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5,000 catalysts · 18,987 approval · 5,000 device 510k · 4,970 phase readout · 4,728 grant · 2,452 8k filing · 2,000 device pma

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2026-07-27: 0 catalysts2026-07-28: 13 catalysts2026-07-29: 12 catalysts2026-07-30: 12 catalysts2026-07-31: 3 catalysts2026-08-01: 0 catalysts2026-08-02: 0 catalysts2026-08-03: 4 catalysts2026-08-04: 12 catalysts2026-08-05: 14 catalysts2026-08-06: 10 catalysts2026-08-07: 1 catalyst2026-08-08: 0 catalysts2026-08-09: 0 catalysts2026-08-10: 1 catalyst2026-08-11: 1 catalyst2026-08-12: 1 catalyst2026-08-13: 0 catalysts2026-08-14: 0 catalysts2026-08-15: 0 catalysts2026-08-16: 0 catalysts2026-08-17: 0 catalysts2026-08-18: 1 catalyst2026-08-19: 0 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: 0 catalysts2026-08-27: 0 catalysts2026-08-28: 0 catalysts2026-08-29: 0 catalysts2026-08-30: 0 catalysts2026-08-31: 0 catalysts2026-09-01: 1 catalyst2026-09-02: 0 catalysts2026-09-03: 0 catalysts2026-09-04: 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: 0 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: 0 catalysts2026-10-09: 0 catalysts2026-10-10: 0 catalysts2026-10-11: 0 catalysts2026-10-12: 0 catalysts2026-10-13: 0 catalysts2026-10-14: 0 catalysts2026-10-15: 0 catalysts2026-10-16: 0 catalysts2026-10-17: 0 catalysts2026-10-18: 0 catalysts2026-10-19: 0 catalysts2026-10-20: 1 catalyst2026-10-21: 0 catalysts2026-10-22: 1 catalyst2026-10-23: 0 catalysts2026-10-24: 0 catalysts2026-10-25: 0 catalysts
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type: device 510k×clear all
type
  • approval18,987
  • device 510k5,000
  • phase readout4,970
  • grant4,728
  • 8k filing2,452
  • device pma2,000
  • device recall2,000
  • recall1,126
  • device adverse event1,000
  • earnings296
  • therapy area

    no tagged catalysts yet

    Week of Apr 21, 2025

    28
    ›Apr 24, 2025device 510k460d agoExo, Inc. — Lung AI (LAI001) (510k cleared)

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

    full page →fda device 510k ↗
    ›Apr 25, 2025device 510k459d agoMicroaire Surgical Instruments, LLC — PAL 7020 Console (510k cleared)

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

    full page →fda device 510k ↗
    ›Apr 25, 2025device 510k459d agoMako Surgical Corp. — Mako Total Knee Application (3.0); Hybrid Tip Pointer (510k cleared)

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

    full page →fda device 510k ↗
    ›Apr 25, 2025device 510k459d agoCardio Flow Inc., — FreedomFlow™ Orbital Circumferential Atherectomy System (H6005/ 4Fr 3-Sphere Configuration) (510k cleared)

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

    full page →fda device 510k ↗
    ›Apr 25, 2025device 510k459d agoVarian Medical Systems — Intracavitary/Interstitial System (510k cleared)

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

    full page →fda device 510k ↗
    ›Apr 25, 2025device 510k459d agoPromethean Restorative, LLC — DYNAMIS™ Implant System (510k cleared)

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

    full page →fda device 510k ↗
    ›Apr 25, 2025device 510k459d agoEchoNous, Inc. — Kosmos (510k cleared)

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

    full page →fda device 510k ↗
    ›Apr 25, 2025device 510k459d agoWellmed Dental Medical Supply Co., Ltd. — Self Sealing Sterilization Pouches (510k cleared)

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

    full page →fda device 510k ↗
    ›Apr 25, 2025device 510k459d agoSorin Group Italia S.R.L. — DHF 0.2 Hemoconcentrator (DHF 02); DHF 0.6 Hemoconcentrator (DHF 06); SH 14 Hemoconcentrator (SH 14) (510k cleared)

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

    full page →fda device 510k ↗
    ›Apr 25, 2025device 510k459d agoA.M.I. Agency For Medical Innovations GmbH — i-Cut (510k cleared)

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

    full page →fda device 510k ↗
    ›Apr 25, 2025device 510k459d agoRoche Molecular Systems, Inc. — cobas liat SARS-CoV-2 & Influenza A/B v2 nucleic acid test (510k cleared)

