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3,380 catalysts · 4,728 grant · 3,603 8k filing · 3,380 device 510k · 2,862 approval · 2,000 device pma · 2,000 device recall

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type: device 510k×from 2025-03-31×clear all
type
  • grant4,728
  • 8k filing3,603
  • device 510k3,380
  • approval2,862
  • device pma2,000
  • device recall2,000
device adverse event
1,000
  • recall848
  • earnings585
  • phase 2 completion172
  • therapy area

    no tagged catalysts yet

    Week of Mar 31, 2025

    50
    ›Mar 31, 2025device 510k518d agoTribusmed Beheer BV — TribusConnect (510k cleared)

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

    full page →fda device 510k ↗
    ›Mar 31, 2025device 510k518d agoShantou Institute of Ultrasonic Instruments Co., Ltd. — Digital Color Doppler Ultrasound Imaging System (Apogee C1); Digital Color Doppler Ultrasound Imaging System (Apogee C2); Digital Color Doppler Ultrasound Imaging System (Apogee C3); Digital Color Doppler Ultrasound Imaging System (Apogee C5); Digital Color Doppler Ultrasound Imaging System (Apogee K1); Digital Color Doppler Ultrasound Imaging System (Apogee K2); Digital Color Doppler Ultrasound Imaging System (Apogee K3); Digital Color Doppler Ultrasound Imaging System (Apogee K5); Di (510k cleared)

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

    full page →fda device 510k ↗
    ›Mar 31, 2025device 510k518d agoTaewoong Medical Co., Ltd. — Niti-S Duodenal Comfort Stent, Niti-S Colonic Comfort Stent (510k cleared)

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

    full page →fda device 510k ↗
    ›Mar 31, 2025device 510k518d agoHangzhou SHINING3D Dental Technology Co., Ltd. — Denture Base Resin DT20 (510k cleared)

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

    full page →fda device 510k ↗
    ›Mar 31, 2025device 510k518d agoOlympus Medical Systems Corp. — Disposable Grasping Forceps FG-52D/FG-54D (510k cleared)

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

    full page →fda device 510k ↗
    ›Mar 31, 2025device 510k518d agoBridge TO Life — Belzer UW® Cold Storage Solution (BTLBUW-001) (510k cleared)

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

    full page →fda device 510k ↗
    ›Apr 1, 2025device 510k517d agoAdvalight Aps — AdvaTx (510k cleared)

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

    full page →fda device 510k ↗
    ›Apr 1, 2025device 510k517d 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 510k517d 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 510k517d 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 510k517d 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 510k517d 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 510k517d 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 510k517d 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 510k517d 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 510k517d agoEMA Aesthetics , Ltd. — Préime DermaFacial (MicroT) (510k cleared)

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

    full page →fda device 510k ↗
    ›Apr 2, 2025device 510k516d 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 510k516d 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 510k516d 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 510k516d 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 510k516d agoOsteoremedies, LLC — SPECTRUM GV Bone Cement (510k cleared)

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

    full page →fda device 510k ↗
    ›Apr 2, 2025device 510k516d 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 510k516d 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 510k516d 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 510k516d 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 510k516d 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 510k516d agoProgenix, LLC — Progenix Select Stim (510k cleared)

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

    full page →fda device 510k ↗
    ›Apr 2, 2025device 510k516d 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 510k516d 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 510k516d 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 510k516d 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 510k516d 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 510k516d 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 510k516d 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 510k515d 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 510k515d 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 510k515d 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 510k515d 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 510k515d 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 510k515d 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 510k515d 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 510k515d 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 510k515d 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 510k515d agoMasimo Corporation — Masimo W1 (510k cleared)MASIMO CORP

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

    full page →fda device 510k ↗
    ›Apr 4, 2025device 510k514d 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 510k514d 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 510k514d 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 510k514d agoABBOTT MEDICAL — JETi Hydrodynamic Thrombectomy System (510k cleared)

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

    full page →fda device 510k ↗
    ›Apr 4, 2025device 510k514d agoDeski — HeartFocus (V.1.1.1) (510k cleared)

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

    full page →fda device 510k ↗
    ›Apr 4, 2025device 510k514d 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 ↗
    ← prev
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    $FRTRY
    $SNN28.97-0.55%
    $BWXT
    $ICUI175.100.00%
    $ICUI175.100.00%
    $HCA417.82-0.36%
    $KIDS
    $ICUI175.100.00%
    $ISRG372.60+1.51%
    $FMS23.10-0.73%
    $MASI