| Trans-anal Introducer (K171208) | Visionsense, Ltd. | 2018-02-05 |
| IMD's Lumbar Puncture Needle (K170112) | International Medical Development, Inc.(Imd) | 2018-02-02 |
| PICO 7 Single Use Negative Pressure Wound Therapy System (K172005) | Smith & Nephew Medical Limited | 2018-02-02 |
| Bicera Resorbable Bone Substitute (K172237) | Wiltrom Corporation Limited | 2018-02-02 |
| OralTox Oral Fluid Drug Test (K171403) | Premier Biotech, Inc. | 2018-02-02 |
| SMAXEL CO2 Surgical Laser System (K180036) | Ids, Ltd. | 2018-02-02 |
| The Plateau-LO Spacer System (K172105) | Life Spine, Inc. | 2018-02-02 |
| Glooko Mobile Insulin Dosing System (K171450) | Glooko, Inc. | 2018-02-02 |
| Camber Spine Technologies SPIRA - V™ Open Matrix Corpectomy Cage (K173800) | Camber Spine Technologies | 2018-02-02 |
| Materialise TKA Guide System (K173445) | Materialise NV | 2018-02-02 |
| Triathlon Total Knee System (K173849) | Stryker Orthopaedics | 2018-02-02 |
| KARL STORZ Slim Nasopharyngolaryngoscope (K171402) | KARL STORZ Endoscopy-America, Inc. | 2018-02-02 |
| ACUSON NX2 Diagnostic Ultrasound System, ACUSON NX2 Elite Diagnostic Ultrasound System (K173981) | Siemens Medical Solutions USA, Inc. Ultrasound Group | 2018-02-02 |
| ACRO HCG Pregnancy Rapid Test (K172512) | Acro Biotech, Inc. | 2018-02-02 |
| SpeediCath Flex Coude Pro (K180070) | Coloplast | 2018-02-02 |
| The Solstice OCT System (K173047) | Life Spine, Inc. | 2018-02-01 |
| ACUSON NX3 Diagnostic Ultrasound System; ACUSON NX3 ELITE Diagnostic Ultrasound System (K173957) | Siemens Medical Solutions USA, Inc. | 2018-02-01 |
| Micromed BRAIN QUICK system (K171384) | Micromed S.P.A. | 2018-02-01 |
| Duatene bilayer mesh (K172395) | Sofradim Production | 2018-02-01 |
| Specimen Retrieval Bag (K172789) | Beijing Hangtian Kadi Technology R&D Institute | 2018-02-01 |
| MERISTEEL (K172146) | M/s. Meril Endo Surgery Private Limited. | 2018-02-01 |
| ACUSON P600 Diagnostic Ultrasound System (K180039) | Siemens Medical Solutions USA, Inc. | 2018-02-01 |
| AEON Endoscopic Stapler (K173443) | Lexington Medical, Inc. | 2018-02-01 |
| ABCcolla Bone Graft (K171629) | Acro Biomedical Co., Ltd. | 2018-02-01 |
| Sporview VH202 BI (K171287) | Spsmedical Supply Corp. A Division of Cantel Medical | 2018-02-01 |
| PREMIUM Implant Systems SHELTA Implant Systems (K161989) | Sweden & Martina S.P.A. | 2018-02-01 |
| Open-End Ureteral Catheter, Open-End Ureteral Catheter Sof-Flex, EchoTip Open-End Ureteral Catheter, Open-End Flexi-Tip Ureteral Catheter, Flexi-Tip Ureteral Catheter (Closed End), Whistle Tip Ureteral Catheter, Round Tip Ureteral Catheter, Spiral Tip Ureteral Access Catheter, Pediatric Ureteral Catheter (K171662) | Cook Incorporated | 2018-02-01 |
| Double Medical Cage System (K172828) | Double Medical Technology, Inc. | 2018-02-01 |
| Sentosa SA201 HSV 1/2 Qualitative PCR Test (K172509) | Vela Diagnostics USA, Inc. | 2018-02-01 |
| Vitrea Software Toshiba Package VSTP-001A (K173088) | Toshibamedical Systems Corporation | 2018-01-31 |
| AR_N Type Implant System (K171297) | Biotem Co., Ltd. | 2018-01-31 |
