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calendar

2,454 catalysts · 4,728 grant · 3,603 8k filing · 2,679 approval · 2,454 device 510k · 1,997 device recall · 1,723 device pma

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2026-08-24: 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: 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: 1 catalyst2026-10-01: 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: 21 catalysts2026-10-30: 4 catalysts2026-10-31: 0 catalysts2026-11-01: 0 catalysts2026-11-02: 9 catalysts2026-11-03: 18 catalysts2026-11-04: 22 catalysts2026-11-05: 37 catalysts2026-11-06: 2 catalysts2026-11-07: 0 catalysts2026-11-08: 0 catalysts2026-11-09: 1 catalyst2026-11-10: 0 catalysts2026-11-11: 0 catalysts2026-11-12: 0 catalysts2026-11-13: 0 catalysts2026-11-14: 0 catalysts2026-11-15: 0 catalysts2026-11-16: 0 catalysts2026-11-17: 0 catalysts2026-11-18: 0 catalysts2026-11-19: 0 catalysts2026-11-20: 0 catalysts2026-11-21: 0 catalysts2026-11-22: 0 catalysts
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type: device 510k×from 2025-07-03×clear all
type
  • grant4,728
  • 8k filing3,603
  • approval2,679
  • device 510k2,454
  • device recall1,997
  • device pma1,723
device adverse event
1,000
  • recall641
  • earnings585
  • phase 2 completion172
  • therapy area

    no tagged catalysts yet

    Week of Jun 30, 2025

    23
    ›Jul 3, 2025device 510k423d agoTherapixel — MammoScreen® (4) (510k cleared)

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

    full page →fda device 510k ↗
    ›Jul 3, 2025device 510k423d agoSiemens Medical Solutions USA, Inc. — SOMATOM go.Now; SOMATOM go.Up; SOMATOM go.All; SOMATOM go.Top; SOMATOM go.Sim; SOMATOM go.Open Pro; SOMATOM Pro.Pulse (510k cleared)

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

    full page →fda device 510k ↗
    ›Jul 3, 2025device 510k423d agoBoston Scientific — Advanix™ Pancreatic Stent and NaviFlex™ Rapid Exchange (RX) Pancreatic Delivery System and Pushers (510k cleared)BOSTON SCIENTIFIC CORP

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

    full page →fda device 510k ↗
    ›Jul 3, 2025device 510k423d agoLima Corporate S.P.A. — SMR Reverse HP Shoulder System (510k cleared)

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

    full page →fda device 510k ↗
    ›Jul 3, 2025device 510k423d agoHunan Vathin Medical Instrument Co., Ltd. — Single-use Ureteral Access Sheath (510k cleared)

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

    full page →fda device 510k ↗
    ›Jul 3, 2025device 510k423d agoGuangzhou Pinzhi Medical Device Co., Ltd. — Denudation Pipettes (510k cleared)

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

    full page →fda device 510k ↗
    ›Jul 3, 2025device 510k423d agoWontech Co., Ltd. — Pastelle (510k cleared)

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

    full page →fda device 510k ↗
    ›Jul 3, 2025device 510k423d agoThe Magstim Company Limited — Rapid2 Magnetic Stimulators (Magstim Rapid2, Magstim Super Rapid2, Magstim Super Rapid2 Plus1) (510k cleared)

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

    full page →fda device 510k ↗
    ›Jul 3, 2025device 510k423d agoW&H Dentalwerk Buermoos GmbH — Piezomed Pro (Piezomed Pro module M-PM100 incl. handpiece M-PH350, Piezomed Pro instruments (various tips) and accessories) (510k cleared)

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

    full page →fda device 510k ↗
    ›Jul 3, 2025device 510k423d agoAveera Medical, Inc. — Boomerang Valvulotome (BMGVT080); Boomerang Push Valvulotome (BMGPVT125) (510k cleared)AVITA Medical, Inc.

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

    full page →fda device 510k ↗
    ›Jul 3, 2025device 510k423d agoBioventus, LLC — TalisMann Neuromodulation System (510k cleared)Bioventus Inc.

