| Hansen Medical Magellan Robotic Catheter 6Fr and Accessory Components (K151463) | Hansen Medical, Inc. | 2015-08-18 |
| Contour Eyelid Weight Implants, ThinProfile Eyelid Weight Implants (K150986) | Meddev Corporation | 2015-08-17 |
| Nexus Universal, Nexus Universal Chroma (K151332) | Sybron Dental Specialties | 2015-08-17 |
| EDOSE (K150767) | Guangzhou Raydose Software Technology., LLC | 2015-08-17 |
| SOPIX (K142995) | Sopro - Acteon Group | 2015-08-17 |
| VesselNavigator Rel. 1.0 (K151598) | Philips Medical Systems Nederland B.V. | 2015-08-17 |
| IDODENTINE DISC, IDODENTINE BLOCK (K150432) | Union Dental S.A. | 2015-08-14 |
| Low Dose CT Lung Cancer Screening Option for Qualified GE Systems (K151372) | Ge Medical Systems, LLC | 2015-08-14 |
| Flexor Radial Hydrophilic Introducer Access Set (K152044) | Cook Incorporated | 2015-08-14 |
| Wartie Advanced Wart Remover or other proprietary name (K151309) | Youmedical Corp BV | 2015-08-14 |
| Vyntus / SentrySuite Product Line (K150810) | Carefusion Germany 234 GmbH | 2015-08-14 |
| Banana Gold (K150857) | Hankook Latex Gongup Co., Ltd. | 2015-08-14 |
| Transcutaneous Electrical Nerve Stimulators (TENS) (K150043) | Andon Health Co, Ltd. | 2015-08-14 |
| XPS Nexus System, XPS Nexus Foot Control, XPS Nexus IV Pole (K150728) | Medtronic Xomed, Inc. | 2015-08-14 |
| MRXperion MR Injection System, MRXperion MR Injection System Syringe Kit (K143538) | Bayer Medical Care, Inc. | 2015-08-14 |
| MASTERGRAFT Contain (K151172) | Medtronic Sofamor Danek USA, Inc. | 2015-08-14 |
| Sertera Biopsy Device (K150169) | Hologic, Inc. | 2015-08-14 |
| PaxWire Occlusion Balloon System (K143613) | Accessclosure, Inc. | 2015-08-14 |
| Respiratory Gating for Scanners (K151533) | Varian Medical Systems, Inc. | 2015-08-13 |
| IVOBASE CAD FOR ZENOTEC, IVOBASE CAD BOND, IVOBASE CAD MODELLING LIQUID (K151142) | Wieland Dental + Technik GmbH & Co. KG | 2015-08-13 |
| Modpod (K150695) | Hollywog, LLC | 2015-08-13 |
| Narval Brux (K143623) | Resmed Sas | 2015-08-13 |
| Foundation Interbody Devices (K150847) | Corelink, LLC | 2015-08-13 |
| U2 Hip Stem, Ti Porous Coated, Matrix (K151316) | United Orthopedic Corporation | 2015-08-13 |
| Arc Endocuff Vision (K151801) | Boddingtons Plastics, Ltd. | 2015-08-13 |
| syngo.via RT Image Suite (K151380) | Siemens Medical Solutions USA, Inc. | 2015-08-13 |
| Reusable Full Silicone Cover (K151702) | Laerdal Medical AS | 2015-08-13 |
| CLEARFIL CERAMIC PRIMER PLUS, CLEARFIL CERAMIC PRIMER PLUS (Trial) (K150703) | Kuraray Noritake Dental, Inc. | 2015-08-13 |
| Neurosplint (K143458) | Neurospectrum, LLC | 2015-08-13 |
| Heagen Multi-Drug Urine Test Cup, Healgen Multi-Drug Urine Test Dip Card (K151642) | Healgen Scientific,, LLC | 2015-08-13 |
| Continuum and Trilogy Integrated Taper (IT) Acetabular Systems (K151448) | Zimmer, Inc. | 2015-08-13 |
| ComboCath OTW PTA Dilatation Catheter (K150452) | Summa Therapeutics, LLC | 2015-08-13 |
| Conventus PRS System (K151379) | Conventus Orthopaedics, Inc. | 2015-08-13 |
| STRATAFIX Spiral MONOCRYL Knotless Tissue Control Device, STRATAFIX Spiral MONOCRYL Plus Knotless Tissue Control Device (K151200) | ETHICON, Inc. | 2015-08-13 |
