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5,000 catalysts · 18,987 approval · 5,256 phase readout · 5,000 device 510k · 4,728 grant · 2,563 8k filing · 2,000 device pma

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2026-07-27: 0 catalysts2026-07-28: 0 catalysts2026-07-29: 0 catalysts2026-07-30: 62 catalysts2026-07-31: 3 catalysts2026-08-01: 0 catalysts2026-08-02: 0 catalysts2026-08-03: 4 catalysts2026-08-04: 13 catalysts2026-08-05: 16 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: 1 catalyst2026-08-14: 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: 1 catalyst2026-10-22: 2 catalysts2026-10-23: 0 catalysts2026-10-24: 0 catalysts2026-10-25: 0 catalysts
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type: device 510k×clear all
type
  • approval18,987
  • phase readout5,256
  • device 510k5,000
  • grant4,728
  • 8k filing2,563
  • device pma2,000
  • device recall2,000
  • recall1,126
  • device adverse event1,000
  • pdufa325
  • therapy area

    no tagged catalysts yet

    Week of Jul 7, 2025

    32
    ›Jul 10, 2025device 510k386d agoLivaNova USA, Inc. — RAP Femoral Venous Cannulae (510k cleared)

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

    full page →fda device 510k ↗
    ›Jul 10, 2025device 510k386d agoAvalign Technologies, Inc. — CONDUIT™ SYNFIX™ Evolution Secured Spacer System (510k cleared)ALIGN TECHNOLOGY INC

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

    full page →fda device 510k ↗
    ›Jul 10, 2025device 510k386d agoArthrex, Inc. — Arthrex PushLock Suture Anchors (510k cleared)

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

    full page →fda device 510k ↗
    ›Jul 10, 2025device 510k386d agoFUJIFILM Sonosite, Inc. — Sonosite LX Ultrasound System (510k cleared)

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

    full page →fda device 510k ↗
    ›Jul 10, 2025device 510k386d agoProvidence Medical Technology, Inc. — CAVUX Facet Fixation System (CAVUX FFS) and CORUS-LX Implant (510k cleared)

    Product code: MRW. Advisory committee: Unknown. Type: Special

    full page →fda device 510k ↗
    ›Jul 10, 2025device 510k386d agoGE Medical Systems Ultrasound and Primary Care Diagnostics — Vivid Pioneer (510k cleared)

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

    full page →fda device 510k ↗
    ›Jul 11, 2025device 510k385d agoShenzhen Ulike Smart Electronics Co., Ltd. — Ice Cooling IPL Hair Removal Device (UI20S DB, UI20S RE, UI20S PW, UI20S GP, UI20S GR, UI20S BK, UI20 DB, UI20 RE, UI20 PW, UI20 GP, UI20 GR, UI20 BK) (510k cleared)

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

    full page →fda device 510k ↗
    ›Jul 11, 2025device 510k385d agoCeragem Co., Ltd. — Ceragem Automatic Thermal Massager (CGM MB-2401) (510k cleared)

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

    full page →fda device 510k ↗
    ›Jul 11, 2025device 510k385d agoSinolinks Medical Innovation, Inc. — Disposable Trocars (510k cleared)

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

    full page →fda device 510k ↗
    ›Jul 11, 2025device 510k385d agoPhilips Medical Systems Nederland B.V. — Achieva; Intera; Ingenia 1.5T; Ingenia 3.0T; Ingenia 1.5T CX; Ingenia 3.0T CX; Ingenia Elition S; Ingenia Elition X; Ingenia Ambition S; Ingenia Ambition X; and MR 5300 MR Systems (510k cleared)

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

    full page →fda device 510k ↗
    ›Jul 11, 2025device 510k385d agoTriMed, Inc. — RipCord (510k cleared)

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

    full page →fda device 510k ↗
    ›Jul 11, 2025device 510k385d agoBisco, Inc. — Choice 2 DC (510k cleared)

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

    full page →fda device 510k ↗
    ›Jul 11, 2025device 510k385d agoAccutome, Inc. Doing Business AS Keeler USA — B-Scan (510k cleared)

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

    full page →fda device 510k ↗
    ›Jul 11, 2025device 510k385d agoShenzhen Kaiyan Medical Equipment Co., Ltd. — KALA Therapy Wand (Model: KALA-03) (510k cleared)

