| Promisemed Covered Safety Pen Needle (K202681) | Promisemed Hangzhou Meditech Co., Ltd. | 2020-12-31 |
| Surgical Gown (Sterile), Surgical Gown (Non-sterile) (K202706) | B.J.ZH.F.PANTHER MEDICAL EQUIPMENT CO., Ltd. | 2020-12-31 |
| NuEra Tight Family, EMS Model (K201239) | Bios S.R.L. | 2020-12-31 |
| Sirius MRI Markers, Cs-131 Preloaded Strands with Sirius MRI Markers in 18 Gauge Needles (K202267) | Isoray Medical, Inc. | 2020-12-31 |
| Sim&Size (K202322) | Sim&Cure | 2020-12-31 |
| HANAROSTENT Trachea/Bronchium (CCC) (K201342) | M.I.Tech Co., Ltd. | 2020-12-31 |
| Nordiwell Medical Face Mask (K202615) | Changzhou Combat Protective Equipment Co., Ltd. | 2020-12-31 |
| PENTAX Medical Ultrasound Upper GI Video Scope EG34-J10U, PENTAX Medical Ultrasound Upper GI Video Scope EG36-J10UR, PENTAX Medical Ultrasound Upper GI Video Scope EG38-J10UT, PENTAX Medical Ultrasound Video Bronchoscope EB19-J10U (K203166) | Pentax of America, Inc. | 2020-12-30 |
| Foley Balloon Catheter for Urology (K201776) | Apollon Co., Ltd. | 2020-12-30 |
| CryoTreQ (K202038) | VitreQ BV | 2020-12-30 |
| NeuroAmp II, NeuroAmp II.5s (K193159) | Corscience GmbH & Co. KG | 2020-12-30 |
| CrossRoads Tray System (K202268) | Crossroads Extremity Systems, LLC | 2020-12-30 |
| Upper Arm Electronic Blood Pressure Monitor (K202372) | Conmo Electronic Company Limited | 2020-12-30 |
| Arthrex Low Profile Screws (K203239) | Arthrex, Inc. | 2020-12-30 |
| JianYu Surgical Mask (K201754) | Jiangsu Jianyu Health Medical Co., Ltd. | 2020-12-30 |
| Remunity Pump for Remodulin (treprostinil) Injection (K202690) | Deka Research and Development | 2020-12-30 |
| Aixplorer®MACH20, Aixplorer®MACH30, Supersonic MACH40, Supersonic MACH30 & Supersoinc MACH20 Ultrasonic Diagnostic Systems (K202455) | Supersonic Imagine | 2020-12-29 |
| Baby Gorilla/Gorilla Plating System (K203511) | Paragon 28, Inc. | 2020-12-29 |
| First Relief v1 (K202940) | Dyansys, Inc. | 2020-12-29 |
| XR-MX/1000 (K200965) | Karl Storz Endoscopy America, Inc. | 2020-12-29 |
| BriefCase (K203508) | Aidoc Medical , Ltd. | 2020-12-29 |
| E-Cath STIM acc. Tsui (K202699) | PAJUNK GmbH Medizintechnologie | 2020-12-29 |
| Venue Fit (K203137) | GE Medical Systems Ultrasound and Primary Care Diagnostics | 2020-12-29 |
| M5 Recorder (K202456) | Global Instrumentation, LLC | 2020-12-29 |
| Trevo XP ProVue Retriever and Trevo NXT™ ProVue Retriever (K203219) | Stryker Neurovascular | 2020-12-29 |
| Self-Contained Biological Indicator (K200970) | True Indicating, LLC | 2020-12-28 |
| Attune Revision Sleeve LPS Femoral Adaptors (K202248) | Depuy Ireland UC | 2020-12-28 |
| Uni-FuZe-P Bone Putty (K201781) | Zavation Medical Products, LLC | 2020-12-28 |
| Smart SPACE Shoulder System (K202454) | Techmah Medical, LLC | 2020-12-28 |
| ABC33L, ABC35L, ABC37L, ABC39L, ABC33R, ABC35R, ABC37R, ABC39R (K200968) | Insung Medical Co., Ltd. | 2020-12-28 |
| Quadra-P (K202730) | Medacta International S.A. | 2020-12-28 |
| Portable Dental X-ray (NR-F350, CS 2400P, CS 2300P, R2 Port-X) (K201800) | Nanoray Co., Ltd. | 2020-12-28 |
| Optiflux Series of Dialyzers F160NR, F180NR, F200NR (K203062) | Fresenius Medical Care Renal Therapies Group, LLC | 2020-12-28 |
