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23,398 catalysts · 5,000 device 510k · 4,728 grant · 3,753 approval · 3,126 8k filing · 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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  • device 510k5,000
  • grant4,728
  • approval3,753
  • 8k filing3,126
  • device pma2,000
  • device recall2,000
recall
1,126
  • 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

    8
    ›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

    42
    ›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 7 of 468
    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 ↗
    ›Oct 9, 2024approval672d agoBUTALBITAL, ASPIRIN, CAFFEINE, AND CODEINE PHOSPHATE (ASPIRIN) — FDA approvalNovitium Pharma LLC

    Sponsor: STEVENS J. Form: CAPSULE. Route: ORAL

    full page →fda approvals ↗
    ›Oct 9, 2024approval672d agoHYDROCODONE BITARTRATE AND IBUPROFEN (HYDROCODONE BITARTRATE) — FDA approvalStrides Pharma Inc

    Sponsor: SUN PHARM INDS INC. Form: TABLET. Route: ORAL

    full page →fda approvals ↗
    ›Oct 9, 2024approval672d agoBALVERSA (ERDAFITINIB) — FDA approvalerdafitinib

    Sponsor: JANSSEN BIOTECH. Form: TABLET. Route: ORAL

    full page →erdafitinib →fda approvals ↗
    ›Oct 9, 2024device 510k672d agoTruabutment, Inc. — TruAbutment DS; TruBase (510k cleared)

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

    full page →fda device 510k ↗
    ›Oct 9, 2024device 510k672d agoWeero Co., Ltd. — eMVFit (MVF-10M) (510k cleared)

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

    full page →fda device 510k ↗
    ›Oct 9, 2024device 510k672d agoShanghai Care US Medical Product Co., Ltd. — CAREUS Contact Lens Case (Model 1, Model 2, Model 3, Model 4, Model 5, Model 6) (510k cleared)

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

    full page →fda device 510k ↗
    ›Oct 9, 2024device 510k672d agoCarlsmed, Inc. — aprevo® anterior lumbar interbody fusion device with interfixation (510k cleared)CARLSMED, INC.

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

    full page →fda device 510k ↗
    ›Oct 9, 2024device 510k672d agoSu-Ko Technologies, LLC — SER Pen Carain MicroSystem (MP1209SP) (510k cleared)

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

    full page →fda device 510k ↗
    ›Oct 9, 2024device 510k672d agoH.S Hospital Service S.P.A — TRAP EASY (510k cleared)

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

    full page →fda device 510k ↗
    ›Oct 9, 2024device 510k672d agoThermo Fisher Scientific — The Sensititre 20 - 24 hour Haemophilus influenzae/Streptococcus pneumoniae (HP) MIC or Breakpoint Susceptibility System with Meropenem in the dilution range of 0.015 - 32 ug/ml. (510k cleared)THERMO FISHER SCIENTIFIC INC.

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

    full page →fda device 510k ↗
    ›Oct 9, 2024device 510k672d agoOsteoCentric Technologies — OsteoCentric Technologies Cannulated Fasteners and Nuts (510k cleared)

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

    full page →fda device 510k ↗
    ›Oct 9, 2024device 510k672d agoAuxein Medical Pvt., Ltd. — Clavicle and Scapula System (510k cleared)

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

    full page →fda device 510k ↗
    ›Oct 9, 2024device 510k672d agoLimbus Ai, Inc. — Limbus Contour (510k cleared)

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

    full page →fda device 510k ↗
    ›Oct 9, 2024device 510k672d agoMedicreations, LLC — MEDIYAG (510k cleared)

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

    full page →fda device 510k ↗
    ›Oct 10, 2024approval671d agoITOVEBI (INAVOLISIB) — FDA approvalinavolisib

    Sponsor: GENENTECH INC. Form: TABLET. Route: ORAL

    full page →inavolisib →fda approvals ↗
    ›Oct 10, 2024approval671d agoEYLEA HD (AFLIBERCEPT) — FDA approvalEYLEA HD

    Sponsor: REGENERON PHARMACEUTICALS. Form: INJECTABLE. Route: INJECTION

    full page →EYLEA HD →fda approvals ↗
    ›Oct 10, 2024approval671d agoCARISOPRODOL, ASPIRIN AND CODEINE PHOSPHATE (ASPIRIN) — FDA approvalCosette Pharmaceuticals Inc

    Sponsor: INGENUS PHARMS NJ. Form: TABLET. Route: ORAL

    full page →fda approvals ↗
    $SYK348.15+0.68%
    $TMCI4.1900+4.49%
    $ACBM
    $UTMD69.19+0.06%
    $SNN30.01-0.23%
    $HCA411.73-0.56%
    $LNTCY
    $CARL
    $CHD102.78-0.50%
    $REGN802.21-0.72%
    $TMO447.81+1.31%