Calendar

pharmadog

Week of Jan 12, 2026

Jan 15, 2026device 510k209d agoNano-Ditech Corporation — Nano-Check Influenza A+B Test (510k cleared)

Product code: PSZ. Advisory committee: Microbiology. Type: Dual Track

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Jan 15, 2026device pma209d agoETHICON, Inc. — SURGICEL® Absorbable Hemostats (PMA supplement)

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

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Jan 15, 2026device pma209d agoGuardant Health, Inc. — Guardant360 CDx (PMA supplement)Guardant Health, Inc.

Supplement type: Panel Track. Product code: PQP. Advisory committee: PA. Decision: APPR

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Jan 15, 2026device pma209d agoSt Jude Medical — Livewire TC XLS (PMA supplement)

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

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Jan 15, 2026device pma209d agoCentinel Spine, LLC — prodisc® C (PMA supplement)

Supplement type: 30-Day Notice. Product code: MJO. Advisory committee: OR. Decision: OK30

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Jan 15, 2026device pma209d agoW. L. Gore & Associates, Inc. — GORE® EXCLUDER® Thoracoabdominal Branch Endoprosthesis (PMA supplement)

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

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Jan 15, 2026device pma209d agoABBOTT MEDICAL — FlexAbility and FlexAbility Sensor Enabled (PMA supplement)

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

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Jan 15, 2026device pma209d agoMicroPort CRM USA, Inc. — VEGA Steroid-Eluting Endocardial Leads (VEGA R45, VEGA R52, and VEGA R58) (PMA supplement)

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

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Jan 15, 2026device pma209d 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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Jan 15, 2026device pma209d agoABBOTT MEDICAL — TactiFlex Sensor Enabled (PMA supplement)

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

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Jan 15, 2026device pma209d agoIrvine Biomedical,Inc.(Ibi) — Safire TX Bi-directional and Therapy Dual-8 (PMA supplement)

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

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Jan 15, 2026device pma209d agoSt Jude Medical — TactiCath Sensor Enabled (PMA supplement)

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

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Jan 15, 2026device recall209d agoEncore Medical, LP device recall (Cls II)Encore Medical, Inc.

Brand Name: Reverse Shoulder Prosthesis (RSP) Product Name: RSP HUMERAL SOCKET INSERT, 32MM +4MM, STANDARD HXe-plus Model/Catalog Number: 509-00-432 — Reason: Knee and Humeral socket implants contain incorrect labeling. — Status: Ongoing

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Jan 15, 2026device recall209d agoEncore Medical, LP device recall (Cls II)Encore Medical, Inc.

Brand Name: Reverse Shoulder Prosthesis (RSP) Product Name: RSP STANDARD HUMERAL SOCKET INSERT, 36MM, HXe-plus Model/Catalog Number: 509-00-036 — Reason: Knee and Humeral socket implants contain incorrect labeling. — Status: Ongoing

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Jan 15, 2026device recall209d agoAesculap Inc device recall (Cls II)

Brand Name: AESCULAP Product Name: MINOP TROCAR 150MM 4 WKING CHANNEL6.0MM Model/Catalog Number: FF399R Software Version: N/A Product Description: MINOP TROCAR 150MM 4 WKING CHANNEL6.0MM Component: N/A — Reason: There is the potential for the length of the trocar shaft to be too long. — Status: Ongoing

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Jan 15, 2026device recall209d agoKOB GmbH device recall (Cls II)

MEDLINE UNNA-Z STRETCH ZINC PASTE BANDAGE, REF NONUNNAS40 KOB article #40307010 — Reason: Due to labeling error. Incomplete ingredients listed. Labeling did not include castor oil or calamine. — Status: Ongoing

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Jan 15, 2026device recall209d agoEncore Medical, LP device recall (Cls II)Encore Medical, Inc.

Brand Name: EMPOWR 3D KNEE Product Name: EMPOWR 3D KNEE INS, 7L 16MM, VE Model/Catalog Number: 341-16-707 — Reason: Knee and Humeral socket implants contain incorrect labeling. — Status: Ongoing

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Jan 15, 2026grant209d agoUNIVERSITY OF WISCONSIN MILWAUKEE — Effects of older age on the neural basis of memory generalization

AG grant. $293,454. PI: Caitlin R. Bowman

Week of Jan 12, 2026