & Thrive, Distributed by: McKesson Corp., via SSSL, Memphis, TN 38141, NDC 70677-1158-1; g) GoodSense, Distributed By: Perrigo Direct Inc., Peachtree City, GA 30269, www.PerrigoDirect.com, NDC 50804-130-01; h) TopCare health, DISTRIBUTED BY TOPCO ASSOCIATES LLC, ELKGROVE VILLAGE, IL 60007, UPC 0 36800 03641 3; I) DG health Sterile, DISTRIBUTED BY OLD EAST MAIN CO., 100 MISSION RIDGE, GOODLETTSVILLE, TN 37072, UPC 0 95072 02556 3; j) Fast Acting, CODE RED Eye Drops, Sterile, Distributed by: 4 Trees, LLC, NDC 83817-963-01. — Reason: Lack of Assurance of Sterility — Status: Ongoing

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Apr 8, 2026recall144d agoK.C. Pharmaceuticals, Inc recall (Cls II)CNS Pharmaceuticals, Inc.

Sterile EYE DROPS AC (tetrahydrozoline HCl 0.05%, zinc sulfate 0.25%), 0.5 fl. oz. (15 mL) bottles; a) Best Choice, PROUDLY DISTRIBUTED BY: VALU MERCHANDISERS, CO., 5000 KANSAS AVE, KANSAS CITY, KS 66106, UPC 0 70038 47010 6; b) QC-Quality Choice, Sterile Eye drops Irritation Relief, Distributed by: CDMA, Inc., Novi, MI 48375, NDC 83324-190-14; c) Discount drug mart, Eye Drops A.C., Discount Drug Mart Food Fair, Medina, OH 44256, UPC 0 93351 01158 0; d) Good Sense Sterile Eye Drops, Distributed By: Perrigo Direct, Inc., Peachtree City, GA 30269, www.PerrigoDirect.com, NDC 50804-160-01; e) Walgreens, Eye Drops, DISTRIBUTED BY: WALGREEN CO., DEERFIELD, IL 60015, UPC 3 11917 17954 4; f) CAREONE, Itchy relief Eye drops, DISTRIBUTED BY: FOODHOLD U.S.A, LLC., LANDOVER, MD 20785; g) Equaline, DISTRIBUTED BY: UNFI, PROVIDENCE, RI 02908 UPC 0 41163 25114 4; h) TopCare health TM, DISTRIBUTED BY: TOPCO ASSOCIATES LLC, ELK GROVE VILLAGE, IL 60007, UPC 0 36800 03640 6; i) meijer, DIST. BY MEIJER DISTRIBUTION, INC., GRAND RAPIDS, MI 49544, www.meijer.com, NDC 41250-598-01; j) H.E.B A.C. Eye Drops, MADE WITH PRIDE & CARE FOR H-E-B, SAN ANTONIO, TX 78204, UPC 0 41220 43746 7 — Reason: Lack of Assurance of Sterility — Status: Ongoing

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Apr 8, 2026recall144d agoK.C. Pharmaceuticals, Inc recall (Cls II)CNS Pharmaceuticals, Inc.

STERILE EYE DROPS SOOTHING TEARS (polyethylene glycol 400 0.4% and propylene glycol 0.3%), 0.5 OZ 0.5 fl oz (15 mL) bottles; a) Rugby LUBRICATING EYE DROPS, Distributed by: Rugby Laboratories, Livonia, MI 48152, NDC 0536-1219-94; b) Walgreens, Lubricant Eye Drops, DISTRIBUTED BY: WALGREEN CO., DEERFIELD, IL 60015, UPC 3 11917 20300 3 — Reason: Lack of Assurance of Sterility — Status: Ongoing

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Apr 8, 2026device 510k144d agoSTERIS Corporation — SYSTEM 1E Liquid Chemical Sterilant Processing System, Model P6700; SYSTEM 1 endo Liquid Chemical Sterilant Processing System, Model P6900 (510k cleared)STERIS plc

Product code: MED. Advisory committee: General Hospital. Type: Traditional

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Apr 8, 2026device 510k144d agoResmed Corp — myAir (510k cleared)RESMED INC

Product code: MNS. Advisory committee: Anesthesiology. Type: Traditional

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Apr 8, 2026device 510k144d agoHangzhou AGS MedTech Co., Ltd. — Hemoclip (510k cleared)

Product code: PKL. Advisory committee: Gastroenterology, Urology. Type: Traditional

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Apr 8, 2026device 510k144d agoChangzhou Sifary Medical Technology Co., Ltd. — Apex Locator (FindPex) (510k cleared)

