| Kalitec Direct InSePtion™ MIS Fixation System (K163471) | Kalitec Direct, LLC | 2017-03-16 |
| VALIDATE Heparin Calibration Verification/Linearity Test Kit (K163498) | Maine Standards Company, LLC | 2017-03-16 |
| U2 Total Knee System E-XPE products (K161705) | United Orthopedic Corporation | 2017-03-16 |
| 6200 Ultrasound System and 6250 Ultrasound System (K163082) | Esaote, S.p.A. | 2017-03-16 |
| LINK® SP-CL® Hip System PoroLink® (microporous) and HX® (CaP) coated & LINK® LCU® Hip System PoroLink® (microporous) and HX® (CaP) coated (K161840) | Waldemar Link GmbH & Co. KG | 2017-03-16 |
| NuVasive Modulus XLIF Interbody System (K163230) | Nu Vasive, Incorporated | 2017-03-16 |
| MOJAVE Expandable Interbody System (K163364) | K2m | 2017-03-15 |
| Spectra 9Plus (K162415) | Uzinmedicare Company | 2017-03-15 |
| LV Liberty Vision Model 1 90 Yttrium Brachytherapy Source (K163572) | Lv Liberty Vision Corp. | 2017-03-15 |
| SleepWeaver 3D Nasal Mask (K162905) | Circadiance, LLC | 2017-03-15 |
| HardyDisk Ceftolozane/Tazobactam, (30/10 ug)-C/T40 (K170127) | Hardy Diagnostics | 2017-03-14 |
| FilmArray Warrior Control Panel M290 (K163522) | Maine Molecular Quality Controls, Inc. | 2017-03-14 |
| NobelZygoma 0° (K161598) | Nobel Biocare AB | 2017-03-14 |
| NIVR58-T kit (K161880) | Barco N.V. | 2017-03-14 |
| Rapid Barostat Bag (RBB) Pump and Catheter (K160287) | Mui Scientific | 2017-03-14 |
| THD ANOPRESS (K161785) | Thd Spa | 2017-03-14 |
| TotalC-Ram (K162960) | Itena Clinical | 2017-03-14 |
| Safety Blood Collection Set (K163093) | Jiangsu Shenli Medical Production Co., Ltd. | 2017-03-14 |
| Liofilchem MIC Test Strip (MTS) Telavancin 0.016 - 256.0 µg/mL (K163517) | Liofilchem s.r.l. | 2017-03-14 |
| mollosil plus (K162654) | Detax GmbH & Co. KG | 2017-03-13 |
| ORTHOLOC® 3Di Small Bones Plating (K163039) | Wrightmedicaltechnologyinc | 2017-03-13 |
| Navigated Instrument System (K162921) | Orthofix, Inc. | 2017-03-13 |
| FUJIFILM Surgical System (K162836) | Fujifilm New Development U.S.A., Inc. | 2017-03-13 |
| VITEK 2 AST-GN Gentamicin (<=1 – >=16 µg/mL) (K163563) | bioMerieux, Inc. | 2017-03-13 |
| NOVATECH TALCAIR (K170030) | Novatech SA | 2017-03-13 |
| Thermi Injectable RF Electrodes (K170116) | Thermi | 2017-03-13 |
| ZipE Knotless Tissue Repair and Attachment Devices (K162429) | Ziptek, LLC | 2017-03-13 |
| PROLENE Soft Polypropylene Mesh (K163152) | ETHICON, Inc. | 2017-03-11 |
| AdvanCE capsule endoscope delivery device (K163495) | United States Endoscopy Group, Inc. | 2017-03-10 |
| InterLock Trocar (K170084) | Fujifilm New Development U.S.A., Inc. | 2017-03-10 |
| iFuse Implant System® - iFuse-3D implant (K162733) | SI-BONE, Inc. | 2017-03-10 |
| Adscope 658 Electronic Stethoscope (K162589) | American Diagnostic Corp. | 2017-03-10 |
| CAVUX CervicalCage-L SA System (K163474) | Providence Medical Technology, Inc. | 2017-03-10 |
| EndoWrist Stapler 45 Instrument, EndoWrist Stapler 45 Reloads, EndoWrist Stapler 30 Instrument, EndoWrist Stapler 30 Reloads (K170508) | Intuitive Surgical, Inc. | 2017-03-10 |
| RHYTHMIA HDx Mapping System (K162793) | Boston Scientific Corporation | 2017-03-10 |
