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21,746 catalysts · 4,728 grant · 4,110 device 510k · 3,152 8k filing · 3,118 approval · 2,000 device pma · 2,000 device recall

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2026-08-10: 0 catalysts2026-08-11: 0 catalysts2026-08-12: 45 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: 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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  • grant4,728
  • device 510k4,110
  • 8k filing3,152
  • approval3,118
  • device pma2,000
  • device recall2,000
device adverse event
1,000
  • recall973
  • earnings584
  • phase 2 completion172
  • therapy area
    • Oncology148
    • Infectious Disease46
    • Cardiology37
    • Immunology35
    • Dermatology31
    • Pulmonology22
    • Women's Health19
    • Ophthalmology16
    • Pain15

    Week of Feb 17, 2025

    27
    ›Feb 21, 2025approval538d agoBUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE (BUPRENORPHINE HYDROCHLORIDE) — FDA approvalBUPRENORPHINE HYDROCHLORIDE

    Sponsor: SPECGX LLC. Form: TABLET. Route: SUBLINGUAL

    full page →BUPRENORPHINE HYDROCHLORIDE →fda approvals ↗
    ›Feb 21, 2025approval538d agoBUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE (BUPRENORPHINE HYDROCHLORIDE) — FDA approvalBUPRENORPHINE HYDROCHLORIDE

    Sponsor: LANNETT CO INC. Form: TABLET. Route: SUBLINGUAL

    full page →BUPRENORPHINE HYDROCHLORIDE →fda approvals ↗
    ›Feb 21, 2025approval538d agoBUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE (BUPRENORPHINE HYDROCHLORIDE) — FDA approvalAmneal Pharmaceuticals, Inc.

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

    full page →fda approvals ↗
    ›Feb 21, 2025approval538d agoBUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE (BUPRENORPHINE HYDROCHLORIDE) — FDA approvalBUPRENORPHINE HYDROCHLORIDE

    Sponsor: ACTAVIS ELIZABETH. Form: TABLET. Route: SUBLINGUAL

    full page →BUPRENORPHINE HYDROCHLORIDE →fda approvals ↗
    ›Feb 21, 2025approval538d agoANASTROZOLE — FDA approvalANASTROZOLE

    Sponsor: HIKMA. Form: TABLET. Route: ORAL

    full page →ANASTROZOLE →fda approvals ↗
    ›Feb 21, 2025device 510k538d agoOrthopediatrics Canada Ulc Dba Pega Medical — Fassier-Duval Telescoping IM System (510k cleared)

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

    full page →fda device 510k ↗
    ›Feb 21, 2025device 510k538d agoTaiwan Dental Materials Co., Ltd. — TEMP MASTER, PMMA-based dental resin (510k cleared)

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

    full page →fda device 510k ↗
    ›Feb 21, 2025device 510k538d agoLyma Life , Ltd. — LYMA Laser PRO (510k cleared)

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

    full page →fda device 510k ↗
    ›Feb 21, 2025device 510k538d agoSpinal Elements, Inc. — Primus Spinal Fixation System (510k cleared)

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

    full page →fda device 510k ↗
    ›Feb 21, 2025device 510k538d agoExtremity Medical, LLC — Extremity Medical External Fixation System (510k cleared)

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

    full page →fda device 510k ↗
    ›Feb 21, 2025device 510k538d agoScandiags AG — ScanDiags Ortho L-Spine MR-Q (510k cleared)

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

    full page →fda device 510k ↗
    ›Feb 21, 2025device 510k538d agoChurch & Dwight Co., Inc. — Trojan™ Ultra Ribbed Ecstasy latex condom with lubricant (Trojan™ Ultra Ribbed Ecstasy) (510k cleared)CHURCH & DWIGHT CO INC /DE/

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

    full page →fda device 510k ↗
    ›Feb 21, 2025device 510k538d agoIntradin (Shanghai) Machinery Co., Ltd. — Powered Mobility Scooter (510k cleared)

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

    full page →fda device 510k ↗
    ›Feb 21, 2025device 510k538d agoVATECH Co., Ltd. — Green X 12 SE (PHT-40CHS) (510k cleared)

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

    full page →fda device 510k ↗
    ›Feb 21, 2025device 510k538d agoShenzhen Dazhou Medical Technology Co., Ltd. — Synthetic Bone Graft Particulate (510k cleared)Guangzhou Dazhou Biomedical Technology Co Ltd

