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5,000 catalysts · 18,987 approval · 5,000 device 510k · 4,876 phase readout · 4,728 grant · 2,415 8k filing · 2,000 device pma

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type: device 510k×clear all
type
  • approval18,987
  • device 510k5,000
  • phase readout4,876
  • grant4,728
  • 8k filing2,415
  • device pma2,000
  • device recall2,000
  • recall1,126
  • device adverse event1,000
  • earnings295
  • therapy area

    no tagged catalysts yet

    Week of Feb 10, 2025

    10
    ›Feb 14, 2025device 510k528d agoTerrats Medical SL — DESS Dental Smart Solutions (510k cleared)

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

    full page →fda device 510k ↗
    ›Feb 14, 2025device 510k528d agoNew World Medical, Inc. — VIA360™ Surgical System (510k cleared)

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

    full page →fda device 510k ↗
    ›Feb 14, 2025device 510k528d agoWontech Co., Ltd. — WONTECH Surgical Optic Fibers (BA400/BA400R/BA600/BA600R) (510k cleared)

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

    full page →fda device 510k ↗
    ›Feb 14, 2025device 510k528d agoWontech Co., Ltd. — Pastelle Pro (510k cleared)

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

    full page →fda device 510k ↗
    ›Feb 14, 2025device 510k528d agoWard 24/7 Aps — WARD-CSS (v1.2.x) (510k cleared)

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

    full page →fda device 510k ↗
    ›Feb 14, 2025device 510k528d agoShenzhen Finicare Co., Ltd. — Non-contact Forehead Infrared Thermometer (FC-IR2000, FC-IR205, FC-IR202, FC-IR206, FC-IR207, FC-IR209) (510k cleared)

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

    full page →fda device 510k ↗
    ›Feb 14, 2025device 510k528d agoBrainomix Limited — Brainomix 360 e-ASPECTS (510k cleared)

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

    full page →fda device 510k ↗
    ›Feb 14, 2025device 510k528d agoVATECH Co., Ltd. — Green X 21 (PHT-90CHO) (510k cleared)

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

    full page →fda device 510k ↗
    ›Feb 14, 2025device 510k528d agoNatus Medical Denmark Aps — ICS Dizcovery (1091) (510k cleared)

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

    full page →fda device 510k ↗
    ›Feb 15, 2025device 510k527d agoSway Medical, Inc. — Sway System Sports Plus (510k cleared)

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

    full page →fda device 510k ↗

    Week of Feb 17, 2025

    40
    ›Feb 18, 2025device 510k524d agoStryker Neurovascular — AXS Lift Intracranial Base Catheter (510k cleared)

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

    full page →fda device 510k ↗
    ›Feb 18, 2025device 510k
    ← prev
    page 26 of 100
    next →
    524d ago
    Basic Medical Technology, Inc. — Nitrile Powder-Free Exam Gloves Tested for Use with Chemotherapy Drugs, Opioid Fentanyl Citrate (Black,White) (510k cleared)Medical Care Technologies Inc.

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

    full page →fda device 510k ↗
    ›Feb 18, 2025device 510k524d agoOkamoto USA, Inc. — 0.04 ZERO ZERO FOUR Male Latex Condom (510k cleared)

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

    full page →fda device 510k ↗
    ›Feb 18, 2025device 510k524d agoMicroport Orthopedics, Inc. — Evolution® Total Knee Systems - Kinematic Alignment Instrumentation and Technique (510k cleared)

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

    full page →fda device 510k ↗
    ›Feb 18, 2025device 510k524d agoJeil Medical Corporation — FIX-C 3D Ti ACIF System (510k cleared)

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

    full page →fda device 510k ↗
    ›Feb 18, 2025device 510k524d agoSmith & Nephew Medical, Ltd. — RENASYS Foam Wound Dressing Kit with AIRLOCK Technology and Soft Port; RENASYS Gauze Wound Dressing Kit with AIRLOCK Technology and Soft Port (510k cleared)SMITH & NEPHEW PLC

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

    full page →fda device 510k ↗
    ›Feb 19, 2025device 510k523d agoInstitut Straumann AG — Straumann InLab Validated Workflow (510k cleared)

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

    full page →fda device 510k ↗
    ›Feb 19, 2025device 510k523d agoVisby Medical, Inc. — Visby Medical Respiratory Health Test (510k cleared)Vivani Medical, Inc.

