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calendar

20,195 catalysts · 4,728 grant · 3,136 8k filing · 3,102 device 510k · 2,791 approval · 2,000 device pma · 2,000 device recall

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2026-08-10: 0 catalysts2026-08-11: 0 catalysts2026-08-12: 29 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 filing3,136
  • device 510k3,102
  • approval2,791
  • device pma2,000
  • device recall2,000
  • device adverse event1,000
  • recall773
  • earnings584
  • phase 2 completion172
  • therapy area
    • Oncology148
    • Infectious Disease46
    • Cardiology37
    • Immunology35
    • Dermatology31
    • Pulmonology22
    • Women's Health19
    • Ophthalmology16
    • Pain15

    Week of May 26, 2025

    50
    ›May 28, 2025device pma441d agoVistakon, Division of Johnson & Johnson Vision Car — VISTAKON® (senofilcon A) Brand Contact Lenses (PMA supplement)JOHNSON & JOHNSON

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

    full page →fda device pma ↗
    ›May 28, 2025device pma441d agoCerenovus, Inc. — TRUFILL n-BCA Liquid Embolic System (LES) and Procedural Set (PMA supplement)

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

    full page →fda device pma ↗
    ›May 28, 2025device pma441d agoFerring Pharmaceuticals, Inc. — EUFLEXXA (1% SODIUM HYALURONATE) (PMA supplement)Ferring Pharmaceuticals Inc

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

    full page →fda device pma ↗
    ›May 28, 2025device pma441d agoColoplast Corp. — Titan Inflatable Penile Prosthesis (PMA supplement)

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

    full page →fda device pma ↗
    ›May 28, 2025device pma441d agoMedtronic Cardiac Rhythm Disease Management — Cobalt MRI CRT-D DTPB2D1, DTPB2D4, DTPB2Q1, DTPB2QQ; Cobalt XT MRI CRT-D DTPA2D1, DTPA2D4, DTPA2Q1, DTPA2QQ; Crome MRI C (PMA supplement)

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

    full page →fda device pma ↗
    ›May 28, 2025device pma441d agoMedtronic Cardiac Rhythm Disease Management — Cobalt MRI ICD DVPB3D1, DVPB3D4; Cobalt MRI ICD DDPB3D1, DDPB3D4; Cobalt XT MRI ICD DDPA2D1, DVPA2D1; Cobalt XT MRI ICD (PMA supplement)

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

    full page →fda device pma ↗
    ›May 28, 2025device pma441d agoBoston Scientific Corp — AMS 800™ Artificial Urinary Sphincter (AUS) (PMA supplement)BOSTON SCIENTIFIC CORP

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

    full page →fda device pma ↗
    ›May 28, 2025device pma441d agoCordis US Corporation — S.M.A.R.T. AND S.M.A.R.T. CONTROL NITINOL STENT SYSTEM (PMA supplement)

    Supplement type: Special (Immediate Track). Product code: NIO. Advisory committee: CV. Decision: APPR

    full page →fda device pma ↗
    ›May 28, 2025device pma441d agoIrvine Biomedical, Inc. — IBI THERAPY COOL PATH ABLATION CATHETER & IBI-1500T9 RF (PMA supplement)RNR BioMedical Inc

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

    full page →fda device pma ↗
    ›May 28, 2025device pma441d 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

    full page →fda device pma ↗
    ›May 28, 2025device 510k441d agoResmed Corp — myAir (510k cleared)RESMED INC

    Product code: BZD. Advisory committee: Anesthesiology. Type: Traditional

    full page →fda device 510k ↗
    ›May 28, 2025device 510k441d agoLivermoretech, Inc. — Europa (Alternative: AiRTouch) portable X-ray system (510k cleared)

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

    full page →fda device 510k ↗
    ›May 28, 2025device 510k441d agoPacific Care Limited — Disposable Prophy Angle (510k cleared)

    Product code: EGS. Advisory committee: Dental. Type: Abbreviated

    full page →fda device 510k ↗
    ›May 28, 2025device 510k441d agoShenzhen Insighters Medical Technology Co., Ltd. — Insighters™ Single-use Bronchoscope/Insight Bimodel-Integral iS-B12A 4.6/2.0; Insighters™ Single-use Bronchoscope/Insight Bimodel-Integral iS-B22A 5.5 /2.6; Insighters™ Single-use Bronchoscope/Insight Bimodel-Integral iS-B26A 6.0/3.0; Insighters™ Insight Workstation iS-PF1. (510k cleared)

