FDA 510(k) clearances — page 3
clearances on record, most recent first.
Clearances — page 3
201–300 of 176,428- K254238 — MINT MONO Sutures
- K260008 — Deterioration Index Version 2
- K261047 — Dental Diode Laser Device (Laser-Pen)
- K261102 — UNIDRIVE Select System
- K261229 — SCENARIA View Phase 6.0
- K261855 — Elucid PlaqueIQ
- K262098 — EnHAnce PEEK Bunion System
- K262262 — Pathfinder Endoscope Overtube
- K262524 — Sapphire Cooling IPL Hair Removal Device (Ice 2.0, Ice 2.1, Ice 2.2, Ice 2.0B, Ice 2.1B, Ice 2.2B)
- K262532 — NORMOFLO Irrigation Fluid Warming Sets and Accessories (IR-601, IR-501, IR-61, PL-61)
- K262599 — Biolinq Shine Autonomous Time-in-Range Microsensor
- K262637 — SLIT LAMP SL-D4 (Type: LED)
- K262817 — CrossFAST Integrated Microcatheter Advanced Delivery System
- K252995 — Durashield Device Kit
- K254196 — HARMONIC 1100 Shears (HAR1120); HARMONIC 1100 Shears (HAR1136)
- K254203 — Wearable Breast Pump (Model S36)
- K254260 — The VEGA Cervical Screw System
- K260173 — M-Vizion Femoral Revision System Extension
- K260677 — Vessel Closure Device (VCD177213P)
- K261266 — MOWANA Auto Duo
- K261275 — Unity Total Knee System, Unity Knee Cementless CR Femur
- K261392 — TriActive Dental Implant System
- K261673 — LED Therapy Device (QLXY-01)
- K261729 — EnSite X EP System
- K261817 — Diode Laser Therapy System (PZ-BDT67-01, PZ-BDT67-02)
- K261869 — Integrity Retractable Implant Inserter (6000127)
- K261959 — Neptune® SafeAir® 10ft Smoke Evacuation Pencil, Square Coated, 70mm Blade, Push Button Switch (0703-046-100) +3 more
- K262073 — Hygienic Protective Bite Cover (2207-010-50)
- K262091 — FRAXION Spinal Fixation System
- K262495 — Miru 1day UpSide (midafilcon A)
- K262913 — Protégé EverFlex Self-expanding Peripheral Stent System
- K254142 — Dia-X Sil Heavy Body
- K254152 — Dia-X Sil Light Body
- K254181 — Aristotle 65 Macrowire
- K254212 — NC PTA Balloon Dilatation Catheter
- K260220 — Route 92 Medical Full Length 046 Access System
- K260226 — ElintMAX Respiratory Monitor (ElintMAX Monitor A1)
- K260309 — Ambu® aScope 5 Broncho 2.7/1.2; Ambu® aScope 5 Broncho 4.2/2.2; Ambu® aScope 5 Broncho 4.2/2.2 Sampler Set
- K260906 — a2z-Abdo-Triage
- K261283 — APERTO Lucent MRI System
- K261370 — LED Light Therapy Masks (LED Face Mask Pulse (FAC06NA))
- K261400 — Ambu® aScope Gastro; Ambu® aScope Gastro Large
- K261467 — GT Metabolic Magnet System (MAG-04, DS-01)GT Metabolic Magnet System (MAG-05, DS-01)
- K261623 — EchoPAC Software Only / EchoPAC Plug-in (v211)
- K261712 — Ceribell EEG Analysis Software
- K261758 — Embrace Vision Neonatal MRI System
- K261778 — JADE SCORE PTA Scoring Balloon Dilatation Catheter
- K261865 — AerFrame Alignment Laser Box (LBV2)
- K261888 — ClearClub Impression Material
- K261896 — iOS CamAPS FX
- K261913 — X°Port Heart Preservation System
- K261919 — Multifunctional wheelchair (YJ-059)
- K262054 — Electric Wheelchair
- K262559 — Mouth Guard
- K262877 — SOLTIVE Laser System (SOLTIVE Pro SuperPulsed Laser, SOLTIVE Premium SuperPulsed Laser, SOLTIVE Laser Fibers, and Accessories)
- K254214 — OOOPDS
- K254299 — CLEARVISION Irrigation Sheath 0° (7241AS) +2 more
- K260141 — Bariatric Heavy Duty Wheelchair (YJ-010V, YJ-010C)
- K260144 — Reclining wheelchair (YJ-013L)
- K260145 — YJ-K1K2 Wheelchair (YJ-013F)
- K260446 — Tontarra Punches and Rongeurs
- K261070 — LigaSure RAS Maryland Jaw Vessel Sealer/Divider, Nano-coated
- K261447 — CVAC® Aspiration System
- K261677 — Artificial Intelligence Renal Assessment (AIRA) Version 1
- K261861 — SPINEsim v1.0
- K262057 — GMK Extension
- K262963 — TMC Implant Fixation System
- K253481 — colonic FTRD Set (200.70); diagnostic FTRD Set (200.76); gastroduodenal FTRD Set (200.72)
- K260781 — Yumizen H550
- K260795 — Hand-held Dental X-ray System (HyperLight-M)
- K261089 — Radical 064 Reperfusion Catheter; Radical 076 Reperfusion Catheter; Radical Aspiration Tubing Kit
- K261438 — HORIZON 8AF (Integrated OXY MODULE 8AF and Horizon CVR) (US5305)
- K261517 — qCT Lung (v1.0)
- K262163 — BD BBL Mueller Hinton II Broth (Cation-Adjusted); BD Difco Mueller Hinton Broth
- K262193 — RIVA® Posterior Fixation System with NanoACTIV Surface Technology +1 more
- K262526 — Safety lancet (XL)
- K260133 — CADDIE
- K261287 — Digistat Care
- K253063 — Venti-Trach Tracheostomy Tube (4 models)
- K254041 — SkinSmart Antimicrobial HydroGel
- K254051 — Extroducer Infusion Catheter System
- K254072 — BoneVue
- K254119 — Wearable ECG Recorder (8 models)
- K254123 — Ecomed Disposable Administration Sets
- K254174 — Surgical Power System
- K254177 — Disposable Sterile Skull Drill (LZ)
- K254185 — Potenza Prime
- K260001 — Mint ACE Pump
- K260063 — GSPE Spacer
- K260115 — DRIM-Nail System
- K260410 — Single Use Ureteral Access Sheath
- K261019 — ANTERION
- K261255 — KOWA FM-600
- K261305 — MICSI-PET
- K261338 — RENASYS DYNAFLOW Kit (66807741)
- K261580 — ZBPro Diagnostic (Version 2.0)
- K261807 — Sequential Circulator (SC-4004-DL, SC-4008-DL)
- K261837 — FINDER Flu A&B/SARS-CoV-2 Test
- K262007 — PRIMED AAMI Level 3 Open Back Gowns
- K262025 — Innovasis AxTiHA® Stand-Alone ALIF System +2 more
Data sourced from openFDA. This site is unofficial and independent of the FDA.