| Resolution 360™ ULTRA Clip (K193424) | Boston Scientific Corporation | 2020-09-01 |
| VICTUS Femtosecond Laser Platform (K200724) | Technolas Perfect Vision GmbH | 2020-09-01 |
| Penumbra System (Penumbra JET 7 Reperfusion Catheter with Xtra Flex Technology; Penumbra JET 7MAX) (K202251) | Penumbra, Inc. | 2020-08-31 |
| CONFIDENCE Spinal Cement System (K201831) | Depuy Spine, Inc. | 2020-08-31 |
| KLS Martin Individual Patient Solutions (IPS) Planning System (K201052) | KLS-Martin L.P. | 2020-08-31 |
| TrueTear Intranasal Tear Neurostimulator (K193589) | Allergan | 2020-08-31 |
| LabPro Data Management System (K201405) | Beckman Coulter, Inc. | 2020-08-30 |
| Masimo O3 Regional Oximeter System (K201432) | Masimo Corporation | 2020-08-29 |
| Temno Elite Biopsy System (K201166) | Merit Medical Systems, Inc. | 2020-08-28 |
| MODULIF-A Anterior Lumbar Interbody Fusion System (K200958) | Spinal Stability, LLC | 2020-08-28 |
| External Counterpulsation System, Soulaire (K202108) | Vamed Medical Instrument Co., Ltd. | 2020-08-28 |
| DreaMed Advisor Pro (K201476) | DreaMed Diabetes, Ltd. | 2020-08-28 |
| Infinity M300 (K200859) | Draeger Medical Systems, Inc. | 2020-08-28 |
| AOS Galileo™ Trochanteric Nail System (K202099) | Advanced Orthopaedic Solutions, Inc. | 2020-08-28 |
| OES Elite Ureteroscopes and Accessories (K200369) | Olympus Winter & Ibe GmbH | 2020-08-28 |
| SpaceOAR System (K202224) | Boston Scientific Corporation | 2020-08-28 |
| Hemostatic Xerogel Sponge (K192671) | Solaplus Biotech Co., Ltd. | 2020-08-28 |
| Theranova Dialyzers, Theranova 400 Dialyzer, Theranova 500 Dialyzer (DEN190042) | Baxter Healthcare Corporation | 2020-08-28 |
| FitRelief TENS&EMS Wireless Device (K191938) | Heat IN A Click, LLC | 2020-08-28 |
| DIMI RRT System (K193005) | Dialco Medical, Inc. | 2020-08-28 |
| Orthodontic Fixation Screw [Smart Anchor Miniscrew] (K191041) | Gni Co., Ltd. | 2020-08-28 |
| OrthoGold 100 (K200926) | Tissue Regeneration Technologies, LLC | 2020-08-28 |
| Jada System (K201199) | Alydia Health | 2020-08-28 |
| Next Generation Balloon Dilation System (K201115) | Acclarent, Inc. | 2020-08-27 |
| ANSER Clavicle Pin (K201830) | BAAT Medical Products B.V. | 2020-08-27 |
| Oral-B iO Test Drive Power Brush Trial Program Kit (K200881) | The Procter & Gamble Company | 2020-08-27 |
| ANCORIS (K201807) | Miegmbh | 2020-08-27 |
| Magicore System (K201981) | Innobiosurg Co., Ltd. | 2020-08-27 |
| Synapse 3D Cardiac Tools (K200973) | Fujifilm Corporaton | 2020-08-27 |
| Essence 55SP Large Monitor System (K201162) | Shenyang Torch-Bigtide Digital Technology Co., Ltd. | 2020-08-27 |
| Nucleoss T6 Dental Implant System (K192062) | Sanlilar Tibbi Cihazlar Medikal Kimya Sanayi Ticaret Ltd. ST | 2020-08-27 |
| APTOS Threads – Polypropylene Surgical Sutures (K192953) | Aptos, LLC | 2020-08-27 |
| Konix Anti-Fog Solution (K190864) | Turkuaz Saglik Hizmetleri Medikal Temizlik Kimyasal Urunler | 2020-08-27 |
| TK Intravascular Administration Set (K191640) | Anhui Tiankang Medical Technology Co., Ltd. | 2020-08-26 |
