FDA 510(k) clearances — page 323
clearances on record, most recent first.
Clearances — page 323
32,201–32,300 of 175,699- K151943 — Vas-Q-Clip
- K152200 — SurgTech Interbody System
- K152274 — MSCB-001
- K152470 — Great Basin Staph ID/R Blood Culture Panel
- K152808 — U&U Insulin Syringe with/without Safety Retractable Device
- K152978 — DeRoyal Angiography Kits
- K153337 — Corvocet Biopsy System
- K153441 — VibraPEP
- K153595 — Optetrak Logic Metaphyseal Cones
- K153721 — iTotal Cruciate Retaining (CR) Knee Replacement System
- K153725 — Corin TaperFit Hip Stem
- K160191 — Align Anterior Ankle Fusion Plate
- K160273 — truFreeze System
- K160277 — LOGIQ F8 Expert, LOGIQ F8, LOGIQ F6
- K150702 — Exceed Tx
- K151342 — Arthrex SwiveLock Anchors
- K151461 — Hybernite RT
- K151778 — Cardinal HealthTM Sterile Latex Powder-Free Orthopedic Surgical Gloves with Hydrogel Coating
- K151881 — X-Fix Line Additions
- K152253 — Biomet Microfixation RibFix Blu Thoracic Fixation System
- K152716 — EV Insite System
- K153202 — iMESH Tacker
- K153226 — Solex 7 Intravascular Heat Exchange Catheter, ZOLL Start-Up Kit
- K153392 — STERIZONE VP4 Sterilizer
- K153667 — TRUESPAN Meniscal Repair System
- K153782 — NuVasive® Lumbar Interbody Implants
- K160547 — Cascadia Interbody System
- K152090 — Reprocessed Steerable Introducer
- K152199 — RejuvatoneMD
- K152631 — MPO Total Knee Systems MR Labeling
- K152933 — Vesalius
- K152975 — VDT985US Vicks SmartTemp Thermometer
- K153758 — Straumann Bone Level Tapered Implants
- K160259 — ZELTIQ CoolSculpting System
- K160466 — Response 5.5 Spine System
- K160479 — PointerShell Universal, PointerShell LS
- K143468 — QbCheck
- K151754 — Glide-On Vinyl Examination Gloves
- K152051 — ClearMet
- K152337 — cryoFORM cryoICE cryoablation probe
- K152955 — Great Basin Shiga Toxin Direct Test
- K153324 — Ingenia 1.5T and Ingenia 1.5T S R5.2
- K160098 — Single Use Aspiration Needle NA-U401SX
- K160362 — Z-Span Plate System
- K160521 — ECHELON FLEX 60 Powered Plus Compact Articulating Endoscopic Linear Cutter, 280mm
- K150566 — Oniris
- K153019 — Disposable Adhesive Surface Electrodes, Disposable/Reusable Cup Electrodes
- K153510 — Powder Free Polychloroprene Examination Glove Green
- K153554 — Genesis Low Temperature Reusable Rigid Container System
- K153717 — Venus Versa System
- K153770 — OS2(R)-VP Varisation Staple
- K160120 — D-SPECT Processing and Reviewing Workstation
- K160229 — Echotip Ultra Endobronchial High Definition Ultrasound Needle, Echotip Procore Endobronchial High Definition Ultrasound Biopsy Needle
- K160420 — SpeqT
- K150588 — OVA1 Next Generation
- K150915 — SPINAUT-P
- K151433 — AUDICOR CA300/CC100 Analyzer with SDB
- K151499 — CareTaker Continuous Non-Invasive Blood Pressure Monitor, CareTaker Wireless VItal Signs Monitor
- K151722 — Slim UP ULTRA
- K151749 — somatom Scope(with syngo CT VC30-easyIQ version), SOMATOM Scope Power(with syngo CT VC30-easyIQ version)
- K151845 — Infant Heel Warmer (Model 24401) and WarmGel Infant Heel Warmer (Model 20418)
- K152938 — DBB-06 Hemodialysis Delivery System
- K152999 — CorPath 200 System
- K153646 — SAFECARE Urine Test Amphetamine, SAFECARE Urine Test Cocaine, SAFECARE Urine Test Marijuana
- K153693 — Immunalysis Methamphetamine Urine Enzyme Immunoassay, Immunalysis Multi-Drug Calibrators
- K153710 — Tuxedo Digital Dental Sensor
- K153741 — CLUNGENE Methamphetamine Test, CLUNGENE Morphine Test, CLUNGENE Marijuana Test
- K160208 — NILE Alternative Fixation Spinal System
- K160454 — AtriClip LAA Exclusion System with preloaded Gillinov-Cosgrove Clip
- K160484 — Optetrak Advanced Patella
- K160513 — Quanta System Surgical Laser fibers
- K160524 — FibroScan 530 Compact
- K151689 — MetaNeb 4 System
- K151706 — Specular Microscope CEM- 530
- K152334 — Sungshim Insulin Pen Needle
- K152598 — Endo Keeper
- K152686 — CONQUEST FN
- K152699 — Apollo System
- K152705 — Jiayuan Nitrile Powder Free Patient Examination Gloves, Blue Color
- K152707 — Minghao Nitrile Powder Free Patient Examination Gloves, Blue Color
- K152814 — Giraffe OmniBed Carestation CS1
- K152935 — LiDCOunity Monitor
- K153079 — Axeo 3 Patient Monitor
- K153627 — NuVasive® TLX Interbody System
- K160234 — OVENT
- K160417 — Rezum System
- K160434 — ClearPoint System
- K160462 — FilmArray Meningitis/Encephalitis (ME) Panel for use with FilmArray Torch
- K151268 — SPINAUT-V, SPINAUT-S, SPINAUT-I
- K151665 — SUSTAIN Additional Implants
- K152093 — NobelZygoma 45°
- K153250 — Renovis Tesera SC Stand-alone Anterior Cervical Fusion (ACF) System
- K153355 — Xeleris 4.0 Processing and Review Workstation
- K153519 — DReal
- K153613 — Cerafix Dura Substitute
- K160150 — Vitrea CT Colon Analysis
- K160406 — FUJIFILM FC1 Ultrasound System
- K160445 — HemosIL Silica Clotting Time
- K151135 — MODEL 621/624 BIOMAGNETOMETER
- K151763 — PerioLase Nd:YAG Pulsed Dental Laser System
Data sourced from openFDA. This site is unofficial and independent of the FDA.