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2,431 catalysts · 4,728 grant · 3,350 8k filing · 2,678 approval · 2,431 device 510k · 1,921 device recall · 1,709 device pma

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type: device 510k×from 2025-07-07×clear all
type
  • grant4,728
  • 8k filing3,350
  • approval2,678
  • device 510k2,431
  • device recall1,921
  • device pma1,709
device adverse event
1,000
  • recall641
  • earnings584
  • phase 2 completion172
  • therapy area

    no tagged catalysts yet

    Week of Jul 7, 2025

    50
    ›Jul 7, 2025device 510k405d agoLife Spine, Inc. — TruLift® Lateral Expandable Spacer & Lateral Buttress Plate System (510k cleared)

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

    full page →fda device 510k ↗
    ›Jul 7, 2025device 510k405d agoZibo Shengkun Chemical Industry Co., Ltd. — Powder Free Polyurethane Examination Gloves (Green, Blue, Pink, White) (510k cleared)

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

    full page →fda device 510k ↗
    ›Jul 7, 2025device 510k405d agoCarlsmed, Inc. — aprevo® anterior lumbar interbody fusion device; aprevo® lateral lumbar interbody fusion device; aprevo® anterior lumbar interbody fusion device with interfixation; aprevo® transforaminal lumbar interbody fusion device; aprevo® TLIF-CA Articulating System; aprevo® Cervical ACDF; aprevo® Cervical ACDF-X; aprevo® Cervical ACDF-X No Cams (510k cleared)CARLSMED, INC.

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

    full page →fda device 510k ↗
    ›Jul 7, 2025device 510k405d agoCaranx Medical — TAVIPILOT (510k cleared)

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

    full page →fda device 510k ↗
    ›Jul 7, 2025device 510k405d agoCustomsurg AG — CustomSurg OrthoPlanner (510k cleared)

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

    full page →fda device 510k ↗
    ›Jul 8, 2025device 510k404d agoSimBioSys, Inc. — TumorSight Viz (510k cleared)

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

    full page →fda device 510k ↗
    ›Jul 8, 2025device 510k404d agoEncompass Industries Sdn. Bhd. — Powder-Free Polychloroprene Examination Glove (Green Color) Tested for Use with Chemotherapy Drugs and Fentanyl (510k cleared)NutriBand Inc.

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

    full page →fda device 510k ↗
    ›Jul 8, 2025device 510k404d agoS.M.A.I.O — KHEIRON® Spinal Fixation System, including patient specific K-ROD (510k cleared)

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

    full page →fda device 510k ↗
    ›Jul 8, 2025device 510k404d agoShenzhen HugeMed Medical Technical Development Co., Ltd. — Single-use Ureteral Access Sheath (510k cleared)

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

    full page →fda device 510k ↗
    ›Jul 8, 2025device 510k404d agoTerumo Europe N.V. — K-Pack Embrace Active Safety Needle (KNAS-2516RB, KNAS-2525RB) (510k cleared)

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

    full page →fda device 510k ↗
    ›Jul 8, 2025device 510k404d agoEncore Medical L.P. — EMPOWR Revision Knee™ (EMPOWR Revision VVC+, e+ Tibial Insert) (510k cleared)Encore Medical, Inc.

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

    full page →fda device 510k ↗
    ›Jul 8, 2025device 510k404d agoJeisys Medical Incorporated — DENSITY; DENZA; DENSITY Noir (510k cleared)

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

    full page →fda device 510k ↗
    ›Jul 8, 2025device 510k404d agoSpectrum Medical , Ltd. — Quantum Micro-Cardioplegia Delivery System; Quantum Micro-Cardioplegia Delivery Module (QMCDM) (510k cleared)

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

    full page →fda device 510k ↗
    ›Jul 8, 2025device 510k404d agoL&K BIOMED Co., Ltd. — PathLoc Lumbar Interbody Fusion Cage System (510k cleared)NeuCen BioMed Co Ltd

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

    full page →fda device 510k ↗
    ›Jul 8, 2025device 510k404d agoMomentis Surgical , Ltd. — Anovo Surgical System (Model 6Ne); Anovo Instrument ARM Curved Scissors ; Anovo Instrument ARM Hook Electrode (510k cleared)

