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19,605 catalysts · 4,728 grant · 3,152 8k filing · 2,737 device 510k · 2,721 approval · 2,000 device recall · 1,916 device pma

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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
  • 8k filing3,152
  • device 510k2,737
  • approval2,721
  • device recall2,000
  • device pma1,916
device adverse event
1,000
  • recall686
  • earnings584
  • phase 2 completion172
  • therapy area
    • Oncology148
    • Infectious Disease46
    • Cardiology37
    • Immunology35
    • Dermatology31
    • Pulmonology22
    • Women's Health19
    • Ophthalmology16
    • Pain15

    Week of Jun 23, 2025

    50
    ›Jun 26, 2025device pma413d agoEdwards Lifesciences, LLC — Edwards Commander Delivery System (PMA supplement)Edwards Lifesciences Corp

    Supplement type: 30-Day Notice. Product code: NPV. Advisory committee: CV. Decision: OK30

    full page →fda device pma ↗
    ›Jun 26, 2025device pma413d agoMedtronic, Inc. — Avalus Bioprosthesis, Model 400 (PMA supplement)Medtronic plc

    Supplement type: 30-Day Notice. Product code: LWR. Advisory committee: CV. Decision: OK30

    full page →fda device pma ↗
    ›Jun 26, 2025device pma413d agoMedtronic Vascular — Resolute Onyx (PMA supplement)

    Supplement type: 30-Day Notice. Product code: NIQ. Advisory committee: CV. Decision: OK30

    full page →fda device pma ↗
    ›Jun 26, 2025device pma413d agoMedtronic Vascular, Inc. — EverFlex™ Self-expanding Peripheral Stent with Entrust™ Delivery System (PMA supplement)

    Supplement type: 30-Day Notice. Product code: NIP. Advisory committee: CV. Decision: OK30

    full page →fda device pma ↗
    ›Jun 26, 2025device pma413d agoBiosense Webster, Inc. — VARIPULSE™ Platform (VARIPULSE™ Catheter; TRUPULSE™ Generator; Sterile Interface Cable; nGEN™ Pump) (PMA supplement)

    Supplement type: Special (Immediate Track). Product code: QZI. Advisory committee: CV. Decision: APPR

    full page →fda device pma ↗
    ›Jun 26, 2025device pma413d agoMedtronic, Inc. — Avalus Bioprosthesis, Model 400 (PMA supplement)Medtronic plc

    Supplement type: 30-Day Notice. Product code: LWR. Advisory committee: CV. Decision: OK30

    full page →fda device pma ↗
    ›Jun 26, 2025device pma413d agoVeryan Medical, Ltd. — BioMimics 3D Vascular Stent System (PMA supplement)

    Supplement type: Normal 180 Day Track. Product code: NIP. Advisory committee: CV. Decision: APPR

    full page →fda device pma ↗
    ›Jun 26, 2025device pma413d agoMedtronic, Inc. — Mosaic Bioprosthesis, Models 305, 310 (PMA supplement)Medtronic plc

    Supplement type: 30-Day Notice. Product code: DYE. Advisory committee: CV. Decision: OK30

    full page →fda device pma ↗
    ›Jun 26, 2025device pma413d agoMedtronic, Inc. — Hancock II Bioprosthesis, Models T505, T510 (PMA supplement)Medtronic plc

    Supplement type: 30-Day Notice. Product code: DYE. Advisory committee: CV. Decision: OK30

    full page →fda device pma ↗
    ›Jun 26, 2025device pma413d agoMerz North America, Inc. — RADIESSE® Injectable Implant, RADIESSE® Hands, RADIESSE® (+) Lidocaine, RADIESSE® (+) Jawline (PMA supplement)Sustained Therapeutics Inc

    Supplement type: 30-Day Notice. Product code: LMH. Advisory committee: SU. Decision: OK30

    full page →fda device pma ↗
    ›Jun 26, 2025device pma413d agoMedtronic, Inc. — Sphere-9 Catheter and Affera Ablation System (PMA supplement)Medtronic plc

    Supplement type: 30-Day Notice. Product code: QZI. Advisory committee: CV. Decision: OK30

    full page →fda device pma ↗
    ›Jun 26, 2025device pma413d agoC.R. Bard, Inc. — Covera™ Vascular Covered Stents (PMA supplement)

    Supplement type: 30-Day Notice. Product code: PFV. Advisory committee: CV. Decision: OK30

    full page →fda device pma ↗
    ›Jun 26, 2025device pma413d agoEdwards Lifesciences, LLC — Edwards Commander Delivery System (PMA supplement)Edwards Lifesciences Corp

    Supplement type: 30-Day Notice. Product code: NPT. Advisory committee: CV. Decision: OK30

    full page →fda device pma ↗
    ›Jun 26, 2025device 510k413d agoVerity Medical , Ltd. — NeuroTrac® MyoPlus Pro (MYO120U) (510k cleared)

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

    full page →fda device 510k ↗
    ›Jun 26, 2025device 510k413d agoMaxx Orthopedics, Inc. — Freedom® Total Knee System – Titanium Tibial Base Plate (510k cleared)

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

    full page →fda device 510k ↗
    ›Jun 26, 2025device 510k413d agoInMode , Ltd. — Optimas MAX System (510k cleared)InMode Ltd.

