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5,000 catalysts · 18,987 approval · 5,000 device 510k · 4,970 phase readout · 4,728 grant · 2,429 8k filing · 2,000 device pma

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type: device 510k×clear all
type
  • approval18,987
  • device 510k5,000
  • phase readout4,970
  • grant4,728
  • 8k filing2,429
  • device pma2,000
  • device recall2,000
  • recall1,126
  • device adverse event1,000
  • earnings296
  • therapy area

    no tagged catalysts yet

    Week of Mar 10, 2025

    34
    ›Mar 13, 2025device 510k502d agoMedcad — MedCAD® AccuStride™ System (510k cleared)

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

    full page →fda device 510k ↗
    ›Mar 13, 2025device 510k502d agoMY01, Inc. — MY01 Continuous Compartmental Pressure Monitor (510k cleared)

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

    full page →fda device 510k ↗
    ›Mar 13, 2025device 510k502d agoZiehm Imaging GmbH — Ziehm Vision FD (510k cleared)

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

    full page →fda device 510k ↗
    ›Mar 13, 2025device 510k502d agoSioxmed, LLC — SiOxC Cream (510k cleared)

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

    full page →fda device 510k ↗
    ›Mar 13, 2025device 510k502d agoCryosurgery, Inc. — CryoFreeze Wart and Skin Tag Remover (510k cleared)

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

    full page →fda device 510k ↗
    ›Mar 13, 2025device 510k502d agoXemis Medical Technology (Shenzhen) Co., Ltd. — Photon Therapy Apparatus (BL-10) (510k cleared)NewBay Medical Technology Co Ltd

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

    full page →fda device 510k ↗
    ›Mar 13, 2025device 510k502d agoMaxx Orthopedics, Inc. — Freedom Total Knee System (All-poly Tibial Plate) (510k cleared)

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

    full page →fda device 510k ↗
    ›Mar 13, 2025device 510k502d agoInari Medical, Inc. — FlowTriever2 Catheter (510k cleared)Mobia Medical, Inc.

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

    full page →fda device 510k ↗
    ›Mar 13, 2025device 510k502d agoAugmedics, Ltd. — xvision Spine system (510k cleared)

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

    full page →fda device 510k ↗
    ›Mar 13, 2025device 510k502d agoSurgify Medical OY — Surgify Halo (54.085.SHD.H1); Surgify Halo (54.140.SHD.H1); Surgify Halo (54.070.NVG.H1); Surgify Halo (54.125.NVG.H1); Surgify Halo (54.000.SEE.H1) (510k cleared)

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

    full page →fda device 510k ↗
    ›Mar 13, 2025device 510k502d agoG.N.S Neolaser , Ltd. — neoLaser Laser Surgery Fibers (510k cleared)

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

    full page →fda device 510k ↗
    ›Mar 13, 2025device 510k502d agoSpectranetics — Turbo-Elite Laser Atherectomy Catheter (510k cleared)

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

    full page →fda device 510k ↗
    ›Mar 14, 2025device 510k501d agoOrthoPediatrics Corp. — VerteGlide Spinal Growth Guidance System (510k cleared)ORTHOPEDIATRICS CORP

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

    full page →fda device 510k ↗
    ›Mar 14, 2025device 510k501d agoAion Biosystems, Inc. — AION TempShield™ (510k cleared)NED Biosystems Inc

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

    full page →fda device 510k ↗
    ›Mar 14, 2025device 510k501d agoShenzhen Sanping Image Technology Co., Ltd. — Bronchoscope System, The Single-use Bronchoscope (Single-use Bronchoscope: SP-Y-ZQGJ2.8, SP-Y-ZQGJ3.8, SP-Y-ZQGJ4.2, SP-Y-ZQGJ4.8, SP-Y-ZQGJ5.2, SP-Y-ZQGJ5.8; Electronic Endoscope Imaging Processor: SP-TXCLQ12.1) (510k cleared)

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

    full page →fda device 510k ↗
    ›Mar 14, 2025device 510k501d agoDosisoft SA — PLANET Onco Dose (3.2) (510k cleared)

