| ACTICOAT Surgical Dressing (K153723) | Smith & Nephew Medical Limited | 2016-09-14 |
| Anexa Wound Flush, Sterile Water & Sterile Normal Saline (K161658) | Anexa Biomedical, Inc. | 2016-09-14 |
| TXM Guiding Sheath (K153771) | Texasmedical Technologies, Inc. | 2016-09-13 |
| Initial LiSi Block (K153130) | GC America, Inc. | 2016-09-13 |
| OptoMonitor II (K161263) | Opsens, Inc. | 2016-09-13 |
| TR-100 (K161551) | BTL Industries, Inc. | 2016-09-13 |
| Profound System (K161043) | Syneron Candela Corporation | 2016-09-12 |
| Pavati Z40.2 Zirconia (K160867) | Ccri, Inc. | 2016-09-12 |
| Implance Dental Implant System, Implance Dental Abutment System (K160221) | Ags Medikal Urunleri Ith. Ihr. Tic. Ltd. Sti. | 2016-09-12 |
| JULIET® LL Lateral Lumbar Cage (K161888) | Spineart | 2016-09-12 |
| NeuroStar TMS Therapy System (K161519) | Neuronetics, Inc. | 2016-09-11 |
| Self-retaining Retractor (K161004) | Fetzer Medical GmbH & Co. KG | 2016-09-09 |
| ClearRead CT (K161201) | Riverain Technologies, LLC | 2016-09-09 |
| AbClose - Port Site Closure Device (K160117) | Medeon Biodesign, Inc. | 2016-09-09 |
| Liberator Powered Wheelchair with Solar Companion (K153636) | Solar Mobilityllc | 2016-09-09 |
| Sure-Fine Insulin Syringes (K152879) | Shina Med Corporation | 2016-09-09 |
| ULYSS Multi View Sinuscope (K153701) | Sopro-Comeg GmbH | 2016-09-09 |
| Arthrex Synergy RF System (K161581) | Arthrex, Inc. | 2016-09-09 |
| Tritium® Sternal Cable Plate System (K161876) | Pioneer Surgical Technology, Inc., Dba Rti Surgical, Inc. | 2016-09-09 |
| EMG Blue Nitrile Examination Gloves Powder Free with Tested for use with Chemotherapy Drugs (K161187) | Eco Medi Glove Sdn. Bhd. | 2016-09-09 |
| All-Bond Universal w/BAC (not finalized) (K161051) | Bisco, Inc. | 2016-09-09 |
| S9 VPAP Adapt, VPAP Adapt, AirCurve 10 ASV (K160822) | Resmed, Ltd. | 2016-09-09 |
| Matrix LS-40 CO2 Laser System (K161356) | Shanghai Wonderful Opto-Electrics Tech.Co.,Ltd | 2016-09-09 |
| TorqVue Low Profile Delivery Catheter (K162228) | Aga Medical Corporation (Wholly Owned by St.Jude Medical Cor | 2016-09-09 |
| VPAP Adapt SV, VPAP Tx, S9 VPAP Tx (K161487) | Resmed, Ltd. | 2016-09-09 |
| Trojan XOXO Ribbed Male Natural Rubber Latex Condom with Silicone and Aloe Lubricant (K161915) | Church & Dwight Co., Inc. | 2016-09-09 |
| Venclose Radiofrequency System (digiRF Generator, EVSRF Catheter) (K160754) | Venclose, Inc. | 2016-09-09 |
| Enseal X1 Large Jaw Tissue Sealer (K160554) | Ethicon Endo-Surgery, LLC | 2016-09-09 |
| AMC Health VitalCaregiving System (K151839) | Amc Health | 2016-09-09 |
| PerkinElmer XRpad2 4336 HWC-M Flat Panel Detector (K161966) | Perkinelmer, Inc. | 2016-09-08 |
| Navident (K161406) | Claronav, Inc. | 2016-09-08 |
| StageOne Select Cement Spacer Molds for Temporary Hip Replacement (K161166) | Biomet, Inc. | 2016-09-08 |
| RTS Flexible 1 MPJ Implant w/Grommets (K153609) | In2bones USA, LLC | 2016-09-08 |
| PILLAR SA PTC (K161129) | Orthofix, Inc. | 2016-09-08 |
| SeaSpine® NewPort™ Spinal System (K161535) | SeaSpine Orthopedics Corporation | 2016-09-08 |
