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5,000 catalysts · 18,987 approval · 5,811 phase readout · 5,000 device 510k · 4,728 grant · 2,984 8k filing · 2,000 device pma

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2026-08-03: 0 catalysts2026-08-04: 0 catalysts2026-08-05: 0 catalysts2026-08-06: 0 catalysts2026-08-07: 0 catalysts2026-08-08: 0 catalysts2026-08-09: 0 catalysts2026-08-10: 14 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: 11 catalysts2026-10-29: 20 catalysts2026-10-30: 4 catalysts2026-10-31: 0 catalysts2026-11-01: 0 catalysts
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type: device 510k×clear all
type
  • approval18,987
  • phase readout5,811
  • device 510k5,000
  • grant4,728
  • 8k filing2,984
  • device pma2,000
  • device recall2,000
  • recall1,126
  • device adverse event1,000
  • earnings572
  • therapy area

    no tagged catalysts yet

    Week of Mar 16, 2026

    34
    ›Mar 19, 2026device 510k143d agoArbor Endovascular, LLC — Willow 24 Guidewire (510k cleared)

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

    full page →fda device 510k ↗
    ›Mar 19, 2026device 510k143d agoVy Spine, LLC — DiversiVy™ Facet Screw System (510k cleared)

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

    full page →fda device 510k ↗
    ›Mar 19, 2026device 510k143d agoNipro Medical Corporation — ELISIO™-H (510k cleared)

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

    full page →fda device 510k ↗
    ›Mar 19, 2026device 510k143d agoMirco-Tech (Nanjing) Co., Ltd. — Disposable Distal Cap (510k cleared)

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

    full page →fda device 510k ↗
    ›Mar 19, 2026device 510k143d agoYamaha Motor Co., Ltd. — JWG-1 (510k cleared)Yamaha Motor Co., Ltd.

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

    full page →fda device 510k ↗
    ›Mar 19, 2026device 510k143d agoDiaDent Group International — Dia-X Sil Bite (510k cleared)PS International Group Ltd.

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

    full page →fda device 510k ↗
    ›Mar 19, 2026device 510k143d agoRadformation, Inc. — AutoContour (RADAC V5) (510k cleared)

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

    full page →fda device 510k ↗
    ›Mar 19, 2026device 510k143d agoL&K BIOMED Co., Ltd. — CastleLoc Pectus Bar System (510k cleared)NeuCen BioMed Co Ltd

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

    full page →fda device 510k ↗
    ›Mar 19, 2026device 510k143d agoSt. shine Optical Co., Ltd. — Saview SH Optic 38 UV (Senofilcon A) Visibility Tinted Soft (Hydrophilic) Contact Lens; Saview SH Optic 38 UV toric (Senofilcon A) Visibility Tinted Soft (Hydrophilic) Contact Lens; Saview SH Optic 38 UV multifocal (Senofilcon A) Visibility Tinted Soft (Hydrophilic) Contact Lens (510k cleared)

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

    full page →fda device 510k ↗
    ›Mar 19, 2026device 510k143d agoWuhan PHOMED Technology Company , Ltd. — CureLight Medical Diode Laser Systems (CureLight F2-A15; CureLight F2-B15; CureLight F2-A30; CureLight F2-B30; CureLight F3-AB30; CureLight F3-AB60.) (510k cleared)

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

    full page →fda device 510k ↗
    ›Mar 19, 2026device 510k143d agoGeistlich Pharma AG — Derma-Gide (510k cleared)

    Product code: KGN. Advisory committee: Unknown. Type: Special

    full page →fda device 510k ↗
    ›Mar 19, 2026device 510k143d agoLake Region Medical — Enroute 0.014'' Transcarotid Guidewire (510k cleared)

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

    full page →fda device 510k ↗
    ›Mar 20, 2026device 510k142d agoIcu Medical, Inc. — ClaveQS™ Bag (510k cleared)ICU MEDICAL INC/DE

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

    full page →fda device 510k ↗
    ›Mar 20, 2026device 510k142d agoNexstim Oyj — Nexstim Navigated Brain Stimulation (NBS) 6 System (NBS6) (510k cleared)

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

    full page →fda device 510k ↗
    ›Mar 20, 2026device 510k142d agoVoco GmbH — Bifix Veneer LC, Bifix Veneer Try-In (510k cleared)

