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20,252 catalysts · 4,728 grant · 3,163 device 510k · 3,118 8k filing · 2,805 approval · 2,000 device pma · 2,000 device recall

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2026-08-10: 0 catalysts2026-08-11: 89 catalysts2026-08-12: 19 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: 2 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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type
  • grant4,728
  • device 510k3,163
  • 8k filing3,118
  • approval2,805
  • device pma2,000
  • device recall2,000
device adverse event
1,000
  • recall773
  • earnings583
  • phase 2 completion172
  • therapy area
    • Oncology148
    • Infectious Disease46
    • Cardiology37
    • Immunology35
    • Dermatology31
    • Pulmonology22
    • Women's Health19
    • Ophthalmology16
    • Pain15

    Week of May 5, 2025

    33
    ›May 8, 2025device 510k461d agoPreat Corporation — Preat Abutments (510k cleared)

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

    full page →fda device 510k ↗
    ›May 8, 2025device 510k461d agoNextstep Arthropedix — NextStep Arthropedix Total Knee System (510k cleared)

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

    full page →fda device 510k ↗
    ›May 8, 2025device 510k461d agoPhilips Ultrasound — Lumify Diagnostic Ultrasound System (510k cleared)Ocuvex Therapeutics Inc

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

    full page →fda device 510k ↗
    ›May 8, 2025device 510k461d agoTelesair, Inc. — AVEA disposable expiratory filter/water trap (11790) (510k cleared)

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

    full page →fda device 510k ↗
    ›May 8, 2025device 510k461d agoSuntech UK , Ltd. — eFOLDi Navigator Powerchair (STPC-A) (510k cleared)

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

    full page →fda device 510k ↗
    ›May 8, 2025device 510k461d agoSynoross Dba Osseone — OsseOne Dental Implant System (510k cleared)

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

    full page →fda device 510k ↗
    ›May 8, 2025device 510k461d agoFissiontech, LLC — Advanced Anti Snoring Device 4.0 Clear/ Advanced Anti Snoring Device 4.0 Blue (510k cleared)

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

    full page →fda device 510k ↗
    ›May 8, 2025device 510k461d agoClarius Mobile Health Corp. — Clarius Median Nerve AI (510k cleared)

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

    full page →fda device 510k ↗
    ›May 8, 2025device 510k461d agoLeltek, Inc. — Ultrasound Imaging System (LU700 Series); Ultrasound Imaging System (128 Series); Ultrasound Imaging System (LX Series) (510k cleared)

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

    full page →fda device 510k ↗
    ›May 8, 2025device 510k461d agoCG Bio Co., Ltd. — COLONNADE Posterior Screw Fixation System (510k cleared)3H Bio Co Ltd

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

    full page →fda device 510k ↗
    ›May 9, 2025approval460d agoBUTALBITAL, ASPIRIN, CAFFEINE, AND CODEINE PHOSPHATE (ASPIRIN) — FDA approvalNovitium Pharma LLC

    Sponsor: LGM PHARMA. Form: CAPSULE. Route: ORAL

    full page →fda approvals ↗
    ›May 9, 2025device 510k460d agoChangshu Pingfang Wheelchair Co., Ltd. — Electric Wheelchair (F309) (510k cleared)

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

    full page →fda device 510k ↗
    ›May 9, 2025device 510k460d agoPhilips Ultrasound, LLC — EPIQ Series Diagnostic Ultrasound Systems; Affiniti Series Diagnostic Ultrasound Systems (510k cleared)

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

    full page →fda device 510k ↗
    ›May 9, 2025device 510k460d agoBTL Industries, Inc. — BTL-785MJ (510k cleared)NL INDUSTRIES INC

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

    full page →fda device 510k ↗
    ›May 9, 2025device 510k460d agoAltaviz, LLC — Altaviz Intravitreal Syringe (510k cleared)

