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5,000 catalysts · 18,987 approval · 5,539 phase readout · 5,000 device 510k · 4,728 grant · 2,730 8k filing · 2,000 device pma

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2026-08-03: 0 catalysts2026-08-04: 0 catalysts2026-08-05: 18 catalysts2026-08-06: 12 catalysts2026-08-07: 1 catalyst2026-08-08: 0 catalysts2026-08-09: 0 catalysts2026-08-10: 2 catalysts2026-08-11: 1 catalyst2026-08-12: 2 catalysts2026-08-13: 2 catalysts2026-08-14: 1 catalyst2026-08-15: 0 catalysts2026-08-16: 0 catalysts2026-08-17: 0 catalysts2026-08-18: 1 catalyst2026-08-19: 0 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: 0 catalysts2026-08-27: 0 catalysts2026-08-28: 0 catalysts2026-08-29: 0 catalysts2026-08-30: 0 catalysts2026-08-31: 0 catalysts2026-09-01: 1 catalyst2026-09-02: 0 catalysts2026-09-03: 0 catalysts2026-09-04: 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: 1 catalyst2026-09-24: 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: 0 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: 0 catalysts2026-10-20: 2 catalysts2026-10-21: 1 catalyst2026-10-22: 2 catalysts2026-10-23: 0 catalysts2026-10-24: 0 catalysts2026-10-25: 0 catalysts2026-10-26: 0 catalysts2026-10-27: 2 catalysts2026-10-28: 1 catalyst2026-10-29: 3 catalysts2026-10-30: 2 catalysts2026-10-31: 0 catalysts2026-11-01: 0 catalysts
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type: device 510k×clear all
type
  • approval18,987
  • phase readout5,539
  • device 510k5,000
  • grant4,728
  • 8k filing2,730
  • device pma2,000
  • device recall2,000
  • recall1,126
  • device adverse event1,000
  • earnings328
  • therapy area

    no tagged catalysts yet

    Week of Dec 29, 2025

    19
    ›Dec 29, 2025device 510k219d agoToetal Solutions — ZipToe™ Hammertoe Fusion System (510k cleared)

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

    full page →fda device 510k ↗
    ›Dec 29, 2025device 510k219d agoCelebrace — Celebrace Software (510k cleared)

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

    full page →fda device 510k ↗
    ›Dec 29, 2025device 510k219d agoCovidien, LLC — Shiley™ Adult Flexible Tracheostomy Tube XLT with TaperGuard™ Cuff, Distal with Disposable Inner Cannula; Shiley™ Adult Flexible Tracheostomy Tube XLT with TaperGuard™ Cuff, Proximal with Disposable Inner Cannula; Shiley™ Adult Flexible Tracheostomy Tube XLT Cuffless, Distal with Disposable Inner Cannula ; Shiley™ Adult Flexible Tracheostomy Tube XLT Cuffless, Proximal with Disposable Inner Cannula; Shiley™ Adult Flexible Disposable Inner Cannula XLT (510k cleared)

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

    full page →fda device 510k ↗
    ›Dec 29, 2025device 510k219d agoCovidien, LLC — Mon-a-Therm™ Esophageal Stethoscope with Temperature Sensor 400TM (90041, 90042, 90043, 90049) (510k cleared)

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

    full page →fda device 510k ↗
    ›Dec 30, 2025device 510k218d agoTruvian Health — Lipids (510k cleared)

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

    full page →fda device 510k ↗
    ›Dec 30, 2025device 510k218d agoMediso Medical Imaging Systems, Ltd. — AnyScan 3.0 NM Scanner Family (510k cleared)

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

    full page →fda device 510k ↗
    ›Dec 30, 2025device 510k218d agoTechno-Path Manufacturing , Ltd. — Multichem ID-G (09339892190); Multichem ID-G (SR102G); Multichem ID-G (SR102MG); Multichem ID-GNeg (09339906190); Multichem ID-GNeg (SR102N); Multichem ID-GNeg (SR102MN) (510k cleared)PATH

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

    full page →fda device 510k ↗
    ›Dec 30, 2025device 510k218d agoSpectrum Dynamics Medical, Ltd. — TruSPECT Processing Station (510k cleared)

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

    full page →fda device 510k ↗
    ›Dec 30, 2025device 510k218d agoArthrex, Inc. — Arthrex SwiveLock Suture Anchor, 3.5 x 10 mm (510k cleared)

