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calendar

2,488 catalysts · 4,728 grant · 3,189 8k filing · 2,681 approval · 2,488 device 510k · 2,000 device recall · 1,743 device pma

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2026-08-10: 0 catalysts2026-08-11: 0 catalysts2026-08-12: 0 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: 3 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: 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 catalysts
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type: device 510k×from 2025-07-01×clear all
type
  • grant4,728
  • 8k filing3,189
  • approval2,681
  • device 510k2,488
  • device recall2,000
  • device pma1,743
device adverse event
1,000
  • recall663
  • earnings584
  • phase 2 completion172
  • therapy area

    no tagged catalysts yet

    Week of Jun 30, 2025

    50
    ›Jul 1, 2025device 510k408d agoAbbott Molecular, Inc. — Alinity m CMV (510k cleared)

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

    full page →fda device 510k ↗
    ›Jul 1, 2025device 510k408d agoHtl-Strefa S.A — droplet® personal lancets (510k cleared)

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

    full page →fda device 510k ↗
    ›Jul 1, 2025device 510k408d agoAccess Vascular, Inc. — Dual Lumen 5Fr HydroPICC Catheter (PICC-251CM) (PICC-251CM); Dual Lumen 5Fr HydroPICC Catheter (PICC-252CM) (PICC-252CM) (510k cleared)

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

    full page →fda device 510k ↗
    ›Jul 1, 2025device 510k408d agoFasikl Incorporated — Felix NeuroAI System (510k cleared)

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

    full page →fda device 510k ↗
    ›Jul 1, 2025device 510k408d agoMedacta International S.A. — SnugFit ASA Extension (510k cleared)Stemedica International S.A.

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

    full page →fda device 510k ↗
    ›Jul 1, 2025device 510k408d agoCircle Cardiovascular Imaging, Inc. — StrokeSENS ASPECTS Software Application (510k cleared)

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

    full page →fda device 510k ↗
    ›Jul 1, 2025device 510k408d agoConvatec — Cure Twist Female 8 Catheter (T8); Cure Twist Female 10 Catheter (T10); Cure Twist Female 12 Catheter (T12); Cure Twist Female 14 Catheter (T14); Cure Twist Female 16 Catheter (T16); Cure Twist Female 8 Catheter Kit with supplies (T8K); Cure Twist Female 10 Catheter Kit with supplies (T10K); Cure Twist Female 12 Catheter Kit with supplies (T12K); Cure Twist Female 14 Catheter Kit with supplies (T14K); Cure Twist Female 16 Catheter Kit with supplies (T16K) (510k cleared)

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

    full page →fda device 510k ↗
    ›Jul 1, 2025device 510k408d agoMedtronic Minimed, Inc. — MiniMed 780G insulin pump (510k cleared)Medtronic USA Inc

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

    full page →fda device 510k ↗
    ›Jul 1, 2025device 510k408d agoArthrex, Inc. — Arthrex iBalance Partial Knee System (510k cleared)

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

    full page →fda device 510k ↗
    ›Jul 1, 2025device 510k408d agoPAJUNK GmbH Medizintechnologie — SonoMSK (510k cleared)

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

    full page →fda device 510k ↗
    ›Jul 1, 2025device 510k408d agoBunkerHill Health — Bunkerhill Abdominal Aortic Quantification (AAQ) (510k cleared)

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

    full page →fda device 510k ↗
    ›Jul 1, 2025device 510k408d agoShenzhen Sophway Technology Co., Ltd. — Endoscopic Camera System (510k cleared)Fortior Technology (Shenzhen) Co., Ltd./ADR

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

    full page →fda device 510k ↗
    ›Jul 1, 2025device 510k408d agoUlrich Medical USA, Inc. — Momentum® Posterior Spinal Fixation System (510k cleared)

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

    full page →fda device 510k ↗
    ›Jul 2, 2025device 510k407d agoNanospectra Biosciences, Inc. — AuroLase® System (510k cleared)

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

    full page →fda device 510k ↗
    ›Jul 2, 2025device 510k407d agoShanghai Apolo Medical Technology Co., Ltd. — Fiber Laser Treatment Systems (HS-232,HS-233) (510k cleared)NewBay Medical Technology Co Ltd

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

    full page →fda device 510k ↗
    ›Jul 2, 2025device 510k407d agoZimmer, Inc. — Identity Shoulder System (510k cleared)

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

    full page →fda device 510k ↗
    ›Jul 2, 2025device 510k407d agoAktiia SA — G0 Blood Pressure Monitoring System (G0) (510k cleared)

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

    full page →fda device 510k ↗
    ›Jul 2, 2025device 510k407d agoVive Health, LLC — Power Wheelchair (MOB1107) (510k cleared)

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

    full page →fda device 510k ↗
    ›Jul 2, 2025device 510k407d agoPegavision Corporation — Pegavision (Toufilcon B) Daily Disposable Soft (Hydrophilic) Contact Lenses; Pegavision (Toufilcon B) Soft (Hydrophilic) Contact Lenses (510k cleared)

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

    full page →fda device 510k ↗
    ›Jul 2, 2025device 510k407d agoEncore Medical L.P. — EMPOWR Revision Knee™ (EMPOWR Revision Knee™ Symmetric TT Cones) (510k cleared)Encore Medical, Inc.

