| Actreen Hi-Lite Cath, Actreen Hi-Lite Set (K180801) | B.Braun Medical, Inc. | 2018-11-05 |
| 1688 Camera Control Unit ; 1688 AIM 4K Camera Head, C-Mount ; 1688 AIM 4K Camera Head with Integrated Coupler ; AIM 4K Coupler, 20mm, C-Mount ; L11 LED Light Source with AIM (K182160) | Stryker | 2018-11-05 |
| Spinal Elements Ti-Bond coated devices (K181837) | Spinal Elements, Inc. | 2018-11-02 |
| Innova IGS 5, Innova IGS 6, Discovery IGS 7, Discovery IGS 7 OR (K181403) | GE Healthcare | 2018-11-02 |
| Sterile Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs Aqua Blue (ABLU), Sterile Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs Violet Blue (VBLU) - Extended Cuff (K180786) | Hartalega Sdn Bhd | 2018-11-02 |
| Mazor X System (Mazor X Stealth Edition) (K182077) | Mazor Robotics , Ltd. | 2018-11-02 |
| Cellene CO2 Laser System (K182270) | Bio-Med USA, Inc. | 2018-11-02 |
| Halyard Purple Nitrile Max Powder-Free Exam Gloves for Use with Chemotherapy Drugs (K182096) | Owens & Minor Halyard, Inc. | 2018-11-02 |
| Interlude 100% Cotton Tampon (K181911) | Albaad Fem | 2018-11-02 |
| CDI Blood Parameter Monitoring System 550 (K182110) | Terumo Cardiovascular Systems Corporation | 2018-11-02 |
| Sheridan Endobronchial Tubes (K180253) | Teleflex Medical | 2018-11-02 |
| ClearPoint System (K181195) | Mri Interventions, Inc. | 2018-11-02 |
| MTS Eravacycline 0.002 - 32 µg/mL (K182557) | Liofilchem s.r.l. | 2018-11-02 |
| Panta 2 Arthrodesis Nail System (K181639) | Integra LifeSciences Corporation | 2018-11-02 |
| NvisionVLE Imaging System, NvisionVLE Optical Probe, NvisionVLE Inflation System (K182616) | Ninepoint Medical, Inc. | 2018-11-02 |
| Invia White Foam NPWT (K180415) | Medela AG | 2018-11-02 |
| Vygon Midline 3 Fr SL Catheter; Vygon Midline 4 Fr SL Catheter; Vygon Midline 5 Fr DL Catheter (K181208) | Vygon USA | 2018-11-02 |
| Xario200G and Xario100G, Software V1.1 Diagnostic Ultrasound System (K182596) | Canon Medical Systems Corporation | 2018-11-02 |
| Afina (K181501) | Neurovision Imaging, LLC | 2018-11-02 |
| Rotograph Prime 3D (under Trade mark Villa Sistemi Medicali), I-MAX 3D (under Trade mark Owandy Radiology) (K180601) | Villa Sistemi Medicali S.P.A. | 2018-11-02 |
| Dexcom Pro Q Continuous Glucose Monitoring System (K182405) | Dexcom, Inc. | 2018-11-02 |
| Fluobeam 800 Clinic Imaging Device used with Fluocase 800 Control System (DEN170092) | Fluoptics | 2018-11-02 |
| Parathyroid Detection (Model PTeye) System (DEN170056) | Aibiomed, Corp. | 2018-11-02 |
| PRODENSE Bone Graft Substitute (K182823) | Wrightmedicaltechnologyinc | 2018-11-02 |
| HANAROSTENT LowAxTM Colon/Rectum (NNN), HANAROSTENT LowAxTM Duodenum/Pylorus (NNN) (K180180) | M.I.Tech Co., Ltd. | 2018-11-02 |
| NavLock Trackers, Robotic Reference Frame (K182104) | Medtronic Navigation | 2018-11-02 |
| Wrist Blood Pressure Monitor Model BP6100 (K182127) | Omron Healthcare, Inc. | 2018-11-02 |
| Aplio a550 and a450, Software V2.8 Diagnostic Ultrasound System (K182427) | Canon Medical Systems Corporation | 2018-11-02 |
| CD HORIZON Spinal System Instruments for use with MAZOR X Stealth Edition (K182121) | Medtronic Sofamor Danek USA, Inc. | 2018-11-02 |
| Implantswiss Dental Implant System, Implantswiss Dental Abutment System (K181266) | Novodent SA | 2018-11-01 |
