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2,254 catalysts · 4,728 grant · 3,603 8k filing · 2,655 approval · 2,254 device 510k · 1,816 device recall · 1,567 device pma

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2026-08-24: 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: 1 catalyst2026-09-04: 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: 2 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: 1 catalyst2026-10-01: 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: 2 catalysts2026-10-09: 0 catalysts2026-10-10: 0 catalysts2026-10-11: 0 catalysts2026-10-12: 0 catalysts2026-10-13: 1 catalyst2026-10-14: 1 catalyst2026-10-15: 0 catalysts2026-10-16: 0 catalysts2026-10-17: 0 catalysts2026-10-18: 0 catalysts2026-10-19: 1 catalyst2026-10-20: 2 catalysts2026-10-21: 2 catalysts2026-10-22: 2 catalysts2026-10-23: 1 catalyst2026-10-24: 0 catalysts2026-10-25: 0 catalysts2026-10-26: 1 catalyst2026-10-27: 8 catalysts2026-10-28: 12 catalysts2026-10-29: 21 catalysts2026-10-30: 4 catalysts2026-10-31: 0 catalysts2026-11-01: 0 catalysts2026-11-02: 9 catalysts2026-11-03: 18 catalysts2026-11-04: 22 catalysts2026-11-05: 37 catalysts2026-11-06: 2 catalysts2026-11-07: 0 catalysts2026-11-08: 0 catalysts2026-11-09: 1 catalyst2026-11-10: 0 catalysts2026-11-11: 0 catalysts2026-11-12: 0 catalysts2026-11-13: 0 catalysts2026-11-14: 0 catalysts2026-11-15: 0 catalysts2026-11-16: 0 catalysts2026-11-17: 0 catalysts2026-11-18: 0 catalysts2026-11-19: 0 catalysts2026-11-20: 0 catalysts2026-11-21: 0 catalysts2026-11-22: 0 catalysts
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type: device 510k×from 2025-07-28×clear all
type
  • grant4,728
  • 8k filing3,603
  • approval2,655
  • device 510k2,254
  • device recall1,816
  • device pma1,567
device adverse event
1,000
  • recall600
  • earnings585
  • phase 2 completion172
  • therapy area

    no tagged catalysts yet

    Week of Jul 28, 2025

    50
    ›Jul 28, 2025device 510k399d agoInfinitum Eta, Ltd. — NUVENTUS NV.C™ Prosthetic Components (510k cleared)

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

    full page →fda device 510k ↗
    ›Jul 28, 2025device 510k399d agoChangsha Anxiang Medical Technology Co., Ltd. — 3 in 1 TENS UNIT (TC1241, TC2241, TS1241) (510k cleared)

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

    full page →fda device 510k ↗
    ›Jul 28, 2025device 510k399d agoSeum Medi Co., Ltd. — ISO Abutment (510k cleared)

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

    full page →fda device 510k ↗
    ›Jul 28, 2025device 510k399d agoAnumana, Inc. — ECG-AI Low Ejection Fraction (LEF) 12-Lead algorithm (1010) (510k cleared)

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

    full page →fda device 510k ↗
    ›Jul 28, 2025device 510k399d agoBaxter Healthcare Corporation — SIGMA Spectrum Infusion Pump with Master Drug Library (510k cleared)Baxter Healthcare Corp

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

    full page →fda device 510k ↗
    ›Jul 28, 2025device 510k399d agoBaxter Healthcare Corporation — Spectrum IQ Infusion System with Dose IQ Safety Software (3570009) (510k cleared)Baxter Healthcare Corp

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

    full page →fda device 510k ↗
    ›Jul 28, 2025device 510k399d agoSiemens Medical Solutions USA, Inc. — NAEOTOM Alpha.Peak/NAEOTOM Alpha; NAEOTOM Alpha.Pro; NAEOTOM Alpha.Prime (510k cleared)

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

    full page →fda device 510k ↗
    ›Jul 28, 2025device 510k399d agoAbbott Molecular, Inc. — Alinity m EBV (09N43-095) (510k cleared)

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

    full page →fda device 510k ↗
    ›Jul 29, 2025device 510k398d agoBecton, Dickinson and Company — BD Plastipak™ Syringe (510k cleared)BECTON DICKINSON & CO

