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23,358 catalysts · 5,000 device 510k · 4,728 grant · 3,753 approval · 3,086 8k filing · 2,000 device pma · 2,000 device recall

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2026-08-10: 0 catalysts2026-08-11: 57 catalysts2026-08-12: 19 catalysts2026-08-13: 19 catalysts2026-08-14: 4 catalysts2026-08-15: 0 catalysts2026-08-16: 0 catalysts2026-08-17: 1 catalyst2026-08-18: 2 catalysts2026-08-19: 2 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 filing3,086
  • device pma2,000
  • device recall2,000
recall
1,126
  • device adverse event1,000
  • earnings583
  • phase 2 completion172
  • therapy area
    • Oncology148
    • Infectious Disease46
    • Cardiology37
    • Immunology35
    • Dermatology31
    • Pulmonology22
    • Women's Health19
    • Ophthalmology16
    • Pain15

    Week of Sep 23, 2024

    31
    ›Sep 27, 2024approval684d agoXELJANZ XR (TOFACITINIB CITRATE) — FDA approvaltofacitinib citrate ER

    Sponsor: PFIZER. Form: TABLET, EXTENDED RELEASE. Route: ORAL

    full page →tofacitinib citrate ER →fda approvals ↗
    ›Sep 27, 2024approval684d agoXELJANZ (TOFACITINIB CITRATE) — FDA approvalBiocon Pharma Ltd

    Sponsor: PF PRISM CV. Form: TABLET. Route: ORAL

    full page →fda approvals ↗
    ›Sep 27, 2024approval684d agoXELJANZ (TOFACITINIB CITRATE) — FDA approvaltofacitinib citrate ER

    Sponsor: PFIZER. Form: SOLUTION. Route: ORAL

    full page →tofacitinib citrate ER →fda approvals ↗
    ›Sep 27, 2024approval684d agoAMPICILLIN AND SULBACTAM (AMPICILLIN SODIUM) — FDA approvalUNASYN

    Sponsor: SANDOZ. Form: INJECTABLE. Route: INJECTION

    full page →UNASYN →fda approvals ↗
    ›Sep 27, 2024approval684d agoOTULFI (USTEKINUMAB-AAUZ) — FDA approvalOTULFI

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

    full page →OTULFI →fda approvals ↗
    ›Sep 27, 2024approval684d agoRETEVMO (SELPERCATINIB) — FDA approvalselpercatinib

    Sponsor: ELI LILLY AND CO. Form: CAPSULE. Route: ORAL

    full page →selpercatinib →fda approvals ↗
    ›Sep 27, 2024approval684d agoRETEVMO (SELPERCATINIB) — FDA approvalselpercatinib

    Sponsor: ELI LILLY AND CO. Form: CAPSULE. Route: ORAL

    full page →selpercatinib →fda approvals ↗
    ›Sep 27, 2024approval684d agoRETEVMO (SELPERCATINIB) — FDA approvalselpercatinib

    Sponsor: ELI LILLY AND CO. Form: CAPSULE. Route: ORAL

    full page →selpercatinib →fda approvals ↗
    ›Sep 27, 2024approval684d agoRETEVMO (SELPERCATINIB) — FDA approvalselpercatinib

    Sponsor: ELI LILLY AND CO. Form: CAPSULE. Route: ORAL

    full page →selpercatinib →fda approvals ↗
    ›Sep 27, 2024device 510k684d agoHangzhou AllTest Biotech Co., Ltd. — AllTest Multi-Drug Urine Test Panel; AllTest Multi-Drug Rapid Urine Test Panel (510k cleared)Hangzhou DAC Biotech Co Ltd

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

    full page →fda device 510k ↗
    ›Sep 27, 2024device 510k684d agoWestridge Laboratories, Inc. — ID Free Personal Lubricant (510k cleared)G&W Laboratories Inc

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

    full page →fda device 510k ↗
    ›Sep 27, 2024device 510k684d agoBrain Electrophysiology Laboratory Company, LLC — Sourcerer (510k cleared)

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

    full page →fda device 510k ↗
    ›Sep 27, 2024device 510k684d agoShockwave Medical, Inc. — Shockwave Intravascular Lithotripsy (IVL) System with the Javelin Peripheral Intravascular Lithotripsy (IVL) Catheter (510k cleared)

