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3,374 catalysts · 4,728 grant · 3,374 device 510k · 3,045 8k filing · 2,856 approval · 2,000 device pma · 2,000 device recall

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2026-08-10: 0 catalysts2026-08-11: 16 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: 8 catalysts2026-11-03: 17 catalysts2026-11-04: 22 catalysts2026-11-05: 36 catalysts2026-11-06: 2 catalysts2026-11-07: 0 catalysts2026-11-08: 0 catalysts
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type: device 510k×from 2025-04-01×clear all
type
  • grant4,728
  • device 510k3,374
  • 8k filing3,045
  • approval2,856
  • device pma2,000
  • device recall2,000
device adverse event
1,000
  • recall848
  • earnings579
  • phase 2 completion172
  • therapy area

    no tagged catalysts yet

    Week of Mar 31, 2025

    50
    ›Apr 1, 2025device 510k497d agoAdvalight Aps — AdvaTx (510k cleared)

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

    full page →fda device 510k ↗
    ›Apr 1, 2025device 510k497d agoScientia Vascular, Inc. — Aristotle 14 Guidewire; Aristotle 18 Guidewire; Aristotle 24 Guidewire; Zoom Wire 14 Guidewire; Aristotle Colossus Guidewire (510k cleared)

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

    full page →fda device 510k ↗
    ›Apr 1, 2025device 510k497d agoGigaalaser Company , Ltd. — Medical Diode Laser Systems (THEIA808) (510k cleared)

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

    full page →fda device 510k ↗
    ›Apr 1, 2025device 510k497d agoTaiwan Medical Electronics Co., Ltd. — STOPWET iontophoresis apparatus (SW01) (510k cleared)

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

    full page →fda device 510k ↗
    ›Apr 1, 2025device 510k497d agoIntuitive Surgical, Inc. — da Vinci Xi Surgical System (IS4000); da Vinci X Surgical System (IS4200) (510k cleared)INTUITIVE SURGICAL INC

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

    full page →fda device 510k ↗
    ›Apr 1, 2025device 510k497d agoEssity Higiene Y Salud Mexico. S.A. DE C.V. — SABA Tampons (510k cleared)

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

    full page →fda device 510k ↗
    ›Apr 1, 2025device 510k497d agoOrthoPediatrics Corp. — Pediatric Nailing Platform Tibia Pediatric Nailing Platform Femur (510k cleared)ORTHOPEDIATRICS CORP

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

    full page →fda device 510k ↗
    ›Apr 1, 2025device 510k497d agoGE Healthcare — MR Contour DL (510k cleared)HCA Healthcare, Inc.

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

    full page →fda device 510k ↗
    ›Apr 1, 2025device 510k497d agoCareglove Global Sdn. Bhd. — Nitrile Examination Gloves Powder Free Tested for Use With Chemotherapy Drugs & Fentanyl Citrate (Blue & Black) (510k cleared)Teva Pharmaceuticals USA Inc

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

    full page →fda device 510k ↗
    ›Apr 1, 2025device 510k497d agoEMA Aesthetics , Ltd. — Préime DermaFacial (MicroT) (510k cleared)

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

    full page →fda device 510k ↗
    ›Apr 2, 2025device 510k496d agoOrthocell, Ltd. — Remplir (ON-152, 15 x 20 mm); Remplir (ON-203, 20 x 30 mm); Remplir (ON-304, 30 x 40 mm); Remplir (ON-405, 40 x 50 mm) (510k cleared)

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

    full page →fda device 510k ↗
    ›Apr 2, 2025device 510k496d agoIcu Medical, Inc. — Plum Duo™ Precision IV Pump (510k cleared)ICU MEDICAL INC/DE

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

    full page →fda device 510k ↗
    ›Apr 2, 2025device 510k496d agoDeka Research & Development Corp. — twiist system (510k cleared)

    Product code: QFG. Advisory committee: Clinical Chemistry. Type: Special

    full page →fda device 510k ↗
    ›Apr 2, 2025device 510k496d agoSmith & Nephew, Inc. — LEGION Total Knee System (510k cleared)SMITH & NEPHEW PLC

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

    full page →fda device 510k ↗
    ›Apr 2, 2025device 510k496d agoOsteoremedies, LLC — SPECTRUM GV Bone Cement (510k cleared)

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

    full page →fda device 510k ↗
    ›Apr 2, 2025device 510k496d agoIcu Medical, Inc. — Plum Solo™ Precision IV Pump (510k cleared)ICU MEDICAL INC/DE

