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23,610 catalysts · 5,000 device 510k · 4,728 grant · 3,778 approval · 3,313 8k filing · 2,000 device pma · 2,000 device recall

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type
  • device 510k5,000
  • grant4,728
  • approval3,778
  • 8k filing3,313
  • 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 9, 2024

    37
    ›Dec 12, 2024approval611d agoNURTEC ODT (RIMEGEPANT SULFATE) — FDA approvalrimegepant sulfate ODT

    Sponsor: PFIZER. Form: TABLET, ORALLY DISINTEGRATING. Route: ORAL

    full page →rimegepant sulfate ODT →fda approvals ↗
    ›Dec 12, 2024device 510k611d agoBredent GmbH & Co. KG — visio.lign color, visio.lign shield (510k cleared)

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

    full page →fda device 510k ↗
    ›Dec 12, 2024device 510k611d agoEb Neuro S.P.A. — NExT Station; NExT Station Advanced (510k cleared)

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

    full page →fda device 510k ↗
    ›Dec 12, 2024device 510k611d agoInfrascan, Inc. — Infrascanner Model 2500 (Model 2500) (510k cleared)

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

    full page →fda device 510k ↗
    ›Dec 12, 2024device 510k611d agoGe Medical Systems Information Technologies, Inc. — Mac-Lab (AltiX AI.i); CardioLab (AltiX AI.i); ComboLab (AltiX AI.i); MLCL Client Software (AltiX AI.i) (510k cleared)

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

    full page →fda device 510k ↗
    ›Dec 12, 2024device 510k611d agoCmf Medicon Surgical, Inc. — Medicon Epiplating System (510k cleared)

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

    full page →fda device 510k ↗
    ›Dec 12, 2024device 510k611d agoPhilips Ultrasound, LLC — EPIQ Series Diagnostic Ultrasound System; Affiniti Series Diagnostic Ultrasound System (510k cleared)

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

    full page →fda device 510k ↗
    ›Dec 12, 2024device 510k611d agoTerragene S.A. — Terragene® Bionova® Photon Process Challenge Device with unique-point integrator (PCD225-2);Terragene® Bionova® Photon Process Challenge Device with moving-front integrator (PCD225-C) (510k cleared)

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

    full page →fda device 510k ↗
    ›Dec 12, 2024device 510k611d agoGeniova Technologies Sociedad Limitada — GENIOVA aligners (510k cleared)

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

    full page →fda device 510k ↗
    ›Dec 12, 2024device 510k611d agoShanghai United Imaging Healthcare Co., Ltd. — uMI Panvivo (uMI Panvivo); uMI Panvivo (uMI Panvivo S) (510k cleared)

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

    full page →fda device 510k ↗
    ›Dec 12, 2024device 510k611d agoLongly Biotechnology (Wuhan) Co., Ltd. — Bioceramic Root Canal Sealer and Repair Materials (i-MTA BP) (510k cleared)Cellyan Biotechnology Co., Ltd

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

    full page →fda device 510k ↗
    ›Dec 12, 2024device 510k611d agoNatus Neurology Incorporated — Natus Ultrapro S100 (982A0594) (510k cleared)

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

    full page →fda device 510k ↗
    ›Dec 12, 2024device 510k611d agoAqua Medical, Inc. — Aqua Medical RF Vapor Ablation System (510k cleared)AVITA Medical, Inc.

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

    full page →fda device 510k ↗
    ›Dec 13, 2024approval610d agoORKAMBI (IVACAFTOR) — FDA approval(ivacaftor + lumacaftor)

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

    full page →(ivacaftor + lumacaftor) →fda approvals ↗
    ›Dec 13, 2024approval610d agoORKAMBI (IVACAFTOR) — FDA approval(ivacaftor + lumacaftor)

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

    full page →(ivacaftor + lumacaftor) →fda approvals ↗
    ›Dec 13, 2024approval610d agoTYENNE (TOCILIZUMAB-AAZG) — FDA approvalTYENNE

