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calendar

23,301 catalysts · 4,900 device 510k · 4,728 grant · 3,532 approval · 3,350 8k filing · 2,000 device pma · 2,000 device recall

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  • device 510k4,900
  • grant4,728
  • approval3,532
  • 8k filing3,350
  • 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 Dec 16, 2024

    50
    ›Dec 19, 2024device 510k604d agoThermo Fisher Scientific — The Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with Ceftobiprole in the dilution range of 0.008-16 ug/mL (510k cleared)THERMO FISHER SCIENTIFIC INC.

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

    full page →fda device 510k ↗
    ›Dec 19, 2024device 510k604d agoImplant Protesis Dental 2004, S.L. — IPD Dental Implant Abutments (510k cleared)

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

    full page →fda device 510k ↗
    ›Dec 19, 2024device 510k604d agoOnward Medical, Inc. — ARC-EX System (510k cleared)Picard Medical, Inc.

    Product code: SDO. Advisory committee: Physical Medicine. Type: Direct

    full page →fda device 510k ↗
    ›Dec 19, 2024device 510k604d agoMedline Industries, LP — Hudson RCI Comfort Flo® CubCannula™ (510k cleared)

    Product code: BTT. Advisory committee: Anesthesiology. Type: Traditional

    full page →fda device 510k ↗
    ›Dec 19, 2024device 510k604d agoImbio, Inc. — IQ-UIP (510k cleared)

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

    full page →fda device 510k ↗
    ›Dec 19, 2024device 510k604d agoDmc Importacao E Exportacao DE Equipamentos Ltda — Therapy EC, Therapy XT (510k cleared)

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

    full page →fda device 510k ↗
    ›Dec 19, 2024device 510k604d agoSimpson Interventions, Inc. — Shadow Catheter (510k cleared)

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

    full page →fda device 510k ↗
    ›Dec 19, 2024device 510k604d agoQuantumtx Pte. , Ltd. — Quantum Mitohormesis (QMT) (M2101) (510k cleared)

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

    full page →fda device 510k ↗
    ›Dec 19, 2024device 510k604d agoVivosonic, Inc. — Integrity V500 (Integrity, Integrity with VEMP) (510k cleared)VIVOS INC

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

    full page →fda device 510k ↗
    ›Dec 19, 2024device 510k604d agoTELA Bio, Inc. — OviTex PRS (Long-Term Resorbable) (510k cleared)TELA Bio, Inc.

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

    full page →fda device 510k ↗
    ›Dec 20, 2024approval603d agoSKYCLARYS (OMAVELOXOLONE) — FDA approvalReata Pharmaceuticals Inc

    Sponsor: BIOGEN US. Form: CAPSULE. Route: ORAL

    full page →fda approvals ↗
    ›Dec 20, 2024approval603d agoSKYCLARYS (OMAVELOXOLONE) — FDA approvalReata Pharmaceuticals Inc

    Sponsor: BIOGEN US. Form: CAPSULE. Route: ORAL

    full page →fda approvals ↗
    ›Dec 20, 2024approval603d agoALYFTREK (DEUTIVACAFTOR) — FDA approval(deutivacaftor + tezacaftor + vanzacaftor calcium)

    Sponsor: VERTEX PHARMS INC. Form: TABLET. Route: ORAL

    full page →(deutivacaftor + tezacaftor + vanzacaftor calcium) →fda approvals ↗
    ›Dec 20, 2024approval603d agoTRIKAFTA (COPACKAGED) (ELEXACAFTOR, IVACAFTOR, TEZACAFTOR) — FDA approvalTRIKAFTA (COPACKAGED)

    Sponsor: VERTEX PHARMS INC. Form: TABLET. Route: ORAL

    full page →TRIKAFTA (COPACKAGED) →fda approvals ↗
    ›Dec 20, 2024approval603d agoTRIKAFTA (COPACKAGED) (ELEXACAFTOR, IVACAFTOR, TEZACAFTOR) — FDA approvalTRIKAFTA (COPACKAGED)

    Sponsor: VERTEX PHARMS INC. Form: TABLET. Route: ORAL

    full page →TRIKAFTA (COPACKAGED) →fda approvals ↗
    ›Dec 20, 2024approval603d agoTRIKAFTA (COPACKAGED) (ELEXACAFTOR, IVACAFTOR, TEZACAFTOR) — FDA approvalTRIKAFTA (COPACKAGED)