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

    full page →fda device 510k ↗
    ›Mar 14, 2025device 510k501d agoCenters for Disease Control and Prevention — CDC Human Influenza Virus Real-time RT-PCR Diagnostic Panel: Influenza A/B Typing Kit (VER 2); Influenza A Subtyping Kit (VER 4); Influenza B Lineage Genotyping Kit (VER 1.1 and 2); and Influenza A/H5 Subtyping Kit (VER 4) (510k cleared)Hubei Provincial Center for Disease Control and Prevention

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

    full page →fda device 510k ↗
    ›Mar 14, 2025device 510k501d agoNexxt Spine — NEXXT MATRIXX® SI System (510k cleared)

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

    full page →fda device 510k ↗
    ›Mar 14, 2025device 510k501d agoArrow International, LLC (A subsidiary of Teleflex, Inc.) — Arrow™ Endurance™ Extended Dwell Peripheral Catheter System (EDC-00818) (510k cleared)Arrow International LLC

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

    full page →fda device 510k ↗
    ›Mar 14, 2025device 510k501d agoAidite (Qinhuangdao) Technology Co., Ltd. — Porcelain Powder (Enamel/ Modifier,Stain/Glaze,Stain/Glaze-A,Modeling Fluid ) (510k cleared)

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

    full page →fda device 510k ↗
    ›Mar 14, 2025device 510k501d agoKettenbach GmbH & Co. KG — Visalys® Bulk Fill 1 x 4 g Syringe (15060); Visalys® Bulk Fill 15 x 0.25 g Caps (15062); Visalys® Bulk Flow 1 x 2 g Syringe (15064); Visalys® Bulk Flow 15 x 0.25 g Caps (15066); Visalys® Bulk Flow Intro pack (15067); Visalys® Bulk Intro pack (15068) (510k cleared)

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

    full page →fda device 510k ↗
    ›Mar 14, 2025device 510k501d agoKorot Co., Ltd. — KOROT Blood Pressure Monitor (KOROT P3 Accurate) (510k cleared)Kowa Co Ltd

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

    full page →fda device 510k ↗
    ›Mar 14, 2025device 510k501d agoLumea, Inc. — Viewer+ (510k cleared)

    Product code: QKQ. Advisory committee: Pathology. Type: Traditional

    full page →fda device 510k ↗
    ›Mar 14, 2025device 510k501d agoBaxter Healthcare Corporation — Solution Administration Sets (510k cleared)Baxter Healthcare Corp

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

    full page →fda device 510k ↗
    ›Mar 14, 2025device 510k501d agoArthrex, Inc. — Arthrex 4.75 mm Double Loaded Knotless Corkscrew Suture Anchor (510k cleared)

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

    full page →fda device 510k ↗
    ›Mar 14, 2025device 510k501d agoNeurologica Corporation, A Subsidiary of Samsung — BodyTom 64 (510k cleared)

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

    full page →fda device 510k ↗
    ›Mar 14, 2025device 510k501d agoMediclus Co., Ltd. — One-Fil Putty (510k cleared)

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

    full page →fda device 510k ↗
    ›Mar 14, 2025device 510k501d agoNox Medical Ehf — DeepRESP (510k cleared)

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

    full page →fda device 510k ↗
    ›Mar 14, 2025device 510k501d agoPromisemed Hangzhou Meditech Co., Ltd. — Promisemed Safety Huber Needles (510k cleared)

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

    full page →fda device 510k ↗
    ›Mar 14, 2025device 510k501d agobioMerieux, Inc. — VITEK COMPACT PRO (510k cleared)BIOMERICA INC

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

    full page →fda device 510k ↗
    ›Mar 14, 2025device 510k501d agoMonogram Orthopaedics, Inc. — mBôs (Monogram mBôs TKA System) (510k cleared)

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

    full page →fda device 510k ↗
    ›Mar 14, 2025device 510k501d agoMoon Surgical — Maestro System (REF100) (510k cleared)

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

    full page →fda device 510k ↗
    ›Mar 14, 2025device 510k501d agoPenumbra, Inc. — Ruby XL System (510k cleared)Penumbra Inc

