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23,587 catalysts · 5,000 device 510k · 4,728 grant · 3,753 approval · 3,315 8k filing · 2,000 device pma · 2,000 device recall

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2026-08-10: 0 catalysts2026-08-11: 0 catalysts2026-08-12: 0 catalysts2026-08-13: 0 catalysts2026-08-14: 31 catalysts2026-08-15: 0 catalysts2026-08-16: 0 catalysts2026-08-17: 1 catalyst2026-08-18: 2 catalysts2026-08-19: 3 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: 1 catalyst2026-08-27: 1 catalyst2026-08-28: 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: 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: 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 catalysts
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  • device 510k5,000
  • grant4,728
  • approval3,753
  • 8k filing3,315
  • device pma2,000
  • device recall2,000
recall
1,126
  • device adverse event1,000
  • earnings584
  • phase 2 completion172
  • therapy area
    • Oncology148
    • Infectious Disease46
    • Cardiology37
    • Immunology35
    • Dermatology31
    • Pulmonology22
    • Women's Health19
    • Ophthalmology16
    • Pain15

    Week of Dec 9, 2024

    12
    ›Dec 13, 2024device 510k610d agoBiosys Biyomedikal Muhendislik San. VE Tic. A.S. — Bioscope Neuromonitor Device (510k cleared)

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

    full page →fda device 510k ↗
    ›Dec 13, 2024device 510k610d agoHeartbeam, Inc. — HeartBeam AIMIGo(TM) System (510k cleared)HeartBeam, Inc.

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

    full page →fda device 510k ↗
    ›Dec 13, 2024device 510k610d agoBrainu Co., Ltd. — CAIs Sensor (CAIs-001) (510k cleared)

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

    full page →fda device 510k ↗
    ›Dec 13, 2024device 510k610d agoZOLL Medical Corporation — 731 Series Ventilator (510k cleared)

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

    full page →fda device 510k ↗
    ›Dec 13, 2024device 510k610d agoHeidelberg Engineering GmbH — Anterion (510k cleared)

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

    full page →fda device 510k ↗
    ›Dec 13, 2024device 510k610d agoVarian Medical Systems, Inc. — ARIA Radiation Therapy Management System (18.1) (510k cleared)MERIT MEDICAL SYSTEMS INC

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

    full page →fda device 510k ↗
    ›Dec 13, 2024device 510k610d agoUroviu Corporation — Uro-G HD Cystoscope (1520) (510k cleared)

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

    full page →fda device 510k ↗
    ›Dec 13, 2024device 510k610d agoLock-In USA Corp — LOCK-IN Spinal Fixation System (510k cleared)

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

    full page →fda device 510k ↗
    ›Dec 13, 2024device 510k610d agoBarco N.V. — LCD Monitor (MDEC-2523) (510k cleared)

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

    full page →fda device 510k ↗
    ›Dec 13, 2024device 510k610d agoCarlsmed, Inc. — aprevo® anterior lumbar interbody fusion device with interfixation (510k cleared)CARLSMED, INC.

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

    full page →fda device 510k ↗
    ›Dec 13, 2024device 510k610d agoLaminar Digital Health, Inc. — Laminar P1 (LDH-HW-001) (510k cleared)

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

    full page →fda device 510k ↗
    ›Dec 14, 2024device 510k609d agoSim&Cure — Sim&Size (510k cleared)

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

    full page →fda device 510k ↗

    Week of Dec 16, 2024

    38
    ›Dec 16, 2024approval607d agoDEPO-SUBQ PROVERA 104 (MEDROXYPROGESTERONE ACETATE) — FDA approvalmedroxyprogesterone acetate

    Sponsor: PFIZER. Form: INJECTABLE. Route: SUBCUTANEOUS

    full page →medroxyprogesterone acetate →fda approvals ↗
    ›Dec 16, 2024device 510k
    ← prev
    page 29 of 472
    next →
    607d ago
    Huizhou Foryou Medical Devices Co., Ltd. — LUOFUCON® Silver Collagen Dressing (510k cleared)

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

    full page →fda device 510k ↗
    ›Dec 16, 2024device 510k607d agoYung Sheng Optical Co., Ltd. — Eye Secret 38 UV Aspheric (polymacon) and Air Light 38 UV Aspheric (polymacon) Soft (hydrophilic) Contact Lens for Daily Wear (510k cleared)

