| Vantage Galan 3T, MRT-3020, V6.0 with AiCE Reconstruction Processing Unit for MR (K192574) | Canon Medical Systems Corporation | 2020-03-09 |
| Pre-Milled Blank (K193425) | Arum Dentistry Co., Ltd. | 2020-03-09 |
| LiquiBand Plus (K183570) | Advanced Medical Solutions Limited | 2020-03-09 |
| Senhance Surgical System (K200049) | Transenterix, Inc. | 2020-03-09 |
| F&P Nivairo RT047 Vented Hospital Full Face Mask, Anti-Asphyxiation Valve Version (K191624) | Fisher & Paykel Healthcare Limited | 2020-03-09 |
| Edwards eSheath Introducer Set (K200258) | Edwards Lifesciences | 2020-03-09 |
| DR 600 with Tomosynthesis (K193262) | Agfa N.V. | 2020-03-09 |
| Single Use Guide Sheath Kit K-401, K-402, & Single Use Guiding Device CC-220DR (K192164) | Olympus Medical Systems Corp. | 2020-03-06 |
| VersaWrap Tendon Protector (K200311) | Alafair Biosciences, Inc. | 2020-03-06 |
| OSSIOfiber™ Hammertoe Fixation System/OSSIOfiber™ Hammertoe Fixation Implant (K190652) | OSSIO , Ltd. | 2020-03-06 |
| NightOwl (K191031) | Ectosense NV | 2020-03-06 |
| PhotonBlade with Smoke Evacuation (K191583) | Invuity, Inc. | 2020-03-06 |
| SwabTip Male Disinfectant Cap (K190918) | Icu Medical | 2020-03-06 |
| CentriMag Circulatory Support System, CentriMag Return (Arterial) Cannula Kit, CentriMag Drainage (Venous) Cannula Kit (K200306) | Abbott (Formerly Thoratec Corporation) | 2020-03-06 |
| MEGAFIX® Pedicle Screw Spinal System (K191655) | Seohancare Co., Ltd. | 2020-03-06 |
| Yumizen C1200 Ferritin, Yumizen C1200 Transferrin, Yumizen C1200 Rheumatoid Factor (K191562) | HORIBA ABX SAS | 2020-03-06 |
| EPIQ Diagnostic Ultrasound System (K200304) | Philips Ultrasound, Inc. | 2020-03-06 |
| Avinent Surgical Tray (K191566) | Avinent Implant System S.L.U. | 2020-03-06 |
| 1688 Pendulum 4K Camera Head with Integrated Coupler, 1688 4K Camera Control Unit with Advanced Imaging Modality (K200310) | Stryker | 2020-03-06 |
| Plasma IQ (K192813) | Neauvia North America, Inc. | 2020-03-06 |
| sam 2.0 Long Duration Ultrasound System (K191568) | ZetrOZ Systems, LLC | 2020-03-06 |
| SensiCare Sterile Power-Free Polymer Coated Polyisoprene Sugical Glove, Coated with Aloe V (K191915) | Medline Industries, Inc. | 2020-03-06 |
| LOSPA® IS™ Spinal Fixation System (K200267) | Corentec Co., Ltd. | 2020-03-06 |
| BOND Ready-to-Use Primary Antibody Progesterone Receptor (16), Novocastra Liquid Mouse Monoclonal Antibody Progesterone Receptor Clone 16 (Concentrated Liquid Antibody Format). (K193393) | Leica Biosystems Newcastle, Ltd. | 2020-03-06 |
| Insight Enhanced DRF Digital Imaging System (K200396) | Imaging Engineering, LLC | 2020-03-06 |
| Ezfil (K191991) | Meta Biomed Co., Ltd. | 2020-03-05 |
| Instinct Plus Endoscopic Clipping Device (K192697) | Cook Endoscopy | 2020-03-05 |
| V-STRUT Vertebral Implant (K191709) | Hyprevention Sas | 2020-03-05 |
| ATLANTIS Abutment for MIS Conical Connection Implants (K193529) | Dentsply Sirona | 2020-03-05 |
| ImmuView S pneumoniae and L pneumophila Urinary Antigen Test (K191184) | Ssi Diagnostica A/S | 2020-03-05 |
| TrackX (K200360) | Track X Technology, LLC | 2020-03-05 |
