Calendar

Week of Sep 22, 2025

Sep 24, 2025device 510k330d agoDentimax, Inc. — Digital X-Ray DentiMax Pro Imaging System (510k cleared)

Product code: MUH. Advisory committee: Dental. Type: Traditional

Sep 24, 2025device 510k330d agoAlma Lasers, Inc. — Alma FemiLift Pixel CO2 Laser System, Delivery Devices and Accessories (510k cleared)

Product code: GEX. Advisory committee: General, Plastic Surgery. Type: Traditional

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Sep 24, 2025device 510k330d agoTandem Diabetes Care, Inc. — t:slim X2 insulin pump with interoperable technology (510k cleared)TANDEM DIABETES CARE INC

Product code: QFG. Advisory committee: Clinical Chemistry. Type: Traditional

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Sep 24, 2025device 510k330d agoProverum Limited — ProVee Video Processing Unit (PV-003) (510k cleared)

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

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Sep 24, 2025device 510k330d agoKulzer, LLC — Retraxil (510k cleared)

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

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Sep 24, 2025device 510k330d agoImaxeon Pty, Ltd. — MEDRAD Centargo CT Injection System; MEDRAD Centargo Day Set; MEDRAD Centargo Patient Line; MEDRAD Centargo Replacement Spike; MEDRAD ISI2 Module (ISI2) (510k cleared)

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

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Sep 24, 2025device 510k330d agoSurmodics,Inc. — Pounce(TM) Sheath (510k cleared)

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

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Sep 24, 2025device 510k330d agoEndorobotics Co., Ltd. — ROBOPERA (ER-R-002); ROBOPERA (ER-R-003) (510k cleared)

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

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Sep 24, 2025device pma330d agoAbiomed, Inc. — Impella CP with SmartAssist (PMA supplement)Abion Inc

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

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Sep 24, 2025device pma330d agoFarapulse, Inc. — FARASTAR Pulsed Field Ablation (PFA) Generator; FARASTAR Mapping System Module (MSM); FARASTAR Recording System Modul (PMA supplement)

Supplement type: Normal 180 Day Track. Product code: QZI. Advisory committee: CV. Decision: APPR

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Sep 24, 2025device pma330d agoABBOTT MEDICAL — CardioMEMS HF System (PMA supplement)

Supplement type: Special (Immediate Track). Product code: MOM. Advisory committee: CV. Decision: APPR

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Sep 24, 2025device pma330d agoAbbott Molecular, Inc. — Alinity m HBV (PMA supplement)

Supplement type: Real-Time Process. Product code: MKT. Advisory committee: MI. Decision: APPR

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Sep 24, 2025device pma330d agoETHICON, Inc. — GYNECARE INTERCEED Absorbable Adhesion Barrier (PMA supplement)

Supplement type: 30-Day Notice. Product code: MCN. Advisory committee: OB. Decision: OK30

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Sep 24, 2025device pma330d agoETHICON, Inc. — SURGICEL® Absorbable Hemostats; SURGICEL® POWDER Absorbable Hemostatic Powder (PMA supplement)

Supplement type: 30-Day Notice. Product code: LMG. Advisory committee: SU. Decision: OK30

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Sep 24, 2025device pma330d agoABBOTT MEDICAL — AVEIR Patient Transmitter (model, LSRM01), AVEIR Patient Transmitter Software (model, LSRM1000 v 1.0), AVEIR Patient T (PMA supplement)

Supplement type: Normal 180 Day Track. Product code: OSR. Advisory committee: CV. Decision: APPR

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Sep 24, 2025device pma330d agoAbbott Molecular, Inc. — Alinity m HR HPV (PMA supplement)

Supplement type: Real-Time Process. Product code: MAQ. Advisory committee: MI. Decision: APPR

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Sep 24, 2025device recall330d agoAesculap Inc device recall (Cls II)

Brand Name: Aesculap Product Name: SEALING UNIT F/10/12MM TROCARS W.REDUCER Model/Catalog Number: EK083P Software Version: N/A Product Description: SEALING UNIT F/10/12MM TROCARS W.REDUCER Component: N/A — Reason: It was determined there is the potential of silicone fragments detaching from the yellow sealing component. — Status: Ongoing

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Sep 24, 2025device recall330d agoAesculap Inc device recall (Cls II)

Brand Name: AESCULAP Product Name: REDUCING CONVERTER 10/12MM TO 5MM Model/Catalog Number: EK087P Software Version: N/A Product Description: REDUCING CONVERTER 10/12MM TO 5MM Component: N/A — Reason: It was determined there is the potential of silicone fragments detaching from the yellow sealing component. — Status: Ongoing

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Sep 24, 2025device recall330d agoAesculap Inc device recall (Cls II)

Brand Name: Aesculap Product Name: SEALING CAP FOR 10/12MM TROCARS Model/Catalog Number: EK085P Software Version: N/A Product Description: SEALING CAP FOR 10/12MM TROCARS Component: N/A — Reason: It was determined there is the potential of silicone fragments detaching from the yellow sealing component. — Status: Ongoing

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Sep 24, 2025device recall330d agoAesculap Inc device recall (Cls II)

Brand Name: AESCULAP Product Name: SEALING UNIT FOR 10/12MM TROCARS Model/Catalog Number: EK086P Software Version: N/A Product Description: SEALING UNIT FOR 10/12MM TROCARS Component: N/A — Reason: It was determined there is the potential of silicone fragments detaching from the yellow sealing component. — Status: Ongoing

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Sep 24, 2025device recall330d agoStryker Sustainability Solutions device recall (Cls II)

HARMONIC FOCUS Shears + Adaptive Tissue Technology, 9 cm Length REF: HAR9F, Reprocessed Device for Single Use, STERILEEO, RX ONLY — Reason: Due to manufacturing issue, reprocessed shears, may become stuck in the "on position" resulting in continuous activation. — Status: Ongoing

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Sep 24, 2025grant330d agoDUKE UNIVERSITY — Innovative data science and geospatial methods to identify environmental driv...Duke University

HL grant. $606,057. PI: Mercedes Aurelia Bravo

Week of Sep 22, 2025