| MEDRAD Stellant FLEX CT Injection System with Certegra Workstation, MEDRAD Stellant FLEX Syringe Kits, MEDRAD Stellant CT Injection System with Certegra Workstation, MEDRAD Stellant Syringe Kits, MEDRAD Stellant Connector Tubing, P3T Cardiac, P3T PA, P3T Abdomen, ISI, Connect.CT (K182273) | Bayer Medical Care, Inc. | 2018-11-01 |
| N Latex FLC kappa assay, N Latex FLC lambda assay (K182098) | Siemens Healthcare Diagnostics Products GmbH | 2018-11-01 |
| Medline Unite Mini Plates and Screws (K181820) | Medline Industries, Inc. | 2018-11-01 |
| Largan 55 UV Color (Ocufilcon D) Daily Wear Soft (hydrophilic) Contact Lens (K182523) | Largan Medical Co., Ltd. | 2018-11-01 |
| GLUCOCARD Shine Connex Blood Glucose Monitoring System, GLUCOCARD Shine Express Blood Glucose Monitoring System (K181273) | I-Sens, Inc. | 2018-11-01 |
| Clear-Tip EUS-FNA (K180363) | Finemedix Co., Ltd. | 2018-11-01 |
| MEDRAD MRXperion MR Injection System and MR Injection System Syringe Kit (K182276) | Bayer Medical Care, Inc. | 2018-11-01 |
| DAEHAN Adhesive Surface Electrodes (K180247) | Daehan Medical Systems Co., Ltd. | 2018-11-01 |
| DePuy Synthes Trauma Orthopedic Plates and Screws (K180310) | Synthes (Usa) Products, LLC / Depuy Orthopaedics, Inc. | 2018-11-01 |
| Spectra Optia Apheresis System (K181049) | Terumobct, Inc. | 2018-11-01 |
| Immunalysis Ethyl Alcohol Enzyme Assay (K181553) | Immunalysis Corporation | 2018-10-31 |
| Single Use Aspiration Needle NA-U201H (K181994) | Olympus Medical Systems Corp. | 2018-10-31 |
| DynaMesh-POSTERIOR (K182087) | Feg Textiltechnik Forschungs- Und Entwicklungsgesellschaft | 2018-10-31 |
| LUXEN Zr, LUXEN Smile (K171585) | Dentalmax Co., Ltd. | 2018-10-31 |
| XS Dynamis, XP Dynamis, SP Dynamis, XP Spectro, SP Spectro (K182088) | Fotona D.O.O. | 2018-10-31 |
| Endomat Select (K180735) | Karl Storz SE & CO. KG | 2018-10-31 |
| Aplio i900/i800/i700/i600 Diagnostic Ultrasound System, V3.1 (K182679) | Canon Medical Systems Corporation | 2018-10-31 |
| Medline ReNewal Reprocessed LigaSure Maryland Jaw Sealer/Divider (K182588) | Surgical Instrument Service and Savings Inc.(Dba Medline Ren | 2018-10-31 |
| Balanced Knee Revision System Trabecular Tibial Cone Augments (K182085) | Ortho Development Corporation | 2018-10-31 |
| Halifax Imaging Kit (K182880) | Halifax Biomedical, Inc. | 2018-10-31 |
| Panpac Flexi Shelf Pessary (K173351) | Panpac Medical Corporation | 2018-10-31 |
| Tumark for Eviva, Tumark for Brevera (K182082) | Somatex Medical Technologies GmbH | 2018-10-31 |
| AVIEW (K171199) | Coreline Soft Co., Ltd. | 2018-10-31 |
| 23andMe Personal Genome Service (PGS) Pharmacogenetic Reports (DEN180028) | 23AndMe, Inc. | 2018-10-31 |
| Universal Base Abutment (K180899) | Nobel Biocare AB | 2018-10-31 |
| DiLumen Endolumenal Interventional Platform (K182540) | Lumendi, LLC | 2018-10-30 |
| Frozen C (K182392) | B.M. Tech. Worldwide Co., Ltd. | 2018-10-30 |
| Cios Spin (K181550) | Siemens Medical Solutions USA, Inc. | 2018-10-30 |
| ORTHODONTIC PLASTIC BRACKETS AND ACCESSORIES (K180718) | Tomy, Inc. | 2018-10-30 |
| AOS Calcaneal Plating System (K182466) | Advanced Orthopaedic Solutions | 2018-10-30 |
| Wilson-Cook Mini Basket (K182381) | Wilson-Cook Medical, Inc. | 2018-10-30 |
| Sysmex UD-10, Fully Automated Urine Particle Digital Imaging Device (K182062) | Sysmex America, Inc. | 2018-10-30 |
| VITROS Chemistry Products CRBM Slides, VITROS Chemistry Products CREA Slides, VITROS Chemistry Products TBIL Slides, VITROS XT 7600 Integrated System (K182063) | Ortho-Clinical Diagnostics, Inc. | 2018-10-30 |
