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5,000 catalysts · 18,987 approval · 5,347 phase readout · 5,000 device 510k · 4,728 grant · 2,603 8k filing · 2,000 device pma

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type: device 510k×clear all
type
  • approval18,987
  • phase readout5,347
  • device 510k5,000
  • grant4,728
  • 8k filing2,603
  • device pma2,000
  • device recall2,000
  • recall1,126
  • device adverse event1,000
  • pdufa347
  • therapy area

    no tagged catalysts yet

    Week of Sep 22, 2025

    36
    ›Sep 25, 2025device 510k311d agoHologic — Panther Fusion GI Bacterial Assay (510k cleared)

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

    full page →fda device 510k ↗
    ›Sep 25, 2025device 510k311d agoJdentalcare Srl — JDEvolution Plus L and JDEvolution Plus LE (510k cleared)

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

    full page →fda device 510k ↗
    ›Sep 25, 2025device 510k311d agoAbbott Molecular, Inc. — Alinity m HCV (510k cleared)

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

    full page →fda device 510k ↗
    ›Sep 25, 2025device 510k311d agoCovidien, LLC — Shiley™ Oral/Nasal Tracheal Tube with TaperGuard™ Cuff Reinforced, Murphy Eye Shiley™ Tracheal Tube TaperGuard™ Cuff Reinforced with Stylet Shiley™ Lo-Contour Oral/Nasal Tracheal Tube Cuffed Reinforced Shiley™ Lo-Contour Oral/Nasal Tracheal Tube Cuffed Reinforced, Murphy Eye Shiley™ Oral/Nasal Tracheal Tube Cuffless Reinforced (510k cleared)

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

    full page →fda device 510k ↗
    ›Sep 25, 2025device 510k311d agoOlympus Medical Systems Corporation — Single-Use Biopsy Valve (MAJ-1555) (510k cleared)

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

    full page →fda device 510k ↗
    ›Sep 25, 2025device 510k311d agoWuhan Dimed Laser Technology Co., Ltd. — Medical Diode Laser Systems (BERYLAS-12N); Medical Diode Laser Systems (BERYLAS-15N); Medical Diode Laser Systems (HARLAS-45JN); Medical Diode Laser Systems (HARLAS-46JN) (510k cleared)

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

    full page →fda device 510k ↗
    ›Sep 25, 2025device 510k311d agoShanghai Berry Electronic Tech Co., Ltd. — Pulse Oximeter (510k cleared)

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

    full page →fda device 510k ↗
    ›Sep 25, 2025device 510k311d agoHologic, Inc. — Panther Fusion GI Expanded Bacterial Assay (510k cleared)

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

    full page →fda device 510k ↗
    ›Sep 25, 2025device 510k311d agoEnpuno Biotechnology Co., Ltd. — Root canal repair materials (nRoot BP) (510k cleared)TaiGen Biotechnology Co Ltd

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

    full page →fda device 510k ↗
    ›Sep 25, 2025device 510k311d agoABBOTT MEDICAL — EnSite™ X EP System (510k cleared)

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

    full page →fda device 510k ↗
    ›Sep 25, 2025device 510k311d agoShanghai United Imaging Healthcare Co., Ltd. — uMR 680 (510k cleared)

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

    full page →fda device 510k ↗
    ›Sep 25, 2025device 510k311d agoNeuravi Limited — EMBOTRAP III Revascularization Device (510k cleared)

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

    full page →fda device 510k ↗
    ›Sep 25, 2025device 510k311d agoInnovasis — Endeavor™ Stand-Alone Cervical IBF System (510k cleared)

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

    full page →fda device 510k ↗
    ›Sep 25, 2025device 510k311d agoMagnolia Medical Technologies — Steripath® Flow™ Blood Collection System (510k cleared)Medical Care Technologies Inc.

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

    full page →fda device 510k ↗
    ›Sep 25, 2025device 510k311d agoThermo Fisher Scientific — The Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with Colistin in the dilution range of 0.12-16 ug/mL (510k cleared)THERMO FISHER SCIENTIFIC INC.

