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5,000 catalysts · 18,987 approval · 5,000 device 510k · 4,779 phase readout · 4,728 grant · 2,391 8k filing · 2,000 device pma

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type: device 510k×clear all
type
  • approval18,987
  • device 510k5,000
  • phase readout4,779
  • grant4,728
  • 8k filing2,391
  • device pma2,000
  • device recall2,000
  • recall1,126
  • device adverse event1,000
  • earnings295
  • therapy area

    no tagged catalysts yet

    Week of Nov 18, 2024

    39
    ›Nov 20, 2024device 510k611d agoIndiba S. A. U. — INDIBA COMPACT devices (510k cleared)

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

    full page →fda device 510k ↗
    ›Nov 20, 2024device 510k611d agoPro Surgical, Inc. — ProAM ACDF System (510k cleared)

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

    full page →fda device 510k ↗
    ›Nov 20, 2024device 510k611d agoOsstem Implant Co., Ltd. — Estar-ZE (510k cleared)

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

    full page →fda device 510k ↗
    ›Nov 20, 2024device 510k611d agoExo, Inc. — Strain AI (SAI001) (510k cleared)

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

    full page →fda device 510k ↗
    ›Nov 20, 2024device 510k611d agoShenzhen Ruiyi Business Technology Co., Ltd. — Leg Massager (Models:RP-ALM070H, RP-ALM071H) (510k cleared)

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

    full page →fda device 510k ↗
    ›Nov 20, 2024device 510k611d agoGostar Co., Ltd. — TD-7301 Spirometer (TD-7301) (510k cleared)

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

    full page →fda device 510k ↗
    ›Nov 20, 2024device 510k611d agoQ'Apel Medical, Inc. — Neurovascular Access System Family (510k cleared)

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

    full page →fda device 510k ↗
    ›Nov 20, 2024device 510k611d agoShenzhen Kaiyan Medical Equipment Co., Ltd. — HIGHERDOSE Red Light Hat (HG-120K) (510k cleared)

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

    full page →fda device 510k ↗
    ›Nov 21, 2024device 510k610d agoFink Engineering Pty, Ltd. — FESL FINK Chamber; FEDL FINK Chamber; FETL FINK Chamber (510k cleared)

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

    full page →fda device 510k ↗
    ›Nov 21, 2024device 510k610d agoVarian Medical Systems, Inc. — Gating Reflector Block (510k cleared)MERIT MEDICAL SYSTEMS INC

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

    full page →fda device 510k ↗
    ›Nov 21, 2024device 510k610d agoLifenet Health — PliaFX Flo (510k cleared)

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

    full page →fda device 510k ↗
    ›Nov 21, 2024device 510k610d agoIlooda Co,., Ltd. — Secret MAX Multi-platform RF System (510k cleared)

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

    full page →fda device 510k ↗
    ›Nov 21, 2024device 510k610d agoKonica Minolta, Inc. — SKR 3000 (510k cleared)

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

    full page →fda device 510k ↗
    ›Nov 21, 2024device 510k610d agoGM Dos Reis Industria e Comercio Ltda. — Versalock Mini and Micro Plating System (510k cleared)

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

    full page →fda device 510k ↗
    ›Nov 21, 2024device 510k610d agoGeneral Vibronics, Inc. — MIRARI® Cold Plasma System ( GV-M2-01) (510k cleared)

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

    full page →fda device 510k ↗
    ›Nov 21, 2024device 510k610d agoSurGenTec, LLC — TiLink-P Joint Fusion System (510k cleared)

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

    full page →fda device 510k ↗
    ›Nov 21, 2024device 510k610d agoShenzhen Smallsignal Technology Co., Ltd. — Fingertip Pulse Oximeter, models Alpine20, Alpine20A, Alpine20H, Alpine20HA, Alpine20B, Alpine20BA, Alpine20BH, Alpine20BHA, Alpine30, Alpine30A, Alpine30H, Alpine30HA, Alpine30B, Alpine30BA, Alpine30BH, Alpine30BHA, Alpine20L, Alpine20LB, Alpine20LH, Alpine20LBH, Alpine30L, Alpine30LB, Alpine30LH, Alpine30LBH (510k cleared)

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

    full page →fda device 510k ↗
    ›Nov 21, 2024device 510k610d agoColoplast Corp. — Luja Coude (510k cleared)

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

    full page →fda device 510k ↗
    ›Nov 21, 2024device 510k610d agoJazz Imaging — Jazz Classic (510k cleared)

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

    full page →fda device 510k ↗
    ›Nov 21, 2024device 510k610d agoCepheid® — Xpert vanA (510k cleared)

    Product code: NIJ. Advisory committee: Microbiology. Type: Special

    full page →fda device 510k ↗
    ›Nov 21, 2024device 510k610d agoDepuy Ireland UC — ATTUNE™ Revision Hinge Knee (510k cleared)

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

    full page →fda device 510k ↗
    ›Nov 21, 2024device 510k610d agoGM Dos Reis Industria e Comercio Ltda. — GMReis Ankle Plating System (510k cleared)

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

    full page →fda device 510k ↗
    ›Nov 22, 2024device 510k609d agoFlower Orthopedics Corporation Dba Conventus Flower Ortho — OsteoCoil™ Nitinol Compression System (Multiple Component PNs) (510k cleared)

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

    full page →fda device 510k ↗
    ›Nov 22, 2024device 510k609d agoPAJUNK GmbH Medizintechnologie — SPROTTE® STANDARD (LUER/ NRFit®) Anesthesiology (510k cleared)

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

    full page →fda device 510k ↗
    ›Nov 22, 2024device 510k609d agoXf Agencija Limited — Nooro Body & Foot Stimulator (SM9141, SM9142) (510k cleared)