| Airlock® osteosynthesis plate system (K151277) | Novastep | 2015-08-13 |
| Aesculap T-Space PEEK and XP Spinal System (K151056) | Aesculap Implant Systems, LLC | 2015-08-13 |
| Mitsar-EEG (K143233) | Mitsar Co., Ltd. | 2015-08-13 |
| Stryker Suture Tape (K150584) | Stryker | 2015-08-13 |
| Turnpike catheter (K151981) | Vascular Solution, Inc. | 2015-08-13 |
| Accu-Chek FlexLink Plus infusion set (K143446) | Roche Diagnostics GmbH | 2015-08-13 |
| RS80A Diagnostic Ultrasound System (K151663) | Samsung Medison Co., Ltd. | 2015-08-12 |
| Spaulding Electrocardiograph 2100iQ (K150564) | Spaulding Clinical Research, LLC | 2015-08-12 |
| Arthrex BioSync® Bone Wedge (K151256) | Arthex, Inc. | 2015-08-12 |
| RECON system (K151407) | Normed Medizin-Technik GmbH | 2015-08-12 |
| SI-TECHNOLOGY® SI-DESIS® SCREWS (K151462) | Si-Technology, LLC | 2015-08-12 |
| Solitaire-C Cervical Spacer System, C-Thru Anterior Spinal System, Breckenridge Small Intervertebral Body Fusion System (K151064) | Biomet Spine | 2015-08-12 |
| Synapse Cardiovascular (K151859) | Fujifilm Medical Systems U.S.A, Inc. | 2015-08-12 |
| Central Venous Pressure System (K151776) | Mespere Lifesciences, Inc. | 2015-08-12 |
| PERSYST 13 (P13) EEG REVIEW AND ANALYSIS SOFTWARE (K151929) | Persyst Development Corporation | 2015-08-12 |
| Alere Signify H. pylori Whole Blood, Serum, Plasma; Alere Signify H. pylori Whole Blood Only;Alere Clearview H. pylori Whole Blood, Serum, Plasma; Alere Clearview H. pylori Whole Blood Only (K151935) | Alere San Diego, Incorporated | 2015-08-12 |
| LightSheer Desire Light Laser System (K151947) | Lumenis, Ltd. | 2015-08-12 |
| McKesson Cardiology (K151850) | Mckesson Israel , Ltd. | 2015-08-11 |
| syngo.CT Single Source Dual Energy (K150745) | Siemens Medical Solutions USA, Inc. | 2015-08-11 |
| syngo.CT Dual Energy (K150757) | Siemens Medical Solutions USA, Inc. | 2015-08-11 |
| Disposable Pressure Manometer (DPM) (K143148) | Westmed, Inc. | 2015-08-11 |
| TM SAFETY NEEDLE (K142765) | Thinkmed Medical Technology Co., Ltd. | 2015-08-11 |
| Cathivex ¿GV filter units (K143583) | Merck Millipore , Ltd. | 2015-08-11 |
| Eye Secret 55 UV Aspheric (Methafilcon A) Soft (hydrophilic) Contact Lens (K151586) | Yung Sheng Optical Co., Ltd. | 2015-08-10 |
| Unimicro Trocar Kit, models: Auto-Locking Trocar, Hasson Trocar, Bladeless Trocar (K141594) | Unimicro Medical Systems (Shenzhen) Co., Ltd. | 2015-08-10 |
| Materialise TKA Guide System, Materialise TKA Planner, Materialise TKA Guides (K150928) | Materialise NV | 2015-08-10 |
| Everest Spinal System (K151216) | K2m, Inc. | 2015-08-10 |
| NC Straumann Screw Retained Abutments (K151247) | Straumann USA, LLC | 2015-08-10 |
| Straumann Screw-Retained Abutment (K150814) | Straumann USA, LLC | 2015-08-10 |
| Restoration Anatomic Shell (K151264) | Stryker Orthopaedics | 2015-08-10 |
| Omega LIF System (K150395) | Amendia, Inc. | 2015-08-10 |
| WASTON Metallic Bone Plate and Screw Systems (K151057) | Changzhou Waston Medical Appliance Co., Ltd. | 2015-08-10 |