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

    full page →fda device 510k ↗
    ›Apr 2, 2025device 510k496d agoProsum Medical Limited — Small Volume 0.2mL Syringe (510k cleared)

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

    full page →fda device 510k ↗
    ›Apr 2, 2025device 510k496d agoStepone Fertility Ltd (T/A Béa Fertility) — Béa Applicator (BAP-GB-01) (510k cleared)

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

    full page →fda device 510k ↗
    ›Apr 2, 2025device 510k496d agoHi-D Imaging AG — Hi-D Imaging 4TAVR (510k cleared)

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

    full page →fda device 510k ↗
    ›Apr 2, 2025device 510k496d agoSeaSpine Orthopedics Corporation — FLASH™ Facet Fusion Instruments, IsoTis® Facet Fusion Instruments (510k cleared)

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

    full page →fda device 510k ↗
    ›Apr 2, 2025device 510k496d agoProgenix, LLC — Progenix Select Stim (510k cleared)

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

    full page →fda device 510k ↗
    ›Apr 2, 2025device 510k496d agoOlympus Corporations of the Americas — VISERA ELITE III VIDEO SYSTEM CENTER OLYMPUS OTV-S700; VISERA ELITE III LED LIGHT SOURCE OLYMPUS CLL-S700; 4K CAMERA HEAD OLYMPUS CH-S700-XZ-EA (510k cleared)

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

    full page →fda device 510k ↗
    ›Apr 2, 2025device 510k496d agoBiocircuit Technologies, Inc. — Nerve Wrap (07-DW-001-TAB) (510k cleared)BWX Technologies, Inc.

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

    full page →fda device 510k ↗
    ›Apr 2, 2025device 510k496d agoGynesonics, Inc. — Sonata Transcervical Fibroid Ablation System 2.2 (510k cleared)

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

    full page →fda device 510k ↗
    ›Apr 2, 2025device 510k496d agoIcu Medical, Inc. — LifeShield Infusion Safety Software Suite (510k cleared)ICU MEDICAL INC/DE

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

    full page →fda device 510k ↗
    ›Apr 2, 2025device 510k496d agoNvision Biomedical Technologies, Inc. — SnapHammer Hammertoe Correction System (510k cleared)

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

    full page →fda device 510k ↗
    ›Apr 2, 2025device 510k496d agoAsahi Intecc Co., Ltd. — SION blue PLUS (510k cleared)

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

    full page →fda device 510k ↗
    ›Apr 2, 2025device 510k496d agoShenzhen TPH Technology Co., Ltd. — eufy Wearable Breast Pump S1 (T8D02) Model T8D02; eufy Wearable Breast Pump E10 (T8D03) Model T8D03; eufy Wearable Breast Pump S1 Pro (T8D04) Model T8D04; eufy Wearable Breast Pump E20 (T6060) Model T6060; (510k cleared)Fortior Technology (Shenzhen) Co., Ltd./ADR

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

    full page →fda device 510k ↗
    ›Apr 3, 2025device 510k495d agoSiemens Healthcare GmbH — syngo Dynamics (Version VA41D) (510k cleared)

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

    full page →fda device 510k ↗
    ›Apr 3, 2025device 510k495d agoFresenius Medical Care Renal Therapies Group, LLC — stay•safe® catheter extension set with Safe- Lock, 12 inch; stay•safe® catheter extension set with Luer-Lock, 6 inch; stay•safe® catheter extension set with Luer-Lock, 12 inch; stay•safe® catheter extension set with Luer-Lock, 18 inch; stay•safe® to Luer-Lock Adapter, 4 inch (510k cleared)Fresenius Medical Care AG

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

    full page →fda device 510k ↗
    ›Apr 3, 2025device 510k495d agoCarbon (Shenzhen) Medical Device Co., Ltd. — Venus Ultimate-Dual, Venus Ultimate-Hepa, Venus Ultimate-Uro Diagnostic Ultrasound System (510k cleared)

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

    full page →fda device 510k ↗
    ›Apr 3, 2025device 510k495d agoShina Med Corporation — SureFine Pen Needle (510k cleared)

    Product code: FMI. Advisory committee: General Hospital. Type: Special

    full page →fda device 510k ↗
    ›Apr 3, 2025device 510k495d agoBeaver-Visitec International, Inc. — Leos Laser and Endoscopy System (510k cleared)

