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calendar

20,308 catalysts · 4,728 grant · 3,189 8k filing · 3,149 device 510k · 2,804 approval · 2,000 device pma · 2,000 device recall

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2026-08-10: 0 catalysts2026-08-11: 0 catalysts2026-08-12: 0 catalysts2026-08-13: 19 catalysts2026-08-14: 4 catalysts2026-08-15: 0 catalysts2026-08-16: 0 catalysts2026-08-17: 1 catalyst2026-08-18: 2 catalysts2026-08-19: 3 catalysts2026-08-20: 0 catalysts2026-08-21: 0 catalysts2026-08-22: 0 catalysts2026-08-23: 0 catalysts2026-08-24: 0 catalysts2026-08-25: 0 catalysts2026-08-26: 1 catalyst2026-08-27: 1 catalyst2026-08-28: 0 catalysts2026-08-29: 0 catalysts2026-08-30: 0 catalysts2026-08-31: 0 catalysts2026-09-01: 1 catalyst2026-09-02: 0 catalysts2026-09-03: 1 catalyst2026-09-04: 0 catalysts2026-09-05: 0 catalysts2026-09-06: 0 catalysts2026-09-07: 0 catalysts2026-09-08: 0 catalysts2026-09-09: 0 catalysts2026-09-10: 0 catalysts2026-09-11: 0 catalysts2026-09-12: 0 catalysts2026-09-13: 0 catalysts2026-09-14: 0 catalysts2026-09-15: 0 catalysts2026-09-16: 0 catalysts2026-09-17: 0 catalysts2026-09-18: 0 catalysts2026-09-19: 0 catalysts2026-09-20: 0 catalysts2026-09-21: 0 catalysts2026-09-22: 0 catalysts2026-09-23: 2 catalysts2026-09-24: 0 catalysts2026-09-25: 0 catalysts2026-09-26: 0 catalysts2026-09-27: 0 catalysts2026-09-28: 0 catalysts2026-09-29: 0 catalysts2026-09-30: 0 catalysts2026-10-01: 0 catalysts2026-10-02: 0 catalysts2026-10-03: 0 catalysts2026-10-04: 0 catalysts2026-10-05: 0 catalysts2026-10-06: 0 catalysts2026-10-07: 0 catalysts2026-10-08: 2 catalysts2026-10-09: 0 catalysts2026-10-10: 0 catalysts2026-10-11: 0 catalysts2026-10-12: 0 catalysts2026-10-13: 1 catalyst2026-10-14: 1 catalyst2026-10-15: 0 catalysts2026-10-16: 0 catalysts2026-10-17: 0 catalysts2026-10-18: 0 catalysts2026-10-19: 1 catalyst2026-10-20: 2 catalysts2026-10-21: 2 catalysts2026-10-22: 2 catalysts2026-10-23: 1 catalyst2026-10-24: 0 catalysts2026-10-25: 0 catalysts2026-10-26: 1 catalyst2026-10-27: 8 catalysts2026-10-28: 12 catalysts2026-10-29: 21 catalysts2026-10-30: 4 catalysts2026-10-31: 0 catalysts2026-11-01: 0 catalysts2026-11-02: 9 catalysts2026-11-03: 18 catalysts2026-11-04: 22 catalysts2026-11-05: 37 catalysts2026-11-06: 2 catalysts2026-11-07: 0 catalysts2026-11-08: 0 catalysts
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  • grant4,728
  • 8k filing3,189
  • device 510k3,149
  • approval2,804
  • device pma2,000
  • device recall2,000
device adverse event
1,000
  • recall773
  • earnings584
  • phase 2 completion172
  • therapy area
    • Oncology148
    • Infectious Disease46
    • Cardiology37
    • Immunology35
    • Dermatology31
    • Pulmonology22
    • Women's Health19
    • Ophthalmology16
    • Pain15

    Week of Jun 9, 2025

    9
    ›Jun 13, 2025device 510k426d agoMedacta International S.A. — Mfinity Femoral System (510k cleared)Stemedica International S.A.

