| Nio Color 5.8MP (MDNC-6121) (K170476) | Barco N.V. | 2017-03-28 |
| MR8 Drill System (K163565) | Medtronic Powered Surgical Solutions | 2017-03-28 |
| Powder Free Nitrile Examination Gloves Tested For Use With Chemotherapy Drugs Labeling Claim (White); Powder Free Nitrile Examination Gloves Tested For Use With Chemotherapy Drugs Labeling Claim (Blue) (K162405) | Comfort Rubber Gloves Industries Sdn. Bhd. | 2017-03-28 |
| Plum 360(TM) Infusion System with MedNet/ Smart Card Plug and Play Module (K161469) | Hospira, Inc. | 2017-03-28 |
| BacT/ALERT VIRTUO Microbial Detection System, BacT/ALERT VIRTUO, VIRTUO (K161816) | bioMerieux, Inc. | 2017-03-28 |
| Sapphire Infusion Pump (K161667) | Q Core Medical , Ltd. | 2017-03-27 |
| ipsogen JAK2 RGQ PCR Kit (DEN160028) | Qiagen, Inc. | 2017-03-27 |
| Cleveland Multiport Ventricular Catheter Set (K161731) | Parker Hannifin Corp. | 2017-03-27 |
| Freedom Syringe (K161812) | Procedure Products, Inc. | 2017-03-27 |
| Expect Pulmonary Endobronchial Ultrasound Transbronchial Aspiration Needle (K163248) | Boston Scientific Corporation | 2017-03-27 |
| Silk'n HST (K162784) | Home Skinovations , Ltd. | 2017-03-25 |
| NMUC Brand Small And Large Fragment Osteosynthesis Plating System, NMUC Brand of DHS/DCS Plating System (K163425) | Narang Medical USA Corporation | 2017-03-24 |
| Stellaris Elite Vision Enhancement System (K162342) | Bausch+Lomb | 2017-03-24 |
| NITRILE EXAMINATION GLOVE (K163267) | Brightway Holdings Sdn. Bhd. | 2017-03-24 |
| iovera system (K161835) | Myoscience, Inc. | 2017-03-24 |
| K3PRO Konus Additional Abutments and Implants (K160581) | Argon Med. Productions Vertriebs Gesellschaft Mbh CO KG | 2017-03-24 |
| LIGHTFUSION LED SYSTEM (K162556) | Vitage Led, Ltd. | 2017-03-24 |
| NuVasive CoRoent Small Interbody System (K163491) | Nu Vasive, Incorporated | 2017-03-24 |
| PREMIUM - SHELTA Prosthetic Components (K162028) | Sweden & Martina S.P.A. | 2017-03-24 |
| LUVENA VAGINAL MOISTURIZER & LUBRICANT (K162235) | Laclede, Inc. | 2017-03-24 |
| VERIFY Assert Self-Contained Biological Indicator (K162701) | STERIS Corporation | 2017-03-24 |
| Mould Applicator Set (K162615) | Varian Medical Systems, Inc. | 2017-03-24 |
| nuance UNIVERSAL (K162967) | Den-Mat Holdings, LLC | 2017-03-24 |
| Custom Stable(TM) Rigid Gas Permeable Scleral Contact Lens (K170335) | Valley Contax, Inc. | 2017-03-24 |
| Scan&GO (K163297) | Siemens Medical Solutions USA, Inc. | 2017-03-24 |
| VERIFY Incubator for Assert Self Contained Biological Indicators (K163587) | STERIS Corporation | 2017-03-24 |
| MEDICON Spinal Spreading Systems (K161680) | Medicon EG | 2017-03-24 |
| FFR Link, FFR Signal Processing Module (K170204) | Boston Scientific Corporation | 2017-03-24 |
| GoSpiro (K163249) | Monitored Therapeutics, Inc. | 2017-03-24 |
| Stealth System, Stealth Sensor, Stealth Smart Cable, StealthView Software (K162503) | Cardiac Insight, Inc. | 2017-03-24 |
| INFINITT ULite (K163290) | Infinitt Co., Ltd. | 2017-03-24 |
| GuideMia Ortho+ (K162850) | Guidemia Technologies, LLC | 2017-03-24 |
| Basic, Dominant Flex (K170329) | Modela AG | 2017-03-24 |
| GEN_2 and GEN_3 Mechanical Wheelchairs (K170701) | Free Wheelchair Mission | 2017-03-24 |
| Veloxion System (K162979) | Corinth Medtech, Inc. | 2017-03-24 |
| CardioDay V2.5 (K162023) | Getemed Medizin- Und Informationstechnik AG | 2017-03-24 |
| Eclipse with VEMP (K162037) | Interacoustics A/S | 2017-03-23 |
