| Headless Compression Screw System (K200259) | Osteocentric Extremities, LLC | 2020-05-04 |
| Aspire MAX 7 - 11F Mechanical Thrombectomy System and Aspire Mechanical Aspirator (K200871) | Control Medical Technology | 2020-05-04 |
| LIVIA (K183110) | Lifecare , Ltd. | 2020-05-04 |
| Revitive Medic Plus, Revitive Advanced 2 (K192887) | Actegy , Ltd. | 2020-05-04 |
| Ultravision Visual Field Clearing System (K200035) | Alesi Surgical, Ltd. | 2020-05-04 |
| BOSS Balloon Guide Catheter (K200910) | Marblehead Medical | 2020-05-02 |
| RIST Radial Access Catheter (K200417) | Rist Neurovascular, Inc. | 2020-05-02 |
| FUJIFILM EP-6000 Video Processor (K192286) | Fujifilm Corporation | 2020-05-01 |
| Stone Retrieval Balloon (K200173) | Hangzhou AGS MedTech Co., Ltd. | 2020-05-01 |
| Wireless Digital Flat Panel Detector Model Name Mars1417V-TSI, Wireless Digital Flat Panel Detector Model Name Mano4336W (K201004) | Iray Technology Taicang , Ltd. | 2020-05-01 |
| NON-STERILE, POWDER FREE NITRILE EXAMINATION GLOVES, LOW DERMATITIS POTENTIAL, AND TESTED FOR USE WITH CHEMOTHERAPY DRUGS BLUE-AC (K200453) | Yty Industry (Manjung) Sdn Bhd | 2020-05-01 |
| Optimized Positioning System (OPS) Insight (K192656) | Corin USA | 2020-05-01 |
| PERLA® Posterior Occipito-Cervico-Thoracic Fixation System (K200571) | Spineart | 2020-05-01 |
| GUS831 Compressor Nebulizer (K192633) | Globalcare Medical Technology Co., Ltd. | 2020-05-01 |
| ImmunoCAP Allergen o215, Component nGal-alpha-1,3-Gal(alpha-Gal) Thyroglobulin, bovine (K200279) | Phadia AB | 2020-05-01 |
| Azurion R2.1 (K200917) | Philips Medical Systems Nederland B.V. | 2020-05-01 |
| O-Genesis Graft Delivery System (K200606) | Orthofix, Inc. | 2020-05-01 |
| EPIQ Diagnostic Ultrasound System Series, Affiniti Diagnostic Ultrasound System Series, CX50 Diagnostic Ultrasound System, Sparq Diagnostic Ultrasound System, Lumify Diagnostic Ultrasound System (K201012) | Philips Ultrasound, Inc. | 2020-05-01 |
| Kitazato ET Catheters (K192540) | Kitazato Corporation | 2020-05-01 |
| Carnation Ambulatory Monitor (K200870) | Bardy Diagnostics, Inc. | 2020-05-01 |
| PDT-FACE (K192295) | Beijing Adss Development Co., Ltd. | 2020-05-01 |
| OGmend Implant System (DEN180065) | Woven Orthopedic Technologies, LLC | 2020-05-01 |
| iTEAR Neurostimulator (DEN190026) | Olympic Ophthalmics, Inc. | 2020-05-01 |
| Image Guidance System for Radiotherapy (K192405) | Jiangsu Rayer Medical Technology Co., Ltd. | 2020-05-01 |
| ArthrexVIP Web Portal (K193523) | Arthrex, Inc. | 2020-04-30 |
| SpineEX Sagittae Lateral Lumbar Interbody Fusion Devices (K200816) | Spineex, Inc. | 2020-04-30 |
| Biolign® Roto-Loc Cervical Plate System (K200523) | Elite Surgical Supplies (Pty), Ltd. | 2020-04-30 |
| 50g SMS Standard Surgical Gown, 45g SMS Surgical Gown with Reinforcement, 68g BVB Surgical Gown, 68g BVB Splicing Surgical Gown (K192290) | Xuchang Zhengde Environstar Medical Products Co., Ltd. | 2020-04-30 |
| CarboClear® II Pedicle Screw System (K200519) | CarboFix Orthopedics , Ltd. | 2020-04-30 |
