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calendar

5,000 catalysts · 18,987 approval · 5,347 phase readout · 5,000 device 510k · 4,728 grant · 2,580 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: 20 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 readout5,347
  • device 510k5,000
  • grant4,728
  • 8k filing2,580
  • device pma2,000
  • device recall2,000
  • recall1,126
  • device adverse event1,000
  • pdufa347
  • therapy area

    no tagged catalysts yet

    Week of Aug 4, 2025

    9
    ›Aug 8, 2025device 510k358d agoGuangzhou Red Pine Medical Instrument Co., Ltd. — Single-Use Video Flexible Cysto-Nephroscope (RP-U-C01F, RP-U-C01FS) (510k cleared)

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

    full page →fda device 510k ↗
    ›Aug 8, 2025device 510k358d agoGlobal Protection Corp. — Plain Water-based Lubricant (510k cleared)

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

    full page →fda device 510k ↗
    ›Aug 8, 2025device 510k358d agoCarl Zeiss Meditec Cataract Technology, Inc. — MICOR 700 with Auto I/A (510k cleared)

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

    full page →fda device 510k ↗
    ›Aug 8, 2025device 510k358d agoTonica Elektronik A/S — MagVenture TMS Therapy System (510k cleared)

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

    full page →fda device 510k ↗
    ›Aug 8, 2025device 510k358d agoBecton, Dickinson and Company — BD Phoenix Automated Microbiology System - GN Eravacycline (0.125-2 µg/mL) (510k cleared)BECTON DICKINSON & CO

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

    full page →fda device 510k ↗
    ›Aug 8, 2025device 510k358d agoGlobal Protection Corp. — Water-based Lubricant (510k cleared)

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

    full page →fda device 510k ↗
    ›Aug 8, 2025device 510k358d agoAmdt Holdings, Inc. — SixFix™ Hexapod Fixator and Deformity Analysis and Correction Software (DACS) (510k cleared)AMAZE HOLDINGS, INC.

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

    full page →fda device 510k ↗
    ›Aug 8, 2025device 510k358d agoHebei Newangie Technology Co., Ltd. — Diode laser device (BM091) (510k cleared)

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

    full page →fda device 510k ↗
    ›Aug 8, 2025device 510k358d agoMr Surgical Solutions, LLC — OptiVu™ Shoulder (510k cleared)

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

    full page →fda device 510k ↗

    Week of Aug 11, 2025

    41
    ›Aug 11, 2025device 510k355d agoZhejiang UE Medical Corp. — UE BRONCHO Single-Use Bronchoscopes (EBS-380C); UE BRONCHO Single-Use Bronchoscopes (EBS-500C); UE BRONCHO Single-Use Bronchoscopes (EBS-600C); UE Display (UE-M10S) (510k cleared)

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

    full page →fda device 510k ↗
    ›Aug 11, 2025device 510k
    ← prev
    page 58 of 100
    next →
    355d ago
    Paragon 28, Inc. — External Fixation Bone Distractor (510k cleared)

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

    full page →fda device 510k ↗
    ›Aug 11, 2025device 510k355d agoZimmer, Inc. — Identity Revision Humeral Stems (510k cleared)

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

    full page →fda device 510k ↗
    ›Aug 11, 2025device 510k355d agoTonica Elektronik A/S — MagVenture TMS Therapy System (510k cleared)

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

    full page →fda device 510k ↗
    ›Aug 11, 2025device 510k355d agoLutronic Corporation — XERF (510k cleared)

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

    full page →fda device 510k ↗
    ›Aug 11, 2025device 510k355d agoMediott, Inc. — RW-1 (510k cleared)

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

    full page →fda device 510k ↗
    ›Aug 11, 2025device 510k355d agoBio-Med Device, Inc. — OxyMinder Pro (10310) (510k cleared)

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

    full page →fda device 510k ↗
    ›Aug 11, 2025device 510k355d agoCnc Technologies — Duoblade Plus SE (DB1EP, DB1EP-T, DB1EP-H, DB1EP-TH); Duoblade Prime (DB1P, DB1P-T, DB1P-H, DB1P-TH) (510k cleared)Q/C TECHNOLOGIES, INC.

