| K201483 — Impression Material | Zhengzhou Huaer Electro Optics Technology Co., Ltd. Oct 8, 2020 |
| K201525 — ECG App | Apple, Inc. Oct 8, 2020 |
| K192703 — Cranial Image Guided Surgery System, Navigation Software Cranial, Navigation Software ENT, Registration Software Cranial, Automatic Registration 2.0, Ultrasound Navigation Software (BK), Intraoperative Structure Update | Brainlab AG Oct 8, 2020 |
| K202478 — Captivator Single-Use Polypectomy Snares, Captiflex Single-Use Polypectomy Snares | Boston Scientific Corporation Oct 8, 2020 |
| K193542 — Clearum HS Family, Clearum HS Models: HS 13, HS 15, HS 17, HS 20, HS 22 | Bellco Srl Oct 8, 2020 |
| K202119 — AcuSee AS-P1000 System | Weipeng (Suzhou) Medical Devices Co., Ltd. Oct 7, 2020 |
| K200725 — Citregen Tendon Interference Screw and Citrelock | Acuitive Technologies Oct 7, 2020 |
| K200817 — URIS OMNI Narrow System & Prosthetic | Truabutment, Inc. Oct 7, 2020 |
| K201453 — Fortilink Cages with TiPlus Technology | Paradigm Spine GmbH Oct 7, 2020 |
| K192949 — Flower Suture Anchor Set | Flower Orthopedics Corporation Oct 7, 2020 |
| K201380 — Livocare Surgical Mask | Andon Health Co, Ltd. Oct 7, 2020 |
| K200802 — Infrared Thermometer | Shenzhen Urion Technology Co., Ltd. Oct 7, 2020 |
| K202633 — ScanX Edge | Dürr Dental SE Oct 7, 2020 |
| K200100 — Abutment Design | 3Shape A/S Oct 7, 2020 |
| K202293 — Radiographic System Challenge X | Sedecal., Sa. Oct 7, 2020 |
| K201701 — R3 HA Coated Acetabular Shells | Smith & Nephew, Inc. Oct 6, 2020 |
| K200953 — NuVasive® Cohere® Thoracolumbar Interbody System | Nu Vasive, Incorporated Oct 6, 2020 |
| K202584 — iSleeve Introducer Set | Boston Scientific Corporation Oct 6, 2020 |
| K202253 — TruForm Sievers Annuloplasty Ring | Genesee Biomedical, Inc. Oct 6, 2020 |
| K202114 — CoolSeal Generator/CSL-200-50, CoolSeal Trinity (30 cm shaft)/CSL-TR105-30, CoolSeal Trinity (37 cm shaft)/CSL-TR105-37, CoolSeal Trinity (44 cm shaft)/CSL-TR105-44, CoolSeal Mini (20cm shaft)/CSL-MN103-20 | Bolder Surgical, LLC Oct 6, 2020 |
| K200728 — Pitkar DeftFix System | S.H.Pitkar Orthotools Pvt. , Ltd. Oct 6, 2020 |
| K200792 — MySpine S2-Alar/Alar-Iliac Pedicle Screw Placement Guides | Medacta Inernational SA Oct 5, 2020 |
| K200031 — Neonatal Phototherapy System | Avalon Biomedical (Shenzhen) Limited Oct 5, 2020 |
| K202294 — Affirm Contrast Biopsy | Hologic, Inc. Oct 5, 2020 |
| K201561 — Membrane Screws and Membrane Tacks | Neoss Limited Oct 5, 2020 |
| K201659 — KHEIRON® Spinal Fixation System | S.M.A.I.O Oct 5, 2020 |
| K202292 — UDE | Ebm Technologies, Inc. Oct 5, 2020 |
| K200217 — ClearEndoclip | Finemedix Co., Ltd. Oct 5, 2020 |
| K193410 — SOZO Body Fluid Analyzer | ImpediMed Limited Oct 2, 2020 |
| K201546 — OsOpia Synthetic Bone Void Filler | Revisios BV Oct 2, 2020 |
| K191320 — Slow Wave DS8 | Slow Wave, Inc. Oct 2, 2020 |
| K202280 — Cleerly Labs v2.0 | Cleerly, Inc. Oct 2, 2020 |
| K200682 — BZF-29 | GC America, Inc. Oct 2, 2020 |
| K201238 — Encore System | Siesta Medical, Inc. Oct 2, 2020 |
| K202207 — Materialise PKA Guide System | Materialise NV Oct 2, 2020 |
| K200623 — OssGuide | Sk Bioland Co., Ltd. Oct 2, 2020 |
| K201559 — HAL for Medical Use(Lower Limb type) | Cyberdyne, Inc. Oct 2, 2020 |
| K201161 — Infrared Thermometer Model E127 | Bioland Technology, Ltd. Oct 2, 2020 |
| K202190 — Oculus-SA Lumbar Cage System | Neurostructures Oct 2, 2020 |
| K201748 — Latex Powder Free Surgical Glove with Protein Labelling Claim of 50 Microgram or Less per Gram of Glove and Tested for use with Chemotherapy Drugs | Hartalega Sdn Bhd Oct 2, 2020 |
| K190707 — Arthrex SoftStitch | Arthrex, Inc. Oct 2, 2020 |
| K201301 — X100 with Full Field Peripheral Blood Smear (PBS) Application | Scopio Labs , Ltd. Oct 2, 2020 |
| K202170 — LiverMultiScan | Perspectum, Ltd. Oct 2, 2020 |
| K202557 — Quantum Workstation 12 Elite | Spectrum Medical , Ltd. Oct 2, 2020 |
| K202218 — ZelanteDVT THrombectomy System, ZelanteDVT ClotHunter Helical Rotation Device | Boston Scientific Corporation Oct 2, 2020 |
| K200710 — Infrared PT2L Digital No-Touch Thermometer | Andon Health Co, Ltd. Oct 1, 2020 |
| K200127 — TELEGRAPH® EVOLUTION Humeral Nailing System | FH Industrie Oct 1, 2020 |
| K202357 — Nutricare Clear-ISOSAF Nasogastric Feeding Tube | Three Circles Consulting Limited Oct 1, 2020 |
| K201381 — Philips Avent Single/Double electric breast pump Advanced | Philips Consumer Lifestyle - Innovation Site Eindhoven Oct 1, 2020 |
| K200544 — SmartLyte® Plus Electrolyte Analyzer Na+/K+/Cl-/Ca++/Li+ | Diamond Diagnostics, Inc. Oct 1, 2020 |