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calendar

20,272 catalysts · 4,728 grant · 3,153 8k filing · 3,149 device 510k · 2,804 approval · 2,000 device pma · 2,000 device recall

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  • grant4,728
  • 8k filing3,153
  • device 510k3,149
  • approval2,804
  • device pma2,000
  • device recall2,000
device adverse event
1,000
  • recall773
  • earnings584
  • phase 2 completion172
  • therapy area
    • Oncology148
    • Infectious Disease46
    • Cardiology37
    • Immunology35
    • Dermatology31
    • Pulmonology22
    • Women's Health19
    • Ophthalmology16
    • Pain15

    Week of May 19, 2025

    50
    ›May 21, 2025device 510k449d agoStryker Endoscopy — Stryker AlphaVent™ Knotless SP Biocomposite Anchor (510k cleared)

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

    full page →fda device 510k ↗
    ›May 21, 2025device 510k449d agoHyperfine, Inc. — Swoop® Portable MR Imaging® System (510k cleared)Hyperfine, Inc.

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

    full page →fda device 510k ↗
    ›May 21, 2025device 510k449d agoPrintbio, Inc. — 3DMatrix DynaFlex (DynaFlex) (510k cleared)

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

    full page →fda device 510k ↗
    ›May 21, 2025device 510k449d agoHjy Smart Medical Device Co., Ltd. — HJY VisualNext 3D Endoscopic Vision System (510k cleared)

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

    full page →fda device 510k ↗
    ›May 21, 2025device 510k449d agoTandem Diabetes Care, Inc. — Control-IQ+ technology (510k cleared)TANDEM DIABETES CARE INC

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

    full page →fda device 510k ↗
    ›May 21, 2025device 510k449d agoFinemedix Co., Ltd. — ClearHemograsper (510k cleared)

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

    full page →fda device 510k ↗
    ›May 21, 2025device 510k449d agoPhilips Ultrasound, LLC — EPIQ Series Diagnostic Ultrasound System; Affiniti Series Diagnostic Ultrasound System (510k cleared)

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

    full page →fda device 510k ↗
    ›May 21, 2025device 510k449d agoInVision Medical Technology Corporation — InVision Precision Cardiac Amyloid (510k cleared)

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

    full page →fda device 510k ↗
    ›May 21, 2025device 510k449d agoAnx Robotica Corporation — MotiliCap GI Monitoring System (510k cleared)

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

    full page →fda device 510k ↗
    ›May 21, 2025device 510k449d agoAlma Lasers, Inc. — The Alma Hybrid Laser System (510k cleared)

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

    full page →fda device 510k ↗
    ›May 22, 2025approval448d agoKEYTRUDA (PEMBROLIZUMAB) — FDA approvalpembrolizumab

    Sponsor: MERCK SHARP DOHME. Form: SOLUTION. Route: INTRAVENOUS

    full page →pembrolizumab →fda approvals ↗
    ›May 22, 2025approval448d agoKALYDECO (IVACAFTOR) — FDA approvalVertex, Inc.

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

    full page →fda approvals ↗
    ›May 22, 2025approval448d agoKALYDECO (IVACAFTOR) — FDA approvalivacaftor

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

    full page →ivacaftor →fda approvals ↗
    ›May 22, 2025approval448d agoISOTRETINOIN — FDA approvalZydus Therapeutics Inc

    Sponsor: ZYDUS PHARMS. Form: CAPSULE. Route: ORAL

    full page →fda approvals ↗
    ›May 22, 2025approval448d agoTECHNESCAN PYP KIT (TECHNETIUM TC-99M PYROPHOSPHATE KIT) — FDA approval

    Sponsor: CURIUM. Form: INJECTABLE. Route: INJECTION

    full page →fda approvals ↗
    ›May 22, 2025approval448d agoTECHNESCAN HDP (TECHNETIUM TC-99M OXIDRONATE KIT) — FDA approval

    Sponsor: CURIUM. Form: INJECTABLE. Route: INJECTION

    full page →fda approvals ↗
    ›May 22, 2025approval448d agoLUPRON DEPOT-PED KIT (LEUPROLIDE ACETATE) — FDA approvalAmneal Pharmaceuticals, Inc.