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

    full page →fda device 510k ↗
    ›May 28, 2025device 510k441d agoImperative Care, Inc. — Zoom 7X Catheter; Zoom Aspiration Tubing; Zoom POD Aspiration Tubing (510k cleared)

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

    full page →fda device 510k ↗
    ›May 28, 2025device 510k441d agoTermosalud S.L. — Zionic Pro Max (Radiofrequency) (510k cleared)

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

    full page →fda device 510k ↗
    ›May 28, 2025device 510k441d agoBoston Scientific Corporation — OptiMap™ System (510k cleared)BOSTON SCIENTIFIC CORP

    Product code: DQK. Advisory committee: Cardiovascular. Type: Special

    full page →fda device 510k ↗
    ›May 28, 2025device 510k441d agoTaiwan Medical Imaging Co., Ltd. — TAIMedImg DeepMets (510k cleared)

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

    full page →fda device 510k ↗
    ›May 28, 2025device 510k441d agoSurGenTec, LLC — OsteoFlo HydroFiber (510k cleared)

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

    full page →fda device 510k ↗
    ›May 28, 2025device 510k441d agoOpcom Medical, Inc. — Flexible Ureteroscope (U-Scope)(2.8/1.2) (OMI161-2F28-CH12-US); Flexible Ureteroscope (U-Scope)(2.5/1.2) (OMI161-2F25-CH12-US); Images Systems (Camera-Controlled Unit) (OMI01M12) (510k cleared)

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

    full page →fda device 510k ↗
    ›May 28, 2025device 510k441d agoIradimed Corporation — MRidium 3870 MRI Infusion Pump System (3870) (510k cleared)IRADIMED CORP

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

    full page →fda device 510k ↗
    ›May 28, 2025device 510k441d agoIschemaview, Inc. — Rapid MLS (510k cleared)

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

    full page →fda device 510k ↗
    ›May 28, 2025device 510k441d agoSmart Soft Healthcare AD — CoLumboX (510k cleared)

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

    full page →fda device 510k ↗
    ›May 29, 2025approval440d agoFOCINVEZ (FOSAPREPITANT DIMEGLUMINE) — FDA approvalAthenex Inc (Inactive)

    Sponsor: STERISCIENCE. Form: SOLUTION. Route: INTRAVENOUS

    full page →fda approvals ↗
    ›May 29, 2025approval440d agoMETHOTREXATE — FDA approvalMaxtrex

    Sponsor: ACCORD HLTHCARE. Form: SOLUTION. Route: INTRAVENOUS

    full page →Maxtrex →fda approvals ↗
    ›May 29, 2025device pma440d agoPremia Spine, Ltd. — TOPS™ System (PMA supplement)

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

    full page →fda device pma ↗
    ›May 29, 2025device pma440d agoNuvasive, Inc. — Simplify® Cervical Artificial Disc (PMA supplement)

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

    full page →fda device pma ↗
    ›May 29, 2025device pma440d agoMedtronic Vascular, Inc. — IN.PACT AV Paclitaxel-Coated Percutaneous Transluminal Angioplasty (PTA) Balloon Catheter (PMA supplement)DFB Soria LLC

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

    full page →fda device pma ↗
    ›May 29, 2025device pma440d agoMedtronic, Inc. — IN.PACT Admiral Paclitaxel-Coated Percutaneous Transluminal Angioplasty (PTA) Balloon Catheter; IN.PACT 018 Paclitaxel-C (PMA supplement)Medtronic plc

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

    full page →fda device pma ↗
    ›May 29, 2025device pma440d agoPramand, LLC — CraniSeal Dural Sealant (PMA supplement)

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

    full page →fda device pma ↗
    ›May 29, 2025device pma440d agoOrbusNeich Medical (Shenzhen) Co., Ltd. — Scoreflex NC Scoring PTCA Catheter (PMA supplement)

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

    full page →fda device pma ↗
    ›May 29, 2025device pma440d agoJohnson & Johnson Surgical Vision, Inc. — Intraocular Lenses (IOLs) in the DaisyWheel and TECNIS SIMPLICITY Delivery System (PMA supplement)JOHNSON & JOHNSON

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

    full page →fda device pma ↗
    ›May 29, 2025device pma440d agoBoston Scientific Corp — VERCISE DEEP BRAIN STIMULATION (DBS)SYSTEM (PMA supplement)BOSTON SCIENTIFIC CORP