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

    full page →fda device 510k ↗
    ›Feb 19, 2025device 510k523d agoDci International, LLC — Dental Delivery System Series 5 and Dental Delivery System Series 5 Plus (510k cleared)Arrow International LLC

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

    full page →fda device 510k ↗
    ›Feb 19, 2025device 510k523d agoAvita Corporation — AViTA Pulse Oximeter (SP62B) (510k cleared)Teva Pharmaceuticals USA Inc

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

    full page →fda device 510k ↗
    ›Feb 19, 2025device 510k523d agoSichuan Qianli-Beoka Medical Technology, Inc. — Air compression massager (ACM-PLUS-A1, ACM-PLUS-A2, ACM-PLUS-A3, ACM-PLUS-A4, ACM-PLUS-A5, ACM-PLUS-A6) (510k cleared)

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

    full page →fda device 510k ↗
    ›Feb 19, 2025device 510k523d agoOptosurgical, LLC — OPTOVISION Endoscopic Light Source Unit (510k cleared)

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

    full page →fda device 510k ↗
    ›Feb 19, 2025device 510k523d agoArcuro Medical , Ltd. — SuperBall-RC™ (510k cleared)

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

    full page →fda device 510k ↗
    ›Feb 19, 2025device 510k523d agoDavol, Inc., A Subsidiary of C.R. Bard, Inc. — Phasix ST Umbilical Hernia Patch (510k cleared)

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

    full page →fda device 510k ↗
    ›Feb 19, 2025device 510k523d agoShenzhen Bsx Technology Electronics Co., Ltd. — Wrist Digital Blood Pressure Monitor (BSX312, BSX313, BSX315, BSX322, BSX323, BSX353, BSX355) (510k cleared)

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

    full page →fda device 510k ↗
    ›Feb 19, 2025device 510k523d agoBrainomix Limited — Brainomix 360 e-Lung (510k cleared)

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

    full page →fda device 510k ↗
    ›Feb 19, 2025device 510k523d agoQuanta System Spa — Single Use CO2 Laser Fiber (HAF005001) (510k cleared)

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

    full page →fda device 510k ↗
    ›Feb 19, 2025device 510k523d agoImplant Microdent System S.L.U. — Microdent Sterilization Cassette (510k cleared)

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

    full page →fda device 510k ↗
    ›Feb 19, 2025device 510k523d agoBiomet Orthopedics — A.L.P.S. Small Fragment Plating System (510k cleared)

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

    full page →fda device 510k ↗
    ›Feb 19, 2025device 510k523d agoSmith & Nephew — EVOS Pelvic and Acetabular System (510k cleared)SMITH & NEPHEW PLC

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

    full page →fda device 510k ↗
    ›Feb 20, 2025device 510k522d agoGuangzhou Decheng Biotechnology Co., Ltd. — Dochek® Multi-Drug Urine Test Cup; Dochek® Multi-Drug Urine Test Cup Pro (510k cleared)Guangzhou Zhiyi Biotechnology Co Ltd

    Product code: NGL. Advisory committee: Clinical Toxicology. Type: Traditional

    full page →fda device 510k ↗
    ›Feb 20, 2025device 510k522d agoReveal Lasers , Ltd. — Medical diode laser systems (CHARISMA, REGAL) (510k cleared)

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

    full page →fda device 510k ↗
    ›Feb 20, 2025device 510k522d agoSteris Corparation — Defendo Fujifilm 700 Single Use Cleaning Adapter (510k cleared)

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

    full page →fda device 510k ↗
    ›Feb 20, 2025device 510k522d agoArthrex, Inc. — Arthrex FiberTape and TigerTape Cerclage Sutures; Arthrex Radiopaque FiberTape Cerclage Sutures (510k cleared)

