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5,000 catalysts · 18,987 approval · 5,256 phase readout · 5,000 device 510k · 4,728 grant · 2,563 8k filing · 2,000 device pma

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2026-07-27: 0 catalysts2026-07-28: 0 catalysts2026-07-29: 0 catalysts2026-07-30: 0 catalysts2026-07-31: 3 catalysts2026-08-01: 0 catalysts2026-08-02: 0 catalysts2026-08-03: 4 catalysts2026-08-04: 13 catalysts2026-08-05: 16 catalysts2026-08-06: 10 catalysts2026-08-07: 1 catalyst2026-08-08: 0 catalysts2026-08-09: 0 catalysts2026-08-10: 1 catalyst2026-08-11: 1 catalyst2026-08-12: 1 catalyst2026-08-13: 1 catalyst2026-08-14: 0 catalysts2026-08-15: 0 catalysts2026-08-16: 0 catalysts2026-08-17: 0 catalysts2026-08-18: 1 catalyst2026-08-19: 0 catalysts2026-08-20: 0 catalysts2026-08-21: 0 catalysts2026-08-22: 0 catalysts2026-08-23: 0 catalysts2026-08-24: 0 catalysts2026-08-25: 0 catalysts2026-08-26: 0 catalysts2026-08-27: 0 catalysts2026-08-28: 0 catalysts2026-08-29: 0 catalysts2026-08-30: 0 catalysts2026-08-31: 0 catalysts2026-09-01: 1 catalyst2026-09-02: 0 catalysts2026-09-03: 0 catalysts2026-09-04: 0 catalysts2026-09-05: 0 catalysts2026-09-06: 0 catalysts2026-09-07: 0 catalysts2026-09-08: 0 catalysts2026-09-09: 0 catalysts2026-09-10: 0 catalysts2026-09-11: 0 catalysts2026-09-12: 0 catalysts2026-09-13: 0 catalysts2026-09-14: 0 catalysts2026-09-15: 0 catalysts2026-09-16: 0 catalysts2026-09-17: 0 catalysts2026-09-18: 0 catalysts2026-09-19: 0 catalysts2026-09-20: 0 catalysts2026-09-21: 0 catalysts2026-09-22: 0 catalysts2026-09-23: 0 catalysts2026-09-24: 0 catalysts2026-09-25: 0 catalysts2026-09-26: 0 catalysts2026-09-27: 0 catalysts2026-09-28: 0 catalysts2026-09-29: 0 catalysts2026-09-30: 0 catalysts2026-10-01: 0 catalysts2026-10-02: 0 catalysts2026-10-03: 0 catalysts2026-10-04: 0 catalysts2026-10-05: 0 catalysts2026-10-06: 0 catalysts2026-10-07: 0 catalysts2026-10-08: 0 catalysts2026-10-09: 0 catalysts2026-10-10: 0 catalysts2026-10-11: 0 catalysts2026-10-12: 0 catalysts2026-10-13: 0 catalysts2026-10-14: 0 catalysts2026-10-15: 0 catalysts2026-10-16: 0 catalysts2026-10-17: 0 catalysts2026-10-18: 0 catalysts2026-10-19: 0 catalysts2026-10-20: 1 catalyst2026-10-21: 1 catalyst2026-10-22: 2 catalysts2026-10-23: 0 catalysts2026-10-24: 0 catalysts2026-10-25: 0 catalysts
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type: device 510k×clear all
type
  • approval18,987
  • phase readout5,256
  • device 510k5,000
  • grant4,728
  • 8k filing2,563
  • device pma2,000
  • device recall2,000
  • recall1,126
  • device adverse event1,000
  • pdufa325
  • therapy area

    no tagged catalysts yet

    Week of Jul 14, 2025

    41
    ›Jul 15, 2025device 510k381d agoIsoaid, LLC — IsoSphere (510k cleared)

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

    full page →fda device 510k ↗
    ›Jul 15, 2025device 510k381d agoXiros Limited — Jewel Soft Tissue Reinforcement Device (102-6005) (510k cleared)

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

    full page →fda device 510k ↗
    ›Jul 16, 2025device 510k380d 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 ↗
    ›Jul 16, 2025device 510k380d agoSpectrawave, Inc. — HyperVue™ Software (510k cleared)

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

    full page →fda device 510k ↗
    ›Jul 16, 2025device 510k380d agoQ3 Medical USA, LLC (C/O Q3 Medical Devices Ltd.) — ARCHIMEDES Biodegradable Pancreatic Stent (510k cleared)

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

    full page →fda device 510k ↗
    ›Jul 16, 2025device 510k380d agoOlympus Medical Systems Corporation — Suction Valve (MAJ-1443); Air/Water Valve (MAJ-1444) (510k cleared)

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

    full page →fda device 510k ↗
    ›Jul 16, 2025device 510k380d agoKerecis Limited — Marigen Wound Extra; Kerecis Silicone; Kerecis Parvus (510k cleared)