| Battalion Universal Spacer System (K160958) | Alphatec Spine | 2016-09-08 |
| SonoSite iViz Ultrasound System (K162288) | FUJIFILM Sonosite, Inc. | 2016-09-08 |
| BBX1, BBX2, BBX1MO, BBX1MC (K142846) | Globaldental, Inc. | 2016-09-08 |
| Luna CPAP and Auto CPAP System (K153387) | 3B Medical, Inc. | 2016-09-08 |
| Cytosurg non-resorbable PTFE Membrane, 25mm x 30mm, Cytosurg non-resorbable PTFE Membrane, 12mm x 24mm (K160493) | Salvin Dental Specialties | 2016-09-08 |
| Symbia 6.5 (K162337) | Siemens Medical Solutions USA, Inc. | 2016-09-08 |
| 2MP Color LCD Monitor CCL214 (CL21214) (K161895) | Jvckenwood Corporation | 2016-09-08 |
| coflex-IF (K153302) | Paradigm Spine, LLC | 2016-09-08 |
| BioFlo Midline Catheter (K161866) | Navilyst Medical, Inc. | 2016-09-08 |
| Next Science Irrigation Solution (K161165) | Next Science, LLC | 2016-09-07 |
| Central Monitoring System (K153580) | Guangdong Biolight Meditech Co., Ltd. | 2016-09-07 |
| ELITech Clinical Systems GLUCOSE HK SL, ELITech Clinical Systems ELICAL 2, ELITech Clinical Systems ELITROL I and ELITROL II (K153644) | Elitechgroup | 2016-09-07 |
| Additive Orthopaedics Bone Wedge System (K153207) | Additive Orthopaedics, LLC | 2016-09-07 |
| Procellera (K160783) | Vomaris Innovations, Inc. | 2016-09-07 |
| Symmetry Sharp Kerrison Rongeur (K161744) | Symmetry Surgical, Inc. | 2016-09-07 |
| Signia sterilization tray (K161347) | Covidien | 2016-09-07 |
| CareSens Pen Needle, Softip Pen Needle (K160575) | Yidobio, Inc. | 2016-09-07 |
| Pelican Sling Retractor (K153542) | Beacon Surgical, Inc. | 2016-09-07 |
| GENflex2 Total Knee System (K162222) | Stelkast, Inc. | 2016-09-07 |
| ADVIA Chemistry Creatine Kinase (CK_L) Assay, ADVIA Chemistry Enzyme 3 Calibrator (K160724) | Siemens Healthcare Diagnostics, Inc. | 2016-09-07 |
| Weck Auto Endo10 Automatic Endoscopic Clip Applier (K161758) | Teleflex Medical | 2016-09-07 |
| 3Shape Abutment Designer Software (K151455) | 3Shape A/S | 2016-09-06 |
| Resona 7/Resona 7CV/Resona 7EXP/Resona 7S/Resona 7OB Diagnostic Ultrasound System (K162267) | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 2016-09-06 |
| ACUSON S1000 / S2000 / S3000 Diagnostic Ultrasound System (K162243) | Siemens Medi Cal Solutions, Inc. | 2016-09-06 |
| BD MAX CT/GC/TV, BD MAX INSTRUMENT (K151589) | Becton, Dickinson and Company | 2016-09-06 |
| HALYARD* PURPLE NITRILE – XTRA* Powder-Free Exam Gloves (K160709) | Halyard Health | 2016-09-06 |
| Surgical Face Masks (Ear loops and Tie-on) (K160269) | San-M Package Co., Ltd. | 2016-09-06 |
| Resection Electrodes (K161600) | Olympus Winter & Ibe GmbH | 2016-09-06 |
| Xenco Medical Posterior Cervical System (K161478) | Xenco Medical, LLC | 2016-09-06 |
| HAMILTON-MR1 (K153046) | Hamilton Medical AG | 2016-09-06 |
| CG+ Arrow JACC (K161765) | Arrow International, Inc. (Subsidiary of Teleflex | 2016-09-06 |
| Nanovis Intervertebral Body Fusion System and Forticore(R) (K161485) | Nanovis, LLC | 2016-09-06 |
