FDA 510(k) clearances — page 228
clearances on record, most recent first.
Clearances — page 228
22,701–22,800 of 175,699- K183461 — Rusch Flocath Hydrophilic Intermittent Catheter, Rusch MMG Hydrophilic Intermittent Catheter
- K190092 — UNiD Patient specific 3D printed TLIF cage
- K190147 — COLOSSEUM Mesh
- K190187 — Gynescope System
- K190223 — Cepheid Xpert CT/NG Control Panel
- K190567 — KeYi Spinal Fixation System
- K181854 — OssBuilder System
- K182865 — Neodent Instruments Kits
- K183016 — SteriCap Mini Needle
- K183432 — cobas u 601 urinalysis test system
- K183512 — Moore Park Mask
- K183701 — Stryker ChestShield Sterilization Tray System
- K190161 — Ethyl Chloride Medium Jet Stream, Ethyl Chloride Fine Pinpoint spray, Ethyl Chloride Mist, Ethyl Chloride Accustream 360* Medium Spray, Ethyl Chloride Accustream 360* Fine Spray
- K190649 — FUJIFILM Endoscope Model EC-760S-V/L
- K191011 — Scope ProTech
- K182460 — MD-6000P Bladder Scanner
- K190159 — Showa(R) Medical Exam Glove (Green) powder-free, disposable nitrile glove
- K190165 — Capstone Control Spinal System
- K190182 — Unity Subcutaneous Delivery System for Remodulin
- K190362 — HealthPNX
- K190643 — Medline Electrocautery Pencil
- K190900 — Biograph Vision
- K190941 — BioCardia 8.5 F Avance Steerable lntroducer
- K182437 — Wireless Intelligent Thermometer
- K183577 — Medline Quick-Clear Wand
- K180309 — Manual Wheelchair W54
- K182118 — armor LC
- K182430 — CLEARFIL MAJESTY IC
- K182877 — HALF DOME Posterior Lumbar Interbody System
- K183188 — Flexible Sensor-Ureterorenoscopes BOA Vision EF, Flexible Sensor-Ureterorenoscopes COBRA Vision EF
- K190083 — Leaf Photocoagulator
- K190222 — FilmArray Pneumonia/Pneumoniaplus Control
- K190266 — NeoLSD MSMS Kit
- K190278 — AuraGen 123 Suction Lipoplasty System (A123)
- K190287 — Arthrex DynaNite® PIP (Hammertoe) Implant
- K190409 — MatrixRIB Fixation System
- K190504 — Intracept Intraosseous Nerve Ablation System (RF Probe), Intracept Intraosseous Nerve Ablation System (Access Instruments), Relievant RF Generator
- K190525 — RELIEVA ULTIRRA Sinus Balloon Catheter
- K190532 — TruDi NAV Wire
- K190599 — Aptis Medical Distal Radio Ulnar Joint Implant
- K190879 — N Latex FLC kappa, N Latex FLC lambda
- K181671 — Cocoon Convective Warming System
- K182474 — alpha-AMYLASE DIRECT, alpha-AMYLASE EPS, alpha-AMYLASE PANCREATIC, BILIRUBIN DIRECT, BILIRUBIN TOTAL
- K183199 — TRIO Handpiece
- K190233 — K-Shield Advantage Port Access Infusion Set (PAIS)
- K190376 — PASS LP Spinal System
- K190540 — Ponto 4
- K190560 — SenSmart Model 8006CA Reusable Regional Oximetry Sensor, SenSmart Model 8006PI Disposable Patient Interface
- K190851 — HYDRASHIFT 2/4 daratumumab
- K180510 — NS 120P-TRS Airway Pressure Gauge
- K182231 — Brush Biopsy Set ; Deflectable Brush Biopsy Set
- K182646 — Vitreq disposable laser probes, light fibers and Chandelier
- K183394 — CARESCAPE Respiratory Modules, E-sCO, E-sCOV, E-sCOVX, E-sCAiO
- K183413 — TruWave Disposable Pressure Transducer
- K190154 — ETEST Piperacillin/Tazobactam (P/T) (0.016/4-256/4 ug/mL)
- K190227 — Boomerang Anterior Cervical Plate System
- K190551 — VASERlipo System
- 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
Data sourced from openFDA. This site is unofficial and independent of the FDA.