| BD Nexiva Closed IV Catheter System (Single Port) with MaxZero Needleless Connector (K170336) | Becton, Dickinson and Company | 2017-03-10 |
| Interstitial Needles (K160815) | Varian Medical Systems, Inc. | 2017-03-10 |
| Rapid2 Therapy System (K162935) | Magstim Company, Ltd. | 2017-03-10 |
| Audit MicroControls Linearity FD Tumor Markers II (K163629) | Aalto Scientific, Ltd. | 2017-03-10 |
| Mikro-Cath Pressure Catheter (K163376) | Millar, Inc. | 2017-03-10 |
| Infrared Non-contact Thermometer, Model ACT8100 (K162509) | Easywell Biomedicals, Inc. | 2017-03-10 |
| Altus Spine Titanium Interbody Fusion System (K170512) | Altus Partners, LLC | 2017-03-10 |
| Sterispine™ PS (K170528) | Safe Orthopaedics | 2017-03-09 |
| SeaSpine® Daytona® Small Stature Spinal System (K163604) | SeaSpine Orthopedics Corporation | 2017-03-09 |
| Hoggan Scientific® microFET2™ (K162412) | Hoggan Scientific, LLC | 2017-03-09 |
| FLEX Microwave Ablation System and Accessories (K163118) | Neuwave Medical, Inc. | 2017-03-09 |
| NuVasive® Reline® 4.5-5.0 System (K170126) | Nu Vasive, Incorporated | 2017-03-09 |
| Transem and EchoGen Embryo Transfer Catheters (K161547) | Origio A/S | 2017-03-09 |
| ANSiStim-PP (K170391) | Dyansys, Inc. | 2017-03-09 |
| PhotoFix Decellularized Bovine Pericardium (K162506) | Cryolife, Inc. | 2017-03-09 |
| Atellica Solution, Atellica A-LYTE Integrated Multisensor Na+/K+/CI-, Atellica CH Albumin BCP Reagent (Alb_p), Atellica IM Thyroid Stimulating Hormone TSH, Atellica CH Vancomycin (Vanc) (K161954) | Siemens Healthcare Diagnostics | 2017-03-09 |
| ARTIS pheno (K163286) | Siemens Medical Solution USA, Inc. | 2017-03-09 |
| ADVIA® Chemistry Total Bilirubin_2 (TBIL_2) (K170065) | Siemens Healthcare Diagnostics, Inc. | 2017-03-09 |
| Level One Hand Plating System (K170124) | KLS Martin L.P. | 2017-03-09 |
| JAZZ SOLO Sensor (K163224) | Jazz Imaging, LLC | 2017-03-09 |
| 3.3 mm Laurimed Microdebrider; 4.0 mm Laurimed Microdebrider (K163247) | Laurimed, LLC | 2017-03-09 |
| BGM009 Plus Blood Glucose Monitoring System (K170267) | Apex BioTechnology Corp. | 2017-03-09 |
| Q2 Low Pressure Power Injection Extension Set (K162804) | Quest Medical, Inc. | 2017-03-08 |
| Solitaire Platinum Revascularization Device, 6x40 mm (K160641) | Micro Therapeutics, Inc. d/b/a ev3 Neurovascular | 2017-03-08 |
| CRC-77tHR (K162394) | Capintec, Inc. | 2017-03-08 |
| BLT 02.9mm SC, SLA or SLActive, RXD, Loxim, SC Closure Cap and Healing Abutments, SC Temporary Abutments, SC Variobase Abutments, SC CARES Abutment (K162890) | Straumann USA, LLC | 2017-03-08 |
| Expro Elite Snare, Sympro Elite Snare (K163307) | Vascular Solutions, Inc. | 2017-03-08 |
| Rampart(TM) T Lumbar Interbody Fusion Device (K163409) | Spineology, Inc. | 2017-03-08 |
| INSPIRE SVR 1200, INSPIRE 6F C, INSPIRE 8F C (K161733) | Sorin Group Italia S.R.L. | 2017-03-08 |
| VIVA combo RF System (K163450) | Starmed Co., Ltd. | 2017-03-08 |
| DyeVert Plus Contrast Modulation/Monitoring System, Contrast Monitoring System (K163054) | Osprey Medical, Inc. | 2017-03-08 |