    Sponsor: FRESENIUS KABI USA. Form: INJECTABLE. Route: INTRAVENOUS

    full page →TYENNE →fda approvals ↗
    ›Dec 13, 2024approval610d agoUNLOXCYT (COSIBELIMAB-IPDL) — FDA approvalcosibelimab

    Sponsor: CHECKPOINT THERAPEUTICS INC. Form: INJECTABLE. Route: INJECTION

    full page →cosibelimab →fda approvals ↗
    ›Dec 13, 2024device 510k610d agoRadiometer Medicals Aps — ABL90 FLEX PLUS System (510k cleared)

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

    full page →fda device 510k ↗
    ›Dec 13, 2024device 510k610d agoABBOTT MEDICAL — Agilis NxT Steerable Introducer Dual-Reach (510k cleared)

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

    full page →fda device 510k ↗
    ›Dec 13, 2024device 510k610d agoBreas Medical AB — Vivo 1, Vivo 2 (510k cleared)

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

    full page →fda device 510k ↗
    ›Dec 13, 2024device 510k610d agoBreas Medical AB — Vivo 3 (510k cleared)

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

    full page →fda device 510k ↗
    ›Dec 13, 2024device 510k610d agoRemex Medical Corp. — Remex Spine Surgery Navigation Instrument (510k cleared)Medicale Corp.

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

    full page →fda device 510k ↗
    ›Dec 13, 2024device 510k610d agoBTL Industries, Inc. — BTL-785BNF-E (510k cleared)NL INDUSTRIES INC

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

    full page →fda device 510k ↗
    ›Dec 13, 2024device 510k610d agoGastro Concepts, LLC — Gastro Concepts Air Assist (510k cleared)

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

    full page →fda device 510k ↗
    ›Dec 13, 2024device 510k610d agoShenzhen Ulike Smart Electronics Co., Ltd. — Ice Cooling IPL Hair Removal Device (UI20 DB, UI20 RE, UI20 GP, UI20 PW, UI20S DB, UI20S RE, UI20S PW, UI20S GP,UI20 WH, UI20 GR, UI20 BS, UI20 MP, UI20 BL, UI20 PN, UI20 BR, UI20WG, UI20S WH, UI20S GR, UI20S BS, UI20S MP) (510k cleared)

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

    full page →fda device 510k ↗
    ›Dec 13, 2024device 510k610d agoBiosys Biyomedikal Muhendislik San. VE Tic. A.S. — Bioscope Neuromonitor Device (510k cleared)

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

    full page →fda device 510k ↗
    ›Dec 13, 2024device 510k610d agoHeartbeam, Inc. — HeartBeam AIMIGo(TM) System (510k cleared)HeartBeam, Inc.

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

    full page →fda device 510k ↗
    ›Dec 13, 2024device 510k610d agoBrainu Co., Ltd. — CAIs Sensor (CAIs-001) (510k cleared)

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

    full page →fda device 510k ↗
    ›Dec 13, 2024device 510k610d agoZOLL Medical Corporation — 731 Series Ventilator (510k cleared)

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

    full page →fda device 510k ↗
    ›Dec 13, 2024device 510k610d agoHeidelberg Engineering GmbH — Anterion (510k cleared)

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

    full page →fda device 510k ↗
    ›Dec 13, 2024device 510k610d agoVarian Medical Systems, Inc. — ARIA Radiation Therapy Management System (18.1) (510k cleared)MERIT MEDICAL SYSTEMS INC

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

    full page →fda device 510k ↗
    ›Dec 13, 2024device 510k610d agoUroviu Corporation — Uro-G HD Cystoscope (1520) (510k cleared)

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

    full page →fda device 510k ↗
    ›Dec 13, 2024device 510k610d agoLock-In USA Corp — LOCK-IN Spinal Fixation System (510k cleared)

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

    full page →fda device 510k ↗
    ›Dec 13, 2024device 510k610d agoBarco N.V. — LCD Monitor (MDEC-2523) (510k cleared)

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

    full page →fda device 510k ↗
    ›Dec 13, 2024device 510k610d agoCarlsmed, Inc. — aprevo® anterior lumbar interbody fusion device with interfixation (510k cleared)CARLSMED, INC.

