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4,428 catalysts · 4,728 grant · 4,428 device 510k · 3,605 8k filing · 3,192 approval · 2,000 device pma · 2,000 device recall

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2026-08-31: 2 catalysts2026-09-01: 1 catalyst2026-09-02: 0 catalysts2026-09-03: 1 catalyst2026-09-04: 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: 2 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: 1 catalyst2026-10-01: 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: 2 catalysts2026-10-09: 0 catalysts2026-10-10: 0 catalysts2026-10-11: 0 catalysts2026-10-12: 0 catalysts2026-10-13: 1 catalyst2026-10-14: 1 catalyst2026-10-15: 0 catalysts2026-10-16: 0 catalysts2026-10-17: 0 catalysts2026-10-18: 0 catalysts2026-10-19: 1 catalyst2026-10-20: 2 catalysts2026-10-21: 2 catalysts2026-10-22: 2 catalysts2026-10-23: 1 catalyst2026-10-24: 0 catalysts2026-10-25: 0 catalysts2026-10-26: 1 catalyst2026-10-27: 8 catalysts2026-10-28: 12 catalysts2026-10-29: 21 catalysts2026-10-30: 4 catalysts2026-10-31: 0 catalysts2026-11-01: 0 catalysts2026-11-02: 9 catalysts2026-11-03: 18 catalysts2026-11-04: 22 catalysts2026-11-05: 37 catalysts2026-11-06: 2 catalysts2026-11-07: 0 catalysts2026-11-08: 0 catalysts2026-11-09: 1 catalyst2026-11-10: 0 catalysts2026-11-11: 0 catalysts2026-11-12: 0 catalysts2026-11-13: 0 catalysts2026-11-14: 0 catalysts2026-11-15: 0 catalysts2026-11-16: 0 catalysts2026-11-17: 0 catalysts2026-11-18: 0 catalysts2026-11-19: 0 catalysts2026-11-20: 0 catalysts2026-11-21: 0 catalysts2026-11-22: 0 catalysts2026-11-23: 0 catalysts2026-11-24: 0 catalysts2026-11-25: 0 catalysts2026-11-26: 0 catalysts2026-11-27: 0 catalysts2026-11-28: 0 catalysts2026-11-29: 0 catalysts
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type: device 510k×from 2024-11-27×clear all
type
  • grant4,728
  • device 510k4,428
  • 8k filing3,605
  • approval3,192
  • device pma2,000
  • device recall2,000
recall
1,093
  • device adverse event1,000
  • earnings585
  • phase 2 completion172
  • therapy area

    no tagged catalysts yet

    Week of Nov 25, 2024

    22
    ›Nov 27, 2024device 510k642d agoNextbiomedical Co., Ltd. — Nexpowder (510k cleared)ACRO BIOMEDICAL CO., LTD.

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

    full page →fda device 510k ↗
    ›Nov 27, 2024device 510k642d agoDeka Research & Development Corp. — Remunity System (510k cleared)

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

    full page →fda device 510k ↗
    ›Nov 27, 2024device 510k642d agoEizo Corporation — RadiForce RX570; RadiForce RX570-AR (510k cleared)

    Product code: PGY. Advisory committee: Radiology. Type: Abbreviated

    full page →fda device 510k ↗
    ›Nov 27, 2024device 510k642d agoOntact Health Co., Ltd. — Sonix Health (510k cleared)

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

    full page →fda device 510k ↗
    ›Nov 27, 2024device 510k642d agoSamsung Medison Co., Ltd. — HERA W10 Diagnostic Ultrasound System; HERA W9 Diagnostic Ultrasound System (510k cleared)

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

    full page →fda device 510k ↗
    ›Nov 27, 2024device 510k642d agoEasymed Instruments Co., Ltd. — Pelvic Floor Stimulator (Intrelief PFE) (510k cleared)

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

    full page →fda device 510k ↗
    ›Nov 27, 2024device 510k642d agoShenzhen Walton Technology Co., Ltd. — LED Light Therapy Machine (G1, G3, G4, G6) (510k cleared)Fortior Technology (Shenzhen) Co., Ltd./ADR

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

    full page →fda device 510k ↗
    ›Nov 27, 2024device 510k642d agoCyden Limited — SmoothSkin Pure Switch (SSC1) (510k cleared)

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

    full page →fda device 510k ↗
    ›Nov 27, 2024device 510k642d agoKarl Storz SE & CO. KG — KARL STORZ Pediatric Cysto-Urethro-Fiberscope (11274BCU1) (510k cleared)

