FDA 510(k) clearances — page 237
clearances on record, most recent first.
Clearances — page 237
23,601–23,700 of 176,542- K190555 — PowerX Lipo System
- K190817 — HS Fiber
- K190843 — Synchro2 Support Guidewire
- K182092 — BD Intelliport System
- K182888 — MRCAT Pelvis
- K183045 — Eclipse 2L
- K183342 — SambaScrew 3D SI Fusion System
- K183540 — Oral/Enteral Syringes with ENFit connector (12 mL to 60 mL), Low Dose Tip Oral/Enteral Syringes with ENFit connector (1 mL to 6 mL)
- K190114 — Flexi-Seal PROTECT PLUS Fecal Management System (with ENFit Connector)
- K190305 — Additive Cap
- K190825 — Medtronic Model 5392 External Pulse Generator (EPG)
- K190866 — XmaruView V1 (Xmaru Chiroview, Xmaru Podview)
- K190894 — TOTIM Patient Cushion Immobilization System
- K182017 — Compex HD
- K182840 — Element Pediatric Wheelchair
- K190006 — Magnetic Surgical System
- K190553 — HardyCHROM CRE
- K190592 — YelloPort Elite Port Access System
- K190619 — Aspiron(TM) Aspiration Catheter
- K190627 — VALO Grand Corded
- K190655 — SeaSpine® Shoreline ACS- Anterior Cervical Standalone System
- K190965 — MyDay
- K181732 — InterSpace Knee Extra-Large Size, InterSpace Knee ATS
- K182108 — Portable Electro-Stimulation Therapy Device
- K182585 — JO Actively Trying Personal Lubricant
- K182637 — Philips IntelliVue XDS Software
- K182830 — Cardinal HealthTM Poly-Coated Open-Back Protective Gown
- K183094 — CyclaPlex Correction System
- K190290 — AltiVate Reverse Humeral Stem, 48mm
- K190464 — Penumbra System 3D Revascularization Device
- K190807 — VITROS XT Chemistry Products TBIL-ALKP Slides
- K181787 — Cediflo Enteral Feeding Tubes & Cediflo Junior Enteral Feeding Tubes
- K182049 — exCellerator Cervical Collection Device
- K182071 — Multi-Sideport Catheter Infusion Set
- K182100 — Smile Makers Personal Lubricant
- K183146 — Ranfac Cartilage Biopsy Needle
- K183248 — Synapse Enterprise Viewer Version 1.0
- K183537 — PANAVIA SA Cement Universal
- K190042 — Brainlab Elements Image Fusion Angio
- K190601 — MasteRad MX30
- K190771 — Xpert MRSA/SA Blood Culture, GeneXpert Dx System, GeneXpert Infinity-48s System, GeneXpert Infinity-80 System
- DEN170064 — Comaneci, Comaneci Petit, Comaneci 17
- K173065 — A&D Medical Blood Pressure Monitors
- K182172 — Medline Level 4 Surgical Gown (Sirus), Medline Level 4 Surgical Gown (Eclipse), Medline Level 4 Surgical Gown (Aurora)
- K183156 — V-Laser
- K183679 — Occlusion Balloon Catheter
- K190043 — Halley resin
- K190113 — Veloxion Controller Kit, Veloxion Fluid Control Set, Veloxion Resectoscope, Veloxion Video Control Unit, Veloxion Roll Stand, Waste Management Tubing, Tissue Catch, Waste Management Bags
- K190212 — AXS Vecta Aspiration System
- K190375 — Parcus ATLAS
- K190496 — hyperion X9 pro, NewTom GiANO HR, X-RADiUS TRiO PLUS
- K190789 — IntelliCartTM System
- K190812 — RAYSCAN a-Expert3D
- K181472 — AEROFLEX(TM) Automatic Endoscope Reprocessor with AUTOSURE(TM) MRC Monitor
- K181971 — Bander Ureteral Diversion Stent Set, Dretler Ureteroscopy Stent Set
- K182386 — Reprocessed Supreme Diagnostic Electrophysiology Catheter
- K182723 — Flexible HD Cysto-Urethroscope System
- K190110 — NanoBone SBX PUTTY, NanoBone QD
- K190489 — Elcam Stopcocks and Manifolds
- K190621 — SB Knife/Short type, SB Knife/Standard type, SB Knife/Jr type, SB Knife/Jr type - Long
- K190753 — EverCrossTM 0.035 OTW PTA Dilatation Catheter
- K182513 — FluChip-8G Influenza A+B Assay
- K182516 — Comprehensive Nano Stemless Shoulder
- K182778 — LC GLOSSFILL XR
- K183613 — exGraft, exGraft Carbon
- K190407 — CryoLab
- DEN180013 — PREVENA 125 and PREVENA PLUS 125 Therapy Units
- DEN180041 — Monarch eTNS System
- K180065 — FUSION Plus Curing Light
- K181571 — OASYS Oral/Nasal Airway System and OASYS Herbst with Dentitrac Patient Monitor
- K183056 — ASSURE® Anterior Cervical Plate System
- K183090 — Relieva Tract Balloon Dilation System
- K183192 — CapsoCam Plus (SV-3)
- K190415 — ATLAS Plating System
- K190463 — Cepheid Xpert C. difficile/Epi Control Panel
- K190729 — SPY Portable Handheld Imaging (SPY-PHI) System
- K190791 — Ez3D-i/E3
- K181747 — Orthodontic Appliance
- K182103 — Psychemedics Microplate EIA for Fentanyl in Hair
- K182457 — Hi-Torque Vektor, .014, 195cm, Str, Hi-Torque Vektor, .014, 195cm, J, Hi-Torque Vektor, .014, 300cm, Str, Hi-Torque Vektor, .014, 300cm, J
- K183593 — Lung Vision System
- K183601 — CryoTouch
- K190109 — MicroScan Dried Gram Negative MIC/Combo Panels with Eravacycline (ERV) (0.016-32 ug/mL)
- K190364 — CancelleX Porous Titanium Lumbar Interbody Device
- K190506 — NeoForm Annuloplasty Ring
- K190644 — Guide Sheath
- K190788 — Disposable Standard Clamp
- K181988 — eMurmur ID
- K182702 — SEKURE Creatine Kinase Assay
- K182944 — Dr. Amplatz Micro Plug
- K182998 — Andorate Auxiliary Water Connector
- K183043 — 0.071 ID MantaRay Reperfusion Catheter, 0.055 ID MantaRay Reperfusion Catheter, 0.045 ID MantaRay Reperfusion Catheter, 0.035 ID MantaRay Reperfusion Catheter
- K183152 — Phoenix
- K183189 — Ultra OTC Facial Toning System
- K183395 — Arthrex 2.5 mm Tenodesis Screw
- K183403 — JETi 88 Peripheral Thrombectomy System
- K183584 — JO H2O Jelly Original Personal Lubricant
- K183634 — Stasis Monitoring System
- K183638 — SmartLinx Vitals Plus Patient Monitoring System
- K190082 — Straumann BLX Variobase Abutment
Data sourced from openFDA. This site is unofficial and independent of the FDA.