| K191296 — Pointe Scientific Creatinine Kinase (CK) Reagent Set | Medtest DX Aug 11, 2020 |
| K200359 — NuEra Tight, NuEra Tight EMS | Bios S.R.L. Aug 11, 2020 |
| K193175 — Lateralized Glenosphere | Medacta Inernational SA Aug 11, 2020 |
| K201933 — ImagenSPECT 3.0 | Cardiovascular Imaging Technologies Aug 11, 2020 |
| K201623 — LION Photocoagulator | Norlase Aps Aug 11, 2020 |
| K193264 — Disposable High Speed Air Turbine Handpiece | Ningbo Hpdove Dental Instruments Co., Ltd. Aug 11, 2020 |
| K193626 — Masimo Rad-97 Pulse CO-Oximeter and Accessories | Masimo Corporation Aug 10, 2020 |
| K201585 — Monterey AL Interbody System | Stryker Corporation Aug 10, 2020 |
| K201567 — Precice® Bone Transport System | Nuvasive Specialized Orthopedics, Inc. Aug 10, 2020 |
| K200592 — GS Medical AnyPlus PEEK Cage System | GS Medical Co., Ltd. Aug 10, 2020 |
| K193006 — MagVenture TMS Therapy for treatment of OCD, MagVenture TMS Therapy system | Tonica Elektronik A/S Aug 9, 2020 |
| K192657 — Sterile High-pressure Angiographic Syringes for Single-use | Shenzhen Boon Medical Supply Co., Ltd. Aug 7, 2020 |
| K201067 — CUPID Brand Male Natural Rubber Latex Condoms (Plain (banana) , Plain (strawberry), Dotted , Multi-textured (Dotted+Contoured + Ribbed)) | Cupid Limited Aug 7, 2020 |
| K200990 — VIDAvision | Vida Diagnostics, Inc. Aug 7, 2020 |
| K201244 — Concorde Models Concorde US and Concorde ST Soft Tissue Biopsy Devices | Transmed7, LLC Aug 7, 2020 |
| K201932 — X-ray Flat Panel Detectors (CareView 1800Cwe /CareView 1500Cwe) | Careray Digital Medical System Co., Ltd. Aug 7, 2020 |
| K201619 — EndoTool IV System | Monarch Medical Technologies, LLC Aug 7, 2020 |
| K201310 — Accipiolx | Maxq AL , Ltd. Aug 7, 2020 |
| K201938 — LZI Fentanyl II Enzyme Immunoassay | Lin-Zhi International, Inc. Aug 7, 2020 |
| K193130 — MVP Aligner System | Mvp Aligners, LLC Aug 7, 2020 |
| K193278 — MedSource CathMED IV Catheter | Medsource Labs Aug 7, 2020 |
| K201883 — 6.5 mm Healix Advance SP Peek Anchor, 6.5 mm Healix Advance SP Biocomposite Anchor | Medos International SARL Aug 7, 2020 |
| K201926 — CarboClear® Pedicle Screw System, CarboClear® II Pedicle Screw System | CarboFix Orthopedics , Ltd. Aug 7, 2020 |
| K200809 — D-LUX+ | DiaDent Group International Aug 7, 2020 |
| K201006 — K2M Navigation Instruments | K2M, Inc. Aug 7, 2020 |
| DEN200001 — Cell-Free DNA BCT | Streck, Inc. Aug 7, 2020 |
| K193082 — Fountain ValveTip Infusion Catheter | Merit Medical Systems, Inc. Aug 7, 2020 |
| K193207 — TaiChiA | Our United Corporation Aug 7, 2020 |
| K192075 — ProSeal Closed System drug Transfer Device (CSTD) | Epic Medical Pte. , Ltd. Aug 7, 2020 |
| K200324 — NHancer Rx | Imds Operations B.V. Aug 6, 2020 |
| K201521 — Medina Anterior Cervical Plate System | Alliance Partners, LLC Aug 6, 2020 |
| K200890 — Invacare Perfecto2V Oxygen Concentrator | Invacare Corporation Aug 6, 2020 |
| K201667 — Midmark Extraoral Imaging System (EOIS) | Midmark Corporation Aug 6, 2020 |
| K191644 — TK Safety Needle | Anhui Tiankang Medical Technology Co., Ltd. Aug 6, 2020 |
| K201907 — ClariVein IC | Merit Medical Systems, Inc. Aug 6, 2020 |
| K193066 — Steripack cases and Tray Systems | Avalign Technologies, Inc. Aug 6, 2020 |
| K201076 — Anchor Dual Lumen Guidewire Catheter | Aqure Medical, Inc. Aug 6, 2020 |
| K200858 — Mini Sterilizable Tray | Implant Direct Sybron Manufacturing, LLC Aug 6, 2020 |
| K201750 — Pentaray Nav eco High-Density Mapping Catheter | Biosense Webster, Inc. Aug 6, 2020 |
| K201641 — Disposable Laparoscope Trocar | Beijing Biosis Healing Biolog Ical Technology Co., Ltd. Aug 6, 2020 |
| K201143 — VICRYL Mesh | ETHICON, Inc. Aug 6, 2020 |
| K201502 — Vitra 810 | Quantel Medical Aug 6, 2020 |
| K200353 — ManaFlow | Manamed, Inc. Aug 6, 2020 |
| K193247 — LATITUDE EV Total Elbow Arthroplasty | Tornier, Inc. Aug 5, 2020 |
| K200780 — XBit Series Digital Color Doppler Ultrasound System | CHISON Medical Technologies Co., Ltd. Aug 5, 2020 |
| K201079 — Aurora® Anterior Lumbar Plate Sytstem | Prism Surgical Design Pty , Ltd. Aug 5, 2020 |
| K200009 — Adaptive Biotechnologies clonoSEQ Assay | Adaptive Biotechnologies Corporation Aug 5, 2020 |
| K192883 — Spartan Hip Stem | Signature Orthopaedics Pty, Ltd. Aug 5, 2020 |
| K201251 — CarboClear Navigated Instruments | CarboFix Orthopedics , Ltd. Aug 5, 2020 |
| K200977 — Modular Toga | Operating Room Innovations, Inc. Aug 5, 2020 |