FDA 510(k) clearances — page 236
clearances on record, most recent first.
Clearances — page 236
23,501–23,600 of 176,542- K181419 — FLIX-EMS
- K190069 — SixFix Hexapod Fixator and Deformity Analysis and Correction Software (DACS)
- K190297 — Celerity HP Incubator
- K190315 — ImmunoCAP Allergen e229, Allergen Component rCan f 4 Dog, ImmunoCAP Allergen e230, Allergen Component rCan f 6 Dog, ImmunoCAP Allergen e231, Allergen Component rFel d 7 Cat
- K190670 — ORTHOLOC 2 Lapidus with Rotation System
- K190848 — JUSHA-M550G/ JUSHA-M550/M550G/M550 LCD Monitor
- K190974 — D'Vill Introducer
- K190985 — BAROnova Insufflation System, BAROnova Accessory Kit
- K183109 — ControlRad Trace Model 8
- K190170 — MVP Cervical Plate System
- K190219 — Simplexa VZV Direct, Simplexa VZV Positive Control Pack
- K190604 — PIVO
- K190764 — SurgicalAR
- K183515 — MR8 Drill System, Midas Rex MR8 ClearView Tools
- K182180 — SPEAC System
- K181545 — Hysteroscope System
- K182612 — Powder Free Nitrile Examination Gloves (Cobalt Blue, Black, Blue and Violet Blue)
- K182959 — Wallace Dual Lumen Oocyte Recovery System
- K183319 — Triangle System
- K183583 — Vanguard Complete Knee System
- K190027 — SteriStay
- K190173 — Ergoline Inspiration 550 Hybrid Technology / Sound, Ergoline Inspiration 550 Hybrid Technology / AC / Sound, Ergoline Planet Fitness 42/4 Hybrid Light Technology / Sound
- K190275 — GenePOC Carba
- K190854 — Therm-X
- K190989 — 6400 Ultrasound System (MyLabX6, MyLabX7)
- K190995 — ExactVu High Resolution Micro-Ultrasound System
- K191046 — L10 LED Light Source with AIM, L11 LED Light Source with AIM
- K181491 — Delta Dual Mobility System
- K181894 — TOF-Cuff monitor
- K181933 — DePuy Synthes Sterilization Container System
- K182617 — ATEC IOM Accessory Instruments
- K183160 — TEG 6s Hemostasis System, TEG 6s Citrated: K, RT, FF Assay Cartridge
- K183310 — Encore System
- K190218 — Unscented Menstrual Tampon
- K190393 — Wingman 14C Crossing Catheter
- K190666 — CYGNUS Anterior Cervical Plate System
- K190699 — Rowheels Revolution 1.0
- K190917 — V-PRO 60 a Low Tempurature Strilization Systems, V-PRO s2 Low Temperature Sterilization Systems
- K190948 — Magic Clear Aligners
- K182238 — Reprocessed ViewFlex Xtra ICE Catheter
- K182428 — GlucoLeader Enhance Blood Glucose Monitoring System
- K183126 — Electrosurgical accessory
- K183443 — SomnoDent Avant
- 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
Data sourced from openFDA. This site is unofficial and independent of the FDA.