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

    full page →fda device 510k ↗
    ›Nov 27, 2024device 510k642d agoVilex, LLC — TACTIX Vector Syndesmosis System (510k cleared)

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

    full page →fda device 510k ↗
    ›Nov 27, 2024device 510k642d agoCeragem Co., Ltd. — Ceragem Automatic Thermal Massager (CGM-MB-1902) (510k cleared)

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

    full page →fda device 510k ↗
    ›Nov 27, 2024device 510k642d agoPrevest Denpro Limited — C&B Ceramic; C&B Permanent; C&B Interim (510k cleared)

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

    full page →fda device 510k ↗
    ›Nov 27, 2024device 510k642d agoCellmyx — AirSculpt Body Contouring System (AIRS-1-SYS) (510k cleared)

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

    full page →fda device 510k ↗
    ›Nov 27, 2024device 510k642d agoSharkninja Operating, LLC — CryoGlow (FW3XXXX) (510k cleared)

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

    full page →fda device 510k ↗
    ›Nov 27, 2024device 510k642d agoBard Access Systems, Inc. — PowerLoc™ Max Power Injectable Infusion Set; SafeStep™ Huber Needle Set (510k cleared)

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

    full page →fda device 510k ↗
    ›Nov 27, 2024device 510k642d agoSpectrum Vascular — SV Spectrum MRC Central Venous Catheter; SV Spectrum MR Central Venous Catheter; SV Central Venous Catheter (510k cleared)

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

    full page →fda device 510k ↗
    ›Nov 27, 2024device 510k642d agoConmed Corporation — BioBrace® (510k cleared)CONMED Corp

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

    full page →fda device 510k ↗
    ›Nov 27, 2024device 510k642d agoZhejiang Zhonglei Medical Technology Co. , Ltd. — Power wheelchair (510k cleared)Zhejiang Xinkanghe Biomedical Technology Co Ltd

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

    full page →fda device 510k ↗
    ›Nov 29, 2024device 510k640d agoSurgical Instrument Service and Savings, Inc. — Medline ReNewal Reprocessed Abbott Inquiry Steerable Diagnostic Catheter (510k cleared)

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

    full page →fda device 510k ↗
    ›Nov 29, 2024device 510k640d agoMovano Inc. Dba Movano Health — Evie Med Ring (510k cleared)

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

    full page →fda device 510k ↗
    ›Nov 29, 2024device 510k640d agoRuthless, LLC Dba Ruthless Spine — Ruthless Spine RJB (510k cleared)

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

    full page →fda device 510k ↗
    ›Nov 29, 2024device 510k640d agoMedical Electronic Systems , Ltd. — YO Home Sperm Test (510k cleared)

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

    full page →fda device 510k ↗

    Week of Dec 2, 2024

    28
    ›Dec 2, 2024device 510k637d agoFlight Medical Innovations , Ltd. — Ventoux VC2; Ventoux VC3 (510k cleared)

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

    full page →fda device 510k ↗
    ›Dec 2, 2024device 510k
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    page 1 of 89
    next →
    637d ago
    Micro Therapeutics, Inc. d/b/a ev3 Neurovascular — Riptide™ Aspiration Pump; Riptide™ Collection Canister with Intermediate Tubing (510k cleared)

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

    full page →fda device 510k ↗
    ›Dec 2, 2024device 510k637d agoPhilips Medical Systems Nederland B.V. — Philips IntelliSite Pathology Solution (510k cleared)

    Product code: PSY. Advisory committee: Pathology. Type: Traditional

    full page →fda device 510k ↗
    ›Dec 2, 2024device 510k637d agoSynthon Hispania S.L. — GripMate (510k cleared)

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

    full page →fda device 510k ↗
    ›Dec 2, 2024device 510k637d agoApira Science, Inc. — GroWell BT Hair Growth System (GW10042) (510k cleared)

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

    full page →fda device 510k ↗
    ›Dec 2, 2024device 510k637d agoSTERIS Corporation — enspire 3000 Cleaning and Liquid Chemical Sterilant Processing System (510k cleared)STERIS plc

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

    full page →fda device 510k ↗
    ›Dec 2, 2024device 510k637d agoIntravu, Inc. — MIDASVu (510k cleared)

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

    full page →fda device 510k ↗
    ›Dec 2, 2024device 510k637d agoVilex, LLC — Hintermann Series H2 Total Ankle System (510k cleared)

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

    full page →fda device 510k ↗
    ›Dec 3, 2024device 510k636d agoOrthofix Srl — TrueLok Elevate (510k cleared)

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

    full page →fda device 510k ↗
    ›Dec 3, 2024device 510k636d agoOsteonic Co., Ltd. — Fix2Lock (Biocomposite medial, Biocomposite lateral, Biocombi Self Punching) (510k cleared)

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

    full page →fda device 510k ↗
    ›Dec 3, 2024device 510k636d agoRiverain Technologies, Inc. — ClearRead CT CAC (510k cleared)RCM TECHNOLOGIES, INC.