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

    full page →fda device 510k ↗
    ›Feb 21, 2025device 510k538d agoInstitut Straumann AG — Custom Abutments (510k cleared)

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

    full page →fda device 510k ↗
    ›Feb 21, 2025device 510k538d agoAikenist Technologies Pvt, Ltd. — QuickRad (510k cleared)Pandorum Technologies Pvt Ltd

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

    full page →fda device 510k ↗
    ›Feb 21, 2025device 510k538d agoMedicom Asia-Pacific Holdings Ltd. Taiwan Branch. — Medicom Sterilization Pouch and Reel (510k cleared)

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

    full page →fda device 510k ↗
    ›Feb 21, 2025device 510k538d agoShenzhen Urion Technology Co., Ltd. — Upper Arm Electronic Blood Pressure Monitor (U87Y series (models including U80Y, U81Y, U82Y,U83Y,U86Y U80N, U81NH), U86E series (including U82E, U80E, U80EH, U81E, U83E, U85E, U80L, U87E ), U81X series (including U81X, U80X, U82X, U83X, U81D, U82D, U83D, U81RH, U82RH) and U83Z series (including U83Z, U80Z, U81Z, U82Z, U85Z, U86Z and U87Z)) (510k cleared)Fortior Technology (Shenzhen) Co., Ltd./ADR

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

    full page →fda device 510k ↗
    ›Feb 21, 2025device 510k538d agoVita Zahnfabrik H.Rauter GmbH & Co. — VITA YZ Multi Translucent (510k cleared)

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

    full page →fda device 510k ↗
    ›Feb 21, 2025device 510k538d agoRti Surgical, Inc. — Moldable Bone Void Filler and Moldable Bone Void Filler + CCC (510k cleared)

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

    full page →fda device 510k ↗
    ›Feb 21, 2025device 510k538d agoCepheid — Xpert® FII & FV (510k cleared)

    Product code: NPR. Advisory committee: Hematology. Type: Special

    full page →fda device 510k ↗
    ›Feb 21, 2025device 510k538d agoMaterialise NV — Materialise Personalized Guides and Models for Craniomaxillofacial Surgery (510k cleared)MATERIALISE NV

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

    full page →fda device 510k ↗
    ›Feb 21, 2025device 510k538d agoShenzhen TPH Technology Co., Ltd. — Wearable breast pump (model W8) (510k cleared)Fortior Technology (Shenzhen) Co., Ltd./ADR

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

    full page →fda device 510k ↗
    ›Feb 21, 2025device 510k538d agoShanghai Jianzhong Medical Packaging Co., Ltd. — Sterilization Pouches and Reels (510k cleared)

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

    full page →fda device 510k ↗
    ›Feb 21, 2025device 510k538d agoProprio, Inc. — Paradigm System (510k cleared)

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

    full page →fda device 510k ↗
    ›Feb 21, 2025device 510k538d agoSonio — Sonio Suspect (510k cleared)

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

    full page →fda device 510k ↗

    Week of Feb 24, 2025

    23
    ›Feb 24, 2025approval535d agoSULFAMETHOXAZOLE AND TRIMETHOPRIM (SULFAMETHOXAZOLE) — FDA approvalTeva Pharmaceuticals USA Inc

    Sponsor: TEVA PHARMS USA. Form: INJECTABLE. Route: INJECTION

    full page →fda approvals ↗
    ›Feb 24, 2025approval
    ← prev
    page 13 of 435
    next →
    535d ago
    POSACONAZOLE — FDA approvalPOSACONAZOLE

    Sponsor: MSN. Form: TABLET, DELAYED RELEASE. Route: ORAL

    full page →POSACONAZOLE →fda approvals ↗
    ›Feb 24, 2025approval535d agoMIUDELLA (COPPER) — FDA approval

    Sponsor: SEBELA WOMENS HLTH. Form: SYSTEM. Route: INTRAUTERINE

    full page →fda approvals ↗
    ›Feb 24, 2025device 510k535d agoAnqing Clean Dental Instrument Technology Co., Ltd. — Sterilization Package/Reel (510k cleared)

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

    full page →fda device 510k ↗
    ›Feb 24, 2025device 510k535d agoLingshi Hongruida Health Protection Technology Co., Ltd. — Powder Free Nitrile Examination Gloves (Violet, Black, Green), Tested for Use with Chemotherapy Drugs, Fentanyl Citrate and Select Other Drugs (510k cleared)Teva Pharmaceuticals USA Inc