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

    full page →fda device 510k ↗
    ›Dec 30, 2025device 510k218d agoLucas Lifecare — Life Ultra 25L Tabletop Mono Chamber Steam Sterilizer (510k cleared)

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

    full page →fda device 510k ↗
    ›Dec 31, 2025device 510k217d agoShenzhen Jiantuo Electronics Co., Ltd. — TENS AND EMS (TENS and Muscle Stimulator) (JT1065, JT1080, JT2080, JT9034) (510k cleared)

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

    full page →fda device 510k ↗
    ›Dec 31, 2025device 510k217d agoNeurofield, Inc. — Genesis Sleep (510k cleared)

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

    full page →fda device 510k ↗
    ›Dec 31, 2025device 510k217d agoStryker Endoscopy — MOLLI 2 System (510k cleared)

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

    full page →fda device 510k ↗
    ›Dec 31, 2025device 510k217d agoTyber Medical, LLC — Tyber Medical Trauma Screw (510k cleared)

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

    full page →fda device 510k ↗
    ›Dec 31, 2025device 510k217d agoArc Trauma, LLC — Laryngoscope Junctional-Arterial Restriction Clamp (L-ARC); Arterial Restriction Clamp (ARC) (510k cleared)

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

    full page →fda device 510k ↗
    ›Jan 2, 2026device 510k215d agoOrthocon, Inc. — MONTAGE XT Cranial Cement (510k cleared)

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

    full page →fda device 510k ↗
    ›Jan 2, 2026device 510k215d agoJamjoom Fullcare Corporation — Ready to use Nelaton Catheter (510k cleared)

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

    full page →fda device 510k ↗
    ›Jan 2, 2026device 510k215d agoNingbo Baichen Medical Devices Co., Ltd. — Mobility Scooter (BC-MS310) (510k cleared)

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

    full page →fda device 510k ↗
    ›Jan 2, 2026device 510k215d agoZuriMED Technologies AG — FiberLocker Implant ; FiberLocker Instrument ; FiberLocker PowerUnit (510k cleared)

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

    full page →fda device 510k ↗

    Week of Jan 5, 2026

    31
    ›Jan 5, 2026device 510k212d agoSiemens Healthcare Diagnostics, Inc. — Atellica IM Total PSA II (tPSAII) (510k cleared)Dawn Sea Therapeutics

    Product code: LTJ. Advisory committee: Immunology. Type: Traditional

    full page →fda device 510k ↗
    ›Jan 5, 2026device 510k
    ← prev
    page 83 of 100
    next →
    212d ago
    Makrite Industries, Inc. — Disposable Medical Face Mask (510k cleared)

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

    full page →fda device 510k ↗
    ›Jan 5, 2026device 510k212d agoKaneka Americas Holding, Inc. — SurfRider 13 Microcatheter (510k cleared)

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

    full page →fda device 510k ↗
    ›Jan 5, 2026device 510k212d agoRadformation, Inc. — ChartCheck (RADCH V1.6) (510k cleared)

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

    full page →fda device 510k ↗
    ›Jan 5, 2026device 510k212d agoMaihub Corp. — maiLink (510k cleared)

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

    full page →fda device 510k ↗
    ›Jan 5, 2026device 510k212d agoSamsung Medison Co., Ltd. — HERA Z20 Diagnostic Ultrasound System; HERA Z20e Diagnostic Ultrasound System; HERA Z20s Diagnostic Ultrasound System; R20 Diagnostic Ultrasound System; HERA Z30 Diagnostic Ultrasound System; R30 Diagnostic Ultrasound System (510k cleared)

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

    full page →fda device 510k ↗
    ›Jan 5, 2026device 510k212d agoInnovacyn, Inc. — Puracyn® Plus Antimicrobial Irrigation Solution (510k cleared)

    Product code: FRO. Advisory committee: Unknown. Type: Traditional

    full page →fda device 510k ↗
    ›Jan 6, 2026device 510k211d agoAbanza Tecnomed S.L — QuadLock™ Fixation System (510k cleared)

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

    full page →fda device 510k ↗
    ›Jan 6, 2026device 510k211d agoHh Global Technology, Inc. — Pen Needle (510k cleared)GSI TECHNOLOGY INC

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

    full page →fda device 510k ↗
    ›Jan 6, 2026device 510k211d agoMaterialise NV — Materialise TKA Guide System (510k cleared)MATERIALISE NV

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

    full page →fda device 510k ↗
    ›Jan 6, 2026device 510k211d agoVesalio, Inc. — V-DAC Catheter (510k cleared)

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

    full page →fda device 510k ↗
    ›Jan 6, 2026device 510k211d agoEl Global Trade, Ltd. — Sensilift Pro (ST300XXYYZZZ) (510k cleared)

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

    full page →fda device 510k ↗
    ›Jan 6, 2026device 510k211d agoCarlsmed, Inc. — aprevo® cervical interbody system (510k cleared)CARLSMED, INC.

