Calendar

pharmadog

Week of Mar 2, 2026

Mar 5, 2026device 510k163d agoIvoclar Vivadent, Inc. — Adhese 2 (510k cleared)

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

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Mar 5, 2026device 510k163d agoArthrex, Inc. — Arthrex FibuLock Nail System (510k cleared)

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

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Mar 5, 2026device 510k163d agoPhilips Medical Systems Nederland B.V. — AV Cardiac CT (510k cleared)

Product code: JAK. Advisory committee: Radiology. Type: Traditional

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Mar 5, 2026device 510k163d agoOrca Dental AI , Ltd. — CEPHX3D (510k cleared)

Product code: QIH. Advisory committee: Radiology. Type: Traditional

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Mar 5, 2026device 510k163d agoJiangsu Yuyue Medical Equipment & Supply Co., Ltd. — YUWELL® Electronic Blood Pressure Monitor (YE630CR) (510k cleared)

Product code: DXN. Advisory committee: Cardiovascular. Type: Traditional

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Mar 5, 2026device 510k163d agoEsaote, S.p.A. — Magnifico Open (100009900) (510k cleared)

Product code: LNH. Advisory committee: Radiology. Type: Traditional

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Mar 5, 2026device pma163d agoBiotronik, Inc. — Acticor Sky VR-T (481989); Rivacor Sky VR-T (481984); Rivacor Rise VR-T (482020); Rivacor Aura VR-T (482015); Acticor Sk (PMA supplement)

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

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Mar 5, 2026device pma163d agoShockwave Medical, Inc. — Shockwave lntravascular Lithotripsy (IVL) System with Shockwave C2 Aero Coronary IVL Catheter (PMA supplement)

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

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Mar 5, 2026device pma163d agoBoston Scientific Corp — ROTAPRO Rotational Atherectomy System (PMA supplement)BOSTON SCIENTIFIC CORP

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

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Mar 5, 2026device pma163d agoBiotronik, Inc. — Edora 8 DR-T (407145); Evity 8 DR-T (407146); Enitra 8 DR-T (407147); Enticos 8 DR-T (407148); Evity 6 DR-T (407149); En (PMA supplement)

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

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Mar 5, 2026device pma163d agoInsightec — Exablate Model 4000 Type 1.0 and 1.1 (Exablate Neuro; Exablate Prime) (PMA supplement)

Supplement type: Real-Time Process. Product code: POH. Advisory committee: NE. Decision: APPR

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Mar 5, 2026device pma163d agoBiotronik, Inc. — Acticor 7 VR-T (429526); Rivacor 7 VR-T (429536); Rivacor 5 VR-T (429565); Rivacor 3 VR-T (429574); Acticor 7 VR-T DX (4 (PMA supplement)

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

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Mar 5, 2026device pma163d agoBiotronik, Inc. — Edora 8 HF-T QP (407137); Edora 8 HF-T (407138); Evity 8 HF-T QP (407139); Evity 8 HF-T (407140); Enitra 8 HF-T QP (4071 (PMA supplement)

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

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Mar 5, 2026device pma163d agoHologic, Inc. — Rapid fFN for the TLiIQ System (PMA supplement)

Supplement type: 30-Day Notice. Product code: LKV. Advisory committee: TX. Decision: OK30

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Mar 5, 2026device pma163d agoHologic, Inc. — Rapid fFN for the TLiIQ System (PMA supplement)

Supplement type: 30-Day Notice. Product code: LKV. Advisory committee: TX. Decision: OK30

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Mar 5, 2026device pma163d agoPhysio-Control, Inc. — LIFEPAK 35 monitor/defibrillator (PMA supplement)

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

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Mar 5, 2026device recall163d agoCook Incorporated device recall (Cls II)

COOK MEDICAL Arterial Pressure Monitoring Tray, Reference Part Number APMY-2.5-15-0-2.5 , Order Number G58412; Reference Part Number APMY-4.0-21J-1-12, Order Number G58419 — Reason: Products from the affected device lots were labeled with expiration dates that exceed the true shelf life. — Status: Ongoing

Week of Mar 2, 2026