| BIOEASY Multi-Drug Test Cup (K193480) | Shenzhen Bioeasy Biotechnology Co., Ltd. | 2020-01-31 |
| HAD1717MC (K200018) | H&Abyz | 2020-01-31 |
| Arc Enterocuff (K191330) | Boddingtons Plastics, Ltd. | 2020-01-31 |
| syngo.MR Applications (K192462) | Siemens Medical Solutions USA, Inc. | 2020-01-31 |
| Noritake Super Porcelain EX-3 (K193060) | Kuraray Noritake Dental, Inc. | 2020-01-30 |
| TruDi Navigation System (K192397) | Biosense Webster | 2020-01-30 |
| EndoClot (K191254) | Endoclot Plus Co., Ltd. | 2020-01-30 |
| TeslaTome Bipolar Sphincterotome, Tesla Bipolar Active Cord (K192339) | Wilson-Cook Medical, Inc. | 2020-01-30 |
| Neo (K192889) | Eemagine Medical Imaging Solutions GmbH | 2020-01-30 |
| GTK Veress Needles (K193339) | Guangzhou T.K Medical Instrument Co., Ltd. | 2020-01-30 |
| ATTUNE All-Polyethylene Tibia (K193057) | Depuy Ireland UC | 2020-01-30 |
| Linshom Respiratory Monitoring Device (LRMD) (K190734) | Linshom Management, LLC | 2020-01-30 |
| SCS 17-01 (K190956) | Anika Therapeutics, Inc. | 2020-01-30 |
| HySil Super Fast Impression Materials (K192941) | Osstem Implant Co., Ltd. | 2020-01-30 |
| Dexcom G6 Glucose Program Continuous Glucose Monitoring (CGM) System (K193642) | Dexcom, Inc. | 2020-01-29 |
| Anatomical Shoulder System (K193099) | Zimmer GmbH | 2020-01-29 |
| Ezvena IPC, Ezvena SQS (K191937) | Eezcare Medical Corp | 2020-01-29 |
| Quantum® Total Ankle Prosthesis (K191380) | In2bones Sas | 2020-01-29 |
| Carescape B850 (K191323) | GE Healthcare Finland Oy | 2020-01-29 |
| MectaTap TI Suture Anchor (K191677) | Medacta International S.A. | 2020-01-29 |
| WVSM (Wireless Vital Signs Monitor) RWC + miniCap (K191989) | Athena Gtx | 2020-01-29 |
| UniSmile Clear Aligner System (K191837) | Vitang Technology, LLC | 2020-01-29 |
| VITA VIONIC Bond (K191926) | Vita Zanhnfabrik H. Rauter GmbH Co. | 2020-01-29 |
| TruAbutment DS (K183106) | Truabutment, Inc. | 2020-01-29 |
| Bosley Revitalizer 96 Laser Cap, Bosley Revitalizer 96 XL Laser Cap (K192585) | Pjm Worldwide, LLC D/B/A Phoenix Medical Technology, LLC | 2020-01-29 |
| Biopsy Needle (K191472) | Ushare Medical, Inc. | 2020-01-29 |
| Cook-Cope Loop Nephrostomy Set, Ultrathane Nephrostomy Set with Mac-Loc, Ultrathane Suprapubic Set with Mac-Loc (K191498) | Cook Incorporated | 2020-01-29 |
| LIAISON Lyme Total Antibody Plus, LIAISON Lyme Total Antibody Plus Control Set (K193051) | DiaSorin, Inc. | 2020-01-29 |
| Terason uSmart3200T Ultrasound System (K193510) | Teratech Corporation | 2020-01-28 |
| MRH ALFA Radiographic System, MRH II Radiographic System, MRH IIE Radiographic System (K193637) | Compania Mexicana DE Radiologia Cgr, S.A. DE C.V. | 2020-01-28 |
| The NightBlocks Appliance (K192581) | Advanced Facialdontics, LLC | 2020-01-28 |
| V-DENUPET (K192146) | Vitromed GmbH | 2020-01-28 |
| M.U.S.T. Pedicle Screw System (K193365) | Medacta International S.A. | 2020-01-27 |
| Xenocor Articulating Xenoscope Laparoscope (K193315) | Xenocor, Inc. | 2020-01-27 |
| CMOS Video Rhino-Laryngoscope SSU (K192090) | Karl Storz SE & CO. KG | 2020-01-27 |
