FDA 510(k) clearances
clearances on record, most recent first.
Most recent clearances
1–100 of 176,428- K253717 — Helo Return
- K260080 — Pro-Line XL Power Injectable Central Venous Catheter and Pro-Line XL Tunneler
- K260096 — Wishbone HAE
- K260156 — TruVision Single-Use 1.9mm Arthroscopy System
- K260687 — VivaChek Blood Glucose and ß-Ketone Dual BLE Monitoring System +1 more
- K260913 — CMF Titanium Splints
- K261234 — The D-Tip Denudation Pipette
- K261521 — Sleep Analysis Module
- K261649 — Excelsior Reach Microcatheter
- K262068 — Khelix Magnetic Sensor Electrophysiology Catheter (SS1-*-*-MAG)
- K262090 — Fertilis microICSI Device
- K262301 — Rapid ICH (v4.0)
- K262352 — IPL Hair Removal Device (AHR01, R3C16-G Pro1, AHR02, AHR03, R4820, R6715, L3B02, JR20, R6312, R6202)
- K262834 — Led and Laser Hair Growth Device (H5520, H5521, H5522, H5523, H5524, H5525, H5530, H5605, H5610, H5615, H5620, H5625, H5630, H6510, H6520, INIA-HM100, ID-FLH-500)
- K262902 — ECHELON Synergy
- K263154 — CarboClear® Cervical Navigated Instruments
- K260426 — MeCare Alpha (MCA2019)
- K261617 — Diagnostic Ultrasound System (11+ models)
- K261805 — NEXT-Cue
- K262244 — Sonopet iQ Series III Console (5700-050-000) +6 more
- K262346 — CureLight Medical Diode Laser Systems (5 models)
- K263150 — V10 Diagnostic Ultrasound System +10 more
- K263680 — One Coat Bond; One Coat Bond SL
- K260075 — eClinics
- K260092 — Vista AI Scan
- K261120 — APEX 3D S Diamond Tibia
- K261692 — Diode Laser Hair Removal Machine (QDTM-03)
- K261733 — Ligence Heart
- K262134 — NeuroDR
- K262368 — B. anthracis Real-time PCR Assay
- K262378 — Dr.AlignNavi
- K262822 — Nasal Aspirator (TLC-N02); Electric NoseFrida Pro (12300400); Electric NoseFrida (12100401)
- K263159 — prodisc® C; prodisc® C SK; prodisc® C Nova; prodisc® C Vivo Instruments
- K260136 — Forza
- K261079 — Power Wheelchair (DC12)
- K261141 — OpenFlo Urinary Catheter
- K261200 — Power Wheelchair (D60)
- K261887 — Normatec Elite Heat (6 models)
- K261938 — APRO 88 Catheter
- K262043 — MEDRAD® MRXperion MR Injection System and MR Injection System Syringe Kit +2 more
- K262516 — TSK OptiXion
- K262798 — LOBO Vascular Occlusion System
- K260005 — MyoVista wavECG (DG-200-B15-003)
- K260523 — QGuideCT (1.0)
- K261655 — RT Elements (4.6)
- K261939 — Glucommander
- K262285 — UV Phototherapy Device (KZX-308nm-BL65, KZX-308nm-BL55, KZX-308nm-BL50, KZX-308nm-BL45, KZX-308nm-BL35)
- K262812 — Air compression massager (ACM-C1, ACM-C2, ACM-C3, ACM-C4, ACM-C5, ACM-C6, ACM-C7, ACM-C8, ACM-C9, ACM-5C1, ACM-5C2, ACM-5C3, ACM-5C4, ACM-5C5, ACM-5C6, ACM-5C7, ACM-5C8, ACM-5C9)
- K262813 — InkSpace Imaging Small Body Array (SBA12PH15x)
- K253422 — OAB Delivery Catheter
- K254030 — cCeLL405
- K260044 — Ventricular Catheters, Thomale Catheter
- K260064 — Neurora
- K260221 — Elecsys EBV EBNA IgG
