| Microlife Upper Arm Automatic Digital Blood Pressure Monitor (K200738) | Microlife Intellectual Property GmbH | 2020-07-23 |
| Pre-Seed™ Fertility Lubricant (K193450) | Church & Dwight Co., Inc. | 2020-07-23 |
| PENTAX Medical EG-J10U Endoscopic Ultrasound System - EG34-J10U Ultrasound Upper GI Video Scope (Convex Array Type), EG36-J10UR Ultrasound Upper GI Video Scope (Radial Array Type), EG38-J10UT Ultrasound Upper GI Video Scope (Convex Array Type) (K200090) | Pentax of America, Inc. | 2020-07-23 |
| EVA 15 Insufflator (K193520) | Palliare , Ltd. | 2020-07-23 |
| Parcus V-lox Titanium Suture Anchors, Parcus Miti Suture Anchors (K201083) | Parcus Medical, LLC | 2020-07-23 |
| LG Pra. L Derma LD Scalp Care (K200464) | Lg Electronics.Inc | 2020-07-23 |
| Vivid E80/ Vivid E90/ Vivid E95 (K200743) | Ge Medical Systems Ultrasound And | 2020-07-23 |
| EVOS Straight Proximal Humerus 7-15 hole Plates (137-225mm) (K201527) | Smith & Nephew, Inc. | 2020-07-22 |
| InMode RF Multi-System (K201150) | InMode , Ltd. | 2020-07-22 |
| Endomat Select, IBS Shaver Software, License (K201355) | Karl Storz SE & CO. KG | 2020-07-22 |
| True Tulip System, True M.I.S. System (K201780) | Innovative Surgical Designs, Inc. | 2020-07-22 |
| DAC Dynamic Active Compression Plate (K200513) | Pioneer Surgical Technology, Inc., Dba Rti Surgical | 2020-07-22 |
| Pedicle Screw System (K201751) | Black Box Medical, LLC | 2020-07-22 |
| SOMATOM On.site and On.scene (K193277) | Siemens Medical Solutions USA, Inc. | 2020-07-22 |
| Rubicon SA System (K200654) | Dymedix Diagnostics, Inc. | 2020-07-22 |
| Empty EVA Bag (K193528) | Haemotronic S.P.A. | 2020-07-22 |
| 8ch Flex Suite (K200836) | Shenzhen RF Tech Co., Ltd. | 2020-07-22 |
| Picowon (K201406) | Wontech Co., Ltd. | 2020-07-22 |
| Medline ReNewal Reprocessed Nellcor OxiMax SpO2 Sensor (K201699) | Surgical Instrument and Savings Inc (Dba Medline Renewal) | 2020-07-22 |
| Duranext Abutments (K200355) | Elegant Dental Corp. | 2020-07-22 |
| Reprocessed BRK Transseptal Needle (K192998) | Innovative Health, LLC | 2020-07-22 |
| Caption Interpretation Automated Ejection Fraction Software (K200621) | Caption Health | 2020-07-22 |
| Gamma3 System (K200869) | Stryker Trauma GmbH | 2020-07-22 |
| Visera Elite II Video System Center (K201200) | Olympus Medical Systems Corp. | 2020-07-22 |
| Venner PneuX™ TT (Tracheostomy Tube) Size 7.0 mm, Venner PneuX™ TT (Tracheostomy Tube) Size 8.0 mm, Venner PneuX™ TT (Tracheostomy Tube) Size 9.0 mm (K192511) | Venner Medical (Singapore) Pte, Ltd. | 2020-07-22 |
| BOBBY Balloon Guide Catheter (K193607) | MicroVention, Inc. | 2020-07-21 |
| Riptide Aspiration System (K201689) | Micro Therapeutics, Inc. d/b/a ev3 Neurovascular | 2020-07-21 |
| Mirage Hydrophilic Guidewire; X-pedion Hydrophilic Guidewire (K201690) | Micro Therapeutics, Inc. d/b/a ev3 Neurovascular | 2020-07-21 |
| Ace Medical Surgical Instruments (K200387) | Ace Medical | 2020-07-21 |
| AUTOLIGN (K192847) | Diorco Co., Ltd. | 2020-07-21 |
| VITA LUMEX AC (K193434) | Vita Zahnfabrik GmbH H Rauter & CO | 2020-07-21 |
| Wiggins Medical Surgical Instruments (K200383) | Wiggins Medical | 2020-07-21 |
| Owgels Oxygen Concentrator (K191875) | Guangzhou Life Light Electronic Technology Co., Ltd. | 2020-07-20 |
