| Blue Beacon Submucosal Injectable Solution (K200071) | Micro-Tech (Nanjing) Co., Ltd. | 2020-11-03 |
| IcePearl 2.1 CX 90° Needle, IcePearl 2.1 CX L 90° Needle, IcePearl 2.1 CX Needle, IceFORCE 2.1 CX 90° Needle, IceFORCE 2.1 CX L 90° Needle, IceFORCE 2.1 CX Needle (K203032) | Galil Medical, Inc. | 2020-11-02 |
| Ellusa Generator, Ellusa Bayonet Tip, Ellusa RF-Cobb Tip, Ellusa SP-Pack and Tips, Ellusa Tip Set (K202562) | Ellusa, LLC | 2020-11-02 |
| Midas Rex Attachments and Dissecting Tools (K202552) | Medtronic Powered Surgical Solutions (Mpss) | 2020-11-02 |
| SpeediCath Compact Set (K192904) | Coloplast | 2020-11-02 |
| e-Motion M25 (K192618) | Alber GmbH | 2020-11-02 |
| Ellusa Bipolar Wands (K202558) | Ellusa, LLC | 2020-11-02 |
| T-Lite (K201988) | Sonoscanner | 2020-10-30 |
| Aesculap Caiman 5 Seal and Cut Technology System (K202938) | Aesculap, Inc. | 2020-10-30 |
| eKuore Pro Series (K203007) | Chip Ideas Electronics S.L. | 2020-10-30 |
| Atlas Spine Rebar (Ti) Spacer System (K202302) | Atlas Spine, Inc. | 2020-10-30 |
| PICO 7 Single Use Negative Pressure Wound Therapy System, PICO 7Y Single Use Negative Pressure Wound Therapy System, PICO 14 Single Use Negative Pressure Wound Therapy System, PICO Fluid Management Pack (K202157) | Smith & Nephew Medical Limited | 2020-10-30 |
| Aulisa Multiple Patient Digital Vital Sign Monitoring System (K202497) | Taiwan Aulisa Medical Devices Technologies, Inc. | 2020-10-30 |
| HS30 Diagnostic Ultrasound System (K202556) | Samsung Medison Co., Ltd. | 2020-10-30 |
| WRDensity by Whiterabbit.ai (K202013) | Whiterabbit.Ai, Inc. | 2020-10-30 |
| AutoContour (K200323) | Radformation, Inc. | 2020-10-30 |
| ScalpelCric (K200190) | VBM Medizintechnik GmbH | 2020-10-30 |
| Patent Hemostasis Band (PH Band) (K201695) | Medical Ingenuities | 2020-10-30 |
| UNiD IB3D ALIF (K200316) | Medicrea International SA | 2020-10-30 |
| eCordum Cardiac Monitor (eCordum CM) (K193296) | Ecordum, Inc. | 2020-10-30 |
| Smart Alarm Interface (K193421) | Boxview, LLC | 2020-10-30 |
| FUJIFILM Distal End Cap (K203028) | Fujifilm Corporation | 2020-10-30 |
| Longeviti ClearFit Cranial Implant (K202901) | Longeviti Neuro Solutions, LLC | 2020-10-30 |
| ANTHEM Fracture System (K202496) | Globus Medical, Inc. | 2020-10-29 |
| HCG Zirconia Ceramic Block (K193090) | Hocheng Corporation | 2020-10-29 |
| CloudVue (K203058) | International Medical Solutions, Inc. | 2020-10-29 |
| Libertas E-XLPE Modular Liner (K192989) | Maxx Orthopedics, Inc. | 2020-10-29 |
| Female Luer Lock Cap (K200425) | Medsafety Solutions, LLC | 2020-10-29 |
| MedCAD® AccuPlan® System (K192282) | Medcad | 2020-10-29 |
| Nelson Sentinel Series Basic Chlorine Sentinel (K193169) | Nelson Environmental Technologies, Inc. | 2020-10-29 |
| ARIX Ankle Distal Tibia System (K202912) | Jeil Medical Corporation | 2020-10-29 |
| Nutriglide(TM) Nasal Feeding Tube (K202539) | Applied Medical Technology, Inc. | 2020-10-29 |
| Visera Elite II Video System Center (K202646) | Olympus Medical Systems Corp. | 2020-10-29 |
| NuVasive Modulus XLIF Interbody System (K201692) | Nu Vasive, Incorporated | 2020-10-29 |