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

    full page →fda device 510k ↗
    ›Jun 13, 2025device 510k426d agoInquis Medical — Aventus Thrombectomy System (510k cleared)

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

    full page →fda device 510k ↗
    ›Jun 13, 2025device 510k426d agoFujifilm Corporation — FUJIFILM Endoscope Model EB-710P; FUJIFILM Processor EP-8000 (510k cleared)Fujifilm Holdings Corp

    Product code: EOQ. Advisory committee: Ear, Nose, Throat. Type: Traditional

    full page →fda device 510k ↗
    ›Jun 13, 2025device 510k426d agoFresenius Medical Care Renal Therapies Group, LLC — 2008T HD SYS. CDX BLUESTAR (191124); 2008T HD SYS. CDX W/bibag BLUESTAR (191126); 2008T HD SYS. W/O CDX BLUESTAR (191128); 2008T HD SYS. W/O CDX W/bibag BLUESTAR (191130) (510k cleared)Fresenius Medical Care AG

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

    full page →fda device 510k ↗
    ›Jun 13, 2025device 510k426d agoInomed Medizintechnik GmbH — ALM Tube I.D. 6.0, O.D. 8.2 (520843), ALM Tube I.D. 7.0, O.D. 9.7 (520845), ALM Tube I.D. 7.5, O.D. 10.3 (520846), ALM Tube I.D. 8.0, O.D. 11.0 (520847) (510k cleared)

    Product code: ETN. Advisory committee: Ear, Nose, Throat. Type: Traditional

    full page →fda device 510k ↗
    ›Jun 13, 2025device 510k426d agoRivanna Medical, Inc. — Accuro® 3S Needle Guide Kit (510k cleared)Vivani Medical, Inc.

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

    full page →fda device 510k ↗
    ›Jun 15, 2025device 510k424d agoBestway Plastic and Metal Products , Ltd. — IPL Hair Removal Device (BHRL-01, BHRL-02, BHRL-03, BHRL-04, BHRL-05, BHRL-06, BHRL-06B, BHRL-07, BHRL-08, BHRL-09, BHRL-10, BHRL-11, BHRL-12, BHRL-13, BHRL-14, BHRL-15, BHRL-16, BHRL-17, BHRL-18, BHRL-19, BHRL-20, BHRL-21, BHRL-22, BHRL-23, BHRL-24, BHRL-25, BHRL-26, BHRL-27, BHRL-28, BHRL-29) (510k cleared)

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

    full page →fda device 510k ↗
    ›Jun 15, 2025device 510k424d agoWithings — Withings ECG App (510k cleared)

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

    full page →fda device 510k ↗
    ›Jun 15, 2025device 510k424d agoBioptimal International Pte. , Ltd. — Bioptimal Bipolar Pacing Catheter (510k cleared)

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

    full page →fda device 510k ↗

    Week of Jun 16, 2025

    41
    ›Jun 16, 2025approval423d agoARYNTA (LISDEXAMFETAMINE DIMESYLATE) — FDA approvalLISDEXAMFETAMINE DIMESYLATE

    Sponsor: AZURITY. Form: SOLUTION. Route: ORAL

    full page →LISDEXAMFETAMINE DIMESYLATE →fda approvals ↗
    ›Jun 16, 2025device pma
    ← prev
    page 17 of 407
    next →
    423d ago
    Beckman Coulter, Inc. — Access Hybritech p2PSA (PMA supplement)

    Supplement type: Normal 180 Day Track. Product code: OYA. Advisory committee: IM. Decision: APPR

    full page →fda device pma ↗
    ›Jun 16, 2025device pma423d agoVentana Medical Systems, Inc. — VENTANA HER2 DualL ISH DNA Probe Cocktail (PMA supplement)MERIT MEDICAL SYSTEMS INC

    Supplement type: 30-Day Notice. Product code: NYQ. Advisory committee: PA. Decision: OK30

    full page →fda device pma ↗
    ›Jun 16, 2025device pma423d agoMerz North America, Inc. — RADIESSE® Injectable Implant (PMA supplement)

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

    full page →fda device pma ↗
    ›Jun 16, 2025device pma423d agoMerz North America, Inc. — RADIESSE® Injectable Implant, RADIESSE® Hands, RADIESSE® (+) Lidocaine, RADIESSE® (+) Jawline (PMA supplement)Sustained Therapeutics Inc

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

    full page →fda device pma ↗
    ›Jun 16, 2025device pma423d agoMerz North America, Inc. — COAPTITE® (PMA supplement)