| ACUSON SC2000 Diagnostic Ultrasound System (K162221) | Siemens Medical Solutions Inc. Ultrasound Group | 2016-09-06 |
| Nexus DRTM Digital X-ray Imaging System (with PaxScan 4336Wv4) (K161459) | Varian Medical Systems, X-Ray Products-Infimed | 2016-09-06 |
| Active-X Total Knee System (K160159) | Signature Orthopaedics Pty, Ltd. | 2016-09-06 |
| Mano and Mano Personal Lubricant (K161585) | Mano and Mano Proprietary Limited | 2016-09-06 |
| SyncVision System (K161756) | Volcano Corporation | 2016-09-05 |
| CardioConfirm (K161465) | Mortara Instrument, Inc. | 2016-09-03 |
| Edwards eSheath Introducer Set (K162184) | Edward Lifesciences | 2016-09-02 |
| Pro-Link® Stand-Alone Cervical Spacer System (K160066) | Life Spine, Inc. | 2016-09-02 |
| Modified Trevo ProVue Retriever, Trevo XP ProVue Retriever 4x20mm, Trevo XP ProVue Retriever 3x20mm, Trevo XP ProVue Retriever 6x25mm, Trevo XP ProVue Retriever 4x30mm (DEN150049) | Concentric Medical, Inc. | 2016-09-02 |
| Tangis Anterior Cervical Plate (K161524) | Nvision Biomedical Technologies, LLC | 2016-09-02 |
| PROcedure Rehearsal Studio (K153705) | 3Dsystems, Simbionix Products | 2016-09-02 |
| Sysmex Automated Blood Coagulation Analyzer CS-5100 (K161317) | Siemens Healthcare Diagnostics Products GmbH | 2016-09-02 |
| Perineologic Access Needle (K160423) | Corbin Clinical Resources, LLC | 2016-09-02 |
| FilmArray RP EZ Control Panel M265 (K161573) | Maine Molecular Quality Controls, Inc. | 2016-09-02 |
| MyLabSix Ultrasound System (K161168) | Esaote Europe B.V. | 2016-09-02 |
| MAGEC® Spinal Bracing and Distraction System (K161751) | Nuvasive Specialized Orthopedics, Inc. | 2016-09-02 |
| Restore PACS (K162141) | Xian Wingspan Electronic Technology Co., Ltd. | 2016-09-02 |
| Nihon Kohden Vital Sign Telemeter (K153707) | Nihon Kohden Corporation | 2016-09-02 |
| Arctic Sun Temperature Management System (K161602) | Medivance, Inc. | 2016-09-02 |
| JET SET 4 DENTURE REPAIR RESIN (K152981) | Lang Dental Manufacturing Company, Inc. | 2016-09-02 |
| LigaPASS (K160698) | Medicrea International SA | 2016-09-02 |
| WiCap (K160582) | Athena Gtx | 2016-09-02 |
| Indy OTW Vascular Retriever (K160593) | Cook Incorporated | 2016-09-02 |
| BC-5D Hematology Control (K160606) | R&D Systems, Inc. | 2016-09-01 |
| XP202 (K161922) | 3M Deutschland GmbH | 2016-09-01 |
| CareView 1500P X-ray Flat Panel Detectors (K162178) | Careray Digital Medical System Co., Ltd. | 2016-09-01 |
| Noiselezz (K160531) | Firma Ingemarsson | 2016-09-01 |
| Sysmex Automated Blood Coagulation Analyzer CS-2100i (K161312) | Siemens Healthcare Diagnostics Products GmbH | 2016-09-01 |
| Monoject Enteral Syringe with ENFit Connector (K161963) | Covidien | 2016-09-01 |
| BC-5390 Auto Hematology Analyzer (K160429) | Mindray Bio-Medical Electronics Co., Ltd. | 2016-09-01 |
| DUO (K161565) | Stetic Medical Aesthetics Development (Shenzhen) Co. ,Ltd | 2016-09-01 |
| Concert Medical Hands-Free Syringe (HFS) (K153599) | Concert Medical, LLC | 2016-09-01 |
| Cathtong I PICC Catheter (K153469) | L&Z Us, Inc. | 2016-09-01 |