FDA 510(k) clearances — page 302
clearances on record, most recent first.
Clearances — page 302
30,101–30,200 of 176,542- K162979 — Veloxion System
- K163249 — GoSpiro
- K163267 — NITRILE EXAMINATION GLOVE
- K163290 — INFINITT ULite
- K163297 — Scan&GO
- K163425 — NMUC Brand Small And Large Fragment Osteosynthesis Plating System, NMUC Brand of DHS/DCS Plating System
- K163491 — NuVasive CoRoent Small Interbody System
- K163587 — VERIFY Incubator for Assert Self Contained Biological Indicators
- K170204 — FFR Link, FFR Signal Processing Module
- K170329 — Basic, Dominant Flex
- K170335 — Custom Stable(TM) Rigid Gas Permeable Scleral Contact Lens
- K170701 — GEN_2 and GEN_3 Mechanical Wheelchairs
- K161428 — PerfectSmooth
- K162037 — Eclipse with VEMP
- K162217 — LOYON
- K163103 — Tranberg CLS Diffusor Laser Fiber
- K163182 — Medtronic Legend Pneumatic +5 more
- K163314 — Guidezilla II Guide Extension Catheter; Guidezilla II LONG Guide Extension Catheter
- K163558 — Synapsys Ulmer Video Nystagmograph
- K170277 — DC-8/DC-8 PRO/DC-8 CV/DC-8 EXP/DC-8S Diagnostic Ultrasound System
- K161141 — ENFit Enteral Pump Syringes PENTA ENFit, ENFit Enteral Pump Syringes NUTRIFIT
- K161979 — ENFit enteral syringe
- K163017 — Nitrile Blue Powder Free Examination Gloves with Low Dermatitis Potential Claim and Tested for Use with Chemotherapy Drugs
- K163099 — My Dose Coach
- K163109 — OxyHeal 4000 Multiplace Hyperbaric Chamber Family
- K163300 — ThermoShield HME Filter
- K170520 — HyperVit Vitrectomy Probe, 23 GA, HyperVit Vitrectomy Probe, 25+, HyperVit Vitrectomy Probe, 27+
- K170530 — Butrex Lumbar Buttress Plating System
- K170636 — Fathom-16 Steerable Guidewires
- K152534 — Medisign MM1000 BT Blood Glucose Monitoring System, Medisign MM1100 BT Blood Glucose Monitoring System, Medisign MM1200 BT Blood Glucose Monitoring System, Smart Diabetes Bluetooth Blood Glucose Monitoring System, Medisign MM 1000 BT MULTI Blood Glucose Monitoring System, Medisign MM 1100 BT MULTI Blood Glucose Monitoring System, Medisign MM 1200 BT MULTI Blood Glucose Monitoring System, Smart Diabetes Bluetooth Pro Blood Glucose Monitoring System
- K162740 — MicroScan Dried Gram-Negative MIC/Combo Panels with Imipenem (0.25 - 8 ug/mL)
- K162758 — VERIFY SixCess Steam Indicators, VERIFY SixCess Flash Indicators, VERIFY Bowie Dick Test Pack, VERIFY SixCess Challenge Pack, VERIFY SixCess FP Challenge Pack
- K163157 — SmartGrid
- K163296 — SOMATOM go.Up, SOMATOM go.Now
- K163320 — LAP-Pump PP110
- K163343 — Icare HOME tonometer
- K163401 — Nix Ultra Lice Treatment Kit
- K163405 — 360KS Implant Positioning System
- K163608 — HAART 300 Aortic Annuloplasty Device 19mm, HAART 300 Aortic Annuloplasty Device 21mm, HAART 300 Aortic Annuloplasty Device 23mm, HAART 300 Aortic Annuloplasty Device 25mm
- K163637 — BD Phoenix Automated Microbiology System - GN Ceftazidime/avibactam (0.25/4- 32/4ug/mL)
- K160139 — Luggie Chair
- K161318 — Phantom Fukushima Neurological Holding Systems, Phantom Mastability Neurological Holding Systems