| Merit Syringe (K173601) | Merit Medical Systems, Inc. | 2018-01-31 |
| ODFS Pace XL (K171396) | Odstock Medical, Ltd. | 2018-01-31 |
| SPI Dental Implant System (K172240) | Msi France | 2018-01-31 |
| GORE Molding and Occlusion Balloon Catheter (K172567) | W. L. Gore and Associates, Inc. | 2018-01-31 |
| Symetri Clear (K172845) | Ormco Corporation | 2018-01-31 |
| AtriClip FLEX-V (K180010) | AtriCure, Inc. | 2018-01-31 |
| Indego(R) (K173530) | Parker-Hannifin Corporation | 2018-01-31 |
| da Vinci Xi Surgical System; da Vinci X Surgical System (K172643) | Intuitive Surgical, Inc. | 2018-01-31 |
| Ecosite Bulk Fill (K171772) | Dmg USA, Inc. | 2018-01-31 |
| Zimmer Persona Personalized Knee System (K173417) | Zimmer, Inc. | 2018-01-30 |
| Irradiation Aesthetic Device (K171835) | Chongqing Peninsula Medical Technology Co., Ltd. | 2018-01-30 |
| MiroCam Capsule Endoscope System (K170438) | Intromedic Co., Ltd. | 2018-01-30 |
| Rex Medical Aspiration Pump (K173389) | Rex Medical, L.P. | 2018-01-30 |
| Luma Light System (K173436) | Luma Therapeutics | 2018-01-30 |
| Getinge GSS67N Series Steam Sterilizer (K172159) | Maquet GmbH | 2018-01-30 |
| Uro-V Cystoscope (K171500) | Uroviu Corporation | 2018-01-30 |
| 40-42mm BiPolar Head and 22mm Femoral Head (K163081) | Signature Orthopaedics Pty, Ltd. | 2018-01-29 |
| Rusch Intermittent Urethral Catheters (K173596) | Teleflex Medical | 2018-01-29 |
| DeGen Medical E3 MIS Pedicle Screw System (K173814) | Degen Medical | 2018-01-29 |
| JOULE SYSTEM (K173285) | Sciton, Inc | 2018-01-29 |
| SANCARE STERILE LATEX EXAMINATION GLOVES (also marketed as GLOVTEK STERILE LATEX EXAMINATION GLOVES) (K171367) | Sanrea Healthcare Products Pvt, Ltd. | 2018-01-26 |
| Arm Type Automatic Blood Pressure Monitor BP310A, BP313A, BP351A, BP362A, BP366A, BP369A, BP380A, BP389A, BP-JC312 (K172896) | Shenzhen Jiacom Technology CO ., Ltd. | 2018-01-26 |
| Mic-Key* SF Over-the-Wire Stoma Measuring Device (K173955) | Halyard Health, Inc. | 2018-01-26 |
| TiGer Shark™ System (K172816) | Choicespine, LP | 2018-01-26 |
| DRAGON X SPSL4HC, DRAGON X SPSL8HC (K173299) | Sedecal., Sa. | 2018-01-26 |
| SyMRI (K173558) | Syntheticmr AB | 2018-01-26 |
| Essence 55S Large Monitor System (K172969) | Shenyang Torch-Bigtide Digital Technology Co., Ltd. | 2018-01-26 |
| uDR 780i (K173953) | Shanghai United Imaging Healthcare Co., Ltd. | 2018-01-26 |
| MiCor A100 Wearable ECG Recorder (K162665) | Mitac International Corp. | 2018-01-26 |
| illumiflow 148 Laser Cap (K173843) | Eglobal, LLC | 2018-01-26 |
| SedLine Sedation Monitor (K172890) | Masimo Corporation | 2018-01-26 |
| Embrace (K172935) | Empatica S.r.l. | 2018-01-26 |
| Panthera Dental Milled Bars (K173466) | Panthera Dental, Inc. | 2018-01-26 |
| Alere i Influenza A & B, Alere i Strep A, Alere i RSV, Alere i Influenza A & B 2 (K173932) | Alere Scarborough, Inc. | 2018-01-26 |
| V2K Rinspiration System (K172716) | V2k Medical, Inc. | 2018-01-26 |
| Stryker 90-S Max SERFAS Energy Probe (K171391) | Stryker | 2018-01-26 |
