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calendar

3,882 catalysts · 4,728 grant · 3,882 device 510k · 3,062 8k filing · 3,057 approval · 2,000 device pma · 2,000 device recall

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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 2025-01-30×clear all
type
  • grant4,728
  • device 510k3,882
  • 8k filing3,062
  • approval3,057
  • device pma2,000
  • device recall2,000
device adverse event
1,000
  • recall931
  • earnings583
  • phase 2 completion172
  • therapy area

    no tagged catalysts yet

    Week of Jan 27, 2025

    27
    ›Jan 30, 2025device 510k558d agoMobius Mobility — iBOT® PMD (510k cleared)

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

    full page →fda device 510k ↗
    ›Jan 30, 2025device 510k558d agoShenzhen Zhongkemingwang Telecommunications Software Corp. — Wrist Blood Pressure Monitor (OHMS11, OHMS12) (510k cleared)

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

    full page →fda device 510k ↗
    ›Jan 30, 2025device 510k558d agoMedacta International S.A. — MyShoulder Planner (5.3SSWPL) (510k cleared)Stemedica International S.A.

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

    full page →fda device 510k ↗
    ›Jan 30, 2025device 510k558d agoResponsive Arthroscopy, Inc. — Osprey Suture Anchor (510k cleared)

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

    full page →fda device 510k ↗
    ›Jan 30, 2025device 510k558d agoBTL Industries, Inc. — BTL-754 (510k cleared)NL INDUSTRIES INC

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

    full page →fda device 510k ↗
    ›Jan 30, 2025device 510k558d agoLaboratorios Biogalenic S.A. DE C.V. — Laboratorios Biogalenic Sterile Water for Inhalation, USP (510k cleared)

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

    full page →fda device 510k ↗
    ›Jan 30, 2025device 510k558d agoAbanza Tecnomed S.L — WasherCap™ Mini Fixation System (Model 45) (510k cleared)

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

    full page →fda device 510k ↗
    ›Jan 30, 2025device 510k558d agoTaiwan Aulisa Medical Devices Technologies, Inc. — Aulisa Infant Oximeter Module (2nd Gen.) (GA-OM0018) (510k cleared)

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

    full page →fda device 510k ↗
    ›Jan 30, 2025device 510k558d agoSeplou (Zhuhai) Co., Ltd. — Ureteral Access Sheath (510k cleared)

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

    full page →fda device 510k ↗
    ›Jan 30, 2025device 510k558d agoLiofilchem s.r.l. — MTS Ceftobiprole 0.002-32 µg/mL (510k cleared)

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

    full page →fda device 510k ↗
    ›Jan 30, 2025device 510k558d agoAbbott Molecular — simpli-COLLECT STI Test (510k cleared)

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

    full page →fda device 510k ↗
    ›Jan 30, 2025device 510k558d agoBard Peripheral Vascular, Inc. — Rotarex Atherectomy System (510k cleared)

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

    full page →fda device 510k ↗
    ›Jan 30, 2025device 510k558d agoGuangdong Transtek Medical Electronics Co., Ltd. — TeleRPM Gen2 Blood Glucose Monitoring System (510k cleared)

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

    full page →fda device 510k ↗
    ›Jan 31, 2025device 510k557d agoAvanos Medical, Inc. — Game Ready system (550500-04); Game Ready Control Unit (550550-04); Game Ready Full Leg Boot Wrap - Medium (590923-04); Game Ready Full Leg Boot Wrap - Large (590922-04); Game Ready C-T Spine Wrap (590502-04); Game Ready Half Leg Boot (590906-04); Game Ready Back Wrap (590500-04); Game Ready Hand/Wrist Wrap (590811-04); Game Ready Flexed Elbow Wrap (590903-04); Game Ready Straight Elbow Wrap (590200-04); Game Ready Shoulder Wrap, Medium, Right (590422-04); Game Ready Shoulder Wrap, La (510k cleared)AVANOS MEDICAL, INC.

