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calendar

2,737 catalysts · 4,728 grant · 3,045 8k filing · 2,737 device 510k · 2,721 approval · 2,000 device recall · 1,916 device pma

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2026-08-10: 0 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: 12 catalysts2026-10-29: 20 catalysts2026-10-30: 4 catalysts2026-10-31: 0 catalysts2026-11-01: 0 catalysts2026-11-02: 8 catalysts2026-11-03: 17 catalysts2026-11-04: 22 catalysts2026-11-05: 36 catalysts2026-11-06: 2 catalysts2026-11-07: 0 catalysts2026-11-08: 0 catalysts
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type: device 510k×from 2025-06-06×clear all
type
  • grant4,728
  • 8k filing3,045
  • device 510k2,737
  • approval2,721
  • device recall2,000
  • device pma1,916
device adverse event
1,000
  • recall686
  • earnings578
  • phase 2 completion172
  • therapy area

    no tagged catalysts yet

    Week of Jun 2, 2025

    25
    ›Jun 6, 2025device 510k431d agoGlobus Medical, Inc. — ONVOY™ Acetabular System (510k cleared)GLOBUS MEDICAL INC

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

    full page →fda device 510k ↗
    ›Jun 6, 2025device 510k431d agoHebei JT Medical Co., Ltd. — Nd: YAG Laser Therapy System (QN-1) (510k cleared)

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

    full page →fda device 510k ↗
    ›Jun 6, 2025device 510k431d agoGeister Medizin Technik GmbH — Geister K-Rex rongeurs (510k cleared)

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

    full page →fda device 510k ↗
    ›Jun 6, 2025device 510k431d agoSpine Wave, Inc. — Annex® 2 Adjacent Level System (510k cleared)

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

    full page →fda device 510k ↗
    ›Jun 6, 2025device 510k431d agoCreo Medical, Ltd. — SpydrBlade Flex Instrument (PRD-RG1-001) (510k cleared)

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

    full page →fda device 510k ↗
    ›Jun 6, 2025device 510k431d agoSora Neuroscience, Inc. — Cirrus Resting State fMRI Software (510k cleared)Alto Neuroscience, Inc.

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

    full page →fda device 510k ↗
    ›Jun 6, 2025device 510k431d agoQuanta System Spa — Discovery Pico; Discovery Pico Plus; Discovery Pico Derm (510k cleared)

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

    full page →fda device 510k ↗
    ›Jun 6, 2025device 510k431d agoEmpatica S.r.l. — Empatica Health Monitoring Platform; EmbracePlus; Empatica Care; Care Portal (510k cleared)

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

    full page →fda device 510k ↗
    ›Jun 6, 2025device 510k431d agoSi-Technology, LLC — SI-TECHNOLOGY® SI-DESIS® X™ Sacroiliac Joint Fusion System (510k cleared)Singh Biotechnology LLC

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

    full page →fda device 510k ↗
    ›Jun 6, 2025device 510k431d agoOmnia Medical, LLC — Omnia Medical PsiF DNA™ System (510k cleared)

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

    full page →fda device 510k ↗
    ›Jun 6, 2025device 510k431d agoTybr Health — TYBR Collagen Gel (510k cleared)

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

    full page →fda device 510k ↗
    ›Jun 6, 2025device 510k431d agoNingbo Ican Machines Co., Ltd. — Steam Sterilizer (2545D) (510k cleared)

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

    full page →fda device 510k ↗
    ›Jun 6, 2025device 510k431d agoConvatec Limited — Cure Catheter Insertion Kit (K1); Cure Catheter Insertion Kit (K2); Cure Catheter Insertion Kit (K2-90); Cure Catheter Insertion Kit (K3); Cure Hydrophilic Catheter Kit (HM12UK); Cure Hydrophilic Catheter Kit (HM14UK); Cure Hydrophilic Catheter Kit (HM16UK); Cure Pocket Catheter Kit (M14UK); Cure Catheter Closed System Kit (CS8); Cure Catheter Closed System Kit (CS10); Cure Catheter Closed System Kit (CS12); Cure Catheter Closed System Kit (CS14); Cure Catheter Closed System Kit (CS14C (510k cleared)

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

    full page →fda device 510k ↗
    ›Jun 6, 2025device 510k431d agoMBA Biotech Co., Ltd. — MBA Biotech Implant System (510k cleared)Oneness Biotech Co Ltd

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

    full page →fda device 510k ↗
    ›Jun 6, 2025device 510k431d agoMah Sing Healthcare Sdn. Bhd. — Nitrile Powder Free Examination Glove with Tremella Fuciformis Extract, Tested for Use with Chemotherapy Drugs and Fentanyl Citrate - Blue (510k cleared)Teva Pharmaceuticals USA Inc