| Novaerus NV1050 (K200321) | Novaerus Us, Inc. | 2020-12-28 |
| Tailored-C Cervical Interbody Fusion System (K200458) | Bespoke Technologies | 2020-12-28 |
| MBT Sepsityper (K193419) | Bruker Daltonik GmbH | 2020-12-27 |
| 8-CH Electroencephalography Amplifier (K201747) | Hipposcreen Neurotech Corp. | 2020-12-27 |
| ImPACT Version 4 (K202485) | Impact Applications, Inc. | 2020-12-25 |
| Image Quality Analyzer (IQA) (K200422) | Visionquest Biomedical, Inc. | 2020-12-24 |
| Acute Dual Lumen Hemodialysis Catheter (K200426) | Health Line International Corporation | 2020-12-24 |
| UltraPulse Surgical and Aesthetic CO2 Laser System, Delivery Devices and Accessories (K203544) | Lumenis, Ltd. | 2020-12-24 |
| Helix Genetic Health Risk App for late-onset Alzheimer’s disease (K192073) | Helix Opco, LLC | 2020-12-23 |
| WishBone Medical Plate and Screw System (K203467) | Wishbone Medical, Inc. | 2020-12-23 |
| Medical Face mask (K202061) | Jiangsu Province Jianerkang Medical Dressing Co., Ltd. | 2020-12-23 |
| SC+ Haemodialysis Machine, SC+ Dialysate Cartridge, SC+ Blood Tube Set (K193670) | Quanta Dialysis Technologies, Ltd. | 2020-12-23 |
| ControlRad Select Model Z (K202431) | Controlrad, Inc. | 2020-12-23 |
| OmniTom Elite (K202526) | Neurologica Corporation, A Subsidiary of Samsung Electronics | 2020-12-23 |
| SR-2300 Portable DR Imaging System, SR-2300S Portable DR Imaging System (K202353) | Shantou Institute of Ultrasonic Instruments Co., Ltd. (Siui) | 2020-12-23 |
| F3D Corpectomy System (K202637) | Corelink, LLC | 2020-12-23 |
| DeRoyal Temperature Monitoring Probe (K200631) | Deroyal Industries, Inc. | 2020-12-23 |
| EndoRotor Device (DEN200016) | Interscope, Inc. | 2020-12-23 |
| Affinity (K202882) | Hermes Medical Solutions AB | 2020-12-23 |
| AtriCure cryoICE cryo-ablation probe (Cryo2), AAtriCure cryoICE cryoSPHERE cryoablation probe (CryoS, CryoS-L) (K200697) | AtriCure, Inc. | 2020-12-23 |
| Bridge Occlusion Balloon (K203540) | Spectranetics, Inc. | 2020-12-23 |
| Scrambler Therapy Technology (Model ST-5A) (K201458) | Delta International Services & Logistics S.R.L | 2020-12-23 |
| AltiVate® Anatomic Pegged Glenoid with Markers (K203026) | Encore Medical L.P. | 2020-12-23 |
| Locking device (K202237) | Hangzhou AGS MedTech Co., Ltd. | 2020-12-23 |
| Omnia Medical TiBrid-SA (K203207) | Omnia Medical, LLC | 2020-12-23 |
| Helix Laboratory Platform (DEN190035) | Helix Opco, LLC | 2020-12-23 |
| Plasdent Disposable Barrier Sleeves and Barrier Film (K201604) | Plasdent Corporation | 2020-12-23 |
| Customized Contour Implant (K200610) | Implantech Associates, Inc. | 2020-12-23 |
| CIRQ Robotic Alignment Module, Cirq, Cirq Robotic Alignment Module Spinal, Cirq Robotic Alignment Cranial and Spine, CIRQ Robotic Alignment Cranial and Spine System (K202320) | Brainlab AG | 2020-12-23 |
| LUBi Water Based Personal Lubricant (K203257) | Boya Biotechnology Co., Ltd. | 2020-12-23 |
| Rapid Reboot (K203552) | Rapid Reboot Recovery Products, LLC | 2020-12-22 |
| Mobile ImagingRing System, IRm, Loop-X Mobile Imaging Robot, Loop-X (K203281) | Medphoton GmbH | 2020-12-22 |
| External Remote Controller ERC 4P (K202348) | Nuvasive Specialized Orthopedics, Inc. | 2020-12-22 |