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

    full page →fda device 510k ↗
    ›Apr 25, 2025device 510k459d agoBhm-Tech Produktionsgesellschaft Mbh — contact forte Alpha (510k cleared)

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

    full page →fda device 510k ↗
    ›Apr 25, 2025device 510k459d ago4Web Medical — Cervical Spine Truss System (CSTS) (510k cleared)

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

    full page →fda device 510k ↗
    ›Apr 25, 2025device 510k459d agoRoche Molecular Systems, Inc. — cobas liat SARS-CoV-2, Influenza A/B & RSV nucleic acid test (510k cleared)

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

    full page →fda device 510k ↗
    ›Apr 25, 2025device 510k459d agoMerit Medical Systems, Inc. — Prelude Wave Hydrophilic Sheath Introducer (510k cleared)MERIT MEDICAL SYSTEMS INC

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

    full page →fda device 510k ↗
    ›Apr 25, 2025device 510k459d agoAgnes Medical Co., Ltd. — RFMagik Lite (510k cleared)

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

    full page →fda device 510k ↗
    ›Apr 25, 2025device 510k459d agoShenzhen Urion Technology Co., Ltd. — Air Compression Leg Massager (UM605, UM606, UM607, UM608,UM609,UM610, UM611, UM617) (510k cleared)Fortior Technology (Shenzhen) Co., Ltd./ADR

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

    full page →fda device 510k ↗
    ›Apr 25, 2025device 510k459d agoInstitut Geroges Lopez — DCX Disposable Cassette (DCX) (510k cleared)

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

    full page →fda device 510k ↗
    ›Apr 25, 2025device 510k459d agoCompact Medical, Inc. — butterflyBVM (510k cleared)

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

    full page →fda device 510k ↗
    ›Apr 25, 2025device 510k459d agoL&K BIOMED Co., Ltd. — CastleLoc Pectus Bar System (510k cleared)NeuCen BioMed Co Ltd

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

    full page →fda device 510k ↗
    ›Apr 25, 2025device 510k459d agoNeuhealth Digital , Ltd. — Neu Platform (510k cleared)

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

    full page →fda device 510k ↗
    ›Apr 25, 2025device 510k459d agoCarefusion 303, Inc. — BD Alaris Infusion System with Guardrails Suite MX (510k cleared)

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

    full page →fda device 510k ↗
    ›Apr 25, 2025device 510k459d agoSTERIS Corporation — VERIFY STEAM Integrating Indicator (510k cleared)STERIS plc

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

    full page →fda device 510k ↗
    ›Apr 25, 2025device 510k459d agoGuangzhou Daxin Health Technology Co., Ltd. — Infrared Thermometer (510k cleared)Guangzhou Dazhou Biomedical Technology Co Ltd

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

    full page →fda device 510k ↗
    ›Apr 25, 2025device 510k459d agoCentinel Spine, LLC — prodisc® L Instruments (510k cleared)

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

    full page →fda device 510k ↗
    ›Apr 25, 2025device 510k459d agoSiemens Healthcare Diagnostics — Dimension LOCI Thyroid Stimulating Hormone Flex reagent cartridge (TSHL); Dimension LOCI Free Thyroxine Flex reagent cartridge (FT4L) (510k cleared)

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

    full page →fda device 510k ↗
    ›Apr 25, 2025device 510k459d agoABBOTT MEDICAL — Amulet™ Steerable Delivery Sheath (510k cleared)

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

    full page →fda device 510k ↗
    ›Apr 26, 2025device 510k458d agoCro, LLC — AIRO Suction Unit (AIRO-01) (510k cleared)

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

    full page →fda device 510k ↗

    Week of Apr 28, 2025

    22
    ›Apr 28, 2025device 510k456d agoBeijing Nubway S&T Co., Ltd. — Diode laser hair removal machine (QDTM-02) (510k cleared)

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

    full page →fda device 510k ↗
    ›Apr 28, 2025device 510k
    ← prev
    page 38 of 100
    next →
    456d ago
    Suturion AB — Suture-TOOL System (510k cleared)

    Product code: NEW. Advisory committee: General, Plastic Surgery. Type: Special

    full page →fda device 510k ↗
    ›Apr 28, 2025device 510k456d agoAventamed Dac — Solo+ Tympanostomy Tube Device (TTD), Solo+ TTD, Solo+ (Solo+ Tympanostomy Tube Handpiece (Catalogue #: 12115-100-000) and Solo+ Tympanostomy Tube Cartridge (Catalogue #: 12115-200-000)) (510k cleared)