| ClickClean (K200902) | Medeon Biodesign, Inc. | 2020-04-30 |
| Turbett Instrument Pod (K200240) | Turbett Surgical, Inc. | 2020-04-30 |
| PulsioFlex Monitoring System with ProAQT Sensor (K192169) | Pulsion Medical Systems SE | 2020-04-30 |
| Medical Non-Ablative Fractional Laser Systems (K192350) | Wingderm Electro-Optics , Ltd. | 2020-04-30 |
| Biowy PICC Catheter S Kit (K192246) | Biowy Corporation | 2020-04-30 |
| CARPEDIEM System (DEN180055) | Bellco Srl (Now Part of Medtronic, Inc) | 2020-04-29 |
| da Vinci Xi Surgical System, da Vinci X Surgical System (K192803) | Intuitive Surgical | 2020-04-29 |
| Humeral Cup Stability & Humeral Cup 135/145o Stability (K193394) | Fx Shoulder USA, Inc. | 2020-04-29 |
| Evry (K200327) | Synaptive Medical, Inc. | 2020-04-29 |
| IRRAflow Catheter, IRRAflow Tube Set, IRRAflow Control Unit (K200807) | Irras USA, Inc. | 2020-04-29 |
| M-Vizion Femoral Revision System Extension (K191816) | Medacta International S.A. | 2020-04-29 |
| GelPOINT Mini Advanced Access Platform (K191866) | Applied Medical | 2020-04-29 |
| PELNAC Bilayer Wound Matrix (K191992) | Gunze Limited | 2020-04-29 |
| Exactech® Equinoxe® Stemless Humeral Components (K192097) | Exactech, Inc. | 2020-04-29 |
| Magicore II System (K192197) | Innobiosurg Co., Ltd. | 2020-04-28 |
| Neodent Implant System - Change in the Shelf Life of Neodent Acqua Implants (K193592) | Jjgc Industria E Comercio DE Materiais Dentarios S.A. | 2020-04-28 |
| Hive™ Stand-alone Anterior Lumbar Interbody System (K200541) | Hd Lifesciences, LLC | 2020-04-28 |
| Solstice CCI (K200896) | Life Spine, Inc. | 2020-04-28 |
| VITEK 2 AST-Gram Positive Delafloxacin (<=0.015 - >=1 µg/mL) (K200590) | bioMerieux, Inc. | 2020-04-28 |
| Affixus(R) Natural Nail(R) System Humeral Nail (K200814) | Zimmer GmbH | 2020-04-28 |
| Implantswiss Dental Implant System and Implantswiss Dental Abutment System (K200867) | Novodent SA | 2020-04-28 |
| Tiger® Occipital-Cervical-Thoracic Spinal Fixation System (K200863) | Corelink, LLC | 2020-04-28 |
| Single Use Injector (K192498) | Olympus Medical Systems Corp. | 2020-04-28 |
| Vicks VNT200 No Touch Forehead Thermometer (K193213) | Kaz USA, Inc., A Helen of Troy Company | 2020-04-28 |
| Panther Stereotactic (K193459) | Prowess, Inc. | 2020-04-27 |
| WOLF Thrombectomy V System (K200101) | Devoro Medical, Inc. | 2020-04-27 |
| Agape Warming Personal Lubricant (K200208) | CC Wellness, LLC | 2020-04-27 |
| GlassLok Kits, GlassLok Powder, GlassLok Liquid (K193388) | Reliance Orthodontic Products, Inc. | 2020-04-27 |
| binx io CT/NG Assay and binx io CT/NG System (K200533) | Binx Health, Inc. | 2020-04-27 |
| Capnostream 35 Portable Respiratory Monitor (K200594) | Oridion Medical 1987 , Ltd. | 2020-04-27 |
| Oxi-W System (K200141) | Ld Technology, LLC | 2020-04-27 |
| Leadtek Fingertip Pulse Oximeter (K193350) | Leadtek Research, Inc. | 2020-04-27 |
| Mydriatic Hyperspectral Retinal Camera (MHRC-C1) (K200254) | Optina Diagnostics | 2020-04-27 |
