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5,000 catalysts · 18,987 approval · 5,539 phase readout · 5,000 device 510k · 4,728 grant · 2,701 8k filing · 2,000 device pma

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2026-08-03: 0 catalysts2026-08-04: 47 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: 0 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: 0 catalysts2026-10-09: 0 catalysts2026-10-10: 0 catalysts2026-10-11: 0 catalysts2026-10-12: 0 catalysts2026-10-13: 1 catalyst2026-10-14: 0 catalysts2026-10-15: 0 catalysts2026-10-16: 0 catalysts2026-10-17: 0 catalysts2026-10-18: 0 catalysts2026-10-19: 0 catalysts2026-10-20: 1 catalyst2026-10-21: 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: 0 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 filing2,701
  • device pma2,000
  • device recall2,000
  • recall1,126
  • device adverse event1,000
  • pdufa347
  • therapy area

    no tagged catalysts yet

    Week of Dec 15, 2025

    35
    ›Dec 19, 2025device 510k229d agoDiabeloop — DBLG2 (510k cleared)

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

    full page →fda device 510k ↗
    ›Dec 19, 2025device 510k229d agoSciton, Inc — JOULE 1064nm System and Accessories (510k cleared)Aston Sci Inc

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

    full page →fda device 510k ↗
    ›Dec 19, 2025device 510k229d agoMedtronic, Inc. — C320LBB Delivery System (C320LBBS45), C320LBB Delivery System (C320LBBS48), C320LBB Delivery System (C320LBBL45), C320LBB Delivery System (C320LBBL48) (510k cleared)Medtronic plc

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

    full page →fda device 510k ↗
    ›Dec 19, 2025device 510k229d agoMikron Makina Sanayi VE Tic. Ltd. Sti. — MSFX MIKRON PEEK CAGES (510k cleared)

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

    full page →fda device 510k ↗
    ›Dec 19, 2025device 510k229d agoLeadoptik, Inc. — LIA-1 Catheter (542-1) (510k cleared)

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

    full page →fda device 510k ↗
    ›Dec 19, 2025device 510k229d agoDiazyme Laboratories, Inc. — Diazyme Human Kappa (k) Free Light Chain Assay; Diazyme Human Lambda (¿) Free Light Chain Assay (510k cleared)Dolby Laboratories, Inc.

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

    full page →fda device 510k ↗
    ›Dec 19, 2025device 510k229d agoRhythm AI, Ltd. — STAR Apollo™ Mapping System (510k cleared)

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

    full page →fda device 510k ↗
    ›Dec 19, 2025device 510k229d agoQingdao Bright Moon Biomedical Materials Co., Ltd. — Enhanced Silver Gelling Fiber Dressing (OTC) Extra Enhanced Silver Gelling Fiber Dressing (Prescription) (510k cleared)

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

    full page →fda device 510k ↗
    ›Dec 19, 2025device 510k229d agoWontech Co., Ltd. — SANDRO Dual (510k cleared)

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

    full page →fda device 510k ↗
    ›Dec 19, 2025device 510k229d agoTruvian Health — Tru Liver Health Test Panel (510k cleared)

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

    full page →fda device 510k ↗
    ›Dec 19, 2025device 510k229d agoTOPIA MEDTECH LIMITED — Alzevita (510k cleared)

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

    full page →fda device 510k ↗
    ›Dec 19, 2025device 510k229d agoSouthern Medical (Pty) , Ltd. — Southern Craniomaxillofacial (CMF) System (510k cleared)

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

    full page →fda device 510k ↗
    ›Dec 19, 2025device 510k229d agoKulzer, LLC — iCEM Universal Plus (510k cleared)

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

    full page →fda device 510k ↗
    ›Dec 19, 2025device 510k229d agoSurgical Instrument Service and Savings, Inc. — Medline ReNewal Reprocessed Abbott Agilis Nxt Steerable Introducer (510k cleared)

