FDA 510(k) clearances — page 332
clearances on record, most recent first.
Clearances — page 332
33,101–33,200 of 176,542- 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
- K153238 — Dignity Dual Port
- K153335 — AlertWatch: OR
- K153584 — NeoTract UroLift System UL500
- K153612 — ArthrexVIP Web Portal
- K153633 — Endoform Reconstructive Template
- K160114 — Xspan Laminoplasty Fixation System
- K160409 — AOS Anterolateral Proximal Humeral Plate
- K160457 — FilmArray Blood Culture Identification (BCID) panel for use with FilmArray Torch
- K152530 — UCP Stem
- K152845 — Allied Biocompat Abutment for Nobel Replace Interface
- K153027 — Cryotop US
- K153041 — Bundled Neurological Shunts and Accessories Product Families Labeling Modification to Support MR Conditional Labeling
- K153119 — Amrad Medical OTS Digital Radiography System, Amrad Medical DFMTS Digital Radiography SystemAmrad Medical FRS Digital Radiography System,
- K153153 — Reprocessed Electrophysiology Catheter
- K153412 — Sleep Profiler
- K153661 — ImmunoCard STAT! HpSA
- K153754 — MicroMatrix
- K160145 — Full Automatic (NIBP) Blood Pressure Monitor
- K151271 — BellaFuse
- K151506 — Demand Nasal Oxygen Cannula, Modified Demand Nasal Oxygen Cannula
- K151559 — ImmuLisa Enhanced Centromere Antibody ELISA
- K151688 — chromID MRSA
- K151748 — Clean & More
- K151780 — CAAS Workstation
- K151965 — Dentti System
- K152178 — StimQ Peripheral Nerve Stimulator (PNS) System
- K152394 — Rapicide PA High-Level Disinfectant Test Strips
- K152646 — SYLK PERSONAL LUBRICANT
- K160064 — MoMe Kardia Wireless Ambulatory ECG Monitoring and Detection System
- K160374 — 20G x 1.25 NovaCath Secure IV Catheter System, 24G x 0.56 NovaCath Secure IV Catheter System
- K160389 — NovaCross Microcatheter
- K160662 — Surefire Infusion System
- K142993 — QuikRead go CRP, QuikRead go CRP Verification Set, QuikRead go CRP Control Set, and QuikRead go Instrument
- K151421 — Nasal CO2 Sample Line, Oral Nasal CO2 Sampling Cannula, O2 Oral/Nasal Co2 Cannula, Sample Lines
- K151940 — Thora-3Di, Model T-01
- K151984 — Thommen Milling Abutment for CAD/CAM
- K152217 — Exactech Vantage Total Ankle System
- K152720 — Xingda Nitrile Powder Free Patient Examination Gloves, Blue Color
- K152919 — OMNI Skirted Heads
- K153090 — Reprocessed Diagnostic Ultrasound Catheter
- K153248 — PEEK Customized Cranial Implant
- K153485 — ENROUTE Transcarotid Neuroprotection System
- K153776 — Optetrak One Logic Femoral Components
- K160069 — Sonoma Fibula Repair System
- K160078 — Vivid T8
- K160369 — GuideWire
- K160386 — ReadeR, VieweR, QuickScan PSP
- K151694 — Gammex PI Hybrid Surgical Gloves
- K152448 — da Vinci Single-Site Instrument and Accessories
- K152625 — MMS Guide Catheter
- K152662 — S-Wire
- K152712 — Nitrile Powder Free Patient Examination Gloves, Blue Color
- K153429 — SmartView 3D Option
- K153671 — Family of CoolGlide Aesthetic Lasers
- K160002 — Piccolo Composite(R) Distal Volar Radius Plate System
- K160058 — Biomet Variable Pitch Compression Screw System
- K160381 — TE7 Diagnostic Ultrasound System
Data sourced from openFDA. This site is unofficial and independent of the FDA.