| EXPERT - Joint Fixation System (K200332) | GM Dos Reis Industria e Comercio Ltda. | 2020-10-29 |
| WiZARD 510 Nasal Mask (K193206) | Apex Medical Corp. | 2020-10-29 |
| LSN (K201092) | Imaging Biometrics, LLC | 2020-10-29 |
| g.Estim FES (K200088) | G.Tec Medical Engineering GmbH | 2020-10-29 |
| Sleepware G3 (K202142) | Respironics, Inc. | 2020-10-29 |
| CONSTRUX Mini PEEK Spacer System (K202949) | Orthofix, Inc. | 2020-10-29 |
| OsteoMed ExtremiFix Mini & Small System Tray (K202105) | Osteomed, LLC | 2020-10-29 |
| Flexible Video Cysto-Urethroscope (C-view) (K202957) | KARL STORZ Endoscopy-America, Inc. | 2020-10-29 |
| Curos Jet Disinfecting Cap (K200299) | 3M Company | 2020-10-29 |
| Tri-Staple 2.0 Reloads (K202864) | Covidien | 2020-10-28 |
| LensHooke X1 PRO Semen Quality Analyzer, LensHooke X1 PRO SE Semen Quality Analyzer (K202089) | Bonraybio Co., Ltd. | 2020-10-28 |
| Parcus GFS II and GFS Mini, GFS Naked, GFS Ultimate, GFS BTB, ATLAS, Synd-EZ Ti, Actiflip Naked, Actiflip Cinch, Actiflip Whip, and GFS Ultimate Hip (K202259) | Parcus Medical, LLC | 2020-10-28 |
| Bright Bond Universal (K200153) | Genoss Co., Ltd. | 2020-10-28 |
| Sterile High-pressure Angiographic Syringes for single-use (K201395) | Youwo (Guangzhou) Medical Device Co., Ltd. | 2020-10-28 |
| EVOS Cabling System (K201497) | Pioneer Surgical Technology, Inc. (Dba Rti Surgical, Inc.) | 2020-10-28 |
| LnK Spinal Fixation System, OpenLoc-L Spinal Fixation System (K200790) | L&K BIOMED Co., Ltd. | 2020-10-28 |
| Thermoforming Sheet Materials (K200125) | Erkodent Erich Kopp GmbH | 2020-10-28 |
| NIM Vital, Nerve Integrity Monitor (K200759) | Medtronic Xomed, Inc. | 2020-10-28 |
| Comprehensive Shoulder System (K193038) | Biomet Manufacturing Corp | 2020-10-28 |
| Syntec Femoral Nail Extended System (K202935) | Syntec Scientific Corporation | 2020-10-28 |
| Ultimate Contour, Ultimate Contour Mini (K201475) | CAO Group, Inc. | 2020-10-28 |
| NP1 Instrument, Creo Electrosurgical System (K200003) | Creo Medical, Ltd. | 2020-10-28 |
| NextAR TKA Platform (K202152) | Medacta International S.A. | 2020-10-27 |
| Triathlon PKR System (K203099) | Howmedica Osteonics Corp. A.K.A. Stryker Orthopaedics | 2020-10-27 |
| Mazor X (K203005) | Mazor Robotics , Ltd. | 2020-10-27 |
| TIB Abutment System (K193084) | Southern Implants (Pty), Ltd. | 2020-10-27 |
| General Cutting Contra Handpiece (K202960) | Nakanishi, Inc. | 2020-10-27 |
| Dental Computed Tomography X-Ray System, Green X (K201627) | VATECH Co., Ltd. | 2020-10-27 |
| OrthoNext Platform System (K202519) | Orthofix Srl | 2020-10-27 |
| Bright Low Flow (K200156) | Genoss Co., Ltd. | 2020-10-27 |
| FREEPRINT temp (K200273) | Detax GmbH & Co. KG | 2020-10-27 |
| IlluminOss Bone Stabilization System (K202887) | Illuminoss Medical, Inc. | 2020-10-27 |
| Medline Glide-On 3G Vinyl Examination Gloves (Tested for use with Chemotherapy Drugs) (K202179) | Medline Industries, Inc. | 2020-10-26 |
| G-EYE System (K202469) | Smart Medical Systems , Ltd. | 2020-10-26 |
| ACURA Stabilization System (K200937) | Indius Medical Technologies Pvt. , Ltd. | 2020-10-26 |