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

    full page →fda device 510k ↗
    ›Dec 19, 2025device 510k229d agoSunglor Technology Co., Ltd. — LED Light Therapy Device (Models: SG-FM, SG-FE) (510k cleared)Viomi Technology Co., Ltd

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

    full page →fda device 510k ↗
    ›Dec 19, 2025device 510k229d agoCsd Labs — eMurmur Heart AI (510k cleared)

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

    full page →fda device 510k ↗
    ›Dec 19, 2025device 510k229d agoFisher & Paykel Healthcare, Ltd. — Optiflow Switch+ Filtered Nasal Interface with CO2 Sampling (AA042J) (510k cleared)

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

    full page →fda device 510k ↗
    ›Dec 19, 2025device 510k229d agoUnipack, LLC — Chiavaye Personal Moisturizer (510k cleared)

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

    full page →fda device 510k ↗
    ›Dec 19, 2025device 510k229d agoOrtho Development Corp. — Balanced Knee System TriMax Porous Femoral Components (510k cleared)DeFi Development Corp.

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

    full page →fda device 510k ↗
    ›Dec 19, 2025device 510k229d agoEncore Medical L.P. — EMPOWR Knee (510k cleared)Encore Medical, Inc.

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

    full page →fda device 510k ↗
    ›Dec 19, 2025device 510k229d agoLeadoptik, Inc. — LIA Console (542-7) (510k cleared)

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

    full page →fda device 510k ↗
    ›Dec 19, 2025device 510k229d agoMerit Medical Systems, Inc. — SCOUT MD Surgical Guidance System (510k cleared)MERIT MEDICAL SYSTEMS INC

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

    full page →fda device 510k ↗
    ›Dec 19, 2025device 510k229d agoRadformation, Inc. — ClearCalc Model RADCA V2.6 (510k cleared)

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

    full page →fda device 510k ↗
    ›Dec 19, 2025device 510k229d agoShenzhen Beacon Display Technology Co., Ltd. — LCD Monitor (CL1902A, CL2103F) (510k cleared)

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

    full page →fda device 510k ↗
    ›Dec 19, 2025device 510k229d agoGuangdong Youmeng Electrical Technology Co., Ltd. — Wearable Electric Breast Pump (YM-8803) (510k cleared)

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

    full page →fda device 510k ↗
    ›Dec 19, 2025device 510k229d agoPoskom Co., Ltd. — Airbile-100 (510k cleared)

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

    full page →fda device 510k ↗
    ›Dec 19, 2025device 510k229d agoShenzhen Xinlong Precision Plastic Mold Products Co., Ltd. — LED Light Therapy Mask (M19, M19-1, M19-2, M19-3, M19-5, M19-6) (510k cleared)

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

    full page →fda device 510k ↗
    ›Dec 19, 2025device 510k229d agoNucletron B.V. — Rectal Applicator (510k cleared)

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

    full page →fda device 510k ↗
    ›Dec 19, 2025device 510k229d agoGuangdong Youmeng Electrical Technology Co., Ltd. — Electric Breast Pump (YM-8807, YM-8805, YM-8806, YM-8810) (510k cleared)

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

    full page →fda device 510k ↗
    ›Dec 19, 2025device 510k229d agoSiemens Healthcare GmbH — MAGNETOM Sola; MAGNETOM Altea; MAGNETOM Sola Fit; MAGNETOM Viato.Mobile; MAGNETOM Vida; MAGNETOM Lumina; MAGNETOM Vida Fit; MAGNETOM Flow.Elite; MAGNETOM Flow.Neo; MAGNETOM Flow.Rise (510k cleared)

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

    full page →fda device 510k ↗
    ›Dec 19, 2025device 510k229d agoPari Respiratory Equipment, Inc. — eRapid with eTrack System (510k cleared)PARI Respiratory Equipment Inc

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

    full page →fda device 510k ↗
    ›Dec 19, 2025device 510k229d agoMedicrea International S.A.S. (Medtronic) — IB3D™ PL Spinal System (A24000000 / IB3D Universal Implant Inserter) (510k cleared)

