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23,503 catalysts · 5,000 device 510k · 4,728 grant · 3,696 approval · 3,288 8k filing · 2,000 device pma · 2,000 device recall

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2026-08-10: 0 catalysts2026-08-11: 0 catalysts2026-08-12: 0 catalysts2026-08-13: 118 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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  • device 510k5,000
  • grant4,728
  • approval3,696
  • 8k filing3,288
  • device pma2,000
  • device recall2,000
recall
1,126
  • device adverse event1,000
  • earnings584
  • phase 2 completion172
  • therapy area
    • Oncology148
    • Infectious Disease46
    • Cardiology37
    • Immunology35
    • Dermatology31
    • Pulmonology22
    • Women's Health19
    • Ophthalmology16
    • Pain15

    Week of Nov 11, 2024

    19
    ›Nov 15, 2024device 510k637d agoDent4you AG — Speedex Light Body; Speedex Medium; Speedex Putty; Speedex Putty Soft; Speedex Universal Activator (510k cleared)

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

    full page →fda device 510k ↗
    ›Nov 15, 2024device 510k637d agoCarlsmed, Inc. — aprevo® Cervical ACDF; aprevo® Cervical ACDF-X; aprevo® Cervical ACDF-X NO CAM (510k cleared)CARLSMED, INC.

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

    full page →fda device 510k ↗
    ›Nov 15, 2024device 510k637d agoVuno, Inc. — VUNO Med-Chest X-ray Triage/VUNO Med-CXR Link Triage (510k cleared)

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

    full page →fda device 510k ↗
    ›Nov 15, 2024device 510k637d agoKoios Medical, Inc. — Koios DS (510k cleared)

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

    full page →fda device 510k ↗
    ›Nov 15, 2024device 510k637d agoVascutek, Ltd. — Gelsoft™ Plus Vascular Prostheses (510k cleared)

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

    full page →fda device 510k ↗
    ›Nov 15, 2024device 510k637d agoTianjin Huahong Technology Co., Ltd. — Lancet (IA, IB, IC, ID, IE, IK, IL, IM, IIA, IIB, III, V, VI, VII, VIII, IX); Lancing device (HH-X-T, HH-XV-T, HH-XVI-T, HH-XVII-T, HH-XVIII-T, HH-XIX, HH-XXI-T, HH-XXII-T, HH-XXIII-T, HH-XXIV-T, HH-XXV-T, HH-XXVI-T, HH-XXVIII-T, HH-XXIX-T, HH-XXX-T, HH-XIII-T, HH-XXVII-T) (510k cleared)

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

    full page →fda device 510k ↗
    ›Nov 15, 2024device 510k637d agoMycardium AI Limited — 1CMR Pro (510k cleared)

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

    full page →fda device 510k ↗
    ›Nov 15, 2024device 510k637d agoCreagh Medical Ltd. Dba Surmodics, Inc. — 018 Hydrophilic Coated OTW PTA Balloon Dilatation Catheter (510k cleared)

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

    full page →fda device 510k ↗
    ›Nov 15, 2024device 510k637d agoUltromics Limited — EchoGo Amyloidosis (1.0) (510k cleared)

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

    full page →fda device 510k ↗
    ›Nov 15, 2024device 510k637d agoPhilips Ultrasound, LLC — The 5000 Compact Series Ultrasound Systems (510k cleared)

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

    full page →fda device 510k ↗
    ›Nov 15, 2024device 510k637d agoVieworks Co., Ltd. — VIVIX-S 1751S (510k cleared)

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

    full page →fda device 510k ↗
    ›Nov 15, 2024device 510k637d agoBlue Belt Technologies, Inc. — CORIOGRAPH Pre-Op Planning and Modeling Services (510k cleared)BETA Technologies, Inc.

    Advisory committee: Unknown. Type: Traditional

    full page →fda device 510k ↗
    ›Nov 15, 2024device 510k637d agoShenzhen Vitavitro Biotech Co., Ltd. — VitaVitro® Single Lumen Oocyte Retrieval Needle (ORNS-17G, ORNS-18G), VitaVitro® Double Lumen Oocyte Retrieval Needle (ORND-17G) (510k cleared)Shenzhen MagicRNA Biotech Co Ltd

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

    full page →fda device 510k ↗
    ›Nov 15, 2024device 510k637d agoInfinitum Eta, Ltd. — NUVENTUS NV.C™ Dental Implant System (510k cleared)

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

    full page →fda device 510k ↗
    ›Nov 15, 2024device 510k637d agoB-One Ortho, Corp. — b-ONE® Total Hip System (510k cleared)