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

    full page →fda device 510k ↗
    ›Sep 25, 2025device 510k311d agoYung Sheng Optical Co., Ltd. — Pure Plus UV Aspheric (Otufilcon A) Silicone Soft (hydrophilic) Contact Lens for Daily Wear (Daily Wear); Pure Plus UV Aspheric (Otufilcon A) 1-Day Silicone Soft (hydrophilic) Contact Lens (Daily Disposable) (510k cleared)

    Product code: LPL. Advisory committee: Ophthalmic. Type: Traditional

    full page →fda device 510k ↗
    ›Sep 25, 2025device 510k311d agoAuxano Medical, LLC — Auxano® Wedge Fixation System (510k cleared)

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

    full page →fda device 510k ↗
    ›Sep 25, 2025device 510k311d agoStryker Instruments — RPS Primary TKA Software; RPS Console; RPS Saw One; RPS Cable; RPS Saw Oscillating Tip Cartridge; RPS Console Cart Attachment; Ball Tip Pointer (510k cleared)

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

    full page →fda device 510k ↗
    ›Sep 25, 2025device 510k311d agoUnited Orthopedic Corporation — Stem Extension Line (U2 Total Knee System—PSA Type) (510k cleared)

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

    full page →fda device 510k ↗
    ›Sep 25, 2025device 510k311d agoQuantib B.V. — Brain WMH (510k cleared)

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

    full page →fda device 510k ↗
    ›Sep 25, 2025device 510k311d agoEssilor Of America, Inc. — Essilor® Stellest® (510k cleared)

    Product code: QUR. Advisory committee: Ophthalmic. Type: Direct

    full page →fda device 510k ↗
    ›Sep 26, 2025device 510k310d agoBoston Scientific Corporation — Radial Jaw 4 Pulmonary Biopsy Forceps (510k cleared)BOSTON SCIENTIFIC CORP

    Product code: BWH. Advisory committee: Ear, Nose, Throat. Type: Special

    full page →fda device 510k ↗
    ›Sep 26, 2025device 510k310d agoCanon Medical Systems Corporation — Self-Propelled CT Scan Base Kit, CGBA-035A; Alphenix, INFX-8000C/B, INFX-8000C/S, V9.6 with Calculated DAP (510k cleared)

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

    full page →fda device 510k ↗
    ›Sep 26, 2025device 510k310d agoBalt USA, LLC — Optima Coil System (Optima Packing Coil System) (510k cleared)Bayer USA LLC

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

    full page →fda device 510k ↗
    ›Sep 26, 2025device 510k310d agoFUJIFILM Healthcare Americas Corporation — FUJIFILM Stiffening Wire Device (SW-2000) (510k cleared)

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

    full page →fda device 510k ↗
    ›Sep 26, 2025device 510k310d agoCaretaker Medical — VitalStream ART Connect; VitalStream-Hemo (510k cleared)

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

    full page →fda device 510k ↗
    ›Sep 26, 2025device 510k310d agoShoulder Innovations, Inc. — Inset Reverse Total Shoulder System (510k cleared)SHOULDER INNOVATIONS, INC.

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

    full page →fda device 510k ↗
    ›Sep 26, 2025device 510k310d agoOlympus Medical Systems Corporation — AUXILIARY WATER TUBE MAJ-855 (510k cleared)

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

    full page →fda device 510k ↗
    ›Sep 26, 2025device 510k310d agoLevita Magnetics International Corp — Magnetic Surgical System (510k cleared)

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

    full page →fda device 510k ↗
    ›Sep 26, 2025device 510k310d agoPlanmed OY — Planmed XFI (510k cleared)

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

    full page →fda device 510k ↗
    ›Sep 26, 2025device 510k310d agoNanjing Bestview Laser S&T Co., Ltd. — Thulium Laser System (Deluxlase) (510k cleared)

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

    full page →fda device 510k ↗
    ›Sep 26, 2025device 510k310d agoS.I.N. Implant System Ltda — S.I.N. Dental Implant System (510k cleared)

