| NuFACE Gel Primer (K161654) | Carol Cole Company | 2016-12-30 |
| MultiBand SENSE (K162940) | Philips Medical Systems Nederland B.V. | 2016-12-30 |
| Teeter Manual Inversion Table; Teeter Gravity Boots; Teeter Forward Rotation Decompression Device; Teeter Portable Decompression Device; Teeter Horizontal Decompression Table (K162702) | Stl International, Inc. | 2016-12-30 |
| Cranial Reducing Tubes (K162604) | Medtronic Navigation, Inc. | 2016-12-30 |
| Hubble II (K163180) | Orbbo Surgical, LLC | 2016-12-29 |
| Disposable Insulin Syringe (K162180) | Berpu Medical Technology Co., Ltd. | 2016-12-29 |
| STERISPINE CC (K162531) | Safe Orthopaedics | 2016-12-29 |
| Envision 3D: Image Guidance System (K162375) | 7D Surgical, Inc. | 2016-12-29 |
| Hang&Go PAC (K161613) | Rand S.R.L. | 2016-12-28 |
| Kuschall K-Series Attract Manual Wheelchair (K162692) | Invacare Corporation | 2016-12-28 |
| Medline ReNewal Reprocessed Stryker External Fixation Devices (K163028) | Surgical Instrument Service and Savings, Inc. | 2016-12-28 |
| Kuschall Advance Manual Wheelchair (K162696) | Invacare Corporation | 2016-12-28 |
| Masimo Rainbow SET Intellivue Module Pulse CO-Oximeter (K162675) | Masimo Corporation | 2016-12-28 |
| ClearView cCAD (K161959) | Clearview Diagnostics, Inc. | 2016-12-28 |
| Kuschall Champion Manual Wheelchair (K162686) | Invacare Corporation | 2016-12-28 |
| Gexfix External Fixation (K160972) | Gexfix International Corp. | 2016-12-28 |
| BLUEPRINT Patient Specific Instrumentation (K161789) | Tornier S.A.S. | 2016-12-27 |
| SMARTO (K163308) | Jeil Medical Corporation | 2016-12-27 |
| Sysmex CS-2100i (K162688) | Siemens Healthcare Diagnostics Products GmbH | 2016-12-26 |
| Zilver 635 Biliary Stent (K163018) | Cook Ireland, Ltd. | 2016-12-23 |
| BGM014 Blood Glucose Monitoring System, BGM014 Pro Blood Glucose Monitoring System (K161299) | Apex BioTechnology Corp. | 2016-12-23 |
| XenMatrix AB Surgical Graft (K162193) | C. R. Bard | 2016-12-23 |
| AMPLATZER TorqVue 45x45 Delivery Sheath (K163000) | Aga Medical COrporation (Wholly Owned by St. Jude Medical CO | 2016-12-23 |
| Ez3D-i / E3 (K163539) | Ewoosoft Co., Ltd. | 2016-12-23 |
| ARIES GBS Assay (K162772) | Luminex Corporation | 2016-12-23 |
| Kurin Blood Culture Collection Set (K162233) | Pathway, LLC | 2016-12-23 |
| Model X-100C CO-Met™ Oximetry System (K160231) | Nonin Medical, Inc. | 2016-12-23 |
| Reprocessed Kendall SCD Express Foot Cuff (K163055) | Covidien | 2016-12-23 |
| CardioChek Plus Test System, CardioChek Home Test System, CardioChek PA Test System, CardioChek PA Home Test System (K151545) | Polymer Technology Systems, Inc. | 2016-12-22 |
| The Small PLATEAU (PLATEAU-C) Spacer System (K161127) | Life Spine, Inc. | 2016-12-22 |
| VPS Rhythm Device with TipTracker Technology (K160925) | Arrow International, Inc. (A Subsidiary of Teleflex, Inc.) | 2016-12-22 |
| Go Dose System (K160949) | Eli Lilly and Company | 2016-12-22 |
| Patient Monitor (K160981) | Edan Instruments, Inc. | 2016-12-22 |
| HydraGuard 10 UltraFilter (K161467) | Nephros, Inc. | 2016-12-22 |
