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3,435 catalysts · 4,728 grant · 3,603 8k filing · 3,435 device 510k · 2,886 approval · 2,000 device pma · 2,000 device recall

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type: device 510k×from 2025-03-24×clear all
type
  • grant4,728
  • 8k filing3,603
  • device 510k3,435
  • approval2,886
  • device pma2,000
  • device recall2,000
device adverse event
1,000
  • recall863
  • earnings585
  • phase 2 completion172
  • therapy area

    no tagged catalysts yet

    Week of Mar 24, 2025

    50
    ›Mar 24, 2025device 510k525d agoLuma Vision Limited — VERAFEYE System VERAFEYE Imaging Catheter & VERAFEYE Imaging System (510k cleared)

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

    full page →fda device 510k ↗
    ›Mar 24, 2025device 510k525d agoAbbott Molecular, Inc. — Alinity m BKV (510k cleared)

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

    full page →fda device 510k ↗
    ›Mar 24, 2025device 510k525d agoXplr , Ltd. — LMNT O2 (510k cleared)

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

    full page →fda device 510k ↗
    ›Mar 24, 2025device 510k525d agoAurora Spine — AERO MIS Facet Fusion System (510k cleared)

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

    full page →fda device 510k ↗
    ›Mar 24, 2025device 510k525d agoStryker Instruments — Sonopet iQ Ultrasonic Aspirator System (5500-050-000) (510k cleared)

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

    full page →fda device 510k ↗
    ›Mar 24, 2025device 510k525d agoBright Uro, Inc. — Glean Urodynamics System Male Delivery System (GUS-1000-M); Glean Urodynamics System Female Delivery System (GUS-1000-F); Glean Urodynamics System Uroflowmeter (UFM-1000 (Uroflowmeter)) (510k cleared)

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

    full page →fda device 510k ↗
    ›Mar 24, 2025device 510k525d agoRestor3D, Inc. — TIDAL Fusion Cage System (510k cleared)

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

    full page →fda device 510k ↗
    ›Mar 24, 2025device 510k525d agoControl Medical Technology, Inc. / Dba Ventiv Scientific — VentiV 7Fr -12Fr MP Mechanical Thrombectomy System (VS7-MP60S, VS7-MP90S, VS8-MP60S, VS8-MP90S, VS8-MP100B, VS10-MP100B, VS11-MP60S, VS11-MP90S, VS12-MP100B, 7F-MP60S, 7F-MP90S, 8F-MP60S, 8F-MP100B, 10F-MP100B, 11F-MP60S, 11F-MP90S, 11P-MP60S, 11P-MP90S, 12F-MP100B, V30-ASP) (510k cleared)

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

    full page →fda device 510k ↗
    ›Mar 24, 2025device 510k525d agoInnovasis, Inc. — Innovasis Navigation Instruments (510k cleared)

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

    full page →fda device 510k ↗
    ›Mar 24, 2025device 510k525d agoInnovasis — AxTiHA® Stand-Alone ALIF System (510k cleared)

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

    full page →fda device 510k ↗
    ›Mar 24, 2025device 510k525d agoPAJUNK GmbH Medizintechnologie — SonoTAP and SonoTAP II (510k cleared)

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

    full page →fda device 510k ↗
    ›Mar 24, 2025device 510k525d agoTotal Joint Othopedics, Inc. — Klassic Knee System - Revision Tibial Baseplate (510k cleared)

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

    full page →fda device 510k ↗
    ›Mar 24, 2025device 510k525d agoBard Peripheral Vascular, Inc. — UltraCor™ Twirl™ Breast Tissue Marker (510k cleared)

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

    full page →fda device 510k ↗
    ›Mar 25, 2025device 510k524d agoBolt Medical, Inc. — Bolt Intravascular Lithotripsy (IVL) System (510k cleared)B. Braun Medical Inc

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

    full page →fda device 510k ↗
    ›Mar 25, 2025device 510k524d agoInquis Medical — Aventus Thrombectomy System (IM-2100) (510k cleared)

