Calendar

pharmadog

Week of Apr 6, 2026

Apr 8, 2026device 510k125d agoResmed Corp — myAir (510k cleared)RESMED INC

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

full page →fda device 510k ↗

Apr 8, 2026device 510k125d agoHangzhou AGS MedTech Co., Ltd. — Hemoclip (510k cleared)

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

full page →fda device 510k ↗

Apr 8, 2026device 510k125d agoChangzhou Sifary Medical Technology Co., Ltd. — Apex Locator (FindPex) (510k cleared)

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

full page →fda device 510k ↗

Apr 8, 2026device 510k125d agoSTERIS Corporation — Celerity 5 HP Biological Indicator (LCB052) (510k cleared)STERIS plc

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

full page →fda device 510k ↗

Apr 8, 2026device 510k125d 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 510k125d 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 510k125d agoTenon Medical — CATAMARAN SI Joint Fusion System (510k cleared)Tenon Medical, Inc.

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

full page →fda device 510k ↗

Apr 8, 2026device 510k125d agoModular Medical — Pivot Insulin Delivery System (510k cleared)Modular Medical, Inc.

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

full page →fda device 510k ↗

Apr 8, 2026device 510k125d 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

full page →fda device 510k ↗

Apr 8, 2026device 510k125d 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 510k125d 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 510k125d 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 510k125d 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 pma125d 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 pma125d 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 pma125d 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

full page →fda device pma ↗

Apr 8, 2026grant125d agoWASHINGTON UNIVERSITY — Transcriptomic Signatures of Ischemic Stroke: Unlocking Human-Specific Target...

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

Week of Apr 6, 2026