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

    full page →fda device 510k ↗
    ›May 9, 2025device 510k460d agoVigeon Technology Co., Ltd. — Vigeon Laparoscopic Universal Smoke Evacuator (VG003) (510k cleared)Viomi Technology Co., Ltd

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

    full page →fda device 510k ↗
    ›May 9, 2025device 510k460d agoCapillary Biomedical, LLC — SteadiSet Infusion Set (510k cleared)

    Product code: FPA. Advisory committee: General Hospital. Type: Abbreviated

    full page →fda device 510k ↗
    ›May 9, 2025device 510k460d agoAvidhrt, Inc. — Avidhrt Sense SpO2 (510k cleared)

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

    full page →fda device 510k ↗
    ›May 9, 2025device 510k460d agoMectron S.P.A. — turbodent touch (510k cleared)

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

    full page →fda device 510k ↗
    ›May 9, 2025device 510k460d agoTeal Health, Inc. — Teal Wand (510k cleared)Health In Tech, Inc.

    Product code: SEP. Advisory committee: Microbiology. Type: Direct

    full page →fda device 510k ↗
    ›May 9, 2025device 510k460d agoPearl, Inc. — Second Opinion® BLE (510k cleared)

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

    full page →fda device 510k ↗
    ›May 9, 2025device 510k460d agoVolta Medical — Volta AF-Xplorer (510k cleared)

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

    full page →fda device 510k ↗
    ›May 9, 2025device 510k460d agoTristel Solutions , Ltd. — Tristel OPH (510k cleared)

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

    full page →fda device 510k ↗
    ›May 9, 2025device 510k460d agoDongguan Yanxuan Biotechnology Co., Ltd. — Water Solubility Human Body Lubricant (510k cleared)Cellyan Biotechnology Co., Ltd

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

    full page →fda device 510k ↗
    ›May 9, 2025device 510k460d agoVarian Medical Systems, Inc. — CT/ MR Tandem and Ovoid Set (510k cleared)MERIT MEDICAL SYSTEMS INC

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

    full page →fda device 510k ↗
    ›May 9, 2025device 510k460d agoDiasys Diagnostic Systems GmbH — DiaSys Procalcitonin FS; DiaSys TruCal Procalcitonin Calibrator Set; DiaSys TruLab Procalcitonin Bi-Level Controls (510k cleared)

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

    full page →fda device 510k ↗
    ›May 9, 2025device 510k460d agoShenzhen Jiantuo Electronics Co., Ltd. — TENS AND EMS (TENS and Muscle Stimulator) (JT8012, JT8012B) (510k cleared)

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

    full page →fda device 510k ↗
    ›May 9, 2025device 510k460d agoCrossroads Neurovascular, Inc. — PATH BGC (510k cleared)PATH

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

    full page →fda device 510k ↗
    ›May 9, 2025device 510k460d agoIterative Health — SKOUT system (510k cleared)

    Product code: QNP. Advisory committee: Gastroenterology, Urology. Type: Special

    full page →fda device 510k ↗
    ›May 9, 2025device 510k460d agoPhilips Image Guided Therapy Corporation — VeriSight Intracardiac Echocardiography Catheter (VSICE2D); VeriSight Pro Intracardiac Echocardiography Catheter (VSICE3D) (510k cleared)

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

    full page →fda device 510k ↗
    ›May 9, 2025device 510k460d agoBonraybio Co., Ltd. — LensHooke X12 PRO Semen Analysis System (510k cleared)

    Product code: POV. Advisory committee: Hematology. Type: Traditional

    full page →fda device 510k ↗
    ›May 10, 2025device 510k459d agoACON Laboratories, Inc. — Flowflex Plus COVID-19 + Flu A/B Home Test (510k cleared)Alcon Laboratories Inc

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

    full page →fda device 510k ↗
    ›May 11, 2025device 510k458d agoShenzhen Jiantuo Electronics Co., Ltd. — TENS AND EMS (TENS and Muscle Stimulator) (JT8012C,JT8016,JT9020E,JT9026) (510k cleared)