| 1212FCA (K202722) | Rayence Co., Ltd. | 2020-10-26 |
| coraForce and coraFlex Support Catheters (K201811) | Reflow Medical, Inc. | 2020-10-26 |
| AOS Fibonacci Lower Extremity Plating System – AOS Proximal Tibia Plating System (K202489) | Advanced Orthopaedic Solutions, Inc. | 2020-10-26 |
| Cannulated Power Driver Attachment (K202528) | K2m, Inc. | 2020-10-26 |
| Medline Powder-Free Orange Nitrile Patient Examination Glove (Tested for use with Fentanyl) (K200150) | Medline Industries, Inc. | 2020-10-26 |
| DOLOMITE Anterior Cervical Stabilization System (K202065) | Astura Medical, LLC | 2020-10-26 |
| Li-Battery powered OTC TENS/EMS Combination Stimulator (K201335) | Everyway Medical Instruments Co.,Ltd | 2020-10-24 |
| Wiltrom Spinal Fixation System (K202894) | Wiltrom Corporation Limited | 2020-10-23 |
| SURGIPHOR Wound Irrigation System (K202071) | Orthophor, LLC | 2020-10-23 |
| SIR-Spheres Microspheres Activity Calculator (SMAC) (K202392) | Sirtex Medical US Holdings, Inc. | 2020-10-23 |
| MaxZero Extension Sets with Needle-Free Connector(s) (K193088) | Carefusion, Inc. | 2020-10-23 |
| Planmed Clarity 2D and Clarity S (K192317) | Planmed OY | 2020-10-23 |
| Drakon and Sequre Microcatheters (K202797) | Accurate Medical Therapeutics, Ltd. | 2020-10-23 |
| Mobio Total Knee System (K202429) | B-One Ortho, Corp. | 2020-10-23 |
| PocketDoc™ Micro Wound Therapy System (K200223) | Pensar Medical, LLC | 2020-10-23 |
| Nerivio (K201824) | Theranica Bio-Electronics, Ltd. | 2020-10-23 |
| OXY-1 System (K200109) | Abiomed, Inc. | 2020-10-23 |
| Cryocheck Hex LA (K193556) | Precision Biologic | 2020-10-23 |
| Infrared ear and forehead thermometer, model YI-100 (K201843) | Wenzhou Yosun Medical Technology Co.,Ltd | 2020-10-23 |
| Sequential Culture Media (Fertilization Medium [without HSA/rHA, with HSA, with rHA], Cleavage Medium [without HSA/rHA, with HSA, with rHA], Blastocyst Medium [without HSA/rHA, with HSA, with rHA]) (K200249) | Kitazato Corporation | 2020-10-23 |
| BenestaTM Tissue Removal Device (K192811) | Caldera Medical, Inc. | 2020-10-23 |
| V-Mix (K193357) | Inter-Med/Vista Dental Products | 2020-10-23 |
| EzOrtho (K202948) | Ewoosoft Co., Ltd. | 2020-10-22 |
| DIOnavi-Denture (K193623) | Dio Corporation | 2020-10-22 |
| UNIDRIVE S II ENT, DrillCut-X II-35 Shaver Handpiece, DrillCut-X II-35 N Shaver Handpiece (K200318) | KARL STORZ Endoscopy-America, Inc. | 2020-10-22 |
| GEO Bone Screw System (K202817) | Gramercy Extremity Orthopedics, LLC | 2020-10-22 |
| AcuPulse W CO2 Laser Systems, Delivery Devices and Accessories (K202428) | Lumenis, Ltd. | 2020-10-22 |
| Voluson E10 (K201768) | GE Healthcare | 2020-10-22 |
| Broncoflex Agile; Product Reference: 20030001 , Broncoflex Vortex; Product Reference: 10030001, Screeni; Product Reference: 30030001 (K202180) | Axess Vision Technology | 2020-10-22 |
| ReNew XR Handpiece, ReNew XR Handpiece 34cm, ReNew XR Handpiece 42cm, ReNew XR Handpiece 25cm, Ratcheted ReNew XR Handpiece 34cm (K201884) | Microline Surgical, Inc. | 2020-10-21 |
| PRO-DENSE LoVisc Bone Graft Substitute (K200507) | Wrightmedicaltechnologyinc | 2020-10-21 |