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5,000 catalysts · 18,987 approval · 5,443 phase readout · 5,000 device 510k · 4,728 grant · 2,672 8k filing · 2,000 device pma

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2026-08-03: 0 catalysts2026-08-04: 18 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: 0 catalysts2026-10-14: 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 readout5,443
  • device 510k5,000
  • grant4,728
  • 8k filing2,672
  • device pma2,000
  • device recall2,000
  • recall1,126
  • device adverse event1,000
  • pdufa347
  • therapy area

    no tagged catalysts yet

    Week of Dec 15, 2025

    50
    ›Dec 16, 2025device 510k231d agoGordian Surgical, Ltd. — TroClose 1200 (510k cleared)

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

    full page →fda device 510k ↗
    ›Dec 16, 2025device 510k231d agoGuangzhou Red Pine Medical Instrument Co., Ltd. — Single-Use Video Flexible Ureterorenoscope (RP-U-C03R9, RP-U-C03R3, RP-U-C03S9, RP-U-C03S3); Endoscopic Video Image Processor (RP-IPD-V2000EF); Endoscopic Video Image Processor (RP-IPD-V1000F) (510k cleared)

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

    full page →fda device 510k ↗
    ›Dec 16, 2025device 510k231d agoSignature Orthopaedics Pty, Ltd. — Cambridge Partial Knee (510k cleared)

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

    full page →fda device 510k ↗
    ›Dec 16, 2025device 510k231d agoSkanray Technologies Limited — SKAN C PULSAR (510k cleared)

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

    full page →fda device 510k ↗
    ›Dec 16, 2025device 510k231d agoProlaio, Inc. — prolaio eVO2peak Module (Version 1.0) (510k cleared)

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

    full page →fda device 510k ↗
    ›Dec 16, 2025device 510k231d agoShenzhen Harveymed Technology Co., Ltd. — V series portable oxygen concentrator (V5, V5C, V6, V6C) (510k cleared)

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

    full page →fda device 510k ↗
    ›Dec 16, 2025device 510k231d agoVarian Medical Systems, Inc. — IDENTIFY (5.0) (510k cleared)MERIT MEDICAL SYSTEMS INC

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

    full page →fda device 510k ↗
    ›Dec 16, 2025device 510k231d agoCompanion Spine France — Companion Spine DIAM™ Instrumentation (510k cleared)

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

    full page →fda device 510k ↗
    ›Dec 16, 2025device 510k231d agoPolyConversions, Inc. — VR® Personal Protective Level 3 Gown (VR Gowns) (510k cleared)

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

    full page →fda device 510k ↗
    ›Dec 17, 2025device 510k230d agoDexcom, Inc. — Dexcom G7 Continuous Glucose Monitoring (CGM) System, Dexcom G7 15 Day Continuous Glucose Monitoring (CGM) System (510k cleared)DEXCOM INC

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

    full page →fda device 510k ↗
    ›Dec 17, 2025device 510k230d agoShenzhen Goodwind Technology Development Co., Ltd. — Wrinkle Retreat Pro Light Therapy Face Mask (Model: PH-m03) (510k cleared)

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

    full page →fda device 510k ↗
    ›Dec 17, 2025device 510k230d 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 ↗
    ›Dec 17, 2025device 510k230d agoShenzhen Comen Medical Instruments Co.,Ltd — Multi-parameter Patient Monitor (N10); Multi-parameter Patient Monitor (N12); Multi-parameter Patient Monitor (N15); Multi-parameter Patient Monitor (N10MPro); Multi-parameter Patient Monitor (N12MPro); Multi-parameter Patient Monitor (N15MPro) (510k cleared)

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

    full page →fda device 510k ↗
    ›Dec 17, 2025device 510k230d agoTerumo Medical Products (Hangzhou) Co., Ltd. — SURFLO Hybria Closed System Safety IV Catheter (510k cleared)

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

    full page →fda device 510k ↗
    ›Dec 17, 2025device 510k230d agoUnibeauty (Hubei) Technology Co., Ltd. — Unscented Menstrual Long Applicator Tampon; Unscented Menstrual Cardboard Applicator Tampon; Unscented Menstrual Digital Tampons (510k cleared)

