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5,000 catalysts · 18,987 approval · 5,159 phase readout · 5,000 device 510k · 4,728 grant · 2,486 8k filing · 2,000 device pma

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2026-07-27: 0 catalysts2026-07-28: 0 catalysts2026-07-29: 29 catalysts2026-07-30: 13 catalysts2026-07-31: 3 catalysts2026-08-01: 0 catalysts2026-08-02: 0 catalysts2026-08-03: 4 catalysts2026-08-04: 12 catalysts2026-08-05: 14 catalysts2026-08-06: 10 catalysts2026-08-07: 1 catalyst2026-08-08: 0 catalysts2026-08-09: 0 catalysts2026-08-10: 1 catalyst2026-08-11: 1 catalyst2026-08-12: 1 catalyst2026-08-13: 0 catalysts2026-08-14: 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: 0 catalysts2026-10-22: 1 catalyst2026-10-23: 0 catalysts2026-10-24: 0 catalysts2026-10-25: 0 catalysts
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type: device 510k×clear all
type
  • approval18,987
  • phase readout5,159
  • device 510k5,000
  • grant4,728
  • 8k filing2,486
  • device pma2,000
  • device recall2,000
  • recall1,126
  • device adverse event1,000
  • pdufa319
  • therapy area

    no tagged catalysts yet

    Week of May 26, 2025

    50
    ›May 27, 2025device 510k429d agoOlympus Medical Systems Corp. — Single Use Cannula V PR-V223Q/V414Q/V416Q/V418Q/V420Q/V427Q/V434Q/V435Q; Single Use 2-Lumen Cannula V PR-V614M (510k cleared)

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

    full page →fda device 510k ↗
    ›May 27, 2025device 510k429d agoMipont Medical Equipment Co., Ltd. — Integral Dental Units (510k cleared)

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

    full page →fda device 510k ↗
    ›May 27, 2025device 510k429d agoABBOTT MEDICAL — Disposable RF Electrode (RFDE-5/RFDE-10/RFDE-15/RFDE-20) (510k cleared)

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

    full page →fda device 510k ↗
    ›May 28, 2025device 510k428d agoResmed Corp — myAir (510k cleared)RESMED INC

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

    full page →fda device 510k ↗
    ›May 28, 2025device 510k428d agoLivermoretech, Inc. — Europa (Alternative: AiRTouch) portable X-ray system (510k cleared)

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

    full page →fda device 510k ↗
    ›May 28, 2025device 510k428d agoPacific Care Limited — Disposable Prophy Angle (510k cleared)

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

    full page →fda device 510k ↗
    ›May 28, 2025device 510k428d agoShenzhen Insighters Medical Technology Co., Ltd. — Insighters™ Single-use Bronchoscope/Insight Bimodel-Integral iS-B12A 4.6/2.0; Insighters™ Single-use Bronchoscope/Insight Bimodel-Integral iS-B22A 5.5 /2.6; Insighters™ Single-use Bronchoscope/Insight Bimodel-Integral iS-B26A 6.0/3.0; Insighters™ Insight Workstation iS-PF1. (510k cleared)

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

    full page →fda device 510k ↗
    ›May 28, 2025device 510k428d agoImperative Care, Inc. — Zoom 7X Catheter; Zoom Aspiration Tubing; Zoom POD Aspiration Tubing (510k cleared)

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

    full page →fda device 510k ↗
    ›May 28, 2025device 510k428d agoTermosalud S.L. — Zionic Pro Max (Radiofrequency) (510k cleared)

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

    full page →fda device 510k ↗
    ›May 28, 2025device 510k428d agoBoston Scientific Corporation — OptiMap™ System (510k cleared)BOSTON SCIENTIFIC CORP

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

    full page →fda device 510k ↗
    ›May 28, 2025device 510k428d agoTaiwan Medical Imaging Co., Ltd. — TAIMedImg DeepMets (510k cleared)

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

    full page →fda device 510k ↗
    ›May 28, 2025device 510k428d agoSurGenTec, LLC — OsteoFlo HydroFiber (510k cleared)

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

    full page →fda device 510k ↗
    ›May 28, 2025device 510k428d agoOpcom Medical, Inc. — Flexible Ureteroscope (U-Scope)(2.8/1.2) (OMI161-2F28-CH12-US); Flexible Ureteroscope (U-Scope)(2.5/1.2) (OMI161-2F25-CH12-US); Images Systems (Camera-Controlled Unit) (OMI01M12) (510k cleared)

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

    full page →fda device 510k ↗
    ›May 28, 2025device 510k428d agoIradimed Corporation — MRidium 3870 MRI Infusion Pump System (3870) (510k cleared)IRADIMED CORP