| VITROS Chemistry Products Cl-Slides, VITROS Chemistry Products ECO2 Slides, VITROS Chemistry Products GLU Slides (K182072) | Ortho-Clinical Diagnostics, Inc. | 2018-10-30 |
| LIGACLIP 12mm L Endoscopic Rotating Multiple Clip Applier (K181488) | Ethicon Endo-Surgery, LLC | 2018-10-30 |
| UroGen Ureteral Catheter (K180354) | Urogen Pharma, Ltd. | 2018-10-30 |
| O'Brien Suprapubic Introducer Set, Cook SP Tube Introducer Set (K182066) | Cook Incorporated | 2018-10-30 |
| ClearLink Controlled Phototherapy Equipment (K182215) | Daavlin Distributing Company | 2018-10-29 |
| Infrared Forehead Thermometer, Infrared Ear/Forehead Thermometer (K181239) | Joytech Healthcare Co. , Ltd. | 2018-10-29 |
| MC3 Vascular Access Kit 21030 (K182914) | Mc3 Incorporated | 2018-10-29 |
| HSV 1 & 2 ELITe MGB Kit; ELITe InGenius (K180559) | Elitechgroup | 2018-10-29 |
| HemoScreen Hematology Analyzer (K180020) | Pixcell Medical Technologies, Ltd. | 2018-10-29 |
| Reprocessed Advisor FL Sensor Enabled Circular Mapping Catheter (K181458) | Innovative Health, LLC | 2018-10-27 |
| ORTHROS™ Posterior Stabilization System; ORTHROS™ MIS Posterior Stabilization System (K180980) | Camber Spine Technologies, LLC | 2018-10-27 |
| Peak.me (K180487) | Breathe Me, Ltd. | 2018-10-26 |
| PENTAX Medical Video Colonoscope EC34-i10T Series (K180285) | Pentax Medical of America, Inc. | 2018-10-26 |
| MAGNETOM Aera (K182299) | Siemens Medical Solutions USA, Inc. | 2018-10-26 |
| Two-Step Implant System (K181898) | Trilliant Surgical | 2018-10-26 |
| Dexcom G6 Glucose Program Continuous Glucose Monitoring System (K182041) | Dexcom, Inc. | 2018-10-26 |
| Polyethylene Catheter (K180286) | Cook Incorporated | 2018-10-26 |
| Accipiolx (K182177) | Maxq-Al , Ltd. | 2018-10-26 |
| Margolin HSG Cannula, Goldstein Sonohysterography Catheter (K180300) | Cook Incorporated | 2018-10-26 |
| Implant Planning Software (K173965) | Inteware Co., Ltd. | 2018-10-26 |
| V2 OTC Pain Relief TENS (K182767) | Everyway Medical Instruments Co.,Ltd | 2018-10-26 |
| Cook Silicone Balloon HSG Catheter (K180291) | Cook Incorporated | 2018-10-26 |
| A6 OTC Pain Relief TENS (K182753) | Everyway Medical Instruments Co.,Ltd | 2018-10-26 |
| Biomate Dental Implant System (K170732) | Biomate Medical Devices Technology Co., Ltd. | 2018-10-26 |
| Hair Laser Headband (K182501) | Pulsaderm, LLC | 2018-10-26 |
| TSI Transseptal Introducer (K181031) | Pressure Products Medical Device Manufacturing, LLC | 2018-10-26 |
| Invisalign System with Mandibular Advancement Feature (K181739) | Align Technology, Inc. | 2018-10-26 |
| SpeediCath Standard (K180258) | Coloplast | 2018-10-25 |
| 074 Zenith Flex System (K181354) | Inneuroco, Inc. | 2018-10-25 |
| Swaive Thermometer SWT1A (K170723) | E-Care Technology Co., Ltd. | 2018-10-25 |
| Endocular Viewing Lenses and Silicone Ring (K173944) | Phakos | 2018-10-25 |
| PeekMed (K182464) | Peek Health, S.A. | 2018-10-25 |
| CONVIVO (K181116) | Carl Zeiss Meditec, AG | 2018-10-25 |
| DyeVert PLUS EZ Contrast Reduction System (K181936) | Osprey Medical, Inc. | 2018-10-25 |
| Vivid E80, Vivid E90, Vivid E95 (K181685) | GE Medical Systems Ultrasound and Primary Care Diagnostics | 2018-10-25 |
| External upper limb tremor stimulator (K182706) | Cala Health, Inc. | 2018-10-25 |
| Codman Certas Plus Electronic Tool Kit (K181902) | Integra Lifesciences Corp. | 2018-10-25 |