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

    full page →fda device 510k ↗
    ›Sep 26, 2025device 510k310d agoLigence Uab — Ligence Heart (510k cleared)

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

    full page →fda device 510k ↗
    ›Sep 26, 2025device 510k310d agoLinshom Medical, Inc. — Linshom Continuous Predictive Respiratory Monitoring System (CPRMS) (510k cleared)

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

    full page →fda device 510k ↗
    ›Sep 26, 2025device 510k310d agoWellspect AB — LoFric Origo (510k cleared)

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

    full page →fda device 510k ↗
    ›Sep 26, 2025device 510k310d agoTuned , Ltd. — Tuned Self-Fitting Mobile App (510k cleared)

    Product code: SCR. Advisory committee: Ear, Nose, Throat. Type: Traditional

    full page →fda device 510k ↗

    Week of Sep 29, 2025

    14
    ›Sep 29, 2025device 510k307d agoSouth53, LLC — Primero Safe Access System (510k cleared)

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

    full page →fda device 510k ↗
    ›Sep 29, 2025device 510k
    ← prev
    page 66 of 100
    next →
    307d ago
    Beta Bionics, Inc. — iLet ACE Pump (510k cleared)Beta Bionics, Inc.

    Product code: QFG. Advisory committee: Clinical Chemistry. Type: Special

    full page →fda device 510k ↗
    ›Sep 29, 2025device 510k307d agoSurgical Theater, Inc. — SpineAR SNAP (SyncAR Spine) (510k cleared)

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

    full page →fda device 510k ↗
    ›Sep 29, 2025device 510k307d agoLongfian Scitech Co., Ltd. — Portable oxygen concentrator (JAY-1000P) (510k cleared)

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

    full page →fda device 510k ↗
    ›Sep 29, 2025device 510k307d agoSonex Health — UltraGuideCTR® image guided soft tissue release system (510k cleared)

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

    full page →fda device 510k ↗
    ›Sep 29, 2025device 510k307d agoHironic Co., Ltd. — NEW DOUBLO 2.0 (510k cleared)

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

    full page →fda device 510k ↗
    ›Sep 29, 2025device 510k307d agoPaltop Advanced Dental Solutions, Ltd. — Paltop Dental Implant System (510k cleared)

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

    full page →fda device 510k ↗
    ›Sep 29, 2025device 510k307d agoWilson-Cook Medical — SureTome™ SW Sphincterotome with DomeTip (510k cleared)

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

    full page →fda device 510k ↗
    ›Sep 29, 2025device 510k307d agoGraphenano Dental S.L. — G-BLOCK (510k cleared)

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

    full page →fda device 510k ↗
    ›Sep 29, 2025device 510k307d agoDisior, Ltd. — SMART PCFD (510k cleared)

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

    full page →fda device 510k ↗
    ›Sep 29, 2025device 510k307d agoHager& Meisinger GmbH — Master-Pin X (MP Pin with thread) (36BMP000030 / MP30) (510k cleared)

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

    full page →fda device 510k ↗
    ›Sep 29, 2025device 510k307d agoTulavi Therapeutics, Inc. — allay Nerve Cap (TL5515-1); allay Nerve Cap (TL5515-2); Delivery Tips (TL-7627) (510k cleared)Turn Therapeutics Inc.

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

    full page →fda device 510k ↗
    ›Sep 30, 2025device 510k306d agoJiangsu Bangbang Intelligent Technology Co., Ltd. — Mobility Scooter (BBR-Q40-01); Mobility Scooter (BBR-Q40-02); Mobility Scooter (BBR-Q40-03); Mobility Scooter (BBR-Q40-04); Mobility Scooter (BBR-Q40-05); Mobility Scooter (BBR-Q40-06) (510k cleared)

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

    full page →fda device 510k ↗
    ›Sep 30, 2025device 510k306d agoMidiagnostics NV — miDiagnostics HSV-1&2 CSF Test (510k cleared)

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

    full page →fda device 510k ↗
    $SI
    $MDCE0.00020.00%
    $BSX46.73+1.59%
    $TMO447.81+1.31%
    $TTRX
    $BBNX13.88+5.23%