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

    full page →fda device 510k ↗
    ›Feb 20, 2025device 510k522d agoCaristo Diagnostics , Ltd. — CaRi-Plaque (510k cleared)

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

    full page →fda device 510k ↗
    ›Feb 20, 2025device 510k522d agoUnimed Medical Supplies, Inc. — Unimed Reusable Finger Clip SpO2 Sensors (UXXX-91 Series) (U403-91); Unimed Reusable Finger Clip SpO2 Sensors (UXXX-91 Series) (U410-91) (510k cleared)

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

    full page →fda device 510k ↗
    ›Feb 20, 2025device 510k522d agoIpreg Incorporation — SperSort™ Sperm Sorting Chip (IPG02) (510k cleared)

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

    full page →fda device 510k ↗
    ›Feb 20, 2025device 510k522d agoEver Fortune.Ai, Co., Ltd. — EFAI Chestsuite XR Malpositioned ETT Assessment System (ETT-XR-100) (510k cleared)

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

    full page →fda device 510k ↗
    ›Feb 20, 2025device 510k522d agoOrmco Corporation — SparkTM Clear Aligner System (510k cleared)

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

    full page →fda device 510k ↗
    ›Feb 20, 2025device 510k522d agoSteritec Products, Inc. (A Getinge Company) — Green Card Bowie-Dick Test (BD115) (510k cleared)

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

    full page →fda device 510k ↗
    ›Feb 20, 2025device 510k522d agoNurodata, Inc. — NUSONO Handheld Ultrasound Scanner (NUSONO-C35); NUSONO Handheld Ultrasound Scanner (NUSONO-L75); NUSONO Handheld Ultrasound Scanner (NUSONO-P25) (510k cleared)

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

    full page →fda device 510k ↗
    ›Feb 20, 2025device 510k522d agoCardiocalm Srl — CER-S (510k cleared)

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

    full page →fda device 510k ↗
    ›Feb 20, 2025device 510k522d agoLinkBio Corp. — CORE Shoulder System (510k cleared)

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

    full page →fda device 510k ↗
    ›Feb 20, 2025device 510k522d agoCompumedics Limited — Falcon HST (510k cleared)

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

    full page →fda device 510k ↗
    ›Feb 20, 2025device 510k522d agoEdan Instruments, Inc. — Acclarix AX8 Series Diagnostic Ultrasound System (Model: Acclarix AX7, Acclarix AX8, Acclarix AX75, Acclarix AX78, Acclarix AX8 Exp, Acclarix AX8 Super), Acclarix AX9 Series Diagnostic Ultrasound Szystem (Model: Acclarix AX9 Basic, Acclarix AX9, Acclarix AX9 Exp, Acclarix AX9 Super, Acclarix AX85, Acclarix AX88) (510k cleared)VEECO INSTRUMENTS INC

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

    full page →fda device 510k ↗
    ›Feb 20, 2025device 510k522d agoAbbott Laboratories — Alinity h-series System (510k cleared)ABBOTT LABORATORIES

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

    full page →fda device 510k ↗
    ›Feb 21, 2025device 510k521d agoOrthopediatrics Canada Ulc Dba Pega Medical — Fassier-Duval Telescoping IM System (510k cleared)

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

    full page →fda device 510k ↗
    ›Feb 21, 2025device 510k521d agoTaiwan Dental Materials Co., Ltd. — TEMP MASTER, PMMA-based dental resin (510k cleared)

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

    full page →fda device 510k ↗
    ›Feb 21, 2025device 510k521d agoLyma Life , Ltd. — LYMA Laser PRO (510k cleared)

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

    full page →fda device 510k ↗
    ›Feb 21, 2025device 510k521d agoSpinal Elements, Inc. — Primus Spinal Fixation System (510k cleared)

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

    full page →fda device 510k ↗
    $VECO59.42+2.95%
    $SNN30.25+5.29%
    $VANI1.6000+18.52%
    $SNN30.25+5.29%
    $MDCE0.00020.00%
    $ABT103.06+2.29%