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

    full page →fda device 510k ↗
    ›Apr 28, 2025device 510k456d agoEminent Spine — Eminent Spine 3D Titanium Pedicle Screw System (510k cleared)

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

    full page →fda device 510k ↗
    ›Apr 28, 2025device 510k456d agoShanghai United Imaging Healthcare Co., Ltd. — uAngio AVIVA CX (510k cleared)

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

    full page →fda device 510k ↗
    ›Apr 28, 2025device 510k456d agoContra Healthcare Solutions, LLC — LumiRex Ureteroscope (510k cleared)

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

    full page →fda device 510k ↗
    ›Apr 28, 2025device 510k456d agoAlembic, LLC — APRO 55 Swift Catheter and Alembic Aspiration Tubing (510k cleared)Alembic Pharmaceuticals Inc

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

    full page →fda device 510k ↗
    ›Apr 28, 2025device 510k456d agoZhe Jiang Cleisman Industry and Trade Co.,Ltd — Electric Wheelchair (ZH-W001,ZH-W002 ,ZH-W003) (510k cleared)

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

    full page →fda device 510k ↗
    ›Apr 28, 2025device 510k456d agoAlcon Laboratories, Inc. — LenSx Laser System (8065998162) (510k cleared)Alcon Laboratories Inc

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

    full page →fda device 510k ↗
    ›Apr 28, 2025device 510k456d agoPhilips Ultrasound, LLC — Flash Ultrasound System 5100 Point of Care (510k cleared)

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

    full page →fda device 510k ↗
    ›Apr 29, 2025device 510k455d agoMedex — Qitexio® 4-Way Stopcock (QIT014) (510k cleared)

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

    full page →fda device 510k ↗
    ›Apr 29, 2025device 510k455d agoSprintray, Inc. — Apex Flex (510k cleared)

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

    full page →fda device 510k ↗
    ›Apr 29, 2025device 510k455d agoEnchant Tek Co. , Ltd. — AllNEB (510k cleared)

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

    full page →fda device 510k ↗
    ›Apr 29, 2025device 510k455d agoInrad, Inc. — ExpressCore Biopsy Device (510k cleared)

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

    full page →fda device 510k ↗
    ›Apr 29, 2025device 510k455d agoAlembic, LLC — APRO 55 Intermediate Catheter (510k cleared)Alembic Pharmaceuticals Inc

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

    full page →fda device 510k ↗
    ›Apr 29, 2025device 510k455d agoCoaptech, Inc. — PUMA-G Pediatric System (510k cleared)

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

    full page →fda device 510k ↗
    ›Apr 29, 2025device 510k455d agoComfort Rubber Gloves Industries Sdn. Bhd. — Powder Free Natural Rubber Latex Examination Gloves – Blue, Non-Sterile and Protein Claim Of 50 Micrograms per dm2 Or Less Protein (510k cleared)

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

    full page →fda device 510k ↗
    ›Apr 29, 2025device 510k455d agoDongguan Boyuan Intelligent Technology Co.,Ltd — Hair Growth Device (KCA441-200, KCA441-120, KCA441-88, KCA441-56, KCA441-200S, KCA441-120S, KCA441-88S, KCA441-56S, KCA451-200, KCA451-120, KCA451-88, KCA451-56, KCA451-200S, KCA451-120S, KCA451-88S, KCA451-56S) (510k cleared)

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

    full page →fda device 510k ↗
    ›Apr 29, 2025device 510k455d agoTeleflex Medical — LMA Fastrach ETT SU (510k cleared)

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

    full page →fda device 510k ↗
    ›Apr 29, 2025device 510k455d agoOrthoPediatrics Corp. — Pediatric Plating Platform Hip (510k cleared)ORTHOPEDIATRICS CORP

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

    full page →fda device 510k ↗
    ›Apr 30, 2025device 510k454d agoMedivance, Inc. — Arctic Sun Stat Temperature Management System (510k cleared)

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

    full page →fda device 510k ↗
    ›Apr 30, 2025device 510k454d agoCenterPoint Systems, LLC — AuST Steerable Sheath (510k cleared)

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

    full page →fda device 510k ↗
    $FRTRY
    $MMSI76.10+2.40%
    $STE218.40+2.02%
    $KIDS