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

    full page →fda device 510k ↗
    ›Jul 29, 2025device 510k398d agoIntuitive Surgical, Inc. — da Vinci Surgical System, IS5000 (510k cleared)INTUITIVE SURGICAL INC

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

    full page →fda device 510k ↗
    ›Jul 29, 2025device 510k398d agoOlympus Medical Systems Corporation — Single Use Aspiration Needle (NA-201SX-4021); Single Use Aspiration Needle (NA-201SX-4022) (510k cleared)

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

    full page →fda device 510k ↗
    ›Jul 29, 2025device 510k398d agoSivantage — SImmetry+ System (510k cleared)

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

    full page →fda device 510k ↗
    ›Jul 29, 2025device 510k398d agoSiemens Medical Solutions USA, Inc. — Cios Spin (510k cleared)

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

    full page →fda device 510k ↗
    ›Jul 29, 2025device 510k398d agoInfobionic, Inc. — MoMe ARC® Wireless Ambulatory ECG Monitoring and Detection System (32000) (510k cleared)

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

    full page →fda device 510k ↗
    ›Jul 29, 2025device 510k398d agoForcyte Medical, LLC — Forcyte Autograft Harvest Kit (510k cleared)

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

    full page →fda device 510k ↗
    ›Jul 29, 2025device 510k398d agoSleepiz AG — Sleepiz One+ (2.5) (510k cleared)

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

    full page →fda device 510k ↗
    ›Jul 29, 2025device 510k398d agoEdan Instruments, Inc. — Patient Monitor (CX10, CX12, CX15, UX10, UX12, UX15) (510k cleared)VEECO INSTRUMENTS INC

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

    full page →fda device 510k ↗
    ›Jul 29, 2025device 510k398d agoPrognosys Medical Systems Private Limited — PRORAD ATLAS ULTRAPORTABLE; PRORAD ATLAS ULTRAPORTABLE PLUS (510k cleared)

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

    full page →fda device 510k ↗
    ›Jul 30, 2025device 510k397d agoShenzhen Lifotronic Technology Co., Ltd. — Diode Laser Hair Removal Machine (models: T60A, T60B, T60C, T60D, T60E) (510k cleared)

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

    full page →fda device 510k ↗
    ›Jul 30, 2025device 510k397d agoABBOTT MEDICAL — EnSite™ X EP System (510k cleared)

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

    full page →fda device 510k ↗
    ›Jul 30, 2025device 510k397d agoProvidence Medical Technology, Inc. — CORUS™ Navigation System-GX (510k cleared)

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

    full page →fda device 510k ↗
    ›Jul 30, 2025device 510k397d agoRiverpoint Medical — Iconix Speed Anchor; Iconix Speed HA+ Anchor (510k cleared)

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

    full page →fda device 510k ↗
    ›Jul 30, 2025device 510k397d agoE.O.S Co., Ltd. — P-CON (polymacon) Soft (hydrophilic) Contact Lenses (Tinted, Color) (510k cleared)

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

    full page →fda device 510k ↗
    ›Jul 30, 2025device 510k397d agoSpectrum Vascular — Intraosseous Infusion Needles (510k cleared)

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

    full page →fda device 510k ↗
    ›Jul 30, 2025device 510k397d agoTsk Laboratory, Japan — TSK Syringe (510k cleared)

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

    full page →fda device 510k ↗
    ›Jul 30, 2025device 510k397d agoChangsha Anxiang Medical Technology Co., Ltd. — TENS and EMS Unit (510k cleared)

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

    full page →fda device 510k ↗
    ›Jul 30, 2025device 510k397d agoHartalega NGC Sdn. Bhd. — Sterile Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs and Fentanyl Citrate (Blue); Sterile Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs and Fentanyl Citrate (Blue) – Extended Cuff (510k cleared)Teva Pharmaceuticals USA Inc

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

    full page →fda device 510k ↗
    ›Jul 30, 2025device 510k397d agoHermes Medical Solutions AB — Voxel Dosimetry (00859873006226) (510k cleared)

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

    full page →fda device 510k ↗
    ›Jul 30, 2025device 510k397d agoHydrocision, Inc. — SpineSite Endoscope System (510k cleared)

