510(k) clearances

Newest records

• Zylox PanFlex Percutaneous Transluminal Angioplasty Scoring Catheter

  Zylox Medtech Co., Ltd. · Cardiovascular

  2026-10-22K260686Substantially EquivalentTraditionalPNO
  FDA page
• MultiNeO Dental Implant System

  Alpha Bio Tec , Ltd. · Dental

  2026-10-22K261295Substantially EquivalentTraditionalDZE
  FDA page
• Needle Stimulator (SDZ-IIB, SDZ-IIC, SDZ-III, SDZ-V)

  Suzhou Medical Appliance Factory · Unknown

  2026-10-22K260230Substantially EquivalentTraditionalBWK
  FDA page
• FAQ™ (FAQ 411)

  Foreo, Inc. · Neurology

  2026-10-22K261565Substantially EquivalentTraditionalNFO
  FDA page
• Accelagen Advanced Surgical Collagen Matrix, 1cc (CG-01AA); Accelagen Advanced Surgical Collagen Matrix, 2cc (CG-02AA); Accelagen Advanced Surgical Collagen Matrix, 3cc (CG-03AA); Accelagen Advanced Surgical Collagen Matrix, 5cc (CG-05AA); Accelagen Advanced Surgical Collagen Strip, 125x25x2mm (CG-125X25AA); Accelagen Advanced Surgical Collagen Strip, 250x25x2mm (CG-250X25AA)

  Berkeley Advanced Biomaterials · Unknown

  2026-10-22K260920Substantially EquivalentTraditionalKGN
  FDA page
• PicoPeak Picosecond Nd:Yag Laser System (Bella-9)

  Beijing Sea Heart International Science and Technologyco.Ltd · General, Plastic Surgery

  2026-10-22K262701Substantially EquivalentTraditionalGEX
  FDA page
• Gravity Blood Sets with 200µm Filter

  B.Braun Medical, Inc. · General Hospital

  2026-10-22K260261Substantially EquivalentTraditionalFPA
  FDA page
• Veritas Shoulder System

  restor3d, inc. · Orthopedic

  2026-10-22K263421Substantially EquivalentSpecialPHX
  FDA page
• Cerclage Wires;K-wires;Steinmann Pins

  MK Medical GmbH · Orthopedic

  2026-10-22K262126Substantially EquivalentTraditionalHTY
  FDA page
• GANNET®

  BAAT Medical Products B.V. · Orthopedic

  2026-10-22K262184Substantially EquivalentTraditionalJDO
  FDA page
• PV-iCurve Pro

  Perception Vision Medical Technology Co., Ltd. · Radiology

  2026-10-21K261531Substantially EquivalentTraditionalLLZ
  FDA page
• Eden PACS

  Higia., Inc. d/b/a Eden · Radiology

  2026-10-21K261788Substantially EquivalentAbbreviatedLLZ
  FDA page
• Toro 71 Aspiration Catheter; Toro Aspiration Tubing

  Toro Neurovascular, Inc. · Cardiovascular

  2026-10-21K262021Substantially EquivalentTraditionalNRY
  FDA page
• DASH Flu A/B Test

  Nuclein, LLC · Microbiology

  2026-10-21K261347Substantially EquivalentDual TrackOCC
  FDA page
• Hemotag Analysis Software (HAS)

  Aventusoft, LLC · Cardiovascular

  2026-10-21K252736Substantially EquivalentTraditionalDQD
  FDA page
• ACHM30 AtriClip FLEX-Mini LAA Exclusion System

  AtriCure, Inc. · General, Plastic Surgery

  2026-10-21K263319Substantially EquivalentSpecialPZX
  FDA page
• TeKBrace Knotless Anchor

  TheraMicro · Orthopedic

  2026-10-21K263352Substantially EquivalentSpecialMBI
  FDA page
• BIOFIRE SPOTFIRE Vaginitis (VG) Panel

  Biofire Diagnostics, LLC · Microbiology

  2026-10-21K262136Substantially EquivalentDual TrackPQA
  FDA page
• Sol-Guard™ Safety Pull Button Collection Set; Sol-Guard™ XtraThin Safety Pull-Button Blood Collection Set

  Sol-Millennium Medical, Inc. · Clinical Chemistry

  2026-10-21K260857Substantially EquivalentSpecialJKA
  FDA page
• Versius Surgical System (Versius Plus)

  Cmr Surgical Limited · General, Plastic Surgery

  2026-10-21K261252Substantially EquivalentTraditionalSCV
  FDA page