| Endoscope Tip Protector - Sterile, Endoscope Tip Protector - Non-sterile (K191715) | STERIS Corporation | 2020-01-27 |
| Emission Computed Tomography System (K193241) | Shanghai United Imaging Healthcare Co., Ltd. | 2020-01-26 |
| THD Procto Software System (K193512) | Thd Spa | 2020-01-26 |
| Subdural Strip/Intraoperative Split Electrode, Subdural Grid/Intraoperative Grid Electrode, Dual-Sided Interhemispheric Subdural Electrode, Multi-Strip and Slit Grid Subdural Electrode, Intraoperative Mapping Grid Subdural Electrode (K191186) | Ad-Tech Medical Instrument Corporation | 2020-01-25 |
| APTUS Clavicle System (K192984) | Medartis AG | 2020-01-24 |
| KardiaMobile, KardiaStation (K191406) | AliveCor, Inc. | 2020-01-24 |
| CARESCAPE B450 (K191249) | GE Healthcare Finland Oy | 2020-01-24 |
| Cellvizio 100 Series System with Confocal Miniprobes (K191144) | Mauna Kea Technologies | 2020-01-24 |
| Gemini Titan Sterilization Wrap (K192641) | Medline Industries, Inc. | 2020-01-24 |
| Blue Nitrile Examination Gloves Powder Free (K192333) | Jr Engineering & Medical Technologies (M) Sdn. Bhd. | 2020-01-24 |
| Reprocessed Achieve Catheter Connecting Cable (K193263) | Innovative Health, LLC | 2020-01-24 |
| CareSens S Clear BT Blood Glucose Monitoring System (K192859) | I-Sens, Inc. | 2020-01-24 |
| LCCS VC-S RF Cannula (K191293) | Lccs Products Limited | 2020-01-24 |
| SYPMHONY™ OCT System (K192014) | Medos International SARL | 2020-01-24 |
| CMOS Video Esophagoscope SSU (K192523) | Karl Storz SE & CO. KG | 2020-01-24 |
| MRCAT brain (K193109) | Philips Medical Systems MR Finland | 2020-01-24 |
| Disposable SpO2 Sensor (K192608) | Shenzhen Sino-K Medical Technology Co.,Ltd | 2020-01-24 |
| BD Cathena (TM) Safety IV Catheter (K192493) | Becton Dickinson Infusion Therapy Systems, Inc. | 2020-01-24 |
| Paratrooper Plantar Plate Repair System (K191227) | Paragon 28, Inc. | 2020-01-24 |
| Persona Personalized Knee System (K193223) | Zimmer, Inc. | 2020-01-24 |
| FlightPlan for Embolization (K193261) | GE Medical Systems SCS | 2020-01-24 |
| IQon Spectral CT (K193454) | Philips Medical Systems Nederland B.V. | 2020-01-24 |
| cortiQ PRO (K191432) | G.Tec Medical Engineering GmbH | 2020-01-24 |
| Stat Profile Prime Plus Analyzer System (K193246) | Nova Biomedical Corporation | 2020-01-24 |
| VistaScan USB Ultrasound Imaging System (K192170) | Emagine Solutions Technology, LLC | 2020-01-23 |
| EEA Circular Stapler with Tri-Staple Technology (K192330) | Covidien | 2020-01-23 |
| Healing Abutments and Cover Screws (K192436) | Dentium Co., Ltd. | 2020-01-23 |
| Elements Viewer (K191014) | Brainlab AG | 2020-01-23 |
| STERRAD VELOCITY Biological Indicator/Process Challenge Device and Reader (K192025) | Advanced Sterilization Products (Asp) | 2020-01-23 |
| Bactisure Wound Lavage (K192349) | Next Science, LLC | 2020-01-23 |
| HardyDisk AST Cefiderocol 30ug (FDC30) (K193504) | Hardy Diagnostics | 2020-01-23 |
| VINNO 8, VINNO 6, VINNO 5 (K190120) | Vinno Technology (Suzhou) Co.,Ltd | 2020-01-23 |