    Product code: HEB. Advisory committee: Obstetrics/Gynecology. Type: Special

    full page →fda device 510k ↗
    ›Dec 17, 2025device 510k230d agoRoche Diagnostics — Elecsys Anti-SARS-CoV-2 (510k cleared)

    Product code: QVP. Advisory committee: Microbiology. Type: Special

    full page →fda device 510k ↗
    ›Dec 17, 2025device 510k230d agoBonebridge AG — BRUSIO Trauma Toolbox System; TAMINA 3.5mm Proximal Humerus System (510k cleared)

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

    full page →fda device 510k ↗
    ›Dec 17, 2025device 510k230d agoUltrasight , Ltd. — UltraSight Guidance (510k cleared)

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

    full page →fda device 510k ↗
    ›Dec 17, 2025device 510k230d agoHighridge Medical, LLC — Vital™ Spinal Fixation System (510k cleared)

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

    full page →fda device 510k ↗
    ›Dec 17, 2025device 510k230d agoDuopross Meditech Corporate — DuoprossTM Smart Cap (Type I) (510k cleared)

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

    full page →fda device 510k ↗
    ›Dec 17, 2025device 510k230d agoEthicon Endo-Surgery, LLC — ETHICON™ 4000 45mm Compact Stapler (EC3DT45C); ETHICON™ 4000 45mm Standard Stapler (EC3DT45S); ETHICON™ 4000 45mm Long Stapler (EC3DT45L); ETHICON™ 3D 45mm White Reload (ER45W); ETHICON™ 3D 45mm Blue Reload (ER45B); ETHICON™ 3D 45mm Green Reload (ER45G); ETHICON™ 3D 45mm Black Reload (ER45T) (510k cleared)

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

    full page →fda device 510k ↗
    ›Dec 17, 2025device 510k230d agoInari Medical, Inc. — Intri26 Introducer Sheath (510k cleared)Mobia Medical, Inc.

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

    full page →fda device 510k ↗
    ›Dec 17, 2025device 510k230d agoABBOTT MEDICAL — Amplatzer Piccolo™ Delivery System (9-PDS-04F-045) (510k cleared)

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

    full page →fda device 510k ↗
    ›Dec 17, 2025device 510k230d agoNeosoma, Inc. — Neosoma Brain Mets (510k cleared)

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

    full page →fda device 510k ↗
    ›Dec 18, 2025device 510k229d agoEdwards Lifesciences — HemoSphere Alta Advanced Monitoring Platform (ALTAALL1; ALTACR1; ALTASR1) (510k cleared)Edwards Lifesciences Corp

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

    full page →fda device 510k ↗
    ›Dec 18, 2025device 510k229d agoOvesco Endoscopy AG — OTSCneo System Set (100.03n-14n, 100.27n-31n) (510k cleared)

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

    full page →fda device 510k ↗
    ›Dec 18, 2025device 510k229d agoOlympus Medical Systems Corporation — Single Use Cytology Brush V (BC-V600P-3010) (510k cleared)

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

    full page →fda device 510k ↗
    ›Dec 18, 2025device 510k229d agoNatec Medical , Ltd. — Amethyst HP PTA OTW 0.035 Catheter (510k cleared)

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

    full page →fda device 510k ↗
    ›Dec 18, 2025device 510k229d agoFresenius Medical Care Renal Therapies Group, LLC — FX CorAL 40; FX CorAL 50 (510k cleared)Fresenius Medical Care AG

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

    full page →fda device 510k ↗
    ›Dec 18, 2025device 510k229d agoTomey Corporation — Tomey Optical Biometer OA-2000 (OA-2000) (510k cleared)

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

    full page →fda device 510k ↗
    ›Dec 18, 2025device 510k229d agoEndovascular Engineering, Inc. — Helo Thrombectomy System (510k cleared)