| Nano FortiFix® System (K203452) | Nanovis, LLC | 2020-12-22 |
| Everyway Analog OTC TENS, model N103A/N302 (K202849) | Everyway Medical Instruments Co.,Ltd | 2020-12-22 |
| ChoiceSpine Tiger Shark Cervical Spacer System (K201643) | Choice Spine, LLC | 2020-12-22 |
| COOLIEF Cooled Radiofrequency Kit Advanced (K203066) | Avanos Medical, Inc. | 2020-12-22 |
| ReVene Thrombectomy Catheter (K201705) | Vetex Medical, Ltd. | 2020-12-22 |
| iSMILE (K200908) | 3D Diagnostix, Inc. | 2020-12-22 |
| Disposable Medical Surgical Face Masks (K202211) | Guangdong Kaidi Garments Co.,Ltd | 2020-12-22 |
| Lucent XP, Lucent XP Curved (K202298) | Spinal Elements, Inc. | 2020-12-22 |
| DenTek Fresh Protect Dental Guard (K202974) | Medtech Products, Inc. | 2020-12-22 |
| Australis Anterior Lumbar Cage System (K202820) | Prism Surgical Designs Pty, Ltd. | 2020-12-22 |
| actiTENS (K202159) | Sublimed | 2020-12-22 |
| Serranator PTA Serration Balloon Catheter (K203437) | Cagent Vascular, LLC | 2020-12-22 |
| Cios Flow (K203504) | Siemens Medical Solutions USA, Inc. | 2020-12-22 |
| Impulse Interbody Fusion System (K201287) | Degen Medical | 2020-12-22 |
| SoloAsisst II, Voice Control (K200473) | Aktormed GmbH | 2020-12-22 |
| CAPERE Thrombectomy System (K203476) | Vascular Medcure, Inc. | 2020-12-22 |
| iTotal Identity Cruciate Retaining (CR) Total Knee Replacement, iTotal Identity Posterior Stabilizing (PS) Total Knee Replacement (K203447) | Conformis, Inc. | 2020-12-22 |
| Traveler38 0.038 Stylet Portal Vein Access Set, Traveler21 21ga Needle Portal Vein Access Set, Traveler16 16ga Needle Portal Vein Access set (K201489) | Argon Medical Devices, Inc. | 2020-12-22 |
| Neodent Implant System - Zirconia Implant System (K201491) | Jjgc Industria E Comercio DE Materiais Dentarios S.A. | 2020-12-22 |
| EZTrack (K201910) | Neurologic, LLC | 2020-12-22 |
| Opallis, Opallis Flow (K201707) | Dentscare Ltda | 2020-12-22 |
| PlaniMax Orthodontic Software (K201036) | Choice Biotech, Inc. | 2020-12-22 |
| AI Metrics (K202229) | Ai Metrics, LLC | 2020-12-22 |
| Da Vinci SP Surgical System (K202968) | Intuitive Surgical, Inc. | 2020-12-22 |
| Resascope RS-01/B (K201113) | Advanced Medical Systems Group Srl | 2020-12-21 |
| Monocryl Plus Antibacterial Suture (K201996) | ETHICON, Inc. | 2020-12-21 |
| Trigon HA Stand-Alone Wedge Fixation System (K203445) | Nvision Biomedical Technologies, Inc. | 2020-12-21 |
| Wu's Electrical Scooter (K192308) | Wu'S Tech Co., Ltd. | 2020-12-21 |
| num Vapocoolant (K202782) | 623 Medical, LLC | 2020-12-21 |
| MR Egometer Pedal, MR Ergometer Push/Pull, MR Ergometer Up/Down, MR Ergometer Dorsal Ankle Flex, MR Ergometer Pedal Ultra (K202979) | Lode B.V. | 2020-12-21 |
| Flexitouch Plus System (K203178) | Tactile Systems Technology, Inc. (Dba Tactile Medical) | 2020-12-20 |
| Strados Remote Electronic Stethoscope Platform (RESP) (K201077) | Strados Labs | 2020-12-20 |
| NovoFine Plus 32G Tip x 4 mm (K202005) | Novo Nordisk, Inc. | 2020-12-19 |
| Signature Latex and Signature Latex Micro, Powder-Free, Surgical Glove, Tested for Use with Chemotherapy Drugs with a Protein Content Label Claim of <50µg/dm2 per Glove of Extractable Protein (K202668) | Medline Industries, Inc. | 2020-12-19 |