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

    full page →fda device 510k ↗
    ›Feb 24, 2025device 510k535d agoArum Dentistry Co., Ltd. — SD Implant System (510k cleared)

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

    full page →fda device 510k ↗
    ›Feb 24, 2025device 510k535d agoAlembic, LLC — APRO 70 Swift Catheter and Alembic Aspiration Tubing (510k cleared)Alembic Pharmaceuticals Inc

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

    full page →fda device 510k ↗
    ›Feb 24, 2025device 510k535d agoJpi Healthcare Co, Ltd. — ExamVue Apex (510k cleared)NVP Healthcare Co Ltd

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

    full page →fda device 510k ↗
    ›Feb 24, 2025device 510k535d 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 ↗
    ›Feb 24, 2025device 510k535d agoOncosoft. Co., Ltd. — OncoStudio (OS-01) (510k cleared)

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

    full page →fda device 510k ↗
    ›Feb 24, 2025device 510k535d agoUlthera, Inc. — Ulthera® System (510k cleared)

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

    full page →fda device 510k ↗
    ›Feb 25, 2025approval534d agoSTIVARGA (REGORAFENIB) — FDA approvalBayer AG

    Sponsor: BAYER HLTHCARE. Form: TABLET. Route: ORAL

    full page →fda approvals ↗
    ›Feb 25, 2025device 510k534d agoGE Medical Systems SCS — 3DXR (510k cleared)

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

    full page →fda device 510k ↗
    ›Feb 25, 2025device 510k534d agoTaiwan Aulisa Medical Devices Technologies, Inc. — Aulisa Oximeter Module (2nd Gen.) (GA-OM0007, GA-OM0008) (510k cleared)

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

    full page →fda device 510k ↗
    ›Feb 25, 2025device 510k534d agoFitbit — Loss of Pulse Detection (510k cleared)

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

    full page →fda device 510k ↗
    ›Feb 25, 2025device 510k534d agoAbanza Tecnomed S.L — WasherCap™ Fixation System (510k cleared)

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

    full page →fda device 510k ↗
    ›Feb 25, 2025device 510k534d agoCpmt Laser (Canadian Pioneer Medical Technology Corporation) — EMS (FlexPulse, MagnaCore, Magnetika) (510k cleared)

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

    full page →fda device 510k ↗
    ›Feb 25, 2025device 510k534d agoTherapanacea Sas — ART-Plan+ (v.3.0.0) (510k cleared)

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

    full page →fda device 510k ↗
    ›Feb 25, 2025device 510k534d agoEthicon Endo-Surgery, LLC — ECHELON LINEAR™ Stapler 30mm Stapler (GTX30); ECHELON LINEAR™ Stapler 60mm Stapler (GTX60); ECHELON LINEAR™ Stapler 90mm Stapler (GTX90); ECHELON LINEAR™ Stapler 3D 30mm Blue Reload (GTXR30B); ECHELON LINEAR™ Stapler 3D 30mm Green Reload (GTXR30G); ECHELON LINEAR™ Stapler 3D 60mm Blue Reload (GTXR60B); ECHELON LINEAR™ Stapler 3D 60mm Green Reload (GTXR60G); ECHELON LINEAR™ Stapler 3D 90mm Blue Reload (GTXR90B); ECHELON LINEAR™ Stapler 3D 90mm Green Reload (GTXR90G) (510k cleared)

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

    full page →fda device 510k ↗
    ›Feb 25, 2025device 510k534d agoJLK, Inc. — JLK-AILink (510k cleared)

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

    full page →fda device 510k ↗
    ›Feb 25, 2025device 510k534d agoPrismatik Dentalcraft, Inc. — BruxZir® Esthetic NOW (510k cleared)

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

    full page →fda device 510k ↗
    ›Feb 26, 2025approval533d agoSONAZINE (CHLORPROMAZINE HYDROCHLORIDE) — FDA approvalSaptalis Pharmaceuticals LLC

    Sponsor: SAPTALIS PHARMS. Form: CONCENTRATE. Route: ORAL

    full page →fda approvals ↗
    ›Feb 26, 2025approval533d agoTEPYLUTE (THIOTEPA) — FDA approvalSTI Pharma LLC

    Sponsor: SHORLA. Form: SOLUTION. Route: INTRAVENOUS

    full page →fda approvals ↗
    $AMRX17.10-4.36%
    $CHD102.78-0.50%
    $MTLS6.5600-1.06%
    $FRTRY
    $FRTRY
    $TNDM23.44+2.76%