FDA 510(k) clearances — page 34
clearances on record, most recent first.
Clearances — page 34
3,301–3,400 of 176,479- K253034 — HemoSphere Stream Module
- K253040 — Aevumed FASE Suture Anchor
- K253249 — TriALTIS Spine System
- K242827 — A8 INTEGR8 Porous Pedicle Screws
- K251414 — Miracu Polydioxanone (PDO) Suture and Needle (MONO)
- K252155 — AVAVA Skin Treatment System
- K252277 — Spiral Laminar Flow Vascular Arteriovenous Graft (AV0645)
- K252319 — Q-Switched Nd: YAG Laser machine (LFS-C13U)
- K252640 — VereSee Optical Veres Needle and Endoscopic Camera
- K252665 — brAIn Shoulder Positioning
- K253182 — InkSpace Imaging Small Body Array (SBA12PH30x)
- DEN240076 — Modius Lean
- K250145 — Biopsy Port Adapter
- K250159 — Immunoglobulin Isotypes (GAM) for the EXENT Analyser; EXENT Analyser
- K250178 — Adin Customized Abutments
- K250197 — Estremo Fibular Nail
- K250203 — SureAx-Guide
- K250227 — JOVS Electric Stimulation Beauty Device (JE2)
- K250250 — ADVIA Centaur Anti-Thyroid Peroxidase II
- K250911 — MOSkin Radiation Measurement System
- K250945 — Single Use Preloaded Sphincterotome V (Distal Wire Guided) (KD-VC600 Series) +3 more
- K251146 — IntelliVue Patient monitors MX400, MX450, MX500, MX550
- K251282 — StealthStation S8 Spine Software
- K251355 — X1-FFR
- K251673 — X9 Ultrasound System
- K251778 — Remi Custom Night Guard
- K251832 — InZone IST Detachment System; IZDS Connecting Cable
- K252075 — Program insite® Powder-Free, Disposable Nitrile Exam Gloves
- K252254 — Osteotomy Wedge System
- K252264 — MEGELIN LED Light Therapy Mask (5 models)
- K252266 — S.I.N. Dental Implant System
- K242100 — SurgiAid Collagen Wound Dressing (HA)
- K243727 — Re:Balans
- K250731 — MateLaser Medical Diode Laser Systems (ML-DLS-30)
- K250852 — Coolfase
- K251497 — Elos Accurate Hybrid Base
- K251882 — Uterine Aspiration Set
- K251994 — Arthrex Synergy Vision Imaging System
- K252024 — NeurAxis IB-Stim (01-1020)
- K252093 — Light Therapy Mask (1019055)
- K252153 — FFX Facet Fixation System
- K252223 — Alpha Endo Handpiece (Alpha Endo)
- K252247 — Injector Force Max Single Use Injector (4 models)
- K252476 — Viewer (5.4); Elements Viewer; Mixed Reality Viewer; Smart Layout; Elements Viewer Smart Layout
- K252612 — INDIGO® Aspiration System Lightning Flash Aspiration Tubing; INDIGO® Aspiration System Lightning Bolt Aspiration Tubing
- K252631 — Profoject Disposable Needle
- K253000 — CryoFreeze Wart and Skin Tag Remover
- K253024 — ProZip Knotless Implant
- K253114 — TargetCool (RM-DT02W)
- K250107 — V-soft Line Barbed Surgical Suture (Various)
- K250510 — Sure-Fine Insulin Syringes
- K250979 — Thermogard HQ Temperature Management System, Thermogard XP® Temperature Management System (VitalTemp Universal Pad)
- K251294 — Bonafix Implant Abutments
- K251805 — syngo.CT Dual Energy
- K252020 — TunnelVision Endoscopic Soft Tissue Release System and the HBL Blade Assembly
