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1,373 catalysts · 3,312 8k filing · 2,377 grant · 2,035 approval · 1,373 device 510k · 1,000 device adverse event · 929 device pma

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2026-08-10: 0 catalysts2026-08-11: 0 catalysts2026-08-12: 0 catalysts2026-08-13: 0 catalysts2026-08-14: 28 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 2025-11-04×clear all
type
  • 8k filing3,312
  • grant2,377
  • approval2,035
  • device 510k1,373
  • device adverse event1,000
  • device pma929
device recall
810
  • earnings584
  • recall364
  • phase 2 completion172
  • therapy area

    no tagged catalysts yet

    Week of Nov 3, 2025

    44
    ›Nov 4, 2025device 510k284d agoGM Dos Reis Industria e Comercio Ltda. — GMReis Suture Anchors (510k cleared)

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

    full page →fda device 510k ↗
    ›Nov 4, 2025device 510k284d agoPrimed Medical Products, Inc. — PRIMED Surgical and Procedure Masks (510k cleared)UTAH MEDICAL PRODUCTS INC

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

    full page →fda device 510k ↗
    ›Nov 4, 2025device 510k284d agoKarma Mobility Co, Ltd. — Flexx Junior (FLX-J00, FLX-J50) (510k cleared)

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

    full page →fda device 510k ↗
    ›Nov 4, 2025device 510k284d agoVieworks Co., Ltd. — VXvue (510k cleared)

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

    full page →fda device 510k ↗
    ›Nov 4, 2025device 510k284d agoMedcad — MedCAD® AccuStride™ System (510k cleared)

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

    full page →fda device 510k ↗
    ›Nov 4, 2025device 510k284d agoApplied Medical Resources Corp. — Voyant® Open Fusion Device (EB240/Open Fusion) (510k cleared)

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

    full page →fda device 510k ↗
    ›Nov 4, 2025device 510k284d agoMerit Medical Systems, Inc. — Merit Syringe (510k cleared)MERIT MEDICAL SYSTEMS INC

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

    full page →fda device 510k ↗
    ›Nov 4, 2025device 510k284d agoMenovex Medical Technology (Shenzhen) Co., Ltd. — Tamburo Thulium Fiber Laser System (510k cleared)NewBay Medical Technology Co Ltd

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

    full page →fda device 510k ↗
    ›Nov 4, 2025device 510k284d agoSiemens Medical Solutions USA, Inc. — Cios Select (510k cleared)

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

    full page →fda device 510k ↗
    ›Nov 5, 2025device 510k283d agoGlobus Medical, Inc. — ExcelsiusGPS™ Instruments (510k cleared)GLOBUS MEDICAL INC

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

    full page →fda device 510k ↗
    ›Nov 5, 2025device 510k283d agoPoly Medicure Limited — Polyshield Safety IV Catheters (510k cleared)

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

    full page →fda device 510k ↗
    ›Nov 5, 2025device 510k283d agoPhasor Health, LLC — EVAC-MRI (510k cleared)

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

    full page →fda device 510k ↗
    ›Nov 5, 2025device 510k283d agoWaldemar Link GmbH & Co. KG — Allure Hip Stem and Intramedullary Plugs (510k cleared)

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

    full page →fda device 510k ↗
    ›Nov 5, 2025device 510k283d agoViatherm Therapeutics, LLC — ViVY (510k cleared)VLP Therapeutics LLC

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

    full page →fda device 510k ↗
    ›Nov 5, 2025device 510k283d agoBeijing Sinovation Medical Technology Co., Ltd. — Depth Electrode (RSDE-08); Depth Electrode (RSDE-10); Depth Electrode (RSDE-12); Depth Electrode (RSDE-14); Depth Electrode (RSDE-16); Depth Electrode (RSDE-16F); Depth Electrode (RSDE-08S); Depth Electrode (RSDE-10S); Depth Electrode (RSDE-12S); Depth Electrode (RSDE-14S); Depth Electrode (RSDE-16S); Depth Electrode (RSDE-16G); Depth Electrode (RSDE-18); Depth Electrode (RSDE-18F); Depth Electrode (RSDE-18T); Depth Electrode (RSDE-20); Depth Electrode (RSDE-20F); Dept (510k cleared)

