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5,000 catalysts · 18,987 approval · 5,000 device 510k · 4,876 phase readout · 4,728 grant · 2,429 8k filing · 2,000 device pma

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2026-07-27: 16 catalysts2026-07-28: 4 catalysts2026-07-29: 12 catalysts2026-07-30: 12 catalysts2026-07-31: 3 catalysts2026-08-01: 0 catalysts2026-08-02: 0 catalysts2026-08-03: 4 catalysts2026-08-04: 12 catalysts2026-08-05: 14 catalysts2026-08-06: 10 catalysts2026-08-07: 1 catalyst2026-08-08: 0 catalysts2026-08-09: 0 catalysts2026-08-10: 1 catalyst2026-08-11: 1 catalyst2026-08-12: 1 catalyst2026-08-13: 0 catalysts2026-08-14: 0 catalysts2026-08-15: 0 catalysts2026-08-16: 0 catalysts2026-08-17: 0 catalysts2026-08-18: 1 catalyst2026-08-19: 0 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: 0 catalysts2026-08-27: 0 catalysts2026-08-28: 0 catalysts2026-08-29: 0 catalysts2026-08-30: 0 catalysts2026-08-31: 0 catalysts2026-09-01: 1 catalyst2026-09-02: 0 catalysts2026-09-03: 0 catalysts2026-09-04: 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: 0 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: 0 catalysts2026-10-09: 0 catalysts2026-10-10: 0 catalysts2026-10-11: 0 catalysts2026-10-12: 0 catalysts2026-10-13: 0 catalysts2026-10-14: 0 catalysts2026-10-15: 0 catalysts2026-10-16: 0 catalysts2026-10-17: 0 catalysts2026-10-18: 0 catalysts2026-10-19: 0 catalysts2026-10-20: 1 catalyst2026-10-21: 0 catalysts2026-10-22: 1 catalyst2026-10-23: 0 catalysts2026-10-24: 0 catalysts2026-10-25: 0 catalysts
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type: device 510k×clear all
type
  • approval18,987
  • device 510k5,000
  • phase readout4,876
  • grant4,728
  • 8k filing2,429
  • device pma2,000
  • device recall2,000
  • recall1,126
  • device adverse event1,000
  • earnings295
  • therapy area

    no tagged catalysts yet

    Week of Mar 3, 2025

    25
    ›Mar 6, 2025device 510k509d agoDermaroller GmbH — XCELLARISPRO TWIST microneedling device (510k cleared)

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

    full page →fda device 510k ↗
    ›Mar 6, 2025device 510k509d agoLaboratorios Biogalenic S.A. DE C.V. — Sterile Water USP and Sterile 0.9% Normal Saline USP (510k cleared)Revalesio Corp

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

    full page →fda device 510k ↗
    ›Mar 6, 2025device 510k509d agoCenterline Biomedical, Inc. — Intra-Operative Positioning System (IOPS®) (510k cleared)

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

    full page →fda device 510k ↗
    ›Mar 6, 2025device 510k509d agoXtreem Pulse, LLC — PureLift GLOW (510k cleared)

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

    full page →fda device 510k ↗
    ›Mar 6, 2025device 510k509d agoZimmer, Inc. — Persona® Revision Knee System (Persona Revision SoluTion™ Femoral Components) (510k cleared)

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

    full page →fda device 510k ↗
    ›Mar 6, 2025device 510k509d agoMedacta International S.A. — Versacem Acetabular Shell and Double Mobility HC Liners (510k cleared)Stemedica International S.A.

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

    full page →fda device 510k ↗
    ›Mar 6, 2025device 510k509d agoBecton, Dickinson and Company — BD Phoenix™ Automated Microbiology System (510k cleared)BECTON DICKINSON & CO

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

    full page →fda device 510k ↗
    ›Mar 6, 2025device 510k509d agoMiach Orthopaedics, Inc. — BEAR® (Bridge-Enhanced ACL Restoration) Implant (510k cleared)

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

    full page →fda device 510k ↗
    ›Mar 6, 2025device 510k509d agoPhilips Medical Systems Nederland B.V. — Philips IntelliSite Pathology Solution 5.1 (510k cleared)

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

    full page →fda device 510k ↗
    ›Mar 7, 2025device 510k508d agoEpiwatch, Inc. — EpiWatch Monitoring System (510k cleared)

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

    full page →fda device 510k ↗
    ›Mar 7, 2025device 510k508d agoBatec Mobility, S.L. — Handbike Batec Electric (510k cleared)

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

    full page →fda device 510k ↗
    ›Mar 7, 2025device 510k508d agoFort Defiance Industries, LLC — FRONT-LINE Field Sterilizer (FL135) (510k cleared)

