| PSLT with PASCAL Synthesis, PSLT with PASCAL Synthesis TwinStar (K180402) | Topcon Medical Laser Systems, Inc. | 2018-05-25 |
| inui In-Home Urine Analysis Test System (K180356) | Scanadu, Inc. | 2018-05-25 |
| Infrared Thermometer (K172889) | Shenzhen Pacom Medical Instruments Co., Ltd. | 2018-05-25 |
| TransEnterix Senhance Surgical System (K180163) | Transenterix, Inc. | 2018-05-25 |
| Acclarix LX8 Diagnostic Ultrasound System, Acclarix AX8 Diagnostic Ultrasound System (K180862) | Edan Instruments, Inc. | 2018-05-24 |
| Fresenius Liberty Select Cycler (K181108) | Fresenius Medical Care Renal Therapies Group, LLC | 2018-05-24 |
| McKesson Cardiology (K181080) | Change Healthcare Israel , Ltd. | 2018-05-24 |
| Celling Aspiration Needle (K180807) | Spine Smith Holdings, LLC | 2018-05-24 |
| CS 9600 (K181136) | Trophy | 2018-05-24 |
| PIXX 1717; PIXX 1417; PIXX 1212; Digital Diagnostic X-ray Receptor Panels (K180976) | Pixxgen Corporation | 2018-05-24 |
| GC70, GU60A&GU60A-65, GF50, GF50A, GR40CW, and GM85 (K180543) | Samsung Electronics Co., Ltd. | 2018-05-24 |
| T2Bacteria Panel (K172708) | T2biosystems, Inc. | 2018-05-24 |
| IS-III HActive Fixture (K173938) | Neobiotech Co., Ltd. | 2018-05-24 |
| EUROIMMUN IFA Granulocyte Mosaic™ EUROPattern and EUROIMMUN EUROPLUS Granulocyte Mosaic™ EUROPattern (K172582) | Euroimmun Us, Inc. | 2018-05-24 |
| GBR system (K170697) | Surgident | 2018-05-24 |
| ActiGraph CentrePoint Insight Watch (K181077) | Actigraph | 2018-05-24 |
| EPX-4440FN Digital Video Processor with Light Source (K180414) | Fujifilm New Development U.S.A., Inc. | 2018-05-24 |
| OsteoDetect (DEN180005) | Imagen Technologies, Inc. | 2018-05-24 |
| Safety Wire Guide Introducer (K180756) | Cook Incorporated | 2018-05-24 |
| Classic Cotton Cannulatome®, CannulaTome II® Double Lumen Sphincterotome, Cotton CannulaTome II® PC, UTS® Ultra Taper Sphincterotome, Tri-Tome pc® Triple Lumen Sphincterotome, Howell D.A.S.H.® Sphincterotome with DomeTip®, Billroth II Sphincterotome, Soehendra® BII Sphincterotome, Models ACU-1 and ACU-1-VL active cords (K172665) | Wilson-Cook Medical Inc./Cook Endoscopy | 2018-05-24 |
| Rodo Smilekey (K180609) | Rodo Medical, Inc. | 2018-05-23 |
| ENSEAL X1 Tissue Sealer, Curved Jaw, Articulating 37 cm Shaft Length; ENSEAL X1 Tissue Sealer, Curved Jaw, Articulating 45 cm Shaft Length (K180403) | Ethicon Endo-Surgery, LLC | 2018-05-23 |
| PATRIOT COLONIAL Spacer, SUSTAIN Spacer (K173722) | Globus Medical, Inc. | 2018-05-23 |
| DUS 2GP Reagent Strips, DUS 5 Reagent Strips, DUS 10 Reagent Strips (K181024) | DFI Co., Ltd. | 2018-05-23 |
| AlignX Ankle Fusion System (K181067) | Extremity Medical, LLC | 2018-05-23 |
| geko T-3 Neuromuscular Stimulator (K181059) | Firstkind Limited | 2018-05-23 |
| Route 92 Medical Access System (K180201) | Route 92 Medical, Inc. | 2018-05-23 |
| Biograph Vision (K180811) | Siemens Medical Solutions USA, Inc. | 2018-05-23 |
| DiLumen Endolumenal Interventional Scissors (DiLumen Is) (K173405) | Lumendi, LLC | 2018-05-22 |
| Reusable and Self-Adhesive Electrodes (K180773) | Shaoxing Dongzhi Electrical Technology Co., Ltd. | 2018-05-22 |
| Pantheris System (K173862) | Avinger, Inc. | 2018-05-22 |
| Omni Foot Plating System (K180808) | Extremity Medical, LLC | 2018-05-22 |