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

    full page →fda device 510k ↗
    ›Sep 27, 2024device 510k684d agoO&M Halyard, Inc. — Halyard Purple Nitrile* Powder-Free Exam Gloves, Low Dermatitis Potential, 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 ↗
    ›Sep 27, 2024device 510k684d agoNanosonics Limited — trophon Wireless Ultrasound Probe Holder (510k cleared)

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

    full page →fda device 510k ↗
    ›Sep 27, 2024device 510k684d agoOptmed, Inc. — TearRepair Liquid Skin Protectant (510k cleared)

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

    full page →fda device 510k ↗
    ›Sep 27, 2024device 510k684d agoResmed Corp — EasyCare Tx 2 (510k cleared)RESMED INC

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

    full page →fda device 510k ↗
    ›Sep 27, 2024device 510k684d agoChiaro Technology, Ltd. — Elvie Stride 2 (510k cleared)U-BX Technology Ltd.

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

    full page →fda device 510k ↗
    ›Sep 27, 2024device 510k684d agoIcare Finland OY — iCare ST500 (TA04) (510k cleared)

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

    full page →fda device 510k ↗
    ›Sep 27, 2024device 510k684d agoAit Austrian Institute of Technology GmbH — encevis (2.1) (510k cleared)

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

    full page →fda device 510k ↗
    ›Sep 27, 2024device 510k684d agoDaeju Meditech Engineering Co., Ltd. — ACTIVO (510k cleared)

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

    full page →fda device 510k ↗
    ›Sep 27, 2024device 510k684d agoAmc Health — AMC Health CareConsole (510k cleared)AOP Health

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

    full page →fda device 510k ↗
    ›Sep 27, 2024device 510k684d agoHyundae Meditech Co., Ltd. — Secret Line up (FC1938E80 FC1950E90 FC1960E100 FC1970E120 FC1990E150 FC19100E150 FC19100E280 FC19100E420 FC2038E80 FC2050E90 FC2060E100 FC2070E120 FC2090E150 FC20100E170 FC2138G80 FC2150G90 FC2160G100 FC2170G120 FC2190G150 FC21100G170 FCL18100C160 FCL1938E80 FCL1950E90 FCL1960E100 FCL1970E120 FCL1990E150 FCL19100E160 FCL2138G80 FCL2150G90 FCL2160G100 FCL2170G120 FCL2190G150 FCL21100G160 FCRL1870C162 FCRL18100C185 FCRL1970E162 FCRL19100E185 FCHL1960E90 FCHL1970E120 FCHL19100E160 FCW1938 (510k cleared)

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

    full page →fda device 510k ↗
    ›Sep 27, 2024device 510k684d agoPi-Cardia, Ltd. — ShortCut (510k cleared)

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

    full page →fda device 510k ↗
    ›Sep 27, 2024device 510k684d agoBunkerHill Health — CAC (gated) Algorithm (510k cleared)

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

    full page →fda device 510k ↗
    ›Sep 27, 2024device 510k684d agoBalt USA, LLC — Optima Coil System (OptiBlock Line Extension) (510k cleared)Bayer USA LLC

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

    full page →fda device 510k ↗
    ›Sep 27, 2024device 510k684d agoShenzhen Kaiyan Medical Equipment Co., Ltd. — HIGHERDOSE Red and Infrared Light Mask (MK66-L) (510k cleared)

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

    full page →fda device 510k ↗
    ›Sep 27, 2024device 510k684d agoJLK, Inc. — JBS-LVO (510k cleared)

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

    full page →fda device 510k ↗
    ›Sep 27, 2024device 510k684d agoTaiwan Aulisa Medical Devices Technologies, Inc. — Aulisa Temperature Module (TM0002) (510k cleared)

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

    full page →fda device 510k ↗
    ›Sep 27, 2024device 510k684d agoInari Medical, Inc. — ClotTriever XL Catheter (41-102) (510k cleared)Mobia Medical, Inc.