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

    full page →fda device 510k ↗
    ›Mar 7, 2025device 510k508d agoShenzhen Rogin Medical Co., Ltd. — Apex Locator (510k cleared)

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

    full page →fda device 510k ↗
    ›Mar 7, 2025device 510k508d agoIntradin (Shanghai) Machinery Co., Ltd. — Portable Wheelchair (510k cleared)

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

    full page →fda device 510k ↗
    ›Mar 7, 2025device 510k508d agoShanghai Longmann Tech Co., Ltd. — CuffTrek (510k cleared)

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

    full page →fda device 510k ↗
    ›Mar 7, 2025device 510k508d agoGeistlich Pharma AG — Geistlich Bio-Flow® (510k cleared)

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

    full page →fda device 510k ↗
    ›Mar 7, 2025device 510k508d agoDaeju Meditech Engineering Co., Ltd. — NOABLE LASER (510k cleared)

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

    full page →fda device 510k ↗
    ›Mar 7, 2025device 510k508d agoAtmos Medizintechnik GmbH & Co. KG — ATMOS C 051 Thorax (317.0200.0); Secretion canister 800ml (317.1300.0); Hose system (312.1177.0); Hose system with connector small (312.1206.0); Hose system with connector medium (312.1207.0); Hose system with connector large (312.1208.0); Hose system with Y-connector medium (312.1209.0); Hose system with Y-connector large (312.1210.0); Universal bracket for ATMOS C 051 Thorax (316.0200.0); Bracket for ATMOS C 051 Thorax - Standard rail (317.1160.0); Charger Storage for bracket ATMOS C (510k cleared)

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

    full page →fda device 510k ↗
    ›Mar 7, 2025device 510k508d agoCleerly, Inc. — Cleerly LABS (v2.0) (510k cleared)

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

    full page →fda device 510k ↗
    ›Mar 7, 2025device 510k508d agoSpineart SA — SPINEART Navigation Instrument System (510k cleared)

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

    full page →fda device 510k ↗
    ›Mar 7, 2025device 510k508d agoEcential Robotics — Op.n(TM) Navigation (510k cleared)

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

    full page →fda device 510k ↗
    ›Mar 7, 2025device 510k508d agoLelo, Inc. — Lelo Hex Lubricated Natural Rubber Latex Condom (510k cleared)

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

    full page →fda device 510k ↗
    ›Mar 7, 2025device 510k508d agoMedartis AG — APTUS Hand System; APTUS Elbow Dorsal Olecranon (510k cleared)

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

    full page →fda device 510k ↗
    ›Mar 7, 2025device 510k508d agoShanghai SeeGen Photoelectric Technology Co., Ltd. — Flexible Video-Choledochoscope (CHV-110J-U); Flexible Video-Choledochoscope (CHV-US120J-U) (510k cleared)

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

    full page →fda device 510k ↗
    ›Mar 7, 2025device 510k508d agoOrthoPediatrics Corp. — Orthex External Fixation System (510k cleared)ORTHOPEDIATRICS CORP

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

    full page →fda device 510k ↗

    Week of Mar 10, 2025

    25
    ›Mar 10, 2025device 510k505d agoImplantcast GmbH — AGILON® XO Shoulder Replacement System (510k cleared)

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

    full page →fda device 510k ↗
    ›Mar 10, 2025device 510k
    ← prev
    page 29 of 100
    next →
    505d ago
    Intuitive Surgical, Inc. — da Vinci SP SureForm 45 Staplers and Reloads (SP1098) (510k cleared)INTUITIVE SURGICAL INC

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

    full page →fda device 510k ↗
    ›Mar 10, 2025device 510k505d agoMedtronic Neurosurgery — Duet External Drainage and Monitoring System (EDMS) (510k cleared)

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

    full page →fda device 510k ↗
    ›Mar 10, 2025device 510k505d agoSurgical Instrument Service and Savings, Inc. — Medline ReNewal Reprocessed Siemens ACUSON AcuNav 10F Ultrasound Catheter (for Siemens Systems) (08255790 ); Medline ReNewal Reprocessed Siemens ACUSON AcuNav 10F Ultrasound Catheter (for GE Systems) (10043342) (510k cleared)

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

    full page →fda device 510k ↗
    ›Mar 10, 2025device 510k505d agoExactech, Inc. — Alteon® HA Femoral Stems (510k cleared)

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

    full page →fda device 510k ↗
    ›Mar 10, 2025device 510k505d agoVaporox, Inc. — Wound Treatment System (VHT-200) (510k cleared)

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

    full page →fda device 510k ↗
    ›Mar 11, 2025device 510k504d agoIconocare Health — 8mm Monopolar Curved Scissors (470179) (510k cleared)