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

    full page →fda device 510k ↗
    ›Jan 6, 2026device 510k211d agoCrossroads Extremity Systems — TRILEAP Plating System (510k cleared)

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

    full page →fda device 510k ↗
    ›Jan 6, 2026device 510k211d agoShanghai Medconn Medical Technology Co., Ltd. — Medconn 8K Glycated Hemoglobin Test System (510k cleared)NewBay Medical Technology Co Ltd

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

    full page →fda device 510k ↗
    ›Jan 6, 2026device 510k211d agoInnaccel Technologies Private Limited — Saans (F4-01-00-000-000) (510k cleared)

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

    full page →fda device 510k ↗
    ›Jan 7, 2026device 510k210d agoKerr Corporation — ZenSeal Pro (510k cleared)

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

    full page →fda device 510k ↗
    ›Jan 7, 2026device 510k210d ago3-D Matrix Europe SAS — PuraStat (510k cleared)

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

    full page →fda device 510k ↗
    ›Jan 7, 2026device 510k210d ago3-D Matrix Europe SAS — PuraStat (510k cleared)

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

    full page →fda device 510k ↗
    ›Jan 7, 2026device 510k210d agoDentsply Sirona, Inc. — DS Core Detect (510k cleared)DENTSPLY SIRONA Inc.

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

    full page →fda device 510k ↗
    ›Jan 7, 2026device 510k210d agoGE Medical Systems Ultrasound and Primary Care Diagnostics — LOGIQ Fortis (510k cleared)

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

    full page →fda device 510k ↗
    ›Jan 7, 2026device 510k210d agoRemSleep Holdings, Inc. — DeltaWave Nasal Pillow System (510k cleared)RemSleep Holdings Inc.

    Product code: BZD. Advisory committee: Anesthesiology. Type: Special

    full page →fda device 510k ↗
    ›Jan 7, 2026device 510k210d agoAidoc Medical , Ltd. — BriefCase-Triage: CARE Multi-triage CT Body (510k cleared)

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

    full page →fda device 510k ↗
    ›Jan 7, 2026device 510k210d agoMaterialise NV — Materialise Personalized Guides and Models for Craniomaxillofacial Surgery CMF Titanium Guides; CMF Plastic Models (510k cleared)MATERIALISE NV

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

    full page →fda device 510k ↗
    ›Jan 7, 2026device 510k210d agoBeame Medical Technology (Shenzhen) Limited — Clear Aligner (SCF-3348) (510k cleared)

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

    full page →fda device 510k ↗
    ›Jan 7, 2026device 510k210d agoInnovative Health — Reprocessed Agilis NxT Steerable Introducer (510k cleared)

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

    full page →fda device 510k ↗
    ›Jan 7, 2026device 510k210d agoAvantec Vascular Corporation — Sangria™ Thrombectomy System (510k cleared)

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

    full page →fda device 510k ↗
    ›Jan 7, 2026device 510k210d agoJJGC Indústria e Comércio de Materiais Dentários S.A. — Neodent InLab Validated Workflow (510k cleared)

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

    full page →fda device 510k ↗
    ›Jan 7, 2026device 510k210d agoVy Spine, LLC — VyBrate™ VBR System (510k cleared)

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

    full page →fda device 510k ↗
    ›Jan 7, 2026device 510k210d agoMedtronic Sofamor Danek USA, Inc. — CD Horizon™ ModuLeX™ Spinal System (LigaMAS Head Assembly) (510k cleared)Medtronic USA Inc

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

    full page →fda device 510k ↗
    ›Jan 7, 2026device 510k210d agoS.M.A.I.O — KHEIRON® Spinal Fixation System, including patient specific K-ROD (510k cleared)

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

    full page →fda device 510k ↗
    $MTLS6.5600-1.06%
    $GSIT
    $CARL
    $MTLS6.5600-1.06%
    $RMSL
    $XRAY14.13+5.68%