    Product code: IRP. Advisory committee: Physical Medicine. Type: Special

    full page →fda device 510k ↗
    ›Jan 31, 2025device 510k557d agoZheJiang Decans Medical Devices Co., Ltd. — Crius PEEK Suture Anchor System (Thread-Fix Anchor); Crius PEEK Suture Anchor System (Thread-Fix Ultra Anchor); Crius PEEK Suture Anchor System (Helicoil Anchor); Crius PEEK Suture Anchor System (Pile Anchor) (510k cleared)

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

    full page →fda device 510k ↗
    ›Jan 31, 2025device 510k557d agoMarzzan Lucas Jorge — AGILIS - Multi-function Physical Therapy Table (Model: Plus, Pro and Basic.) (510k cleared)

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

    full page →fda device 510k ↗
    ›Jan 31, 2025device 510k557d agoLuxottica Group S.P.A. — Nuance Audio Hearing Aid Software (510k cleared)

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

    full page →fda device 510k ↗
    ›Jan 31, 2025device 510k557d agoSuzhou Master Machinery Manufacturing Co.,Ltd — Mobility Scooter (MS160A) (510k cleared)

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

    full page →fda device 510k ↗
    ›Jan 31, 2025device 510k557d agoNanjing Synthgene Medical Technology Co., Ltd. — Synthgene Home Test HCG Test Strip; Synthgene Home Test HCG Test Cassette; Synthgene Home Test HCG Test Midstream (510k cleared)

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

    full page →fda device 510k ↗
    ›Jan 31, 2025device 510k557d agoMotilitycount Aps — SwimCount® Harvester (1 mL); SwimCount® Harvester (3 mL) (510k cleared)

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

    full page →fda device 510k ↗
    ›Jan 31, 2025device 510k557d agoDornier Medtech America — Hoover Negative Pressure Access Sheath (Hoover) (Hoover Model #'s IVX-NS-1040, IVX-NS-1050, IVX-NS-1140, IVX-NS-1150, IVX-NS-1240, IVX-NS-1250 (510k cleared)

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

    full page →fda device 510k ↗
    ›Jan 31, 2025device 510k557d agoArthrex, Inc. — Arthrex DynaNite Nitinol Staples (510k cleared)

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

    full page →fda device 510k ↗
    ›Jan 31, 2025device 510k557d agoBasic Medical Technology, Inc. — Nitrile Powder-Free Exam Gloves Tested for Use with Chemotherapy Drugs, Opioid Fentanyl Citrate, Simulated Gastric Acid (Light blue, Dark blue) (510k cleared)Medical Care Technologies Inc.

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

    full page →fda device 510k ↗
    ›Jan 31, 2025device 510k557d agoTae Young Soft Co., Ltd. — ZeTTA PACS (510k cleared)

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

    full page →fda device 510k ↗
    ›Jan 31, 2025device 510k557d agoGentuity, LLC — Gentuity® HF-OCT Imaging System with Vis-Rx Prime® Micro-Imaging Catheter (510k cleared)

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

    full page →fda device 510k ↗
    ›Jan 31, 2025device 510k557d agoInnovate Orthopaedics, Ltd. — Quick-Start Orthopaedic Fixation Screw and Reverse Thread Screw (510k cleared)

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

    full page →fda device 510k ↗
    ›Jan 31, 2025device 510k557d agoC.R. Bard, Inc. — Semi-Floating Temporary Pacing Electrode Catheter, Bipolar, Stainless Steel Electrodes, 115 cm, 4Fr. (006221P); Semi-Floating Temporary Pacing Electrode Catheter, Bipolar, Stainless Steel Electrodes, 115 cm, 5Fr. (006225P); Semi-Floating Temporary Pacing Electrode Catheter, Bipolar, Stainless Steel Electrodes, 125 cm, 6Fr. (006241P); Semi-Floating Temporary Pacing Electrode Catheter, Bipolar, Stainless Steel Electrodes, 125 cm, 7Fr. (006242P); NBIH™ Temporary Pacing Electrode Catheter, (510k cleared)

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

    full page →fda device 510k ↗

    Week of Feb 3, 2025

    23
    ›Feb 3, 2025device 510k554d agoHuntleigh Healthcare , Ltd. — Sonicaid Team3 (510k cleared)

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

    full page →fda device 510k ↗
    ›Feb 3, 2025device 510k
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    554d ago
    Momentis Surgical , Ltd. — Anovo Instrument ARM Curved Scissors; Anovo Instrument ARM Hook Electrode (510k cleared)

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

    full page →fda device 510k ↗
    ›Feb 3, 2025device 510k554d agoShenzhen Ulike Smart Electronics Co., Ltd. — JMOON NouvelleSkin Facial Toning Device (M30U PR, M30U MW, M30U SG, M30U SK, M30U MP) (510k cleared)

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

    full page →fda device 510k ↗
    ›Feb 3, 2025device 510k554d agoGuangzhou Hehong Biotech Co., Ltd. — Minvitro® Vitrification Straw (MVT-VSN series, including MVT-VSNR, MVT-VSNY, MVT-VSNB, MVT-VSNG, MVT-VSNP) (510k cleared)Hangzhou DAC Biotech Co Ltd

