| Fusion Cytology Brush, CytoMax II Double Lumen Cytology Brush (K171573) | Wilson-Cook Medical, Inc. | 2017-12-29 |
| GEM Premier 5000 (K173403) | Instrumentation Laboratory CO | 2017-12-29 |
| AUTOBAHN Nailing System (K171108) | Globus Medical, Inc. | 2017-12-29 |
| Micro Touch Denta Glove Nitrile Hydrasoft Patient Examination Gloves (K171737) | Ansell Healthcare Products, LLC | 2017-12-29 |
| Celerity 20 HP Biological Indicator (K172474) | STERIS Corporation | 2017-12-29 |
| Disposable Powder Free Vinyl Exam Glove, Clear/Yellow (K172357) | Ever Growth (Vietnam) Co. , Ltd. | 2017-12-29 |
| Reliance Cervical IBF System (K173102) | Reliance Medical Systems, LLC | 2017-12-29 |
| Osteo-P Bone Graft Substitute (K170165) | Molecular Matrix, Inc. | 2017-12-29 |
| Medtronic O-arm O2 Imaging System (K173664) | Medtronic, Inc. | 2017-12-29 |
| MIS C1 Narrow Platform Conical Connection Implant System, MIS C1 Wide Platform Conical Connection Abutments (K172505) | Mis Implants Technologies , Ltd. | 2017-12-28 |
| dermaPACE System (DEN160037) | Sanuwave, Inc. | 2017-12-28 |
| MRSASelect II (K171061) | Bio-Rad | 2017-12-28 |
| UroLift System (UL400 and UL500) (K173087) | Neotract, Inc. | 2017-12-28 |
| Planmed Clarity (K163328) | Planmed OY | 2017-12-28 |
| Piccolo Composite Nailing System (K173652) | CarboFix Orthopedics , Ltd. | 2017-12-28 |
| X-PSI Knee System (K171269) | Orthosoft Inc (D/B/A Zimmer Cas) | 2017-12-28 |
| MEVION S250i Proton Beam Radiation Therapy Device (K172848) | Mevion Medical Systems | 2017-12-27 |
| COMPACT S, COMPACT S (LED) (K170104) | Dmetec.Co., Ltd. | 2017-12-27 |
| PoreStar Patient Specific Implant (K171037) | Anatomics Pty, Ltd. | 2017-12-27 |
| Radiomics App v1.0 (K173420) | Microsoft Corp. | 2017-12-27 |
| AltiVate Anatomic to Reverse Conversion Module (K173073) | Encore Medical L.P. | 2017-12-26 |
| IntelliVue Capnography Extension, IntelliVue Microstream Extension (K172904) | Philips Medizin Systeme Boeblingen GmbH | 2017-12-26 |
| Real Time Image Gating System for Proton Beam Therapy Systems (K171049) | Hitachi, Ltd. Healthcare | 2017-12-26 |
| SCS 17-01 (K173008) | Anika Therapeutics, Inc. | 2017-12-26 |
| iLux Instrument, iLux Disposable (K172645) | Tear Film Innovations, Inc. | 2017-12-26 |
| NEURONAUTE (K170138) | Bioserenity | 2017-12-26 |
| CoaguChek Vantus System (K170960) | Roche Diagnostics | 2017-12-25 |
| B. Braun Tear-Away Introducer Needle (K171584) | B.Braun Medical, Inc. | 2017-12-22 |
| SOZO (K172507) | ImpediMed Limited | 2017-12-22 |
| CONQUEST FN (K172785) | Smith & Nephew | 2017-12-22 |
| MRDx BCR-ABL Test, MRDx BCR-ABL Test Software (K173492) | Molecularmd Corporation | 2017-12-22 |
| VPOD ITPR (K172388) | Advanced Circulatory System, A Wholly Owned Subsidiary OF | 2017-12-22 |
| Arthrosurface Bone Screws (K172383) | Arthrosurface, Inc. | 2017-12-22 |
| Align Radial Head System (K172688) | Skeletal Dynamics, LLC | 2017-12-22 |
| SurgeoBite (K172978) | Surgovations, LLC | 2017-12-22 |
| QUANTA Flash Calprotectin Reagents, QUANTA Flash Calprotectin Calibrators, QUANTA Flash Calprotectin Controls, QUANTA Flash Calprotectin Extraction Buffer (K170993) | Inova Diagnostics, Inc. | 2017-12-22 |