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

    full page →fda device 510k ↗
    ›Jul 8, 2025device 510k404d agoGlobus Medical, Inc. — ExcelsiusXR™ (510k cleared)GLOBUS MEDICAL INC

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

    full page →fda device 510k ↗
    ›Jul 9, 2025device 510k403d agoSiemens Medical Solutions USA, Inc. — Cios Alpha; Cios Flow (510k cleared)

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

    full page →fda device 510k ↗
    ›Jul 9, 2025device 510k403d agoBoston Scientific Corporation — Flexiva Pulse Laser Fiber; Flexiva Pulse TracTip Laser Fiber; Flexiva Pulse ID Laser Fiber; Flexiva Pulse ID TracTip Laser Fibers (510k cleared)BOSTON SCIENTIFIC CORP

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

    full page →fda device 510k ↗
    ›Jul 9, 2025device 510k403d agoMr Surgical Solutions, LLC — OptiVu™ Shoulder (510k cleared)

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

    full page →fda device 510k ↗
    ›Jul 9, 2025device 510k403d agoPhasor Health, LLC — EZ-FIDUCIALS (510k cleared)

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

    full page →fda device 510k ↗
    ›Jul 9, 2025device 510k403d agoAbbott Laboratories — ARCHITECT iGentamicin (510k cleared)ABBOTT LABORATORIES

    Product code: LCD. Advisory committee: Clinical Toxicology. Type: Special

    full page →fda device 510k ↗
    ›Jul 9, 2025device 510k403d agoP&A USA — HEXIM Implant; Samwon General Abutments (510k cleared)

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

    full page →fda device 510k ↗
    ›Jul 9, 2025device 510k403d agoWenzel Spine, Inc. — panaSIa SI Fusion System (510k cleared)

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

    full page →fda device 510k ↗
    ›Jul 9, 2025device 510k403d agoNuvascular, Inc. — HARBOR Occlusion Device (510k cleared)

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

    full page →fda device 510k ↗
    ›Jul 9, 2025device 510k403d agoBasic Medical Technology, Inc. — Nitrile Powder-Free Exam Gloves 2.8, Tested for Use with Chemotherapy Drugs, Opioid Fentanyl Citrate, Simulated Gastric Acid (light blue, dark blue) (510k cleared)Medical Care Technologies Inc.

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

    full page →fda device 510k ↗
    ›Jul 9, 2025device 510k403d agoGe Medical Systems Information Technologies, Inc. — Monitor B105M; Monitor B125M; Monitor B155M; Monitor B105P; Monitor B125P (510k cleared)

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

    full page →fda device 510k ↗
    ›Jul 10, 2025device 510k402d agoShenzhen Dachi Communication Co., Ltd. — Microcurrent Facial Device (CEC101, EE0101, EEI101) (510k cleared)

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

    full page →fda device 510k ↗
    ›Jul 10, 2025device 510k402d agoArum Dentistry Co., Ltd. — ARENA Star, Galaxy Star (510k cleared)

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

    full page →fda device 510k ↗
    ›Jul 10, 2025device 510k402d agoBard Peripheral Vascular, Inc. — Marquee™ Disposable Core Biopsy Instrument and Instrument Kit (510k cleared)

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

    full page →fda device 510k ↗
    ›Jul 10, 2025device 510k402d agoZbeats, Inc. — ZBPro Diagnostic (510k cleared)

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

    full page →fda device 510k ↗
    ›Jul 10, 2025device 510k402d agoTriMed, Inc. — TriMed Total Wrist Fusion System (Total Wrist Fusion Plate) (510k cleared)

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

    full page →fda device 510k ↗
    ›Jul 10, 2025device 510k402d agoLivaNova USA, Inc. — RAP Femoral Venous Cannulae (510k cleared)

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

    full page →fda device 510k ↗
    ›Jul 10, 2025device 510k402d agoAvalign Technologies, Inc. — CONDUIT™ SYNFIX™ Evolution Secured Spacer System (510k cleared)ALIGN TECHNOLOGY INC

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

    full page →fda device 510k ↗
    ›Jul 10, 2025device 510k402d agoArthrex, Inc. — Arthrex PushLock Suture Anchors (510k cleared)

