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5,000 catalysts · 18,987 approval · 5,000 device 510k · 4,970 phase readout · 4,728 grant · 2,429 8k filing · 2,000 device pma

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type: device 510k×clear all
type
  • approval18,987
  • device 510k5,000
  • phase readout4,970
  • grant4,728
  • 8k filing2,429
  • device pma2,000
  • device recall2,000
  • recall1,126
  • device adverse event1,000
  • earnings296
  • therapy area

    no tagged catalysts yet

    Week of Mar 17, 2025

    15
    ›Mar 21, 2025device 510k494d agoVentris Medical — Porous Biologic Scaffold (510k cleared)

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

    full page →fda device 510k ↗
    ›Mar 21, 2025device 510k494d agoSignos, Inc. — Signos Glucose Monitoring System (510k cleared)

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

    full page →fda device 510k ↗
    ›Mar 21, 2025device 510k494d agoStryker Neurovascular — Excelsior XT-27 Microcatheter, Excelsior XT-27 Flex Microcatheter, Excelsior XT-27 Pre-Shaped Microcatheter, Excelsior XT-27 Flex Pre-Shaped Microcatheter (510k cleared)

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

    full page →fda device 510k ↗
    ›Mar 21, 2025device 510k494d agoEpitel — REMI Remote EEG Monitoring System (510k cleared)

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

    full page →fda device 510k ↗
    ›Mar 21, 2025device 510k494d agoGuangzhou Potent Medical Equipment Joint-Stock Co., Ltd. — EHL Probe (SCDG-AS); EHL Probe (SCDG-BS); EHL Probe (SCDG-CS) (510k cleared)

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

    full page →fda device 510k ↗
    ›Mar 21, 2025device 510k494d agoTenon Medical — Catamaran SI Joint Fusion System (510k cleared)Tenon Medical, Inc.

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

    full page →fda device 510k ↗
    ›Mar 21, 2025device 510k494d agoDentis Co., Ltd. — ChecQ (AC100) (510k cleared)

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

    full page →fda device 510k ↗
    ›Mar 21, 2025device 510k494d agoYukon Medical, LLC — Arisure® Closed Male Luer with Spike Adapter (YM060) (510k cleared)

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

    full page →fda device 510k ↗
    ›Mar 21, 2025device 510k494d agoCasebioscience, Inc. — CaseMONO™ Culture (CMON); CaseMONO™ w/HEPES (WHMO); CaseBioscience® HTF (HTFC); CaseBioscience® HTF w/HEPES (HHTF) (510k cleared)BJ Bioscience Inc

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

    full page →fda device 510k ↗
    ›Mar 21, 2025device 510k494d agoGuangzhou Potent Medical Equipment Joint-Stock Co., Ltd. — Electrohydraulic Lithotriptor (TCS-B3-II) (510k cleared)

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

    full page →fda device 510k ↗
    ›Mar 21, 2025device 510k494d agoBoston Scientific Corporation — Navigator™ HD Ureteral Access Sheath Set 11/13 F x 28cm (M0062502210); Navigator™ HD Ureteral Access Sheath Set 11/13 F x 36cm (M0062502220); Navigator™ HD Ureteral Access Sheath Set 11/13 F x 46cm (M0062502230); Navigator™ HD Ureteral Access Sheath Set 12/14 F x 28cm (M0062502240); Navigator™ HD Ureteral Access Sheath Set 12/14 F x 36cm (M0062502250); Navigator™ HD Ureteral Access Sheath Set 12/14 F x 46cm (M0062502260); Navigator™ HD Ureteral Access Sheath Set 13/15 F x 28cm (M006 (510k cleared)BOSTON SCIENTIFIC CORP

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

    full page →fda device 510k ↗
    ›Mar 21, 2025device 510k494d agoGetset Surgical, SA — GoLIF! Lumbar Interbody Fusion System (510k cleared)

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

    full page →fda device 510k ↗
    ›Mar 21, 2025device 510k494d agoPhilips Medizin Systeme Böblingen GmbH — Philips Holter Analysis System (510k cleared)

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

    full page →fda device 510k ↗
    ›Mar 21, 2025device 510k494d agoStryker Instruments — Consolidated Operating Room Equipment (CORE) 2 Console (510k cleared)

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

    full page →fda device 510k ↗
    ›Mar 21, 2025device 510k494d agoBecton, Dickinson and Company — BD Vacutainer® Multiple Sample Luer Adapter (510k cleared)BECTON DICKINSON & CO

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

    full page →fda device 510k ↗

    Week of Mar 24, 2025

    35
    ›Mar 24, 2025device 510k491d 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 510k
    ← prev
    page 32 of 100
    next →
    491d ago
    Abbott Molecular, Inc. — Alinity m BKV (510k cleared)

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

    full page →fda device 510k ↗
    ›Mar 24, 2025device 510k491d agoXplr , Ltd. — LMNT O2 (510k cleared)

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

    full page →fda device 510k ↗
    ›Mar 24, 2025device 510k491d 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 510k491d 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 510k491d 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 510k491d agoRestor3D, Inc. — TIDAL Fusion Cage System (510k cleared)

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

    full page →fda device 510k ↗
    ›Mar 24, 2025device 510k491d 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 510k491d agoInnovasis, Inc. — Innovasis Navigation Instruments (510k cleared)

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

    full page →fda device 510k ↗
    ›Mar 24, 2025device 510k491d agoInnovasis — AxTiHA® Stand-Alone ALIF System (510k cleared)

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

    full page →fda device 510k ↗
    ›Mar 24, 2025device 510k491d 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 510k491d 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 510k491d 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 510k490d 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 510k490d 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 510k489d 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 510k489d 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 510k489d 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 510k489d 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 510k489d 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 510k489d 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 510k489d 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 510k489d agoEarlitec Diagnostics — EarliPoint System (510k cleared)

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

    full page →fda device 510k ↗
    ›Mar 26, 2025device 510k489d agoAZmed — Rayvolve LN (510k cleared)

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

    full page →fda device 510k ↗
    ›Mar 26, 2025device 510k489d 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 510k489d 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 510k488d 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 510k488d 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 510k488d agoArtrya Limited — Salix Central (510k cleared)

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

    full page →fda device 510k ↗
    ›Mar 27, 2025device 510k488d 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 510k488d 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 510k488d agoAsahi Intecc Co., Ltd. — Crossloop (510k cleared)

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

    full page →fda device 510k ↗
    ›Mar 27, 2025device 510k488d 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 510k488d 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 510k488d 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 ↗
    $BSX44.25+1.54%
    $BDX156.36+2.22%
    $TNON0.2832-3.11%
    $EW91.33-2.47%