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21,389 catalysts · 4,728 grant · 3,882 device 510k · 3,126 8k filing · 3,057 approval · 2,000 device pma · 2,000 device recall

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2026-08-10: 0 catalysts2026-08-11: 97 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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  • grant4,728
  • device 510k3,882
  • 8k filing3,126
  • approval3,057
  • device pma2,000
  • device recall2,000
  • device adverse event1,000
  • recall931
  • earnings583
  • phase 2 completion172
  • therapy area
    • Oncology148
    • Infectious Disease46
    • Cardiology37
    • Immunology35
    • Dermatology31
    • Pulmonology22
    • Women's Health19
    • Ophthalmology16
    • Pain15

    Week of Jan 27, 2025

    37
    ›Jan 30, 2025approval559d agoBKEMV (ECULIZUMAB-AEEB) — FDA approvaleculizumab biosimilar

    Sponsor: AMGEN INC. Form: INJECTABLE. Route: INJECTION

    full page →eculizumab biosimilar →fda approvals ↗
    ›Jan 30, 2025approval559d agoTAFINLAR (DABRAFENIB MESYLATE) — FDA approvaldabrafenib mesylate ODT

    Sponsor: NOVARTIS. Form: CAPSULE. Route: ORAL

    full page →dabrafenib mesylate ODT →fda approvals ↗
    ›Jan 30, 2025approval559d agoTAFINLAR (DABRAFENIB MESYLATE) — FDA approvaldabrafenib mesylate ODT

    Sponsor: NOVARTIS. Form: CAPSULE. Route: ORAL

    full page →dabrafenib mesylate ODT →fda approvals ↗
    ›Jan 30, 2025approval559d agoJOURNAVX (SUZETRIGINE) — FDA approvalsuzetrigine

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

    full page →suzetrigine →fda approvals ↗
    ›Jan 30, 2025approval559d agoBUPRENORPHINE HYDROCHLORIDE — FDA approvalBUPRENORPHINE HYDROCHLORIDE

    Sponsor: SOMERSET THERAPS LLC. Form: INJECTABLE. Route: INJECTION

    full page →BUPRENORPHINE HYDROCHLORIDE →fda approvals ↗
    ›Jan 30, 2025device 510k559d agoMobius Mobility — iBOT® PMD (510k cleared)

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

    full page →fda device 510k ↗
    ›Jan 30, 2025device 510k559d agoShenzhen Zhongkemingwang Telecommunications Software Corp. — Wrist Blood Pressure Monitor (OHMS11, OHMS12) (510k cleared)

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

    full page →fda device 510k ↗
    ›Jan 30, 2025device 510k559d agoMedacta International S.A. — MyShoulder Planner (5.3SSWPL) (510k cleared)Stemedica International S.A.

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

    full page →fda device 510k ↗
    ›Jan 30, 2025device 510k559d agoResponsive Arthroscopy, Inc. — Osprey Suture Anchor (510k cleared)

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

    full page →fda device 510k ↗
    ›Jan 30, 2025device 510k559d agoBTL Industries, Inc. — BTL-754 (510k cleared)NL INDUSTRIES INC

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

    full page →fda device 510k ↗
    ›Jan 30, 2025device 510k559d agoLaboratorios Biogalenic S.A. DE C.V. — Laboratorios Biogalenic Sterile Water for Inhalation, USP (510k cleared)

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

    full page →fda device 510k ↗
    ›Jan 30, 2025device 510k559d agoAbanza Tecnomed S.L — WasherCap™ Mini Fixation System (Model 45) (510k cleared)

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

    full page →fda device 510k ↗
    ›Jan 30, 2025device 510k559d agoTaiwan Aulisa Medical Devices Technologies, Inc. — Aulisa Infant Oximeter Module (2nd Gen.) (GA-OM0018) (510k cleared)

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

    full page →fda device 510k ↗
    ›Jan 30, 2025device 510k559d agoSeplou (Zhuhai) Co., Ltd. — Ureteral Access Sheath (510k cleared)

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

    full page →fda device 510k ↗
    ›Jan 30, 2025device 510k559d agoLiofilchem s.r.l. — MTS Ceftobiprole 0.002-32 µg/mL (510k cleared)

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

    full page →fda device 510k ↗
    ›Jan 30, 2025device 510k559d agoAbbott Molecular — simpli-COLLECT STI Test (510k cleared)

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

    full page →fda device 510k ↗
    ›Jan 30, 2025device 510k559d agoBard Peripheral Vascular, Inc. — Rotarex Atherectomy System (510k cleared)

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

    full page →fda device 510k ↗
    ›Jan 30, 2025device 510k559d agoGuangdong Transtek Medical Electronics Co., Ltd. — TeleRPM Gen2 Blood Glucose Monitoring System (510k cleared)

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

    full page →fda device 510k ↗
    ›Jan 31, 2025approval558d agoSOGROYA (SOMAPACITAN-BECO) — FDA approvalsomatriptan albumin bound LA