| Kinepict Medical Imaging Tool version v2.2 (K190993) | Kinepict Health, Ltd. | 2020-03-05 |
| ALLthread PEEK Suture Anchor (K193402) | Biomet, Inc. | 2020-03-05 |
| Lucent : IPL (K193072) | Luvo Medical Technologies, Inc. | 2020-03-05 |
| Transpara (K193229) | Screenpoint Medical B.V. | 2020-03-05 |
| ProVecta 3D Prime Ceph (K193139) | Durr Dental SE | 2020-03-05 |
| CURA 778 (K192590) | Fmi Medical Systems, Inc. | 2020-03-05 |
| Omnifix Low Dead Space Luer Lock Syringe (K193101) | B.Braun Medical, Inc. | 2020-03-05 |
| GlidePath Long-Term Hemodialysis Catheters, HemoStar Long-Term Hemodialysis Catheters, HemoStar XK Long-Term Hemodialysis Catheters (K190527) | C. R. Bard | 2020-03-05 |
| Stereotaxis Genesis RMN with Navigant Workstation (NWS) and Cardiodrive System (K193147) | Stereotaxis, Inc. | 2020-03-05 |
| Broncholab (K191550) | Fluidda, Inc. | 2020-03-04 |
| Vista Clear (K193389) | Inter-Med/Vista Dental Products | 2020-03-04 |
| Coronet Soft Tissue Fixation System (K200028) | Conextions Medical | 2020-03-04 |
| TumEase Acupressure Bracelets (K193374) | Mumease | 2020-03-04 |
| Capere Thrombectomy System (K200314) | Vascular Medcure, Inc. | 2020-03-04 |
| DANNIK Disposable Monopolar Laparoscopic Instrument (K193019) | Dannik | 2020-03-04 |
| KinematX Total Wrist Arthroplasty System (K191525) | Extremity Medical, LLC | 2020-03-04 |
| ARIX Ankle System (K193616) | Jeil Medical Corporation | 2020-03-04 |
| L100 Go System (K200262) | Bioness, Inc. | 2020-03-04 |
| Mecta-C Stand Alone (K192906) | Medacta International S.A. | 2020-03-04 |
| Lubrina 2 (K190509) | J. Morita USA, Inc. | 2020-03-04 |
| Sapphire II PRO (K200269) | Orbusneich Medical Trading, Inc. | 2020-03-04 |
| MicroScan Dried Gram-Negative MIC/Combo Panels with Levofloxacin (Lvx) (0.008-16ug/mL) (K193358) | Beckman Coulter, Inc. | 2020-03-03 |
| OVision Imaging System (K200275) | Ophthalmic Labs, Inc. | 2020-03-03 |
| Fixone Biocomposite Small Anchor (K192032) | Aju Pharm Co., Ltd. | 2020-03-03 |
| Atlantis suprastructures (K193064) | Dentsply Sirona, Inc. | 2020-03-03 |
| Vantage Galan 3T, MRT-3020, V6.0 (K192506) | Canon Medical Systems Corporation | 2020-03-02 |
| CarboClear Lumbar Cage System (K193378) | CarboFix Orthopedics , Ltd. | 2020-03-02 |
| Menicon 3% Hydrogen Peroxide Cleaning and Disinfecting Solution (K191872) | Menicon Co, Ltd. | 2020-03-02 |
| BiZact Tonsillectomy Device Advanced Bipolar Tissue Sealer/Divider (K193356) | Covidien, LLC | 2020-03-02 |
| Anjon Bremer Halo System (K193256) | Anjon Holdings, LLC | 2020-03-02 |
| LIAISON Anti-HAV Assay (K193532) | DiaSorin, Inc. | 2020-03-02 |
| CARDIOVIT AT-102 G2 (K183425) | Schiller AG | 2020-03-02 |
| High Strength Suture (K192637) | Yunyi (Beijing) Medical Device Co., Ltd. | 2020-03-02 |
| Kingon P2 Oxygen Concentrator (K190304) | Qingdao Kingon Medical Science and Technology Co. | 2020-02-29 |
| Paragon Adult Maxi PMP Oxygenator (Model: XCMOP405PMP) (K191246) | Chalice Medical , Ltd. | 2020-02-28 |
| scaffolene CL100 Bioresorbable Collagen Matrix (K192346) | Freudenberg Technology Innovation SE & Co. KG | 2020-02-28 |
| icobrain-ctp (K192962) | Icometrix NV | 2020-02-28 |