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

    full page →fda device 510k ↗
    ›Jun 6, 2025device 510k431d agoCnS Medical Co., Ltd. — DELPHI System (510k cleared)

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

    full page →fda device 510k ↗
    ›Jun 6, 2025device 510k431d agoLuminex Corporation — LIAISON PLEX Gram-Positive Blood Culture Assay (510k cleared)

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

    full page →fda device 510k ↗
    ›Jun 6, 2025device 510k431d agoSteris — Celerity 5 HP Biological Indicator (LCB052); Celerity 5 HP Challenge Pack (LCB059); Celerity 20 HP Biological Indicator (LCB044); Celerity 20 HP Challenge Pack (LCB045) (510k cleared)STERIS plc

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

    full page →fda device 510k ↗
    ›Jun 6, 2025device 510k431d agoGeorge Courey, Inc. — GCI Sterilization Wrappers (510k cleared)

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

    full page →fda device 510k ↗
    ›Jun 6, 2025device 510k431d agoMediclus Co., Ltd. — Once-Fil Flow (510k cleared)

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

    full page →fda device 510k ↗
    ›Jun 6, 2025device 510k431d agoMomentis Surgical , Ltd. — Anovo Surgical System (6Ne) (510k cleared)

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

    full page →fda device 510k ↗
    ›Jun 6, 2025device 510k431d agoGuangzhou Ahead Intelligent Technology Co., Ltd. — Light Therapy System (M500, L6) (510k cleared)

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

    full page →fda device 510k ↗
    ›Jun 6, 2025device 510k431d agoKarl Storz SE & CO. KG — KARL STORZ Flexible Video-Uretero-Renoscope (FLEX XC) (510k cleared)

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

    full page →fda device 510k ↗
    ›Jun 6, 2025device 510k431d agoShenzhen Desida Technology Co., Ltd. — Baby Nasal Aspirator (BN002); Baby Nasal Aspirator (BN006); Baby Nasal Aspirator (BN007); Baby Nasal Aspirator (BN008); Baby Nasal Aspirator (BN009) (510k cleared)Fortior Technology (Shenzhen) Co., Ltd./ADR

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

    full page →fda device 510k ↗
    ›Jun 7, 2025device 510k430d agoLevita Magnetics International Corp — Magnetic Surgical System (510k cleared)

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

    full page →fda device 510k ↗

    Week of Jun 9, 2025

    25
    ›Jun 9, 2025device 510k428d agoOneness Biotech Co., Ltd. — Bonvadis® (510k cleared)Oneness Biotech Co Ltd

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

    full page →fda device 510k ↗
    ›Jun 9, 2025device 510k
    ← prev
    page 1 of 55
    next →
    428d ago
    Nanjing Bestview Laser S&T Co., Ltd. — CO2 Laser Machine (Lume) (510k cleared)

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

    full page →fda device 510k ↗
    ›Jun 9, 2025device 510k428d agoBiocorp Production — MallyaG Injection Pen Adapter (MallyaG) (510k cleared)

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

    full page →fda device 510k ↗
    ›Jun 9, 2025device 510k428d agoShenzhen Sungrow Led Technology Co., Ltd. — LED Light Therapy Mask (G15, G15P, G15K, G11P, G11, G10, G13, G14, G17, VISO, PRANA, Chin2Chest, BBL-FACEMASK) (510k cleared)

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

    full page →fda device 510k ↗
    ›Jun 10, 2025device 510k427d agoDRTECH Corporation — EXTRON 3; EXTRON 5; EXTRON 7 (510k cleared)

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

    full page →fda device 510k ↗
    ›Jun 10, 2025device 510k427d agoFujifilm Corporation — FUJIFILM Endoscope Model EG-840N; FUJIFILM Endoscope Model EG-840T; FUJIFILM Endoscope Model EG-840TP (510k cleared)Fujifilm Holdings Corp

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

    full page →fda device 510k ↗
    ›Jun 10, 2025device 510k427d agoEndymed Medical, Ltd. — EndyMed PRO MAX (510k cleared)

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

    full page →fda device 510k ↗
    ›Jun 10, 2025device 510k427d agoNihon Kohden Corporation — TG-980P CO2 Sensor Kit (TG-980P); TG-980P1 CO2 Sensor Kit (TG-980P1) (510k cleared)Nihon Kohden Corporation/ADR

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

    full page →fda device 510k ↗
    ›Jun 10, 2025device 510k427d agoRoche Diagnostics — Elecsys Anti-SARS-CoV-2 (510k cleared)