    Sponsor: NOVO NORDISK INC. Form: SOLUTION. Route: SUBCUTANEOUS

    full page →somatriptan albumin bound LA →fda approvals ↗
    ›Jan 31, 2025approval558d agoPAXLOVID (COPACKAGED) (NIRMATRELVIR) — FDA approvalPAXLOVID (COPACKAGED)

    Sponsor: PFIZER. Form: TABLET. Route: ORAL

    full page →PAXLOVID (COPACKAGED) →fda approvals ↗
    ›Jan 31, 2025approval558d agoTRAMADOL HYDROCHLORIDE — FDA approvaltramadol hydrochloride ER

    Sponsor: MACLEODS PHARMS LTD. Form: TABLET, EXTENDED RELEASE. Route: ORAL

    full page →tramadol hydrochloride ER →fda approvals ↗
    ›Jan 31, 2025approval558d agoUNASYN (AMPICILLIN SODIUM) — FDA approvalUNASYN

    Sponsor: PFIZER. Form: INJECTABLE. Route: INJECTION

    full page →UNASYN →fda approvals ↗
    ›Jan 31, 2025approval558d agoPEPCID COMPLETE (CALCIUM CARBONATE) — FDA approvalKenvue Inc.

    Sponsor: KENVUE BRANDS. Form: TABLET, CHEWABLE. Route: ORAL

    full page →fda approvals ↗
    ›Jan 31, 2025device 510k558d agoAvanos Medical, Inc. — Game Ready system (550500-04); Game Ready Control Unit (550550-04); Game Ready Full Leg Boot Wrap - Medium (590923-04); Game Ready Full Leg Boot Wrap - Large (590922-04); Game Ready C-T Spine Wrap (590502-04); Game Ready Half Leg Boot (590906-04); Game Ready Back Wrap (590500-04); Game Ready Hand/Wrist Wrap (590811-04); Game Ready Flexed Elbow Wrap (590903-04); Game Ready Straight Elbow Wrap (590200-04); Game Ready Shoulder Wrap, Medium, Right (590422-04); Game Ready Shoulder Wrap, La (510k cleared)AVANOS MEDICAL, INC.

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

    full page →fda device 510k ↗
    ›Jan 31, 2025device 510k558d agoZheJiang Decans Medical Devices Co., Ltd. — Crius PEEK Suture Anchor System (Thread-Fix Anchor); Crius PEEK Suture Anchor System (Thread-Fix Ultra Anchor); Crius PEEK Suture Anchor System (Helicoil Anchor); Crius PEEK Suture Anchor System (Pile Anchor) (510k cleared)

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

    full page →fda device 510k ↗
    ›Jan 31, 2025device 510k558d agoMarzzan Lucas Jorge — AGILIS - Multi-function Physical Therapy Table (Model: Plus, Pro and Basic.) (510k cleared)

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

    full page →fda device 510k ↗
    ›Jan 31, 2025device 510k558d agoLuxottica Group S.P.A. — Nuance Audio Hearing Aid Software (510k cleared)

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

    full page →fda device 510k ↗
    ›Jan 31, 2025device 510k558d agoSuzhou Master Machinery Manufacturing Co.,Ltd — Mobility Scooter (MS160A) (510k cleared)

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

    full page →fda device 510k ↗
    ›Jan 31, 2025device 510k558d agoNanjing Synthgene Medical Technology Co., Ltd. — Synthgene Home Test HCG Test Strip; Synthgene Home Test HCG Test Cassette; Synthgene Home Test HCG Test Midstream (510k cleared)

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

    full page →fda device 510k ↗
    ›Jan 31, 2025device 510k558d agoMotilitycount Aps — SwimCount® Harvester (1 mL); SwimCount® Harvester (3 mL) (510k cleared)

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

    full page →fda device 510k ↗
    ›Jan 31, 2025device 510k558d agoDornier Medtech America — Hoover Negative Pressure Access Sheath (Hoover) (Hoover Model #'s IVX-NS-1040, IVX-NS-1050, IVX-NS-1140, IVX-NS-1150, IVX-NS-1240, IVX-NS-1250 (510k cleared)

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

    full page →fda device 510k ↗
    ›Jan 31, 2025device 510k558d agoArthrex, Inc. — Arthrex DynaNite Nitinol Staples (510k cleared)

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

    full page →fda device 510k ↗
    ›Jan 31, 2025device 510k558d agoBasic Medical Technology, Inc. — Nitrile Powder-Free Exam Gloves Tested for Use with Chemotherapy Drugs, Opioid Fentanyl Citrate, Simulated Gastric Acid (Light blue, Dark blue) (510k cleared)Medical Care Technologies Inc.