| DC-8/DC-8 PRO/DC-8 CV/DC-8 EXP/DC-8S Diagnostic Ultrasound System (K170277) | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 2017-03-23 |
| LOYON (K162217) | Oculus Innovative Sciences | 2017-03-23 |
| Guidezilla II Guide Extension Catheter; Guidezilla II LONG Guide Extension Catheter (K163314) | Boston Scientific Corporation | 2017-03-23 |
| PerfectSmooth (K161428) | Shen Zhen Cosbeauty Co., Ltd. | 2017-03-23 |
| Tranberg CLS Diffusor Laser Fiber (K163103) | Clinical Laserthermia Systems, AB | 2017-03-23 |
| Medtronic Legend Pneumatic; MR7 Pneumatic; Triton Pneumatic Drill System incorporating various Pneumatic Handpieces; Attachments; Surgical Dissecting Tools; and System Accessories (K163182) | Medtronic Powered Surgical Solutions | 2017-03-23 |
| Synapsys Ulmer Video Nystagmograph (K163558) | Synapsys SA | 2017-03-23 |
| My Dose Coach (K163099) | Sanofi, Inc. | 2017-03-22 |
| HyperVit Vitrectomy Probe, 23 GA, HyperVit Vitrectomy Probe, 25+, HyperVit Vitrectomy Probe, 27+ (K170520) | Alcon Research, Ltd. | 2017-03-22 |
| ENFit enteral syringe (K161979) | Jiangyin Caina Technology Co., Ltd. | 2017-03-22 |
| ENFit Enteral Pump Syringes PENTA ENFit, ENFit Enteral Pump Syringes NUTRIFIT (K161141) | Pentaferte Italia S.R.L. | 2017-03-22 |
| Nitrile Blue Powder Free Examination Gloves with Low Dermatitis Potential Claim and Tested for Use with Chemotherapy Drugs (K163017) | Gmp Medicare Sdn. Bhd. | 2017-03-22 |
| OxyHeal 4000 Multiplace Hyperbaric Chamber Family (K163109) | Oxyheal Medical Systems, Inc. | 2017-03-22 |
| ThermoShield HME Filter (K163300) | Flexicare Medical Limited. | 2017-03-22 |
| Fathom-16 Steerable Guidewires (K170636) | Boston Scientific Corporation | 2017-03-22 |
| Butrex Lumbar Buttress Plating System (K170530) | X-Spine Systems, Inc. | 2017-03-22 |
| 360KS Implant Positioning System (K163405) | Kico Knee Innovation Company Pty Limited | 2017-03-21 |
| SOMATOM go.Up, SOMATOM go.Now (K163296) | Siemens Medical Solutions USA, Inc. | 2017-03-21 |
| Medisign MM1000 BT Blood Glucose Monitoring System, Medisign MM1100 BT Blood Glucose Monitoring System, Medisign MM1200 BT Blood Glucose Monitoring System, Smart Diabetes Bluetooth Blood Glucose Monitoring System, Medisign MM 1000 BT MULTI Blood Glucose Monitoring System, Medisign MM 1100 BT MULTI Blood Glucose Monitoring System, Medisign MM 1200 BT MULTI Blood Glucose Monitoring System, Smart Diabetes Bluetooth Pro Blood Glucose Monitoring System (K152534) | Tianjin Empecs Medical Device Co., Ltd. | 2017-03-21 |
| BD Phoenix Automated Microbiology System - GN Ceftazidime/avibactam (0.25/4- 32/4ug/mL) (K163637) | Becton Dickinson & Company | 2017-03-21 |
| LAP-Pump PP110 (K163320) | W.O.M. World of Medicine GmbH | 2017-03-21 |
| Nix Ultra Lice Treatment Kit (K163401) | Medtech Products, Inc. | 2017-03-21 |
| SmartGrid (K163157) | Carestream Health | 2017-03-21 |
| VERIFY SixCess Steam Indicators, VERIFY SixCess Flash Indicators, VERIFY Bowie Dick Test Pack, VERIFY SixCess Challenge Pack, VERIFY SixCess FP Challenge Pack (K162758) | STERIS Corporation | 2017-03-21 |
| MicroScan Dried Gram-Negative MIC/Combo Panels with Imipenem (0.25 - 8 ug/mL) (K162740) | Beckman Coulter, Inc. | 2017-03-21 |
| HAART 300 Aortic Annuloplasty Device 19mm, HAART 300 Aortic Annuloplasty Device 21mm, HAART 300 Aortic Annuloplasty Device 23mm, HAART 300 Aortic Annuloplasty Device 25mm (K163608) | Biostable Science & Engineering, Inc. | 2017-03-21 |
