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5,000 catalysts · 18,987 approval · 5,539 phase readout · 5,000 device 510k · 4,728 grant · 2,722 8k filing · 2,000 device pma

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2026-08-03: 0 catalysts2026-08-04: 68 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: 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: 1 catalyst2026-10-31: 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 filing2,722
  • device pma2,000
  • device recall2,000
  • recall1,126
  • device adverse event1,000
  • pdufa383
  • therapy area

    no tagged catalysts yet

    Week of Dec 22, 2025

    47
    ›Dec 22, 2025device 510k226d agoArthrex, Inc. — Syndesmosis TightRope PRO (510k cleared)

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

    full page →fda device 510k ↗
    ›Dec 22, 2025device 510k226d agoZhejiang Gongdong Medical Technology Co., Ltd. — Gongdong Sharps Container (SCR-01Q, SCR-01G, SCR-03G) (510k cleared)Zhejiang Xinkanghe Biomedical Technology Co Ltd

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

    full page →fda device 510k ↗
    ›Dec 22, 2025device 510k226d agoAccurkardia, Inc. — AccurECG Analysis System (v2.0) (510k cleared)

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

    full page →fda device 510k ↗
    ›Dec 22, 2025device 510k226d agoEmed Technologies Corporation — Tetra (TM-20); Tetra (TM-50) (510k cleared)

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

    full page →fda device 510k ↗
    ›Dec 22, 2025device 510k226d agoStimlabs, LLC — Theracor (510k cleared)

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

    full page →fda device 510k ↗
    ›Dec 22, 2025device 510k226d agoShenzhen Homed Medical Device Co., Ltd. — Portable oxygen concentrator (JLO-190P) (510k cleared)

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

    full page →fda device 510k ↗
    ›Dec 22, 2025device 510k226d agoBioteque Corporation — BIOTEQ Drainage Catheter Set: BT-PD1-SERIES-G and BT-PDS-SERIES-G (510k cleared)

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

    full page →fda device 510k ↗
    ›Dec 22, 2025device 510k226d agoSorin Group Italia S.R.L. — Inspire HCR and HCR DUAL cardiotomy reservoirs (510k cleared)

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

    full page →fda device 510k ↗
    ›Dec 22, 2025device 510k226d agoLacerta Life Science — LacertaMatrix (510k cleared)

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

    full page →fda device 510k ↗
    ›Dec 22, 2025device 510k226d agoPeek Health, S.A. — PeekMed web (510k cleared)

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

    full page →fda device 510k ↗
    ›Dec 22, 2025device 510k226d agoZhenjiang Assure Medical Equipment Co., Ltd. — Power wheelchair (510k cleared)

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

    full page →fda device 510k ↗
    ›Dec 22, 2025device 510k226d agoCarlsmed, Inc. — aprevo® cervical plating system (510k cleared)CARLSMED, INC.

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

    full page →fda device 510k ↗
    ›Dec 22, 2025device 510k226d agoKp Trading Co., Ltd. — KP Protective Face Mask (510k cleared)

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

    full page →fda device 510k ↗
    ›Dec 23, 2025device 510k225d agoShenzhen Siken 3D Technology Development Co., Ltd. — Multi-functional Facial Beauty Device ( SKB-1703,SKB-1803,SKB-1909, SKB-2003 SKB-2109,SKB-2129,SKB-2208PRO, SKB-2209) (510k cleared)

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

    full page →fda device 510k ↗
    ›Dec 23, 2025device 510k225d agoNakanishi, Inc. — VarioSurg 4 (510k cleared)

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

    full page →fda device 510k ↗
    ›Dec 23, 2025device 510k225d agoUpdoc, Inc. — UpDoc (510k cleared)

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

    full page →fda device 510k ↗
    ›Dec 23, 2025device 510k225d agoDiasorin Molecular, LLC — LIAISON NES FLU A/B, RSV & COVID-19 (510k cleared)

    Product code: QOF. Advisory committee: Microbiology. Type: Dual Track

    full page →fda device 510k ↗
    ›Dec 23, 2025device 510k225d agoHealgen Scientific,, LLC — Healgen® URS Test Strips (510k cleared)