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

    full page →fda device 510k ↗
    ›Jul 2, 2025device 510k407d agoElekta Solutions AB — Leksell Gamma Knife® (Elekta Esprit); Leksell Gamma Knife® (Icon™); Leksell Gamma Knife® (Perfexion™) (510k cleared)

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

    full page →fda device 510k ↗
    ›Jul 2, 2025device 510k407d agoZiehm-Orthoscan, Inc. — Orthoscan TAU Mini C-Arm (510k cleared)

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

    full page →fda device 510k ↗
    ›Jul 2, 2025device 510k407d agoMicro-Energy Medical Technology Co., Ltd. — SurgiLight 1470 Diode Laser System (Model:Halo) (510k cleared)NewBay Medical Technology Co Ltd

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

    full page →fda device 510k ↗
    ›Jul 2, 2025device 510k407d agoSofwave Medical, Ltd. — Pure Impact (510k cleared)

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

    full page →fda device 510k ↗
    ›Jul 2, 2025device 510k407d agoTerumo Cardiovascular Systems Thi Plant — OPUSWAVE Dual Sensor Imaging System (510k cleared)

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

    full page →fda device 510k ↗
    ›Jul 2, 2025device 510k407d agoBoehringer Laboratories, LLC — Boehringer Laboratories Liver Retractor (510k cleared)

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

    full page →fda device 510k ↗
    ›Jul 2, 2025device 510k407d agoZhejiang Automwheel Tech Co., Ltd. — Electric Wheelchair (HG-630) (510k cleared)

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

    full page →fda device 510k ↗
    ›Jul 2, 2025device 510k407d agoIntuitive Surgical, Inc. — 8 mm Assist Cannula; 12 mm Assist Cannula (510k cleared)INTUITIVE SURGICAL INC

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

    full page →fda device 510k ↗
    ›Jul 2, 2025device 510k407d agoMendaera, Inc. — Mendaera Guidance System (510k cleared)

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

    full page →fda device 510k ↗
    ›Jul 2, 2025device 510k407d agoBelport Company, Inc., Gingi-Pak — RC-SwiftPrep (510k cleared)

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

    full page →fda device 510k ↗
    ›Jul 2, 2025device 510k407d agoCurative Sound Therapeutics — CS-Pro MED (510k cleared)

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

    full page →fda device 510k ↗
    ›Jul 2, 2025device 510k407d agoMedline Industries, LP — Hudson RCI® Comfort Flo Nasal Cannula Premature, Infant; Hudson RCI® Comfort Flo Plus and Soft Plus Cannula Extra Small (510k cleared)

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

    full page →fda device 510k ↗
    ›Jul 2, 2025device 510k407d agoSurGenTec, LLC — OsteoFlo HydroFiber (510k cleared)

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

    full page →fda device 510k ↗
    ›Jul 2, 2025device 510k407d agoJoytech Healthcare Co. , Ltd. — Compressor Nebulizer (NB-1100); Compressor Nebulizer (NB-1101); Compressor Nebulizer (NB-1102); Compressor Nebulizer (NB-1103) (510k cleared)NVP Healthcare Co Ltd

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

    full page →fda device 510k ↗
    ›Jul 3, 2025device 510k406d agoTherapixel — MammoScreen® (4) (510k cleared)

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

    full page →fda device 510k ↗
    ›Jul 3, 2025device 510k406d 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 510k406d 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 510k406d 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 510k406d 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 510k406d 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 510k406d agoWontech Co., Ltd. — Pastelle (510k cleared)

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

    full page →fda device 510k ↗
    ›Jul 3, 2025device 510k406d 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 510k406d 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 510k406d 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 510k406d 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 510k406d 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 510k406d 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 510k406d agoTruabutment, Inc. — URIS Long Implant & Abutments (510k cleared)

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

    full page →fda device 510k ↗
    ›Jul 3, 2025device 510k406d 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 510k406d agoAlphatec Spine, Inc. — IdentiTi II Cervical Interbody System (510k cleared)

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

    full page →fda device 510k ↗
    ← prev
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    $ISRG401.27+0.01%
    $EMI
    $BSX51.42+0.45%
    $RCEL8.1200-0.98%
    $FRTRY
    $BVS8.6700+1.40%
    $BDX183.58+1.20%