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

    full page →fda device 510k ↗
    ›Feb 3, 2025device 510k554d agoCytochip, Inc. — Cito CBC System (510k cleared)

    Product code: GKZ. Advisory committee: Hematology. Type: Dual Track

    full page →fda device 510k ↗
    ›Feb 3, 2025device 510k554d agoAlphatec Spine — IdentiTi Porous Ti Interbody System; IdentiTi NanoTec Interbody System; IdentiTi Cervical Porous Ti Interbody System; IdentiTi NanoTec Cervical Interbody System; IdentiTi Cervical Standalone Interbody System; IdentiTi NanoTec Cervical Standalone Interbody System; IdentiTi ALIF Standalone Interbody System; IdentiTi NanoTec ALIF Standalone Interbody System; Transcend PEEK Interbody System; Transcend NanoTec Interbody System; Transcend Cervical PEEK Interbody System; Transcend NanoTec Cer (510k cleared)

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

    full page →fda device 510k ↗
    ›Feb 3, 2025device 510k554d agoMim Software, Inc. — Contour ProtégéAI+ (510k cleared)ASURE SOFTWARE INC

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

    full page →fda device 510k ↗
    ›Feb 3, 2025device 510k554d agoPranaq Pte. , Ltd. — TipTraQ (TTQ001) (510k cleared)

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

    full page →fda device 510k ↗
    ›Feb 3, 2025device 510k554d agoZavation Medical Products, LLC — Tiger 2 System (510k cleared)

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

    full page →fda device 510k ↗
    ›Feb 3, 2025device 510k554d agoGuangdong Xinyu Electronic and Technology Co., Ltd. — Arm Blood Pressure Monitor (XY-B01, XY-B02, XY-B03, XY-B05, XY-B07, XY-B08, XY-B09) (510k cleared)

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

    full page →fda device 510k ↗
    ›Feb 3, 2025device 510k554d agoIhealth Labs, Inc. — iCare APP (510k cleared)

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

    full page →fda device 510k ↗
    ›Feb 4, 2025device 510k553d agoLargan Medical Co., Ltd. — Largan U38 Color (Polymacon) Daily Wear Soft (hydrophilic) Contact Lens (510k cleared)

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

    full page →fda device 510k ↗
    ›Feb 4, 2025device 510k553d agoRoclub GmbH — rTOP (510k cleared)

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

    full page →fda device 510k ↗
    ›Feb 4, 2025device 510k553d agoVenclose, Inc. — Venclose digiRF Generator (VCRFG1) (510k cleared)

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

    full page →fda device 510k ↗
    ›Feb 4, 2025device 510k553d agoGeon Corporation — Geon (S2) Nasal Aspirator (510k cleared)

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

    full page →fda device 510k ↗
    ›Feb 5, 2025device 510k552d agoShenzhen Eyco Technology Co., Ltd. — LED light therapy mask (E43, E32, E49B, E49C, E100B, E100C, E103B, E104B, E106A, E108A) (510k cleared)Fortior Technology (Shenzhen) Co., Ltd./ADR

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

    full page →fda device 510k ↗
    ›Feb 5, 2025device 510k552d agoClaronav — Navient Image Guide Navigation System (955-NC-NC), Cranial (510k cleared)

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

    full page →fda device 510k ↗
    ›Feb 5, 2025device 510k552d agoTrainfes — TrainFES Advance (510k cleared)

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

    full page →fda device 510k ↗
    ›Feb 5, 2025device 510k552d agoAccurate Meditech, Inc. — Accurate Mini Non-invasive blood pressure monitor (AMB-001) (510k cleared)

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

    full page →fda device 510k ↗
    ›Feb 5, 2025device 510k552d agoDepuy Mitek — GRYPHON™ X Anchor; HEALIX TRANSTEND™ Anchor (510k cleared)

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

    full page →fda device 510k ↗
    ›Feb 5, 2025device 510k552d agoNvision Biomedical Technologies — Caliber Intramedullary Fixation System (510k cleared)

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

    full page →fda device 510k ↗
    ›Feb 5, 2025device 510k552d agoSurGenTec, LLC — GraftGun Universal Graft Delivery System (GDS) (510k cleared)

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

    full page →fda device 510k ↗
    ›Feb 5, 2025device 510k552d agoGleamer Sas — BoneMetrics (US) (510k cleared)

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

    full page →fda device 510k ↗
    $NL6.0500-1.14%
    $AVNS
    $MDCE0.00020.00%
    $FRTRY
    $ASUR8.2700+1.35%