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

    full page →fda device 510k ↗
    ›Nov 6, 2025device 510k282d agoVenus Concept, Inc. — Venus Nova (FP-2001) (510k cleared)

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

    full page →fda device 510k ↗
    ›Nov 6, 2025device 510k282d agoMotive Health, Inc. — Motive™ Muscle Stimulator for Lower Back (OT01-1003) (510k cleared)

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

    full page →fda device 510k ↗
    ›Nov 6, 2025device 510k282d agoAdaptix Limited — Adaptix Ortho350 (510k cleared)

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

    full page →fda device 510k ↗
    ›Nov 6, 2025device 510k282d agoHefei Chimed Intelligent Machine Co., Ltd. — Dual-Mode Mobile C-Arm (Geelin500A, Geelin500M) (510k cleared)

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

    full page →fda device 510k ↗
    ›Nov 6, 2025device 510k282d agoPace Surgical — Ultra™ Compression Screw System (510k cleared)

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

    full page →fda device 510k ↗
    ›Nov 6, 2025device 510k282d agoAiomega, LLC — AIO Breathe (510k cleared)

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

    full page →fda device 510k ↗
    ›Nov 6, 2025device 510k282d agoAidoc Medical , Ltd. — BriefCase-Triage (510k cleared)

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

    full page →fda device 510k ↗
    ›Nov 6, 2025device 510k282d agoTandem Diabetes Care, Inc. — Tandem Mobi insulin pump with interoperable technology (510k cleared)TANDEM DIABETES CARE INC

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

    full page →fda device 510k ↗
    ›Nov 6, 2025device 510k282d agoMedical Bees GmbH — mb-FIX Cranial Stabilization Systems (510k cleared)

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

    full page →fda device 510k ↗
    ›Nov 6, 2025device 510k282d agoStereotaxis, Inc. — Stereotaxis GenesisX RMN with Navigant ™ Workstation (NWS) (510k cleared)Stereotaxis, Inc.

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

    full page →fda device 510k ↗
    ›Nov 6, 2025device 510k282d agoCatalyst Orthoscience, Inc. — Catalyst F1x Shoulder System (510k cleared)

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

    full page →fda device 510k ↗
    ›Nov 6, 2025device 510k282d agoHebei Keylaser Sci-Tech Co.,Ltd — Q-Switched Nd:Yag laser (K690) (510k cleared)

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

    full page →fda device 510k ↗
    ›Nov 6, 2025device 510k282d agoHubly, Inc. — Hubly Drill (H100) (510k cleared)Petros Pharmaceuticals, Inc.

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

    full page →fda device 510k ↗
    ›Nov 6, 2025device 510k282d agoDmp Dental Industry S.A. — MAGNABOND SE; MAGNABOND UNIVERSAL; MAGNABOND UNIVERSAL DCA (510k cleared)

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

    full page →fda device 510k ↗
    ›Nov 7, 2025device 510k281d agoS.I.N. Implant System Ltda — S.I.N. Tapered Pro Conical Zygoma Implant System (510k cleared)

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

    full page →fda device 510k ↗
    ›Nov 7, 2025device 510k281d agoBrainsway , Ltd. — BrainsWay Deep TMS System (510k cleared)Brainsway Ltd.

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

    full page →fda device 510k ↗
    ›Nov 7, 2025device 510k281d agoInion OY — Inion CPS 1.5 Baby Bioabsorbable Fixation System; Inion CPS 1.5/2.0/2.5 Bioabsorbable Fixation System (510k cleared)

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

    full page →fda device 510k ↗
    ›Nov 7, 2025device 510k281d agoImvaria, Inc. — Fibresolve (with PCCP) (510k cleared)

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

    full page →fda device 510k ↗
    ›Nov 7, 2025device 510k281d agoDreve Dentamid GmbH — Primeprint Direct Aligner (510k cleared)

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

    full page →fda device 510k ↗
    ›Nov 7, 2025device 510k281d agoHebei Keylaser Sci-Tech Co.,Ltd — CO2 Laser Therapy System (K106) (510k cleared)