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

    full page →fda device 510k ↗
    ›Jun 10, 2025device 510k427d agoViz. Ai, Inc. — Viz Subdural+, Viz SUBDURAL PLUS (510k cleared)

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

    full page →fda device 510k ↗
    ›Jun 10, 2025device 510k427d agoFomed Industries, Inc. — Dental Barrier and Sleeves (510k cleared)Biomed Industries Inc

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

    full page →fda device 510k ↗
    ›Jun 10, 2025device 510k427d agoVitaltec Corporation — 5300600-5301000 Rota-Trach Disposable Standard Tracheostomy Tube, Cuffed, sizes 6.0-10.0mm; 5310600-5311000 Rota-Trach Disposable Standard Tracheostomy Tube, Cuffed, Fenestrated, sizes 6.0-10.0mm; 5400600-5401000 Rota-Trach Disposable Standard Tracheostomy Tube, Uncuff, sizes 6.0-10.0mm; 5410500-5411000 Rota-Trach Disposable Standard Tracheostomy Tube, Uncuff, Fenestrated, sizes 6.0-10.0mm (510k cleared)

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

    full page →fda device 510k ↗
    ›Jun 11, 2025device 510k426d agoIntuitive Surgical, Inc. — da Vinci X Surgical System (IS4200); da Vinci Xi Surgical System (IS4000) (510k cleared)INTUITIVE SURGICAL INC

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

    full page →fda device 510k ↗
    ›Jun 11, 2025device 510k426d agoNvision Biomedical Technologies — Impact PEEK Union Nail System (510k cleared)

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

    full page →fda device 510k ↗
    ›Jun 11, 2025device 510k426d agoBoston Scientific Corporation — Rezum System (510k cleared)BOSTON SCIENTIFIC CORP

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

    full page →fda device 510k ↗
    ›Jun 11, 2025device 510k426d agoBonebridge AG — LORRAINE 2.5/3.5mm Distal Humerus System (510k cleared)

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

    full page →fda device 510k ↗
    ›Jun 11, 2025device 510k426d agoMedtronic, Ireland — Liberant Thrombectomy System (510k cleared)

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

    full page →fda device 510k ↗
    ›Jun 11, 2025device 510k426d agoWilliam Cook Europe Aps — Frova Intubating Introducer (C-CAE-14.0-70-FII); Frova Intubating Introducer (C-CAE-14.0-70-FI); Frova Intubating Introducer (C-CAE-14.0-70-FIC); Frova Intubating Introducer (C-CAE-14.0-70-FIC-SPOPS) (510k cleared)

    Product code: BTR. Advisory committee: Anesthesiology. Type: Special

    full page →fda device 510k ↗
    ›Jun 11, 2025device 510k426d agoGI Windows, Inc. — Self-Forming Magnet (Flexagon) (510k cleared)

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

    full page →fda device 510k ↗
    ›Jun 11, 2025device 510k426d agoAmbu A/S — Ambu® aScope™ 5 Cysto HD (Standard Deflection); Ambu® aScope™ 5 Cysto HD (Reverse Deflection) (510k cleared)

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

    full page →fda device 510k ↗
    ›Jun 11, 2025device 510k426d agoCarl Zeiss Meditec Cataract Technology, Inc. — MICOR 700 System (N/A); MICOR 700 drive (FG-50631); MICOR 700 extractor (FG-50621); MICOR 700 vitrector (FG-51185) (510k cleared)

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

    full page →fda device 510k ↗
    ›Jun 11, 2025device 510k426d agoEnpuno Co., Ltd. — Injectable Root Canal Bioceramic Sealer (nRoot SP) (510k cleared)

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

    full page →fda device 510k ↗
    ›Jun 12, 2025device 510k425d agoHt Medical D.B.A. Xenix Medical — RIVA Posterior Fixation System; RIVA Posterior Fixation System Navigation Instruments (510k cleared)

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

    full page →fda device 510k ↗
    ›Jun 12, 2025device 510k425d agoNovapproach Spine, LLC — OneLIF™ Interbody Fusion System (510k cleared)

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

    full page →fda device 510k ↗
    ›Jun 12, 2025device 510k425d agoBiomérieux — ETEST Aztreonam/Avibactam (AZA) (0.016/4-256/4 µg/mL) (510k cleared)Bristol-Myers Squibb Co

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

    full page →fda device 510k ↗
    $GMED79.93+1.27%
    $ANRO28.29-1.33%
    $STE238.91+0.61%
    $FRTRY
    $NHNKF
    $ISRG393.38+3.85%
    $BSX50.46+2.33%