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

    full page →fda device 510k ↗
    ›Jul 11, 2025device 510k385d agoBecton Dickinson Infusion Therapy Systems, Inc. — BD Cathena™ Safety IV Catheter (510k cleared)

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

    full page →fda device 510k ↗
    ›Jul 11, 2025device 510k385d agoCodonics.Incorporated — Codonics Safe Labeling System-Point of Care Station (PCS) (SLS-700i and related 610i, 620i, 630i series enabled to retrofit RFID features); Codonics Safe Labeling System-Point of Care Station (PCS) (SLS-1, SLS XXX, Multiple Models Pending Configuration) (510k cleared)

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

    full page →fda device 510k ↗
    ›Jul 11, 2025device 510k385d agoGeistlich Pharma AG — Geistlich Bio-Oss®; Geistlich Bio-Oss Pen® (510k cleared)

    Product code: NPM. Advisory committee: Dental. Type: Special

    full page →fda device 510k ↗
    ›Jul 11, 2025device 510k385d agoShofu Dental Corporation — ResiCem EX (510k cleared)

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

    full page →fda device 510k ↗
    ›Jul 11, 2025device 510k385d agoOlympus Medical Systems Corporation — ULTRASONIC PROBE UM-S20-17S (UM-S20-17S); ULTRASONIC PROBE UM-S20-20R (UM-S20-20R) (510k cleared)

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

    full page →fda device 510k ↗
    ›Jul 11, 2025device 510k385d agoPioneer Surgical Technology, Inc. — Resolve Anterior Cervical Plate System (510k cleared)

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

    full page →fda device 510k ↗
    ›Jul 11, 2025device 510k385d agoCarbon (Shenzhen) Medical Device Co., Ltd. — Disposable Biopsy Needle (510k cleared)

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

    full page →fda device 510k ↗
    ›Jul 11, 2025device 510k385d agoShaoguan Regenex Pharmaceuticals Co., Ltd. — Natural rubber latex male condom (510k cleared)

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

    full page →fda device 510k ↗
    ›Jul 11, 2025device 510k385d agoCutera, Inc. — AviClear Laser System (510k cleared)

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

    full page →fda device 510k ↗
    ›Jul 11, 2025device 510k385d agoCaire, Inc. — FreeStyle Comfort (AS200 / FreeStyle Comfort) (510k cleared)

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

    full page →fda device 510k ↗
    ›Jul 11, 2025device 510k385d agoSurgical Instrument Service and Savings, Inc. — Medline ReNewal Reprocessed Boston Scientific Dynamic XT Unidirectional Steerable Diagnostic Catheter (510k cleared)BOSTON SCIENTIFIC CORP

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

    full page →fda device 510k ↗
    ›Jul 11, 2025device 510k385d agoCenters for Disease Control and Prevention — CDC Human Influenza Virus Real-Time RT-PCR Diagnostic Panel: Influenza A/B Typing Kit (VER 2); Influenza A SubTyping Kit (VER 4); Influenza B Genotyping Kit (VER 1.1 and 2); and Influenza A/H5 Subtyping Kit (VER 4) (510k cleared)Hubei Provincial Center for Disease Control and Prevention

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

    full page →fda device 510k ↗
    ›Jul 11, 2025device 510k385d agoVivaQuant, Inc. — Rhythm Express Remote Cardiac Monitoring System (RX-1 mini) (510k cleared)

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

    full page →fda device 510k ↗
    ›Jul 11, 2025device 510k385d agoLexington Medical, Inc. — AEON™ Endoscopic Powered Stapler (510k cleared)

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

    full page →fda device 510k ↗
    ›Jul 11, 2025device 510k385d agoInion OY — Inion CPS 1.5/2.0/2.5 Bioabsorbable Fixation System; Inion CPS 1.5 Baby Bioabsorbable Fixation System (510k cleared)

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

    full page →fda device 510k ↗
    ›Jul 11, 2025device 510k385d agoSpirair, Inc. — TurbAlign (510k cleared)SPIRE INC

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

    full page →fda device 510k ↗
    ›Jul 12, 2025device 510k384d agoLivassured BV — NightWatch+ US (510k cleared)

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

    full page →fda device 510k ↗
    ›Jul 13, 2025device 510k383d agoWelch Allyn, Inc. — Welch Allyn Connex® 360 (Multiple) (510k cleared)

    Advisory committee: Unknown. Type: Traditional

    full page →fda device 510k ↗

    Week of Jul 14, 2025

    18
    ›Jul 14, 2025device 510k382d agoNarnar, LLC — GECHO (510k cleared)