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

    full page →fda device 510k ↗
    ›Dec 19, 2025device 510k229d agoNingbo Ranor Medical Science & Technology Co., Ltd. — Arm Blood Pressure Monitor (MJ1L, MJ2L, RN3L, RN4L,RN5L) (510k cleared)

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

    full page →fda device 510k ↗
    ›Dec 19, 2025device 510k229d agoSanhe Lefis Electronics Co., Ltd. — CO2 Laser Therapy System (Model: LFS-D9U) (510k cleared)

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

    full page →fda device 510k ↗
    ›Dec 19, 2025device 510k229d agoShenzhen Ykd Technology Co., Ltd. — Spo2 Sensor CSS032D (510k cleared)Fortior Technology (Shenzhen) Co., Ltd./ADR

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

    full page →fda device 510k ↗

    Week of Dec 22, 2025

    15
    ›Dec 22, 2025device 510k226d agoRaySearch Laboratories AB (PUBL) — RayStation (2024A SP3) (510k cleared)

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

    full page →fda device 510k ↗
    ›Dec 22, 2025device 510k
    ← prev
    page 81 of 100
    next →
    226d ago
    Taiwan Surgical Corporation — InnoClip Clip Applier (510k cleared)

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

    full page →fda device 510k ↗
    ›Dec 22, 2025device 510k226d agoTaiwan Surgical Corporation — InnoClip Disposable Clip Applier (510k cleared)

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

    full page →fda device 510k ↗
    ›Dec 22, 2025device 510k226d agoIterative Health — SKOUT system (510k cleared)

    Product code: QNP. Advisory committee: Gastroenterology, Urology. Type: Special

    full page →fda device 510k ↗
    ›Dec 22, 2025device 510k226d agoOxos Medical — MC2 Portable X-ray System (510k cleared)

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

    full page →fda device 510k ↗
    ›Dec 22, 2025device 510k226d agoPression, Inc. — Pression Wave PRO External Counter-Pulsation System (510k cleared)

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

    full page →fda device 510k ↗
    ›Dec 22, 2025device 510k226d agoBioticsai, Inc. — BioticsAI (510k cleared)

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

    full page →fda device 510k ↗
    ›Dec 22, 2025device 510k226d agoEmpatica S.r.l. — EmbraceMini (510k cleared)

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

    full page →fda device 510k ↗
    ›Dec 22, 2025device 510k226d agoGlobus Medical, Inc. — HEDRON™ Cervical Spacers (HEDRON C-MIS™ Spacer) (510k cleared)GLOBUS MEDICAL INC

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

    full page →fda device 510k ↗
    ›Dec 22, 2025device 510k226d agoInstylla, Inc. — Instylla Delivery Kit (510k cleared)

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

    full page →fda device 510k ↗
    ›Dec 22, 2025device 510k226d agoQingdao Kingon Medical Science and Technology Co., Ltd. — Oxygen Concentrator-P2-O5E (510k cleared)

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

    full page →fda device 510k ↗
    ›Dec 22, 2025device 510k226d agoTHINK Surgical, Inc. — TMINI Miniature Robotic System (510k cleared)

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

    full page →fda device 510k ↗
    ›Dec 22, 2025device 510k226d agoDIMPLO, Ltd. — DIMPLO Implant System (510k cleared)

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

    full page →fda device 510k ↗
    ›Dec 22, 2025device 510k226d agoPhilips Ultrasound, LLC — Lumify Diagnostic Ultrasound System (510k cleared)Ocuvex Therapeutics Inc

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

    full page →fda device 510k ↗
    ›Dec 22, 2025device 510k226d agoETHICON, Inc. — STRATAFIX™ Spiral PDS™ Plus Knotless Tissue Control Device; STRATAFIX™ Spiral MONOCRYL™ Plus Knotless Tissue Control Device (510k cleared)

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

    full page →fda device 510k ↗
    $MDT86.68+1.51%
    $VIOT
    $DFUKF
    $FRTRY
    $DLB
    $MMSI85.53+0.61%
    $EMI
    $GMED79.93+1.27%