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5,000 catalysts · 18,987 approval · 5,347 phase readout · 5,000 device 510k · 4,728 grant · 2,603 8k filing · 2,000 device pma

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2026-07-27: 0 catalysts2026-07-28: 0 catalysts2026-07-29: 0 catalysts2026-07-30: 0 catalysts2026-07-31: 0 catalysts2026-08-01: 0 catalysts2026-08-02: 0 catalysts2026-08-03: 4 catalysts2026-08-04: 13 catalysts2026-08-05: 17 catalysts2026-08-06: 10 catalysts2026-08-07: 1 catalyst2026-08-08: 0 catalysts2026-08-09: 0 catalysts2026-08-10: 2 catalysts2026-08-11: 1 catalyst2026-08-12: 1 catalyst2026-08-13: 1 catalyst2026-08-14: 0 catalysts2026-08-15: 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 catalysts
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type: device 510k×clear all
type
  • approval18,987
  • phase readout5,347
  • device 510k5,000
  • grant4,728
  • 8k filing2,603
  • device pma2,000
  • device recall2,000
  • recall1,126
  • device adverse event1,000
  • pdufa347
  • therapy area

    no tagged catalysts yet

    Week of Sep 8, 2025

    16
    ›Sep 12, 2025device 510k324d agoVolta Medical — Volta AF-Xplorer II (510k cleared)

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

    full page →fda device 510k ↗
    ›Sep 12, 2025device 510k324d agoEnraf-Nonius, B.V. — Compact II (510k cleared)

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

    full page →fda device 510k ↗
    ›Sep 12, 2025device 510k324d agoOdin Medical Limited — CADDIE (510k cleared)

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

    full page →fda device 510k ↗
    ›Sep 12, 2025device 510k324d agoBecton, Dickinson and Company — BD PhaSeal™ Optima Connecting Set (C83-O); BD PhaSeal™ Optima Spike Set (C180-O) (510k cleared)BECTON DICKINSON & CO

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

    full page →fda device 510k ↗
    ›Sep 12, 2025device 510k324d agoMedacta International S.A. — PowerKnot High Strength Sutures (510k cleared)Stemedica International S.A.

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

    full page →fda device 510k ↗
    ›Sep 12, 2025device 510k324d agoTangent Endoscopy, LLC — Tangent Single-Use Digital System: Tangent Single-Use Digital Catheter and Tangent Digital Controller (510k cleared)

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

    full page →fda device 510k ↗
    ›Sep 12, 2025device 510k324d agoBoston Scientific Corporation — LUX-Dx II Insertable Cardiac Monitor (M302); LUX-Dx II+ Insertable Cardiac Monitor (M312) (510k cleared)BOSTON SCIENTIFIC CORP

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

    full page →fda device 510k ↗
    ›Sep 12, 2025device 510k324d agoMevion Medical Systems, Inc. — S250-FIT Proton Beam Radiation Therapy Device (S250-FIT) (510k cleared)MERIT MEDICAL SYSTEMS INC

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

    full page →fda device 510k ↗
    ›Sep 12, 2025device 510k324d agoFujifilm Irvine Scientific — Fast Warm - NX (510k cleared)

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

    full page →fda device 510k ↗
    ›Sep 12, 2025device 510k324d agoDiagnoly — FETOLY (510k cleared)

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

    full page →fda device 510k ↗
    ›Sep 12, 2025device 510k324d agoBrainlab AG — Spine & Trauma Navigation Instruments (510k cleared)

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

    full page →fda device 510k ↗
    ›Sep 12, 2025device 510k324d agoVivachek Biotech (Hangzhou) Co., Ltd. — Wisdiag Multi-Drug Urine Test Cup; Wisdiag Multi-Drug Urine Home Test Cup (510k cleared)Hangzhou DAC Biotech Co Ltd

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

    full page →fda device 510k ↗
    ›Sep 12, 2025device 510k324d agoBontech Co., Ltd. — BONX805 (510k cleared)

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

    full page →fda device 510k ↗
    ›Sep 12, 2025device 510k324d agomibeTec GmbH — bite away two (510k cleared)

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

    full page →fda device 510k ↗
    ›Sep 13, 2025device 510k323d agoBrainsway , Ltd. — BrainsWay Deep TMS System (510k cleared)Brainsway Ltd.

