FDA 510(k) clearances — page 110
clearances on record, most recent first.
Clearances — page 110
10,901–11,000 of 175,620- K230141 — LOQTEQ® VA Elbow Plates 2.7/3.5 System
- K230435 — Arthrex 3.9 mm SwiveLock Anchor
- K230441 — EMPOWR Stem Extender, 50mm
- K220673 — Sterile Silver Alginate Wound Dressing
- K222619 — Ensmile
- K222813 — Nitrile Examination Gloves
- K222838 — iSyncBrain©-C
- K222839 — EndoWrist Stapler 30 System, EndoWrist Stapler 45 System, SureForm 45 System, SureForm 60 System, 8 mm SureForm 30 System
- K223084 — MilkMate Breast Pump
- K223095 — Senhance Surgical System
- K223154 — Magstim Horizon 3.0 TMS Therapy System, Horizon 3.0 System, Horizon 3.0, H3.0, Horizon 3.0 with StimGuide+
- K223393 — Electric Wheelchair
- K223828 — BENCOX Delta Option Heads
- K230404 — BIOFIRE FILMARRAY Gastrointestinal (GI) Panel
- K214001 — Comprehensive® Shoulder System, Comprehensive® Reverse Shoulder System
- K220122 — APEX 6
- K220234 — Precice Intramedullary Limb Lengthening System
- K221924 — Digital Routines
- K222983 — NeuroBlate Fusion-S Software V3.17
- K222991 — Air Compression Leg Massager (model: EMK-701)
- K223102 — Tegamen Nitrile Examination Gloves
- K223375 — Powder Free Nitrile Patient Examination Glove, Blue Colored, Non-sterile, Low Dermatitis Potential. Tested for Use with Chemotherapy Drugs and Fentanyl Citrate.
- K223381 — iExaminer System with Panoptic Plus
- K223760 — ECHELON LINEAR 60 mm Cutter (GLC60);ECHELON LINEAR 80mm Cutter (GLC80);ECHELON LINEAR 100 mm Cutter (GLC100);ECHELON LINEAR Cutters 60mm Blue Reload (GLCR60B);ECHELON LINEAR Cutters 60mm Green Reload (GLCR60G);ECHELON LINEAR Cutters 80mm Blue Reload (GLCR80B);ECHELON LINEAR Cutters 80mm Green Reload (GLCR80G);ECHELON LINEAR Cutters 100mm Blue Reload (GLCR100B);ECHELON LINEAR Cutters 100mm Green Reload (GLCR100G)
- K230124 — LUSTRE ClearSkin Renew Pro Facewear Mask(Model: PR4001)
- K212906 — HeartBuds Electronic Stethoscope
- K213247 — JETT PLASMA Medical II
- K223137 — Lexie Lumen Self-Fitting OTC Hearing Aids with Lexie Application
- K223279 — RT Elements (4.0)
- K223464 — Leg and Foot Air Wave Pressure Therapy Device
- K223609 — RevCore Thrombectomy Catheter.