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

    full page →fda device 510k ↗

    Week of May 12, 2025

    17
    ›May 12, 2025approval457d agoINREBIC (FEDRATINIB HYDROCHLORIDE) — FDA approvalfedratinib

    Sponsor: BRISTOL-MYERS. Form: CAPSULE. Route: ORAL

    full page →fedratinib →fda approvals ↗
    ›May 12, 2025approval
    ← prev
    page 5 of 406
    next →
    457d ago
    TYENNE (TOCILIZUMAB-AAZG) — FDA approvalTYENNE

    Sponsor: FRESENIUS KABI USA. Form: INJECTABLE. Route: INTRAVENOUS

    full page →TYENNE →fda approvals ↗
    ›May 12, 2025device 510k457d agoNortheast Scientific, Inc. — NES Reprocessed Visions PV .018 Digital IVUS Catheter (R-86700) (510k cleared)

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

    full page →fda device 510k ↗
    ›May 12, 2025device 510k457d agoUnited Zirconia — ZircaGlow & ZircaGlow HT Zirconia (510k cleared)

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

    full page →fda device 510k ↗
    ›May 12, 2025device 510k457d agoShandong Moonlight Electronics Tech Co., Ltd. — Medical Diode Laser Hair Removal System (MNLT-D1) (510k cleared)

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

    full page →fda device 510k ↗
    ›May 12, 2025device 510k457d agoC.E.I.B.Med — Reon (510k cleared)

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

    full page →fda device 510k ↗
    ›May 12, 2025device 510k457d agoSignature Orthopaedics Pty, Ltd. — Shoulder Soft Tissue Anchors (510k cleared)

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

    full page →fda device 510k ↗
    ›May 12, 2025device 510k457d agoP-Cure, Ltd. — P-Cure Proton Therapy System (PPTS) (510k cleared)

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

    full page →fda device 510k ↗
    ›May 12, 2025device 510k457d agoShanghai United Imaging Healthcare Co., Ltd. — uWS-Angio Basic (510k cleared)

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

    full page →fda device 510k ↗
    ›May 12, 2025device 510k457d agoApyx Medical Corporation — AYON Body Contouring System (AYON SYSTEM) (510k cleared)Apyx Medical Corp

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

    full page →fda device 510k ↗
    ›May 12, 2025device 510k457d agoHeidelberg Engineering GmbH — SPECTRALIS HRA+OCT and variants (510k cleared)

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

    full page →fda device 510k ↗
    ›May 12, 2025device 510k457d ago3D-Side — Archer PSI System (510k cleared)

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

    full page →fda device 510k ↗
    ›May 12, 2025device 510k457d agoInari Medical, Inc. — InThrill™ Thrombectomy System (510k cleared)Mobia Medical, Inc.

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

    full page →fda device 510k ↗
    ›May 13, 2025device 510k456d agoSignature Orthopaedics Pty, Ltd. — Freedom Posterior Cervical Screws (510k cleared)

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

    full page →fda device 510k ↗
    ›May 13, 2025device 510k456d agoIntuitive Surgical, Inc. — SP Endoscope, 0° (430600) (510k cleared)INTUITIVE SURGICAL INC

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

    full page →fda device 510k ↗
    ›May 13, 2025device 510k456d agoCanon Medical Systems Corporation — Aplio i900/i800/i700 Diagnostic Ultrasound System, Software V8.5 (510k cleared)

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

    full page →fda device 510k ↗
    ›May 13, 2025device 510k456d agoUlthera, Inc. — Ulthera System (UC-1 Control Unit PRIME Model 2.1) (510k cleared)

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

    full page →fda device 510k ↗
    $HIT
    $VIOT
    $HKPD
    $NL6.0500-1.14%
    $BMY63.75-1.68%
    $APYX
    $MOBI
    $MMSI91.54+1.99%
    $ISRG400.03+1.69%