| Cellvizio 100 Series Systems with Confocal Miniprobes (K180270) | Mauna Kea Technologies | 2018-05-22 |
| NeuralBot (K180455) | Neural Analytics, Inc. | 2018-05-22 |
| Arthrex FastThread Interference Screw (K180662) | Arthrex, Inc. | 2018-05-22 |
| stay•safe catheter extension set with Safe-Lock, 12 inch, stay•safe catheter extension set with Luer-Lock, 6 inch, stay•safe catheter extension set with Luer-Lock, 12 inch, stay•safe catheter extension set with Luer-Lock, 18 inch, stay•safe to Luer-Lock adapter, 4 inch (K173593) | Fresenius Medical Care Renal Therapies Group, LLC | 2018-05-21 |
| AERIAL™ Interspinous Fixation (K180817) | Globus Medical, Inc. | 2018-05-21 |
| VACUETTE SAFELINK Holder with male luer lock (K180545) | Greiner Bio-One Na, Inc. | 2018-05-21 |
| Biowy PlCC Catheter (K173956) | Biowy Corporation | 2018-05-21 |
| SAGICO OSI Spinal System by Osimplant (K180220) | Spinal Analytics & Geometrical Implant Co, LLC | 2018-05-21 |
| Erchonia FX-635 (K180197) | Erchonia Corporation | 2018-05-21 |
| Polypectomy Snare (K172729) | Hangzhou AGS MedTech Co., Ltd. | 2018-05-21 |
| MECALL CLISIS SYSTEMS, Discovery RF180 (K173395) | General Medical Merate S.P.A | 2018-05-21 |
| LaVid FMTS DIAGNOSTIC X-RAY SYSTEM (K180663) | Livermoretech, Inc. | 2018-05-18 |
| KYPHON HV-R Bone Cement (K180700) | Medtronic Sofamor Danek USA, Inc. | 2018-05-18 |
| EEG-Now (K180524) | Encephalodynamics, Inc. | 2018-05-18 |
| Irrigation Tubing Bipolar Cord Set (K180908) | New Deantronics Taiwan , Ltd. | 2018-05-18 |
| Sterile Hypodermic Needle for Single Use (K180259) | Jiangsu Shenli Medical Production Co., Ltd. | 2018-05-18 |
| Smoklean (K173108) | Sejong Medical Co., Ltd. | 2018-05-18 |
| Liofilchem MIC Test Strip (MTS), Delafloxacin 0.002 - 32 ug/mL (K180886) | Liofilchem s.r.l. | 2018-05-18 |
| BrainScope One (K181179) | Brainscope Company, Inc. | 2018-05-18 |
| Towako Transmyometrial Embryo Transfer Set (K173431) | William A. Cook Australia Pty. , Ltd. | 2018-05-18 |
| Magnesium (K173294) | Abbott Laboratories | 2018-05-18 |
| XSTAT 30, 1-Pack (K180051) | Revmedx, Inc. | 2018-05-18 |
| A.M. Surgical Intramedullary Fixation Device (K180087) | A.M. Surgical, Inc. | 2018-05-18 |
| ArgenIS Titanium Abutments (K172430) | Argen Corporation | 2018-05-18 |
| Acro HCG Pregnancy Rapid Test (K180771) | Acro Biotech, Inc. | 2018-05-18 |
| JOULE SYSTEM (K180508) | Sciton, Inc | 2018-05-18 |
| Esophageal Stent System (K172813) | Micro-Tech (Nanjing) Co., Ltd. | 2018-05-18 |
| DTRAX Spinal System (K180876) | Providence Medical Technology, Inc. | 2018-05-18 |
| AURA ICP MONITORING SYSTEM (K172209) | Branchpoint Technologies, Inc. | 2018-05-18 |
| GRAFTSITE (K173110) | Summit Medical , Ltd. | 2018-05-18 |
| VESTEX Apparel (K180217) | Vestagen Protective Technologies, Inc. | 2018-05-18 |
| Eclipse Treatment Planning System (K181145) | Varian Medical Systems, Inc. | 2018-05-18 |
| Theradome LH40 (K180460) | Theradome, Inc. | 2018-05-18 |
| The IQoolTM Warm System (K180375) | Braincool AB | 2018-05-18 |
| icotec Interbody Cage System (K172480) | Icotec AG | 2018-05-17 |
| Mozec – Rx PTCA Balloon Dilatation Catheter, Mozec NC – Rx PTCA Balloon Dilatation Catheter (K181023) | Meril Life Sciences Private Limited | 2018-05-17 |