| GammaTile (K190839) | Gt Medical Technologies | 2020-01-23 |
| Seca Medical Vital Signs Analyzer 535, Seca mVSA 535, Seca mVSA, Seca 535 (K192092) | Seca GmbH & Co. KG | 2020-01-23 |
| Surefil one Self-adhesive Composite Hybrid (K192530) | Dentsply Sirona | 2020-01-23 |
| FiteBac Cavity Cleanser (K190271) | Largent Health, LLC | 2020-01-23 |
| Parcus Knotless PEEK and PEEK CF Push-In Suture Anchor (K193295) | Parcus Medical, LLC | 2020-01-23 |
| Blue Phantom PT (K191821) | Iba Dosimetry GmbH | 2020-01-23 |
| Proneb Max (K191270) | Pari Respiratory Equipment, Inc. | 2020-01-23 |
| SCARLET AL-T (K192993) | Spineart | 2020-01-22 |
| Q-Rad System (K193574) | Carestream Health, Inc. | 2020-01-22 |
| Isopure Dry Acid Dissolution System (K191093) | Isopure, Corp. | 2020-01-22 |
| Y-Knot OneStep Anchor (K193606) | Conmed Corporation | 2020-01-22 |
| FastFit EMS System (K192161) | Fast Fit, LLC | 2020-01-22 |
| Fundus Camera (K190954) | Chongqing Bio Newvision Medical Equipment , Ltd. | 2020-01-22 |
| E-EEGX, N-EEGX (K191322) | GE Healthcare Finland Oy | 2020-01-22 |
| HydroPearl Microspheres (K192684) | MicroVention, Inc. | 2020-01-22 |
| Spectra Q (K191109) | Uzinmedicare Co. | 2020-01-22 |
| Anatomic PEEK™ Cervical Fusion System, Anatomic PEEK™ PTC Cervical Fusion System, Capstone™ Spinal System, Capstone PTC™ Spinal System, Capstone Control™ Spinal System, Capstone Control PTC™ Spinal System, Clydesdale™ Spinal System, Clydesdale PTC™ Spinal System, Cornerstone™ PSR Cervical Fusion System, Crescent™ Spinal System, Crescent™ Spinal System Titanium, Divergence™ Anterior Cervical Fusion System (For Stand-Alone Interbody Device Only), Divergence-L™ Anterior/Oblique Lumbar Fus (K192502) | Medtronic Sofamor Danek USA, Inc. | 2020-01-22 |
| Internal Hex Implant System (K190837) | Ebi, Inc. | 2020-01-22 |
| TrapIt (K191229) | Imds Operations B.V. | 2020-01-21 |
| ZELTIQ CoolSculpting System (K193566) | Zeltiq Aesthetics, Inc. | 2020-01-21 |
| Hydro-Temp Neonatal Skin Temperature Probe Cover (K191425) | Deroyal Industries, Inc. | 2020-01-21 |
| Disposable Gold Cup EEG Electrodes (K192564) | Dymedix Diagnostics, Inc. | 2020-01-21 |
| PIVO(TM) (K193569) | Velano Vascular | 2020-01-21 |
| Medline Glide-On 3G Vinyl Examination Gloves (K192985) | Medline Industries, Inc. | 2020-01-21 |
| Nexxt Matrixx System (K193370) | Nexxt Spine, LLC | 2020-01-21 |
| CARESCAPE B650 (K191149) | GE Healthcare Finland Oy | 2020-01-21 |
| EzMobile (K192098) | Ewoosoft Co., Ltd. | 2020-01-20 |
| Tyber Medical Anatomical Plating System (K193222) | Tyber Medical, LLC | 2020-01-20 |
| geko™ W-2 (K193045) | Firstkind Limited | 2020-01-18 |
| Mirage Hydrophilic Guidewire, X-pedion Hydrophilic Guidewire (K193548) | Micro Therapeutics, Inc. d/b/a ev3 Neurovascular | 2020-01-18 |
| SAC2 - Electrode Cream (K192606) | Spes Medica Srl | 2020-01-17 |
| Evis Exera III Duodenovideoscope Olympus TJF-Q190V (K193182) | Olympus Medical Systems Corp. | 2020-01-17 |
| Bio-TackS Orthodontic Mini Implant (K190871) | Biocetec Co., Ltd. | 2020-01-17 |