FDA 510(k) clearances — page 189
clearances on record, most recent first.
Clearances — page 189
18,801–18,900 of 175,699- K202176 — Symetrex LTHD Catheter, Symetrex LTHD Catheter with Sideholes
- K202235 — ArtPIX DRF
- K202499 — Diamond Digital Sleep Orthotic (DDSO)
- K192704 — Endofresh Digestive Endoscopy System
- K192830 — Bright Temporary C&B
- K193405 — Simplant Digital Guide
- K193618 — ExactechGPS System
- K200462 — EtchPro Etching Gel
- K200503 — ATL Anchors
- K200516 — OCT-Camera ID 21101A3
- K200812 — VeriSight Intracardiac Echocardiography (ICE) Catheter, VeriSight Pro ICE Catheter
- K200827 — LOCATOR R-Tx
- K200833 — RX-1 Rhythm Express Remote Cardiac Monitoring System
- K201277 — Oral-B Dry Mouth Oral Rinse
- K201552 — ApolloVue S100 Image System
- K201677 — Arthrex Mesh Plates
- K201765 — SmartHDM-510 System
- K202124 — Aesculap PAS-Port Proximal Anastomosis System
- K202169 — Quantum PureFlow Centrifugal Blood Pump CP37, Quantum PureFlow Centrifugal Blood Pump CP22
- K202182 — ZOOM (71, 55, 45, 35) Reperfusion Catheters; ZOOM Aspiration Tubing
- K202215 — cobas BKV, cobas EBV/BKV Control Kit, cobas Buffer Negative Control Kit
- K202216 — EPIQ Series Diagnostic Ultrasound Systems
- K193424 — Resolution 360 ULTRA Clip
- K200724 — VICTUS Femtosecond Laser Platform
- K200916 — Patient Administration Set
- K201135 — Image1 S CCU, Image1 S 4U Camera Head
- K201854 — CAPOGEN Laser Cap
- K201920 — Endoscope Reprocessor OER-Elite
- K202160 — Sonosite PX Ultrasound System, Sonosite SII Ultrasound System, Sonosite iViz Ultrasound System, Sonosite X-Porte Ultrasound System, Sonosite Edge II Ultrasound System, Sonosite Maxx Ultrasound System
- K193589 — TrueTear Intranasal Tear Neurostimulator
- K201052 — KLS Martin Individual Patient Solutions (IPS) Planning System
- K201831 — CONFIDENCE Spinal Cement System
- K202251 — Penumbra System (Penumbra JET 7 Reperfusion Catheter with Xtra Flex Technology; Penumbra JET 7MAX)
- K201405 — LabPro Data Management System
- K201432 — Masimo O3 Regional Oximeter System
- DEN190042 — Theranova Dialyzers, Theranova 400 Dialyzer, Theranova 500 Dialyzer
- K191041 — Orthodontic Fixation Screw [Smart Anchor Miniscrew]
- K191938 — FitRelief TENS&EMS Wireless Device
- K192671 — Hemostatic Xerogel Sponge
- K193005 — DIMI RRT System
- K200369 — OES Elite Ureteroscopes and Accessories
- K200859 — Infinity M300
- K200926 — OrthoGold 100
- K200958 — MODULIF-A Anterior Lumbar Interbody Fusion System
- K201166 — Temno Elite Biopsy System
- K201199 — Jada System
- K201476 — DreaMed Advisor Pro
- K202099 — AOS Galileo Trochanteric Nail System
- K202108 — External Counterpulsation System, Soulaire
- K202224 — SpaceOAR System
- K190864 — Konix Anti-Fog Solution
- K192062 — Nucleoss T6 Dental Implant System
- K192953 — APTOS Threads Polypropylene Surgical Sutures
- K200881 — Oral-B iO Test Drive Power Brush Trial Program Kit
- K200973 — Synapse 3D Cardiac Tools
- K201115 — Next Generation Balloon Dilation System
- K201162 — Essence 55SP Large Monitor System
- K201807 — ANCORIS
- K201830 — ANSER Clavicle Pin
- K201981 — Magicore System
- K191640 — TK Intravascular Administration Set
- K192863 — MONDRIAN Lumbar Interbody Fusion Cage System
- K193177 — CER-S
- K193653 — Hydrophilic Coating Guide Wire
- K200373 — Deltaven Fast Flash Closed I.V. Catheter Systems
- K200714 — AVIEW
- K200796 — Emprint Ablation System with Thermosphere Technology
- K200923 — Single-use Surgical Mask
- K201020 — BriefCase
- K201141 — FIRMM
- K201267 — Adaptix Interbody System with Titan nanoLOCK Surface Technology
- K201472 — VenSure Balloon Device, VenSure Nav Balloon Device
- K201549 — Motex Anti-Fog Surgical Face Mask
- K201805 — VersaOne Reusable Positioning Trocar System
- K201856 — Provicol QM Aesthetic
- K202064 — Admiral ACP System
- K202072 — MindsEye Expandable Port
- K192464 — Injection Pen Needle
- K192809 — Dental Handpiece
- K193338 — Med-link Reusable Temperature Probes, Med-link Disposable Temperature Probes
- K193522 — iMedium Single Step; iMedium Single Step with HSA; iMedium Single Step with rHA
- K200587 — VERASENSE for Exactech Equinoxe Size 38 mm, VERASENSE for Exactech Equinoxe Size 42 mm, LinkStation MINI, LinkStation MINI Evaluation Kit, VERASENSE Software Application for Shoulder
- K201772 — Nitrile Powder Free Examination Gloves with Low Dermatitis Potential Claim and Tested for Use with Chemotherapy Drugs and Fentanyl Citrate (Blue)
- K201979 — Cervical Plate System
- K192380 — ST AIA-PACK BNP
- K193364 — Intimate Rose Kegel Exercise System
- K200695 — MATRx plus
- K202054 — Dynex Ring Fixation System, Diametrix Ring Fixation System
- K201505 — Simplexa Flu A/B & RSV Direct Gen II, Simplexa Flu A/B & RSV Positive Control Pack
- K193201 — BTL-785F
- K193260 — U-Cem Premium & MAZIC Cem
- K200216 — 4K UHD Camera System
- K200957 — Brainsway Deep TMS System
- K201056 — NeuroBlate System
- K201513 — Quantra QPlus System
- K201693 — DC-90/DC-90S/DC-90Q/DC-95/DC-95S/DC-88/DC-88S/DC-80A/DC-80AExp/DC-80A Pro/DC-8X/DC-8Q/DC-81/DC-82 Diagnostic Ultrasound System
- K201749 — Arthrex SwiveLock Anchor
- K202036 — Focus DAILIES / Focus DAILIES Toric / Focus DAILIES Progressives, DAILIES AquaComfort Plus (DACP) / DACP FreshTech / DACP Toric / DACP Multifocal
- K202116 — EzDent-i/ E2/ Prora View/ Smart M Viewer
- K192291 — TidalPort-AP Implantable Apheresis Vascular Access Port
Data sourced from openFDA. This site is unofficial and independent of the FDA.