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5,000 catalysts · 18,987 approval · 5,256 phase readout · 5,000 device 510k · 4,728 grant · 2,559 8k filing · 2,000 device pma

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2026-07-27: 0 catalysts2026-07-28: 0 catalysts2026-07-29: 0 catalysts2026-07-30: 58 catalysts2026-07-31: 3 catalysts2026-08-01: 0 catalysts2026-08-02: 0 catalysts2026-08-03: 4 catalysts2026-08-04: 13 catalysts2026-08-05: 16 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: 1 catalyst2026-08-14: 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: 1 catalyst2026-10-22: 2 catalysts2026-10-23: 0 catalysts2026-10-24: 0 catalysts2026-10-25: 0 catalysts
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type: device 510k×clear all
type
  • approval18,987
  • phase readout5,256
  • device 510k5,000
  • grant4,728
  • 8k filing2,559
  • device pma2,000
  • device recall2,000
  • recall1,126
  • device adverse event1,000
  • pdufa325
  • therapy area

    no tagged catalysts yet

    Week of Jun 23, 2025

    4
    ›Jun 27, 2025device 510k399d agoCork Medical — Nisus ONE Negative Pressure Wound Therapy System (OCMPP-100) (510k cleared)Medicale Corp.

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

    full page →fda device 510k ↗
    ›Jun 27, 2025device 510k399d agoCathegenix (Xiamen) Co., Ltd. — LumenaTM Ureteral Access Sheath (510k cleared)

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

    full page →fda device 510k ↗
    ›Jun 27, 2025device 510k399d agoJeil Medical Corporation — FIX-C PEEK ACIF SA System (510k cleared)

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

    full page →fda device 510k ↗
    ›Jun 29, 2025device 510k397d agoPendracare — Primum Hydrophilic Guiding Catheter (510k cleared)

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

    full page →fda device 510k ↗

    Week of Jun 30, 2025

    46
    ›Jun 30, 2025device 510k396d agoThermo Fisher Scientific — The Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with Ciprofloxacin in the dilution range of 0.002-64 ug/mL (510k cleared)THERMO FISHER SCIENTIFIC INC.

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

    full page →fda device 510k ↗
    ›Jun 30, 2025device 510k
    ← prev
    page 51 of 100
    next →
    396d ago
    Carlsmed, Inc. — aprevo® posterior/transforaminal lumbar interbody fusion device (510k cleared)CARLSMED, INC.

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

    full page →fda device 510k ↗
    ›Jun 30, 2025device 510k396d agoFUJIFILM Healthcare Americas Corporation — Synapse PACS (7.5) (510k cleared)

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

    full page →fda device 510k ↗
    ›Jun 30, 2025device 510k396d agoVoluntis — HeroTracker Sense (510k cleared)

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

    full page →fda device 510k ↗
    ›Jun 30, 2025device 510k396d agoMycardium AI Limited — EchoConfidence (USA) (510k cleared)

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

    full page →fda device 510k ↗
    ›Jun 30, 2025device 510k396d agoShenzhen Chuangtong Yigou Technology Co., Ltd. — Hand-held Hair Removal Device (FZ-200A, FZ-201, FZ-202, CT05, CT06, CT07, CT08, CT09) (510k cleared)

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

    full page →fda device 510k ↗
    ›Jun 30, 2025device 510k396d agoPiur Imaging GmbH — PIUR tUS inside (510k cleared)

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

    full page →fda device 510k ↗
    ›Jun 30, 2025device 510k396d agoOtsuka America Pharmaceutical, Inc. — Otsuka Digital Feedback Device (510k cleared)Otsuka America Pharmaceutical Inc

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

    full page →fda device 510k ↗
    ›Jul 1, 2025device 510k395d agoAbbott Molecular, Inc. — Alinity m CMV (510k cleared)

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

    full page →fda device 510k ↗
    ›Jul 1, 2025device 510k395d 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 510k395d 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 510k395d agoFasikl Incorporated — Felix NeuroAI System (510k cleared)

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

    full page →fda device 510k ↗
    ›Jul 1, 2025device 510k395d 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 510k395d 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 510k395d 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 510k395d 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 510k395d 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 510k395d agoPAJUNK GmbH Medizintechnologie — SonoMSK (510k cleared)

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

    full page →fda device 510k ↗
    ›Jul 1, 2025device 510k395d 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 510k395d 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 510k395d 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 510k394d 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 510k394d 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 510k394d agoZimmer, Inc. — Identity Shoulder System (510k cleared)

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

    full page →fda device 510k ↗
    ›Jul 2, 2025device 510k394d 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 510k394d 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 510k394d 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 510k394d 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 510k394d 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 510k394d 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 510k394d 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 510k394d agoSofwave Medical, Ltd. — Pure Impact (510k cleared)

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

    full page →fda device 510k ↗
    ›Jul 2, 2025device 510k394d 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 510k394d 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 510k394d 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 510k394d 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 510k394d agoMendaera, Inc. — Mendaera Guidance System (510k cleared)

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

    full page →fda device 510k ↗
    ›Jul 2, 2025device 510k394d 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 510k394d 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 510k394d 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 510k394d agoSurGenTec, LLC — OsteoFlo HydroFiber (510k cleared)

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

    full page →fda device 510k ↗
    ›Jul 2, 2025device 510k394d 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 510k393d agoTherapixel — MammoScreen® (4) (510k cleared)

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

    full page →fda device 510k ↗
    ›Jul 3, 2025device 510k393d 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 510k393d 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 510k393d 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 ↗
    $MCLE
    $TMO447.81+1.31%
    $FRTRY
    $CARL
    $EMI
    $BSX46.00-0.09%
    $ISRG351.45-0.47%