| Atlas Spine Expandable Cervical Standalone Interbody System (K192570) | Atlas Spine, Inc. | 2020-02-28 |
| Red Dot (K191556) | Behold.Ai Technologies Limited | 2020-02-28 |
| Zimmer M/L Taper Hip Prosthesis (K192660) | Zimmer, Inc. | 2020-02-28 |
| Arctic Sun Stat Temperature Management System (K200225) | Medivance, Inc. | 2020-02-28 |
| Daytona® Small Stature Spinal System (K200381) | SeaSpine Orthopedics Corporation | 2020-02-28 |
| Steripath Gen2 Blood Collection System (K192247) | Magnolia Medical Technologies, Inc. | 2020-02-28 |
| Magnetom Sola, Magnetom Altea and Magnetom Sola Fit (K192496) | Siemens Medical Solutions USA, Inc. | 2020-02-28 |
| Therm-X (K193550) | Zenith Technical Innovations | 2020-02-28 |
| Cellvizio I.V.E. with Confocal Miniprobes (K193416) | Mauna Kea Technologies | 2020-02-28 |
| SensiCare Neoprene Synthetic Polychloroprene Surgical Glove (Tested for Use with Chemotherapy Drugs) (K192820) | Medline Industries, Inc. | 2020-02-28 |
| Alta Multipurpose Device (K193243) | Qfix | 2020-02-28 |
| AccuContour (K191928) | Xiamen Manteia Technology , Ltd. | 2020-02-28 |
| CONQUEST FN (K193029) | Smith & Nephew, Inc. | 2020-02-28 |
| HARMONIC HD 1000i Shears, 20 cm length, HARMONIC HD 1000i Shears, 36 cm length (K191555) | Ethicon Endo-Surgery, LLC | 2020-02-28 |
| R-Sensor, R-Sensor (K200284) | Remedi Co., Ltd. | 2020-02-28 |
| i-STAT CHEM8+ cartridge with the i-STAT 1 System (K183680) | Abbott Point of Care, Inc. | 2020-02-28 |
| Superelastic Staple (K192447) | Neosteo | 2020-02-28 |
| Basal-IQ Technology (K193483) | Tandem Diabetes Care, Inc. | 2020-02-28 |
| CT F/S/D Compatible Applicators (Fletcher), HDR Compatible Tandem and Ovoid Applicators (Henschke), HDR CT Compatible Split Ring Applicator, Segmented Vaginal Applicator, HDR Miami Applicator HDR Brachytherapy Applicator, 2/3 Endometrial Applicator Sets, CT HDR Ring & Tandem Applicator with Rectal Retractor (K200221) | Mick Radio-Nuclear Instruments, Inc. | 2020-02-28 |
| Proov Test (K191462) | Mfb Fertility, Inc. | 2020-02-27 |
| AXS Vecta 71 Intermediate Catheter, AXS Vecta 74 Intermediate Catheter (K200206) | Stryker Neurovascular | 2020-02-27 |
| Fusion Quattro Extraction Balloon (K200247) | Wilson-Cook Medical, Inc. | 2020-02-27 |
| INTELLIO Tablet Application (K192876) | Smith & Nephew | 2020-02-27 |
| Masimo Rad-97 Pulse CO-Oximeter and Accessories, Masimo Radical-7 Pulse CO-Oximeter and Accessories, Masimo Radius-7 Pulse CO-Oximeter and Accessories (K193242) | Masimo Corporation | 2020-02-27 |
| Colibri Endoscopy System (K192305) | 3nt Medical , Ltd. | 2020-02-27 |
| Biolox delta Ceramic Heads, Biolox delta Option Ceramic Heads (K192683) | Biomet UK, Ltd. | 2020-02-27 |
| APrioCore Plus (K193268) | Apriomed AB | 2020-02-27 |
| Penumbra System Penumbra JET 7X (K191946) | Penumbra, Inc. | 2020-02-27 |
| ST Internal Implant System (K190919) | T-Plus Implant Tech. Co., Ltd. | 2020-02-27 |
| Explorer Mini (K190682) | Permobil AB | 2020-02-27 |
| Omnia Medical Trauma Screws (K192096) | Omnia Medical, LLC | 2020-02-27 |
| Elecsys Anti-TSHR (K193313) | Roche Diagnostics | 2020-02-27 |