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

    full page →fda device 510k ↗
    ›Jul 3, 2025device 510k423d agoBimed Teknik Aletler Sanayi & Ticaret A.S. — 3DOSE 1ml Syringe (510k cleared)

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

    full page →fda device 510k ↗
    ›Jul 3, 2025device 510k423d agoSiemens Medical Solutions USA, Inc. — Biograph Vision PET/CT Systems; Biograph mCT PET/CT Systems (510k cleared)

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

    full page →fda device 510k ↗
    ›Jul 3, 2025device 510k423d agoTruabutment, Inc. — URIS Long Implant & Abutments (510k cleared)

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

    full page →fda device 510k ↗
    ›Jul 3, 2025device 510k423d agoBecton, Dickinson and Company — BD Vacutainer® Eclipse™ Blood Collection Needle (510k cleared)BECTON DICKINSON & CO

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

    full page →fda device 510k ↗
    ›Jul 3, 2025device 510k423d agoAlphatec Spine, Inc. — IdentiTi II Cervical Interbody System (510k cleared)

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

    full page →fda device 510k ↗
    ›Jul 3, 2025device 510k423d agoOnera B.V. — Onera STS 2 (ONERA STS 2) (510k cleared)

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

    full page →fda device 510k ↗
    ›Jul 3, 2025device 510k423d agoSiemens Medical Solutions USA, Inc. — syngo.via MI Workflows; Scenium; syngo MBF (510k cleared)

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

    full page →fda device 510k ↗
    ›Jul 3, 2025device 510k423d agoTeleflex Medical — Hem-o-lok™ PurplePlus™ Large Polymer Ligating Clips (510k cleared)

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

    full page →fda device 510k ↗
    ›Jul 3, 2025device 510k423d agoMedusa (Guangxi)Medical Devices Co., Ltd. — IPL Treatment Device (MDSQMC-01) (510k cleared)

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

    full page →fda device 510k ↗
    ›Jul 3, 2025device 510k423d agoInnovita (Tangshan) Biological Technology Co., Ltd. — Innovita Flu A/B Antigen Rapid Test (510k cleared)

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

    full page →fda device 510k ↗
    ›Jul 3, 2025device 510k423d agoVoco GmbH — MTA vpt (510k cleared)

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

    full page →fda device 510k ↗
    ›Jul 3, 2025device 510k423d agoShenzhen Trious Medical Technology Co., Ltd. — Disposable Percutaneous Nephrostomy Dilatation Kit (510k cleared)NewBay Medical Technology Co Ltd

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

    full page →fda device 510k ↗

    Week of Jul 7, 2025

    27
    ›Jul 7, 2025device 510k419d agoLife Spine, Inc. — TruLift® Lateral Expandable Spacer & Lateral Buttress Plate System (510k cleared)

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

    full page →fda device 510k ↗
    ›Jul 7, 2025device 510k
    ← prev
    page 1 of 50
    next →
    419d ago
    Zibo Shengkun Chemical Industry Co., Ltd. — Powder Free Polyurethane Examination Gloves (Green, Blue, Pink, White) (510k cleared)

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

    full page →fda device 510k ↗
    ›Jul 7, 2025device 510k419d agoCarlsmed, Inc. — aprevo® anterior lumbar interbody fusion device; aprevo® lateral lumbar interbody fusion device; aprevo® anterior lumbar interbody fusion device with interfixation; aprevo® transforaminal lumbar interbody fusion device; aprevo® TLIF-CA Articulating System; aprevo® Cervical ACDF; aprevo® Cervical ACDF-X; aprevo® Cervical ACDF-X No Cams (510k cleared)CARLSMED, INC.

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

    full page →fda device 510k ↗
    ›Jul 7, 2025device 510k419d agoCaranx Medical — TAVIPILOT (510k cleared)

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

    full page →fda device 510k ↗
    ›Jul 7, 2025device 510k419d agoCustomsurg AG — CustomSurg OrthoPlanner (510k cleared)

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

    full page →fda device 510k ↗
    ›Jul 8, 2025device 510k418d agoSimBioSys, Inc. — TumorSight Viz (510k cleared)

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

    full page →fda device 510k ↗
    ›Jul 8, 2025device 510k418d agoEncompass Industries Sdn. Bhd. — Powder-Free Polychloroprene Examination Glove (Green Color) Tested for Use with Chemotherapy Drugs and Fentanyl (510k cleared)NutriBand Inc.

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

    full page →fda device 510k ↗
    ›Jul 8, 2025device 510k418d agoS.M.A.I.O — KHEIRON® Spinal Fixation System, including patient specific K-ROD (510k cleared)

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

    full page →fda device 510k ↗
    ›Jul 8, 2025device 510k418d agoShenzhen HugeMed Medical Technical Development Co., Ltd. — Single-use Ureteral Access Sheath (510k cleared)

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

    full page →fda device 510k ↗
    ›Jul 8, 2025device 510k418d agoTerumo Europe N.V. — K-Pack Embrace Active Safety Needle (KNAS-2516RB, KNAS-2525RB) (510k cleared)

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

    full page →fda device 510k ↗
    ›Jul 8, 2025device 510k418d agoEncore Medical L.P. — EMPOWR Revision Knee™ (EMPOWR Revision VVC+, e+ Tibial Insert) (510k cleared)Encore Medical, Inc.