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

    full page →fda device 510k ↗
    ›Dec 3, 2024device 510k636d agoOsteonic Co., Ltd. — Fix2Lock (PEEK Self Punching) (510k cleared)

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

    full page →fda device 510k ↗
    ›Dec 3, 2024device 510k636d agoCovidien — Sofsilk™ Coated Braided Silk Suture (510k cleared)

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

    full page →fda device 510k ↗
    ›Dec 3, 2024device 510k636d agoCryosurgery, Inc. — Verruca-Freeze H (510k cleared)

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

    full page →fda device 510k ↗
    ›Dec 4, 2024device 510k635d agoAlcon Laboratories, Inc. — Alcon 27GA Chandelier (8065000252); Alcon 27+ DS Wide Angle Endoilluminator (8065000253); Alcon 27+ DS Endoilluminator (8065000256); (510k cleared)Alcon Laboratories Inc

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

    full page →fda device 510k ↗
    ›Dec 4, 2024device 510k635d agoMedicalgorithmics S.A. — DeepRhythmAI (510k cleared)

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

    full page →fda device 510k ↗
    ›Dec 4, 2024device 510k635d agoNano-X Imaging , Ltd. — Nanox.ARC (510k cleared)Nano-X Imaging Ltd.

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

    full page →fda device 510k ↗
    ›Dec 4, 2024device 510k635d agoScientia Vascular, Inc. — Socrates 38 Catheter (510k cleared)

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

    full page →fda device 510k ↗
    ›Dec 4, 2024device 510k635d agoCenterPoint Systems, LLC — SSPC NXT Delivery Catheter (510k cleared)

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

    full page →fda device 510k ↗
    ›Dec 4, 2024device 510k635d agoJjgc Indústria E Comércia DE Materiais Dentários S.A. — Neodent Implant System (510k cleared)

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

    full page →fda device 510k ↗
    ›Dec 4, 2024device 510k635d agoDouble Medical Technology, Inc. — Locking Screw,CoCrMo (510k cleared)

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

    full page →fda device 510k ↗
    ›Dec 4, 2024device 510k635d agoSurGenTec, LLC — Ion 3D (510k cleared)

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

    full page →fda device 510k ↗
    ›Dec 4, 2024device 510k635d agoAppliedvr — RelieVRx (510k cleared)

    Product code: QRA. Advisory committee: Neurology. Type: Special

    full page →fda device 510k ↗
    ›Dec 4, 2024device 510k635d agoRaypia Co., Ltd. — Rextar Pro (510k cleared)

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

    full page →fda device 510k ↗
    ›Dec 4, 2024device 510k635d agoSTERIS Corporation — Chemical Indicator for enspire CLCSPS (LCC015) (510k cleared)STERIS plc

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

    full page →fda device 510k ↗
    ›Dec 4, 2024device 510k635d agoHowmedica Osteonics Corp., Dba Stryker Orthopaedics — Triathlon Knee System; Triathlon Pro Posterior Stabilized Femoral Components; Triathlon Tritanium Tibial Baseplate; Triathlon Low Profile Tibial Tray; Triathlon Metal Backed Patella; Triathlon Partial Knee System; Avon Patello-femoral Joint Prosthesis; Restoris Multi-Compartmental Knee System (510k cleared)

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

    full page →fda device 510k ↗
    ›Dec 4, 2024device 510k635d agoSiemens Healthcare Diagnostics, Inc. — Atellica® CH Creatinine_3 (Crea3) (510k cleared)

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

    full page →fda device 510k ↗
    ›Dec 4, 2024device 510k635d agoXstrahl, Ltd. — XBeam (v2) (510k cleared)

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

    full page →fda device 510k ↗
    $ACBM
    $FRTRY
    $CNMD32.58+1.46%
    $RCMT
    $NNOX1.7300+1.17%
    $STE233.78+0.35%
    $STE233.78+0.35%