Calendar

Week of Mar 23, 2026

Mar 27, 2026approval144d agoCLADRIBINE — FDA approvalMerck KGaA

Sponsor: HOPEWELL PHARMA. Form: TABLET. Route: ORAL

Mar 27, 2026device 510k144d agoCanon Medical Systems Corporation — Vantage Fortian/Orian 1.5T, MRT-1550, V10.0 with AiCE Reconstruction Processing Unit for MR (510k cleared)

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

full page →fda device 510k ↗

Mar 27, 2026device 510k144d agoButterfly Network, Inc. — Butterfly Gestational Age Tool (510k cleared)Butterfly Network, Inc.

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

full page →fda device 510k ↗

Mar 27, 2026device 510k144d agoSS GLOBAL — CyClean Cord (510k cleared)

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

full page →fda device 510k ↗

Mar 27, 2026device 510k144d agoETHICON, Inc. — STRATAFIX Spiral PRONOVA Unidirectional Knotless Tissue Control Device STRATAFIX Spiral PRONOVA Bidirectional Knotless Tissue Control Device (510k cleared)

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

full page →fda device 510k ↗

Mar 27, 2026device 510k144d agoSamsung Medison Co., Ltd. — EVO Q30 Diagnostic Ultrasound System; EVO Q20 Diagnostic Ultrasound System; EVO Q10 Diagnostic Ultrasound System; EVO XQ30 Diagnostic Ultrasound System; EVO XQ20 Diagnostic Ultrasound System; EVO XQ10 Diagnostic Ultrasound System; EVO QH30 Diagnostic Ultrasound System; EVO QH20 Diagnostic Ultrasound System; EVO QH10 Diagnostic Ultrasound System (510k cleared)

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

full page →fda device 510k ↗

Mar 27, 2026device 510k144d agoPhilips Ultrasound, LLC — EPIQ Series Diagnostic Ultrasound System, Affiniti Series Diagnostic Ultrasound System (510k cleared)

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

full page →fda device 510k ↗

Mar 27, 2026device 510k144d agoVy Spine, LLC — VyPlate Anterior Cervical Plate System (510k cleared)

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

full page →fda device 510k ↗

Mar 27, 2026device 510k144d agoFoshan Dahao Medical Technology Co., Ltd. — Electric wheelchair (510k cleared)NewBay Medical Technology Co Ltd

Product code: ITI. Advisory committee: Physical Medicine. Type: Traditional

full page →fda device 510k ↗

Mar 27, 2026device 510k144d agoMedcad — MedCAD® AccuStride System (510k cleared)

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

full page →fda device 510k ↗

Mar 27, 2026device 510k144d agoStreck, LLC — MDx-Chex for BCP (510k cleared)

Product code: PMN. Advisory committee: Microbiology. Type: Traditional

full page →fda device 510k ↗

Mar 27, 2026device 510k144d agoPhilips Medical Systems Technologies , Ltd. — Spectral CT Verida Family (510k cleared)

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

full page →fda device 510k ↗

Mar 27, 2026device 510k144d agoAmerican Medical Endoscopy, Inc. — Strauss Surgical cystoscope, hysteroscope and accessories Instruments (510k cleared)

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

full page →fda device 510k ↗

Mar 27, 2026device 510k144d agoEsaote, S.p.A. — S-scan Open (100001800) (510k cleared)

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

full page →fda device 510k ↗

Mar 27, 2026device 510k144d agoAneuvo — ExaStim® Stimulation System (EXA-001); ExaStim® Stimulation System (EXA-011); ReCure® Electrode Pad (PAD-003); ReCure® Electrode Pad (PAD-013) (510k cleared)

Product code: SDO. Advisory committee: Physical Medicine. Type: Traditional

full page →fda device 510k ↗

Mar 27, 2026device 510k144d agoIcu Medical, Inc. — OTTO Disinfecting Cap (510k cleared)ICU MEDICAL INC/DE