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

    full page →fda device 510k ↗
    ›Dec 16, 2024device 510k607d agoDRGEM Corporation — TOPAZ Mobile X-ray System (Models : TOPAZ-32D, TOPAZ-40D) (510k cleared)

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

    full page →fda device 510k ↗
    ›Dec 16, 2024device 510k607d agoDitron Dental, Ltd. — Dental Implants and Abutments (510k cleared)

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

    full page →fda device 510k ↗
    ›Dec 16, 2024device 510k607d agoIgnite Orthomotion — ACHIEVE Partial Knee System (510k cleared)

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

    full page →fda device 510k ↗
    ›Dec 16, 2024device 510k607d agoInstylla, Inc. — TEMBO Embolic System (510k cleared)

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

    full page →fda device 510k ↗
    ›Dec 16, 2024device 510k607d agoInventeur, LLC — AIM (N/A) (510k cleared)

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

    full page →fda device 510k ↗
    ›Dec 16, 2024device 510k607d 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 ↗
    ›Dec 16, 2024device 510k607d agoMicro-Tech (Nanjing) Co., Ltd. — Extraction Basket (510k cleared)

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

    full page →fda device 510k ↗
    ›Dec 16, 2024device 510k607d agoVinno Technology (Suzhou) Co.,Ltd — ULTIMUS Series Ultrasound Diagnostic System (510k cleared)Viomi Technology Co., Ltd

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

    full page →fda device 510k ↗
    ›Dec 16, 2024device 510k607d agoMskai — MSKai (510k cleared)

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

    full page →fda device 510k ↗
    ›Dec 16, 2024device 510k607d agoAesculap, Inc. — XABO Ventricular Catheter, XABO Peritoneal Catheter, XABO Catheter Set (510k cleared)

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

    full page →fda device 510k ↗
    ›Dec 17, 2024approval606d agoGABAPENTIN — FDA approvalAlmatica Pharma LLC

    Sponsor: ALKEM LABS LTD. Form: TABLET. Route: ORAL

    full page →fda approvals ↗
    ›Dec 17, 2024approval606d agoVIGABATRIN — FDA approvalAmneal Pharmaceuticals, Inc.

    Sponsor: AMNEAL PHARMS. Form: TABLET. Route: ORAL

    full page →fda approvals ↗
    ›Dec 17, 2024approval606d agoVIGABATRIN — FDA approvalTeva Pharmaceuticals USA Inc

    Sponsor: TEVA PHARMS USA. Form: TABLET. Route: ORAL

    full page →fda approvals ↗
    ›Dec 17, 2024approval606d agoSTEQEYMA (USTEKINUMAB-STBA) — FDA approvalSTEQEYMA

    Sponsor: CELLTRION, INC.. Form: INJECTABLE. Route: SUBCUTANEOUS

    full page →STEQEYMA →fda approvals ↗
    ›Dec 17, 2024approval606d agoBLINCYTO (BLINATUMOMAB) — FDA approvalblinatumomab

    Sponsor: AMGEN. Form: INJECTABLE. Route: INJECTION

    full page →blinatumomab →fda approvals ↗
    ›Dec 17, 2024device 510k606d agoVizionfocus, Inc. — VizionFocus (mififilcon A) Silicone Hydrogel Soft (hydrophilic) Daily Disposable Contact Lens; VizionFocus Color (mififilcon A) Silicone Hydrogel Soft (hydrophilic) Daily Disposable Contact Lens (510k cleared)

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

    full page →fda device 510k ↗
    ›Dec 17, 2024device 510k606d agoAsahi Intecc Co., Ltd. — Tornus ES (510k cleared)

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

    full page →fda device 510k ↗
    ›Dec 17, 2024device 510k606d agoBisco, Inc. — Quantium (510k cleared)

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

    full page →fda device 510k ↗
    ›Dec 17, 2024device 510k606d agoO&M Halyard, Inc. — Halyard Black Nitrile Powder-Free Exam Gloves with Textured Grip Technology, Tested for Use with Chemotherapy Drugs, Fentanyl Citrate, Simulated Gastric Acid and Fentanyl in Simulated Gastric Acid (510k cleared)Teva Pharmaceuticals USA Inc