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

    full page →fda device pma ↗
    ›Jun 16, 2025device 510k423d agoExpanding Innovations, Inc. — X-PAC® TLIF Expandable Posterior Cage System; X-PAC® LLIF Expandable Lateral Cage System (510k cleared)

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

    full page →fda device 510k ↗
    ›Jun 16, 2025device 510k423d agoSiemens Healthcare GmbH — MAGNETOM Avanto Fit; MAGNETOM Skyra Fit; MAGNETOM Sola Fit; MAGNETOM Viato.Mobile (510k cleared)

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

    full page →fda device 510k ↗
    ›Jun 16, 2025device 510k423d agoBeckman Coulter, Inc. — Access hsTnI (510k cleared)

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

    full page →fda device 510k ↗
    ›Jun 16, 2025device 510k423d agoGuangdong Ecan Medical Co., Ltd. — Silicone Urethral Catheter (Silicone Urethral Catheter) (510k cleared)

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

    full page →fda device 510k ↗
    ›Jun 16, 2025device 510k423d agoNavier Medical — Mosaic (V1.0.1) (510k cleared)

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

    full page →fda device 510k ↗
    ›Jun 16, 2025device 510k423d agoSiemens Shenzhen Magnetic Resonance , Ltd. — MAGNETOM Flow.Ace; MAGNETOM Flow.Plus (510k cleared)

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

    full page →fda device 510k ↗
    ›Jun 16, 2025device 510k423d agoGeomedi Co,., Ltd. — Geo Abutment (510k cleared)

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

    full page →fda device 510k ↗
    ›Jun 16, 2025device 510k423d agoMethinks Software, S.L — Methinks NCCT Stroke (510k cleared)

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

    full page →fda device 510k ↗
    ›Jun 16, 2025device 510k423d agoEvoEndo, Inc. — EvoEndo Single-Use Endoscopy System (510k cleared)

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

    full page →fda device 510k ↗
    ›Jun 16, 2025device 510k423d agoBecton, Dickinson and Company — BD Veritor System for SARS-CoV-2 (510k cleared)BECTON DICKINSON & CO

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

    full page →fda device 510k ↗
    ›Jun 17, 2025approval422d agoXARELTO (RIVAROXABAN) — FDA approvalJanssen Therapeutics

    Sponsor: JANSSEN PHARMS. Form: TABLET. Route: ORAL

    full page →fda approvals ↗
    ›Jun 17, 2025approval422d agoXARELTO (RIVAROXABAN) — FDA approvalJanssen Therapeutics

    Sponsor: JANSSEN PHARMS. Form: FOR SUSPENSION. Route: ORAL

    full page →fda approvals ↗
    ›Jun 17, 2025approval422d agoMEFENAMIC ACID — FDA approvalMEFENAMIC ACID

    Sponsor: MICRO LABS. Form: CAPSULE. Route: ORAL

    full page →MEFENAMIC ACID →fda approvals ↗
    ›Jun 17, 2025approval422d agoTREMFYA (GUSELKUMAB) — FDA approvalguselkumab

    Sponsor: JANSSEN BIOTECH. Form: INJECTABLE. Route: INJECTION

    full page →guselkumab →fda approvals ↗
    ›Jun 17, 2025device pma422d agoMedtronic, Inc. — Astra S DR MRI IPG, X3DR01; Astra S SR MRI IPG, X3SR01; Astra XT DR MRI IPG, X1DR01; Astra XT SR MRI IPG, X1SR01; Azure (PMA supplement)Medtronic plc

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

    full page →fda device pma ↗
    ›Jun 17, 2025device pma422d agoABBOTT MEDICAL — Microny family of Pacemakers (PMA supplement)

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

    full page →fda device pma ↗
    ›Jun 17, 2025device pma422d agoMedtronic, Inc. — CareLink SmartSync Device Manager Base, 24970A (PMA supplement)Medtronic plc

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

    full page →fda device pma ↗
    ›Jun 17, 2025device pma422d agoABBOTT MEDICAL — Aveir Leadless System (PMA supplement)

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

    full page →fda device pma ↗
    ›Jun 17, 2025device pma422d agoCooperVision, Inc. — MiSight 1 Day (omafilcon A) Soft (Hydrophilic) Contact Lenses for Daily Wear (PMA supplement)

    Supplement type: 30-Day Notice. Product code: QIT. Advisory committee: OP. Decision: OK30

    full page →fda device pma ↗
    ›Jun 17, 2025device pma422d agoAtriCure, Inc. — Synergy Ablation System (PMA supplement)AtriCure, Inc.