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

    full page →fda device 510k ↗
    ›Sep 27, 2024device 510k684d agoMedline Industries, LP — Hudson RCI® Comfort Flo Nasal Cannula; Hudson RCI® Comfort Flo Plus Cannula (510k cleared)

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

    full page →fda device 510k ↗

    Week of Sep 30, 2024

    19
    ›Sep 30, 2024approval681d agoDAYBUE (TROFINETIDE) — FDA approvaltrofinetide

    Sponsor: ACADIA PHARMS INC. Form: SOLUTION. Route: ORAL

    full page →trofinetide →fda approvals ↗
    ›Sep 30, 2024approval
    ← prev
    page 5 of 468
    next →
    681d ago
    DAYBUE (TROFINETIDE) — FDA approvaltrofinetide

    Sponsor: ACADIA PHARMS INC. Form: SOLUTION. Route: ORAL

    full page →trofinetide →fda approvals ↗
    ›Sep 30, 2024device 510k681d agoKem Medical Products Corporation — Kem Medical Lead-free Chemical Indicators for Steam Sterilization (510k cleared)

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

    full page →fda device 510k ↗
    ›Sep 30, 2024device 510k681d agoDentalmax Co., Ltd. — LUXEN 5G (510k cleared)

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

    full page →fda device 510k ↗
    ›Sep 30, 2024device 510k681d agoMikron Makina Sanayi VE Ticaret Ltd. Sti. — MSFX MIKRON SPINAL FIXATION SYSTEM (510k cleared)

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

    full page →fda device 510k ↗
    ›Sep 30, 2024device 510k681d agoRecensmedical, Inc. — OcuCool (510k cleared)

    Product code: QZQ. Advisory committee: Unknown. Type: Direct

    full page →fda device 510k ↗
    ›Sep 30, 2024device 510k681d agoYsi, Inc. — YSI 2900C Biochemistry Analyzer (510k cleared)

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

    full page →fda device 510k ↗
    ›Sep 30, 2024device 510k681d agoGuangzhou Wondfo Biotech Co., Ltd. — Wondfo 2019-nCoV Antigen Test (Lateral Flow Method) (510k cleared)

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

    full page →fda device 510k ↗
    ›Sep 30, 2024device 510k681d agoMicroPort NeuroTech (Shanghai) Co., Ltd. — Numen™ Coil Embolization System; NumenFR™ Detachment System (510k cleared)

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

    full page →fda device 510k ↗
    ›Sep 30, 2024device 510k681d agoProcept Biorobotics — AQUABEAM Robotic System (AB2000) (510k cleared)PROCEPT BioRobotics Corp

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

    full page →fda device 510k ↗
    ›Sep 30, 2024device 510k681d agoVantis Vascular, Inc. — CrossFAST™ Integrated Microcatheter Guide Extension System (CFM55) (510k cleared)

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

    full page →fda device 510k ↗
    ›Oct 1, 2024approval680d agoMEKINIST (TRAMETINIB) — FDA approvalSpexotras

    Sponsor: NOVARTIS. Form: SOLUTION. Route: ORAL

    full page →Spexotras →fda approvals ↗
    ›Oct 1, 2024approval680d agoMEKINIST (TRAMETINIB DIMETHYL SULFOXIDE) — FDA approvalSpexotras

    Sponsor: NOVARTIS. Form: TABLET. Route: ORAL

    full page →Spexotras →fda approvals ↗
    ›Oct 1, 2024device 510k680d agoWallaby Medical — Esperance 3+ Aspiration Catheter System (510k cleared)

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

    full page →fda device 510k ↗
    ›Oct 1, 2024device 510k680d agoSpringbok, Inc. — MuscleView (510k cleared)

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

    full page →fda device 510k ↗
    ›Oct 1, 2024device 510k680d agoBodyvision Medical , Ltd. — LungVision (510k cleared)

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

    full page →fda device 510k ↗
    ›Oct 1, 2024device 510k680d agoYongkang Youha Electric Appliance Co., Ltd. — Electric wheelchair (YHWL002, YHWL003) (510k cleared)

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

    full page →fda device 510k ↗
    ›Oct 1, 2024device 510k680d agoGe Hualun Medical Systems Co. , Ltd. — Definium Pace Select ET (510k cleared)

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

    full page →fda device 510k ↗
    ›Oct 1, 2024device 510k680d agoSamsung Electronics Co., Ltd. — GM85 (510k cleared)

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

    full page →fda device 510k ↗
    $PFE27.05+1.08%
    $RMD220.38+5.13%
    $PFE27.05+1.08%
    $LLY1231.94+3.90%
    $LLY1231.94+3.90%
    $LLY1231.94+3.90%
    $LLY1231.94+3.90%
    $UBXG
    $ACAD29.39+0.62%
    $MOBI
    $PRCT
    $NVS156.79+0.29%
    $NVS156.79+0.29%
    $ACAD29.39+0.62%