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3,766 catalysts · 4,728 grant · 3,766 device 510k · 3,603 8k filing · 3,025 approval · 2,000 device pma · 2,000 device recall

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type: device 510k×from 2025-02-13×clear all
type
  • grant4,728
  • device 510k3,766
  • 8k filing3,603
  • approval3,025
  • device pma2,000
  • device recall2,000
device adverse event
1,000
  • recall916
  • earnings585
  • phase 2 completion172
  • therapy area

    no tagged catalysts yet

    Week of Feb 10, 2025

    26
    ›Feb 13, 2025device 510k564d agoMaxx Orthopedics, Inc. — Freedom® Total Knee System - Porous Tibial Base Plate (510k cleared)

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

    full page →fda device 510k ↗
    ›Feb 13, 2025device 510k564d agoAssure Tech., LLC — FaStep Pregnancy Rapid Test Cassette; Fastep HCG Rapid Test Cassette (510k cleared)

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

    full page →fda device 510k ↗
    ›Feb 13, 2025device 510k564d agoNewclip Technics — Newclip Patient-matched instrumentation non sterile PSI (510k cleared)

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

    full page →fda device 510k ↗
    ›Feb 13, 2025device 510k564d agoDentsply Sirona, Inc. — AH Plus Endodontic Sealer (510k cleared)DENTSPLY SIRONA Inc.

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

    full page →fda device 510k ↗
    ›Feb 13, 2025device 510k564d agoPenumbra, Inc. — Penumbra System (Reperfusion Catheter RED 72) (510k cleared)Penumbra Inc

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

    full page →fda device 510k ↗
    ›Feb 13, 2025device 510k564d agoHologic, Inc. — Aptima SARS-CoV-2 Assay (510k cleared)

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

    full page →fda device 510k ↗
    ›Feb 13, 2025device 510k564d agoBoston Aesthetics, Inc. — Unicorn+ RF System (Unicorn+); Unicorn+ RF System (Unicorn+ I); Unicorn+ RF System (Unicorn+ II); Unicorn+ RF System (Unicorn+ III) (510k cleared)

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

    full page →fda device 510k ↗
    ›Feb 13, 2025device 510k564d agoJmt Co., Ltd. — EDEN ControlCath (510k cleared)

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

    full page →fda device 510k ↗
    ›Feb 13, 2025device 510k564d agoNeuromodulatory Devices & Applications — Ampa One System (AMPA-001) (510k cleared)

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

    full page →fda device 510k ↗
    ›Feb 13, 2025device 510k564d agoDenjoy Dental Co., Ltd. — Integrated Endo System (Meet Endo-II) (510k cleared)

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

    full page →fda device 510k ↗
    ›Feb 13, 2025device 510k564d agoFitbit, LLC — Body Temperature Software (BTS) (510k cleared)

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

    full page →fda device 510k ↗
    ›Feb 14, 2025device 510k563d agoAbbott Molecular, Inc. — Alinity m Resp-4-Plex (510k cleared)

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

    full page →fda device 510k ↗
    ›Feb 14, 2025device 510k563d agoCoreline Soft Co., Ltd. — AVIEW CAC (510k cleared)

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

    full page →fda device 510k ↗
    ›Feb 14, 2025device 510k563d agoShenzhen Kaiyan Medical Equipment Co., Ltd. — CurrentBody™ LED 4 in 1 Zone Facial Mapping Mask (MK-90C, MK-90M, MK66RB-F, MK-90N) (510k cleared)

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

    full page →fda device 510k ↗
    ›Feb 14, 2025device 510k563d agoLimFlow, Inc. — LimFlow V-Ceiver (510k cleared)

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

    full page →fda device 510k ↗
    ›Feb 14, 2025device 510k563d agoAidoc Medical , Ltd. — BriefCase-Triage (510k cleared)

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

    full page →fda device 510k ↗
    ›Feb 14, 2025device 510k563d 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 510k563d 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 510k563d 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 510k563d 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 510k563d 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 510k563d 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 510k563d agoBrainomix Limited — Brainomix 360 e-ASPECTS (510k cleared)

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

    full page →fda device 510k ↗
    ›Feb 14, 2025device 510k563d 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 510k563d 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 510k562d 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

    24
    ›Feb 18, 2025device 510k559d 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 1 of 76
    next →
    559d 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 510k559d 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 510k559d 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 510k559d 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 510k559d 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 510k558d 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 510k558d 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 510k558d 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 510k558d 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 510k558d 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 510k558d 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 510k558d agoArcuro Medical , Ltd. — SuperBall-RC™ (510k cleared)

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

    full page →fda device 510k ↗
    ›Feb 19, 2025device 510k558d 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 510k558d 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 510k558d agoBrainomix Limited — Brainomix 360 e-Lung (510k cleared)

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

    full page →fda device 510k ↗
    ›Feb 19, 2025device 510k558d 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 510k558d 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 510k558d 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 510k558d 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 510k557d 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 510k557d 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 510k557d 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 510k557d 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 ↗
    $PEN324.29-0.11%
    $VANI1.6000+18.52%
    $SNN28.97-0.55%
    $MDCE0.00020.00%
    $XRAY11.12+0.72%
    $SNN28.97-0.55%