- K260232 — Elecsys EBV VCA IgG
- K260233 — Elecsys EBV IgM
- K260468 — H100Plus Hemoglobin Testing System
- K260487 — stentFIX System Set (100.50n)
- K260490 — Ninenovo Blood Oxygen Ring (BORMB-01-6,BORMB-01-7,BORMB-01-8,BORMB-01-9,BORMB-01-10,BORMB-01-11,BORMB-01-12,BORMB-01-13,BORMB-01-14)
- K260689 — CVS Advanced PLUS Blood Glucose Monitoring System
- K261042 — Lung Guidance
- K261217 — AnyPlus II Spinal Fixation System
- K261607 — Minuteman G6 MIS Fusion Plate +6 more
- K261611 — TDM Large Bone Plate and Screw System
- K261741 — Hemostatic Clip
- K261783 — Plenity-V (MC0979 / GS110)
- K261791 — MEDIVATORS ADVANTAGE NXT Automated Endoscope Reprocessor
- K261933 — Voluson Expert 18; Voluson Expert 20; Voluson Expert 22
- K261943 — REMEX-T(K)100C
- K262412 — Coronis Fusion 4MP (MDCC-4630); Coronis Fusion 6MP (MDCC-6630)
- K262985 — Medical Monitor (32MD08WC)
- K263083 — Response Ortho Smart Fixator - Hexapod System
- K263086 — AltiVate Reverse® Glenosphere with RAVN Technology
- K263113 — ZSAlign Cervical Interbody System
- K263116 — OsteoCentric Technologies Cannulated and Soild Fasteners with Nuts
- K263120 — Xpert Xpress CoV-2/Flu plus
- K260027 — Firstar Dental Electric Motor
- K260029 — Firstar Dental Handpieces
- K260283 — VITEK 2 AST-Streptococcus Meropenem (=0.06 - =4 µg/mL)
- K260470 — Electronic Blood Pressure Monitor (BP-204C, BP-204A, BP-215, BP-203C, BP-205A, BP-201C, BP-217, BP-202C, BP-202 BP-205, BP-205B,BP-206)
- K261612 — SwiftSight-BodyComposition
- K262208 — Non-sterile, Powder Free Nitrile Examination Aloe Vera Green Gloves, Low Dermatitis Potential, Tested for use with Chemotherapy Drugs, Fentanyl Citrate and Simulated Gastric Acid +2 more
- K262473 — NEXUS® Hip Stem
- K263016 — Intra-Operative Positioning System (IOPS) and IOPS Visionary System
- K263062 — NOVIX Pedicle Screw System
- K263092 — Dual Stage Venous Cannulae
- K254302 — ECG Analysis Software (AiTiALVSD)
- K261327 — Elos Accurate Hybrid Base
- K261469 — Nexxis 2; Nexxis OR 2; NMS 2; MNA-240; MNA-4x0 (Where x may be any numeric character).
- K261663 — EzSensor HD
- K261975 — Braun Aura 7 (6041)
- K262038 — danumed StomaMeter
- K262257 — Spine Planning (3.0); Spine & Trauma Navigation; Alignment System Spine
- K262621 — Rapid Barostat Bag (RBB) Pump and Catheter System
- K262712 — Duet Spinal Fixation System
- K262893 — Eonis SMA kit
- K263033 — Dental Computed Tomography X-ray System (Rubik XSmart, Rubik X1, Rubik X3) (Matrix 7000, Matrix 7800)
- K263035 — CDC Human Influenza Virus Real-time RT-PCR Diagnostic Panel (includes Influenza A/B Typing Kit, Influenza A Subtyping Kit, Influenza A(H5) Subtyping Kit, and Influenza B Lineage Genotyping Kit)
- K263172 — SAS MIS Pelvic Incidence Rods
- DEN260007 — SmartRead(TM) Medical Device Identifier (4100)
Data sourced from openFDA. This site is unofficial and independent of the FDA.