    Sponsor: ABBVIE ENDOCRINE INC. Form: POWDER. Route: INTRAMUSCULAR

    full page →fda approvals ↗
    ›May 22, 2025approval448d agoEBGLYSS (LEBRIKIZUMAB-LBKZ) — FDA approvallebrikizumab

    Sponsor: ELI LILLY AND CO. Form: INJECTABLE. Route: INJECTION

    full page →lebrikizumab →fda approvals ↗
    ›May 22, 2025device 510k448d agoBasic Medical Technology, Inc. — Nitrile Powder-Free Exam Gloves with Hyaluronic Acid, and tested for Use with Chemotherapy Drugs, Opioid Fentanyl Citrate, Simulated Gastric Acid and Xylazine in Fentanyl Citrate (510k cleared)Medical Care Technologies Inc.

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

    full page →fda device 510k ↗
    ›May 22, 2025device 510k448d agoHua Yue Medical Technology Co., Ltd. — Harioculture TL-16 Time-lapse Incubator (510k cleared)NewBay Medical Technology Co Ltd

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

    full page →fda device 510k ↗
    ›May 22, 2025device 510k448d agoUrotronic, Inc. — Optilume® High Pressure Urological Balloon Dilation Catheter (510k cleared)

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

    full page →fda device 510k ↗
    ›May 22, 2025device 510k448d agoClinical Innovations, LLC — Koala Intrauterine Pressure Catheter (IPC-5000E) (510k cleared)

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

    full page →fda device 510k ↗
    ›May 22, 2025device 510k448d agoTriMed, Inc. — TriMed Fifth Metatarsal System (Fifth Metatarsal Plate); TriMed Fifth Metatarsal System (Fifth Metatarsal Screw) (510k cleared)

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

    full page →fda device 510k ↗
    ›May 22, 2025device 510k448d agoOrtho Development Corp. — Trivicta® Hip Stem (510k cleared)DeFi Development Corp.

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

    full page →fda device 510k ↗
    ›May 22, 2025device 510k448d agoCryoconcepts LP — Skin Clinic Freeze Point for Warts and Skin Tags (510k cleared)

    Product code: GEH. Advisory committee: General, Plastic Surgery. Type: Special

    full page →fda device 510k ↗
    ›May 22, 2025device 510k448d agoRandox Laboratories, Ltd. — ConcizuTrace™ ELISA (510k cleared)Rafa Laboratories Co Ltd

    Product code: SES. Advisory committee: Hematology. Type: Direct

    full page →fda device 510k ↗
    ›May 22, 2025device 510k448d agoArthrex, Inc. — Arthrex Spine Compression FT Screw (510k cleared)

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

    full page →fda device 510k ↗
    ›May 22, 2025device 510k448d agoOvesco Endoscopy AG — ArgoCap (200.52) (510k cleared)

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

    full page →fda device 510k ↗
    ›May 22, 2025device 510k448d agoJiangsu Yuyue Medical Equipment & Supply Co., Ltd. — YUWELL® Infrared Ear Thermometer (YHT100); YUWELL® Infrared Ear Thermometer (YHT107) (510k cleared)

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

    full page →fda device 510k ↗
    ›May 22, 2025device 510k448d agoTerrats Medical SL — DESS Dental Smart Solutions (510k cleared)

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

    full page →fda device 510k ↗
    ›May 22, 2025device 510k448d agoLima Corporate S.P.A. — Physica System (Physica CR Porous Femoral components) (510k cleared)

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

    full page →fda device 510k ↗
    ›May 22, 2025device 510k448d agoThermo Fisher Scientific — The Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with Vancomycin in the dilution range of 0.25-128 ug/mL (510k cleared)THERMO FISHER SCIENTIFIC INC.

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

    full page →fda device 510k ↗
    ›May 22, 2025device 510k448d agoShenzhen Kaiyan Medical Equipment Co., Ltd. — Solawave 2-in-1 Skincare Mini (Model: 61043) (510k cleared)

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

    full page →fda device 510k ↗
    ›May 23, 2025approval447d agoOPDIVO (NIVOLUMAB) — FDA approvalnivolumab

    Sponsor: BRISTOL MYERS SQUIBB. Form: INJECTABLE. Route: INJECTION

    full page →nivolumab →fda approvals ↗
    ›May 23, 2025approval447d agoBUPROPION HYDROCHLORIDE — FDA approvalBUPROPION HYDROCHLORIDE

    Sponsor: YICHANG HUMANWELL. Form: TABLET, EXTENDED RELEASE. Route: ORAL

    full page →BUPROPION HYDROCHLORIDE →fda approvals ↗
    ›May 23, 2025approval447d agoBUPROPION HYDROCHLORIDE — FDA approvalBUPROPION HYDROCHLORIDE

