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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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2026-07-27: 17 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 readout4,970
  • 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 17, 2025

    50
    ›Mar 18, 2025device 510k497d agoShenzhen Perfect Idea Technology Limited — Aglaia LED Beauty Device (BP-D2309) (510k cleared)

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

    full page →fda device 510k ↗
    ›Mar 18, 2025device 510k497d agoTeleflex Medical — QuikClot Control+ Hemostatic Device (510k cleared)

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

    full page →fda device 510k ↗
    ›Mar 18, 2025device 510k497d agoVy Spine, LLC — FortiVy™ OsteoVy™ Lumbar IBF (510k cleared)

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

    full page →fda device 510k ↗
    ›Mar 18, 2025device 510k497d agoBetter Care Plastic Technology Co., Ltd. — Powder Free Nitrile Patient Examination Gloves, Blue Colored, Non Sterile, Low Dermatitis Potential. Tested for Use with Chemotherapy Drugs and Fentanyl Citrate (510k cleared)Teva Pharmaceuticals USA Inc

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

    full page →fda device 510k ↗
    ›Mar 18, 2025device 510k497d agoGlobal Healthcare SG Sdn. Bhd — CarbonCool® System (510k cleared)

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

    full page →fda device 510k ↗
    ›Mar 18, 2025device 510k497d agoOlympus Medical Systems Corp. — Single Use Retrieval Basket V FG-V421PR/V422PR/V431P/V432P (510k cleared)

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

    full page →fda device 510k ↗
    ›Mar 18, 2025device 510k497d agoRadlink, Inc. — Radlink GPS Pro Imaging (510k cleared)

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

    full page →fda device 510k ↗
    ›Mar 18, 2025device 510k497d agoHangzhou Laihe Biotech Co., Ltd. — LYHER® Oral fluid Multi-Drug Test Kit (Cube) (510k cleared)Hangzhou DAC Biotech Co Ltd

    Product code: DJC. Advisory committee: Clinical Toxicology. Type: Traditional

    full page →fda device 510k ↗
    ›Mar 18, 2025device 510k497d agoQuibim S.L. — QP-Prostate® CAD (510k cleared)

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

    full page →fda device 510k ↗
    ›Mar 19, 2025device 510k496d agoNanosonics Limited — CORIS System (510k cleared)

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

    full page →fda device 510k ↗
    ›Mar 19, 2025device 510k496d agoGigaalaser Company , Ltd. — Medical Diode Laser Systems (GBOX-6H, GBOX-10D , GBOX-12D, GBOX-15D, VELAS Pro-30B15D, VELAS II-6H, VELAS II-15D) (510k cleared)

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

    full page →fda device 510k ↗
    ›Mar 19, 2025device 510k496d agoCoreline Soft Co., Ltd. — AVIEW (510k cleared)

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

    full page →fda device 510k ↗
    ›Mar 19, 2025device 510k496d agoCampomats S.R.L. — 1NEED Pro (510k cleared)

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

    full page →fda device 510k ↗
    ›Mar 19, 2025device 510k496d agoTyber Medical, LLC — Tyber Medical Anatomical Plating System (510k cleared)

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

    full page →fda device 510k ↗
    ›Mar 19, 2025device 510k496d agoShenzhen Yang WO Electronic Co., Ltd. — IPL Hair Removal Device (BE965A, BE965B, BE965C) (510k cleared)

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

    full page →fda device 510k ↗
    ›Mar 19, 2025device 510k496d agoPeek Health, S.A. — PeekMed web (510k cleared)

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

    full page →fda device 510k ↗
    ›Mar 19, 2025device 510k496d agoDRTECH Corporation — EXPD 4343N1; EXPD 4343N; EXPD 4343U1; EXPD 4343NU; EXPD 4343NP; EXPD 3643N1; EXPD 3643N; EXPD 3643U1; EXPD 3643NU; EXPD 3643NP (510k cleared)