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

    full page →fda device 510k ↗
    ›Jun 26, 2025device 510k413d agoSonic Incytes Medical Corp — Velacur One (LI-1100) (510k cleared)

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

    full page →fda device 510k ↗
    ›Jun 26, 2025device 510k413d agoShenzhen Bestman Instrument Co., Ltd. — Doppler FHR Detector (BF-500D+, BF-560) (510k cleared)

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

    full page →fda device 510k ↗
    ›Jun 26, 2025device 510k413d agoJoytech Healthcare Co. , Ltd. — Arm-type Fully Automatic Digital Blood Pressure Monitors (DBP-6286B, DBP-6186) (510k cleared)NVP Healthcare Co Ltd

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

    full page →fda device 510k ↗
    ›Jun 26, 2025device 510k413d agoNeuralytix, LLC — Neuralytix iD3 System (NTX-9001) (510k cleared)

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

    full page →fda device 510k ↗
    ›Jun 26, 2025device 510k413d agoPathAI, Inc. — AISight Dx (510k cleared)Pathos AI Inc

    Product code: QKQ. Advisory committee: Pathology. Type: Traditional

    full page →fda device 510k ↗
    ›Jun 26, 2025device 510k413d agoYichang Xinxin Paper Products Co., Ltd. — Sterilization Pouch and Roll (510k cleared)

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

    full page →fda device 510k ↗
    ›Jun 26, 2025device 510k413d agoHardy Diagnostics — HardyDisk AST Gepotidacin 10µg (GEP10) (510k cleared)

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

    full page →fda device 510k ↗
    ›Jun 26, 2025device 510k413d agoExactech, Inc. — Equinoxe® Scapula Fracture System (510k cleared)

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

    full page →fda device 510k ↗
    ›Jun 26, 2025device 510k413d agoOpen Implants, LLC — Sherlock (510k cleared)

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

    full page →fda device 510k ↗
    ›Jun 26, 2025device 510k413d agoVioptix, Inc. — Lap.Ox™ Laparoscopic Tissue Oximeter (510k cleared)

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

    full page →fda device 510k ↗
    ›Jun 26, 2025device 510k413d agoTianjin Huahong Technology Co., Ltd. — safety lancet (510k cleared)

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

    full page →fda device 510k ↗
    ›Jun 26, 2025device 510k413d agoAtmo Biosciences, Ltd. — Atmo Gas Capsule System (510k cleared)Brii Biosciences Ltd

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

    full page →fda device 510k ↗
    ›Jun 26, 2025device 510k413d agoGeistlich Pharma AG — SwissGraft X (510k cleared)

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

    full page →fda device 510k ↗
    ›Jun 26, 2025device 510k413d agoTriMed, Inc. — TriMed Ulnar Osteotomy System (Ulnar Osteotomy Compression Plate); TriMed Ulnar Osteotomy System (Hex Cortical Screw 3.2mm); TriMed Ulnar Osteotomy System (Locking Cortical Screw 3.2mm); TriMed Ulnar Osteotomy System (Lag Screw 3.2mm) (510k cleared)

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

    full page →fda device 510k ↗
    ›Jun 26, 2025device 510k413d agoMedtronic Sofamor Danek USA, Inc. — The Rialto™ SI Fusion System (510k cleared)Medtronic USA Inc

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

    full page →fda device 510k ↗
    ›Jun 26, 2025device 510k413d agoChengdu Daxan Innovative Medical Tech. Co., Ltd. — Disposable Intermittent Catheter (TPU Catheter) (510k cleared)

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

    full page →fda device 510k ↗
    ›Jun 27, 2025approval412d agoSTELARA (USTEKINUMAB) — FDA approvalJOHNSON & JOHNSON

    Sponsor: CENTOCOR ORTHO BIOTECH INC. Form: INJECTABLE. Route: INJECTION

    full page →fda approvals ↗
    ›Jun 27, 2025approval412d agoSTELARA (USTEKINUMAB) — FDA approvalustekinumab

    Sponsor: JANSSEN BIOTECH. Form: INJECTABLE. Route: INJECTION

    full page →ustekinumab →fda approvals ↗
    ›Jun 27, 2025approval412d agoGAMIFANT (EMAPALUMAB-LZSG) — FDA approvalSobi Inc

    Sponsor: NOVIMMUNE S.A.. Form: INJECTABLE. Route: INJECTION

    full page →fda approvals ↗
    ›Jun 27, 2025approval412d agoPYZCHIVA (USTEKINUMAB-TTWE) — FDA approvalPYZCHIVA