| Benesta Medical Sterilization Tray (K193603) | Caldera Medical, Inc. | 2020-07-20 |
| Retractable Safety Insulin Syringe (K193022) | Jiangsu Caina Medical Co.,Ltd | 2020-07-20 |
| CERENOVUS Large Bore Catheter; CERENOVUS Aspiration Tubing Set (K193380) | Codman & Shurtleff, Inc. | 2020-07-20 |
| Smith+Nephew Arthroscopes (K201349) | Smith & Nephew | 2020-07-20 |
| BioSiCar Silicone Implant (K193392) | Metalware Technology Corp. | 2020-07-20 |
| Intravascular Extension Sets and Accessories (K192366) | Baxter Healthcare Corporation | 2020-07-20 |
| GE ApexPro CH SpO2 - Nellcor Cable, GE ApexPro FH SpO2 - Nellcor Cable (K201179) | Covidien, LLC | 2020-07-20 |
| Signia Stapler (with new software) (K201672) | Covidien | 2020-07-17 |
| Synvitro Hyadase (K200680) | Origio A/S, A Coopersurgical Company | 2020-07-17 |
| Syringe with safety needle, Safety needle (K193526) | Jiangsu Caina Medical Co.,Ltd | 2020-07-17 |
| SuRgical Planner (SRP) BrainStorm (K201465) | Surgical Theater, Inc. | 2020-07-17 |
| AeroEclipse* ONE BAN (K200063) | Trudell Medical International | 2020-07-17 |
| myQA iON (K201798) | Iba Dosimetry GmbH | 2020-07-17 |
| LINK TrabecuLink Femoral Cones (K201364) | Waldemar Link GmbH & Co. KG | 2020-07-17 |
| Ambu Duodeno System (K201098) | Ambu Innovation GmbH | 2020-07-17 |
| Visera Elite II Xenon Light Source, Telescope IR/Telescope Ultra, Visera Elite II Video System Center, HD 3CMOS Autoclavable Camera Head, HD 3CMOS Camera Head (K200542) | Olympus Medical Systems Corp. | 2020-07-17 |
| Cryocheck Chromogenic Factor VIII (K193204) | Precision Biologic | 2020-07-17 |
| True 3D Viewer (K201365) | Echopixel, Inc. | 2020-07-17 |
| Rover (K201488) | Micro-X , Ltd. | 2020-07-17 |
| Phantom® Hindfoot TTC/TC Nail System (K201227) | Paragon 28, Inc. | 2020-07-17 |
| S+N Laparoscopes, 4KO, Autoclavable, S+N Bariactric Laparoscopes, 4KO, Autoclavable (K201198) | Smith & Nephew | 2020-07-17 |
| Evis Exera III Colonovideoscope Olympus PCF-H190TL, Evis Exera III Colonovideoscope Olympus PCF-H190TI, Evis Exera III Colonovideoscope Olympus PCF-HQ190L, Evis Exera III Colonovideoscope Olympus PCF-HQ190I (K192793) | Olympus Medical Systems Corp. | 2020-07-17 |
| SCENARIA View (K200498) | Hitachi Healthcare Americas | 2020-07-17 |
| 3DMax MID Anatomical Mesh (K200818) | C.R. Bard, Inc. | 2020-07-17 |
| ZCA All-Poly Acetabular Cups (K191449) | Zimmer, Inc. | 2020-07-16 |
| Infrared Thermometer Model Number RN-50A,RN-50B (K200578) | Ningbo Ranor Medical Science & Technology Co., Ltd. | 2020-07-16 |
| TiN Coated Humeral Head (K191698) | Fx Shoulder USA, Inc. | 2020-07-16 |
| Vivid S60N, Vivid S70N (K200497) | GE Medical Systems Ultrasound and Primary Care Diagnostics | 2020-07-16 |
| AcuPulse W CO2 Laser Systems, Delivery Devices and Accessories (K201663) | Lumenis, Ltd. | 2020-07-16 |
| KMTI Hip Replacement System, Tesera Trabecular Technologies (T3) Acetabular Shell System, Porous Acetabular Cup System (K201660) | Kyocera Medical Technologies, Inc. | 2020-07-16 |
| FibroScan® 630 (K200655) | Echosens | 2020-07-16 |
| Geneva (K201272) | Nucletron B.V. | 2020-07-16 |
| Arm Blood Pressure Monitor (K193456) | Ningbo Ranor Medical Science & Technology Co., Ltd. | 2020-07-16 |