    Sponsor: YICHANG HUMANWELL. Form: TABLET, EXTENDED RELEASE. Route: ORAL

    full page →BUPROPION HYDROCHLORIDE →fda approvals ↗
    ›May 23, 2025approval447d agoBUPROPION HYDROCHLORIDE — FDA approvalBUPROPION HYDROCHLORIDE

    Sponsor: YICHANG HUMANWELL. Form: TABLET, EXTENDED RELEASE. Route: ORAL

    full page →BUPROPION HYDROCHLORIDE →fda approvals ↗
    ›May 23, 2025approval447d agoBUPROPION HYDROCHLORIDE — FDA approvalBUPROPION HYDROCHLORIDE

    Sponsor: YICHANG HUMANWELL. Form: TABLET, EXTENDED RELEASE. Route: ORAL

    full page →BUPROPION HYDROCHLORIDE →fda approvals ↗
    ›May 23, 2025approval447d agoWAKIX (PITOLISANT HYDROCHLORIDE) — FDA approvalpitolisant hydrochloride

    Sponsor: HARMONY. Form: TABLET. Route: ORAL

    full page →pitolisant hydrochloride →fda approvals ↗
    ›May 23, 2025approval447d agoBOSUTINIB MONOHYDRATE — FDA approvalBOSUTINIB MONOHYDRATE

    Sponsor: ALEMBIC. Form: TABLET. Route: ORAL

    full page →BOSUTINIB MONOHYDRATE →fda approvals ↗
    ›May 23, 2025approval447d agoOPDIVO QVANTIG (NIVOLUMAB) — FDA approval(hyaluronidase (recombinant, human) + nivolumab)

    Sponsor: BRISTOL-MYERS SQUIBB. Form: INJECTABLE. Route: SUBCUTANEOUS

    full page →(hyaluronidase (recombinant, human) + nivolumab) →fda approvals ↗
    ›May 23, 2025device 510k447d agoPearl, Inc. — Second Opinion® 3D (510k cleared)

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

    full page →fda device 510k ↗
    ›May 23, 2025device 510k447d agoPiraeus Medical — 93 NeuFlex Catheter (510k cleared)

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

    full page →fda device 510k ↗
    ›May 23, 2025device 510k447d agoKuros Biosciences B.V — MagnetOs MIS (510k cleared)

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

    full page →fda device 510k ↗
    ›May 23, 2025device 510k447d agoGeske Beauty Tech GmbH — SmartAppGuidedTM MicroCurrent Face-Lift Pen 6 in 1 (510k cleared)

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

    full page →fda device 510k ↗
    ›May 23, 2025device 510k447d agoShenzhen Ulike Smart Electronics Co., Ltd. — Ice Cooling IPL Hair Removal Device (MI01 LP, MI01 CB, MI01 GR, MI01 PP, MI01 RM, MI01 WG, MI01 WH, MI01 BK;UI04S PP, UI04S BU, UI04S WH, UI04S PN) (510k cleared)

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

    full page →fda device 510k ↗
    ›May 23, 2025device 510k447d agoLVIS Corporation — NeuroMatch (510k cleared)

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

    full page →fda device 510k ↗
    ›May 23, 2025device 510k447d agoThe Binding Site Group , Ltd. — Optilite® Freelite Mx Kappa Free Kit; Optilite® Freelite Mx Lambda Free Kit (510k cleared)Dawn Sea Therapeutics

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

    full page →fda device 510k ↗
    ›May 23, 2025device 510k447d agoEizo Corporation — RadiForce MX317W-PA (510k cleared)

    Product code: PZZ. Advisory committee: Pathology. Type: Abbreviated

    full page →fda device 510k ↗
    ›May 23, 2025device 510k447d agoEwoosoft Co., Ltd. — Clever One (510k cleared)

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

    full page →fda device 510k ↗
    ← prev
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    $HYPR
    $TNDM23.44+2.76%
    $LLY1214.72-0.02%
    $AMRX17.10-4.36%
    $VERX12.23+0.78%
    $VERX12.23+0.78%
    $MDCE0.00020.00%
    $HRMY39.520.00%
    $BMY63.61-1.90%
    $TMO447.81+1.31%
    $DFUKF
    $BMY63.61-1.90%