Calendar

Week of Mar 30, 2026

Apr 3, 2026device 510k132d agoCeribell, Inc. — Ceribell Brain Monitor Headband (510k cleared)Ceribell, Inc.

Product code: GXY. Advisory committee: Neurology. Type: Abbreviated

Apr 3, 2026device 510k132d agoS.M.A.I.O — KHEIRON® Spinal Fixation System, including patient specific K-ROD (510k cleared)

Product code: NKB. Advisory committee: Orthopedic. Type: Special

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Apr 3, 2026device 510k132d agoMirco-Tech (Nanjing) Co., Ltd. — Single-use Video Scope; PB Digital Controller (510k cleared)

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

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Apr 3, 2026device 510k132d agoHyalex Orthopaedics, Inc. — HYALEX® MTP Hemiarthroplasty Implant (510k cleared)

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

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Apr 3, 2026device 510k132d agoMED-EL Elektromedizinische Geräte GmbH — mGRIP Total Prosthesis (3.00 mm) (58689); mGRIP Total Prosthesis (3.25 mm) (58691); mGRIP Total Prosthesis (3.50 mm) (58693); mGRIP Total Prosthesis (3.75 mm) (58695); mGRIP Total Prosthesis (4.00 mm) (58697); mGRIP Total Prosthesis (4.25 mm) (58699); mGRIP Total Prosthesis (4.50 mm) (58701); mGRIP Total Prosthesis (4.75 mm) (58703); mGRIP Total Prosthesis (5.00 mm) (58705); mGRIP Total Prosthesis (5.50 mm) (58707); mGRIP Total Prosthesis (6.00 mm) (58709); mGRIP Total Prosthesis (6.50 (510k cleared)

Product code: ETA. Advisory committee: Ear, Nose, Throat. Type: Special

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Apr 3, 2026device 510k132d agoAutomated Imaging Diagnostics, LLC — neuropacs (510k cleared)

Product code: SHO. Advisory committee: Neurology. Type: Direct

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Apr 3, 2026device pma132d agoNeuspera Medical, Inc. — Neuspera Sacral Neuromodulation (SNM) System (PMA supplement)

Supplement type: 30-Day Notice. Product code: EZW. Advisory committee: GU. Decision: OK30

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Apr 3, 2026device pma132d agoABBOTT MEDICAL — AVEIR Leadless Pacemaker, ventricular (LSP112V, LSP202V); Aveir Delivery Catheter (LSCD111, LSCD201) (PMA supplement)

Supplement type: Real-Time Process. Product code: PNJ. Advisory committee: CV. Decision: APPR

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Apr 3, 2026device pma132d agoMedtronic Neuromodulation — InterStim Therapy System, Verify Evaluation System (SNS Urinary Implantable Neurostimulators 97800, 97810) (PMA supplement)

Supplement type: 30-Day Notice. Product code: EZW. Advisory committee: GU. Decision: OK30

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Apr 3, 2026device pma132d agoMedtronic, Inc. — Activa Deep Brain Stimulation Therapy System, Percept PC BrainSense (PMA supplement)Medtronic plc

Supplement type: 30-Day Notice. Product code: MHY. Advisory committee: NE. Decision: OK30

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Apr 3, 2026device pma132d agoMedtronic Neuromodulation — Master Intellis , Vanta and Inceptiv Spinal Cord Stimulation Systems (SCS Implantable Neurostimulators 97716, 97715, 9 (PMA supplement)

Supplement type: 30-Day Notice. Product code: LGW. Advisory committee: NE. Decision: OK30

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Apr 3, 2026device pma132d agoMedtronic Neuromodulation — Altaviva (PMA supplement)

Supplement type: 30-Day Notice. Product code: QPT. Advisory committee: GU. Decision: OK30

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Apr 3, 2026device pma132d agoMedtronic Neuromodulation — InterStim Therapy System, Verify Evaluation System (SNS Bowel Implantable Neurostimulators 97800, 97810) (PMA supplement)

Supplement type: 30-Day Notice. Product code: QON. Advisory committee: GU. Decision: OK30

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Apr 3, 2026grant132d agoOHIO STATE UNIVERSITY — A high-throughput, multimodal strategy to improve variant classification

HG grant. $174,430. PI: Megan Lancaster

Week of Mar 30, 2026

Week of Apr 6, 2026