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4,406 catalysts · 4,728 grant · 4,406 device 510k · 3,189 8k filing · 3,188 approval · 2,000 device pma · 2,000 device recall

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2026-08-10: 0 catalysts2026-08-11: 0 catalysts2026-08-12: 0 catalysts2026-08-13: 19 catalysts2026-08-14: 4 catalysts2026-08-15: 0 catalysts2026-08-16: 0 catalysts2026-08-17: 1 catalyst2026-08-18: 2 catalysts2026-08-19: 3 catalysts2026-08-20: 0 catalysts2026-08-21: 0 catalysts2026-08-22: 0 catalysts2026-08-23: 0 catalysts2026-08-24: 0 catalysts2026-08-25: 0 catalysts2026-08-26: 1 catalyst2026-08-27: 1 catalyst2026-08-28: 0 catalysts2026-08-29: 0 catalysts2026-08-30: 0 catalysts2026-08-31: 0 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: 0 catalysts2026-10-01: 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 catalysts
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type: device 510k×from 2024-12-02×clear all
type
  • grant4,728
  • device 510k4,406
  • 8k filing3,189
  • approval3,188
  • device pma2,000
  • device recall2,000
recall
1,078
  • device adverse event1,000
  • earnings584
  • phase 2 completion172
  • therapy area

    no tagged catalysts yet

    Week of Dec 2, 2024

    50
    ›Dec 2, 2024device 510k619d 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 510k619d agoMicro 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 510k619d 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 510k619d agoSynthon Hispania S.L. — GripMate (510k cleared)

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

    full page →fda device 510k ↗
    ›Dec 2, 2024device 510k619d 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 510k619d 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 510k619d agoIntravu, Inc. — MIDASVu (510k cleared)

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

    full page →fda device 510k ↗
    ›Dec 2, 2024device 510k619d 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 510k618d agoOrthofix Srl — TrueLok Elevate (510k cleared)

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

    full page →fda device 510k ↗
    ›Dec 3, 2024device 510k618d 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 510k618d 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 510k618d 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 510k618d 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 510k618d 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 510k617d 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 510k617d agoMedicalgorithmics S.A. — DeepRhythmAI (510k cleared)

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

    full page →fda device 510k ↗
    ›Dec 4, 2024device 510k617d 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 510k617d agoScientia Vascular, Inc. — Socrates 38 Catheter (510k cleared)

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

    full page →fda device 510k ↗
    ›Dec 4, 2024device 510k617d 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 510k617d 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 510k617d 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 510k617d agoSurGenTec, LLC — Ion 3D (510k cleared)

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

    full page →fda device 510k ↗
    ›Dec 4, 2024device 510k617d agoAppliedvr — RelieVRx (510k cleared)

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

    full page →fda device 510k ↗
    ›Dec 4, 2024device 510k617d agoRaypia Co., Ltd. — Rextar Pro (510k cleared)

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

    full page →fda device 510k ↗
    ›Dec 4, 2024device 510k617d 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 510k617d 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 510k617d 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 510k617d agoXstrahl, Ltd. — XBeam (v2) (510k cleared)

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

    full page →fda device 510k ↗
    ›Dec 4, 2024device 510k617d agoCapsoVision, Inc. — CapsoCam Plus (SV-3) Capsule Endoscopy System (510k cleared)CapsoVision, Inc

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

    full page →fda device 510k ↗
    ›Dec 5, 2024device 510k616d agoOrthocon, Inc. — MONTAGE Settable, Resorbable Bone Putty MONTAGE-QS Settable, Resorbable Bone Putty MONTAGE Flowable Settable, Resorbable Bone Paste MONTAGE-XT Settable, Resorbable Hemostatic Bone Putty (510k cleared)

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

    full page →fda device 510k ↗
    ›Dec 5, 2024device 510k616d agoVentana Medical Systems, Inc. — VENTANA Kappa and Lambda Dual ISH mRNA Probe Cocktail (08507023001) (510k cleared)MERIT MEDICAL SYSTEMS INC

    Product code: SDP. Advisory committee: Hematology. Type: Direct

    full page →fda device 510k ↗
    ›Dec 5, 2024device 510k616d agoOssvis Co., Ltd. — LW Pre-milled Abutment (510k cleared)