| Percutaneous Introducer (K200624) | Epimed International, Inc. | 2020-04-27 |
| ControlRad Sterile Cover (K200238) | Controlrad, Inc. | 2020-04-26 |
| MECTA Sigma (K192834) | Mecta Corporation | 2020-04-26 |
| i-ED COIL (K192068) | Kaneka Pharma America, LLC | 2020-04-25 |
| PROFEMUR GLADIATOR Thin HA Classic Hip Stem with Collar (K200007) | Microport Orthopedics, Inc. | 2020-04-25 |
| Gatekeeper Balloon Catheter (K192786) | Arch Catheter, LLC | 2020-04-25 |
| Biodegradable Nitrile Powder Free Examination Gloves Tested for Use with Chemotherapy Drugs and Fentanyl Citrate (Blue) (K200581) | Hartalega NGC Sdn. Bhd. | 2020-04-25 |
| Zircos-Com (K190139) | Bioden Co., Ltd. | 2020-04-24 |
| Citrasate Liquid Acid Concentrate, NaturaLyte Liquid Acid Concentrate (K192017) | Fresenius Medical Care Renal Therapies Group, LLC | 2020-04-24 |
| Smith&Nephew VISIONAIRE Patient Matched Cutting Blocks (K200826) | Smith & Nephew, Inc. | 2020-04-24 |
| Maxxi Position Sensor (K191492) | Neurovirtual USA, Inc. | 2020-04-24 |
| MT One (K192856) | M&T S.R.L. | 2020-04-24 |
| SPIRA-C Integrated Fixation System (K193153) | Camber Spine Technologies | 2020-04-24 |
| Custodiol HTK Solution (K192408) | Dr. Franz Kohler Chemie GmbH | 2020-04-24 |
| Single Use Biopsy Forceps FB-456D (K200397) | Olympus Medical Systems Corp. | 2020-04-24 |
| EXPEDIUM® Spine System; EXPEDIUM VERSE® Spine System (K200245) | Medos International Sàrl | 2020-04-24 |
| SeaSpine Reef TH System (K193636) | SeaSpine Orthopedics Corporation | 2020-04-24 |
| GSI Audera Pro (K193033) | Grason Stadler | 2020-04-24 |
| PGDx elio tissue complete (K192063) | Personal Genome Diagnostics | 2020-04-24 |
| O-arm O2 Imaging System (K200074) | Medtronic, Inc. | 2020-04-24 |
| NemoFAB (K192475) | Software Nemotec S.L. | 2020-04-23 |
| Biomonitor III, Biomonitor IIIm (K200444) | Biotronik, Inc. | 2020-04-23 |
| GM501 SpermAir and GM501 SpermActive (K192644) | Hamilton Thorne Incorporated | 2020-04-23 |
| RocaTub Ureteral Catheter (K192183) | Promepal Sam | 2020-04-23 |
| Pressure Therapy System PT1003 (K192358) | Xiamen Senyang Co., Ltd. | 2020-04-23 |
| Nurochek System (K200705) | Cryptych Pty, Ltd. | 2020-04-23 |
| U-Aligner (K191308) | Universal Orthodontic Laboratory, Inc. | 2020-04-23 |
| Stryker Xia 3 Power Adaptor (K200666) | Stryker Spine | 2020-04-23 |
| CoLink Cfx Plating System (K200762) | In2bones USA, LLC | 2020-04-23 |
| QuikClot Control+ (K200167) | Z-Medica, LLC | 2020-04-23 |
| BSD3543W (K200787) | Bontech Co., Ltd. | 2020-04-23 |
| DynaClip Bone Staple (K193305) | MedShape, Inc. | 2020-04-23 |
| Duo-Flow Side x Side Double Lumen Catheter (K192807) | Medical Components, Inc. (dba MedComp) | 2020-04-23 |
| ARx Spinal System (K200070) | Life Spine, Inc. | 2020-04-23 |
| Surgical Face Mask (K200847) | Mexpo International, Inc. | 2020-04-23 |
| MF SAFECATH (K192230) | Medifirst Co., Ltd. | 2020-04-23 |
| Dermapose Access (K200168) | Puregraft, LLC | 2020-04-22 |
| DB-Orthopedics (K200752) | Dimensional Bioceramics, LLC | 2020-04-22 |