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

    full page →fda device 510k ↗
    ›Jul 30, 2025device 510k397d agoCardio Ring Technologies, Inc. Taiwan Branch — ArteVu (510k cleared)

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

    full page →fda device 510k ↗
    ›Jul 30, 2025device 510k397d agoTonica Elektronik A/S — T65 (9016E061-) (510k cleared)

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

    full page →fda device 510k ↗
    ›Jul 30, 2025device 510k397d agoTyber Medical, LLC — Tyber Medical Distal Radius Plating System (510k cleared)

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

    full page →fda device 510k ↗
    ›Jul 30, 2025device 510k397d agoSuzhou Zenith Vascular SciTech Limited — Micro Catheter (510k cleared)

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

    full page →fda device 510k ↗
    ›Jul 30, 2025device 510k397d agoAcuity Surgical Devices, LLC — Stabilis SA Cervical Stand-Alone System (Various PNs) (510k cleared)

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

    full page →fda device 510k ↗
    ›Jul 31, 2025device 510k396d agoUnited Orthopedic Corporation — U2 Total Knee System – PF+ Patella; USTAR II System– PF+ Patella (510k cleared)

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

    full page →fda device 510k ↗
    ›Jul 31, 2025device 510k396d agoMedacta International S.A. — Mpact Constrained Liner (510k cleared)Stemedica International S.A.

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

    full page →fda device 510k ↗
    ›Jul 31, 2025device 510k396d agoZimmer Biomet — Trabecular Metal Acetabular Revision System, Acetabular Liners and Constrained Liners (510k cleared)ZIMMER BIOMET HOLDINGS, INC.

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

    full page →fda device 510k ↗
    ›Jul 31, 2025device 510k396d agoSiemens Medical Solutions USA, Inc. — Biograph Trinion (510k cleared)

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

    full page →fda device 510k ↗
    ›Jul 31, 2025device 510k396d agoShenzhen TPH Technology Co., Ltd. — Wearable Breast Pump (Model FS12A); Wearable Breast Pump (Model FS12B) (510k cleared)Fortior Technology (Shenzhen) Co., Ltd./ADR

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

    full page →fda device 510k ↗
    ›Jul 31, 2025device 510k396d agoHologic, Inc. — Genius AI Detection 2.0 (510k cleared)

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

    full page →fda device 510k ↗
    ›Jul 31, 2025device 510k396d agoRoche Molecular Systems, Inc. — cobas Respiratory 4-flex for use on the cobas 5800/6800/8800 Systems (510k cleared)

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

    full page →fda device 510k ↗
    ›Jul 31, 2025device 510k396d agoLutronic Corporation — eCO2 3D (510k cleared)

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

    full page →fda device 510k ↗
    ›Jul 31, 2025device 510k396d agoMedacta International S.A. — NextAR(TM) Spine (510k cleared)Stemedica International S.A.

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

    full page →fda device 510k ↗
    ›Jul 31, 2025device 510k396d agoAmbulatory Monitoring, Inc. — Sleep Watch (510k cleared)

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

    full page →fda device 510k ↗
    ›Jul 31, 2025device 510k396d agoArtera, Inc. — ArteraAI Prostate (510k cleared)Arteris, Inc.

    Product code: SFH. Advisory committee: Pathology. Type: Direct

    full page →fda device 510k ↗
    ›Jul 31, 2025device 510k396d agoSiemens Medical Solutions — YSIO X.pree (510k cleared)

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

    full page →fda device 510k ↗
    ›Jul 31, 2025device 510k396d agoRemedi, Inc. — REMEX Xcam6 (510k cleared)

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

    full page →fda device 510k ↗
    ›Jul 31, 2025device 510k396d agoShenzhen Mindray Bio-Medical Electronics Co., Ltd. — BeneVision Central Monitoring System (510k cleared)

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

    full page →fda device 510k ↗
    ›Aug 1, 2025device 510k395d agoShenzhen Huachuangtong Industrial Co., Ltd. — IPL Hair Removal Device (HCT-1208/HCT-1208B/HCT-1208L) (510k cleared)

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

    full page →fda device 510k ↗
    ›Aug 1, 2025device 510k395d agoDiazyme Laboratories, Inc. — Diazyme Colorimetric Lithium Assay (510k cleared)Dolby Laboratories, Inc.

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

    full page →fda device 510k ↗
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