Product code: LQY. Advisory committee: Unknown. Type: Traditional

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Apr 8, 2026device 510k144d agoSTERIS Corporation — Celerity 5 HP Biological Indicator (LCB052) (510k cleared)STERIS plc

Product code: FRC. Advisory committee: General Hospital. Type: Special

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Apr 8, 2026device 510k144d agoSuzhou Shenyun Medical Equipment Co., Ltd. — Shogun Axis Fascial Closure System (1018S, 1018B, 1218S, 1218B, 1518S, 1518B) (510k cleared)

Product code: GCJ. Advisory committee: Gastroenterology, Urology. Type: Traditional

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Apr 8, 2026device 510k144d agoScopix , Ltd. — TL-10 Laparoscopic Scope Cleaner (510k cleared)

Product code: GCJ. Advisory committee: Gastroenterology, Urology. Type: Traditional

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Apr 8, 2026device 510k144d agoTenon Medical — CATAMARAN SI Joint Fusion System (510k cleared)Tenon Medical, Inc.

Product code: OUR. Advisory committee: Orthopedic. Type: Traditional

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Apr 8, 2026device 510k144d agoModular Medical — Pivot Insulin Delivery System (510k cleared)Modular Medical, Inc.

Product code: LZG. Advisory committee: General Hospital. Type: Traditional

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Apr 8, 2026device 510k144d agoMacroLux Medical Technology Co., Ltd. — LoopView® Single-Use Digital Flexible Bronchoscope (B27-C, B27-CG) (510k cleared)NewBay Medical Technology Co Ltd

Product code: EOQ. Advisory committee: Ear, Nose, Throat. Type: Traditional

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Apr 8, 2026device 510k144d agoShenzhen TPH Technology Co., Ltd. — Wearable Breast Pump (Model S21A) (510k cleared)Fortior Technology (Shenzhen) Co., Ltd./ADR

Product code: HGX. Advisory committee: Obstetrics/Gynecology. Type: Traditional

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Apr 8, 2026device 510k144d agoBoston Scientific — OptiCross Coronary Imaging Catheter (H749518110); OptiCross 6 Coronary Imaging Catheter (H7495181160); OptiCross HD Coronary Imaging Catheter (H74939352040); OptiCross 6 HD Coronary Imaging Catheter (H74939354080); OptiCross Coronary Imaging Catheter (Bagless) (H749518130); OptiCross 6 Coronary Imaging Catheter (Bagless) (H7495181360); OptiCross HD Coronary Imaging Catheter (Bagless) (H74939352050); OptiCross 6 HD Coronary Imaging Catheter (Bagless) (H74939354090) (510k cleared)BOSTON SCIENTIFIC CORP

Product code: OBJ. Advisory committee: Cardiovascular. Type: Special

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Apr 8, 2026device 510k144d agoCMT Health PTE., Ltd. — Profoject Enteral/Oral Feeding Syringe; Profoject Reusable Enteral/Oral Feeding Syringe (Model A, Model B); Profoject ENFit Adaptor; Profoject Enteral Feeding Syringes Cap (510k cleared)

Product code: PNR. Advisory committee: Gastroenterology, Urology. Type: Traditional

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Apr 8, 2026device 510k144d agoShenzhen Root Innovation Technology Co., Ltd. — Momcozy Wearable Breast Pump (BP137, BP137-A, BP137-B, BP137-C, BP137-D, BP137Y-A, BP137Y-B, BP141, BP141-A, BP141-B, BP141-C, BP141-D) (510k cleared)Hang Feng Technology Innovation Co., Ltd.

Product code: HGX. Advisory committee: Obstetrics/Gynecology. Type: Traditional

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Apr 8, 2026device pma144d agoGlaukos Corporation — iStent® Trabecular Micro-Bypass Stent System (PMA supplement)GLAUKOS Corp

Supplement type: Real-Time Process. Product code: OGO. Advisory committee: OP. Decision: APPR

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Apr 8, 2026device pma144d agoMedtronic Vascular, Inc. — Abre Venous Self-expanding Stent System (PMA supplement)

Supplement type: 30-Day Notice. Product code: QAN. Advisory committee: CV. Decision: OK30

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Apr 8, 2026device pma144d agoEmpirical Spine, Inc. — LimiFlex Dynamic Sagittal Tether (PMA supplement)

Supplement type: Normal 180 Day Track No User Fee. Product code: SGK. Advisory committee: OR. Decision: APPR

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Apr 8, 2026grant144d agoWASHINGTON UNIVERSITY — Transcriptomic Signatures of Ischemic Stroke: Unlocking Human-Specific Target...

NS grant. $231,264. PI: Destiny Hooper

Week of Apr 6, 2026