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

    full page →fda device 510k ↗
    ›Dec 23, 2025device 510k225d agoHycor Biomedical — NOVEOS Specific IgE (sIgE); Capture Reagent F024, Shrimp (Shrimp spp.); Capture Reagent F207, Clam (Mercenaria mercenaria); Capture Reagent F256, Walnut (Juglans spp.) ; Capture Reagent I006, German Cockroach (Blatella germanica) (510k cleared)Dawn Sea Therapeutics

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

    full page →fda device 510k ↗
    ›Dec 23, 2025device 510k225d agoCylite Pty. , Ltd. — UNITY DX (UDX) (510k cleared)

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

    full page →fda device 510k ↗
    ›Dec 23, 2025device 510k225d agoPhilips Consumer Lifestyle B.V. — Philips Lumea IPL (510k cleared)

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

    full page →fda device 510k ↗
    ›Dec 23, 2025device 510k225d agoSignature Orthopaedics Pty, Ltd. — Active-V Total Knee System; World Total Knee System (510k cleared)

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

    full page →fda device 510k ↗
    ›Dec 23, 2025device 510k225d agoHong Qiangxing (Shenzhen) Electronics Limited — TENS&EMS (HZ9151B, HZ9151C, HZ9151D) (510k cleared)

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

    full page →fda device 510k ↗
    ›Dec 23, 2025device 510k225d agoOrangecad Med GmbH — OrangeCAD Med Abutments (510k cleared)

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

    full page →fda device 510k ↗
    ›Dec 23, 2025device 510k225d agoDynapulse Medical — VEINOPLUS Back (510k cleared)

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

    full page →fda device 510k ↗
    ›Dec 23, 2025device 510k225d agoAura Medical, LLC — Aura Glide (FC40) (510k cleared)QOL Medical LLC

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

    full page →fda device 510k ↗
    ›Dec 23, 2025device 510k225d agoBruno Vision Care, LLC — Deseyne (vifilcon C) Daily Disposable Soft (hydrophilic) Contact Lens with UV Blocking for Presbyopia (EDOF) (510k cleared)

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

    full page →fda device 510k ↗
    ›Dec 23, 2025device 510k225d agoDongguan Yijiaming Technology Co., Ltd. — LED Light Therapy Device (HLGMZ-3W-G1V1,HLGMZ-3W-G2V1,HLG-GJXJ-G1V1,HGMZ-2W-G1V1, HGMZ-2W-G2V1,MRD-GJXJ-G1V1.) (510k cleared)

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

    full page →fda device 510k ↗
    ›Dec 23, 2025device 510k225d agoGe Medical Systems, LLC — AIR Recon DL (510k cleared)

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

    full page →fda device 510k ↗
    ›Dec 23, 2025device 510k225d agoLinhejiacheng (Shenzhen) E-Commerce Co., Ltd. — Paruu Wearable Breast pump (P16, P16-A, P16-B, P16-C, P16-D, P20, P9, P10, P10 PRO, P21, P22, P23, P24, P25, P26, P27, P28, P29, P30, P20-A, P20-B, P20-C, P20-D) (510k cleared)

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

    full page →fda device 510k ↗
    ›Dec 23, 2025device 510k225d agoMedimaging Integrated Solution, Inc (Miis) — MiiS Horus Arthroscope (EJA 100); MiiS Horus Endoscope Display System -Tablet (EDS 500); MiiS Horus Endoscope Display System -Video Box (EVS 700) (510k cleared)

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

    full page →fda device 510k ↗
    ›Dec 23, 2025device 510k225d agoGuangdong Prestige Technology Co., Ltd. — Electric Scooter (S202572J, S2060, M2089, S2050) (510k cleared)

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

    full page →fda device 510k ↗
    ›Dec 23, 2025device 510k225d agoParagon Implant Mfg., LLC — NizPlant Dental Implant System (510k cleared)

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

    full page →fda device 510k ↗
    ›Dec 23, 2025device 510k225d agoHai Solutions — QIKCAP System (510k cleared)