    Sponsor: SAMSUNG BIOEPIS CO LTD. Form: INJECTABLE. Route: INJECTION

    full page →PYZCHIVA →fda approvals ↗
    ›Jun 27, 2025approval412d agoULTOMIRIS (RAVULIZUMAB-CWVZ) — FDA approvalAlexion Pharmaceuticals Inc

    Sponsor: ALEXION PHARM. Form: INJECTABLE. Route: INJECTION

    full page →fda approvals ↗
    ›Jun 27, 2025device pma412d agoMedtronic, Inc. — CapSureFix Novus Lead; Vitatron Crystalline Active Fixation Lead (PMA supplement)Medtronic plc

    Supplement type: 30-Day Notice. Product code: NVN. Advisory committee: CV. Decision: OK30

    full page →fda device pma ↗
    ›Jun 27, 2025device pma412d agoAgilent Technologies, Inc. — PD-L1 IHC 22C3 PHARMDX (PMA supplement)AGILENT TECHNOLOGIES, INC.

    Supplement type: 30-Day Notice. Product code: PLS. Advisory committee: PA. Decision: OK30

    full page →fda device pma ↗
    ›Jun 27, 2025device pma412d agoMedtronic, Inc. — PulseSelect™ Pulsed Field Ablation (PFA) system (PMA supplement)Medtronic plc

    Supplement type: Normal 180 Day Track No User Fee. Product code: QZI. Advisory committee: CV. Decision: APPR

    full page →fda device pma ↗
    ›Jun 27, 2025device pma412d agoABBOTT MEDICAL — Esprit™ BTK Everolimus Eluting Resorbable Scaffold System (PMA supplement)Postsurgical Therapeutics Inc

    Supplement type: Real-Time Process. Product code: NXW. Advisory committee: CV. Decision: APPR

    full page →fda device pma ↗
    ›Jun 27, 2025device pma412d agoMedtronic Cardiac Rhythm Disease Management — SelectSecure Lead (PMA supplement)

    Supplement type: 30-Day Notice. Product code: NVN. Advisory committee: CV. Decision: OK30

    full page →fda device pma ↗
    ›Jun 27, 2025device pma412d agoAgilent Technologies, Inc. — MAGE-A4 IHC 1F9 pharmDx (PMA supplement)AGILENT TECHNOLOGIES, INC.

    Supplement type: 30-Day Notice. Product code: SBL. Advisory committee: PA. Decision: OK30

    full page →fda device pma ↗
    ›Jun 27, 2025device pma412d agoShockwave Medical, Inc. — Shockwave Intravascular Lithotripsy (IVL) 825 Series Generators (PMA supplement)

    Supplement type: Real-Time Process. Product code: QMG. Advisory committee: CV. Decision: APPR

    full page →fda device pma ↗
    ›Jun 27, 2025device pma412d agoAgilent Technologies, Inc. — PD-L1 IHC 28-8 pharmDx (PMA supplement)AGILENT TECHNOLOGIES, INC.

    Supplement type: 30-Day Notice. Advisory committee: PA. Decision: OK30

    full page →fda device pma ↗
    ›Jun 27, 2025device pma412d agoTempus Labs, Inc. — xT CDx (PMA supplement)Tempus AI, Inc.

    Supplement type: Real-Time Process. Product code: PQP. Advisory committee: PA. Decision: APPR

    full page →fda device pma ↗
    ›Jun 27, 2025device 510k412d agoPhilips Medical Systems Nederland B.V. — Philips iCT CT system (510k cleared)

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

    full page →fda device 510k ↗
    ›Jun 27, 2025device 510k412d agoUstomed Instrumente Ulrich Storz GmbH & Co. KG — USTOMED Bone Fixation/Bone Augmentation Systems - PIN (510k cleared)

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

    full page →fda device 510k ↗
    ›Jun 27, 2025device 510k412d agoBecton Dickinson Infusion Therapy Systems, Inc. — BD Insyte™ Autoguard™ Shielded IV Catheter, BD Insyte™ Autoguard™ BC Shielded IV Catheter and BD Insyte™ Autoguard™ BC Pro Shielded IV Catheter (510k cleared)

    Product code: FOZ. Advisory committee: General Hospital. Type: Special

    full page →fda device 510k ↗
    ›Jun 27, 2025device 510k412d agoBiomet 3i, LLC — T3 Pro Implants– ZimVie Packaging System (510k cleared)

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

    full page →fda device 510k ↗
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    $EW91.33-2.47%
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    $MDT90.68+1.42%
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    $MDT90.68+1.42%
    $MDT90.68+1.42%
    $INMD
    $JNJ259.80-0.77%
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    $MDT90.68+1.42%
    $A149.49+0.52%
    $TEM
    $A149.49+0.52%