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

    full page →fda device 510k ↗
    ›Sep 14, 2025device 510k322d agoTeleemg, LLC — CloudTMS Edge (510k cleared)

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

    full page →fda device 510k ↗

    Week of Sep 15, 2025

    34
    ›Sep 15, 2025device 510k321d agoSober Ip, LLC — Sober Self-Test (510k cleared)

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

    full page →fda device 510k ↗
    ›Sep 15, 2025device 510k
    ← prev
    page 64 of 100
    next →
    321d ago
    SI-BONE, Inc. — iGPS Navigation Instruments (510k cleared)SI-BONE, Inc.

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

    full page →fda device 510k ↗
    ›Sep 15, 2025device 510k321d agoShanghai AnQing Medical Instrument Co., Ltd. — Flexible Cystoscope (CY50H-20EU, CY50H-20US, CY55H-24EU, CY55H-24US) (510k cleared)

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

    full page →fda device 510k ↗
    ›Sep 15, 2025device 510k321d agoMiley Technology (Hebei) Co., Ltd. — IPL Hair Removal Device (MLY-M011); IPL Hair Removal Device (MLY-M012); IPL Hair Removal Device (MLY-M013); IPL Hair Removal Device (MLY-M015); IPL Hair Removal Device (MLY-T001); IPL Hair Removal Device (MLY-T002) (510k cleared)

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

    full page →fda device 510k ↗
    ›Sep 15, 2025device 510k321d agoPremium Plus (Dongguan) Limited — Disposable Prophy Angle (3399-60, 3399-090, 3399-105) (510k cleared)

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

    full page →fda device 510k ↗
    ›Sep 15, 2025device 510k321d agoG21, S.R.L. — SpaceFix Shoulder Spacer (510k cleared)

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

    full page →fda device 510k ↗
    ›Sep 15, 2025device 510k321d agoBeijing Infervision Healthcare Medical Technology Co., Ltd. — InferOperate Suite (510k cleared)

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

    full page →fda device 510k ↗
    ›Sep 15, 2025device 510k321d agoUvx, Inc. — Zener® (model ZEN-001-B1) (510k cleared)

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

    full page →fda device 510k ↗
    ›Sep 16, 2025device 510k320d agoCowellmedi Co., Ltd. — SFIT Abutment (510k cleared)

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

    full page →fda device 510k ↗
    ›Sep 16, 2025device 510k320d agoMicrotek Medical, LLC — Medline Microtek C-Flo Bag Decanter, Sterile (2000S); Medline Microtek Bag Decanter II, Sterile (2002S); Medline Microtek Vial Decanter, Sterile (2006S); Medline Microtek Transfer Device, Sterile (2008S) (510k cleared)

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

    full page →fda device 510k ↗
    ›Sep 16, 2025device 510k320d agoImaging Engineering, LLC — Insight Enhanced™ DRF (EN-1002-01) (510k cleared)

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

    full page →fda device 510k ↗
    ›Sep 16, 2025device 510k320d agoMedicel AG — ACCUJECT Injector Set 2.1-1P (LP604590) (510k cleared)

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

    full page →fda device 510k ↗
    ›Sep 17, 2025device 510k319d agoThe Tmj Clinic PC — Double Tube Herbst Appliance (510k cleared)

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

    full page →fda device 510k ↗
    ›Sep 17, 2025device 510k319d agoManamed, LLC — PlasmaFlow X Compression Sleeve Device (XPF0001) (510k cleared)

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

    full page →fda device 510k ↗
    ›Sep 17, 2025device 510k319d agoPegavision Corporation — Pegavision (Hioxifilcon A) Daily Disposable Soft Contact Lenses (510k cleared)

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

    full page →fda device 510k ↗
    ›Sep 17, 2025device 510k319d agoEdwards Lifesciences, LLC — Carpentier-Edwards Physio Annuloplasty Ring (4450) (510k cleared)Edwards Lifesciences Corp

    Product code: KRH. Advisory committee: Cardiovascular. Type: Abbreviated

    full page →fda device 510k ↗
    ›Sep 17, 2025device 510k319d agoKamemizu Chemical Industry Co., Ltd. — DENTURE SOFT EX (Pink set); DENTURE SOFT EX (White set); DENTURE SOFT EX (Pink powder); DENTURE SPFT EX (White powder); DENTURE SOFT EX (Liquid); DENTURE SOFT EX (Trial kit Pink); DENTURE SOFT EX (Trial kit White) (510k cleared)

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

    full page →fda device 510k ↗
    ›Sep 17, 2025device 510k319d agoShenzhen Yicai Health Technology Co., Ltd. — Air Compression Therapy Device (K1002/K1006/K1007/K1008/K1061) (510k cleared)Aimei Health Technology Co., Ltd.