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

    full page →fda device 510k ↗
    ›Dec 17, 2024device 510k606d agoPhilips Medizin Systeme Böblingen GmbH — Cardiac Workstation (5000); Cardiac Workstation (7000) (510k cleared)

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

    full page →fda device 510k ↗
    ›Dec 17, 2024device 510k606d agoPrecision Spine, Inc. — Reform Pedicle Screw System (510k cleared)Precision Dose Inc

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

    full page →fda device 510k ↗
    ›Dec 17, 2024device 510k606d agoHealgen Scientific,, LLC — Healgen Accurate Muti-Drug Urine Drug Screen Cup; Healgen Accurate Home Muti-Drug Urine Test Cup (510k cleared)

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

    full page →fda device 510k ↗
    ›Dec 17, 2024device 510k606d agoHivox Biotek, Inc. — POCKET TENS (EP-300) (510k cleared)

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

    full page →fda device 510k ↗
    ›Dec 17, 2024device 510k606d agoAi Optics — Sentinel Camera (510k cleared)

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

    full page →fda device 510k ↗
    ›Dec 17, 2024device 510k606d agoInova Diagnostics, Inc. — Aptiva APS IgG Reagent; Aptiva APS IgM Reagent (510k cleared)Co-Diagnostics, Inc.

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

    full page →fda device 510k ↗
    ›Dec 17, 2024device 510k606d agoJiangmen New Era External Use Drug Co., Ltd. — Autoclave Indicator Tape; EO Indicator Tape (510k cleared)

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

    full page →fda device 510k ↗
    ›Dec 17, 2024device 510k606d agoSmith & Nephew Medical Limited — BIOBRANE Temporary Wound Dressing; BIOBRANE Glove (510k cleared)SMITH & NEPHEW PLC

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

    full page →fda device 510k ↗
    ›Dec 17, 2024device 510k606d agoVentana Medical Systems, Inc. — Roche Digital Pathology Dx (510k cleared)MERIT MEDICAL SYSTEMS INC

    Product code: PSY. Advisory committee: Pathology. Type: Special

    full page →fda device 510k ↗
    ›Dec 17, 2024device 510k606d agoDentsply Sirona, Inc. — Lucitone Digital Print Denture™ System (510k cleared)DENTSPLY SIRONA Inc.

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

    full page →fda device 510k ↗
    ›Dec 17, 2024device 510k606d agoAllengers Global Healthcare Private Limited — Thulium Fiber Laser (FiberLAZE+, FiberLAZE) (510k cleared)

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

    full page →fda device 510k ↗
    ›Dec 17, 2024device 510k606d agoCntrl+, Inc. — Cntrl+ Bladder Support Pessary (510k cleared)

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

    full page →fda device 510k ↗
    ›Dec 17, 2024device 510k606d agoAllonus Tech Co., Ltd. — ALLONUS Tech Prosthetics (510k cleared)

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

    full page →fda device 510k ↗
    ›Dec 17, 2024device 510k606d agoCentinel Spine, LLC — prodisc® L Instruments (510k cleared)

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

    full page →fda device 510k ↗
    ›Dec 18, 2024approval605d agoENSACOVE (ENSARTINIB HYDROCHLORIDE) — FDA approvalensartinib hydrochloride

    Sponsor: XCOVERY. Form: CAPSULE. Route: ORAL

    full page →ensartinib hydrochloride →fda approvals ↗
    ›Dec 18, 2024approval605d agoIDACIO (ADALIMUMAB-AACF) — FDA approvalIDACIO

    Sponsor: FRESENIUS KABI USA. Form: INJECTABLE. Route: SUBCUTANEOUS

    full page →IDACIO →fda approvals ↗
    $PFE26.61-0.73%
    $CARL
    $BEATW
    $MMSI90.31-0.21%
    $VIOT
    $ISRG401.270.00%
    $AMRX17.66+2.26%
    $CODX1.51000.00%
    $AMGN412.33-1.32%
    $MMSI90.31-0.21%
    $SNN29.81-1.00%
    $XRAY11.58+1.49%