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

    full page →fda device 510k ↗
    ›Mar 19, 2025device 510k496d agoMacromedics BV — DSPS-Prominent® baseplate, MR (113820); DSPS-Prominent® baseplate (113120); DSPS-Prominent® Cradle-I (113140); DSPS-Prominent® Cradle-II (113150); DSPS-Prominent® Cradle-III (113160); DSPS-Prominent® Cradle-IV (113170); DSPS-Prominent® Cradle-VI (113180); DSPS-Prominent® Cradle-VII (113260); Mask DSPS®-PROSCVRL set/5 (113760); Mask DSPS®-PROSC set/5 (113770); Mask DSPS®-PROSCVR set/5 (113780); Mask DSPS®-PROSCL set/5 (113790); Mask DSPS®-PROSHVRL set/5 (113890); Mask DSPS®-PROSH set (510k cleared)

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

    full page →fda device 510k ↗
    ›Mar 19, 2025device 510k496d agoOlympus Medical Systems Corporation — Luer-Split MAJ-2092 (510k cleared)

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

    full page →fda device 510k ↗
    ›Mar 19, 2025device 510k496d agoTriMed, Inc. — TriMed Ankle Fixation System (510k cleared)

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

    full page →fda device 510k ↗
    ›Mar 19, 2025device 510k496d agoTriMed, Inc. — TriMed Elbow and Forearm System (510k cleared)

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

    full page →fda device 510k ↗
    ›Mar 19, 2025device 510k496d agoMustech Electronics Co., Limited — IPL Hair Removal Device (M8011, M8012, M8013, M8015, M8021, M8022, M8023, M8025, M7011, M7012, M7021, M7023) (510k cleared)

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

    full page →fda device 510k ↗
    ›Mar 19, 2025device 510k496d agoShenB Co., Ltd. — Sunny (510k cleared)

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

    full page →fda device 510k ↗
    ›Mar 19, 2025device 510k496d agoScivita Medical Technology Co., Ltd. — Broncho Videoscope System (Single-use Broncho Videoscope (SBV-1A-B, SBV-1A-P, SBV-1B-B, SBV-1B-P, SBV-1C-B, SBV-1C-P); Full HD Visualization Endoscopic Image Processor (HDVS-S300A, HDVS-S300B, HDVS-S300C, HDVS-S300D); Endoscopic Image Processor (HDVS-S100A, HDVS-S100D)) (510k cleared)NewBay Medical Technology Co Ltd

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

    full page →fda device 510k ↗
    ›Mar 19, 2025device 510k496d agoAcurable Limited — AcuPebble Ox (200) (510k cleared)

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

    full page →fda device 510k ↗
    ›Mar 19, 2025device 510k496d agoSafesource Direct, LLC — SafeSource Direct Blue Powder-Free Nitrile Exam Gloves (AMERI-TUFF Series 4000, AMERI-TOUCH Series 5000) (510k cleared)

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

    full page →fda device 510k ↗
    ›Mar 20, 2025device 510k495d agoHangzhou AGS MedTech Co., Ltd. — Endoscopic Water Pump (510k cleared)

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

    full page →fda device 510k ↗
    ›Mar 20, 2025device 510k495d agoHunan Haipuming Technology Co., Ltd. — HPM38 (polymacon) Daily Wear Soft (hydrophilic) Contact Lens (HPM38) (510k cleared)

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

    full page →fda device 510k ↗
    ›Mar 20, 2025device 510k495d agoBoston Scientific — iSLEEVE Introducer Set (510k cleared)BOSTON SCIENTIFIC CORP

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

    full page →fda device 510k ↗
    ›Mar 20, 2025device 510k495d agoCardiovia , Ltd. — ViaOne Epicardial Access System (510k cleared)

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

    full page →fda device 510k ↗
    ›Mar 20, 2025device 510k495d agoDRTECH Corporation — EXPD 114; EXPD 114G; EXPD 114P; EXPD 114PG (510k cleared)