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

    full page →fda device 510k ↗
    ›Mar 26, 2025device 510k523d agoSb-Kawasumi Laboratories, Inc. — SB Knife Jr2 (MD-47702 and MD-47702L) (510k cleared)

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

    full page →fda device 510k ↗
    ›Mar 26, 2025device 510k523d agoArthrex, Inc. — Arthrex Humeral Plating System and Cerclage Button (510k cleared)

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

    full page →fda device 510k ↗
    ›Mar 26, 2025device 510k523d agoArrow International, LLC — AC3™ Range™ Intra-Aortic Balloon Pump (510k cleared)Arrow International LLC

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

    full page →fda device 510k ↗
    ›Mar 26, 2025device 510k523d agoKunshan Hi-Fortune Health Products Co., Ltd. — Electrically powered wheelchair (510k cleared)

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

    full page →fda device 510k ↗
    ›Mar 26, 2025device 510k523d agoBridge TO Life — Belzer MPS® (UW Machine Perfusion Solution) (BMPS-001) (510k cleared)

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

    full page →fda device 510k ↗
    ›Mar 26, 2025device 510k523d agoNingbo Youhuan Automation Technology Co., Ltd. — Power Wheelchair (YH-E6011,YH-E6013A) (510k cleared)

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

    full page →fda device 510k ↗
    ›Mar 26, 2025device 510k523d agoMde Orvosbiológiai Kutató, Fejleszto, — NM-01/CPT neurometer (NM-01/CPT) (510k cleared)

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

    full page →fda device 510k ↗
    ›Mar 26, 2025device 510k523d agoEarlitec Diagnostics — EarliPoint System (510k cleared)

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

    full page →fda device 510k ↗
    ›Mar 26, 2025device 510k523d agoAZmed — Rayvolve LN (510k cleared)

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

    full page →fda device 510k ↗
    ›Mar 26, 2025device 510k523d agoKent Imaging, Inc. — SnapshotGLO (KB100) (510k cleared)

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

    full page →fda device 510k ↗
    ›Mar 26, 2025device 510k523d agoShenzhen Ulike Smart Electronics Co., Ltd. — Ice Cooling IPL Hair Removal Device (UI06S PR, UI06S PN, UI06S WH) (510k cleared)

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

    full page →fda device 510k ↗
    ›Mar 27, 2025device 510k522d agoZmi Electronics , Ltd. — Levina Pelvic Floor Muscle Stimulator (RS-48) (510k cleared)

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

    full page →fda device 510k ↗
    ›Mar 27, 2025device 510k522d agoBiocorp Production — MallyaD injection pen adapter (MallyaD) (510k cleared)

    Product code: QOG. Advisory committee: General Hospital. Type: Special

    full page →fda device 510k ↗
    ›Mar 27, 2025device 510k522d agoArtrya Limited — Salix Central (510k cleared)

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

    full page →fda device 510k ↗
    ›Mar 27, 2025device 510k522d agoEdwards Lifesciences — Edwards eSheath Optima introducer set (510k cleared)Edwards Lifesciences Corp

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

    full page →fda device 510k ↗
    ›Mar 27, 2025device 510k522d agoAccess Vascular, Inc. — HydroMID 5F Dual Lumen Midline Catheter - Basic Kit (70006102); HydroMID 5F Dual Lumen Midline Catheter - Max Barrier Kit (70006104); HydroMID 5F Dual Lumen Midline Catheter - Mobile Max Barrier Kit (90006104) (510k cleared)

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

    full page →fda device 510k ↗
    ›Mar 27, 2025device 510k522d agoAsahi Intecc Co., Ltd. — Crossloop (510k cleared)

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

    full page →fda device 510k ↗
    ›Mar 27, 2025device 510k522d agoThreadstone, LLC — HyperSuture White/Green Extension Line (510k cleared)

