FDA 510(k) clearances — page 191
clearances on record, most recent first.
Clearances — page 191
19,001–19,100 of 175,699- K201244 — Concorde Models Concorde US and Concorde ST Soft Tissue Biopsy Devices
- K201310 — Accipiolx
- K201619 — EndoTool IV System
- K201883 — 6.5 mm Healix Advance SP Peek Anchor, 6.5 mm Healix Advance SP Biocomposite Anchor
- K201926 — CarboClear® Pedicle Screw System, CarboClear® II Pedicle Screw System
- K201932 — X-ray Flat Panel Detectors (CareView 1800Cwe /CareView 1500Cwe)
- K201938 — LZI Fentanyl II Enzyme Immunoassay
- K191644 — TK Safety Needle
- K193066 — Steripack cases and Tray Systems
- K200324 — NHancer Rx
- K200353 — ManaFlow
- K200858 — Mini Sterilizable Tray
- K200890 — Invacare Perfecto2V Oxygen Concentrator
- K201076 — Anchor Dual Lumen Guidewire Catheter
- K201143 — VICRYL Mesh
- K201502 — Vitra 810
- K201521 — Medina Anterior Cervical Plate System
- K201641 — Disposable Laparoscope Trocar
- K201667 — Midmark Extraoral Imaging System (EOIS)
- K201750 — Pentaray Nav eco High-Density Mapping Catheter
- 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; Powder-Free Blue Nitrile Examination Gloves (Tested for use with Chemotherapy Drugs and Fentanyl) - Extended Cuff
- 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
Data sourced from openFDA. This site is unofficial and independent of the FDA.