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

    full page →fda device 510k ↗
    ›Jan 31, 2025device 510k558d agoTae Young Soft Co., Ltd. — ZeTTA PACS (510k cleared)

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

    full page →fda device 510k ↗
    ›Jan 31, 2025device 510k558d agoGentuity, LLC — Gentuity® HF-OCT Imaging System with Vis-Rx Prime® Micro-Imaging Catheter (510k cleared)

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

    full page →fda device 510k ↗
    ›Jan 31, 2025device 510k558d agoInnovate Orthopaedics, Ltd. — Quick-Start Orthopaedic Fixation Screw and Reverse Thread Screw (510k cleared)

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

    full page →fda device 510k ↗
    ›Jan 31, 2025device 510k558d agoC.R. Bard, Inc. — Semi-Floating Temporary Pacing Electrode Catheter, Bipolar, Stainless Steel Electrodes, 115 cm, 4Fr. (006221P); Semi-Floating Temporary Pacing Electrode Catheter, Bipolar, Stainless Steel Electrodes, 115 cm, 5Fr. (006225P); Semi-Floating Temporary Pacing Electrode Catheter, Bipolar, Stainless Steel Electrodes, 125 cm, 6Fr. (006241P); Semi-Floating Temporary Pacing Electrode Catheter, Bipolar, Stainless Steel Electrodes, 125 cm, 7Fr. (006242P); NBIH™ Temporary Pacing Electrode Catheter, (510k cleared)

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

    full page →fda device 510k ↗

    Week of Feb 3, 2025

    13
    ›Feb 3, 2025approval555d agoVALPROIC ACID — FDA approvalCereno Scientific AB

    Sponsor: CHARTWELL RX. Form: SYRUP. Route: ORAL

    full page →fda approvals ↗
    ›Feb 3, 2025device 510k
    ← prev
    page 1 of 428
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    555d ago
    Huntleigh Healthcare , Ltd. — Sonicaid Team3 (510k cleared)

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

    full page →fda device 510k ↗
    ›Feb 3, 2025device 510k555d agoMomentis Surgical , Ltd. — Anovo Instrument ARM Curved Scissors; Anovo Instrument ARM Hook Electrode (510k cleared)

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

    full page →fda device 510k ↗
    ›Feb 3, 2025device 510k555d agoShenzhen Ulike Smart Electronics Co., Ltd. — JMOON NouvelleSkin Facial Toning Device (M30U PR, M30U MW, M30U SG, M30U SK, M30U MP) (510k cleared)

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

    full page →fda device 510k ↗
    ›Feb 3, 2025device 510k555d agoGuangzhou Hehong Biotech Co., Ltd. — Minvitro® Vitrification Straw (MVT-VSN series, including MVT-VSNR, MVT-VSNY, MVT-VSNB, MVT-VSNG, MVT-VSNP) (510k cleared)Hangzhou DAC Biotech Co Ltd

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

    full page →fda device 510k ↗
    ›Feb 3, 2025device 510k555d agoCytochip, Inc. — Cito CBC System (510k cleared)

    Product code: GKZ. Advisory committee: Hematology. Type: Dual Track

    full page →fda device 510k ↗
    ›Feb 3, 2025device 510k555d agoAlphatec Spine — IdentiTi Porous Ti Interbody System; IdentiTi NanoTec Interbody System; IdentiTi Cervical Porous Ti Interbody System; IdentiTi NanoTec Cervical Interbody System; IdentiTi Cervical Standalone Interbody System; IdentiTi NanoTec Cervical Standalone Interbody System; IdentiTi ALIF Standalone Interbody System; IdentiTi NanoTec ALIF Standalone Interbody System; Transcend PEEK Interbody System; Transcend NanoTec Interbody System; Transcend Cervical PEEK Interbody System; Transcend NanoTec Cer (510k cleared)

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

    full page →fda device 510k ↗
    ›Feb 3, 2025device 510k555d agoMim Software, Inc. — Contour ProtégéAI+ (510k cleared)ASURE SOFTWARE INC

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

    full page →fda device 510k ↗
    ›Feb 3, 2025device 510k555d agoPranaq Pte. , Ltd. — TipTraQ (TTQ001) (510k cleared)

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

    full page →fda device 510k ↗
    ›Feb 3, 2025device 510k555d agoZavation Medical Products, LLC — Tiger 2 System (510k cleared)

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

    full page →fda device 510k ↗
    ›Feb 3, 2025device 510k555d agoGuangdong Xinyu Electronic and Technology Co., Ltd. — Arm Blood Pressure Monitor (XY-B01, XY-B02, XY-B03, XY-B05, XY-B07, XY-B08, XY-B09) (510k cleared)

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

    full page →fda device 510k ↗
    ›Feb 3, 2025device 510k555d agoIhealth Labs, Inc. — iCare APP (510k cleared)

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

    full page →fda device 510k ↗
    ›Feb 4, 2025approval554d agoGABAPENTIN — FDA approvalGABAPENTIN

    Sponsor: STRIDES PHARMA. Form: CAPSULE. Route: ORAL

    full page →GABAPENTIN →fda approvals ↗
    $AMGN414.03-0.76%
    $NVS155.21-1.01%
    $VERX12.23+0.78%
    $NL6.0500-1.14%
    $NVO47.30-0.90%
    $NVS155.21-1.01%
    $PFE26.63-1.57%
    $PFE26.63-1.57%
    $AVNS
    $KVUE19.05+0.11%
    $ASUR8.2700+1.35%
    $MDCE0.00020.00%