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

    full page →fda device 510k ↗
    ›Aug 11, 2025device 510k355d agoResnent, LLC — Outlook Surgical Versa One System (8900139) (510k cleared)

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

    full page →fda device 510k ↗
    ›Aug 11, 2025device 510k355d agoUnivlabs Technologies Private Limited — UL UHD-Clear View 4K Camera System (UL-3Chip 4K) (510k cleared)

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

    full page →fda device 510k ↗
    ›Aug 11, 2025device 510k355d agoDeepHealth, Inc. — Saige-Dx (510k cleared)

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

    full page →fda device 510k ↗
    ›Aug 11, 2025device 510k355d agoAnker Innovations Limited — eufy Wearable Breast Pump S1 (T8D02); eufy Wearable Breast Pump E10 (T8D03) (510k cleared)

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

    full page →fda device 510k ↗
    ›Aug 12, 2025device 510k354d agoEko Health, Inc. — Eko Foundation Analysis Software with Transformers (EFAST) (510k cleared)OPKO HEALTH, INC.

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

    full page →fda device 510k ↗
    ›Aug 12, 2025device 510k354d agoDentsply Sirona, Inc. — DS Core Diagnosis (510k cleared)DENTSPLY SIRONA Inc.

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

    full page →fda device 510k ↗
    ›Aug 12, 2025device 510k354d agoIdmed — CuffGuard (510k cleared)

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

    full page →fda device 510k ↗
    ›Aug 12, 2025device 510k354d agoInstitut Straumann AG — Straumann® RidgeFit Implants (510k cleared)

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

    full page →fda device 510k ↗
    ›Aug 12, 2025device 510k354d agoMedical Components, Inc. — 14F Duo-Flow® Side X Side Double Lumen Catheter (510k cleared)

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

    full page →fda device 510k ↗
    ›Aug 12, 2025device 510k354d agoAtraverse Medical, Inc. — HOTWIRE™ System RF Generator and Footswitch (optional accessory) (510k cleared)

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

    full page →fda device 510k ↗
    ›Aug 12, 2025device 510k354d agoLiofilchem — Sulopenem SPM 2 µg (510k cleared)

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

    full page →fda device 510k ↗
    ›Aug 13, 2025device 510k353d agoBaisheng Medical Co., Ltd. — Electrotherapy Electrodes (510k cleared)

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

    full page →fda device 510k ↗
    ›Aug 13, 2025device 510k353d agoBruker Daltonics GmbH & Co. KG — MBT Compass HT CA Software; MBT FAST Shuttle US IVD (510k cleared)

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

    full page →fda device 510k ↗
    ›Aug 13, 2025device 510k353d agoE.M.S Electro Medical Systems S.A — DOLORCLAST Focused Shock Waves (510k cleared)

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

    full page →fda device 510k ↗
    ›Aug 13, 2025device 510k353d agoUnibeauty (Hubei) Technology Co., Ltd. — Unscented menstrual long applicator tampon; Unscented menstrual Compact Applicator Tampon; Unscented menstrual Cardboard Applicator Tampon; Unscented menstrual Digital Tampons (510k cleared)

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

    full page →fda device 510k ↗
    ›Aug 13, 2025device 510k353d agoPipeline Medical Products, LLC — AeroJet Ventilation Catheter (510k cleared)

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

    full page →fda device 510k ↗
    ›Aug 13, 2025device 510k353d agoNuwellis, Inc. — Dual Lumen Extended Length Catheter (dELC), 6F, 12cm (320101); Dual Lumen Extended Length Catheter (dELC), 6F, 16 cm (320102) (510k cleared)Nuwellis, Inc.

