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5,000 catalysts · 18,987 approval · 5,000 device 510k · 4,876 phase readout · 4,728 grant · 2,414 8k filing · 2,000 device pma

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type: device 510k×clear all
type
  • approval18,987
  • device 510k5,000
  • phase readout4,876
  • grant4,728
  • 8k filing2,414
  • device pma2,000
  • device recall2,000
  • recall1,126
  • device adverse event1,000
  • earnings295
  • therapy area

    no tagged catalysts yet

    Week of Dec 9, 2024

    26
    ›Dec 12, 2024device 510k590d 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 510k590d agoGeniova Technologies Sociedad Limitada — GENIOVA aligners (510k cleared)

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

    full page →fda device 510k ↗
    ›Dec 12, 2024device 510k590d 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 510k590d 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 510k590d 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 510k590d 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, 2024device 510k589d 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 510k589d 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 510k589d 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 510k589d agoBreas Medical AB — Vivo 3 (510k cleared)

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

    full page →fda device 510k ↗
    ›Dec 13, 2024device 510k589d 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 510k589d 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 510k589d 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 510k589d 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 510k589d 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 510k589d 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 510k589d 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 510k589d agoZOLL Medical Corporation — 731 Series Ventilator (510k cleared)

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

    full page →fda device 510k ↗
    ›Dec 13, 2024device 510k589d agoHeidelberg Engineering GmbH — Anterion (510k cleared)

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

    full page →fda device 510k ↗
    ›Dec 13, 2024device 510k589d 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 510k589d 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 510k589d 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 510k589d 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 510k589d 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 510k589d 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 510k588d agoSim&Cure — Sim&Size (510k cleared)

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

    full page →fda device 510k ↗

    Week of Dec 16, 2024

    24
    ›Dec 16, 2024device 510k586d agoHuizhou 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 510k
    ← prev
    page 15 of 100
    next →
    586d ago
    Yung 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 510k586d 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 510k586d 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 510k586d agoIgnite Orthomotion — ACHIEVE Partial Knee System (510k cleared)

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

    full page →fda device 510k ↗
    ›Dec 16, 2024device 510k586d agoInstylla, Inc. — TEMBO Embolic System (510k cleared)

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

    full page →fda device 510k ↗
    ›Dec 16, 2024device 510k586d agoInventeur, LLC — AIM (N/A) (510k cleared)

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

    full page →fda device 510k ↗
    ›Dec 16, 2024device 510k586d 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 510k586d 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 510k586d 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 510k586d agoMskai — MSKai (510k cleared)

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

    full page →fda device 510k ↗
    ›Dec 16, 2024device 510k586d 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 ↗
    ›Dec 17, 2024device 510k585d agoVizionfocus, Inc. — VizionFocus (mififilcon A) Silicone Hydrogel Soft (hydrophilic) Daily Disposable Contact Lens; VizionFocus Color (mififilcon A) Silicone Hydrogel Soft (hydrophilic) Daily Disposable Contact Lens (510k cleared)

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

    full page →fda device 510k ↗
    ›Dec 17, 2024device 510k585d agoAsahi Intecc Co., Ltd. — Tornus ES (510k cleared)

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

    full page →fda device 510k ↗
    ›Dec 17, 2024device 510k585d agoBisco, Inc. — Quantium (510k cleared)

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

    full page →fda device 510k ↗
    ›Dec 17, 2024device 510k585d agoO&M Halyard, Inc. — Halyard Black Nitrile Powder-Free Exam Gloves with Textured Grip Technology, Tested for Use with Chemotherapy Drugs, Fentanyl Citrate, Simulated Gastric Acid and Fentanyl in Simulated Gastric Acid (510k cleared)Teva Pharmaceuticals USA Inc

    Product code: LZA. Advisory committee: General Hospital. Type: Abbreviated

    full page →fda device 510k ↗
    ›Dec 17, 2024device 510k585d agoPhilips Medizin Systeme Böblingen GmbH — Cardiac Workstation (5000); Cardiac Workstation (7000) (510k cleared)

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

    full page →fda device 510k ↗
    ›Dec 17, 2024device 510k585d agoPrecision Spine, Inc. — Reform Pedicle Screw System (510k cleared)Precision Dose Inc

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

    full page →fda device 510k ↗
    ›Dec 17, 2024device 510k585d agoHealgen Scientific,, LLC — Healgen Accurate Muti-Drug Urine Drug Screen Cup; Healgen Accurate Home Muti-Drug Urine Test Cup (510k cleared)

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

    full page →fda device 510k ↗
    ›Dec 17, 2024device 510k585d agoHivox Biotek, Inc. — POCKET TENS (EP-300) (510k cleared)

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

    full page →fda device 510k ↗
    ›Dec 17, 2024device 510k585d agoAi Optics — Sentinel Camera (510k cleared)

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

    full page →fda device 510k ↗
    ›Dec 17, 2024device 510k585d agoInova Diagnostics, Inc. — Aptiva APS IgG Reagent; Aptiva APS IgM Reagent (510k cleared)Co-Diagnostics, Inc.

    Product code: MID. Advisory committee: Immunology. Type: Traditional

    full page →fda device 510k ↗
    ›Dec 17, 2024device 510k585d agoJiangmen New Era External Use Drug Co., Ltd. — Autoclave Indicator Tape; EO Indicator Tape (510k cleared)

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

    full page →fda device 510k ↗
    ›Dec 17, 2024device 510k585d agoSmith & Nephew Medical Limited — BIOBRANE Temporary Wound Dressing; BIOBRANE Glove (510k cleared)SMITH & NEPHEW PLC

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

    full page →fda device 510k ↗
    $MCLE
    $BEATW
    $MMSI74.32+1.66%
    $HKPD
    $CARL
    $NL6.0500-1.14%
    $RCEL4.61000.00%
    $VIOT
    $ISRG337.34+1.60%
    $SNN30.25+5.29%
    $CODX2.0800-5.88%