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

    full page →fda device 510k ↗
    ›Sep 17, 2025device 510k319d agoRuthless, LLC Dba Ruthless Spine — Ruthless Spine RJB (510k cleared)

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

    full page →fda device 510k ↗
    ›Sep 17, 2025device 510k319d agoAbbott — Assert-IQ (DM5000); Assert-IQ (DM5300); Assert-IQ (DM5500); Merlin.net (MN7000) (510k cleared)

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

    full page →fda device 510k ↗
    ›Sep 17, 2025device 510k319d agoFujifilm Corporation — ECHELON Synergy (510k cleared)Fujifilm Holdings Corp

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

    full page →fda device 510k ↗
    ›Sep 17, 2025device 510k319d agoVitacore Industries, Inc. — Vitaform Procedural Mask - Blue (Vitaform Blue); Vitaform Procedural Mask with Shield (Vitaform-FS) (510k cleared)

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

    full page →fda device 510k ↗
    ›Sep 17, 2025device 510k319d agoFull Golden Biotech Co., Ltd. — FG Bone Graft M (510k cleared)

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

    full page →fda device 510k ↗
    ›Sep 18, 2025device 510k318d agoAxial Medical Printing Limited — Axial3D Insight (510k cleared)

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

    full page →fda device 510k ↗
    ›Sep 18, 2025device 510k318d agoMedela AG — Magic InBra (510k cleared)

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

    full page →fda device 510k ↗
    ›Sep 18, 2025device 510k318d agoShenB Co., Ltd. — Sunny Plus (Sunny) (510k cleared)

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

    full page →fda device 510k ↗
    ›Sep 18, 2025device 510k318d agoOlympus Medical Systems Corporation — ULTRASONIC PROBE UM-3R (UM-3R); ULTRASONIC PROBE UM-G20-29R (UM-G20-29R) (510k cleared)

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

    full page →fda device 510k ↗
    ›Sep 18, 2025device 510k318d agoMobarn Medical Devices, LLC — Mobarn 80:20 Lumbar Interbody Fusion System (Posterior Lumbar Interbody Fusion Cage (PLIF)); Mobarn 80:20 Lumbar Interbody Fusion System (Transforaminal Lumbar Interbody Fusion Cage (TLIF)); Mobarn 80:20 Lumbar Interbody Fusion System (Direct Lateral Lumbar Interbody Fusion Cage (DLIF)); Mobarn 80:20 Lumbar Interbody Fusion System (Anterior Lumbar Interbody Fusion Cage (ALIF)) (510k cleared)

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

    full page →fda device 510k ↗
    ›Sep 18, 2025device 510k318d agoNormaTec Industries, LP — Normatec Elite Hip (510k cleared)

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

    full page →fda device 510k ↗
    ›Sep 18, 2025device 510k318d agoSuperpi Robot Co., Ltd. — Electric Wheelchair (Model P2) (510k cleared)

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

    full page →fda device 510k ↗
    ›Sep 18, 2025device 510k318d agoPerimetrics, Inc. — InnerView System (510k cleared)

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

    full page →fda device 510k ↗
    ›Sep 19, 2025device 510k317d agoIbramed Equipamentos Médicos — VEGA (510k cleared)

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

    full page →fda device 510k ↗
    ›Sep 19, 2025device 510k317d agoMedacta International S.A. — Coated hip implants (510k cleared)Stemedica International S.A.

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

    full page →fda device 510k ↗
    ›Sep 19, 2025device 510k317d agoBunkerHill Health — Bunkerhill ECG-EF (510k cleared)

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

    full page →fda device 510k ↗
    $BDX165.62+0.10%
    $MMSI85.01+1.99%
    $BSX46.73+1.59%
    $EW91.33-2.47%
    $BWAY
    $SIBN13.41+15.55%
    $AFJKU