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

    full page →fda device pma ↗
    ›Jun 17, 2025device pma422d agoMedtronic, Inc. — Percepta Bipolar CRT- P, WlTR0l; Percepta Quadripolar CRT-P, W4TR01; Serena Bipolar CRT-P, W1TR02; Serena Quadripolar CR (PMA supplement)Medtronic plc

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

    full page →fda device pma ↗
    ›Jun 17, 2025device pma422d agoABBOTT MEDICAL — Promote/+/RF/Q, Promote Accel, Promote Quadra, Unify, Unify Assura, Unify Quadra, Quadra Assura, Epic+/HF/HF+/II HF/II+ (PMA supplement)

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

    full page →fda device pma ↗
    ›Jun 17, 2025device pma422d agoABBOTT MEDICAL — Anthem, Allure/RF, Allure Quadra/RF family of CRT-Ps (PMA supplement)

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

    full page →fda device pma ↗
    ›Jun 17, 2025device pma422d agoABBOTT MEDICAL — Assurity, Assurity+, Endurity, Accent family of Pacemakers (PMA supplement)

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

    full page →fda device pma ↗
    ›Jun 17, 2025device pma422d agoNeuspera Medical, Inc. — Neuspera Sacral Neuromodulation System (PMA)

    Product code: EZW. Advisory committee: GU. Decision: APPR

    full page →fda device pma ↗
    ›Jun 17, 2025device pma422d agoABBOTT MEDICAL — Current, Current Accel, Current+, Ellipse, Fortify, Fortify Assura, Epic/Epic+, Atlas/II/+ family of ICDs (PMA supplement)

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

    full page →fda device pma ↗
    ›Jun 17, 2025device pma422d agoABBOTT MEDICAL — Assurity MRI, Endurity MRI family of Pacemakers (PMA supplement)

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

    full page →fda device pma ↗
    ›Jun 17, 2025device pma422d agoAtriCure, Inc. — EPi-Sense Guided Coagulation System (PMA supplement)AtriCure, Inc.

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

    full page →fda device pma ↗
    ›Jun 17, 2025device pma422d agoCooperVision, Inc. — MiSight 1 Day (omafilcon A) (PMA supplement)

    Supplement type: 30-Day Notice. Product code: QIT. Advisory committee: OP. Decision: OK30

    full page →fda device pma ↗
    ›Jun 17, 2025device 510k422d agoFziomed, Inc. — Oxiplex® (510k cleared)

    Product code: QVL. Advisory committee: Orthopedic. Type: Direct

    full page →fda device 510k ↗
    ›Jun 17, 2025device 510k422d agoNano-Ditech Corporation — Nano-Check Influenza+COVID-19 Dual Test (510k cleared)

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

    full page →fda device 510k ↗
    ›Jun 17, 2025device 510k422d agoKl-Kepong Rubber Products Sdn. Bhd. — Nitrile Powder Free Examination Gloves with Low Dermatitis Potential, Tested for Use with Chemotherapy Drugs, Fentanyl Citrate and Gastric Acid (510k cleared)Teva Pharmaceuticals USA Inc

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

    full page →fda device 510k ↗
    ›Jun 17, 2025device 510k422d agoVitalSigns Technology Co., Ltd. — VitalSigns 1-Lead Holter (VSH101) (510k cleared)Viomi Technology Co., Ltd

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

    full page →fda device 510k ↗
    ›Jun 17, 2025device 510k422d agoAnika Therapeutics, Inc. — Integrity™ Implant (510k cleared)Anika Therapeutics, Inc.

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

    full page →fda device 510k ↗
    ›Jun 17, 2025device 510k422d agoBridge TO Life — EasiSlush® Sodium Chloride Solution for Sterile Slush Preparation (BTLE-1250) (510k cleared)Revalesio Corp

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

    full page →fda device 510k ↗
    $FMS23.72-0.63%
    $VANI1.6000+18.52%
    $ANIK
    $MDT90.76+0.09%
    $BDX183.58+1.20%
    $MDT90.76+0.09%
    $ATRC
    $MMSI91.20+0.10%
    $VIOT
    $MDT90.76+0.09%
    $ATRC