| Burette-type Infusion Sets for Single Use, Disposable Infusion Sets with Precision Filters, Disposable Infusion Set (K161898) | Beijing Fert Technology Co., Ltd. | 2017-03-08 |
| Nipro SafeTouch IV Catheter (K161681) | Nipro Medical Corporation | 2017-03-08 |
| Vial2Bag Direct Connect (K170095) | Medimop Medical Project , Ltd. | 2017-03-08 |
| OrthoSolutions 'System26' Bone Screws (K163489) | Ortho Solutions UK Limited | 2017-03-08 |
| Bovie J-Plasma Precise Open handpiece & Bovie Ultimate Gen 2 High Frequency Electrosurgical Generator (K170188) | Bovie Medical Corporation | 2017-03-08 |
| VersaOne fascial closure system bladed trocar, VersaOne fascial closure system bladeless trocar, VersaOne fascial closure system optical trocar (K163654) | Covidien, LLC | 2017-03-08 |
| CIMLRE F1 and CIMILRE S3 (K162870) | Cimilre Co., Ltd. | 2017-03-07 |
| CenterCross Ultra LV Catheter (K170403) | Roxwood Medical, Inc. | 2017-03-07 |
| Male Latex Condoms (K162919) | Zhejiang Xiangban Latex Products Co., Ltd. | 2017-03-07 |
| PRECICE Intramedullary Limb Lengthening System (K170346) | Nuvasive Specialized Orthopedics, Inc. | 2017-03-07 |
| Straumann PrefGel (K162311) | Institut Straumann AG | 2017-03-07 |
| iSage Rx (iSage Rx Basal Insulin Titration) (K161865) | Isag Rx, Inc. | 2017-03-07 |
| RenovoCath (K160067) | Renovorx, Inc. | 2017-03-07 |
| Flexi-Seal PROTECT Fecal Management System (K162906) | Convatec | 2017-03-07 |
| Vado Steerable Sheath (K160721) | Kalila Medical, Inc. | 2017-03-07 |
| GMK Sphere (K162035) | Medacta International S.A. | 2017-03-06 |
| SALVATION External Fixation System (K162033) | Wright Medical | 2017-03-06 |
| TSolution One Surgical System Model 210 (K170430) | THINK Surgical, Inc. | 2017-03-06 |
| Greiner Vacuette Urine Count and Culture, Mannitol tube (K163436) | Greiner Bio-One Na, Inc. | 2017-03-06 |
| Next Science Wound Gel (Rx) (K163188) | Next Science, LLC | 2017-03-06 |
| Exactech Equinoxe Reverse Shoulder Locking Cap, Exactech Equinoxe Reverse Shoulder Compression Screws, Exactech Equinoxe Reverse Shoulder Glenosphere Locking Screw (K162325) | Exactech, Inc. | 2017-03-06 |
| CINtec Histology (50 tests), CINtec Histology (250 tests) (DEN160019) | Ventana Medical Systems, Inc. | 2017-03-04 |
| Nitrile Powder Free Examination Glove with Low Dermatitis Potential Claim (Blue) (K162646) | Hartalega NGC Sdn. Bhd. | 2017-03-03 |
| 3D OCT-1 Maestro (K170164) | Topcon Corporation | 2017-03-03 |
| iPulse SmoothSkin BARE Hair Removal Device (K163552) | Cyden Limited | 2017-03-03 |
| ACL AcuStar (K170314) | Instrumentation Laboratory CO | 2017-03-03 |
| True 3D Viewer Software (K170167) | Echopixel, Inc. | 2017-03-03 |
| AZUR CX Detachable 18 Peripheral Coil System (K162524) | MicroVention, Inc. | 2017-03-03 |
| Z-LINKPC System (K162575) | Zavation, LLC | 2017-03-03 |
| Dentca Denture Base II (K162044) | Dentca, Inc. | 2017-03-03 |
| Ontex and other proprietary names (K162746) | Ontex Bvba | 2017-03-03 |
| Cyber Ho (K170331) | Quanta System Spa | 2017-03-03 |
| SREE MRI Transport Incubator (K161918) | Advanced Imaging Research Dba Sree Medical Systems | 2017-03-03 |
| Glass Ionomer Cement (K160345) | Shandong Huge Dental Material Corporation | 2017-03-03 |