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4,274 catalysts · 4,728 grant · 4,274 device 510k · 3,605 8k filing · 3,166 approval · 2,000 device pma · 2,000 device recall

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type: device 510k×from 2024-12-16×clear all
type
  • grant4,728
  • device 510k4,274
  • 8k filing3,605
  • approval3,166
  • device pma2,000
  • device recall2,000
recall
1,027
  • device adverse event1,000
  • earnings585
  • phase 2 completion172
  • therapy area

    no tagged catalysts yet

    Week of Dec 16, 2024

    50
    ›Dec 16, 2024device 510k623d 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 510k623d 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 510k623d 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 510k623d 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 510k623d agoIgnite Orthomotion — ACHIEVE Partial Knee System (510k cleared)

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

    full page →fda device 510k ↗
    ›Dec 16, 2024device 510k623d agoInstylla, Inc. — TEMBO Embolic System (510k cleared)

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

    full page →fda device 510k ↗
    ›Dec 16, 2024device 510k623d agoInventeur, LLC — AIM (N/A) (510k cleared)

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

    full page →fda device 510k ↗
    ›Dec 16, 2024device 510k623d 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 510k623d 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 510k623d 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 510k623d agoMskai — MSKai (510k cleared)

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

    full page →fda device 510k ↗
    ›Dec 16, 2024device 510k623d 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 510k622d 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 510k622d 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 510k622d agoBisco, Inc. — Quantium (510k cleared)

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

    full page →fda device 510k ↗
    ›Dec 17, 2024device 510k622d 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 510k622d 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 510k622d 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 510k622d 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 510k622d 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 510k622d agoAi Optics — Sentinel Camera (510k cleared)

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

    full page →fda device 510k ↗
    ›Dec 17, 2024device 510k622d 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 510k622d 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 510k622d 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 ↗
    ›Dec 17, 2024device 510k622d agoVentana Medical Systems, Inc. — Roche Digital Pathology Dx (510k cleared)MERIT MEDICAL SYSTEMS INC

    Product code: PSY. Advisory committee: Pathology. Type: Special

    full page →fda device 510k ↗
    ›Dec 17, 2024device 510k622d agoDentsply Sirona, Inc. — Lucitone Digital Print Denture™ System (510k cleared)DENTSPLY SIRONA Inc.

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

    full page →fda device 510k ↗
    ›Dec 17, 2024device 510k622d agoAllengers Global Healthcare Private Limited — Thulium Fiber Laser (FiberLAZE+, FiberLAZE) (510k cleared)

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

    full page →fda device 510k ↗
    ›Dec 17, 2024device 510k622d agoCntrl+, Inc. — Cntrl+ Bladder Support Pessary (510k cleared)

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

    full page →fda device 510k ↗
    ›Dec 17, 2024device 510k622d agoAllonus Tech Co., Ltd. — ALLONUS Tech Prosthetics (510k cleared)

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

    full page →fda device 510k ↗
    ›Dec 17, 2024device 510k622d agoCentinel Spine, LLC — prodisc® L Instruments (510k cleared)

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

    full page →fda device 510k ↗
    ›Dec 18, 2024device 510k621d agoCepheid® — Xpert MRSA/SA SSTI (510k cleared)

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

    full page →fda device 510k ↗
    ›Dec 18, 2024device 510k621d agoLima Corporate S.P.A. — Physica Porous Femoral Components (510k cleared)

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

    full page →fda device 510k ↗
    ›Dec 18, 2024device 510k621d agoArtsmedia Denmark Aps — ARTSMedia Semen Wash Medium (510k cleared)

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

    full page →fda device 510k ↗
    ›Dec 18, 2024device 510k621d agoArtsmedia Denmark Aps — ARTSMedia Oocyte Aspiration Medium (502020, 502050, 502100) (510k cleared)

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

    full page →fda device 510k ↗
    ›Dec 18, 2024device 510k621d agoNatec Medical , Ltd. — Amethyst HP PTA OTW 0.035 Catheter (510k cleared)

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

    full page →fda device 510k ↗
    ›Dec 18, 2024device 510k621d agoSOADCO, S.L. — Klockner Kits (510k cleared)

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

    full page →fda device 510k ↗
    ›Dec 18, 2024device 510k621d agoChongqing Moffy Innovation Technology Co., Ltd. — Respiratory Muscle Trainer (510k cleared)Hang Feng Technology Innovation Co., Ltd.

