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22,505 catalysts · 4,728 grant · 4,294 device 510k · 3,621 8k filing · 3,170 approval · 2,000 device pma · 2,000 device recall

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  • grant4,728
  • device 510k4,294
  • 8k filing3,621
  • approval3,170
  • device pma2,000
  • device recall2,000
recall
1,027
  • device adverse event1,000
  • earnings585
  • phase 2 completion172
  • therapy area
    • Oncology148
    • Infectious Disease46
    • Cardiology37
    • Immunology35
    • Dermatology31
    • Pulmonology22
    • Women's Health19
    • Ophthalmology16
    • Pain15

    Week of Dec 9, 2024

    24
    ›Dec 13, 2024approval627d agoORKAMBI (IVACAFTOR) — FDA approval(ivacaftor + lumacaftor)

    Sponsor: VERTEX PHARMS INC. Form: GRANULE. Route: ORAL

    full page →(ivacaftor + lumacaftor) →fda approvals ↗
    ›Dec 13, 2024approval627d agoORKAMBI (IVACAFTOR) — FDA approval(ivacaftor + lumacaftor)

    Sponsor: VERTEX PHARMS INC. Form: TABLET. Route: ORAL

    full page →(ivacaftor + lumacaftor) →fda approvals ↗
    ›Dec 13, 2024approval627d agoTYENNE (TOCILIZUMAB-AAZG) — FDA approvalTYENNE

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

    full page →TYENNE →fda approvals ↗
    ›Dec 13, 2024approval627d agoUNLOXCYT (COSIBELIMAB-IPDL) — FDA approvalcosibelimab

    Sponsor: CHECKPOINT THERAPEUTICS INC. Form: INJECTABLE. Route: INJECTION

    full page →cosibelimab →fda approvals ↗
    ›Dec 13, 2024device 510k627d agoRadiometer Medicals Aps — ABL90 FLEX PLUS System (510k cleared)

    Product code: CHL. Advisory committee: Clinical Chemistry. Type: Traditional

    full page →fda device 510k ↗
    ›Dec 13, 2024device 510k627d agoABBOTT MEDICAL — Agilis NxT Steerable Introducer Dual-Reach (510k cleared)

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

    full page →fda device 510k ↗
    ›Dec 13, 2024device 510k627d agoBreas Medical AB — Vivo 1, Vivo 2 (510k cleared)

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

    full page →fda device 510k ↗
    ›Dec 13, 2024device 510k627d agoBreas Medical AB — Vivo 3 (510k cleared)

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

    full page →fda device 510k ↗
    ›Dec 13, 2024device 510k627d agoRemex Medical Corp. — Remex Spine Surgery Navigation Instrument (510k cleared)Medicale Corp.

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

    full page →fda device 510k ↗
    ›Dec 13, 2024device 510k627d agoBTL Industries, Inc. — BTL-785BNF-E (510k cleared)NL INDUSTRIES INC

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

    full page →fda device 510k ↗
    ›Dec 13, 2024device 510k627d agoGastro Concepts, LLC — Gastro Concepts Air Assist (510k cleared)

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

    full page →fda device 510k ↗
    ›Dec 13, 2024device 510k627d agoShenzhen Ulike Smart Electronics Co., Ltd. — Ice Cooling IPL Hair Removal Device (UI20 DB, UI20 RE, UI20 GP, UI20 PW, UI20S DB, UI20S RE, UI20S PW, UI20S GP,UI20 WH, UI20 GR, UI20 BS, UI20 MP, UI20 BL, UI20 PN, UI20 BR, UI20WG, UI20S WH, UI20S GR, UI20S BS, UI20S MP) (510k cleared)

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

    full page →fda device 510k ↗
    ›Dec 13, 2024device 510k627d 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 510k627d 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 510k627d 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 510k627d agoZOLL Medical Corporation — 731 Series Ventilator (510k cleared)

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

    full page →fda device 510k ↗
    ›Dec 13, 2024device 510k627d agoHeidelberg Engineering GmbH — Anterion (510k cleared)

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

    full page →fda device 510k ↗
    ›Dec 13, 2024device 510k627d 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 510k627d 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 510k627d 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 510k627d 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 510k627d 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 510k627d 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 510k626d agoSim&Cure — Sim&Size (510k cleared)

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

    full page →fda device 510k ↗

    Week of Dec 16, 2024

    26
    ›Dec 16, 2024approval624d 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 1 of 451
    next →
    624d 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 510k624d 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 510k624d 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 510k624d 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 510k624d agoIgnite Orthomotion — ACHIEVE Partial Knee System (510k cleared)

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

    full page →fda device 510k ↗
    ›Dec 16, 2024device 510k624d agoInstylla, Inc. — TEMBO Embolic System (510k cleared)

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

    full page →fda device 510k ↗
    ›Dec 16, 2024device 510k624d agoInventeur, LLC — AIM (N/A) (510k cleared)

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

    full page →fda device 510k ↗
    ›Dec 16, 2024device 510k624d 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 510k624d 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 510k624d 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 510k624d agoMskai — MSKai (510k cleared)

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

    full page →fda device 510k ↗
    ›Dec 16, 2024device 510k624d 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, 2024approval623d agoGABAPENTIN — FDA approvalAlmatica Pharma LLC

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

    full page →fda approvals ↗
    ›Dec 17, 2024approval623d agoVIGABATRIN — FDA approvalAmneal Pharmaceuticals, Inc.

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

    full page →fda approvals ↗
    ›Dec 17, 2024approval623d agoVIGABATRIN — FDA approvalTeva Pharmaceuticals USA Inc

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

    full page →fda approvals ↗
    ›Dec 17, 2024approval623d agoSTEQEYMA (USTEKINUMAB-STBA) — FDA approvalSTEQEYMA

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

    full page →STEQEYMA →fda approvals ↗
    ›Dec 17, 2024approval623d agoBLINCYTO (BLINATUMOMAB) — FDA approvalblinatumomab

    Sponsor: AMGEN. Form: INJECTABLE. Route: INJECTION

    full page →blinatumomab →fda approvals ↗
    ›Dec 17, 2024device 510k623d 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 510k623d 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 510k623d agoBisco, Inc. — Quantium (510k cleared)

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

    full page →fda device 510k ↗
    ›Dec 17, 2024device 510k623d 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 510k623d 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 510k623d 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 510k623d 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 510k623d agoHivox Biotek, Inc. — POCKET TENS (EP-300) (510k cleared)

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

    full page →fda device 510k ↗
    $VERX14.16-0.46%
    $PFE28.46+1.79%
    $CARL
    $VERX14.16-0.46%
    $MCLE
    $NL6.0500-1.14%
    $BEATW
    $CCCC
    $MMSI90.90+0.45%
    $ISRG372.60+1.51%
    $AMRX17.54-2.61%
    $VIOT
    $AMGN429.88-0.59%