| AVIEW (K200714) | Coreline Soft Co., Ltd. | 2020-08-26 |
| Motex Anti-Fog Surgical Face Mask (K201549) | Modern Healthcare Corp. | 2020-08-26 |
| Emprint Ablation System with Thermosphere Technology (K200796) | Covidien, LLC | 2020-08-26 |
| Single-use Surgical Mask (K200923) | Byd Precision Manufacturer Co., Ltd. | 2020-08-26 |
| Deltaven Fast Flash Closed I.V. Catheter Systems (K200373) | Delta Med Spa | 2020-08-26 |
| Adaptix Interbody System with Titan nanoLOCK Surface Technology (K201267) | Medtronic Sofamor Danek | 2020-08-26 |
| FIRMM (K201141) | Nous Imaging, Inc. | 2020-08-26 |
| BriefCase (K201020) | Aidoc Medical , Ltd. | 2020-08-26 |
| Provicol QM Aesthetic (K201856) | Voco GmbH | 2020-08-26 |
| VenSure Balloon Device, VenSure Nav Balloon Device (K201472) | Fiagon GmbH | 2020-08-26 |
| CER-S (K193177) | Cardiocalm | 2020-08-26 |
| MindsEye Expandable Port (K202072) | Minnetronix Neuro, Inc. | 2020-08-26 |
| Hydrophilic Coating Guide Wire (K193653) | Suzhou Hengrui Disheng Medical Co., Ltd. | 2020-08-26 |
| VersaOne Reusable Positioning Trocar System (K201805) | Covidien | 2020-08-26 |
| MONDRIAN Lumbar Interbody Fusion Cage System (K192863) | Ctl Medical Corporation | 2020-08-26 |
| Admiral ACP System (K202064) | SeaSpine Orthopedics Corporation | 2020-08-26 |
| iMedium Single Step; iMedium Single Step with HSA; iMedium Single Step with rHA (K193522) | Kitazato Corporation | 2020-08-25 |
| 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 (K200587) | Orthosensor, Inc. | 2020-08-25 |
| Med-link Reusable Temperature Probes, Med-link Disposable Temperature Probes (K193338) | Shenzhen Med-Link Electronics Tech Co., Ltd. | 2020-08-25 |
| Injection Pen Needle (K192464) | Gangan Medical Technology Jiangsu Co., Ltd. | 2020-08-25 |
| Nitrile Powder Free Examination Gloves with Low Dermatitis Potential Claim and Tested for Use with Chemotherapy Drugs and Fentanyl Citrate (Blue) (K201772) | Hartalega NGC Sdn. Bhd. | 2020-08-25 |
| Cervical Plate System (K201979) | Eminent Spine, LLC | 2020-08-25 |
| Dental Handpiece (K192809) | Micro-Nx Co., Ltd. | 2020-08-25 |
| ST AIA-PACK BNP (K192380) | Fujirebio Diagnostics,Inc. | 2020-08-24 |
| Intimate Rose Kegel Exercise System (K193364) | Plus EV Holdings Dba Intimate Rose | 2020-08-24 |
| Dynex Ring Fixation System, Diametrix Ring Fixation System (K202054) | Vilex, LLC | 2020-08-24 |
| MATRx plus (K200695) | Zephyr Sleep Technologies | 2020-08-24 |
| Simplexa Flu A/B & RSV Direct Gen II, Simplexa Flu A/B & RSV Positive Control Pack (K201505) | Diasorin Molecular, LLC | 2020-08-22 |
| Focus DAILIES / Focus DAILIES Toric / Focus DAILIES Progressives, DAILIES AquaComfort Plus (DACP) / DACP FreshTech / DACP Toric / DACP Multifocal (K202036) | Alcon Laboratories, Inc. | 2020-08-21 |
| NeuroBlate System (K201056) | Monteris Medical, Inc. | 2020-08-21 |
| Quantra QPlus System (K201513) | Hemosonics, LLC | 2020-08-21 |
| EzDent-i/ E2/ Prora View/ Smart M Viewer (K202116) | Ewoosoft Co., Ltd. | 2020-08-21 |
| Arthrex SwiveLock Anchor (K201749) | Arthrex, Inc. | 2020-08-21 |