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

    full page →fda device 510k ↗
    ›Jul 10, 2025device 510k402d agoFUJIFILM Sonosite, Inc. — Sonosite LX Ultrasound System (510k cleared)

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

    full page →fda device 510k ↗
    ›Jul 10, 2025device 510k402d agoProvidence Medical Technology, Inc. — CAVUX Facet Fixation System (CAVUX FFS) and CORUS-LX Implant (510k cleared)

    Product code: MRW. Advisory committee: Unknown. Type: Special

    full page →fda device 510k ↗
    ›Jul 10, 2025device 510k402d agoGE Medical Systems Ultrasound and Primary Care Diagnostics — Vivid Pioneer (510k cleared)

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

    full page →fda device 510k ↗
    ›Jul 11, 2025device 510k401d agoShenzhen Ulike Smart Electronics Co., Ltd. — Ice Cooling IPL Hair Removal Device (UI20S DB, UI20S RE, UI20S PW, UI20S GP, UI20S GR, UI20S BK, UI20 DB, UI20 RE, UI20 PW, UI20 GP, UI20 GR, UI20 BK) (510k cleared)

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

    full page →fda device 510k ↗
    ›Jul 11, 2025device 510k401d agoCeragem Co., Ltd. — Ceragem Automatic Thermal Massager (CGM MB-2401) (510k cleared)

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

    full page →fda device 510k ↗
    ›Jul 11, 2025device 510k401d agoSinolinks Medical Innovation, Inc. — Disposable Trocars (510k cleared)

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

    full page →fda device 510k ↗
    ›Jul 11, 2025device 510k401d agoPhilips Medical Systems Nederland B.V. — Achieva; Intera; Ingenia 1.5T; Ingenia 3.0T; Ingenia 1.5T CX; Ingenia 3.0T CX; Ingenia Elition S; Ingenia Elition X; Ingenia Ambition S; Ingenia Ambition X; and MR 5300 MR Systems (510k cleared)

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

    full page →fda device 510k ↗
    ›Jul 11, 2025device 510k401d agoTriMed, Inc. — RipCord (510k cleared)

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

    full page →fda device 510k ↗
    ›Jul 11, 2025device 510k401d agoBisco, Inc. — Choice 2 DC (510k cleared)

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

    full page →fda device 510k ↗
    ›Jul 11, 2025device 510k401d agoAccutome, Inc. Doing Business AS Keeler USA — B-Scan (510k cleared)

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

    full page →fda device 510k ↗
    ›Jul 11, 2025device 510k401d agoShenzhen Kaiyan Medical Equipment Co., Ltd. — KALA Therapy Wand (Model: KALA-03) (510k cleared)

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

    full page →fda device 510k ↗
    ›Jul 11, 2025device 510k401d agoBecton Dickinson Infusion Therapy Systems, Inc. — BD Cathena™ Safety IV Catheter (510k cleared)

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

    full page →fda device 510k ↗
    ›Jul 11, 2025device 510k401d agoCodonics.Incorporated — Codonics Safe Labeling System-Point of Care Station (PCS) (SLS-700i and related 610i, 620i, 630i series enabled to retrofit RFID features); Codonics Safe Labeling System-Point of Care Station (PCS) (SLS-1, SLS XXX, Multiple Models Pending Configuration) (510k cleared)

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

    full page →fda device 510k ↗
    ›Jul 11, 2025device 510k401d agoGeistlich Pharma AG — Geistlich Bio-Oss®; Geistlich Bio-Oss Pen® (510k cleared)

    Product code: NPM. Advisory committee: Dental. Type: Special

    full page →fda device 510k ↗
    ›Jul 11, 2025device 510k401d agoShofu Dental Corporation — ResiCem EX (510k cleared)

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

    full page →fda device 510k ↗
    ›Jul 11, 2025device 510k401d agoOlympus Medical Systems Corporation — ULTRASONIC PROBE UM-S20-17S (UM-S20-17S); ULTRASONIC PROBE UM-S20-20R (UM-S20-20R) (510k cleared)

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

    full page →fda device 510k ↗
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    $NTRB2.9000-11.59%
    $BSX51.83+0.27%
    $ABT111.25-0.02%
    $MDCE0.00020.00%
    $ALGN
    $EMI
    $GMED79.93+1.27%
    $CARL