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

    full page →fda device 510k ↗
    ›Dec 5, 2024device 510k616d agoBiofire Diagnostics, LLC (Biomerieux) — BIOFIRE FILMARRAY Tropical Fever Panel (510k cleared)

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

    full page →fda device 510k ↗
    ›Dec 5, 2024device 510k616d agoTdm Co., Ltd. — TDM Plate and Screw System (510k cleared)

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

    full page →fda device 510k ↗
    ›Dec 5, 2024device 510k616d agoNavbit Pty, Ltd. — Rapid Surgical Plan (RSP-SW-001) (510k cleared)

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

    full page →fda device 510k ↗
    ›Dec 5, 2024device 510k616d agoHeraeus Medical GmbH — OSTEOPAL® V (510k cleared)

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

    full page →fda device 510k ↗
    ›Dec 5, 2024device 510k616d agoNerbio Medical Software Platforms, Inc. — iTOF® (510k cleared)

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

    full page →fda device 510k ↗
    ›Dec 5, 2024device 510k616d agoKyocera Corporation — BIOCERAM AZUL® HEAD (510k cleared)KYOCERA CORP

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

    full page →fda device 510k ↗
    ›Dec 5, 2024device 510k616d agoLiaoning Rachcera Material Technology Co., Ltd. — Dental Lithium Disilicate Glass Ceramic ( HT, ML-HT, LT, ML-LT, MT, MO, HO) (510k cleared)

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

    full page →fda device 510k ↗
    ›Dec 5, 2024device 510k616d agoThermo Fisher Scientific — The Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with Linezolid in the dilution range of 0.25-32 ug/mL (510k cleared)THERMO FISHER SCIENTIFIC INC.

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

    full page →fda device 510k ↗
    ›Dec 5, 2024device 510k616d agoMedtronic, Inc. — Magnetic Localization Patch Kit (AFR-00021) (510k cleared)Medtronic plc

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

    full page →fda device 510k ↗
    ›Dec 6, 2024device 510k615d agoPeek Health, S.A. — PeekMed web (510k cleared)

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

    full page →fda device 510k ↗
    ›Dec 6, 2024device 510k615d agoPiraeus Medical — 87 NeuGlide Catheter (510k cleared)

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

    full page →fda device 510k ↗
    ›Dec 6, 2024device 510k615d agoAbbott Molecular — Alinity m SARS-CoV-2 AMP Kit (09N78-096); Alinity m SARS-CoV-2 CTRL Kit (09N78-086) (510k cleared)

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

    full page →fda device 510k ↗
    ›Dec 6, 2024device 510k615d agoSyntheticmr AB (Publ.) — SyMRI (510k cleared)

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

    full page →fda device 510k ↗
    ›Dec 6, 2024device 510k615d agoShenzhen Dazhou Medical Technology Co., Ltd. — DZ-Tabone Intervertebral Body Fusion Device (510k cleared)Guangzhou Dazhou Biomedical Technology Co Ltd

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

    full page →fda device 510k ↗
    ›Dec 6, 2024device 510k615d agoNeuraxis, Inc. — RED (510k cleared)Neuraxis, INC

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

    full page →fda device 510k ↗
    ›Dec 6, 2024device 510k615d agoProject Chemistry, Inc. — INA Moisturizing Intimate Lubricant Water-Based Personal Lubricant (510k cleared)

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

    full page →fda device 510k ↗
    ›Dec 6, 2024device 510k615d agoFoshan Care Medical Technology Co., Ltd. — Oxygen Concentrator (ZY-10AB/115) (510k cleared)NewBay Medical Technology Co Ltd

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

    full page →fda device 510k ↗
    ›Dec 6, 2024device 510k615d agoOxford Brain Diagnostics, Ltd. — CDM Insights (510k cleared)

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

    full page →fda device 510k ↗
    ← prev
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    $CV
    $MMSI91.20+0.10%
    $NNOX1.7300+1.17%
    $STE236.60-0.68%
    $KYOCY
    $TMO447.81+1.31%
    $STE236.60-0.68%
    $RCMT
    $MDT90.76+0.09%
    $NRXS