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

    full page →fda device 510k ↗
    ›May 28, 2025device 510k428d agoIschemaview, Inc. — Rapid MLS (510k cleared)

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

    full page →fda device 510k ↗
    ›May 28, 2025device 510k428d agoSmart Soft Healthcare AD — CoLumboX (510k cleared)

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

    full page →fda device 510k ↗
    ›May 29, 2025device 510k427d agoShenzhen Astec Technology Co., Ltd. — TENS AND EMS (TENS and Muscle Stimulator) ( Model AS8012C,AS8016,AS8019,AS9020E,AS9026) (510k cleared)Fortior Technology (Shenzhen) Co., Ltd./ADR

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

    full page →fda device 510k ↗
    ›May 29, 2025device 510k427d agoBaylis Medical Company, Inc. — VersaCross Connect™ Transseptal Dilator (510k cleared)

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

    full page →fda device 510k ↗
    ›May 29, 2025device 510k427d agoReflow Medical, Inc. — Spur Peripheral Retrievable Stent System (510k cleared)

    Product code: SEU. Advisory committee: Cardiovascular. Type: Direct

    full page →fda device 510k ↗
    ›May 29, 2025device 510k427d agoMedtronic Navigation — Visualase V2 MRI-guided Laser Ablation System (9736422) (510k cleared)

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

    full page →fda device 510k ↗
    ›May 29, 2025device 510k427d agoOsteonic Co., Ltd. — SIGNEX (510k cleared)

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

    full page →fda device 510k ↗
    ›May 29, 2025device 510k427d agoTerumo Europe N.V. — 27G x 1/2 TW K-Pack Surshield Needle (KN-S2713RBT) (510k cleared)

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

    full page →fda device 510k ↗
    ›May 29, 2025device 510k427d agoShanghai AnQing Medical Instrument Co., Ltd. — Portable Video Processor (EA101), Flexible Bronchoscope BS41H-12EU, BS41H-12US, BS46H-17EU, BS50H-20EU, BS46H-17US, BS50H-20US, BS53H-22EU, BS53H-22US, BS55H-24EU, BS55H-24US, BS59H-28EU, BS59H-28US (510k cleared)

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

    full page →fda device 510k ↗
    ›May 29, 2025device 510k427d agoYueying Medical Instruments (Langfang) Co., Ltd. — Dental Barrier and Sleeves (510k cleared)

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

    full page →fda device 510k ↗
    ›May 29, 2025device 510k427d agoPiccolo Medical, Inc. — PM2+ System and SmartPICC Stylet (510k cleared)Picard Medical, Inc.

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

    full page →fda device 510k ↗
    ›May 29, 2025device 510k427d agoGE Medical Systems Ultrasound and Primary Care Diagnostics — Voluson™ Performance 16; Voluson™ Performance 18 (510k cleared)

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

    full page →fda device 510k ↗
    ›May 29, 2025device 510k427d agoCochlear — Baha 7 Sound Processor; Baha Fitting Software 7 (P2121898); Baha Smart App (iOS) (P1646054); Baha Smart App (Android) (P1646035); Baha SoundBand (510k cleared)

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

    full page →fda device 510k ↗
    ›May 29, 2025device 510k427d agoEpic Medical Pte. , Ltd. — ProSeal™ Bag Spike with Additive Port (423370ST, 423370) (510k cleared)

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

    full page →fda device 510k ↗
    ›May 29, 2025device 510k427d agoNeurent Medical , Ltd. — NEUROMARK System (NMK00301) (510k cleared)

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

    full page →fda device 510k ↗
    ›May 29, 2025device 510k427d agoKuraray Noritake Dental, Inc. — CERABIEN MiLai (510k cleared)

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

    full page →fda device 510k ↗
    ›May 29, 2025device 510k427d agoMasimo Corporation — Radius VSM and Accessories (510k cleared)MASIMO CORP

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

    full page →fda device 510k ↗
    ›May 29, 2025device 510k427d agoRemex Medical Corp. — Anatase Spine Surgery Navigation System and Remex Spine Surgery Navigation System II (510k cleared)Medicale Corp.

