FDA 510(k) clearances — page 199
clearances on record, most recent first.
Clearances — page 199
19,801–19,900 of 176,479- K201907 — ClariVein IC
- K190580 — NADIA SI Fusion System
- K191955 — Enhanced External Counter Pulsation Device Plus Omay-A
- K192883 — Spartan Hip Stem
- K193247 — LATITUDE EV Total Elbow Arthroplasty
- K200009 — Adaptive Biotechnologies clonoSEQ Assay
- K200351 — PlasmaFlight
- K200780 — XBit Series Digital Color Doppler Ultrasound System
- K200977 — Modular Toga
- K201079 — Aurora® Anterior Lumbar Plate Sytstem
- K201240 — Mariner Cap System
- K201251 — CarboClear Navigated Instruments
- K201530 — Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs and Fentanyl, Citrate (Fusion Dark Grey)
- K201531 — Sterile Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs and Fentanyl Citrate (Blue)
- K201715 — Smart Toe II, X Fuse
- K201952 — CrossGlide ETS Plus
- K191670 — CureOs TCP
- K193210 — HYPER DLR
- K193545 — Corin Optimized Positioning System (OPS) Femoral
- K193666 — Powder-Free Blue Nitrile Examination Gloves (Tested for use with Chemotherapy and Fentanyl) Regular Cuff +1 more
- K201168 — ECG Monitor App
- K201217 — HemoCue Hb 301 System
- K201500 — Life Spine Plateau-A Ti Anterior Lumbar Spacer & Plateau-X Ti Lateral Lumbar Spacer
- K201704 — CoFix System
- K201850 — Vector Hammertoe Correction System
- K201958 — ETD Family of Electrotherapy Devices
- K192712 — Attain Select II + SureValve delivery catheter system, Attain Command + SureValve Left Heart Delivery System, Attain Comman + SureValve Guide Catheters for Left Heart Delivery, C315 Delivery Catheter
- K192991 — Vesco Medical Extension Feeding Set
- K193355 — Electrodes Handpieces for Mygen V-1000 RF System
- K200649 — Arm-Type Fully Automatic Digital Blood Pressure Monitor
- K200667 — EyeArt
- K200954 — Glaucoma Module
- K190790 — Flex Fit
- K191101 — Kendall NPWT Incision Management Dressing Kit
- K192294 — I Do
- K192499 — Cyber Blade
- K193237 — Carto Octaray Mapping Catheter with Trueref Technology
- K200039 — P pro Crown & Bridge
- K200584 — xPORT 304 (miCOR) System Lens Fragmentation System
- K200791 — Navigation Enabled Intruments
- K200803 — BEAR and BEAR mini
- K201069 — VibrantVue Scleral Saline
- K201087 — CORBEL Spacers
- K201442 — Lin-Zhi International, Inc. (LZI) Methamphetamine Enzyme Immunoassay for Pictus Analyzers
- K201511 — Reprocessed Endoscopic Trocars and Sleeves
- K201597 — Liver Incytes, Model 1005
- K201833 — BiPad Hand Activated, Disposable Bipolar Electrocautery Cords
- K201837 — UroLift 2 System (formerly UL500), UroLift 2 Delivery Handle, UroLift 2 Implant Cartridge
- K201898 — Clear Guide SCENERGY
- K201951 — Cemented Origin Hip Stem
- DEN200015 — cobas EBV, cobas EBV/BKV Control Kit, cobas Buffer Negative Control Kit
- K192663 — Joimax Intracs System
- K193283 — AI-Rad Companion Prostate MR
- K193321 — MY01 Continuous Compartmental Pressure Monitor
- K193417 — FractureDetect (FX)
- K193660 — OSSIOfiber Compression Screws
- K200060 — Reprocessed NRG Transseptal Needle
- K200082 — BD Univia RightFit Enteral Extension Sets and Transitional Adapters
- K200142 — SpeediCath Soft
- K200280 — MEDRAD Imaging Bulk Package Transfer Spike
- K200678 — PENTAX Medical Video Bronchoscope EB-J10 Series
- K200832 — Safey Peak Flow Meter
- K201002 — Safey Pocket Spirometer
- K201059 — S60 Elite Series/S70 Series Digital Color Doppler Ultrasound System
- K201186 — KY Grosz Jelly
- K201543 — MAGEC® System
- K201648 — Sterispine PS
- K201786 — Arthrex Mini Hip PushLock
- K201834 — HI-TORQUE PROCEED Guide Wire Family
- K201851 — EXULT Femoral component trial - Left, EXULT Femoral component trial - Right
- K182759 — BoniPlus Dental G-Mesh System
- K193647 — Superpipe Angiographic Catheter
- K200413 — Symphony
- K200504 — BONEBRIDGE System, SAMBA 2 BB, SYMFIT 8.0, SAMBA 2 GO, SAMBA 2 Remote
- K200518 — Pitkar External Fixation System - Rail Mechanism
- K200824 — Cardinal Health SMARTGOWN Breathable Surgical Gown, Cardinal Health SMARTGOWN AIR Breathable Surgical Gown
- K200959 — Biolox® delta Ceramic Heads, Biolox® delta Option Ceramic Heads MR Labeling
- K201040 — Bioflux Software II
- K201361 — PNEUMOCLEAR
- K201760 — Zoom 14 Guidewire
- K192481 — AccelFix Lumbar Plate System
- K192681 — Safety scalp vein set, Scalp vein set, Blood collection needle (Scalp vein set type), Blood collection needle (Needle holder type), Safety blood collection needle (Scalp vein set type), Safety blood collection needle (Needle holder type)
- K200801 — Quantisal Oral Fluid Collection Device
- K200805 — Neocis Guidance System (NGS) with Patient Splints
- K201434 — Connected OR Hub with Voice Control, Connected OR Hub with Device Control
- K201616 — SyMRI
- K201792 — TRUSELECT Microcatheter
- K201794 — Jade
- K200242 — StaClear Syringe
- K200550 — Vitalograph Model 2120 In2itive eDiary
- K200785 — Stratum Reduced Size Foot Plating System
- K201132 — Arthrex Compression Screws
- K201280 — Ethicon Circular Stapler, Ethicon Circular Stapler -XL Sealed
- K192669 — Extremely Thin 003, ZERO ZERO THREE
- K193575 — Arthrex SutureTape
- K193601 — Single Use Electrosurgical Knife
- K193625 — Disposable Temperature Probe
- K200496 — Aer X
- K200643 — Hepatus 7/Hepatus 6/Hepatus 5/Hepatus 7S/Hepatus 6S/Hepatus 5S/Hepatus 7T/Hepatus 6T/Hepatus 5T/Fibrous 7/Fibrous
- K200742 — JUSHA-CP610 LCD Monitor
Data sourced from openFDA. This site is unofficial and independent of the FDA.