| Icare HOME tonometer (K163343) | Icare Finland OY | 2017-03-21 |
| Sterile Single-use Syringe with Needle (K163161) | Jiangxi Hongda Medical Equipment Group , Ltd. | 2017-03-20 |
| Direct LDL Cholesterol (LDL) (K161691) | Randox Laboratories Limited | 2017-03-20 |
| CoreCath 2.7S (K170296) | Medtronic Advanced Energy | 2017-03-20 |
| Avitus Bone Harvester with Filter Insert - 5mm, Avitus Bone Harvester - 5mm, Avitus Bone Harvester with Filter Insert - 8mm, Avitus Filter Insert - 8mm, Avitus Filter Insert - 5mm (K170539) | Avitus Orthopaedics, Inc. | 2017-03-20 |
| Dolphix® External Fixation System MR Conditional (K163323) | Citieffe S.R.L. | 2017-03-20 |
| Luggie Chair (K160139) | Freerider Corporation | 2017-03-20 |
| Phantom Fukushima Neurological Holding Systems, Phantom Mastability Neurological Holding Systems (K161318) | Tedan Surgical Innovations, LLC | 2017-03-20 |
| Bel-Cypher Pro (K163175) | Takara Belmont Corporation | 2017-03-20 |
| Sterile Hypodermic Safety Syringes for Single Use (K163162) | Jiangxi Hongda Medical Equipment Group , Ltd. | 2017-03-20 |
| Flex-Thread Clavicle Pin System (K163488) | Intrafuse, LLC | 2017-03-20 |
| Olecranon Plating System (K162898) | Miami Device Solutions, LLC | 2017-03-17 |
| SMARTmatic (K163239) | Kaltenbach & Voigt GmbH | 2017-03-17 |
| Trovita Health Science Safe-T Feed Ready-to-Feed Pouch with ENFit Connector (K163586) | Trovrx, Inc. Dba Trovita Health Science | 2017-03-17 |
| UltraCath Continuous Nerve block Catheter (K162522) | Teleflexmedical, Inc. | 2017-03-17 |
| OC-FLEX Flexible IntraOral Cannula (K161250) | Venture Therapeutics, Inc. | 2017-03-17 |
| RnD TE and RnD SE (K161077) | Apex Dental Materials, Inc. | 2017-03-17 |
| CrossFT Knotless Biocomposite Suture Anchor with Disposable Driver (K170501) | Conmed Corporation | 2017-03-17 |
| Monarch Airway Clearance System (K163378) | Hill-Rom Services Pte, Ltd. | 2017-03-17 |
| Consult Station TS (K153600) | H4D Sas | 2017-03-17 |
| OPT-SHIELD AIR, SUPINE; OPT-SHIELD, LITHOTOMY (K162562) | Bcg Medical, LLC | 2017-03-17 |
| Elecsys CMV IgM (K163569) | Roche Diagnostics | 2017-03-17 |
| Noris Medical MBI-2mm Dental Implant System (K162308) | Noris Medical , Ltd. | 2017-03-17 |
| Intersept Filtered Cardiotomy Reservoir with Cortiva BioActive Surface (K170583) | Medtronic, Inc. | 2017-03-17 |
| Exam Vue PACS (K162868) | Jpi Healthcare Solutions, Inc. | 2017-03-17 |
| Discovery MR750 3.0T; Discovery MR750w 3.0T;Discovery MR450 1.5T; Discovery MR450w 1.5T; SIGNA Architect and SIGNA Artist (K163331) | Ge Medical Systems, LLC | 2017-03-17 |
| MAZIC Duro (K163346) | Vericom Co., Ltd. | 2017-03-17 |
| Sparkling (K163655) | Shanghai Wonderful Opto-Electrics Tech.Co.,Ltd | 2017-03-17 |
| Multi-unit Abutment Plus (K161416) | Nobel Biocare AB | 2017-03-16 |
| NuVasive Next Generation NVM5 System (K162313) | Nu Vasive, Incorporated | 2017-03-16 |
| FDX Console (DR-ID300CL) Software (K170451) | Fujifilm Medical Systems U.S.A, Inc. | 2017-03-16 |
| TIPCAM 1S 3D System (K162880) | Karl Storz Endoscopy America, Inc. | 2017-03-16 |
| JOINIX CANNULAR SYSTEM (K162070) | Aju Pharm Co., Ltd. | 2017-03-16 |
| MectaLIF Anterior Stand Alone (K170455) | Medacta International S.A. | 2017-03-16 |
| LOCI Total Vitamin D Total Assay, LOCI VITD CAL (K162298) | Siemens Healthcare Diagnostics | 2017-03-16 |
| Y3 Proximal Femoral Plate System (K163003) | Pega Medical, Inc. | 2017-03-16 |
| KYMCO EQ10D Scooter (K163201) | Kwang Yang Motor Co., Ltd. | 2017-03-16 |