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

    full page →fda device 510k ↗
    ›Jul 16, 2025device 510k380d agoCemho Medical Technology (Guangdong) Co., Ltd. — Automatic Blood Pressure Monitor (CH-S691L, CH-B607, CH-B606, CH-S692L, CH-S602, CH-W701L, CH-S693L, CH-B601L, CP-B01, CH-S603) (510k cleared)

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

    full page →fda device 510k ↗
    ›Jul 16, 2025device 510k380d agoShanghai United Imaging Healthcare Co., Ltd. — uMR 680 (510k cleared)

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

    full page →fda device 510k ↗
    ›Jul 16, 2025device 510k380d agoIschemaview — Rapid CTA 360 (510k cleared)

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

    full page →fda device 510k ↗
    ›Jul 16, 2025device 510k380d agoBioventus, LLC — StimTrial Neuromodulation System (510k cleared)Bioventus Inc.

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

    full page →fda device 510k ↗
    ›Jul 16, 2025device 510k380d agoGE Medical Systems Ultrasound and Primary Care Diagnostics — EchoPAC Software Only / EchoPAC Plug-in (510k cleared)

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

    full page →fda device 510k ↗
    ›Jul 17, 2025device 510k379d agoRoche Diagnostics — Elecsys Cortisol III (510k cleared)

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

    full page →fda device 510k ↗
    ›Jul 17, 2025device 510k379d agoGeistlich Pharma AG — Device 300423 Granules (510k cleared)

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

    full page →fda device 510k ↗
    ›Jul 17, 2025device 510k379d agoDxtx Medical, Inc. — e2CoilTM Imaging System for the Siemens MAGNETOM 3.0T MRI Systems with Tim 4G Connector (510k cleared)ICU MEDICAL INC/DE

    Product code: MOS. Advisory committee: Radiology. Type: Abbreviated

    full page →fda device 510k ↗
    ›Jul 17, 2025device 510k379d agoTerumo Corporation — DualView Catheter (510k cleared)

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

    full page →fda device 510k ↗
    ›Jul 17, 2025device 510k379d agoMasimo Corporation — Masimo O3 Regional Oximeter (510k cleared)MASIMO CORP

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

    full page →fda device 510k ↗
    ›Jul 17, 2025device 510k379d agoAlafair Biosciences — VersaWrap Nerve Protector (VTP-2201); VersaWrap Nerve Protector (VTP-1201) (510k cleared)

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

    full page →fda device 510k ↗
    ›Jul 17, 2025device 510k379d agoMedacta International S.A. — MectaLIF 3D Metal (510k cleared)Stemedica International S.A.

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

    full page →fda device 510k ↗
    ›Jul 17, 2025device 510k379d agoOsstem Implant Company., Ltd. Chair Business — K5 Cart, K5 Mount, K5 Swing (510k cleared)

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

    full page →fda device 510k ↗
    ›Jul 17, 2025device 510k379d agoArbor Endovascular, LLC — 0.014” Willow Guidewire (510k cleared)

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

    full page →fda device 510k ↗
    ›Jul 17, 2025device 510k379d agoShanghai United Imaging Healthcare Co., Ltd. — uMR Ultra (510k cleared)

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

    full page →fda device 510k ↗
    ›Jul 17, 2025device 510k379d agoShanghai United Imaging Healthcare Co., Ltd. — uMI Panvivo (uMI Panvivo); uMI Panvivo (uMI Panvivo S) (510k cleared)

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

    full page →fda device 510k ↗
    ›Jul 17, 2025device 510k379d agoGenoray Co., Ltd. — HESTIA (510k cleared)

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

    full page →fda device 510k ↗
    ›Jul 18, 2025device 510k378d agoZimmer, Inc. — Z1 Hip System (510k cleared)

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

    full page →fda device 510k ↗
    ›Jul 18, 2025device 510k378d agoHeartFlow, Inc. — HeartFlow Analysis (510k cleared)Heartflow, Inc.

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

    full page →fda device 510k ↗
    ›Jul 18, 2025device 510k378d agoDk Medical Systems Co., Ltd. — INNOVISION-P5 (510k cleared)

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

    full page →fda device 510k ↗
    ›Jul 18, 2025device 510k378d agoMicro Current Technology, Inc. — MF SC GEN2 Facial Toning System (510k cleared)MICRON TECHNOLOGY INC

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

    full page →fda device 510k ↗
    ›Jul 18, 2025device 510k378d agoExcite Medical of Tampa Bay, LLC — True Non-Surgical Spinal Decompression System (DRX9000-SL) (510k cleared)

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

    full page →fda device 510k ↗
    ›Jul 18, 2025device 510k378d agoBeckman Coulter, Inc. — MicroScan Dried Gram-Negative MIC/Combo Panels with Aztreonam (AZT) (0.5-64 µg/mL) (510k cleared)Bristol-Myers Squibb Co