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

    full page →fda device 510k ↗
    ›Mar 20, 2025device 510k495d agoSpectrawave, Inc. — Starlight Imaging Catheter (510k cleared)

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

    full page →fda device 510k ↗
    ›Mar 20, 2025device 510k495d agoPixee Medical — Knee+ (510k cleared)

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

    full page →fda device 510k ↗
    ›Mar 20, 2025device 510k495d agoAvatar Medical — brAIn™ Shoulder Positioning (510k cleared)

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

    full page →fda device 510k ↗
    ›Mar 20, 2025device 510k495d agoRiverpoint Medical, LLC — RootMend MRR (510k cleared)

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

    full page →fda device 510k ↗
    ›Mar 20, 2025device 510k495d agoShenzhen TPH Technology Co., Ltd. — Ameda GLO Wearable Breast Pump (Model W8S) (510k cleared)Fortior Technology (Shenzhen) Co., Ltd./ADR

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

    full page →fda device 510k ↗
    ›Mar 20, 2025device 510k495d agoJoylux, Inc. — Joylux Intimacy Gel (PG3100) (510k cleared)

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

    full page →fda device 510k ↗
    ›Mar 20, 2025device 510k495d agoMeridian Bioscience, Inc. — Revogene (510k cleared)Meridian Corp

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

    full page →fda device 510k ↗
    ›Mar 20, 2025device 510k495d agoKyocera Medical Technologies, Inc. — Tesera-k PL System and Tesera-k XL System (510k cleared)Medical Care Technologies Inc.

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

    full page →fda device 510k ↗
    ›Mar 20, 2025device 510k495d agoVent Creativity — Vent Creativity Knee v1.0 (Hermes) (510k cleared)

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

    full page →fda device 510k ↗
    ›Mar 21, 2025device 510k494d agoAZmed — Rayvolve PTX-PE (510k cleared)

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

    full page →fda device 510k ↗
    ›Mar 21, 2025device 510k494d agoFresenius Medical Care Renal Therapies Group, LLC — FX CorAL 40 (F00009214); FX CorAL 50 (F00009215) (510k cleared)Fresenius Medical Care AG

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

    full page →fda device 510k ↗
    ›Mar 21, 2025device 510k494d agoSolar LS Cjsc — Medical Laser System Incanto / Evoline Platinum /Evoline (510k cleared)

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

    full page →fda device 510k ↗
    ›Mar 21, 2025device 510k494d agoErbe Elektromedizin GmbH — FiAPC plus probes (510k cleared)

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

    full page →fda device 510k ↗
    ›Mar 21, 2025device 510k494d agoPrismatik Dentalcraft, Inc. — Autoclavable Cassette (Glidewell HT™ Implant Guided Surgical Kit, Glidewell HT™ Implant Surgical Kit, Glidewell™ Prosthetic Kit) (510k cleared)

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

    full page →fda device 510k ↗
    ›Mar 21, 2025device 510k494d agoKico Knee Innovation Company Pty Limited — ARVIS Surgical Navigation System (510k cleared)

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

    full page →fda device 510k ↗
    ›Mar 21, 2025device 510k494d agoCytovale, Inc. — IntelliSep Test (CV-ICG-048) (510k cleared)

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

    full page →fda device 510k ↗
    ›Mar 21, 2025device 510k494d agoEdwards Lifesciences, LLC — FloTrac sensors; FloTrac Jr sensors; Acumen IQ sensors; VolumeView sensors (510k cleared)Edwards Lifesciences Corp

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

    full page →fda device 510k ↗
    ›Mar 21, 2025device 510k494d agoNatural Cycles Nordic AB — Natural Cycles (510k cleared)

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

    full page →fda device 510k ↗
    ›Mar 21, 2025device 510k494d agoVitromed GmbH — V-GRAD (510k cleared)

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

    full page →fda device 510k ↗
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    $FMS24.59+0.61%
    $MRBK
    $EW91.33-2.47%
    $MDCE0.00020.00%
    $FRTRY
    $BSX44.25+1.54%