| CardioChek Plus Test System, CardioChek Home Test System (K162282) | Polymer Technology Systems, Inc. D/B/A Pts Diagnostics | 2016-12-22 |
| Neocis Guidance System (K161399) | Neocis, Inc. | 2016-12-22 |
| Neurosoft TMS (K160309) | Teleemg, LLC | 2016-12-22 |
| Collagentex Rx-1 (K162022) | Tanses Technologies, Inc. | 2016-12-22 |
| Stimucel System, Stimucel Generator, Stimucel Treatment Wand, Stimucel Applicator (K162721) | Alliqua Biomedical, Inc. | 2016-12-22 |
| Sphynx™ (K160982) | Eden Spine, LLC | 2016-12-22 |
| ivWatch (K162478) | Ivwatch, LLC | 2016-12-22 |
| Lithoplasty Peripheral Balloon Dilatation Catheter; Lithoplasty Generator And Connector Cable; Lithoplasty Connector Cable (K163306) | Shockwave Medical, Inc. | 2016-12-22 |
| pAguaMedicina PERSISTENT Structural Hydrogel Ureteral Stent (K163068) | Q Urological Corporation | 2016-12-22 |
| XN CAL (K160585) | Streck | 2016-12-22 |
| XN CHECK BF (K160588) | Streck | 2016-12-22 |
| Y-MIC (K161639) | Micron Corporation | 2016-12-22 |
| FORZA Spacer System, PILLAR PEEK Spacer System, PILLAR SA PEEK Spacer System, SKYHAWK Lateral Interbody Fusion System (K162446) | Orthofix, Inc. | 2016-12-22 |
| XN CHECK (K160590) | Streck | 2016-12-22 |
| DynaMesh-VENTRAL (K161550) | Feg Textiltechnik Forschungs- Und Entwicklungsgesellschaft | 2016-12-22 |
| derma+flex QS High Viscosity Tissue Adhesive (K162352) | Chemence Medical, Inc. | 2016-12-22 |
| XN-L CHECK (K160586) | Streck | 2016-12-22 |
| Sysmex XN-L Automated Hematology Analyzer (K160538) | Sysmex America, Inc. | 2016-12-22 |
| neon3™ universal OCT spinal stabilization (K161032) | Ulrich GmbH & Co. KG | 2016-12-22 |
| Scope Buddy Plus Endoscope Flushing Aid (K162128) | Medivators, Inc. | 2016-12-21 |
| VLP MINI-MOD 2.0mm Column Plates (K163086) | Smith & Nephew, Inc. | 2016-12-21 |
| TEETHAN 2.0 (K161716) | Bts S.P.A. | 2016-12-21 |
| Sonablate (K160942) | Sonacare Medical, LLC | 2016-12-21 |
| IntelliCartTM System (K162421) | Dornoch Medical Systems | 2016-12-21 |
| NICO Myriad (K161307) | Nico Corporation | 2016-12-21 |
| EVS 4343, EVS 4343G (K162555) | DRTECH Corporation | 2016-12-21 |
| L- OVC (K162677) | Rhondium, Ltd. | 2016-12-21 |
| Pantheris Catheter (8F); Pantheris Cather (7F); Lightbox HS Imaging Console; Lightbox Sled (K163264) | Avinger, Inc. | 2016-12-21 |
| TRACOE Cuff Pressure Monitor (K152778) | Tracoe Medical GmbH | 2016-12-21 |
| ulrich Transfer Set (K161723) | Ulrich GmbH & Co. KG | 2016-12-21 |
| Brightway Brand Nitrile Examination Gloves, Powder Free, [Sterling/Grey] Tested For Use With Chemotherapy Drugs (K161215) | Brightway Holdings Sdn. Bhd. | 2016-12-21 |
| Ox-Imager CS (K153426) | Modulated Imaging, Inc. | 2016-12-21 |
| DMS Disposable Subdermal Needle Electrodes (K161566) | Daehan Medical Systems Co., Ltd. | 2016-12-21 |
| IMSE Cervical Cage (K162003) | The Institute of Musculoskeletal Science & Education | 2016-12-21 |
| GMK Revision Femoral Distal Augmentation (K163311) | Medacta International S.A. | 2016-12-21 |
| AeroForm Tissue Expander System (DEN150055) | Airxpanders, Inc. | 2016-12-21 |
| DAIYANG Powder Free Vinyl Patient Examination Gloves, Clear (non-colored) (K162259) | Zibo Daiyang Plastic Company | 2016-12-21 |