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

    full page →fda device 510k ↗
    ›Mar 20, 2026device 510k142d agoInstrumentation Laboratory (IL) Co. — HemosIL Factor V Leiden (APC Resistance V) (510k cleared)

    Product code: GGW. Advisory committee: Hematology. Type: Special

    full page →fda device 510k ↗
    ›Mar 20, 2026device 510k142d agoLiviwell, Inc. — Livi Device (510k cleared)

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

    full page →fda device 510k ↗
    ›Mar 20, 2026device 510k142d agoDongguan TT Medical, Inc. — Valvuloplasty Balloon Catheter (ValvuloPro) (510k cleared)

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

    full page →fda device 510k ↗
    ›Mar 20, 2026device 510k142d agoNexstim Oyj — Nexstim Navigated Brain Stimulation (NBS) 6 System (NBS6) (510k cleared)

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

    full page →fda device 510k ↗
    ›Mar 20, 2026device 510k142d agoNox Medical Ehf — Noxturnal Web (510k cleared)

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

    full page →fda device 510k ↗
    ›Mar 20, 2026device 510k142d agoGe Medical Systems, LLC — Photonova Spectra, Photonova Spectra Select (510k cleared)

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

    full page →fda device 510k ↗
    ›Mar 20, 2026device 510k142d agoSiemens Medical Solutions USA, Inc. — SOMATOM X.cite; SOMATOM X.ceed (510k cleared)

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

    full page →fda device 510k ↗
    ›Mar 20, 2026device 510k142d agoArthrex, Inc. — Arthrex FiberTak Suture Anchor (510k cleared)

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

    full page →fda device 510k ↗
    ›Mar 20, 2026device 510k142d agoOlympus Medical Systems Corporation — Disposable Biopsy Forceps FB-211D, FB-221D, FB-231D, FB-241D (510k cleared)

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

    full page →fda device 510k ↗
    ›Mar 20, 2026device 510k142d agoNordicneurolab AS — nordicAudio (1.0) (510k cleared)

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

    full page →fda device 510k ↗
    ›Mar 20, 2026device 510k142d agoZheJiang J&J Mobility Co., Ltd. — Electric wheelchair (JJW-7002, JJW-7003) (510k cleared)

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

    full page →fda device 510k ↗
    ›Mar 20, 2026device 510k142d agoArthrex, Inc. — Arthrex Humeral Nails (510k cleared)

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

    full page →fda device 510k ↗
    ›Mar 20, 2026device 510k142d agoHangzhou Tappa Medical Technology Co., Ltd. — Endobronchial Blocker Tube (EBT0109); Endobronchial Blocker Tube (EBT0107); Endobronchial Blocker Tube (EBT0105); Endobronchial Blocker Tube (EBT0109S); Endobronchial Blocker Tube (EBT0107S); Endobronchial Blocker Tube (EBT0105S); Endobronchial Blocker Tube (EBT0209); Endobronchial Blocker Tube (EBT0207); Endobronchial Blocker Tube (EBT0205); Endobronchial Blocker Tube (EBT0209S); Endobronchial Blocker Tube (EBT0207S); Endobronchial Blocker Tube (EBT0205S) (510k cleared)Guangzhou Dazhou Biomedical Technology Co Ltd

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

    full page →fda device 510k ↗
    ›Mar 20, 2026device 510k142d agoFMD Co., Ltd. — FMD Peripheral Guide Wire F-14 Flex 6; FMD Peripheral Guide Wire F-14 Tapered 40; FMD Peripheral Guide Wire F-18 Flex SP; FMD Peripheral Guide Wire F-18 DP 25; FMD Peripheral Guide Wire F-18 Tapered 40 (510k cleared)

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

    full page →fda device 510k ↗
    ›Mar 20, 2026device 510k142d agoDental Imaging Technologies Corporation — NOMAD Pro 3 (510k cleared)

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

    full page →fda device 510k ↗
    ›Mar 20, 2026device 510k142d agoExpanse Medical, Inc. — FLOWRUNNER Aspiration System (510k cleared)

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

    full page →fda device 510k ↗
    ›Mar 20, 2026device 510k142d agoDegania Silicone , Ltd. — Percutaneous Endoscopic Gastrostomy (PEG) Kit (510k cleared)