| TrueDX hCG Early Result Pregnancy Test (Midstream Format), TrueDX hCG Early Result Pregnancy Test (Cassette Format), VeriClear Early Result Pregnancy Test (Midstream Format), VeriClear Early Result Pregnancy Test (Cassette Format) (K172257) | True Diagnostics, Inc. | 2017-12-22 |
| Neuro Omega System (K171581) | Alpha Omega Engineering , Ltd. | 2017-12-22 |
| GammaPod - Model A (K172706) | Xcision Medical Systems, LLC | 2017-12-22 |
| remOVE System (DEN160014) | Ovesco Endoscopy AG | 2017-12-22 |
| Blustone Synergy Silica System (K172330) | Blustone Synergy | 2017-12-21 |
| FORTIFY and FORTIFY Integrated Corpectomy Spacers, XPand Corpectomy Spacers, NIKO Corpectomy Spacers, SUSTAIN Spacers, COALITION Spacers, PATRIOT Lumbar Spacers, PATRIOT Cervical Spacers, ALTERA Spacers, RISE Spacers, CALIBER Spacers, ELSA Spacers, LATIS Spacers, MONUMENT Spacers, InterContinental Plate-Spacer, MAGNIFY Spacers, INDEPENDENCE Spacers (K171848) | Globus Medical, Inc. | 2017-12-21 |
| Life Spine Foot and Ankle Plating System (K172973) | Life Spine, Inc. | 2017-12-21 |
| OMNI ARC Anteverted Neck Hip Stem (K172467) | Omnilife Science | 2017-12-21 |
| Ureteric Catheters, Flush Ureteric Catheters, Floppy Tip Hydro-Coated Ureteric Catheters (K171043) | Coloplast Corp. | 2017-12-21 |
| NuVasive Navigation Instruments (K172623) | Nu Vasive, Incorporated | 2017-12-21 |
| PREMIUM ONE Implant Systems (K172560) | Sweden & Martina S.P.A. | 2017-12-21 |
| Praxiject 0.9% NaCl (K171109) | Medxl, Inc. | 2017-12-21 |
| FLEX Monoclonal Rabbit Anti-Human Estrogen Receptor a, Clone EPI, RTU (Dako Onmis) (K170028) | Dako Denmark A/S | 2017-12-21 |
| Deltaven XiV Max, Deltaven XiV Max FF (K171530) | Delta Med Spa | 2017-12-21 |
| Riptide Aspiration System (K172448) | Micro Therapeutics, Inc. d/b/a ev3 Neurovascular | 2017-12-21 |
| easyEndoTM Linear Cutting Stapler and Loading Units for Single Use, easyEndoTM Universal Linear Cutting Stapler and Loading Units for Single Use (K172960) | Ezisurg Medical Co., Ltd. | 2017-12-21 |
| Ives MR Conditional Cup Electrode (K171102) | Ives Egg Solutions | 2017-12-21 |
| Solana GBS Assay (K173250) | Quidel Corporation | 2017-12-21 |
| Shepard, Insemi-Cath, and Soft-Pass Coaxial - Cook Intrauterine Insemination Catheters (K172321) | Cook Incorporated | 2017-12-21 |
| Elite HV Radial (K173287) | Galt Medical Corp. | 2017-12-21 |
| FLEX Monoclonal Mouse Anti-Human Progesterone Receptor, Clone PgR 1294, Ready-to-Use (Dako Omnis) (K170005) | Dako Denmark A/S | 2017-12-21 |
| ROCCIA® MultiLIF (K171434) | Silony Medical GmbH | 2017-12-21 |
| AQUABEAM System (DEN170024) | Procept Biorobotics, Corporation | 2017-12-21 |
| Anterior Cervical Plate System (K173375) | Evolution Spine, LLC | 2017-12-21 |
| SeaSpine Vu cPOD, Zuma-C, Complete Cervical (K172926) | SeaSpine Orthopedics Corporation | 2017-12-21 |
| Tyber Medical PT Interbody Spacer System (K172185) | Tyber Medical, LLC | 2017-12-21 |
| SLM-1ER, SLM-2ER, SLM-3ER (K171877) | Chongqing Kanghua Ruiming S&T Co., Ltd. | 2017-12-21 |
| MMPC-4127F1 (K172922) | Barco N.V. | 2017-12-21 |
| OMNI Surgical System (K173332) | Sight Sciences, Inc. | 2017-12-21 |
| Sofia Strep A+ FIA, Sofia 2 Analyzer (K171976) | Quidel Corporation | 2017-12-21 |
| SafeSept Needle Free Transseptal Guidewire (K172893) | Pressure Products Medical Device Manufacturing, LLC | 2017-12-21 |
| Well-Root ST (K170950) | Vericom Co., Ltd. | 2017-12-20 |
