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23,100 catalysts · 4,935 device 510k · 4,728 grant · 3,535 approval · 3,111 8k filing · 2,000 device pma · 2,000 device recall

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2026-08-10: 0 catalysts2026-08-11: 82 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 510k4,935
  • grant4,728
  • approval3,535
  • 8k filing3,111
  • device pma2,000
  • device recall2,000
  • recall1,126
  • 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 30, 2024

    25
    ›Oct 4, 2024approval677d agoCOSENTYX (SECUKINUMAB) — FDA approvalNOVARTIS AG

    Sponsor: NOVARTIS PHARMS CORP. Form: INJECTABLE. Route: INJECTION

    full page →fda approvals ↗
    ›Oct 4, 2024approval677d agoCOSENTYX (SECUKINUMAB) — FDA approvalNOVARTIS AG

    Sponsor: NOVARTIS PHARMS CORP. Form: INJECTABLE. Route: INJECTION

    full page →fda approvals ↗
    ›Oct 4, 2024approval677d agoPYRIDOSTIGMINE BROMIDE — FDA approvalBausch Health US LLC

    Sponsor: US ARMY. Form: TABLET. Route: ORAL

    full page →fda approvals ↗
    ›Oct 4, 2024device 510k677d agoFengh Medical Co., Ltd. — Disposable Powered Articulating Endoscopic Linear Cutter Stapler & Reloads (30mm series); Disposable Powered Articulating Endoscopic Linear Cutter Stapler & Reloads (45mm series); Disposable Powered Articulating Endoscopic Linear Cutter Stapler & Reloads (60mm series) (510k cleared)

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

    full page →fda device 510k ↗
    ›Oct 4, 2024device 510k677d agoHunan Vathin Medical Instrument Co., Ltd. — Video Ureteroscope System (510k cleared)

    Product code: FGB. Advisory committee: Gastroenterology, Urology. Type: Special

    full page →fda device 510k ↗
    ›Oct 4, 2024device 510k677d agoCenterPoint Systems, LLC — AuST Steerable Sheath (510k cleared)

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

    full page →fda device 510k ↗
    ›Oct 4, 2024device 510k677d agoAdvamedix, GmbH — Bladeless Trocar; Bladed Trocar; Hasson Trocar (510k cleared)

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

    full page →fda device 510k ↗
    ›Oct 4, 2024device 510k677d agoZeta Surgical, Inc. — Zeta Cranial Navigation System (ZNS131-US) (510k cleared)

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

    full page →fda device 510k ↗
    ›Oct 4, 2024device 510k677d agoAlphatec Spine, Inc. — IdentiTi™ II Interbody System (510k cleared)

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

    full page →fda device 510k ↗
    ›Oct 4, 2024device 510k677d agoDia Imaging Analysis, Ltd. — LVivo Software Application (510k cleared)

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

    full page →fda device 510k ↗
    ›Oct 4, 2024device 510k677d agoShenzhen Besdata Technology Co., Ltd. — Single use flexible ureteroscope (UR-D1); Single use flexible ureteroscope (UR-D2); Single use flexible ureteroscope (UR-F1); Single use flexible ureteroscope (UR-F2) (510k cleared)Fortior Technology (Shenzhen) Co., Ltd./ADR

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

    full page →fda device 510k ↗
    ›Oct 4, 2024device 510k677d agoLunit, Inc. — Lunit INSIGHT DBT v1.1 (510k cleared)

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

    full page →fda device 510k ↗
    ›Oct 4, 2024device 510k677d agoUnited Medical Resources, LLC — UMED REPROCESSED AIRCAST VENAFLOW FOOT CUFF; UMED REPROCESSED KENDALL SCD EXPRESS SLEEVE; UMED REPROCESSED AIRCAST ELITE CALF CUFF 3040 3050; UMED REPROCESSED CTC VP 501 CALF CUFF; UMED REPROCESSED CTC VP 520 FOOT CUFF (510k cleared)

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

    full page →fda device 510k ↗
    ›Oct 4, 2024device 510k677d agoOrthonovis, Inc. — BPS Wrist Fracture System (510k cleared)

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

    full page →fda device 510k ↗
    ›Oct 4, 2024device 510k677d agoAnhui Jbh Medical Apparatus Co., Ltd. — Power Wheelchair (510k cleared)