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

    full page →fda device 510k ↗
    ›Jul 18, 2025device 510k378d agoCMT Health PTE., Ltd. — Profoject™ Enteral Feeding Syringe (510k cleared)

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

    full page →fda device 510k ↗
    ›Jul 18, 2025device 510k378d agoStryker Endoscopy — SPY Cystoscope/Hysteroscope (510k cleared)

    Product code: HIH. Advisory committee: Obstetrics/Gynecology. Type: Special

    full page →fda device 510k ↗
    ›Jul 18, 2025device 510k378d agoArthrex, Inc. — Arthrex FiberTak Suture Anchor (510k cleared)

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

    full page →fda device 510k ↗
    ›Jul 18, 2025device 510k378d agoTomey Corporation — Tomey Cornea/Anterior Segment OCT (CASIA2) (510k cleared)

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

    full page →fda device 510k ↗
    ›Jul 18, 2025device 510k378d agoAlafair Biosciences — VersaCoat Tendon Protector (VTP-44G2); VersaCoat Tendon Protector (VTP-12G1) (510k cleared)

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

    full page →fda device 510k ↗
    ›Jul 18, 2025device 510k378d agoSamsung Medison Co., Ltd. — V8 Diagnostic Ultrasound System; cV8 Diagnostic Ultrasound System; V7 Diagnostic Ultrasound System; cV7 Diagnostic Ultrasound System; V6 Diagnostic Ultrasound System; cV6 Diagnostic Ultrasound System; V5 Diagnostic Ultrasound System; cV5 Diagnostic Ultrasound System; V4 Diagnostic Ultrasound System; cV4 Diagnostic Ultrasound System (510k cleared)

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

    full page →fda device 510k ↗
    ›Jul 18, 2025device 510k378d agoOnepass Medical , Ltd. — InstaFAN (510k cleared)

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

    full page →fda device 510k ↗
    ›Jul 18, 2025device 510k378d agoMicro-Nx Co., Ltd. — ELEC ENGINE (Model: ISE-170L) (510k cleared)

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

    full page →fda device 510k ↗
    ›Jul 18, 2025device 510k378d agoTakeda Pharmaceuticals — HyHub™ and HyHub™ Duo Vial Access Devices (510k cleared)TAKEDA PHARMACEUTICAL CO LTD

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

    full page →fda device 510k ↗
    ›Jul 18, 2025device 510k378d agoParagon 28, Inc. — Baby Gorilla®/Gorilla® Plating System (510k cleared)

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

    full page →fda device 510k ↗
    ›Jul 19, 2025device 510k377d agoJiangsu Tingsn Technology Co., Ltd. — TINGSN FINDERS 2 Color Doppler Diagnostic Ultrasound System (510k cleared)Jiangsu Maoxing Technology Co Ltd

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

    full page →fda device 510k ↗

    Week of Jul 21, 2025

    9
    ›Jul 21, 2025device 510k375d agoIline Microsystems, S.L. — microINR System (510k cleared)

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

    full page →fda device 510k ↗
    ›Jul 22, 2025device 510k
    ← prev
    page 54 of 100
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    374d ago
    Minnesota Medical Technologies — Minnesota Medical Technologies Fecal Incontinence Insert (My Miracle) (510k cleared)

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

    full page →fda device 510k ↗
    ›Jul 22, 2025device 510k374d agoDentsply Sirona, Inc. — Plastic Surgical Kits (510k cleared)DENTSPLY SIRONA Inc.

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

    full page →fda device 510k ↗
    ›Jul 22, 2025device 510k374d agoCardiosense, Inc. — CardioTag™ (510k cleared)

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

    full page →fda device 510k ↗
    ›Jul 22, 2025device 510k374d agoBrainlab AG — Vascular Navigation PAD 2.0; Navigation Software Vascular PAD (510k cleared)

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

    full page →fda device 510k ↗
    ›Jul 22, 2025device 510k374d agoAlafair Biosciences — VersaCoat Nerve Protector (VTP-44G2); VersaCoat Nerve Protector (VTP-12G1) (510k cleared)

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

    full page →fda device 510k ↗
    ›Jul 22, 2025device 510k374d agoOts Medical , Ltd. — OTS 25-L (100-5) (510k cleared)KAHR medical Ltd

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

    full page →fda device 510k ↗
    ›Jul 22, 2025device 510k374d agoOds Co., Ltd. — Clear Miracle (510k cleared)

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

    full page →fda device 510k ↗
    ›Jul 22, 2025device 510k374d agoInnocare Optoelectronics Corp. — Yushan X-Ray Flat Panel Detector (510k cleared)

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

    full page →fda device 510k ↗
    $TAK17.25-2.82%
    $HTFL
    $MU874.66+18.36%
    $ICUI168.38+1.11%
    $ISRG352.97-0.04%
    $BVS8.6700+1.40%
    $MASI
    $XRAY13.74-3.24%