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23,077 catalysts · 4,900 device 510k · 4,728 grant · 3,532 approval · 3,126 8k filing · 2,000 device pma · 2,000 device recall

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  • device 510k4,900
  • grant4,728
  • approval3,532
  • 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 Oct 7, 2024

    50
    ›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 ↗
    ›Oct 10, 2024approval671d agoRIFADIN (RIFAMPIN) — FDA approvalRIFADIN

    Sponsor: SANOFI AVENTIS US. Form: INJECTABLE. Route: INJECTION

    full page →RIFADIN →fda approvals ↗
    ›Oct 10, 2024approval671d agoRIFATER (ISONIAZID) — FDA approvalRIFATER

    Sponsor: SANOFI AVENTIS US. Form: TABLET. Route: ORAL

    full page →RIFATER →fda approvals ↗
    ›Oct 10, 2024approval671d agoRIFADIN (RIFAMPIN) — FDA approvalRIFADIN

    Sponsor: SANOFI AVENTIS US. Form: CAPSULE. Route: ORAL

    full page →RIFADIN →fda approvals ↗
    ›Oct 10, 2024approval671d agoIMULDOSA (USTEKINUMAB-SRLF) — FDA approvalustekinumab biosimilar

    Sponsor: ACCORD BIOPHARMA INC.. Form: INJECTABLE. Route: INTRAVENOUS

    full page →ustekinumab biosimilar →fda approvals ↗
    ›Oct 10, 2024device 510k671d agoGreens Surgicals Pvt. , Ltd. — GREENS BRAND Posterior, Non-cervical Pedicle Screw Spinal System (510k cleared)

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

    full page →fda device 510k ↗
    ›Oct 10, 2024device 510k671d agoEpic Medical Pte. , Ltd. — ProSeal™ In Line Pump Set (423850) (510k cleared)

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

    full page →fda device 510k ↗
    ›Oct 10, 2024device 510k671d agoBausch & Lomb, Incorporated — EyeGility™ Inserter for Preloaded enVista IOLs (510k cleared)Bausch & Lomb Corp

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

    full page →fda device 510k ↗
    ›Oct 10, 2024device 510k671d agoHeartLung Corporation — AutoChamber (510k cleared)

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

    full page →fda device 510k ↗
    ›Oct 10, 2024device 510k671d agoYilink (Tianjin) Biotechnology Co., Ltd. — Dental porcelain powder (510k cleared)

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

    full page →fda device 510k ↗
    ›Oct 10, 2024device 510k671d agoSiemens Healthcare Diagnostics Products GmbH — INNOVANCE Anti-Xa (OPPU05); INNOVANCE Apixaban Standards (OPPW05); INNOVANCE Apixaban Controls (OPPS05) (510k cleared)Taho Pharmaceuticals Ltd

    Product code: QLU. Advisory committee: Hematology. Type: Traditional

    full page →fda device 510k ↗
    ›Oct 10, 2024device 510k671d agoCtl Medical Corporation — KLIMT™ Expandable Lumbar Interbody Fusion (LIF) Cage System (510k cleared)

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

    full page →fda device 510k ↗
    ›Oct 10, 2024device 510k671d agoIcardio.Ai — EchoMeasure (510k cleared)

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

    full page →fda device 510k ↗
    ›Oct 10, 2024device 510k671d agoB.T.I. Biotechnology Institute, Sl. — BTI Interna 3.0 Dental Implant System UnicCa® (510k cleared)

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

    full page →fda device 510k ↗
    ›Oct 10, 2024device 510k671d agoBLUECORE COMPANY Co., Ltd. — Lasya-Trinity (510k cleared)

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

    full page →fda device 510k ↗
    ›Oct 10, 2024device 510k671d agoStryker Corporation (Tornier, S.A.S.) — Blueprint Patient-Specific Instrumentation; Shoulder iD Primary Reversed Glenoid (510k cleared)

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

    full page →fda device 510k ↗
    ›Oct 10, 2024device 510k671d agoShanghai United Imaging Healthcare Co., Ltd. — uDR 380i Pro (510k cleared)

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

    full page →fda device 510k ↗
    ›Oct 10, 2024device 510k671d agoQuanta System Spa — Youlaser PRIME; Youlaser PRIME CO2; Youlaser PRIME MT (510k cleared)

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

    full page →fda device 510k ↗
    ›Oct 10, 2024device 510k671d agoWeero Co., Ltd. — eMVFit (MVF-10M) (510k cleared)

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

    full page →fda device 510k ↗
    ›Oct 10, 2024device 510k671d agoAmbu A/S — Ambu® aScope™ 5 Cysto HD (Standard Deflection); Ambu® aScope™ 5 Cysto HD (Reverse Deflection); Ambu® aView™ 2 Advance (510k cleared)

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

    full page →fda device 510k ↗
    ›Oct 11, 2024approval670d agoMETHYLPREDNISOLONE — FDA approvalPFIZER INC

    Sponsor: TIANJIN TIANYAO. Form: TABLET. Route: ORAL

    full page →fda approvals ↗
    ›Oct 11, 2024approval670d agoMETHYLPREDNISOLONE — FDA approvalPFIZER INC

    Sponsor: TIANJIN TIANYAO. Form: TABLET. Route: ORAL

    full page →fda approvals ↗
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    $ABVC
    $HCA411.73-0.56%
    $CHD102.78-0.50%
    $BLCO16.87+0.24%
    $CARL
    $REGN802.21-0.72%
    $LNTCY
    $TMO447.81+1.31%
    $ACBM
    $PFE26.63-1.57%
    $PFE26.63-1.57%