    Supplement type: Special (Immediate Track). Product code: NHL. Advisory committee: NE. Decision: APPR

    full page →fda device pma ↗
    ›May 29, 2025device 510k440d agoShenzhen Astec Technology Co., Ltd. — TENS AND EMS (TENS and Muscle Stimulator) ( Model AS8012C,AS8016,AS8019,AS9020E,AS9026) (510k cleared)Fortior Technology (Shenzhen) Co., Ltd./ADR

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

    full page →fda device 510k ↗
    ›May 29, 2025device 510k440d agoBaylis Medical Company, Inc. — VersaCross Connect™ Transseptal Dilator (510k cleared)

    Product code: DRE. Advisory committee: Cardiovascular. Type: Special

    full page →fda device 510k ↗
    ›May 29, 2025device 510k440d agoReflow Medical, Inc. — Spur Peripheral Retrievable Stent System (510k cleared)

    Product code: SEU. Advisory committee: Cardiovascular. Type: Direct

    full page →fda device 510k ↗
    ›May 29, 2025device 510k440d agoMedtronic Navigation — Visualase V2 MRI-guided Laser Ablation System (9736422) (510k cleared)

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

    full page →fda device 510k ↗
    ›May 29, 2025device 510k440d agoOsteonic Co., Ltd. — SIGNEX (510k cleared)

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

    full page →fda device 510k ↗
    ›May 29, 2025device 510k440d agoTerumo Europe N.V. — 27G x 1/2 TW K-Pack Surshield Needle (KN-S2713RBT) (510k cleared)

    Product code: FMI. Advisory committee: General Hospital. Type: Special

    full page →fda device 510k ↗
    ›May 29, 2025device 510k440d agoShanghai AnQing Medical Instrument Co., Ltd. — Portable Video Processor (EA101), Flexible Bronchoscope BS41H-12EU, BS41H-12US, BS46H-17EU, BS50H-20EU, BS46H-17US, BS50H-20US, BS53H-22EU, BS53H-22US, BS55H-24EU, BS55H-24US, BS59H-28EU, BS59H-28US (510k cleared)

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

    full page →fda device 510k ↗
    ›May 29, 2025device 510k440d agoYueying Medical Instruments (Langfang) Co., Ltd. — Dental Barrier and Sleeves (510k cleared)

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

    full page →fda device 510k ↗
    ›May 29, 2025device 510k440d agoPiccolo Medical, Inc. — PM2+ System and SmartPICC Stylet (510k cleared)Picard Medical, Inc.

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

    full page →fda device 510k ↗
    ›May 29, 2025device 510k440d agoGE Medical Systems Ultrasound and Primary Care Diagnostics — Voluson™ Performance 16; Voluson™ Performance 18 (510k cleared)

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

    full page →fda device 510k ↗
    ›May 29, 2025device 510k440d agoCochlear — Baha 7 Sound Processor; Baha Fitting Software 7 (P2121898); Baha Smart App (iOS) (P1646054); Baha Smart App (Android) (P1646035); Baha SoundBand (510k cleared)

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

    full page →fda device 510k ↗
    ›May 29, 2025device 510k440d agoEpic Medical Pte. , Ltd. — ProSeal™ Bag Spike with Additive Port (423370ST, 423370) (510k cleared)

    Product code: ONB. Advisory committee: General Hospital. Type: Special

    full page →fda device 510k ↗
    ›May 29, 2025device 510k440d agoNeurent Medical , Ltd. — NEUROMARK System (NMK00301) (510k cleared)

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

    full page →fda device 510k ↗
    ›May 29, 2025device 510k440d agoKuraray Noritake Dental, Inc. — CERABIEN MiLai (510k cleared)

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

    full page →fda device 510k ↗
    ›May 29, 2025device 510k440d agoMasimo Corporation — Radius VSM and Accessories (510k cleared)MASIMO CORP

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

    full page →fda device 510k ↗
    ›May 29, 2025device 510k440d agoRemex Medical Corp. — Anatase Spine Surgery Navigation System and Remex Spine Surgery Navigation System II (510k cleared)Medicale Corp.

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

    full page →fda device 510k ↗
    ›May 29, 2025device 510k440d agoGerium Medical, Ltd. — BiliWrap (510k cleared)

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

    full page →fda device 510k ↗
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    $JNJ259.80-0.77%
    $BSX51.19+1.45%
    $RMD220.38+5.13%
    $BSX51.19+1.45%
    $BSX51.19+1.45%
    $MDT90.68+1.42%
    $IRMD
    $JNJ259.80-0.77%
    $FRTRY
    $MASI
    $BSX51.19+1.45%
    $PMI0.1821-4.66%
    $MCLE