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

    full page →fda device 510k ↗
    ›Dec 18, 2024device 510k621d agoViasonix , Ltd. — Falcon/Xpress (Falcon/Xpress) (510k cleared)

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

    full page →fda device 510k ↗
    ›Dec 18, 2024device 510k621d agoCadwell Industries, Inc. — Bluebird Single-Use Respiratory Effort Belt (510k cleared)POWELL INDUSTRIES INC

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

    full page →fda device 510k ↗
    ›Dec 18, 2024device 510k621d agoChangsha Anxiang Medical Technology Co., Ltd. — Tens & Ems Device (TU1080) (510k cleared)

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

    full page →fda device 510k ↗
    ›Dec 18, 2024device 510k621d agoDeltamed GmbH — 3Delta UNlimited (510k cleared)

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

    full page →fda device 510k ↗
    ›Dec 18, 2024device 510k621d agoTeknimed Sas — GENTAFIX® (1, 3, 3MV) (510k cleared)

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

    full page →fda device 510k ↗
    ›Dec 18, 2024device 510k621d agoHunan Vathin Medical Instrument Co., Ltd. — Single-use Flexible Cystoscope (CY-E2E01, CY-E2E01R, CY-E2F01, CY-E2F01R, CY-E2G01, CY-E2G01R, CY-S2E01, CY-S2E01R); Digital Video Monitor (DVM-D1, DVM-D2) (510k cleared)

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

    full page →fda device 510k ↗
    ›Dec 18, 2024device 510k621d agoVentris Medical — Porous Biologic Scaffold (510k cleared)

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

    full page →fda device 510k ↗
    ›Dec 18, 2024device 510k621d agoCaerus Corporation — Active System; Avenue8 (510k cleared)

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

    full page →fda device 510k ↗
    ›Dec 18, 2024device 510k621d agoQuest Medical, Inc. — Lyka® PORT Needle Free Access Device (4170Y) (510k cleared)

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

    full page →fda device 510k ↗
    ›Dec 18, 2024device 510k621d agoEtex Corporation — EquivaBone Osteoinductive Bone Graft Substitute (EquivaBone ) (510k cleared)

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

    full page →fda device 510k ↗
    ›Dec 18, 2024device 510k621d agoFreudenberg Medical, LLC — FirstFit Surgical Kit (510k cleared)

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

    full page →fda device 510k ↗
    ›Dec 19, 2024device 510k620d agoCardinalhealth — Monoject™ Enteral Syringe with ENFit Connector (401SE); Monoject™ Enteral Syringe with ENFit Connector (403SE); Monoject™ Enteral Syringe with ENFit Connector (406SE); Monoject™ Enteral Syringe with ENFit Connector (412SE); Monoject™ Enteral Syringe with ENFit Connector (435SE); Monoject™ Enteral Syringe with ENFit Connector (460SE) (510k cleared)CARDINAL HEALTH INC

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

    full page →fda device 510k ↗
    ›Dec 19, 2024device 510k620d agoWassenburg Medical, Inc. — System 83 Revolve Endoscope Washer/Disinfector (510k cleared)

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

    full page →fda device 510k ↗
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    $VIOT
    $FOFO3.0000+2.39%
    $POWL
    $XRAY11.12+0.72%
    $ISRG372.60+1.51%
    $SNN28.97-0.55%
    $CAH234.55-0.25%
    $MMSI90.49+1.06%
    $CODX1.51000.00%