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

    full page →fda device 510k ↗
    ›Jul 8, 2025device 510k418d agoJeisys Medical Incorporated — DENSITY; DENZA; DENSITY Noir (510k cleared)

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

    full page →fda device 510k ↗
    ›Jul 8, 2025device 510k418d agoSpectrum Medical , Ltd. — Quantum Micro-Cardioplegia Delivery System; Quantum Micro-Cardioplegia Delivery Module (QMCDM) (510k cleared)

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

    full page →fda device 510k ↗
    ›Jul 8, 2025device 510k418d agoL&K BIOMED Co., Ltd. — PathLoc Lumbar Interbody Fusion Cage System (510k cleared)NeuCen BioMed Co Ltd

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

    full page →fda device 510k ↗
    ›Jul 8, 2025device 510k418d agoMomentis Surgical , Ltd. — Anovo Surgical System (Model 6Ne); Anovo Instrument ARM Curved Scissors ; Anovo Instrument ARM Hook Electrode (510k cleared)

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

    full page →fda device 510k ↗
    ›Jul 8, 2025device 510k418d agoGlobus Medical, Inc. — ExcelsiusXR™ (510k cleared)GLOBUS MEDICAL INC

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

    full page →fda device 510k ↗
    ›Jul 9, 2025device 510k417d agoSiemens Medical Solutions USA, Inc. — Cios Alpha; Cios Flow (510k cleared)

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

    full page →fda device 510k ↗
    ›Jul 9, 2025device 510k417d agoBoston Scientific Corporation — Flexiva Pulse Laser Fiber; Flexiva Pulse TracTip Laser Fiber; Flexiva Pulse ID Laser Fiber; Flexiva Pulse ID TracTip Laser Fibers (510k cleared)BOSTON SCIENTIFIC CORP

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

    full page →fda device 510k ↗
    ›Jul 9, 2025device 510k417d agoMr Surgical Solutions, LLC — OptiVu™ Shoulder (510k cleared)

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

    full page →fda device 510k ↗
    ›Jul 9, 2025device 510k417d agoPhasor Health, LLC — EZ-FIDUCIALS (510k cleared)

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

    full page →fda device 510k ↗
    ›Jul 9, 2025device 510k417d agoAbbott Laboratories — ARCHITECT iGentamicin (510k cleared)ABBOTT LABORATORIES

    Product code: LCD. Advisory committee: Clinical Toxicology. Type: Special

    full page →fda device 510k ↗
    ›Jul 9, 2025device 510k417d agoP&A USA — HEXIM Implant; Samwon General Abutments (510k cleared)

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

    full page →fda device 510k ↗
    ›Jul 9, 2025device 510k417d agoWenzel Spine, Inc. — panaSIa SI Fusion System (510k cleared)

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

    full page →fda device 510k ↗
    ›Jul 9, 2025device 510k417d agoNuvascular, Inc. — HARBOR Occlusion Device (510k cleared)

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

    full page →fda device 510k ↗
    ›Jul 9, 2025device 510k417d agoBasic Medical Technology, Inc. — Nitrile Powder-Free Exam Gloves 2.8, Tested for Use with Chemotherapy Drugs, Opioid Fentanyl Citrate, Simulated Gastric Acid (light blue, dark blue) (510k cleared)Medical Care Technologies Inc.

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

    full page →fda device 510k ↗
    ›Jul 9, 2025device 510k417d agoGe Medical Systems Information Technologies, Inc. — Monitor B105M; Monitor B125M; Monitor B155M; Monitor B105P; Monitor B125P (510k cleared)

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

    full page →fda device 510k ↗
    ›Jul 10, 2025device 510k416d agoShenzhen Dachi Communication Co., Ltd. — Microcurrent Facial Device (CEC101, EE0101, EEI101) (510k cleared)

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

    full page →fda device 510k ↗
    $BDX189.52+0.74%
    $BVS8.6700+1.40%
    $RCEL10.32-2.55%
    $BSX46.84+0.36%
    $CARL
    $GMED79.93+1.27%
    $ABT112.47+0.79%
    $EMI
    $NTRB2.9000-11.59%
    $BSX46.84+0.36%
    $MDCE0.00020.00%