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

    full page →fda device 510k ↗
    ›Aug 13, 2025device 510k353d agoAppliedvr — RelieVRx (Pico G3) (510k cleared)

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

    full page →fda device 510k ↗
    ›Aug 13, 2025device 510k353d agoKarl Storz SE & CO. KG — KARL STORZ HOPKINS Telescopes for Urology (510k cleared)

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

    full page →fda device 510k ↗
    ›Aug 13, 2025device 510k353d agoUnimed Medical Supplies, Inc. — Unimed Reusable SpO2 Sensors (-117 and -121 Series) (U403-117); Unimed Reusable SpO2 Sensors (-117 and -121 Series) (U103-117); Unimed Reusable SpO2 Sensors (-117 and -121 Series) (U410-121); Unimed Reusable SpO2 Sensors (-117 and -121 Series) (U110-121) (510k cleared)

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

    full page →fda device 510k ↗
    ›Aug 13, 2025device 510k353d agoOsstem Implant Co., Ltd. — Bone Screw (510k cleared)

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

    full page →fda device 510k ↗
    ›Aug 13, 2025device 510k353d agoS.I.N. Implant System Ltda — S.I.N. Dental Implant System (510k cleared)

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

    full page →fda device 510k ↗
    ›Aug 13, 2025device 510k353d agoHuizhou Lvb Maternal and Infant Supplies Co., Ltd. — Wearable Breast Pump (P9, P10, P16, P20, P21, P22, P23, P25) (510k cleared)

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

    full page →fda device 510k ↗
    ›Aug 13, 2025device 510k353d agoStryker GmbH — T2 Alpha Femur Retrograde Nailing System (510k cleared)STRYKER CORP

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

    full page →fda device 510k ↗
    ›Aug 13, 2025device 510k353d agoRiverpoint Medical — HS Fiber (510k cleared)

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

    full page →fda device 510k ↗
    ›Aug 14, 2025device 510k352d agoGuangzhou Ajax Medical Equipment Co., Ltd. — Cassette Autoclave (ACA5) (510k cleared)

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

    full page →fda device 510k ↗
    ›Aug 14, 2025device 510k352d agoShenzhen Kaiyan Medical Equipment Co., Ltd. — TRUDERMAL Pro (ZLD-390) (510k cleared)

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

    full page →fda device 510k ↗
    ›Aug 14, 2025device 510k352d agoGM Dos Reis Industria e Comercio Ltda. — Stitch Cerclage – Suture Tapes (510k cleared)

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

    full page →fda device 510k ↗
    ›Aug 14, 2025device 510k352d agoForus Health Pvt.Ltd — 3nethra neo HD FA; 3nethra neo HD (510k cleared)

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

    full page →fda device 510k ↗
    ›Aug 14, 2025device 510k352d agoMom Incubators Limited — mOm Essential Incubator (ME1) (510k cleared)

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

    full page →fda device 510k ↗
    ›Aug 14, 2025device 510k352d agoStryker Sustainability Solutions — Reprocessed HARMONIC 700 Shears (HAR723/Reprocessed HARMONIC 700, 5mm Diameter Shears with Advanced Hemostasis x 23cm); Reprocessed HARMONIC 700 Shears (HAR736/Reprocessed HARMONIC 700, 5mm Diameter Shears with Advanced Hemostasis x 36cm); Reprocessed HARMONIC 700 Shears (HAR745/Reprocessed HARMONIC 700, 5mm Diameter SHears with Advanced Hemostasis x 45cm) (510k cleared)

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

    full page →fda device 510k ↗
    ›Aug 14, 2025device 510k352d agoShenzhen Leaflife Technology Co., Ltd. — WinForth (LM-E470KA) (510k cleared)Fortior Technology (Shenzhen) Co., Ltd./ADR

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

    full page →fda device 510k ↗
    ›Aug 14, 2025device 510k352d agoMaine Molecular Quality Controls, Inc. — FilmArray GI Control Panel M238 (510k cleared)

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

    full page →fda device 510k ↗
    $BDX162.84-1.58%
    $AMZE
    $SYK348.04-1.20%
    $OPK
    $FRTRY
    $XRAY13.74-3.24%
    $QCLS
    $NUWE