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

    full page →fda device 510k ↗
    ›Mar 11, 2025device 510k504d agoStryker Instruments — iBur 3.0mm Diamond Match Head, Distal Bend (8431-107-030D); iBur 3.0mm Precision Round, Distal Bend (8431-009-030); iBur 4.0mm Precision Round, Distal Bend (8431-009-040); iBur 2.0mm Diamond Round, Distal Bend (8431-012-020D); iBur 3.0mm Diamond Round, Distal Bend (8431-012-030D); iBur 4.0mm Diamond Round, Distal Bend (8431-012-040D); iBur 3.0mm Coarse Diamond Round, Distal Bend (8431-013-030DC); iBur 4.0mm Coarse Diamond Round, Distal Bend (8431-013-040DC); iBur 5.0mm Coarse Diamond R (510k cleared)

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

    full page →fda device 510k ↗
    ›Mar 11, 2025device 510k504d agoDeka Research & Development Corp. — RemunityPRO™ Pump for Remodulin® (treprostinil) Injection (510k cleared)UNITED THERAPEUTICS Corp

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

    full page →fda device 510k ↗
    ›Mar 11, 2025device 510k504d agoArthrex, Inc. — Arthrex TightRope Soft Button, RT (510k cleared)

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

    full page →fda device 510k ↗
    ›Mar 11, 2025device 510k504d agoDisa Medinotec — OutFlo Aortic Valve Dilatation Balloon Catheter (510k cleared)

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

    full page →fda device 510k ↗
    ›Mar 11, 2025device 510k504d agoBetter Diagnostics AI Corp. — Better Diagnostics Caries Assist (BDCA) Version 1.0 (510k cleared)CS DIAGNOSTICS CORP.

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

    full page →fda device 510k ↗
    ›Mar 11, 2025device 510k504d agoSignature Orthopaedics Pty, Ltd. — Origin™ TT Stem (510k cleared)

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

    full page →fda device 510k ↗
    ›Mar 12, 2025device 510k503d agoRewalk Robotics Ltd. Dba Lifeward — ReWalk® 7 Personal Exoskeleton (50-20-0005) (510k cleared)

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

    full page →fda device 510k ↗
    ›Mar 12, 2025device 510k503d agoCutting Edge Spine, LLC — EVOL® ha – Hyper C Cervical Interbody Fusion System (510k cleared)

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

    full page →fda device 510k ↗
    ›Mar 12, 2025device 510k503d agoShenzhen Zuowei Technology Co., Ltd. — Walking rehabilitation training electric wheelchair (ZW518) (510k cleared)Fortior Technology (Shenzhen) Co., Ltd./ADR

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

    full page →fda device 510k ↗
    ›Mar 12, 2025device 510k503d agoQuantalx Neroscience — Delphi Amplifier (510k cleared)

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

    full page →fda device 510k ↗
    ›Mar 12, 2025device 510k503d agoChangsha Anxiang Medical Technology Co., Ltd. — Wireless TENS & EMS Unit (510k cleared)

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

    full page →fda device 510k ↗
    ›Mar 12, 2025device 510k503d agoRay Co., Ltd. — RCT600 (510k cleared)Ray Therapeutics Inc

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

    full page →fda device 510k ↗
    ›Mar 12, 2025device 510k503d agoRayence Co., Ltd. — 2430TCA with Xmaru W (510k cleared)

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

    full page →fda device 510k ↗
    ›Mar 12, 2025device 510k503d agoWontech Co., Ltd. — PICOALEX (510k cleared)

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

    full page →fda device 510k ↗
    ›Mar 12, 2025device 510k503d agoDannik, LLC — DANNIK® Laparoscopic Single-Use Poly Specimen Retrieval System (510k cleared)

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

    full page →fda device 510k ↗
    ›Mar 12, 2025device 510k503d agoBiofire Defense, LLC — BioFire Warrior Panel; BioFire Warrior Panel Control Kit (510k cleared)Dawn Sea Therapeutics

    Product code: PRD. Advisory committee: Immunology. Type: Traditional

    full page →fda device 510k ↗
    ›Mar 13, 2025device 510k502d agoBioserenity Medical Devices Group — IceCap product line (510k cleared)

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

    full page →fda device 510k ↗
    ›Mar 13, 2025device 510k502d agoBoston Aesthetics, Inc. — 308nm UV Phototherapy System (UV-K); 308nm UV Phototherapy System (UV-X); 308nm UV Phototherapy System (UV-Y); 308nm UV Phototherapy System (UV-Z) (510k cleared)

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

    full page →fda device 510k ↗
    $BDX156.36+2.22%
    $KIDS
    $UTHR528.47-0.20%
    $ISRG337.50+1.65%
    $FRTRY
    $CSDX0.0634-32.91%