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

    full page →fda device 510k ↗
    ›Nov 22, 2024device 510k609d agoAdvamedix, GmbH — Suction Irrigation Tubing Set (510k cleared)

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

    full page →fda device 510k ↗
    ›Nov 22, 2024device 510k609d agoNeuvotion, Inc. — Neuvotion NeuStim NN-01 (510k cleared)

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

    full page →fda device 510k ↗
    ›Nov 22, 2024device 510k609d agoNova Biomedical Corporation — Nova Allegro HbA1c Assay, Nova Allegro Analyzer (510k cleared)

    Product code: LCP. Advisory committee: Hematology. Type: Dual Track

    full page →fda device 510k ↗
    ›Nov 22, 2024device 510k609d agoZimmer, Inc. — Persona the Personalized Knee System (Persona Ti-Nidium PPS Femurs) (510k cleared)

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

    full page →fda device 510k ↗
    ›Nov 22, 2024device 510k609d agoSichuan Ast Medical Equipment Co., Ltd. — Manual Wheelchair (MASY23) (510k cleared)

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

    full page →fda device 510k ↗
    ›Nov 22, 2024device 510k609d agoAidite (Qinhuangdao) Technology Co., Ltd. — Additively Manufactured Denture Resin (510k cleared)

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

    full page →fda device 510k ↗
    ›Nov 22, 2024device 510k609d agoGravitas Medical, Inc. — Entarik NI Feeding Tube System (510k cleared)AVITA Medical, Inc.

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

    full page →fda device 510k ↗
    ›Nov 22, 2024device 510k609d agoAidoc Medical , Ltd. — BriefCase-Quantification (510k cleared)

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

    full page →fda device 510k ↗
    ›Nov 22, 2024device 510k609d agoFemasys, Inc. — FemVue MINI Saline-Air Device (510k cleared)FEMASYS INC

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

    full page →fda device 510k ↗
    ›Nov 22, 2024device 510k609d agoGimbo Medical Technology Shenzhen Co., Ltd. — Giftlife® Single-Step Medium Plus (510k cleared)NewBay Medical Technology Co Ltd

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

    full page →fda device 510k ↗
    ›Nov 22, 2024device 510k609d agoZhejiang Nysin Medical Co., Ltd. — Powered Wheelchair (NXN20-209) (510k cleared)Zhejiang Medicine Co Ltd

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

    full page →fda device 510k ↗
    ›Nov 22, 2024device 510k609d agoJasberry Healthcare Private Limited — Jasmate® Toothpaste (510k cleared)

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

    full page →fda device 510k ↗
    ›Nov 22, 2024device 510k609d agoBeacon Biosignals, Inc. — Dreem 3S (510k cleared)

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

    full page →fda device 510k ↗
    ›Nov 22, 2024device 510k609d agoCala Health, Inc. — Cala kIQ (510k cleared)CARDINAL HEALTH INC

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

    full page →fda device 510k ↗

    Week of Nov 25, 2024

    11
    ›Nov 25, 2024device 510k606d agoHeroic Faith International , Ltd. — AccurSound Electronic Stethoscope (AS101) (510k cleared)TH International Ltd

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

    full page →fda device 510k ↗
    ›Nov 25, 2024device 510k
    ← prev
    page 11 of 100
    next →
    606d ago
    Signature Orthopaedics Pty, Ltd. — World Liner (510k cleared)

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

    full page →fda device 510k ↗
    ›Nov 25, 2024device 510k606d ago3M Company — 3M™ Attest™ Super Rapid Readout Biological Indicator 1493; 3M™ Attest™ Super Rapid Steam Gravity Clear Challenge Pack 1493PCDG; 3M™ Attest™ Auto-reader 490; 3M™ Attest™ Auto-reader 490H; 3M™ Attest™ Mini Auto-reader 490M (510k cleared)3M CO

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

    full page →fda device 510k ↗
    ›Nov 25, 2024device 510k606d agoZhejiang Kairui Medical Device Co., Ltd. — Electric Wheelchair (KR8803) (510k cleared)

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

    full page →fda device 510k ↗
    ›Nov 25, 2024device 510k606d agoDentsply Sirona, Inc. — MIS LYNX Conical Connection Implant System (510k cleared)DENTSPLY SIRONA Inc.

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

    full page →fda device 510k ↗
    ›Nov 25, 2024device 510k606d agoShandong Huamei Technology Co., Ltd. — EMS Sculpt Machine (510k cleared)Shandong Boan Biotechnology Co Ltd

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

    full page →fda device 510k ↗
    ›Nov 25, 2024device 510k606d agoScreenpoint Medical B.V. — Transpara (2.1.0) (510k cleared)

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

    full page →fda device 510k ↗
    ›Nov 25, 2024device 510k606d agoHologic, Inc. — Aptima BV Assay; Aptima CV/TV Assay (510k cleared)

    Product code: PQA. Advisory committee: Microbiology. Type: Special

    full page →fda device 510k ↗
    ›Nov 25, 2024device 510k606d agoArum Dentistry Co., Ltd. — Customized Abutment (510k cleared)

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

    full page →fda device 510k ↗
    ›Nov 25, 2024device 510k606d agoEemagine Medical Imaging Solutions GmbH — WaveGuard Net EEG Cap (NA-245, NA-255, NA-261, NA-265, NA-271, NA-281) (510k cleared)

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

    full page →fda device 510k ↗
    ›Nov 25, 2024device 510k606d agoFH Industrie — JARVIS Glenoid Reverse Shoulder Prosthesis (510k cleared)

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

    full page →fda device 510k ↗
    $THCH
    $MMSI73.110.00%
    $FEMY
    $CAH225.98+2.47%
    $RCEL4.6100-6.68%
    $XRAY12.72-4.14%
    $MMM