- K252199 — AGFA HealthCare Enterprise Imaging
- K252367 — InbellaMulti System
- K252920 — ELEOS Limb Salvage System with NanoCept® Technology
- K252944 — LOCATOR® Angled Abutment
- K252946 — BioBrace® Extra-Articular Ligament Augmentation Kit
- K253348 — TargetCool-e
- K250115 — Hemastyl() Wound Dressing
- K250776 — Lithoblast Single Use Holmium Laser Fibers
- K251715 — FlowArt® Vial Access Device Vented
- K251874 — PureWay Sharps Container 1-Gal, 2-Gal, 3-Gal (800011 800012, 800013)
- K252234 — IPL Home Use Hair Removal Device (Models: FDA11, FDA12, FDA13, FDA14, FDA15, FDA16, FDA17, FDA18, FDA19, FDA20, FDA21S, FDA22S, FDA23S, FDA24S, FDA25, FDA26, FDA27, FDA28, FDA29S, FDA30S, FDA31S)
- K252637 — Community Containers (Flap and Daisy)
- K253010 — Mini Superhawk Suture Anchor System
- K253099 — LIFEPAK 15 AC Power Adapter (41577-000333)
- K253331 — PressON Spinal Fixation System
- K253461 — Demi Pro
- K251522 — Mg OSTEOINJECT; Mg OSTEOREVIVE; Mg OSTEOCRETE
- K242227 — GENEO X ELITE
- K251034 — Radiant Renewal Skincare Lid (HD-59A, HD-59B, HD-70); Radiant Renewal Skincare Wand (HD-44)
- K251595 — COVID-19 Detect Rapid Self -Test
- K243078 — HexaPLUS S OneDrill Implant System
- K243815 — SoClean 3+
- K250085 — On Call® Sure GK Blood Glucose & Ketone Monitoring System +1 more
- K250249 — Gold Standard Diagnostics (GSD) AIX1000 Rapid Plasma Reagin (RPR) Automated Test System
- K250351 — Single Use Electrosurgical Knife (3 models)
- K251082 — HYDROS Robotic System (HY1000); HYDROS Handpiece (HH1000); HYDROS TRUS Probe (HU1000)
- K251602 — Alphenix, INFX-8000V/B, INFX-8000V/S, V9.6 with aEvolve Imaging
- K251708 — EvoEndo Single-Use Endoscopy System
- K251835 — Yomi Robotic System
- K251866 — Tegaderm Post-Op Transparent Antimicrobial Dressing
- K251927 — Zeta Navigation System (ZNS131-US)
- K252001 — Collagen Wound Dressing
- K252209 — IPL Home Use Hair Removal Device (JD-TM016, JD-TM023, JD-TM027, JD-TM028, JD-TM032)
- K252312 — Eleganz IM Threaded Nail System (IM Threaded Nail System)
- K252544 — TMINI Miniature Robotic System
- K252737 — DeGen Medical Latitude-C AM Cervical Interbody Fusion System
- K252903 — Verruca-Freeze H Plus
- K250645 — SleeveLUX 24 Anoscope/Proctoscope (P2001); SleeveLUX 16 Anoscope/Proctoscope (P2002)
- K251366 — EEG-1260A Neurofax System (EEG-1260A); JE-940A EEG Amplifier Unit (JE-940A); LS-940A Photic Stimulator (LS-940A)
- K251651 — EPIQ Series Diagnostic Ultrasound System; Affiniti Series Diagnostic Ultrasound System
- K251795 — Wrist automatic blood pressure monitor (LD-735, LD-752, LD-753)
- K251851 — DIASAFEplusUS (F00013010)
- K251876 — cleadew GP hydra one
- K252272 — ORA Method LED Gua Sha (GS-04)
- K252553 — Facial & Body Beauty Device (INIA-BD001, INIA-BD002, INIA-BD003, INIA-BD004, F2C15, F3222 Pro, F5516, F3606, F2210 Pro, F5808, INIA-ED001, INIA-ED002, INIA-BLD001, E1507)
Data sourced from openFDA. This site is unofficial and independent of the FDA.