| Vantage Galan 3T, V4.6 (K173382) | Toshibamedical Systems Corporation | 2018-01-26 |
| SeQure® NF and SeQure® Microcatheters (K173430) | Accurate Medical Therapeutics, Ltd. | 2018-01-26 |
| Zenith Support, 95 cm, Zenith Support, 105 cm, Zenith Support, 115 cm (K173709) | Inneuroco, Inc. | 2018-01-26 |
| Non Woven Face Mask (Models: VQN0185W (earloop) and VQN0185B (ties)) (K173062) | V&Q Manufacturing Corporation | 2018-01-25 |
| CliniCloud Stethoscope (K173448) | Stethocloud Pty.Ltd (Clinicloud) | 2018-01-25 |
| Gallant PTCA Dilatation Catheter (K173581) | Medinol, Ltd. | 2018-01-25 |
| ClearLine IV (K171954) | Clearline MD | 2018-01-25 |
| Comprehensive Metabolic Panel, skyla Clinical Chemistry Analyzer, Minicare C300 Clinical Chemistry Analyzer (K171971) | Lite-On Technology Corp. H.S.P.B. | 2018-01-25 |
| Arterys Oncology DL (K173542) | Arterys, Inc. | 2018-01-25 |
| EchoGlo Needle (K171968) | Smiths Medical Asd, Inc. | 2018-01-25 |
| Royal Flush Catheter (K171264) | Cook Incorporated | 2018-01-25 |
| Stryker iVAS Elite Inflatable Vertebral Augmentation System (Stryker iVAS Elite Balloon Catheter) (K172116) | Stryker Corporation | 2018-01-25 |
| F&P NivairoTM RT046 Non-Vented Hospital Full Face Mask, Standard Elbow Version (K173060) | Fisher and Paykel Healthcare Limited | 2018-01-25 |
| Electrocardiograph (K171942) | Edan Instruments, Inc. | 2018-01-24 |
| Bladder Scanner (model: PadScan DS3, PadScan Z3, PadScan Z5) (K171528) | Avantsonic Technology Co., Ltd. | 2018-01-24 |
| Cybird LED Curing Light (K173876) | Dxm Co., Ltd. | 2018-01-24 |
| SUNTOUCH Dental Dressing (K173196) | Huizhou Foryou Medical Devices Co., Ltd. | 2018-01-24 |
| SeaSpine Cabo ACP (Anterior Cervical Plate) System (K173521) | SeaSpine Orthopedics Corporation | 2018-01-24 |
| Cycler Drain Bag Set (K173363) | Fresenius Medical Care Renal Therapies Group, LLC | 2018-01-24 |
| C2 CryoBalloon Ablation System (K163684) | C2 Therapeutics, Inc. | 2018-01-23 |
| TruAbutment DS (K172304) | Truabutment, Inc. | 2018-01-23 |
| ARROW Reverse Porous Glenoid (K171789) | Fournitures Hospitalieres Industrie | 2018-01-23 |
| gammaCore-S (K173442) | Electrocore, LLC | 2018-01-23 |
| CAMPYLOBACTER CHEK (K173219) | Techlab, Inc. | 2018-01-22 |
| Centurion POCT System (K180025) | Orthofix, Inc. | 2018-01-22 |
| CONTEC™ Electrocardiograph (K171360) | Contec Medical Systems Co.,Ltd | 2018-01-22 |
| 3D APT (K172920) | Philips Medical Systems Nederland B.V. | 2018-01-22 |
| 3M Attest Super Rapid Readout Biological Indicator, 3M Attest Auto-reader, 3M Attest Auto-reader (K173584) | 3M Company | 2018-01-22 |
| EZ Plate (K173306) | Zavation Medical Products, LLC | 2018-01-22 |
| FortiCore® (K171312) | Nanovis, LLC | 2018-01-22 |
| CAMPYLOBACTER QUIK CHEK (K173217) | Techlab, Inc. | 2018-01-22 |
| Kit Boxes and Kit Plates (K163600) | Nobel Biocare AB | 2018-01-22 |
| Aristotle 14 Guidewire, 200cm, Soft Profile, Aristotle 14 Guidewire, 200cm, Support Profile, Aristotle 14 Guidewire, 300cm, Soft Profile, Aristotle 14 Guidewire, 300cm, Support Profile (K173235) | Scientia Vascular, LLC | 2018-01-22 |