| Biograph mCT Family of PET/CT Systems (K173578) | Siemens Medical Solutions USA, Inc. | 2017-12-20 |
| Micropuncture Introducer Set, Micropuncture Introducer Set with Push-Plus Design, Micropuncture Introducer Set with Silhouette Transitionless Design, Micropuncture Introducer Set with Silhouette Transitionless Design and Push-Plus Design (K171275) | Cook Incorporated | 2017-12-20 |
| Advantage/Advantage Fit Delivery Device, Lynx Delivery Device, Obtryx Delivery Device (Curved & Halo), Obtryx II Delivery Device (Curved & Halo), Solyx SIS Delivery Device (K172565) | Boston Scientific Corporation | 2017-12-20 |
| ProLift® Expandable System (K173182) | Life Spine, Inc. | 2017-12-20 |
| T2 STRATOSPHERE™ Expandable Corpectomy System (K173125) | Medtronic Sofamor Danek | 2017-12-20 |
| COALITION® and COALITION® TPS, COALITION MIS® and COALITION MIS® TPS, COALITION AGX® and COALITION AGX® TPS (K173115) | Globus Medical, Inc. | 2017-12-20 |
| Peel-Away Introducer Set (K173685) | Cook Incorporated | 2017-12-20 |
| Pobling MIITY 2 (K163550) | Habalan Med & Beauty Co.,Ltd | 2017-12-20 |
| Operio (K173349) | Toul Meditech AB | 2017-12-20 |
| Apex Tibial Nailing System (K170972) | Orthoxel | 2017-12-20 |
| Sentrant Introducer Sheath with Hydrophilic Coating (K171866) | Medtronic Vascular, Inc. | 2017-12-20 |
| LOGIQ E10 (K173555) | GE Healthcare | 2017-12-20 |
| Breakaway Screw System (K172886) | Paragon 28 | 2017-12-20 |
| Electric Breast Pump (K172989) | Joytech Healthcare Co. , Ltd. | 2017-12-20 |
| speX Support Catheter (K173662) | Reflow Medical, Inc. | 2017-12-20 |
| Xpert Xpress Flu, Xpert Nasopharyngeal Sample Collection Kit, Xpert Nasal Sample Collection Kit, GeneXpert Xpress II, GeneXpert Xpress IV (K171552) | Cepheid | 2017-12-19 |
| G Surgical OCT Spinal System (K171834) | G Surgical, LLC | 2017-12-19 |
| Reusable Blood Pressure Cuff (K171889) | Suzhou Minhua Medical Apparatus Supplies Co., Ltd. | 2017-12-19 |
| Vesair 0 degree Cystoscope, Vesair 30 degree Long Cystoscope, Vesair 70 degree Long Cystoscope,Vesair 30 degree Cystoscope,Vesair 70 degree Cystoscope (K170862) | Solace Therapeutics, Inc. | 2017-12-19 |
| Liofilchem MIC Test Strip (MTS), Meropenem/vaborbactam 0.016/8 - 256/8 µg/mL (K173307) | Liofilchem s.r.l. | 2017-12-19 |
| TBL-ABI System (K173696) | Ld Technology, LLC | 2017-12-19 |
| ACUSON AcuNav Volume Intracardiac Echocardiography Catheter (K173618) | Siemens Medical Solutions USA, Inc. | 2017-12-19 |
| Digital thermometer(with disposable thermometer cover) (K172861) | Hangzhou Hua'An Medical&Health Instruments Co.,Ltd | 2017-12-19 |
| LumiCoil Platinum Fiducial Marker (K173251) | Boston Scientific Corporation | 2017-12-19 |
| VITEK 2 AST-GN Ceftazidime/Avibactam <=0.12 – >=16 µg/mL (K172944) | bioMerieux, Inc. | 2017-12-19 |
| ContainOR (DEN170075) | Advanced Surgical Concepts, Ltd. | 2017-12-19 |
| Zmachine Synergy (K172986) | Consolidated Research of Richmond, Inc. Dba General Sleep CO | 2017-12-19 |
| IlluminOss Bone Stabilization System (DEN160062) | Illminoss Medical, Inc. | 2017-12-19 |
| SuperGrow 272, Ultimate 272 (K172982) | Super Grow Lasers | 2017-12-19 |
| Veraview X800 (K171012) | J. Morita USA, Inc. | 2017-12-19 |
| FS Ergo (K173646) | Palodex Group OY | 2017-12-19 |
| Advantage Plus Pass-Thru (K172677) | Medivators, Inc. | 2017-12-19 |