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calendar

2,156 catalysts · 4,728 grant · 3,062 8k filing · 2,627 approval · 2,156 device 510k · 1,745 device recall · 1,501 device pma

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2026-08-10: 0 catalysts2026-08-11: 33 catalysts2026-08-12: 19 catalysts2026-08-13: 19 catalysts2026-08-14: 4 catalysts2026-08-15: 0 catalysts2026-08-16: 0 catalysts2026-08-17: 1 catalyst2026-08-18: 2 catalysts2026-08-19: 2 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: 1 catalyst2026-08-27: 1 catalyst2026-08-28: 0 catalysts2026-08-29: 0 catalysts2026-08-30: 0 catalysts2026-08-31: 0 catalysts2026-09-01: 1 catalyst2026-09-02: 0 catalysts2026-09-03: 1 catalyst2026-09-04: 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: 2 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: 2 catalysts2026-10-09: 0 catalysts2026-10-10: 0 catalysts2026-10-11: 0 catalysts2026-10-12: 0 catalysts2026-10-13: 1 catalyst2026-10-14: 1 catalyst2026-10-15: 0 catalysts2026-10-16: 0 catalysts2026-10-17: 0 catalysts2026-10-18: 0 catalysts2026-10-19: 1 catalyst2026-10-20: 2 catalysts2026-10-21: 2 catalysts2026-10-22: 2 catalysts2026-10-23: 1 catalyst2026-10-24: 0 catalysts2026-10-25: 0 catalysts2026-10-26: 1 catalyst2026-10-27: 8 catalysts2026-10-28: 12 catalysts2026-10-29: 21 catalysts2026-10-30: 4 catalysts2026-10-31: 0 catalysts2026-11-01: 0 catalysts2026-11-02: 9 catalysts2026-11-03: 18 catalysts2026-11-04: 22 catalysts2026-11-05: 37 catalysts2026-11-06: 2 catalysts2026-11-07: 0 catalysts2026-11-08: 0 catalysts
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type: device 510k×from 2025-08-08×clear all
type
  • grant4,728
  • 8k filing3,062
  • approval2,627
  • device 510k2,156
  • device recall1,745
  • device pma1,501
device adverse event
1,000
  • recall586
  • earnings583
  • phase 2 completion172
  • therapy area

    no tagged catalysts yet

    Week of Aug 4, 2025

    15
    ›Aug 8, 2025device 510k368d agoVive Health, LLC — Coretech Compression System (Coretech RHB3003) (510k cleared)

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

    full page →fda device 510k ↗
    ›Aug 8, 2025device 510k368d agoAqua Medical, Inc. — Aqua Medical RF Vapor Ablation System (510k cleared)AVITA Medical, Inc.

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

    full page →fda device 510k ↗
    ›Aug 8, 2025device 510k368d agoParkell, Inc. — Parkell Pit and Fissure Sealant (510k cleared)

    Product code: EBC. Advisory committee: Dental. Type: Abbreviated

    full page →fda device 510k ↗
    ›Aug 8, 2025device 510k368d agoIntegra Lifesciences Production Corporation — Codman Libertís Shunt Catheter with Bactiseal and Endexo Technology (510k cleared)

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

    full page →fda device 510k ↗
    ›Aug 8, 2025device 510k368d agoEmblation Limited — swiftPro System (SWF-SPS); Swift System (SWF-SYS) (510k cleared)

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

    full page →fda device 510k ↗
    ›Aug 8, 2025device 510k368d agoElevation Spine — SABER-C System (510k cleared)

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

    full page →fda device 510k ↗
    ›Aug 8, 2025device 510k368d 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 510k368d 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 510k368d 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 510k368d 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 510k368d 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 510k368d 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 510k368d 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 510k368d 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 510k368d 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

    35
    ›Aug 11, 2025device 510k365d 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 1 of 44
    next →
    365d 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 510k365d agoZimmer, Inc. — Identity Revision Humeral Stems (510k cleared)

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

    full page →fda device 510k ↗
    ›Aug 11, 2025device 510k365d 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 510k365d agoLutronic Corporation — XERF (510k cleared)

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

    full page →fda device 510k ↗
    ›Aug 11, 2025device 510k365d agoMediott, Inc. — RW-1 (510k cleared)

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

    full page →fda device 510k ↗
    ›Aug 11, 2025device 510k365d 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 510k365d 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 510k365d 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 510k365d 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 510k365d agoDeepHealth, Inc. — Saige-Dx (510k cleared)

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

    full page →fda device 510k ↗
    ›Aug 11, 2025device 510k365d 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 510k364d 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 510k364d 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 510k364d agoIdmed — CuffGuard (510k cleared)

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

    full page →fda device 510k ↗
    ›Aug 12, 2025device 510k364d agoInstitut Straumann AG — Straumann® RidgeFit Implants (510k cleared)

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

    full page →fda device 510k ↗
    ›Aug 12, 2025device 510k364d 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 510k364d 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 510k364d agoLiofilchem — Sulopenem SPM 2 µg (510k cleared)

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

    full page →fda device 510k ↗
    ›Aug 13, 2025device 510k363d agoBaisheng Medical Co., Ltd. — Electrotherapy Electrodes (510k cleared)

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

    full page →fda device 510k ↗
    ›Aug 13, 2025device 510k363d 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 510k363d 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 510k363d 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 510k363d 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 510k363d 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 510k363d agoAppliedvr — RelieVRx (Pico G3) (510k cleared)

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

    full page →fda device 510k ↗
    ›Aug 13, 2025device 510k363d 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 510k363d 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 510k363d agoOsstem Implant Co., Ltd. — Bone Screw (510k cleared)

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

    full page →fda device 510k ↗
    ›Aug 13, 2025device 510k363d 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 510k363d 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 510k363d 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 510k363d agoRiverpoint Medical — HS Fiber (510k cleared)

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

    full page →fda device 510k ↗
    ›Aug 14, 2025device 510k362d 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 510k362d 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 ↗
    $AMZE
    $RCEL7.6000-2.19%
    $BDX179.63+1.57%
    $QCLS
    $NUWE
    $XRAY11.66-3.80%
    $SYK345.81+2.00%
    $OPK1.3900+1.46%