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

    full page →fda device 510k ↗
    ›Oct 4, 2024device 510k677d agoEcho IQ, Ltd. — EchoSolv AS (510k cleared)

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

    full page →fda device 510k ↗
    ›Oct 4, 2024device 510k677d agoSurgnova Healthcare Technologies (Zhejiang) Co., Ltd. — Electroporation System (N3000) (510k cleared)

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

    full page →fda device 510k ↗
    ›Oct 4, 2024device 510k677d agoActuated Medical, Inc. — GripTract-GI Endoscopic Tissue Manipulator Lower GI Models (510k cleared)

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

    full page →fda device 510k ↗
    ›Oct 4, 2024device 510k677d agoPromisemed Hangzhou Meditech Co., Ltd. — Endoscopic Injection Needles (510k cleared)

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

    full page →fda device 510k ↗
    ›Oct 4, 2024device 510k677d agoTreace Medical Concepts, Inc. — Treace Medical Concepts (TMC) Screw Fixation System (510k cleared)TREACE MEDICAL CONCEPTS, INC.

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

    full page →fda device 510k ↗
    ›Oct 4, 2024device 510k677d agoTroCare, LLC — TroCare TroKit Laparoscope Lens Wiper (CP000626) (510k cleared)

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

    full page →fda device 510k ↗
    ›Oct 4, 2024device 510k677d agoVivachek Biotech (Hangzhou) Co., Ltd. — BioSieve™ Fentanyl FIA Home Test Kit; BioSieve™ Fentanyl FIA Pro Test Kit; BioSieve™ Toxismart Reader (510k cleared)Hangzhou DAC Biotech Co Ltd

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

    full page →fda device 510k ↗
    ›Oct 4, 2024device 510k677d agoShenzhen Finicare Co., Ltd. — Upper Arm Electronic Blood Pressure Monitor (FC-BP103, FC-BP106, FC-BP113, FC-BP120, FC-BP121, FC-BP130, FC-BP131) (510k cleared)

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

    full page →fda device 510k ↗
    ›Oct 4, 2024device 510k677d agoEventum Orthopaedics, Ltd. — QUADSENSE (510k cleared)

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

    full page →fda device 510k ↗
    ›Oct 6, 2024device 510k675d agoStryker GmbH — Pangea Platform; Pangea Femur Plating System; Pangea Humerus Plating System; Pangea Tibia Plating System (510k cleared)STRYKER CORP

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

    full page →fda device 510k ↗

    Week of Oct 7, 2024

    25
    ›Oct 7, 2024device 510k674d agoOlympus Medical Systems Corporation — Water Container (MAJ-901); Water Container (MAJ-902) (510k cleared)

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

    full page →fda device 510k ↗
    ›Oct 7, 2024device 510k
    ← prev
    page 1 of 462
    next →
    674d ago
    Overture Orthopaedics — OvertureTi Knee Resurfacing SystemTM (510k cleared)

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

    full page →fda device 510k ↗
    ›Oct 7, 2024device 510k674d agoPrimed Medical Products, Inc. — PRIMED Sterilization Wrap (P100, P200, P300, P400, P500, P600) (510k cleared)UTAH MEDICAL PRODUCTS INC

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

    full page →fda device 510k ↗
    ›Oct 7, 2024device 510k674d agoVerdure Imaging — SpineUs™ System (510k cleared)

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

    full page →fda device 510k ↗
    ›Oct 7, 2024device 510k674d agoClimbing Steps, Inc. — GENESIS (MS-P02-GEN) (510k cleared)

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

    full page →fda device 510k ↗
    ›Oct 7, 2024device 510k674d agoHuizhou Foryou Medical Devices Co., Ltd. — LUOFUCON® Extra Silver Gelling Fiber Dressing Plus (Prescription use),LUOFUCON® Silver Antimicrobial Gelling Fiber Dressing Plus (OTC use) (510k cleared)

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

    full page →fda device 510k ↗
    ›Oct 7, 2024device 510k674d agoDepuy Ireland UC — EMPHASYS Acetabular Shell with RapiTite HA (510k cleared)

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

    full page →fda device 510k ↗
    ›Oct 7, 2024device 510k674d agoPhilips Ultrasound, LLC — EPIQ Series Diagnostic Ultrasound System (510k cleared)

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

    full page →fda device 510k ↗
    ›Oct 7, 2024device 510k674d agoSmith & Nephew, Inc. — OR3O Dual Mobility System (510k cleared)SMITH & NEPHEW PLC