    Product code: SGX. Advisory committee: General Hospital. Type: Direct

    full page →fda device 510k ↗
    ›Dec 23, 2025device 510k225d agoShenzhen Safesecure Medical Infection Control Tech Co. , Ltd. — SafeSecure Steam Sterilization Process Indicator (4012, 4013, 4014, 4016); SafeSecure Vaporized Hydrogen Peroxide Sterilization Process Indicator (4211, 4212, 4213) (510k cleared)Kortuc Japan LLC

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

    full page →fda device 510k ↗
    ›Dec 23, 2025device 510k225d agoEdan Instruments, Inc. — Diagnostic Ultrasound System (Nano C5, Nano C5 EXP, Nano L12, and Nano L12 EXP) (510k cleared)VEECO INSTRUMENTS INC

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

    full page →fda device 510k ↗
    ›Dec 23, 2025device 510k225d agoHealgen Scientific,, LLC — Healgen Accurate Urine Drug Screen Dip Card; Healgen Accurate Home Urine Drug Test Dip Card (510k cleared)

    Product code: NGL. Advisory committee: Clinical Toxicology. Type: Traditional

    full page →fda device 510k ↗
    ›Dec 23, 2025device 510k225d agoDiaSorin, Inc. — LIAISON® XL MUREX Anti-HDV (318260); LIAISON® XL MUREX Control Anti-HDV (318261) (510k cleared)Dawn Sea Therapeutics

    Product code: SGW. Advisory committee: Immunology. Type: Direct

    full page →fda device 510k ↗
    ›Dec 23, 2025device 510k225d agoParagon Implant Mfg., LLC — GEN5™ and GEN5+™ 3.3mmD Dental Implants (510k cleared)

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

    full page →fda device 510k ↗
    ›Dec 23, 2025device 510k225d agoMedentika GmbH — Custom Abutments AS (510k cleared)

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

    full page →fda device 510k ↗
    ›Dec 23, 2025device 510k225d agoTherapanacea Sas — ART-Plan+ (v3.1.0) (510k cleared)

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

    full page →fda device 510k ↗
    ›Dec 23, 2025device 510k225d agoSim&Cure — Sim&Size (510k cleared)

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

    full page →fda device 510k ↗
    ›Dec 23, 2025device 510k225d agoOsteoremedies, LLC — OsteoRemedies Hip Spacer System (510k cleared)

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

    full page →fda device 510k ↗
    ›Dec 24, 2025device 510k224d agoLight Tree Ventures Europe B.V. — Hair Regrowth Cap (Model: T-119-HRC) (510k cleared)

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

    full page →fda device 510k ↗
    ›Dec 24, 2025device 510k224d agoShenzhen Saidi Light Therapy Technology Co., Ltd. — LED Light Therapy Face Mask (FM60X, FM60X-B, FM60X-W, FM80-W, FM80, VAP1, FM100X, FM100X-B, FM100X-W) (510k cleared)

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

    full page →fda device 510k ↗
    ›Dec 24, 2025device 510k224d agoSpeclipse, Inc. — PICO-K (510k cleared)

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

    full page →fda device 510k ↗
    ›Dec 24, 2025device 510k224d agoHeat IN A Click, LLC — Feather/numiere 05 06 07 (05) (510k cleared)

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

    full page →fda device 510k ↗

    Week of Dec 29, 2025

    3
    ›Dec 29, 2025device 510k219d agoFoshan Kycare Medical Equipment Co., Ltd. — Oxygen Concentrator (J10A) (510k cleared)

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

    full page →fda device 510k ↗
    ›Dec 29, 2025device 510k
    ← prev
    page 82 of 100
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    219d ago
    Taewoong Medical Co., Ltd. — Niti-S Biliary Stent; Niti-S Biliary Slim M Stent (510k cleared)

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

    full page →fda device 510k ↗
    ›Dec 29, 2025device 510k219d agoShenzhen Fansizhe Science and Technology Co., Ltd. — Intense Pulsed Light (IPL) System (Models: T033KQ, T033KD, T033KF, T033MQ, T033MD, T033MF, T055KQ, T055KD, T055KH, T505KQ, T505KH, T505KF, SL-B505WM) (510k cleared)

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

    full page →fda device 510k ↗
    $VECO59.42+2.95%
    $CARL