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

    full page →fda device 510k ↗
    ›Nov 7, 2025device 510k281d agoShenzhen Mindray Bio-Medical Electronics Co., Ltd. — Consona N5, Consona N5 Pro, Consona N5 Super, Consona N5 Exp, Consona ER, Consona N5S, Consona EI, Consona EF, Consona N5 Elite, Consona N5 Ultra, Consona N3, Consona N3 Exp Diagnostic Ultrasound System (510k cleared)

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

    full page →fda device 510k ↗
    ›Nov 7, 2025device 510k281d agoBaoding Te'Anzhou Electronic Technology Co., Ltd. — Medical Diode Laser Systems (VeinCure) (510k cleared)

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

    full page →fda device 510k ↗
    ›Nov 7, 2025device 510k281d agoRollz International BV — Electric Wheelchair (Rollz Motion Electric 2M) (510k cleared)

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

    full page →fda device 510k ↗
    ›Nov 7, 2025device 510k281d agoUlrich GmbH & Co. KG — ulrichINJECT CT Motion (XD 8000) (510k cleared)

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

    full page →fda device 510k ↗
    ›Nov 7, 2025device 510k281d agoPremier Dental Products Company — MultiMatch Flow Chameleon AntiMicrobial Composite (510k cleared)

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

    full page →fda device 510k ↗
    ›Nov 7, 2025device 510k281d agoTopcon Corporation — AUTO KERATO-REFRACTO TONOMETER TRK-3 OMNIA (510k cleared)

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

    full page →fda device 510k ↗
    ›Nov 7, 2025device 510k281d agoSigma Biomedical — Triathlon Pro (510k cleared)

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

    full page →fda device 510k ↗
    ›Nov 7, 2025device 510k281d agoBench7, Inc. — SugarBug (1.x) (510k cleared)

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

    full page →fda device 510k ↗
    ›Nov 9, 2025device 510k279d agoWilliam Cook Europe Aps — Lunderquist Extra Stiff Wire Guide (510k cleared)

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

    full page →fda device 510k ↗

    Week of Nov 10, 2025

    6
    ›Nov 10, 2025device 510k278d agoVesalio, Inc. — NeVasc Aspiration System (510k cleared)

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

    full page →fda device 510k ↗
    ›Nov 10, 2025device 510k
    ← prev
    page 1 of 28
    next →
    278d ago
    Atlas Spine, Inc. — Atlas Spine HiRISE™ Expandable Cervical Corpectomy System (510k cleared)

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

    full page →fda device 510k ↗
    ›Nov 10, 2025device 510k278d agoMedical Microinstruments, Inc. — Symani Surgical System (510k cleared)

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

    full page →fda device 510k ↗
    ›Nov 10, 2025device 510k278d agoKLS-Martin L.P. — KLS Martin Cranial Implants - MR Conditional; K944565: KLS-Martin Micro Osteosynthesis System (1.5MM); K971297: KLS Martin Centre-Drive Drill-Free Screw; K060177: KLS Martin Rigid Fixation - Sterile; K062570: Individual Patient Solutions - Ti (IPS-Ti); K072707: Individual Patient Solutions - PEEK (IPS-PEEK) ; K151382: Individual Patient Solutions - (IPS-PEEK) - STERILE (510k cleared)

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

    full page →fda device 510k ↗
    ›Nov 10, 2025device 510k278d agoQpix Solutions, Inc. — EzSensor HD, EzSensor UHD (510k cleared)UL Solutions Inc.

    Product code: MUH. Advisory committee: Dental. Type: Special

    full page →fda device 510k ↗
    ›Nov 10, 2025device 510k278d agoPhilips Medizin Systeme Böblingen GmbH — IntelliVue Patient Monitor MX750; IntelliVue Patient Monitor MX850; IntelliVue 4-Slot Module Rack FMX-4 (866471 866470 866468 ) (510k cleared)

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

    full page →fda device 510k ↗
    $BWAY
    $PTPI
    $UTMD69.19+0.06%
    $STXS1.8800+5.62%
    $GMED79.93+1.27%
    $MMSI90.31-0.21%
    $TNDM22.53-2.59%
    $ULS