- K223753 — Cervical Plate System
- K230019 — SofWave System
- K230145 — ONE-CUF
- K221352 — Surgical Face Mask
- K222775 — Aarhus Applicator Set
- K222954 — Innova Vision Hydrogel (Etafilcon A) Soft (Hydrophilic) Contact Lens
- K223321 — Omnia Medical Coupler-C Anterior Cervical Plate
- K223350 — Remi Robotic Navigation System
- K222456 — High Protection Surgical Gown
- K213744 — Avoset Infusion Pump System
- K220398 — Aristotle 14 Guidewire; Aristotle 18 Guidewire; Aristotle 24 Guidewire; Volo 14 Guidewire; Zoom Wire 14 Guidewire
- K221129 — CloudTMS for OCD
- K221198 — Sensititre YeastOne Susceptibility System with Fluconazole in the dilution range of 0.12-128ug/mL
- K221292 — Uni Knee Resurfacing System
- K221623 — FlexSys, FlexSys UVB EPL 308 nm, FlexSys UVB EPL lite 308 nm, FlexSys IR 1550 nm
- K222478 — BD Vacutainer® Luer-Lok Access Device, BD Vacutainer® Blood Transfer Device
- K222718 — Vial Adapter
- K223175 — lntravascular Administration Sets with Stopcock and Manifold
- K223325 — uMI Panorama
- K230295 — ATTUNE® Revision Cones
- K230349 — Lyra RSV+hMPV Assay
- K230433 — Arthrex Knotless FiberTak Suture Anchor
- K221301 — DESS Dental Smart Solutions
- K221373 — Essenz HLM
- K221700 — AutoPulse NXT Resuscitation System
- K221706 — AccuContour
- K221816 — Wesper Lab
- K221919 — DOUBLEFLO INFLOW/OUTFLOW PUMP, accessories and tubing sets
- K221930 — CEREGLIDE 71 Intermediate Catheter
- K221934 — CEREGLIDE 71 Intermediate Catheter; Cerenovus Aspiration Tubing Set
- K222430 — VITEK 2 AST-Gram Negative Fosfomycin (<=4 - >=256 µg/mL), VITEK 2 AST-GN Fosfomycin (<=4 - >=256 µg/mL), VITEK 2 AST-GN Fosfomycin
- K222663 — MultiStage Balloon Dilatation Catheter
- K222875 — Powered Muscle Stimulator (Model name:MagGraver F200)
- K223432 — Vassallo GT 018 Hybrid
- K223514 — Spectral Bone Marrow
- K223642 — LED Lip Perfector, model: ZC-05
- K223693 — Electric breast pump (model: M5)
- K223790 — Huvex Interspinous Fusion System
- K230363 — CPS Locator 3D Delivery Catheter
- DEN220039 — Sofia 2 SARS Antigen+ FIA, Sofia 2 SARS Antigen+ FIA Control Swab Set
- K213906 — extriCARE 1000 Negative Pressure Wound Therapy System
- K220101 — Pulse Oximeter
- K220613 — Bausch + Lomb (kalifilcon A) Soft (hydrophilic) Contact Lens, Bausch + Lomb (kalifilcon A) Soft (hydrophilic) Contact Lens for Astigmatism, and, Bausch + Lomb (kalifilcon A) Soft (hydrophilic) Contact Lens for Presbyopia
- K220966 — SINEFIX
- K221209 — PRECISION ECO Compostable / Plant Based Procedural Mask with Earloops
- K222007 — Arthrex Virtual Implant Positioning (VIP) System
- K222098 — ManaSport+
- K222136 — Cryo-Thermo Compression Device (FGK002)
- K222355 — PathKeeper System
- K223681 — Respiree Cardio-Respiratory Monitor
- K223688 — CONDUIT Lateral Lumbar Intervertebral Fusion Cage, CONDUIT Instruments
- K223742 — Dental Ceramic Blocks
- K230076 — Enhanced AURORA Medical Diode System, and related accessories
- K230321 — Persona Personalized Knee System
- K213892 — Grosz Warming Liquid, Grosz Play Tingling, Grosz KY Yours & Mine
- K220407 — Visby Medical Sexual Health Test
- K220549 — MINT Product Family (Including MINT, MINT Lift, and MINT-I Sutures), MINT Lift ML 1043, MINT Lift ML 1013, MINT Lift 1019, MINT Lift Mini 1014
- K221883 — Solero Microwave Tissue Ablation (MTA) System and Accessories
- K222465 — Tyber Medical Anatomical Plating System
- K222897 — Enlight 2100
- K223024 — MedCAD AccuPlan System
- K223401 — Disposable Surgical Gowns (S,M,L,XL,XXL,XXXL)
- K223726 — Aquilion Precision (TSX-304A/4) V10.14 with AiCE
- K230301 — Athena III Cervical Plate System
- K230331 — Protrieve Sheath
- DEN210033 — Lenire Tinnitus Treatment Device
- K212161 — Radical-7 Pulse CO-Oximeter and Accessories, Rad-97 and Accessories
- K221158 — Single-Use Video Flexible Ureterorenoscope System
- K221621 — Pro-X1 Trochanteric Nailing System
Data sourced from openFDA. This site is unofficial and independent of the FDA.