    Sponsor: VERTEX PHARMS INC. Form: GRANULES. Route: ORAL

    full page →TRIKAFTA (COPACKAGED) →fda approvals ↗
    ›Dec 20, 2024approval603d agoTRIKAFTA (COPACKAGED) (ELEXACAFTOR, IVACAFTOR, TEZACAFTOR) — FDA approvalTRIKAFTA (COPACKAGED)

    Sponsor: VERTEX PHARMS INC. Form: GRANULES. Route: ORAL

    full page →TRIKAFTA (COPACKAGED) →fda approvals ↗
    ›Dec 20, 2024approval603d agoIMCIVREE (SETMELANOTIDE ACETATE) — FDA approvalsetmelanotide

    Sponsor: RHYTHM. Form: SOLUTION. Route: SUBCUTANEOUS

    full page →setmelanotide →fda approvals ↗
    ›Dec 20, 2024approval603d agoZEPBOUND (TIRZEPATIDE) — FDA approvalZEPBOUND

    Sponsor: ELI LILLY AND CO. Form: SOLUTION. Route: SUBCUTANEOUS

    full page →ZEPBOUND →fda approvals ↗
    ›Dec 20, 2024approval603d agoBRAFTOVI (ENCORAFENIB) — FDA approvalencorafenib

    Sponsor: ARRAY BIOPHARMA INC. Form: CAPSULE. Route: ORAL

    full page →encorafenib →fda approvals ↗
    ›Dec 20, 2024approval603d agoPYZCHIVA (USTEKINUMAB-TTWE) — FDA approvalPYZCHIVA

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

    full page →PYZCHIVA →fda approvals ↗
    ›Dec 20, 2024approval603d agoPYZCHIVA (USTEKINUMAB-TTWE) — FDA approvalPYZCHIVA

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

    full page →PYZCHIVA →fda approvals ↗
    ›Dec 20, 2024approval603d agoPYZCHIVA (USTEKINUMAB-TTWE) — FDA approvalPYZCHIVA

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

    full page →PYZCHIVA →fda approvals ↗
    ›Dec 20, 2024approval603d agoIMBRUVICA (IBRUTINIB) — FDA approvalAbbVie Inc.

    Sponsor: PHARMACYCLICS LLC. Form: CAPSULE. Route: ORAL

    full page →fda approvals ↗
    ›Dec 20, 2024approval603d agoIMBRUVICA (IBRUTINIB) — FDA approvalAbbVie Inc.

    Sponsor: PHARMACYCLICS LLC. Form: SUSPENSION. Route: ORAL

    full page →fda approvals ↗
    ›Dec 20, 2024approval603d agoIMBRUVICA (IBRUTINIB) — FDA approvalAbbVie Inc.

    Sponsor: PHARMACYCLICS LLC. Form: TABLET. Route: ORAL

    full page →fda approvals ↗
    ›Dec 20, 2024device 510k603d agoAndon Health Co, Ltd. — iHealth® Early Pregnancy Test; iHealth® Early Pregnancy Test Strip (510k cleared)

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

    full page →fda device 510k ↗
    ›Dec 20, 2024device 510k603d agoOkami Medical, Inc. — SENDERO MAX Delivery Catheter (510k cleared)

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

    full page →fda device 510k ↗
    ›Dec 20, 2024device 510k603d agoRizhao Huge Biomaterials Company, Ltd. — HF-Etchant Hydrofluoric Acid Etching Gel (510k cleared)

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

    full page →fda device 510k ↗
    ›Dec 20, 2024device 510k603d agoShenzhen Root Innovation Technology Co., Ltd. — Momcozy Wearable Breast Pump (BP311) (510k cleared)Hang Feng Technology Innovation Co., Ltd.

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

    full page →fda device 510k ↗
    ›Dec 20, 2024device 510k603d agoZimmer Biomet — Zimmer® Persona® Personalized Knee System (510k cleared)ZIMMER BIOMET HOLDINGS, INC.

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

    full page →fda device 510k ↗
    ›Dec 20, 2024device 510k603d agoBeijing Adss Development Co., Ltd. — Fractional CO2 Laser Therapy System (FG900-S); Fractional CO2 Laser Therapy System (FG900-S2) (510k cleared)

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

    full page →fda device 510k ↗
    ›Dec 20, 2024device 510k603d agoVydence Medical — HandPICO Fractional Laser Handpiece Tip (510k cleared)

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

    full page →fda device 510k ↗
    ›Dec 20, 2024device 510k603d agoLichtmega Technology Co., Ltd. — Scooter (PS30) (510k cleared)

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

    full page →fda device 510k ↗
    ›Dec 20, 2024device 510k603d agoSkingrab Co., Ltd. — Finiff System (510k cleared)