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

    full page →fda device 510k ↗
    ›Nov 15, 2024device 510k637d agoTHINK Surgical, Inc. — TMINI Miniature Robotic System (510k cleared)

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

    full page →fda device 510k ↗
    ›Nov 15, 2024device 510k637d agoSurgical Instrument Service and Savings Inc.(Dba Medline Ren — Medline ReNewal Reprocessed Biosense Webster Webster CS Catheter with EZ Steer Technology and Medline ReNewal Reprocessed Biosense Webster Webster CS Catheter with EZ Steer Technology and Auto ID Technology (BD710DF282CT, BD710DF282RTS, BD710FJ282RTS, BD710FJ282CT) (510k cleared)

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

    full page →fda device 510k ↗
    ›Nov 15, 2024device 510k637d agoSiemens Medical Solutions USA, Inc. — ACUSON Redwood Diagnostic Ultrasound System (510k cleared)

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

    full page →fda device 510k ↗
    ›Nov 15, 2024device 510k637d agoLivsmed, Inc. — ArtiSeal Vessel Sealing System-ArtiSeal Instruments; ArtiSeal Vessel Sealing System-ArtiSeal Generator (510k cleared)

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

    full page →fda device 510k ↗

    Week of Nov 18, 2024

    31
    ›Nov 18, 2024device 510k634d agoMindset Medical, Inc. — Informed Vital Core Application (IVC App) (510k cleared)Outset Medical, Inc.

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

    full page →fda device 510k ↗
    ›Nov 18, 2024device 510k
    ← prev
    page 20 of 471
    next →
    634d ago
    Sorin Group Italia S.R.L. — MICRO Arterial Filters (510k cleared)

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

    full page →fda device 510k ↗
    ›Nov 18, 2024device 510k634d agoZhejiang Innuovo Rehabilitation Devices Co.,Ltd — Power Wheelchair (W5538) (510k cleared)

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

    full page →fda device 510k ↗
    ›Nov 18, 2024device 510k634d agoOrthocon, Inc. — Montage-XT Settable Bone Putty (510k cleared)

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

    full page →fda device 510k ↗
    ›Nov 18, 2024device 510k634d agoZhejiang Zhonglei Medical Technology Co. , Ltd. — Power wheelchair (510k cleared)Zhejiang Xinkanghe Biomedical Technology Co Ltd

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

    full page →fda device 510k ↗
    ›Nov 18, 2024device 510k634d agoTrice Medical, Inc. — Tenex 2nd Generation System (510k cleared)Tenon Medical, Inc.

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

    full page →fda device 510k ↗
    ›Nov 18, 2024device 510k634d agoDeepHealth, Inc. — Saige-Dx (510k cleared)

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

    full page →fda device 510k ↗
    ›Nov 18, 2024device 510k634d agoXiamen Weiyou Intelligent Technology Co., Ltd. — Air Pressure Therapy System (VU-IPC04B) (510k cleared)

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

    full page →fda device 510k ↗
    ›Nov 18, 2024device 510k634d agoHebei Keylaser Sci-Tech Co.,Ltd — Diode laser Treatment System (K18) (510k cleared)

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

    full page →fda device 510k ↗
    ›Nov 18, 2024device 510k634d agoEnlight Medical Technologies (Shenzhen) Co., Ltd. — Synxess Neurovascular Guidewire (510k cleared)

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

    full page →fda device 510k ↗
    ›Nov 18, 2024device 510k634d agoIntuitive Surgical, Inc. — da Vinci SP Instruments (SP1098) (510k cleared)INTUITIVE SURGICAL INC

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

    full page →fda device 510k ↗
    ›Nov 18, 2024device 510k634d agoPhilips Healthcare (Suzhou) Co., Ltd. — CT Collaboration Live (510k cleared)

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

    full page →fda device 510k ↗
    ›Nov 19, 2024approval633d agoQSYMIA (PHENTERMINE HYDROCHLORIDE) — FDA approval(phentermine hydrochloride + topiramate) ER

    Sponsor: VIVUS LLC. Form: CAPSULE, EXTENDED RELEASE. Route: ORAL

    full page →(phentermine hydrochloride + topiramate) ER →fda approvals ↗
    ›Nov 19, 2024approval633d agoPAXLOVID (COPACKAGED) (NIRMATRELVIR) — FDA approvalPAXLOVID (COPACKAGED)