| CAPI 3 IMMUNOTYPING, CAPILLARYS 3 TERA, IT/IF CONTROL (K161928) | Sebia | 2016-12-21 |
| Evolution Esophageal Stent System – Partially Covered (K162717) | Cook Ireland, Ltd. | 2016-12-21 |
| EndoVac Pure (K162436) | Kerr Corporation | 2016-12-21 |
| Alere i Influenza A & B, Alere i Influenza A & B Control Swab Kit, Alere i Instrument (K163266) | Alere Scarborough, Inc. | 2016-12-21 |
| TelePatch Cardiac Monitor (K161916) | Medicomp, Inc. | 2016-12-21 |
| Reprocessed Viking Diagnostic Electrophysiology Catheters (K162251) | Innovative Health, LLC | 2016-12-21 |
| CipherOx CRI Tablet (DEN160020) | Flashback Technologies, Inc. | 2016-12-21 |
| Orthodontic Screw (K161197) | Osstem Implant Co., Ltd. | 2016-12-21 |
| CD HORIZON® Spinal System (K163301) | Medtronic Sofamor Danek USA, Inc. | 2016-12-20 |
| CONFIDENCE™ High Viscosity Spinal Cement, VIPER® and EXPEDIUM® Fenestrated Screw Systems (K160879) | Medos International Sàrl | 2016-12-20 |
| CP Relief Wand-OTC (K162630) | Mid-America Medical Innovations, LLC | 2016-12-20 |
| K3PRO SURGICAL TRAY (K160574) | Argon Med. Productions Vertriebs Gesellschaft Mbh CO KG | 2016-12-20 |
| Ultravision Visual Clearing System (DEN150022) | Alesi Surgical, Ltd. | 2016-12-20 |
| INNOLUX RIC (K162344) | Innolux Corporation | 2016-12-20 |
| Latex Polymer Coated Powder Free Surgical Glove with Protein Labeling Claim of 50 microgram or Less per Gram of Glove (Natural), Latex Polymer Coated Powder Free Surgical Glove with Protein Labeling Claim of 50 microgram or Less per Gram of Glove (Green) (K160928) | Hartalega Sdb. Bhd. | 2016-12-20 |
| Endoform Plastics and Reconstructive Matrix (K162461) | Aroa Biosurgery (Formerly Mesynthes Limited) | 2016-12-20 |
| Paclitaxel Sets (K160007) | Baxter Healthcare Corporation | 2016-12-19 |
| KLS Martin Cannulated Headless Screws (K161259) | KLS Martin L.P. | 2016-12-19 |
| Elecsys AMH, AMH CalSet, PreciControl AMH, AMH CalCheck 5 (DEN150057) | Roche Diagnostics | 2016-12-19 |
| Hem-Avert Perianal Stabilizer (DEN160005) | Stetrix, Inc. | 2016-12-19 |
| Destiknee Total Knee System (K160771) | Meril Healthcare Private Limited | 2016-12-19 |
| Liofilchem MIC Test Strip (MTS) Meropenem 0.002-32.0 ug/ml (K162854) | Liofilchem s.r.l. | 2016-12-19 |
| Vinyl Exam Gloves, Powder Free, Clear (K161390) | Zibo Hongchin Plastic and Rubber Co., Ltd. | 2016-12-19 |
| EVA (Enhanced Visual Assessment) System (K161871) | Mobileodt , Ltd. | 2016-12-19 |
| Aquamax (Etafilcon A) Bi-Weekly Soft, Aquamax (Etafilcon A) Daily Disposable Soft (Hydrophilic) Contact Lenses (K161739) | Pegavision Corporation | 2016-12-19 |
| cobas c513 Analyzer, cobas c13 Tina-quant HbA1cDx Gen.3 Assay (K160571) | Roche Diagnostics Operations (Rdo) | 2016-12-19 |
| Multi-Modality Tumor Tracking (MMTT) application (K162955) | Philips Medical Systems Nederland B.V. | 2016-12-19 |
| PS2 Knee System (K160515) | Consensus Orthopedics, Inc. | 2016-12-19 |
| BD 1ml Luer-lok Hypodermic Syringe, BD 1 mL Luer-Lok Hypodermic Syringe with BD Hypodermic Needle or BD Eclipse Hypodermic Needle, BD 1ml Luer-lok Insulin Syringe (K162081) | Becton, Dickinson and Company | 2016-12-19 |