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2,415 catalysts · 4,728 grant · 3,603 8k filing · 2,677 approval · 2,415 device 510k · 1,912 device recall · 1,705 device pma

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type: device 510k×from 2025-07-09×clear all
type
  • grant4,728
  • 8k filing3,603
  • approval2,677
  • device 510k2,415
  • device recall1,912
  • device pma1,705
device adverse event
1,000
  • recall641
  • earnings585
  • phase 2 completion172
  • therapy area

    no tagged catalysts yet

    Week of Jul 7, 2025

    47
    ›Jul 9, 2025device 510k417d agoSiemens Medical Solutions USA, Inc. — Cios Alpha; Cios Flow (510k cleared)

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

    full page →fda device 510k ↗
    ›Jul 9, 2025device 510k417d agoBoston Scientific Corporation — Flexiva Pulse Laser Fiber; Flexiva Pulse TracTip Laser Fiber; Flexiva Pulse ID Laser Fiber; Flexiva Pulse ID TracTip Laser Fibers (510k cleared)BOSTON SCIENTIFIC CORP

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

    full page →fda device 510k ↗
    ›Jul 9, 2025device 510k417d agoMr Surgical Solutions, LLC — OptiVu™ Shoulder (510k cleared)

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

    full page →fda device 510k ↗
    ›Jul 9, 2025device 510k417d agoPhasor Health, LLC — EZ-FIDUCIALS (510k cleared)

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

    full page →fda device 510k ↗
    ›Jul 9, 2025device 510k417d agoAbbott Laboratories — ARCHITECT iGentamicin (510k cleared)ABBOTT LABORATORIES

    Product code: LCD. Advisory committee: Clinical Toxicology. Type: Special

    full page →fda device 510k ↗
    ›Jul 9, 2025device 510k417d agoP&A USA — HEXIM Implant; Samwon General Abutments (510k cleared)

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

    full page →fda device 510k ↗
    ›Jul 9, 2025device 510k417d agoWenzel Spine, Inc. — panaSIa SI Fusion System (510k cleared)

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

    full page →fda device 510k ↗
    ›Jul 9, 2025device 510k417d agoNuvascular, Inc. — HARBOR Occlusion Device (510k cleared)

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

    full page →fda device 510k ↗
    ›Jul 9, 2025device 510k417d agoBasic Medical Technology, Inc. — Nitrile Powder-Free Exam Gloves 2.8, Tested for Use with Chemotherapy Drugs, Opioid Fentanyl Citrate, Simulated Gastric Acid (light blue, dark blue) (510k cleared)Medical Care Technologies Inc.

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

    full page →fda device 510k ↗
    ›Jul 9, 2025device 510k417d agoGe Medical Systems Information Technologies, Inc. — Monitor B105M; Monitor B125M; Monitor B155M; Monitor B105P; Monitor B125P (510k cleared)

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

    full page →fda device 510k ↗
    ›Jul 10, 2025device 510k416d agoShenzhen Dachi Communication Co., Ltd. — Microcurrent Facial Device (CEC101, EE0101, EEI101) (510k cleared)

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

    full page →fda device 510k ↗
    ›Jul 10, 2025device 510k416d agoArum Dentistry Co., Ltd. — ARENA Star, Galaxy Star (510k cleared)

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

    full page →fda device 510k ↗
    ›Jul 10, 2025device 510k416d agoBard Peripheral Vascular, Inc. — Marquee™ Disposable Core Biopsy Instrument and Instrument Kit (510k cleared)

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

    full page →fda device 510k ↗
    ›Jul 10, 2025device 510k416d agoZbeats, Inc. — ZBPro Diagnostic (510k cleared)

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

    full page →fda device 510k ↗
    ›Jul 10, 2025device 510k416d agoTriMed, Inc. — TriMed Total Wrist Fusion System (Total Wrist Fusion Plate) (510k cleared)

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

    full page →fda device 510k ↗
    ›Jul 10, 2025device 510k416d 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 510k416d 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 510k416d agoArthrex, Inc. — Arthrex PushLock Suture Anchors (510k cleared)

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

    full page →fda device 510k ↗
    ›Jul 10, 2025device 510k416d 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 510k416d 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 510k416d 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 510k415d 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 510k415d 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 510k415d 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 510k415d 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 510k415d agoTriMed, Inc. — RipCord (510k cleared)

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

    full page →fda device 510k ↗
    ›Jul 11, 2025device 510k415d agoBisco, Inc. — Choice 2 DC (510k cleared)

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

    full page →fda device 510k ↗
    ›Jul 11, 2025device 510k415d 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 510k415d 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 510k415d 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 510k415d 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 510k415d 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 510k415d agoShofu Dental Corporation — ResiCem EX (510k cleared)

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

    full page →fda device 510k ↗
    ›Jul 11, 2025device 510k415d 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 510k415d 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 510k415d 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 510k415d 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 510k415d 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 510k415d 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 510k415d 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 510k415d 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 510k415d 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 510k415d 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 510k415d 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 510k415d 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 510k414d agoLivassured BV — NightWatch+ US (510k cleared)

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

    full page →fda device 510k ↗
    ›Jul 13, 2025device 510k413d 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

    3
    ›Jul 14, 2025device 510k412d agoNarnar, LLC — GECHO (510k cleared)

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

    full page →fda device 510k ↗
    ›Jul 14, 2025device 510k
    ← prev
    page 1 of 49
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    412d 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 510k412d agoZimmer Medizinsysteme GmbH — CoolTone (510k cleared)

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

    full page →fda device 510k ↗
    $ABT112.47+0.79%
    $BSX46.84+0.36%
    $SRJN
    $BSX46.84+0.36%
    $MDCE0.00020.00%
    $ALGN