| Barricaid Instrument Tray (K201676) | Intrinsic Therapeutics, Inc. | 2020-07-16 |
| KeraStat Cream (K192386) | Keranetics | 2020-07-16 |
| REDUCT® Headless Compression Screw System (K201662) | Skeletal Dynamics, Inc. | 2020-07-16 |
| HealthMammo (K200905) | Zebra Medical Vision, Ltd. | 2020-07-16 |
| CoLink Plating System (K201149) | In2bones USA, LLC | 2020-07-15 |
| Daily Breeze B (olifilcon B) Spherical Silicone Hydrogel Soft Contact Lens, Daily Breeze B (olifilcon B) Toric Silicone Hydrogel Soft Contact Lens, Daily Breeze B (olifilcon B) Multifocal Silicone Hydrogel Soft Contact Lens (K201080) | Visco Vision, Inc. | 2020-07-15 |
| Nalu Neurostimulation SCS system (K201618) | Boston Scientific Neuromodulation | 2020-07-15 |
| FullFocus (K201005) | Paige.Ai, Inc. | 2020-07-15 |
| CO2 Laser Therapy System (K201109) | Shanghai Apolo Medical Technology Co., Ltd. | 2020-07-15 |
| TxTiHA IBF System, AxTiHA Stand-Alone ALIF System (K201614) | Innovasis, Inc. | 2020-07-15 |
| V30 System, V20 System, V10 System, V-FR Handpiece (K201064) | Viora , Ltd. | 2020-07-15 |
| Humelock TiN Coated Glenosphere (K191146) | Fx Shoulder USA, Inc. | 2020-07-15 |
| Magicore II System (K201621) | Innobiosurg Co., Ltd. | 2020-07-15 |
| LifeSignals ECG Remote Monitoring Patch Platform (K200690) | Lifesignals, Inc. | 2020-07-15 |
| iHealth Infrared No-Touch Forehead Thermometer (K200531) | Andon Health Co, Ltd. | 2020-07-15 |
| Encision AEM enTouch 2X Scissor (K201018) | Encision, Inc. | 2020-07-15 |
| BD SoloShot Mini Syringe/ BD Auto Disable Syringe (K201234) | Becton, Dickinson and Company | 2020-07-15 |
| EIT Cellular Titanium Cervical Cage, EIT Cellular Titanium ALIF Cage, EIT Cellular Titanium TLIF Cage, EIT Cellular Titanium LLIF Cage, EIT Cellular Titanium T/PLIF Cage (K201605) | Eit Emerging Implant Technologies GmbH | 2020-07-15 |
| Mako Total Knee Application (K193515) | Mako Surgical Corp. | 2020-07-14 |
| Orbit Subretinal Delivery System (K200325) | Orbit Biomedical | 2020-07-14 |
| EMBOTRAP III Revascularization Device (K193063) | Neuravi, Ltd. | 2020-07-14 |
| Vantage Orian 1.5T, MRT-1550, V6.0 with AiCE Reconstruction Processing Unit for MR (K193097) | Canon Medical Systems Corporation | 2020-07-14 |
| Biodesign Staple Line Reinforcement (K201000) | Cook Biotech Incorporated | 2020-07-13 |
| TRAUS SUS20 (K192561) | Saeshin Precision Co., Ltd. | 2020-07-13 |
| ExacTrac Dynamic (K201276) | Brainlab AG | 2020-07-13 |
| Digiscan FDX (K200218) | Allengers Medical Systems Limited | 2020-07-13 |
| Medline Powder Free Examination Gloves (Tested for use with Chemotherapy Drugs) (K200960) | Medline Industires, Inc. | 2020-07-13 |
| Allograft MIS Delivery System (K201338) | Lifenet Health | 2020-07-13 |
| PROBEAT-CR (K201042) | Hitachi , Ltd. | 2020-07-13 |
| AGE Automatic Wrist Blood Pressure Monitor (K193628) | Dongguan E-Test Technology Co., Ltd. | 2020-07-12 |
| Automatic Upper Arm Blood Pressure Monitor (K193627) | Dongguan E-Test Technology Co., Ltd. | 2020-07-12 |
| X-Cube 70 (K200450) | Alpinion Medical Systems Co., Ltd. | 2020-07-10 |
| Triathlon Total KneeSystem (K201343) | Howmedica Osteonics Corp., Dba Stryker Orthopaedics | 2020-07-10 |
| Pelvital System (K200409) | Pelvital USA, Inc. | 2020-07-10 |