| Natus VikingQuest (K172743) | Natus Neurology Incorporated | 2017-12-19 |
| MAGNETOM Amira (K173600) | Siemens Medical Solutions USA, Inc. | 2017-12-19 |
| Reform® Midline Cortical Screw System (K173130) | Precision Spine, Inc. | 2017-12-19 |
| Automated Blood Coagulation Analyzer CS-2500 (K172286) | Siemens Healthcare Diagnostic Products GmbH | 2017-12-18 |
| PEEK Biosolution (K173124) | Merz Dental GmbH | 2017-12-18 |
| DEXIS Titanium, KaVo IXS HD (Size 1, Size 2) (K172918) | Kavo Dental Technologies, LLC | 2017-12-18 |
| PERIO-FLOW nozzle (K171174) | E.M.S Electro Medical Systems S.A | 2017-12-18 |
| Sidus Stem-Free Shoulder (K171858) | Zimmer GmbH | 2017-12-18 |
| Certa Catheter (K171193) | Ferrosan Medical Devices Sp. Z.O.O. | 2017-12-18 |
| HAL for Medical Use (Lower Limb Type) (K171909) | Cyberdyne, Inc. | 2017-12-17 |
| pioli IOL Delivery System (K172228) | Ast Products, Inc. | 2017-12-15 |
| Cellvizio 100 Series System with Confocal Miniprobes (K172844) | Mauna Kea Technologies | 2017-12-15 |
| BioFlux Device (K172311) | Biotricity, Inc. | 2017-12-15 |
| LifeStyles® SKYN® Intimate Moments Personal Lubricant (K172473) | Sxwell USA, LLC | 2017-12-15 |
| BD Nexiva Diffusics Closed IV Catheter Systems (K173354) | Becton Dickinson Infusion Therapy Systems, Inc. | 2017-12-15 |
| FloPump 32mL, Sterile, FloPump 32mL, Non-Sterile (K170029) | International Biophysics Corporation | 2017-12-15 |
| AxSOS 3 Ti (K172350) | Stryker GmbH | 2017-12-15 |
| ECG Acquisition Systems (K163607) | Vales & Hills Biomedical Tech. , Ltd. | 2017-12-15 |
| Idys™ TLIF 3DTi Cages (K172465) | Clariance, Sas | 2017-12-15 |
| Proficient® Posterior Cervical Spine System (K172594) | Spine Wave, Inc. | 2017-12-15 |
| ReBOSSIS85 (K172573) | Orthorebirth Co., Ltd. | 2017-12-15 |
| Polyform Synthetic Mesh (K171271) | Boston Scientific Corporation | 2017-12-15 |
| MicroScan Dried Gram Negative MIC/Combo Panels with Ceftazidime/Avibactam (0.25/4 - 64/4 ug/mL) (K172337) | Beckman Coulter, Inc. | 2017-12-15 |
| Composite Removable Sinus Stent System (K170913) | Sts Medical | 2017-12-15 |
| Double Lumen Ovum Aspiration Needles (K171611) | William A. Cook Australia Pty. , Ltd. | 2017-12-15 |
| PROTEUS PTA Balloon Catheter with Embolic Capture Feature (K172494) | Angioslide, Ltd. | 2017-12-15 |
| EIT Cellular Titanium® Cervical Cages, EIT Cellular Titanium® PLIF Cages, EIT Cellular Titanium® TLIF Cages, EIT Cellular Titanium® ALIF Cages (K172888) | Eit Emerging Implant Technologies GmbH | 2017-12-15 |
| Strange Bile Duct Stone Exploration Set (K173687) | Cook Incorporated | 2017-12-15 |
| Kindguard Powder Free Vinyl Patient Examination Gloves, Clear (non-colored) (K173017) | Anhui Kindguard Medical Supplies Technology Co., Ltd. | 2017-12-15 |
| ArchFlo CT Midline (K171483) | Medcomp (Dba Medical Components, Inc.) | 2017-12-15 |
| V10 (K170497) | Mediana Co., Ltd. | 2017-12-15 |
| The Nellcor pulse oximetry monitor interface cable (K172482) | Covidien | 2017-12-15 |
| Raider Guidewire (K173532) | Vascular Solutions, Inc. | 2017-12-15 |