- K161691 — Direct LDL Cholesterol (LDL)
- K163161 — Sterile Single-use Syringe with Needle
- K163162 — Sterile Hypodermic Safety Syringes for Single Use
- K163175 — Bel-Cypher Pro
- K163323 — Dolphix® External Fixation System MR Conditional
- K163488 — Flex-Thread Clavicle Pin System
- K170296 — CoreCath 2.7S
- K170539 — Avitus Bone Harvester with Filter Insert - 5mm, Avitus Bone Harvester - 5mm, Avitus Bone Harvester with Filter Insert - 8mm, Avitus Filter Insert - 8mm, Avitus Filter Insert - 5mm
- K153600 — Consult Station TS
- K161077 — RnD TE and RnD SE
- K161250 — OC-FLEX Flexible IntraOral Cannula
- K162308 — Noris Medical MBI-2mm Dental Implant System
- K162522 — UltraCath Continuous Nerve block Catheter
- K162562 — OPT-SHIELD AIR, SUPINE; OPT-SHIELD, LITHOTOMY
- K162868 — Exam Vue PACS
- K162898 — Olecranon Plating System
- K163239 — SMARTmatic
- K163331 — Discovery MR750 3.0T +4 more
- K163346 — MAZIC Duro
- K163378 — Monarch Airway Clearance System
- K163569 — Elecsys CMV IgM
- K163586 — Trovita Health Science Safe-T Feed Ready-to-Feed Pouch with ENFit Connector
- K163655 — Sparkling
- K170501 — CrossFT Knotless Biocomposite Suture Anchor with Disposable Driver
- K170583 — Intersept Filtered Cardiotomy Reservoir with Cortiva BioActive Surface
- K161416 — Multi-unit Abutment Plus
- K161705 — U2 Total Knee System E-XPE products
- K161840 — LINK® SP-CL® Hip System PoroLink® (microporous) and HX® (CaP) coated & LINK® LCU® Hip System PoroLink® (microporous) and HX® (CaP) coated
- K162070 — JOINIX CANNULAR SYSTEM
- K162298 — LOCI Total Vitamin D Total Assay, LOCI VITD CAL
- K162313 — NuVasive Next Generation NVM5 System
- K162880 — TIPCAM 1S 3D System
- K163003 — Y3 Proximal Femoral Plate System
- K163082 — 6200 Ultrasound System and 6250 Ultrasound System
- K163201 — KYMCO EQ10D Scooter
- K163230 — NuVasive Modulus XLIF Interbody System
- K163471 — Kalitec Direct InSePtion MIS Fixation System
- K163498 — VALIDATE Heparin Calibration Verification/Linearity Test Kit
- K170451 — FDX Console (DR-ID300CL) Software
- K170455 — MectaLIF Anterior Stand Alone
- K162415 — Spectra 9Plus
- K162905 — SleepWeaver 3D Nasal Mask
- K163364 — MOJAVE Expandable Interbody System
- K163572 — LV Liberty Vision Model 1 90 Yttrium Brachytherapy Source
- K160287 — Rapid Barostat Bag (RBB) Pump and Catheter
- K161598 — NobelZygoma 0°
- K161785 — THD ANOPRESS
- K161880 — NIVR58-T kit
- K162960 — TotalC-Ram
- K163093 — Safety Blood Collection Set
- K163517 — Liofilchem MIC Test Strip (MTS) Telavancin 0.016 - 256.0 µg/mL
- K163522 — FilmArray Warrior Control Panel M290
- K170127 — HardyDisk Ceftolozane/Tazobactam, (30/10 ug)-C/T40
- K162429 — ZipE Knotless Tissue Repair and Attachment Devices
- K162654 — mollosil plus
- K162836 — FUJIFILM Surgical System
- K162921 — Navigated Instrument System
- K163039 — ORTHOLOC® 3Di Small Bones Plating
Data sourced from openFDA. This site is unofficial and independent of the FDA.