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

    full page →fda device 510k ↗
    ›Jul 14, 2025device 510k
    ← prev
    page 53 of 100
    next →
    382d ago
    Peek Health, S.A. — PeekMed web (510k cleared)

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

    full page →fda device 510k ↗
    ›Jul 14, 2025device 510k382d agoZimmer Medizinsysteme GmbH — CoolTone (510k cleared)

    Product code: NGX. Advisory committee: Physical Medicine. Type: Special

    full page →fda device 510k ↗
    ›Jul 14, 2025device 510k382d agoAcumed, LLC — The Acumed Wrist Fixation System - Plates; The Acumed Wrist Fixation System - Screws (510k cleared)

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

    full page →fda device 510k ↗
    ›Jul 14, 2025device 510k382d agoFisher & Paykel Healthcare, Ltd. — F&P Optiflow Air/Oxygen Flow Source (510k cleared)

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

    full page →fda device 510k ↗
    ›Jul 14, 2025device 510k382d agoShenzhen Fansizhe Science and Technology Co., Ltd. — Intense Pulsed Light (IPL) System (T033KQ, T033KD, T033KF, T033MQ, T033MD, T033MF, T055KQ, T055KD, T055KH, T002AQ, T002AD, T002AF, T002BQ, T002BD, T002BF, T050KQ, T050KD, T050KF) (510k cleared)

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

    full page →fda device 510k ↗
    ›Jul 14, 2025device 510k382d agoSiemens Medical Solutions — LUMINOS Q.namix T; LUMINOS Q.namix R (510k cleared)

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

    full page →fda device 510k ↗
    ›Jul 14, 2025device 510k382d agoParagon 28, Inc. — Phantom® Hindfoot TTC/TC Nail System (510k cleared)

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

    full page →fda device 510k ↗
    ›Jul 14, 2025device 510k382d agoCeramoptec GmbH — Leonardo Duster (510k cleared)

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

    full page →fda device 510k ↗
    ›Jul 14, 2025device 510k382d agoExpanse Medical, Inc. — FLOWRUNNER Aspiration System (510k cleared)

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

    full page →fda device 510k ↗
    ›Jul 14, 2025device 510k382d agoMaterialise NV — Materialise TKA Guide System (510k cleared)MATERIALISE NV

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

    full page →fda device 510k ↗
    ›Jul 14, 2025device 510k382d agoJiangxi Aicare Medical Technology Co., Ltd. — Electronic Sphygmomanometers (ZH-X9, ZH-X12, ZH-X16, ZH-X17, ZH-X18, ZH-X19, ZH-X23, ZH-X24) (510k cleared)NewBay Medical Technology Co Ltd

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

    full page →fda device 510k ↗
    ›Jul 15, 2025device 510k381d agoShenzhen TPH Technology Co., Ltd. — Thrive 2-in-1 Breast Pump (Model P3) (510k cleared)Fortior Technology (Shenzhen) Co., Ltd./ADR

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

    full page →fda device 510k ↗
    ›Jul 15, 2025device 510k381d agoUnimed Medical Supplies, Inc. — Disposable Neonatal NIBP Cuff (U1682S-C51N); Disposable Neonatal NIBP Cuff (U1683S-C51N); Disposable Neonatal NIBP Cuff (U1684S-C51N); Disposable Neonatal NIBP Cuff (U1685S-C51N) (510k cleared)

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

    full page →fda device 510k ↗
    ›Jul 15, 2025device 510k381d agoTempus AI, Inc. — Tempus ECG-Low EF (510k cleared)Tempus AI, Inc.

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

    full page →fda device 510k ↗
    ›Jul 15, 2025device 510k381d agoPhilips Medical Systems Nederland B.V. — AV Viewer (510k cleared)

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

    full page →fda device 510k ↗
    ›Jul 15, 2025device 510k381d agoKerecis Limited — Kerecis SurgiBind (50241) (510k cleared)

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

    full page →fda device 510k ↗
    ›Jul 15, 2025device 510k381d agoHangzhou AllTest Biotech Co., Ltd. — Shinetell PlusTM Digital Early Pregnancy Test (510k cleared)Hangzhou DAC Biotech Co Ltd

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

    full page →fda device 510k ↗
    $BSX46.00-0.09%
    $SRJN
    $ALGN
    $FRTRY
    $TEM
    $MTLS6.5600-1.06%