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5,000 catalysts · 18,987 approval · 5,000 device 510k · 4,876 phase readout · 4,728 grant · 2,398 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 filing2,398
  • device pma2,000
  • device recall2,000
  • recall1,126
  • device adverse event1,000
  • earnings295
  • therapy area

    no tagged catalysts yet

    Week of Dec 2, 2024

    50
    ›Dec 2, 2024device 510k600d agoIntravu, Inc. — MIDASVu (510k cleared)

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

    full page →fda device 510k ↗
    ›Dec 2, 2024device 510k600d 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 510k599d agoOrthofix Srl — TrueLok Elevate (510k cleared)

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

    full page →fda device 510k ↗
    ›Dec 3, 2024device 510k599d 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 510k599d 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 510k599d 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 510k599d 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 510k599d 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 510k598d 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 510k598d agoMedicalgorithmics S.A. — DeepRhythmAI (510k cleared)

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

    full page →fda device 510k ↗
    ›Dec 4, 2024device 510k598d 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 510k598d agoScientia Vascular, Inc. — Socrates 38 Catheter (510k cleared)

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

    full page →fda device 510k ↗
    ›Dec 4, 2024device 510k598d 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 510k598d 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 510k598d 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 510k598d agoSurGenTec, LLC — Ion 3D (510k cleared)

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

    full page →fda device 510k ↗
    ›Dec 4, 2024device 510k598d agoAppliedvr — RelieVRx (510k cleared)

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

    full page →fda device 510k ↗
    ›Dec 4, 2024device 510k598d agoRaypia Co., Ltd. — Rextar Pro (510k cleared)

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

    full page →fda device 510k ↗
    ›Dec 4, 2024device 510k598d 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 510k598d 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 510k598d 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 510k598d agoXstrahl, Ltd. — XBeam (v2) (510k cleared)

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

    full page →fda device 510k ↗
    ›Dec 4, 2024device 510k598d 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 510k597d 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 510k597d 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 510k597d 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 510k597d 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 510k597d 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 510k597d 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 510k597d agoHeraeus Medical GmbH — OSTEOPAL® V (510k cleared)

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

    full page →fda device 510k ↗
    ›Dec 5, 2024device 510k597d agoNerbio Medical Software Platforms, Inc. — iTOF® (510k cleared)

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

    full page →fda device 510k ↗
    ›Dec 5, 2024device 510k597d 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 510k597d 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 510k597d 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 510k597d 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 510k596d agoPeek Health, S.A. — PeekMed web (510k cleared)

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

    full page →fda device 510k ↗
    ›Dec 6, 2024device 510k596d agoPiraeus Medical — 87 NeuGlide Catheter (510k cleared)

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

    full page →fda device 510k ↗
    ›Dec 6, 2024device 510k596d 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 510k596d agoSyntheticmr AB (Publ.) — SyMRI (510k cleared)

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

    full page →fda device 510k ↗
    ›Dec 6, 2024device 510k596d 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 510k596d agoNeuraxis, Inc. — RED (510k cleared)Neuraxis, INC

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

    full page →fda device 510k ↗
    ›Dec 6, 2024device 510k596d 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 510k596d 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 510k596d agoOxford Brain Diagnostics, Ltd. — CDM Insights (510k cleared)

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

    full page →fda device 510k ↗
    ›Dec 6, 2024device 510k596d agoEver Fortune.Ai, Co., Ltd. — EFAI Neurosuite CT Midline Shift Assessment System (MLS-CT-100) (510k cleared)

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

    full page →fda device 510k ↗
    ›Dec 6, 2024device 510k596d agoShenzhen Jianchao Intelligent Technology Co., Ltd. — Hair Removal Device (R3C16-P, R3C16-W, R3C16-G, R3C16-P Pro, R3C16-W Pro, R3C16-G Pro, R3505-W, R3505-B, R3505-W Pro, R3505-B Pro) (510k cleared)

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

    full page →fda device 510k ↗
    ›Dec 6, 2024device 510k596d agoPentax of America, Inc. — PENTAX Medical Video Upper GI Scope (EG27-i20c); PENTAX Medical Video Colonoscope (EC34-i20cL) (510k cleared)

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

    full page →fda device 510k ↗
    ›Dec 6, 2024device 510k596d agoAngioDynamics, Inc. — NanoKnife Generator (H78720300301US0); NanoKnife Single Electrode Activation Probe, 15 cm (H787204001090); NanoKnife Single Electrode Activation Probe, 25 cm (H787204001100); NanoKnife Single Electrode Probe Spacer (H787204003010) (510k cleared)ANGIODYNAMICS INC

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

    full page →fda device 510k ↗
    ›Dec 6, 2024device 510k596d agoVinbrain Joint Stock Company — DrAid™ for Liver Segmentation (510k cleared)

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

    full page →fda device 510k ↗
    ›Dec 6, 2024device 510k596d agoAmes Medical Prosthetic Solutions, S.A.U. — OsteoSinter® EVANS and COTTON wedges and related accessories (510k cleared)

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

    full page →fda device 510k ↗
    ← prev
    page 13 of 100
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    $CV
    $TMO447.81+1.31%
    $NNOX1.7300+1.17%
    $STE210.64+0.03%
    $MMSI73.110.00%
    $KYOCY
    $NRXS
    $MDT82.01+0.15%
    $RCMT
    $ANGO13.82-2.81%