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

    full page →fda device 510k ↗
    ›Dec 13, 2024device 510k610d agoLaminar Digital Health, Inc. — Laminar P1 (LDH-HW-001) (510k cleared)

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

    full page →fda device 510k ↗
    ›Dec 14, 2024device 510k609d agoSim&Cure — Sim&Size (510k cleared)

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

    full page →fda device 510k ↗

    Week of Dec 16, 2024

    13
    ›Dec 16, 2024approval607d agoDEPO-SUBQ PROVERA 104 (MEDROXYPROGESTERONE ACETATE) — FDA approvalmedroxyprogesterone acetate

    Sponsor: PFIZER. Form: INJECTABLE. Route: SUBCUTANEOUS

    full page →medroxyprogesterone acetate →fda approvals ↗
    ›Dec 16, 2024device 510k
    ← prev
    page 29 of 473
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    607d ago
    Huizhou Foryou Medical Devices Co., Ltd. — LUOFUCON® Silver Collagen Dressing (510k cleared)

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

    full page →fda device 510k ↗
    ›Dec 16, 2024device 510k607d agoYung Sheng Optical Co., Ltd. — Eye Secret 38 UV Aspheric (polymacon) and Air Light 38 UV Aspheric (polymacon) Soft (hydrophilic) Contact Lens for Daily Wear (510k cleared)

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

    full page →fda device 510k ↗
    ›Dec 16, 2024device 510k607d agoDRGEM Corporation — TOPAZ Mobile X-ray System (Models : TOPAZ-32D, TOPAZ-40D) (510k cleared)

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

    full page →fda device 510k ↗
    ›Dec 16, 2024device 510k607d agoDitron Dental, Ltd. — Dental Implants and Abutments (510k cleared)

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

    full page →fda device 510k ↗
    ›Dec 16, 2024device 510k607d agoIgnite Orthomotion — ACHIEVE Partial Knee System (510k cleared)

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

    full page →fda device 510k ↗
    ›Dec 16, 2024device 510k607d agoInstylla, Inc. — TEMBO Embolic System (510k cleared)

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

    full page →fda device 510k ↗
    ›Dec 16, 2024device 510k607d agoInventeur, LLC — AIM (N/A) (510k cleared)

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

    full page →fda device 510k ↗
    ›Dec 16, 2024device 510k607d agoIntuitive Surgical, Inc. — da Vinci Surgical System (IS5000) (510k cleared)INTUITIVE SURGICAL INC

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

    full page →fda device 510k ↗
    ›Dec 16, 2024device 510k607d agoMicro-Tech (Nanjing) Co., Ltd. — Extraction Basket (510k cleared)

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

    full page →fda device 510k ↗
    ›Dec 16, 2024device 510k607d agoVinno Technology (Suzhou) Co.,Ltd — ULTIMUS Series Ultrasound Diagnostic System (510k cleared)Viomi Technology Co., Ltd

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

    full page →fda device 510k ↗
    ›Dec 16, 2024device 510k607d agoMskai — MSKai (510k cleared)

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

    full page →fda device 510k ↗
    ›Dec 16, 2024device 510k607d agoAesculap, Inc. — XABO Ventricular Catheter, XABO Peritoneal Catheter, XABO Catheter Set (510k cleared)

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

    full page →fda device 510k ↗
    $PFE26.61-0.73%
    $HKPD
    $VERX12.84-3.13%
    $RCEL7.9400-0.87%
    $VERX12.84-3.13%
    $MCLE
    $NL6.0500-1.14%
    $CCCC
    $BEATW
    $MMSI90.31-0.21%
    $CARL
    $ISRG401.270.00%
    $PFE26.61-0.73%
    $VIOT