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

    full page →fda device 510k ↗
    ›Mar 27, 2025device 510k522d agoRestor3D, Inc. — iTotal® Identity™ Cruciate Retaining 3DP Porous Knee Replacement System (510k cleared)

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

    full page →fda device 510k ↗
    ›Mar 27, 2025device 510k522d agoScivita Medical Technology Co., Ltd. — Urology Videoscope System (Single-use Flexible Ureteroscope: SUV-1A-B, SUV-1A-P, SUV-2A-B, SUV-2A-P, SUV-2B-B, SUB-2B-P, SUV-2C-B, SUV-2C-P;Single-use Flexible Cystoscope: SUV-1D-B, SUV-1D-P; Endoscopic Image Processor: HDVS-S100A, HDVS-S100D.) (510k cleared)NewBay Medical Technology Co Ltd

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

    full page →fda device 510k ↗
    ›Mar 27, 2025device 510k522d agoFotona D.O.O. — StarFormer (M008-3T) (510k cleared)

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

    full page →fda device 510k ↗
    ›Mar 27, 2025device 510k522d agoMedtronic, Inc. — SelectSite C304 Deflectable Catheter System (C304); C315 Delivery System (C315) (510k cleared)Medtronic plc

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

    full page →fda device 510k ↗
    ›Mar 27, 2025device 510k522d agoHC Biologics, LLC — HC Biologics Osteopoint Spinal Fixation System (510k cleared)Hema Biologics LLC

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

    full page →fda device 510k ↗
    ›Mar 27, 2025device 510k522d agoSiemens Healthcare GmbH — AI-Rad Companion Organs RT (510k cleared)

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

    full page →fda device 510k ↗
    ›Mar 27, 2025device 510k522d agoV5med, Inc. — V5med Lung AI (510k cleared)

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

    full page →fda device 510k ↗
    ›Mar 27, 2025device 510k522d agoHeadsafe Mfg Pty, Ltd. — Nurochek-Pro System (510k cleared)

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

    full page →fda device 510k ↗
    ›Mar 28, 2025device 510k521d agoMedphoton GmbH — ImagingRing m (Version 2.0); Loop-X (Version 2.0); Loop-X Mobile Imaging Robot (Version 2.0) (510k cleared)

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

    full page →fda device 510k ↗
    ›Mar 28, 2025device 510k521d agoSiemens Healthcare Diagnostic Products GmbH — INNOVANCE Antithrombin (510k cleared)

    Product code: JBQ. Advisory committee: Hematology. Type: Traditional

    full page →fda device 510k ↗
    ›Mar 28, 2025device 510k521d agoWuxi Jiajian Medical Instrument Co., Ltd. — Needle Stimulator (CMNS6-1 PLUS, CMNS6-3) (510k cleared)

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

    full page →fda device 510k ↗
    ›Mar 28, 2025device 510k521d agoBeckman Coulter, Inc. — Access Toxo IgG (510k cleared)

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

    full page →fda device 510k ↗
    ›Mar 28, 2025device 510k521d agoConvatec — Flexi-Seal AIR (with ENFit Connector) (510k cleared)

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

    full page →fda device 510k ↗
    ›Mar 28, 2025device 510k521d agoArthrex, Inc. — Arthrex FiberTak Suture Anchor (510k cleared)

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

    full page →fda device 510k ↗
    ›Mar 28, 2025device 510k521d agoMakani Science, Inc. — Makani Science™ Respiration Monitoring System (510k cleared)

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

    full page →fda device 510k ↗
    ›Mar 28, 2025device 510k521d agoTuring Medical Technologies, Inc. — Bullsai Confirm (510k cleared)Medical Care Technologies Inc.

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

    full page →fda device 510k ↗
    ›Mar 28, 2025device 510k521d agoSmith & Nephew, Inc. — CATALYSTEM Femoral Stems (510k cleared)SMITH & NEPHEW PLC

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

    full page →fda device 510k ↗
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    $SNN28.97-0.55%
    $MDCE0.00020.00%
    $EW91.33-2.47%
    $MDT91.23+1.40%