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

    full page →fda device 510k ↗
    ›May 29, 2025device 510k427d agoGerium Medical, Ltd. — BiliWrap (510k cleared)

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

    full page →fda device 510k ↗
    ›May 29, 2025device 510k427d agoArthrex, Inc. — SuturePatch Tissue Reinforcement (510k cleared)

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

    full page →fda device 510k ↗
    ›May 30, 2025device 510k426d agoMatelaser, Inc. — MateLaser Medical Laser Therapy Systems (ML-HIL-30, ML-HIL-60) (510k cleared)

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

    full page →fda device 510k ↗
    ›May 30, 2025device 510k426d agoShenzhen Mindray Bio-Medical Electronics Co., Ltd. — TE Air Diagnostic Ultrasound System (510k cleared)

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

    full page →fda device 510k ↗
    ›May 30, 2025device 510k426d agoShenzhen TPH Technology Co., Ltd. — Wearable Breast Pump (Model S21) (510k cleared)Fortior Technology (Shenzhen) Co., Ltd./ADR

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

    full page →fda device 510k ↗
    ›May 30, 2025device 510k426d agoOsang, LLC — OHC COVID-19 Antigen Self Test (510k cleared)

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

    full page →fda device 510k ↗
    ›May 30, 2025device 510k426d agoNingbo Youhe Electrical Appliance Technology Co., Ltd. — Youha electric breast pumps (The INs, The INs Gen2, The INs NEXT, and P3) and BEBEBAO electric breast pump (P1s) (510k cleared)

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

    full page →fda device 510k ↗
    ›May 30, 2025device 510k426d agoMindset Medical, Inc. — Informed Vital Core Application (IVC App) (v2.0.0.2.0.0) (510k cleared)Outset Medical, Inc.

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

    full page →fda device 510k ↗
    ›May 30, 2025device 510k426d agoThi Total Healthcare Innovation GmbH — ViVi® Toga Premium (510k cleared)

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

    full page →fda device 510k ↗
    ›May 30, 2025device 510k426d agoAidoc Medical , Ltd. — BriefCase-Triage (510k cleared)

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

    full page →fda device 510k ↗
    ›May 30, 2025device 510k426d agoXbody Hungary Kft. — XBody Go USA, XBody Pro USA (510k cleared)

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

    full page →fda device 510k ↗
    ›May 30, 2025device 510k426d agoSorin Group Italia S.R.L. — VANGUARD Blood cardioplegia Systems (Vanguard 4:1 Blood cardioplegia set); VANGUARD Blood cardioplegia Systems (Vanguard 4:1 Blood cardioplegia set with shunt); VANGUARD Blood cardioplegia Systems (Vanguard 4:1 Blood Cardioplegia Set Mini) (510k cleared)

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

    full page →fda device 510k ↗
    ›May 30, 2025device 510k426d agoJeil Medical Corporation — ARIX Pectus Bar System (510k cleared)

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

    full page →fda device 510k ↗
    ›May 30, 2025device 510k426d agoAmber Implants — VCFix Spinal System (510k cleared)

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

    full page →fda device 510k ↗
    ›May 30, 2025device 510k426d agoOwens & Minor (O&M) Halyard, Inc. — Fluidshield * 3 Fog-Free Surgical Mask with Wraparound Anti-Glare Visor (28804); Fluidshield * 3 Surgical Mask with SO SOFT* Lining (48208); Fluidshield * 3 Fog-Free Surgical Mask with SO SOFT* Lining (48207); Fluidshield * 3 Fog-Free Surgical Mask with SO SOFT* Lining, with Visor (48237); Fluidshield* 3 Fog-Free Surgical Mask with SO SOFT* Lining, Anti-Glare WrapAround Visor (48247); Fluidshield * 3 Fog-Free Procedure Mask with SO SOFT* Earloops (28797); Fluidshield * 3 Fog-Free Proce (510k cleared)

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

    full page →fda device 510k ↗
    ›May 30, 2025device 510k426d agoFresenius Medical Care Renal Therapies Group, LLC — 5008X Hemodialysis System (510k cleared)Fresenius Medical Care AG

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

    full page →fda device 510k ↗
    ›May 30, 2025device 510k426d agoBonraybio Co., Ltd. — LensHooke X3 PRO Semen Quality Analyzer; LensHooke X3 PRO SE Semen Quality Analyzer (510k cleared)

    Product code: POV. Advisory committee: Hematology. Type: Traditional

    full page →fda device 510k ↗
    ›May 30, 2025device 510k426d agoShenzhen TPH Technology Co., Ltd. — Motif Aura Glow breast pump (Model Motif Aura Glow) (510k cleared)Fortior Technology (Shenzhen) Co., Ltd./ADR

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

    full page →fda device 510k ↗
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    page 44 of 100
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    $PMI0.1821-4.66%
    $MCLE
    $BSX46.06+1.21%
    $RMD220.38+5.13%
    $MASI
    $IRMD
    $FRTRY
    $FMS24.75-0.48%
    $FRTRY
    $OM4.5200-1.09%
    $FRTRY