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

    full page →fda device 510k ↗
    ›Dec 18, 2025device 510k229d agoJiangsu Jiyuan Medical Technology Co., Ltd. — ARMI® Endoscopic Video Image Processor (JY-MIP-3000); ARMI® Single-Use Hysteroscope (SH-01A, SH-02A, SH-03A, SH-04A, SH-05A, SH-01B, SH-02B, SH-03B, SH-04B, SH-01C, SH-02C, SH-03C, SH-04C) (510k cleared)Jiangsu Maoxing Technology Co Ltd

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

    full page →fda device 510k ↗
    ›Dec 18, 2025device 510k229d agoMedizin Produkte Neustadt GmbH (Mpn) — Dental Cone; Dental Sponge (510k cleared)

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

    full page →fda device 510k ↗
    ›Dec 18, 2025device 510k229d agoTerumo Medical Products (Hangzhou) Co., Ltd. — Midline Catheter (510k cleared)

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

    full page →fda device 510k ↗
    ›Dec 18, 2025device 510k229d agoCrescom Co., Ltd. — MediAI-BA (510k cleared)

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

    full page →fda device 510k ↗
    ›Dec 18, 2025device 510k229d agoPark Dental Research Corp. — Park Dental Nylon MAD (510k cleared)

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

    full page →fda device 510k ↗
    ›Dec 18, 2025device 510k229d agoReflexion Medical, Inc. — RefleXion Medical Radiotherapy System, Reflexion X2 (510k cleared)

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

    full page →fda device 510k ↗
    ›Dec 18, 2025device 510k229d agoABBOTT MEDICAL — Assert-IQ (DM5100) (510k cleared)

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

    full page →fda device 510k ↗
    ›Dec 18, 2025device 510k229d agoUltrasight , Ltd. — PVAD IQ Software (510k cleared)

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

    full page →fda device 510k ↗
    ›Dec 18, 2025device 510k229d agoSimda Co., Ltd. — SIMDA Abutments (510k cleared)

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

    full page →fda device 510k ↗
    ›Dec 18, 2025device 510k229d agoErbe Elektromedizin GmbH — MOVIVA® Hybrid Ablation Probe (510k cleared)

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

    full page →fda device 510k ↗
    ›Dec 19, 2025device 510k228d agoHeartLung Corporation — AI-CVD (510k cleared)

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

    full page →fda device 510k ↗
    ›Dec 19, 2025device 510k228d agoParagon 28, Inc. — Monkey Rings External Ring Fixation System (510k cleared)

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

    full page →fda device 510k ↗
    ›Dec 19, 2025device 510k228d agoMedskin Solutions Dr. Suwelack AG — MatriDerm pluS+ Bi-Layer (510k cleared)

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

    full page →fda device 510k ↗
    ›Dec 19, 2025device 510k228d agoStryker GmbH — Hoffmann LRF System (510k cleared)STRYKER CORP

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

    full page →fda device 510k ↗
    ›Dec 19, 2025device 510k228d agoSorin Group Italia S.R.L. — ProtekDilate Vascular Access Kit (510k cleared)

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

    full page →fda device 510k ↗
    ›Dec 19, 2025device 510k228d agoGm Dos Reis Industria E Comercio — Pectus Versa System (510k cleared)

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

    full page →fda device 510k ↗
    ›Dec 19, 2025device 510k228d agoCathegenix (Xiamen) Co., Ltd. — Endura™ Ureteral Stent and Stent Set (510k cleared)

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

    full page →fda device 510k ↗
    ›Dec 19, 2025device 510k228d agoCapsoVision, Inc. — CE Deliver (DLV) (510k cleared)CapsoVision, Inc

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

    full page →fda device 510k ↗
    ›Dec 19, 2025device 510k228d agoOconnell Regulatory Consultants, Inc. — Vivo 45 LS (510k cleared)

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

    full page →fda device 510k ↗
    ← prev
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    $CV
    $FMS25.26-1.56%
    $MMSI85.53+0.61%
    $MOBI
    $EW91.33-2.47%
    $DXCM87.31+4.63%
    $SYK341.20+4.76%