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

    full page →fda device 510k ↗
    ›Mar 16, 2025device 510k499d agoContract Medical International, GmbH — Catapult Guide Sheath; 4F; 15cm (US-34015-F-ST-H); Catapult Guide Sheath; 4F; 45cm (US-34045-F-ST-H); Catapult Guide Sheath; 4F; 60cm (US-34060-F-ST-H); Catapult Guide Sheath; 4F; 90cm (US-34090-F-ST-H); Catapult Guide Sheath; 4F; 130cm (US-34130-F-ST-H); Catapult Guide Sheath; 5F; 15cm (US-35015-F-ST-H); Catapult Guide Sheath; 5F; 45cm (US-35045-F-ST-H); Catapult Guide Sheath; 5F; 45cm; Hockey Stick (US-35045-F-HS-H); Catapult Guide Sheath; 5F; 45cm; Multipurpose (US-35045-F-MP-H); Ca (510k cleared)

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

    full page →fda device 510k ↗

    Week of Mar 17, 2025

    16
    ›Mar 17, 2025device 510k498d agoCarlsmed, Inc. — aprevo® anterior and lateral lumbar interbody fusion device, aprevo® anterior lumbar interbody fusion device with interfixation (510k cleared)CARLSMED, INC.

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

    full page →fda device 510k ↗
    ›Mar 17, 2025device 510k
    ← prev
    page 30 of 100
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    498d ago
    Cranial Technologies, Inc. — DOC Band 3D (510k cleared)Q/C TECHNOLOGIES, INC.

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

    full page →fda device 510k ↗
    ›Mar 17, 2025device 510k498d agoLagis Enterprise Co., Ltd. — LAGIS Suction Irrigation System (510k cleared)Cre8 Enterprise Ltd

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

    full page →fda device 510k ↗
    ›Mar 17, 2025device 510k498d agoServ Medical Pte., Ltd. — SERV MEDICAL CDSS (510k cleared)

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

    full page →fda device 510k ↗
    ›Mar 17, 2025device 510k498d agoDia Imaging Analysis, Ltd. — LVivo Software Application (510k cleared)

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

    full page →fda device 510k ↗
    ›Mar 17, 2025device 510k498d agoJiale Health Technology Shenzhen Co., Ltd. — Air Compression Leg Massager (K-705) (510k cleared)Aimei Health Technology Co., Ltd.

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

    full page →fda device 510k ↗
    ›Mar 17, 2025device 510k498d agoThe Magstim Company Limited — Horizon® 3.0 TMS Therapy System (Horizon 3.0 Inspire); Horizon® 3.0 TMS Therapy System (Horizon 3.0 with StimGuide Pro); Horizon® 3.0 TMS Therapy System (Horizon 3.0) (510k cleared)

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

    full page →fda device 510k ↗
    ›Mar 17, 2025device 510k498d agoOrthonovis, Inc. — BPS Wrist Fracture System (510k cleared)

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

    full page →fda device 510k ↗
    ›Mar 17, 2025device 510k498d agoGe Medical Systems, LLC — SIGNA Prime Elite (510k cleared)

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

    full page →fda device 510k ↗
    ›Mar 17, 2025device 510k498d agoZiehm Imaging GmbH — Ziehm Solo FD (510k cleared)

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

    full page →fda device 510k ↗
    ›Mar 17, 2025device 510k498d agoSpecialty Water Technologies, Inc. — UPT Series Medical RO Water Treatment System (510k cleared)WATTS WATER TECHNOLOGIES INC

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

    full page →fda device 510k ↗
    ›Mar 17, 2025device 510k498d agoCentervue S.P.A. — MAIA (AHMACME001) (510k cleared)

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

    full page →fda device 510k ↗
    ›Mar 18, 2025device 510k497d agoKlarity Medical & Equipment (GZ) Co., Ltd. — Klarity SGRT System (ARSG-E1A, ARSG-E3A) (510k cleared)

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

    full page →fda device 510k ↗
    ›Mar 18, 2025device 510k497d agoWhip Mix Corporation — Hard Splint & Thermo-Adaptive Splint (510k cleared)

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

    full page →fda device 510k ↗
    ›Mar 18, 2025device 510k497d agoOsteoCentric Technologies — The OsteoCentric Bone Plate and Screw System (510k cleared)

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

    full page →fda device 510k ↗
    ›Mar 18, 2025device 510k497d agoIray Imaging Technology (Haining) Limited — Lux HD 35 Detector (Lux HD 35); Lux HD 43 Detector (Lux HD 43) (510k cleared)

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

    full page →fda device 510k ↗
    $KIDS
    $BMRA
    $MOBI
    $CARL
    $PEN324.29-0.11%
    $AFJKU
    $QCLS
    $CRE
    $WTS