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

full page →fda device 510k ↗

Mar 27, 2026device 510k144d agoBoston Scientific Corporation — Asurys Fluid Management System (510k cleared)BOSTON SCIENTIFIC CORP

Product code: HIG. Advisory committee: Obstetrics/Gynecology. Type: Traditional

full page →fda device 510k ↗

Mar 27, 2026device 510k144d agoSurgical Fusion Technologies GmbH — SF Push-in Anchor (510k cleared)

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

full page →fda device 510k ↗

Mar 27, 2026device 510k144d agoTerumo Corporation — Ryurei (510k cleared)

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

full page →fda device 510k ↗

Mar 27, 2026device 510k144d agoGE Medical Systems Ultrasound & Primary Care Diagnostics, LLC — Automated Aortic Stenosis Software (AutoAS) (510k cleared)

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

full page →fda device 510k ↗

Mar 27, 2026device 510k144d agoArtiness S.R.L — ARTICOR planner (510k cleared)

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

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Mar 27, 2026device 510k144d agoSynergy Spine Solutions, Inc. — Synergy Disc Instruments (510k cleared)

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

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Mar 27, 2026device 510k144d agoMim Software, Inc. — Contour ProtégéAI+ (510k cleared)ASURE SOFTWARE INC

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

full page →fda device 510k ↗

Mar 27, 2026device 510k144d agoNingbo Zhishan Medical Technology Co., Ltd. — Power wheelchair (ZS-EW8026) (510k cleared)NewBay Medical Technology Co Ltd

Product code: ITI. Advisory committee: Physical Medicine. Type: Traditional

full page →fda device 510k ↗

Mar 27, 2026device 510k144d agoYurob Rehabilitation Medical Co., Ltd. — Electrically Powered Wheelchair (Model YC-01) (510k cleared)

Product code: ITI. Advisory committee: Physical Medicine. Type: Traditional

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Mar 27, 2026device 510k144d agoMedos International SARL — SYMPHONY Navigation Ready Instruments (510k cleared)

Product code: OLO. Advisory committee: Neurology. Type: Traditional

full page →fda device 510k ↗

Mar 27, 2026device 510k144d agoAventix Medical, Inc. — AVENTIX PFX System (PFX01); NOVOCLEAR Device (CLR001) (510k cleared)AVITA Medical, Inc.

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

full page →fda device 510k ↗

Mar 27, 2026device 510k144d agoZhuhai Fitlens Medical Technology Co., Ltd. — GPA (hexafocon A) Rigid Gas Permeable Contact Lenses (510k cleared)

Product code: HQD. Advisory committee: Ophthalmic. Type: Traditional

full page →fda device 510k ↗

Mar 27, 2026device 510k144d agoLincotek Medical — SportLinc Syndesmosis Device (510k cleared)

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

full page →fda device 510k ↗

Mar 27, 2026device pma144d agoEBR Systems, Inc. — WiSE® (Wireless Stimulation of the Endocardium Technology) CRT System (PMA supplement)EBR Systems, Inc.

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

full page →fda device pma ↗

Mar 27, 2026device pma144d agoMedtronic, Inc. — Medtronic CoreValve EnVeo PRO Delivery Catheter System; Medtronic Evolut PRO+ Delivery Catheter System; Medtronic Evolut (PMA supplement)Medtronic plc

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

full page →fda device pma ↗

Mar 27, 2026device pma144d agoMedtronic, Inc. — Adapta, Versa, Sensia IPG (ADDR01, ADDR03, ADDRS1, SED01, SEDR01, SES01, VEDR01); Adapta, Versa, Sensia IPG (SEDRL1); Ad (PMA supplement)Medtronic plc

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

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Mar 27, 2026device pma144d agoBiotronik, Inc. — Pulse Generator, Permanent Implantable Edora 8 DR-T Evity 8 DR-T Enitra 8 DR-T Enticos 8 DR-T Evity 6 DR-T Enitra 6 DR-T (PMA supplement)