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

    full page →fda device 510k ↗
    ›Apr 3, 2025device 510k495d agoOSSIO , Ltd. — OSSIOfiber® Suture Anchor 2.5-3.5 mm (510k cleared)

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

    full page →fda device 510k ↗
    ›Apr 3, 2025device 510k495d agoXsto Co., Ltd. — Powered wheelchair (mobility robot) (M4, M4U) (510k cleared)

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

    full page →fda device 510k ↗
    ›Apr 3, 2025device 510k495d agoStaclear, Inc. — StaClear Syringe (SC250AN); StaClear Syringe (SC250LS); StaClear Syringe (SC250LL) (510k cleared)

    Product code: QLY. Advisory committee: General Hospital. Type: Special

    full page →fda device 510k ↗
    ›Apr 3, 2025device 510k495d agoSpine Wave, Inc. — Salvo® Robotic Navigation Instruments (510k cleared)

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

    full page →fda device 510k ↗
    ›Apr 3, 2025device 510k495d agoMasimo Corporation — Masimo W1 (510k cleared)MASIMO CORP

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

    full page →fda device 510k ↗
    ›Apr 4, 2025device 510k494d agoBiotronik, Inc. — Passeo-35 Xeo Peripheral Dilatation Catheter; Passeo-18 Peripheral Dilatation Catheters; Passeo-14 Peripheral Dilatation Catheter; Oscar Peripheral Multifunctional Catheter System; Pantera Pro Percutaneous Transluminal Coronary Angioplasty Catheter; Pantera LEO Percutaneous Transluminal Coronary Angioplasty (PTCA) Catheter (510k cleared)

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

    full page →fda device 510k ↗
    ›Apr 4, 2025device 510k494d agoNingbo Dechang Electrical Machinery Made Co.,Ltd — LED Light Therapy Mask (RT01) (510k cleared)

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

    full page →fda device 510k ↗
    ›Apr 4, 2025device 510k494d agoPhilips Medical Systems Nederland B.V. — Philips VSC-MEDlib (510k cleared)

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

    full page →fda device 510k ↗
    ›Apr 4, 2025device 510k494d agoABBOTT MEDICAL — JETi Hydrodynamic Thrombectomy System (510k cleared)

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

    full page →fda device 510k ↗
    ›Apr 4, 2025device 510k494d agoDeski — HeartFocus (V.1.1.1) (510k cleared)

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

    full page →fda device 510k ↗
    ›Apr 4, 2025device 510k494d agoTerumo Europe N.V. — K-Pack Enhance Needle (KH-2713RBBTC and KH-2913RBBTC) (510k cleared)

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

    full page →fda device 510k ↗
    ›Apr 4, 2025device 510k494d agoHighridge Medical, LLC — Virage® OCT Spinal Fixation System (510k cleared)

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

    full page →fda device 510k ↗
    ›Apr 4, 2025device 510k494d agoWuhan Pioon Technology Co., Ltd. — Medical Diode Laser (Models: MZ-GK, MZ-K20, MZ-N75) (510k cleared)

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

    full page →fda device 510k ↗
    ›Apr 4, 2025device 510k494d agoTurbett Surgical — Turbett Surgical Instrument Pod (TS1500); Turbett Surgical Instrument Pod (TS1200); Turbett Surgical Instrument Pod (TS1000) (510k cleared)

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

    full page →fda device 510k ↗
    ›Apr 4, 2025device 510k494d agoHangzhou AllTest Biotech Co., Ltd. — AllTest Viral Transport Medium (510k cleared)Hangzhou DAC Biotech Co Ltd

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

    full page →fda device 510k ↗
    ›Apr 4, 2025device 510k494d agoPrapela, Inc. — Prapela SVS hospital bassinet pad (model P01) (510k cleared)

    Product code: QVY. Advisory committee: General Hospital. Type: Direct

    full page →fda device 510k ↗
    ›Apr 4, 2025device 510k494d agoApex BioTechnology Corp. — UASure II Blood Uric Acid Monitoring System (510k cleared)PDS Biotechnology Corp

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

    full page →fda device 510k ↗
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    $BWXT
    $ICUI182.42-1.16%
    $FRTRY
    $KIDS
    $ISRG393.38+3.85%
    $ICUI182.42-1.16%
    $HCA414.03+0.16%
    $FMS24.35+0.33%
    $ICUI182.42-1.16%
    $SNN30.08-0.10%
    $MASI
    $PDSB0.7311-5.16%