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

    full page →fda device 510k ↗
    ›Mar 20, 2026device 510k142d agoSurGenTec, LLC — TiLink-L Navigation Instruments (510k cleared)

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

    full page →fda device 510k ↗
    ›Mar 20, 2026device 510k142d agoPhilips Healthcare (Suzhou) Co., Ltd. — Smart Fit TorsoCardiac 1.5T (510k cleared)

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

    full page →fda device 510k ↗

    Week of Mar 23, 2026

    16
    ›Mar 23, 2026device 510k139d agoStreck — MDx-Chex for BCN (510k cleared)

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

    full page →fda device 510k ↗
    ›Mar 23, 2026device 510k
    ← prev
    page 96 of 100
    next →
    139d ago
    Stabiliz Orthopaedics, Inc. — QuikFix External Fixator: Knee-Spanning Pack (510k cleared)

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

    full page →fda device 510k ↗
    ›Mar 23, 2026device 510k139d agoGe Healthcare Japan Corporation — True Definition DL (510k cleared)

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

    full page →fda device 510k ↗
    ›Mar 23, 2026device 510k139d agoPhilips Healthcare (Suzhou) Co., Ltd. — CT Rembra RT; CT Areta RT; CT Rembra (510k cleared)

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

    full page →fda device 510k ↗
    ›Mar 23, 2026device 510k139d agoAdin Dental Implant Systems , Ltd. — Adin Long Dental Implant System (510k cleared)

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

    full page →fda device 510k ↗
    ›Mar 23, 2026device 510k139d agoGuangdong Newdermo Biotech Co., Ltd. — LED Light Therapy Masks (LumiLips FAC07NA) (510k cleared)

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

    full page →fda device 510k ↗
    ›Mar 23, 2026device 510k139d agoThreadstone, LLC — HyperSuture All Green Extension Line (510k cleared)

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

    full page →fda device 510k ↗
    ›Mar 23, 2026device 510k139d agoSkeletal Dynamics, Inc. — Clavicle Fixation System (510k cleared)

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

    full page →fda device 510k ↗
    ›Mar 24, 2026device 510k138d agoGE Medical Systems SCS — Senographe Pristina; SenoBright HD; Pristina Serena; Pristina Serena Bright (510k cleared)

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

    full page →fda device 510k ↗
    ›Mar 24, 2026device 510k138d agoAngiodynamics — NanoKnife Generator (H78720300351US0) (510k cleared)ANGIODYNAMICS INC

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

    full page →fda device 510k ↗
    ›Mar 24, 2026device 510k138d agoLumos Diagnostics, Inc. — FebriDx Bacterial/Non-bacterial Assay (510k cleared)Lucid Diagnostics Inc.

    Product code: QXA. Advisory committee: Microbiology. Type: Dual Track

    full page →fda device 510k ↗
    ›Mar 24, 2026device 510k138d agoJLK, Inc. — JLK-NCCT (510k cleared)

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

    full page →fda device 510k ↗
    ›Mar 24, 2026device 510k138d agoNanjing CareMoving Rehabilitation Equipment Co.,Ltd — Electric Wheelchair (E201) (510k cleared)

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

    full page →fda device 510k ↗
    ›Mar 24, 2026device 510k138d agoAap Implantate AG — LOQTEQ® VA Proximal Humerus Plate 3.5 (510k cleared)

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

    full page →fda device 510k ↗
    ›Mar 24, 2026device 510k138d agoNipro Medical Corporation — PRESSONE™ (510k cleared)

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

    full page →fda device 510k ↗
    ›Mar 24, 2026device 510k138d agoGE Medical Systems Ultrasound and Primary Care Diagnostics — LOGIQ Vita; LOGIQ Vita Pro; LOGIQ Vita Express; LOGIQ Vita Plus; LOGIQ Vita Power; LOGIQ S20; LOGIQ S20 Pro; LOGIQ S20 Express; LOGIQ S20 Plus; LOGIQ S20 Power (510k cleared)

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

    full page →fda device 510k ↗
    $ICUI184.56+10.93%
    $YAMHF7.15000.00%
    $PSIG11.200.00%
    $LUCD0.9455+0.05%
    $ANGO13.82-2.81%