| Akros FibuLink™ Syndesmosis Repair Kit (K173550) | Akros Medical | 2017-12-14 |
| Arthrex Univers Revers Apex Humeral Stems (K170414) | Arthrex, Inc. | 2017-12-14 |
| Vitrification Kit and Thawing Kit (K171748) | Kitazato Corporation | 2017-12-14 |
| E-CUBE 8 (K172732) | Alpinion Medical Systems Co., Ltd. | 2017-12-14 |
| WishBone K-Wire System (K173013) | Wishbone Medical, Inc. | 2017-12-14 |
| NuVasive® Modulus-C Interbody System (K172676) | Nu Vasive, Incorporated | 2017-12-14 |
| InFill® Interbody Fusion Device (K172349) | Pinnacle Spine Group, LLC | 2017-12-14 |
| ISP Safety Huber Needle Infusion Set (K170881) | Infusion Safety Products, Inc. | 2017-12-14 |
| NobelPerfect Abutments (K172854) | Nobel Biocare AB | 2017-12-14 |
| CAREline Airless Hemodialysis Blood Tubing Sets (K172238) | Fresenius Medical Care Renal Therapies Group, LLC | 2017-12-14 |
| Cannulated Screw Internal Fixation System (K173286) | Life Spine, Inc. | 2017-12-14 |
| 2MP Color LCD Monitor CL-S200, 3MP Color LCD Monitor CL-S300 (K173434) | Jvckenwood Corporation | 2017-12-14 |
| Cascadia Interbody System (K172009) | K2m, Inc. | 2017-12-14 |
| Holycon Synthetic Absorbable Sutures (K173043) | Nantong Holycon Medical Devices Co., Ltd. | 2017-12-14 |
| TAURUS PEEK Cage System (K170389) | Medyssey USA, Inc. | 2017-12-14 |
| Infinix-i, INFX-8000V, V7.0 (K172863) | Toshibamedical Systems Corporation | 2017-12-14 |
| eVox System (K171781) | Evoke Neuroscience, Inc. | 2017-12-13 |
| Advocate PTA Catheter (K173621) | Merit Medical Systems, Inc. | 2017-12-13 |
| ANAX 5.5™ Spinal System (K173524) | U&I Corporation | 2017-12-13 |
| Fixtemp C&B (K171729) | Dreve Dentamid GmbH | 2017-12-13 |
| SAM CRRT Unit, SAM Cassette CRRT (K170790) | Spectral Medical, Inc. | 2017-12-13 |
| DC-30/DC-32/DC-28/DC-26/DC-25 Diagnostic Ultrasound System (K173369) | Shenzhen Mindray Bio-Meidcal Electronics Co., Ltd. | 2017-12-13 |
| Alere BinaxNOW Influenza A & B Card 2, Alere Reader, Alere BinaxNOW Influenza A & B Card 2 Control Swab Kit (K173502) | Alere Scarborough, Inc. | 2017-12-13 |
| Prodigio Stain Powder (K171167) | Operart, LLC | 2017-12-13 |
| Adhesive Electrodes (K171381) | Shenzhen Quality Medical Technology Co.,Ltd | 2017-12-13 |
| Flexor Ureteral Access Sheath and Flexor Parallel Rapid Release Ureteral Access Sheath (K172217) | Cook Incorporated | 2017-12-13 |
| TSV BellaTek Encode Healing Abutments (K173374) | Biomet 3i | 2017-12-13 |
| 2940 nm Er:Yag Laser Handpiece (K173002) | Quanta System Spa | 2017-12-13 |
| Arthrex DynaNite Nitinol Staple (K172052) | Arthrex, Inc. | 2017-12-13 |
| Medacta Shoulder System: Threaded Glenoid Baseplate (K171058) | Medacta International S.A. | 2017-12-13 |
| Tangible Hydrogel with Tangible Polymer (etafilcon A) Soft (Hydrophilic) Daily Disposable Contact Lens (K172692) | Tangible Science, LLC | 2017-12-13 |
| InnoSight Diagnostic Ultrasound System (K172056) | Qisda Corporation | 2017-12-13 |
| NoCoding1 Plus Blood Glucose Monitoring System, VeraSens Blood Glucose Monitoring System (K171480) | I-Sens, Inc. | 2017-12-13 |