| EnsoETM (K180742) | Advanced Cooling Therapy, Inc. D/B/A Attune Medical | 2018-05-17 |
| Zimmer Persona Personalized Knee System (K172524) | Zimmer, Inc. | 2018-05-17 |
| InTice™-C Porous Ti Cervical Interbody System (K173832) | X-Spine Systems, Inc. | 2018-05-17 |
| FlowTriever Retrieval/Aspiration System (K180466) | Inari Medical, Inc. | 2018-05-17 |
| Dimesol Disposable AV Fistula Needle Set (Non-Safety Series) and Dimesol Disposable AV Fistula Needle Set (Safety Series) (K171505) | Dimesol, Inc. | 2018-05-17 |
| Ultra ICE Plus – PI 9 MHz Peripheral Imaging Catheter (K181042) | Boston Scientific Corporation | 2018-05-17 |
| CADD Yellow High Volume Administration Set with NRFit connector (K172592) | Smiths Medical Asd, Inc. | 2018-05-17 |
| TrueTear Intranasal Tear Neurostimulator (DEN170086) | Allergan | 2018-05-17 |
| Athena 190 (K173360) | Medical Rehab Products, LLC | 2018-05-17 |
| MindMotion(TM) GO (K173931) | Mindmaze SA | 2018-05-17 |
| 15.5F X 19 cm Symetrex Long Term Hemodialysis Catheter with Sideholes, 15.5F X 23 cm Symetrex Long Term Hemodialysis Catheter with Sideholes, 15.5F X 28 cm Symetrex Long Term Hemodialysis Catheter with Sideholes, 15.5F X 33 cm Symetrex Long Term Hemodialysis Catheter with Sideholes, 15.5F X 37 cm Symetrex Long Term Hemodialysis Catheter with Sideholes (K173667) | Medical Components, Inc. (dba MedComp) | 2018-05-17 |
| Infrared Thermometer (K172894) | Shenzhen Jiacom Technology CO ., Ltd. | 2018-05-17 |
| Navigated INFINITY Instruments (K181111) | Medtronic Sofamor Danek USA, Inc. | 2018-05-17 |
| Varian Cervical Sleeves (K172675) | Varian Medical Systems, Inc. | 2018-05-16 |
| IS3 (K180527) | Hiossen, Inc. | 2018-05-16 |
| Conformis iTotal Cruciate Retaining (CR) Knee Replacement System (K180906) | Conformis, Inc. | 2018-05-16 |
| Additive Orthopaedics Patient Specific 3D Printed Bone Segments (K180239) | Additive Orthopaedics, LLC | 2018-05-16 |
| Low Dose CT Lung Cancer Screening Option (K180901) | Hitachi Healthcare Americas | 2018-05-16 |
| HARRIER-SA™ Lumbar Interbody System (K180519) | Choicespine, LP | 2018-05-16 |
| One Day Flat Pack (hioxifilcon A) Daily Disposable Soft Contact Lens (K180819) | Menicon Co, Ltd. | 2018-05-16 |
| Reliance Lumber IBF System (K180687) | Reliance Medical Systems | 2018-05-15 |
| Guided Growth Plate System Plus (K180624) | Orthofix Srl | 2018-05-15 |
| 5D Viewer (K180883) | Samsung Medison Co., Ltd. | 2018-05-15 |
| Powder Free Nitrile Examination Gloves Tested for Use with Chemotherapy Drugs (K180476) | Comfort Rubber Gloves Industries Sdn. Bhd. | 2018-05-15 |
| CustomizedBone Service (K180513) | Fin-Ceramica Faenza S.P.A. | 2018-05-15 |
| Metacem (K171449) | Meta Biomed Co., Ltd. | 2018-05-15 |
| Indigo Aspiration System (CAT RX and Separator 4)- Penumbra Engine Pump and Canister (K180412) | Penumbra, Inc. | 2018-05-15 |
| VIVIX-S 1717V (K181003) | Vieworks Co., Ltd. | 2018-05-15 |
| XableCath Support Catheter Product Family (K180986) | Xablecath, Inc. | 2018-05-15 |
| reVive Light Therapy LED Ultrasonic Wrinkle System (K180445) | Led Technologies, Inc. | 2018-05-15 |
| Astroid Planning App (K173940) | .Decimal, LLC | 2018-05-15 |
| ICEfx Cryoablation System (K181153) | Galil Medical, Inc. | 2018-05-15 |