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

    full page →fda device 510k ↗
    ›Dec 20, 2024device 510k603d agoDiality, Inc. — Moda-flx Hemodialysis System™ Cartridge (102121-001 ) (510k cleared)

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

    full page →fda device 510k ↗
    ›Dec 20, 2024device 510k603d agoXplora 3D Europe S.L — Fas Aligner System (510k cleared)

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

    full page →fda device 510k ↗
    ›Dec 20, 2024device 510k603d agoGlobus Medical, Inc. — ExcelsiusGPS® Instruments (510k cleared)GLOBUS MEDICAL INC

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

    full page →fda device 510k ↗
    ›Dec 20, 2024device 510k603d agoBonebridge AG — Bonebridge Osteosynthesis Plating System (SALGINA 2.5mm Distal Radius System, CASCELLA 3.5mm Superior Clavicle System, LEPORELLO 3.5mm Olecranon Syste) (510k cleared)

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

    full page →fda device 510k ↗
    ›Dec 20, 2024device 510k603d agoSorin Group Italia S.R.L. — KIDS Arterial Filters (510k cleared)

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

    full page →fda device 510k ↗
    ›Dec 20, 2024device 510k603d agoCarlsmed, Inc. — aprevo® Digital Planning (510k cleared)CARLSMED, INC.

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

    full page →fda device 510k ↗
    ›Dec 20, 2024device 510k603d agoInkspace Imaging, Inc. — InkSpace Imaging Small Body Array (510k cleared)

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

    full page →fda device 510k ↗
    ›Dec 20, 2024device 510k603d agoArrow International, LLC (A subsidiary of Teleflex, Inc.) — Arrow Endurance Extended Dwell Peripheral Catheter System (EDC-00620); Arrow Endurance Extended Dwell Peripheral Catheter System (EDC-00622); Arrow Endurance Extended Dwell Peripheral Catheter System (EDC-00820); Arrow Endurance Extended Dwell Peripheral Catheter System (EDC-00822) (510k cleared)Arrow International LLC

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

    full page →fda device 510k ↗
    ›Dec 20, 2024device 510k603d agoAlpha Dent Implants GmbH — Alpha Dent Implants Dental Implants System (510k cleared)

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

    full page →fda device 510k ↗
    ›Dec 20, 2024device 510k603d agoGE Medical Systems Ultrasound and Primary Care Diagnostics — Voluson Expert 18; Voluson Expert 20; Voluson Expert 22 (510k cleared)

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

    full page →fda device 510k ↗
    ›Dec 20, 2024device 510k603d agoBiofire Diagnostics, LLC — BIOFIRE Blood Culture Identification 2 (BCID2) Panel (RFIT-ASY-0147 (30 pack) RFIT-ASY-0148 (6 pack)) (510k cleared)

    Product code: PEN. Advisory committee: Microbiology. Type: Special

    full page →fda device 510k ↗
    ›Dec 20, 2024device 510k603d agoShenzhen Siken 3D Technology Development Co., Ltd. — LED Light Therapy Mask (SKB-1818P,SKB-1918,SKB-1918P,SKB-1918PLUS,SKB-2318L,SKB-2318P,SKB-2318PRO,IN-FM002, SKB-2418) (510k cleared)

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

    full page →fda device 510k ↗
    ›Dec 20, 2024device 510k603d agoUnited Orthopedic Corporation — Cellbrick Knee Spacer (510k cleared)

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

    full page →fda device 510k ↗
    ›Dec 20, 2024device 510k603d agoWelch Allyn, Inc. — Welch Allyn Connex® Spot Monitor; 901058 Vital Signs Monitor Core (CSM) (510k cleared)

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

    full page →fda device 510k ↗
    ›Dec 20, 2024device 510k603d agoCongruence Medical Solutions, LLC — Microliter Dosing Syringe (9, 20, 25, 37.5, 50 and 100 microliter models) (510k cleared)

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

    full page →fda device 510k ↗
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    $TMO447.81+1.31%
    $VERX12.72-4.00%
    $VERX12.72-4.00%
    $PMI0.1821-4.66%
    $VERX12.72-4.00%
    $VERX12.72-4.00%
    $RDGL
    $TELA
    $VERX12.72-4.00%
    $LLY1180.16-2.25%
    $RYTM115.48-0.47%
    $AVBP29.51-1.63%
    $ABBV249.46-0.54%
    $ABBV249.46-0.54%
    $ABBV249.46-0.54%
    $FOFO3.0000+2.39%
    $GMED79.93+1.27%
    $ZBH87.97+0.93%
    $CARL