| True Flow Valvuloplasty Perfusion Catheter (K172932) | C.R. Bard, Inc. | 2017-12-13 |
| FMP Extended Liners (K172651) | Encore Medical L.P. | 2017-12-13 |
| Neurosoft TMS (also CloudTMS) (K173441) | Teleemg, LLC | 2017-12-13 |
| DropSafe Safety Pen Needle (K170988) | Htl-Strefa S.A | 2017-12-12 |
| Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs (Pink) (K173137) | Hartalega Sdn Bhd | 2017-12-12 |
| Advanced Diffusion Analysis (ADA) application (K173467) | Philips Medical Systems Nederland B.V. | 2017-12-12 |
| T2Candida 1.1 Panel (K173536) | T2biosystems, Inc. | 2017-12-12 |
| Disposable High Pressure Syringe (K170279) | Union Medical Shenzhen Co., Ltd. | 2017-12-12 |
| Wittich Nitinol Stone Basket (K170898) | Cook Incorporated | 2017-12-12 |
| SporView Rapid Read Biological Indicator (K172432) | Crosstex/Spsmedical, A Division of Cantel Medical | 2017-12-12 |
| MESIRE - Balloon Sinus Dilatation System (K172737) | M/S. Meril Life Sciences Private Limited | 2017-12-12 |
| Sterile Endoscope Biopsy Sampling Needle (K171956) | Changzhou Detain Medical Devices Co., Ltd. | 2017-12-12 |
| Pure-Vu System (K173392) | Motus GI Medical Technologies , Ltd. | 2017-12-12 |
| Xario 200 Diagnostic Ultrasound System V6.0 (K172276) | Toshibamedical Systems Corporation | 2017-12-12 |
| CorticaLINK Spinal Fusion Platform (K173484) | Linkspine, Inc. | 2017-12-11 |
| Safety Blood Collection Device for Single Use (K170276) | Gemtier Medical (Shanghai), Inc. | 2017-12-11 |
| SNIPER STAPLE SYSTEM, NON-STERILE (K172405) | Trilliant Surgical | 2017-12-11 |
| Optima XR646 HD (K173612) | Ge Hualun Medical Systems Co. , Ltd. | 2017-12-11 |
| Crystalsert Lens Delivery System (K173480) | Bausch & Lomb, Inc. | 2017-12-11 |
| Anti-Borrelia burgdorferi US EUROLINE-WB (IgM) (K172722) | Euroimmun Us, Inc. | 2017-12-10 |
| Lumipulse G B•R•A•H•M•S PCT Immunoreaction Cartridges, Lumipulse G B•R•A•H•M•S PCT Calibrators set (K172713) | Fujirebio Diagnostics,Inc. | 2017-12-10 |
| LipiVage (K172714) | Genesis Biosystems, Inc. | 2017-12-08 |
| Varian cage (K172756) | Medyssey USA, Inc. | 2017-12-08 |
| RoyalGuard Surgical Gown, i600, Breathable (K172445) | Gri Medical & Electrical Technology Co., Ltd. | 2017-12-08 |
| Wireless Pain Relieve Device Model: LT5018C (K173462) | Shenzhen Dongdixin Technology Co., Ltd. | 2017-12-08 |
| 8ch Flex Suite (K172222) | Shenzhen RF Tech Co., Ltd. | 2017-12-08 |
| Cerebrotech CMS-5000 (K171186) | Cerebrotech Medical Systems | 2017-12-08 |
| W&H Assistina Twin (K171553) | W&H Dentalwerk Buermoos GmbH | 2017-12-08 |
| MDS Plating System (K172786) | Miami Device Solutions, LLC | 2017-12-08 |
| VITEK 2 AST-GN Amikacin (<=1 ->=64 ug/mL) (K172731) | bioMerieux, Inc. | 2017-12-08 |
| CMS-2000 Central Monitoring System (K172966) | Advanced Instumentations, Inc. | 2017-12-08 |
| Rexious Spinal Fixation System (K173131) | Huvexel Co. , Ltd. | 2017-12-08 |
| Clear Guide SCENERGY (K171677) | Clear Guide Medical | 2017-12-08 |
| Med-Hot Thermal Imaging Systems (K171928) | Med-Hot Thermal Imaging, Inc. | 2017-12-08 |