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

full page →fda device pma ↗

Mar 27, 2026device pma144d agoDepuy, Inc. — LCS® Total Knee System (PMA supplement)

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

full page →fda device pma ↗

Mar 27, 2026device pma144d agoMedtronic Cardiac Rhythm Disease Management — Cobalt MRI ICD; Cobalt XT MRI ICD; Crome MRI ICD (PMA supplement)

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

full page →fda device pma ↗

Mar 27, 2026device pma144d agoMedtronic, Inc. — Percepta Bipolar CRT-P; Percepta Quadripolar CRT-P; Serena Bipolar CRT-P; Serena Quadripolar CRT-P; Solara Bipolar CRT-P (PMA supplement)Medtronic plc

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

full page →fda device pma ↗

Mar 27, 2026device pma144d agoBoston Scientific Corporation — Axonics Sacral Neuromodulation System (PMA supplement)BOSTON SCIENTIFIC CORP

Supplement type: Normal 180 Day Track. Product code: EZW. Advisory committee: GU. Decision: APPR

full page →fda device pma ↗

Mar 27, 2026device pma144d agoABBOTT MEDICAL — Avant (CDVRA700Q, CDDRA700Q, CDVRA700T, CDDRA700T); Neutrino NxT (CDVRA800Q, CDVRA600Q CDDRA800Q, CDDRA600Q CDVRA600T, C (PMA supplement)

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

full page →fda device pma ↗

Mar 27, 2026device pma144d agoCardiva Medical, Inc. — VASCADE MVP XL VVCS Model 800-1014XL (PMA supplement)Picard Medical, Inc.

Supplement type: Panel Track. Product code: MGB. Advisory committee: CV. Decision: APPR

full page →fda device pma ↗

Mar 27, 2026device pma144d agoMedtronic Cardiac Rhythm Disease Management — Cobalt MRI CRT-D; Cobalt XT MRI CRT-D; Crome MRI CRT-D (PMA supplement)

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

full page →fda device pma ↗

Mar 27, 2026device pma144d agoBoston Scientific Corporation — Axonics Sacral Neuromodulation System (PMA supplement)BOSTON SCIENTIFIC CORP

Supplement type: Normal 180 Day Track. Product code: QON. Advisory committee: GU. Decision: APPR

full page →fda device pma ↗

Mar 27, 2026device pma144d agoMedtronic, Inc. — Astra S DR MRI IPG; Astra S SR MRI IPG; Astra XT DR MRI IPG; Astra XT SR MRI IPG; Azure S DR MRI IPG; Azure S SR MRI IPG (PMA supplement)Medtronic plc

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

full page →fda device pma ↗

Mar 27, 2026device pma144d agoABBOTT MEDICAL — Avant (CDHFA700Q, CDHFA700B, CDHFA700D, CDHFA700T); Neutrino NxT (CDHFA800Q, CDHFA800B, CDHFA800D, CDHFA800T); Gallant ( (PMA supplement)

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

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Mar 28, 2026device 510k143d agoSanhe Meditech Co., Ltd. — CO2 Laser System (510k cleared)

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

full page →fda device 510k ↗

Mar 28, 2026device 510k143d agoAnumana, Inc. — ECG-AI Pulmonary Hypertension (PH) 12-Lead algorithm (1020) (510k cleared)

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

full page →fda device 510k ↗

Mar 28, 2026grant143d agoRUTGERS THE STATE UNIV OF NJ NEWARK — Neural and Behavioral Correlates of Similarity, Trustworthiness, and Stress i...

DA grant. $81,580. PI: William John Mitchell

full page →nih reporter ↗

Week of Mar 30, 2026

Mar 30, 2026approval141d agoLAMOTRIGINE — FDA approvalTorrent Pharma Inc

Sponsor: TARO PHARM INDS. Form: TABLET. Route: ORAL

full page →fda approvals ↗

Mar 30, 2026approval

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Week of Mar 23, 2026

Week of Mar 30, 2026