| Philips Spectral CT Applications (K150665) | Philips Medical Systems Nethrlands BV | 2015-08-07 |
| Q-Rad Radiographic System with Auto-Tracker Option (K151924) | Quantum Medical Imaging Divison of Carestream | 2015-08-07 |
| Corvocet Coaxial Introducer (K151373) | Merit Medical Systems, Inc. | 2015-08-07 |
| 8ch Foot Ankle Coil (K151653) | Shenzhen RF Tech Co., Ltd. | 2015-08-07 |
| Synchro-Medical TIGER TRACK Screw System (K151241) | Synchro Medical | 2015-08-07 |
| Digital Automatic Wrist Blood Pressure Monitor MD3200 (K151587) | Grandway Technology (Shenzhen) Limited | 2015-08-07 |
| STA R MAX (K151867) | Diagnostica Stago S.A.S | 2015-08-07 |
| syngo.MR Neurology, syngo.MR Oncology (K151353) | Siemens Medical Solutions USA, Inc. | 2015-08-07 |
| PerioType Rapid (K143758) | Clinical House Europe GmbH | 2015-08-07 |
| Urgoclean Ag, Antibacterial Absorbent Wound Dressing with Silver (K143017) | Laboratoires Urgo | 2015-08-07 |
| Selectra Catheters and Selectra Accessory Kit (K151409) | Biotronik, Inc. | 2015-08-07 |
| Precision Spine Interspinous Plate System (K151863) | Precision Spine, Inc. | 2015-08-07 |
| MicroTract Access System (K151877) | Arstasis, Inc. | 2015-08-07 |
| .decimal p.d (K151369) | .Decimal, LLC | 2015-08-07 |
| Wingman Crossing Catheter (K151880) | Reflow Medical | 2015-08-07 |
| Wondfo One Step HCG Urine Pregnancy Test Strip, Wondfo One Step HCG Urine Pregnancy Test Cassette, Wondfo One Step HCG Urine Pregnancy Test Midstream (K150022) | Guangzhou Wondfo Biotech Co., Ltd. | 2015-08-07 |
| Digital Automatic Wrist Blood Pressure Monitor MD3900 (K151583) | Grandway Technology (Shenzhen) Limited | 2015-08-07 |
| Confida Adaptive Sheath (K152054) | Medtronic, Inc. | 2015-08-07 |
| Assure Prism multi Blood Glucose Monitoring System (K151164) | I-Sens, Inc. | 2015-08-07 |
| Shielded Applicator Set, Cervical Stop (K151657) | Varian Medical Systems, Inc. | 2015-08-07 |
| LEECH, MEDICINAL (K140907) | Carolina Biological Supply Co. | 2015-08-07 |
| GAL-1F Blood Glucose Monitoring System, GAL-1F Pro Blood Glucose Monitoring System (K142689) | Apex BioTechnology Corp. | 2015-08-06 |
| Cornea Cold (K151061) | Eurobio | 2015-08-06 |
| NuVasive MLX-Medial Lateral Expandable Lumbar Interbody System, NuVasive AP Expandable XLIF System (K151374) | Nu Vasive, Incorporated | 2015-08-06 |
| Medline Foot Plates and Screws (K151235) | Medline Industries, Inc. | 2015-08-06 |
| VIKINI Diode Laser System (K151232) | Ilooda Co,., Ltd. | 2015-08-06 |
| EUM 100Pro (K150398) | Ob Tools, Ltd. | 2015-08-06 |
| Resolution Clip (K151802) | Boston Scientific Corporation | 2015-08-06 |
| VariAx 2 One-Third Tubular Plating System (K151879) | Stryker GmbH | 2015-08-06 |
| Elecsys CA-125 II assay (K143534) | Roche Professional Diagnostics | 2015-08-06 |
| ReDs Wearable System (K150095) | Sensible Medical Innovations , Ltd. | 2015-08-06 |
| Reveal LINQ (K150614) | Medtronic, Inc. | 2015-08-06 |
| Total Knee Application (TKA) (K143752) | Mako Surgical Corp. | 2015-08-06 |
| Penumbra System 110 Aspiration Tubing (K151623) | Penumbra, Inc. | 2015-08-06 |