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

    full page →fda device 510k ↗
    ›Oct 7, 2024device 510k674d agoHealgen — Healgen Rapid Check COVID-19/Flu A&B Antigen Test (510k cleared)

    Product code: SCA. Advisory committee: Microbiology. Type: Direct

    full page →fda device 510k ↗
    ›Oct 7, 2024device 510k674d agoDeka Research and Development Corporation — DEKA Infusion System, DEKA Administration Set (510k cleared)

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

    full page →fda device 510k ↗
    ›Oct 7, 2024device 510k674d agoEpic Medical Pte. , Ltd. — SMARTeZ™ Elastomeric Infusion Pump (498111, 498121, 498131, 498141) (510k cleared)

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

    full page →fda device 510k ↗
    ›Oct 7, 2024device 510k674d agoRetropsoas Technologies, LLC — EARP Interbody System (510k cleared)

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

    full page →fda device 510k ↗
    ›Oct 8, 2024approval673d agoIBANDRONATE SODIUM — FDA approvalIBANDRONATE SODIUM

    Sponsor: MACLEODS PHARMS LTD. Form: TABLET. Route: ORAL

    full page →IBANDRONATE SODIUM →fda approvals ↗
    ›Oct 8, 2024device 510k673d agoTheranica Bio-Electronics, Ltd. — Nerivio; NerivioInfinity (510k cleared)

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

    full page →fda device 510k ↗
    ›Oct 8, 2024device 510k673d agoZheJiang Decans Medical Devices Co., Ltd. — Gemini Medical Cage System (510k cleared)

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

    full page →fda device 510k ↗
    ›Oct 8, 2024device 510k673d agoSichuan Qianii-Beoka Medical Technoiogy Lnc. — Air Compression Massager (ACM-A1, ACM-A2, ACM-A3, ACM-A4) (510k cleared)

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

    full page →fda device 510k ↗
    ›Oct 8, 2024device 510k673d agoHunan Vathin Medical Instrument Co., Ltd. — Single-use Ureteral Access Sheath (510k cleared)

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

    full page →fda device 510k ↗
    ›Oct 8, 2024device 510k673d agoOmron Healthcare, Inc. — Omron Blood Pressure Monitor with Atrial Fibrillation (AFib) Detection Feature (BP7460 (HEM-7371T1-AZ)); Omron Blood Pressure Monitor with Atrial Fibrillation (AFib) Detection Feature (BP5460 (HEM-7372T1-AZAZ)) (510k cleared)HCA Healthcare, Inc.

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

    full page →fda device 510k ↗
    ›Oct 8, 2024device 510k673d agoSejoy Biomedical Co., Ltd. — Sejoy Blood Glucose Monitoring System; Sejoy Advance Link Blood Glucose Monitoring System (510k cleared)ACRO BIOMEDICAL CO., LTD.

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

    full page →fda device 510k ↗
    ›Oct 8, 2024device 510k673d agoLucens Technology Co., Ltd. — Lucens 41 (senofilcon C) Silicone Hydrogel Soft (Hydrophilic) Contact Lens (510k cleared)Lens Technology Co., Ltd./ADR

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

    full page →fda device 510k ↗
    ›Oct 8, 2024device 510k673d agoChurch & Dwight Co., Inc. — TROJAN SIS Synthetic Latex Condom with Silicone Lubricant (510k cleared)CHURCH & DWIGHT CO INC /DE/

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

    full page →fda device 510k ↗
    ›Oct 8, 2024device 510k673d agoLife Spine, Inc. — ProLift Wedge Expandable Spacer System (510k cleared)

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

    full page →fda device 510k ↗
    ›Oct 8, 2024device 510k673d agoMeta Biomed Co., Ltd. — Jet Flow Bulk (510k cleared)

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

    full page →fda device 510k ↗
    ›Oct 8, 2024device 510k673d agoZheJiang J&J Mobility Co., Ltd. — Power Wheelchair (JJW-6001) (510k cleared)

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

    full page →fda device 510k ↗
    $NVS155.21-1.01%
    $FRTRY
    $TMCI4.1900+4.49%
    $SYK347.77+0.57%
    $NVS155.21-1.01%
    $SNN30.11+0.12%
    $UTMD69.19+0.06%
    $ACBM
    $HCA411.73-0.56%
    $LNTCY
    $CHD102.41-0.86%