| 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 (K201693) | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 2020-08-21 |
| 4K UHD Camera System (K200216) | Scivita Medical Technology Co., Ltd. | 2020-08-21 |
| BTL-785F (K193201) | Btl | 2020-08-21 |
| Brainsway Deep TMS System (K200957) | Brainsway , Ltd. | 2020-08-21 |
| U-Cem Premium & MAZIC Cem (K193260) | Vericom Co., Ltd. | 2020-08-21 |
| Electronic Blood Pressure Monitor (K200939) | Jiangsu Yuyue Medical Equipment & Supply Co., Ltd. | 2020-08-20 |
| Synthetic Nitrile Patient Exam Gloves, Powder Free, Blue, Tested for Use w/Chemotherapy Drug (K200093) | Anhui Lntco Medical Products Co., Ltd. | 2020-08-20 |
| Hercules Suture Anchor System (K201636) | In2bones USA, LLC | 2020-08-20 |
| TidalPort-AP Implantable Apheresis Vascular Access Port (K192291) | Norfolk Medical Products, Inc. | 2020-08-20 |
| Non-spermicidal Lubricated Male Latex Condom (K193578) | Global Protection Corp. | 2020-08-20 |
| Straumann TLX Implant System (K200586) | Institut Straumann AG | 2020-08-20 |
| Distinct® Early Detection Pregnancy Test (K193318) | ACON Laboratories, Inc. | 2020-08-20 |
| FUJIFILM Video Laparoscope (K202130) | Fujifilm Corporation | 2020-08-20 |
| Straumann BLX Gold Abutments (K200597) | Straumann USA, LLC (On Behalf of Institut Straumann Ag) | 2020-08-19 |
| Sirona Dental CAD/CAM System with InLab Software (K200191) | Dentsply Sirona | 2020-08-19 |
| Omnichroma Flow (K193537) | Tokuyama Dental Corporation | 2020-08-19 |
| Indigo Aspiration System - Aspiration Catheter 7 and Separator 7 (K193595) | Penumbra, Inc. | 2020-08-19 |
| CUBEScan BioCon-1100 (K201995) | Mcube Technology Co., Ltd. | 2020-08-19 |
| Cranial 4Pi Immobilization (K202050) | Brainlab AG | 2020-08-19 |
| Medline ReNewal Reprocessed Harmonic ACE+7 Shears (K193563) | Surgical Instrument Service and Savings Inc.(Dba Medline Ren | 2020-08-19 |
| CD Horizon™ Fenestrated Screw Set, CD Horizon™ Spinal System, Kyphon™ HV-R™ Bone Cement (K201362) | Medtronic | 2020-08-19 |
| VariLymph 12 pro (K193476) | Slk Medical GmbH | 2020-08-19 |
| HemosIL von Willebrand Factor Antigen (K200033) | Instrumentation Laboratory CO | 2020-08-19 |
| Reusable and Disposable SpO2 Sensors (K201360) | Xinkang Medical Instrument Co. , Ltd. | 2020-08-19 |
| invisa-RED ELITE (K192275) | IR Technology, LLC | 2020-08-19 |
| Asept Surgical Face Mask (K201137) | Pfm Medical, Inc. | 2020-08-19 |
| Keystone Dental XL Dental Implant System (K201334) | Keystone Dental, Inc. | 2020-08-18 |
| Coloring Liquid (K192723) | Aidite (Qinhuangdao) Technology Co., Ltd. | 2020-08-18 |
| BB Base 3D printing resin for denture base (K191591) | Enlighten Materials Co., Ltd. | 2020-08-18 |
| Mammotome Revolve Dual Vacuum Assisted Biopsy (VAB) System (K202012) | Devicor Medical Products, Inc. | 2020-08-18 |
| ORION Spinal System (K190600) | Orion Biotech, Inc. | 2020-08-18 |
| Universal Cylinder Applicator Family (K193240) | Varian Medical Systems, Inc. | 2020-08-17 |
| 3D Auto LAA (K201352) | Philips Health Care | 2020-08-17 |