    Sponsor: PFIZER. Form: TABLET. Route: ORAL

    full page →PAXLOVID (COPACKAGED) →fda approvals ↗
    ›Nov 19, 2024device 510k633d agoCerrozone, LLC — CerroZone Mini (510k cleared)

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

    full page →fda device 510k ↗
    ›Nov 19, 2024device 510k633d agoNova Biomedical Corporation — Nova Allegro UACR Assay, Nova Allegro Analyzer (510k cleared)

    Product code: CGX. Advisory committee: Clinical Chemistry. Type: Dual Track

    full page →fda device 510k ↗
    ›Nov 19, 2024device 510k633d agoMaxx Orthopedics, Inc. — Freedom® Medial Congruent Liner (510k cleared)

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

    full page →fda device 510k ↗
    ›Nov 19, 2024device 510k633d agoPolarean, Inc. — XENOVIEW 3.0T Chest Coil (510k cleared)Polaris Inc.

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

    full page →fda device 510k ↗
    ›Nov 19, 2024device 510k633d agoRiverpoint Medical — Iconix Knotless Anchor (510k cleared)

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

    full page →fda device 510k ↗
    ›Nov 19, 2024device 510k633d agoDongguanshi Yiyingmei Technology Co., Ltd. — Nasal Aspirator (BC-021, BC-022, BC-023, BC-024, BC-025, BC-026) (510k cleared)

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

    full page →fda device 510k ↗
    ›Nov 19, 2024device 510k633d agoEieling Technology (Shenzhen) Limited — Portable Liver Elastography Ultrasound Diagnostic System (Liverscan C) (510k cleared)

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

    full page →fda device 510k ↗
    ›Nov 19, 2024device 510k633d agoBraxx Biotech Co., Ltd. — “BRAXX” Esophageal Brachytherapy Applicator (Model: BKMI2001, BKMI2002) (510k cleared)

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

    full page →fda device 510k ↗
    ›Nov 19, 2024device 510k633d agoTaidoc Technology Corporation — XPER Technology PREMIUM Pro Blood Glucose Monitoring System (510k cleared)

    Product code: PZI. Advisory committee: Clinical Chemistry. Type: Dual Track

    full page →fda device 510k ↗
    ›Nov 19, 2024device 510k633d agoRhein Laser Technologies Co., Ltd. — Medical Thulium Fiber Laser Systems (UroFiber 60Q) (510k cleared)

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

    full page →fda device 510k ↗
    ›Nov 19, 2024device 510k633d agoMiRus, LLC — EUROPA™ Posterior Cervical Fusion System (510k cleared)

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

    full page →fda device 510k ↗
    ›Nov 19, 2024device 510k633d agoNatus Medical Incorporated Dba Excel-Tech Ltd. (Xltek) — Natus BrainWatch System (510k cleared)

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

    full page →fda device 510k ↗
    ›Nov 19, 2024device 510k633d agoSiemens Medical Solutions USA, Inc. — ACUSON Sequoia Diagnostic Ultrasound System; ACUSON Sequoia Select Diagnostic Ultrasound System; ACUSON Origin Diagnostic Ultrasound System; ACUSON Origin ICE Diagnostic Ultrasound System (510k cleared)

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

    full page →fda device 510k ↗
    ›Nov 20, 2024approval632d agoKEYTRUDA (PEMBROLIZUMAB) — FDA approvalpembrolizumab

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

    full page →pembrolizumab →fda approvals ↗
    ›Nov 20, 2024approval632d agoADRENACLICK (EPINEPHRINE) — FDA approvalViatris Inc

    Sponsor: IMPAX. Form: INJECTABLE. Route: INTRAMUSCULAR, SUBCUTANEOUS

    full page →fda approvals ↗
    ›Nov 20, 2024approval632d agoOXYCODONE AND ACETAMINOPHEN (ACETAMINOPHEN) — FDA approvalIGC Pharma, Inc.

    Sponsor: SANALUZ. Form: TABLET. Route: ORAL

    full page →fda approvals ↗
    ›Nov 20, 2024approval632d agoHYDROCODONE BITARTRATE AND ACETAMINOPHEN (ACETAMINOPHEN) — FDA approvalIGC Pharma, Inc.

    Sponsor: SANALUZ. Form: TABLET. Route: ORAL

    full page →fda approvals ↗
    $CARL
    $BETA16.10+2.09%
    $OM4.5200-1.09%
    $IGC0.2670+0.41%
    $PII68.38-0.20%
    $TNON0.2832-3.11%
    $ISRG401.270.00%
    $VTRS16.04-0.37%
    $IGC0.2670+0.41%
    $PFE26.80+1.86%