| Invictus Medical GelShield (K150243) | Invictus Medical, Inc. | 2015-05-01 |
| Nuance FLOW (K143679) | Den-Mat Holdings, LLC | 2015-05-01 |
| Helio A7 Manual Wheelchair, Move Manual Wheelchair (K143101) | Motion Composites | 2015-05-01 |
| COVA MONITORING SYSTEM (K142087) | Tosense, Inc. | 2015-05-01 |
| Stryker MIS Attachments and Cutting Accessories (K143540) | Stryker Corporation | 2015-05-01 |
| INVISIPORT (K141146) | Stealth Therapeutics, Incorporated | 2015-05-01 |
| G7 Dual Mobility System (K150522) | Biomet, Inc. | 2015-05-01 |
| BNX Fine Needle Aspiration System and SharkCore LG Fine Needle Biopsy System (K150891) | Covidien, LLC( Formerly Beacon Endoscopic Corp.) | 2015-05-01 |
| Digital Dental Intra Oral Sensor, EzSensor Smart (K150797) | Rayence Co., Ltd. | 2015-05-01 |
| MERITS TRANSFORMER POWER SCOOTER, S941 (K142162) | Merits Health Products Co., Ltd. | 2015-05-01 |
| Terumo Pump Tubing (K150542) | Terumo Cardiovascular Systems Corporation | 2015-05-01 |
| Vaginal Moisturizing Gel (K150615) | Combe Incorporated | 2015-05-01 |
| Tablo Console with Wireless Capability (K150880) | Outset Medical | 2015-05-01 |
| BIOLENS Sphere (mangofilcon A) Soft (hydrophilic) Contact Lens for Daily Wear, BIOLENS Toric (mangofilcon A) Soft (hydrophilie) Contact Lens for Daily Wear, BIOLENS Multifocal (mangofilcon A) Soft (hydrophilic) contact lens for daily wear, BIOLENS Toric Multifocal (mangofilcon A) Soft (hydrophilic) contact lens for daily wear (K142820) | Abb Optical Group, LLC | 2015-04-30 |
| INCITE ANCHORED CERVICAL INTERBODY DEVICE (K150913) | Incite Innovation | 2015-04-30 |
| Mission Urinalysis Reagent Strips (Microalbumin/Creatinine) (K150330) | ACON Laboratories, Inc. | 2015-04-30 |
| XLR8 White Foam Dressing Kit and XLR8 White Foam Small Dressing Kit and (K142646) | Genadyne Biotechnologies, Inc. | 2015-04-30 |
| G3 Active Plate Large Fragment System (K150649) | Genesis Fracture Care, Inc. | 2015-04-30 |
| VALIDATE Anemia Calibration Verification/ Linearity Test Kit (K142964) | Maine Standards Company, LLC | 2015-04-30 |
| iTClamp50 (K150813) | Innovative Trauma Care, Inc. | 2015-04-30 |
| SILVERLON BURN CONTACT DRESSINGS (K150256) | Argentum Medical | 2015-04-30 |
| Vitaphone Tele ECG Loop Recorder (K151013) | Vitasystems GmbH | 2015-04-30 |
| ViSi Mobile Monitoring System (K150361) | Sotera Wireless, Inc. | 2015-04-30 |
| NaturalVue (etafilcon A) Daily Disposable Soft (Hydrophilic) Contact Lenses (K150385) | Visioneering Technologies, Inc. | 2015-04-30 |
| ApneaLink Air (K143272) | Resmed Germany, Inc. | 2015-04-30 |
| aap Cortical Screw 1.5, self-tapping, aap Cortical Screw 1.5, self-tapping, Titanium (K150974) | Aap Implantate AG | 2015-04-29 |
| Arthrex Plates, Screws, and Staples (K150456) | Arthrex, Inc. | 2015-04-29 |
| GenCut Core Biopsy System (K142839) | Covidien, LLC | 2015-04-29 |
| Republic Spine Dark Star Spinal System (K150283) | Republic Spine, LLC | 2015-04-29 |
| FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR (K141984) | Andon Health Co, Ltd. | 2015-04-29 |
| SMV Scientific 4.5 mm Bone Screws (K150188) | Summit Medventures | 2015-04-29 |
| IS4000 Small Clip Applier, IS4000 Long Bipolar Forceps (K150837) | Intuitive Surgical, Inc. | 2015-04-29 |
| ST'RIM (K142073) | Thiebaud Sas | 2015-04-29 |
| DARCO Locking Bone Plate System (K150520) | Wrightmedicaltechnologyinc | 2015-04-29 |
| RENASYS; EZ MAX Negative Pressure Wound Therapy; Foam NPWT Wound Dressing Kits with Soft Port; Gauze NPWT Wound Dressing Kits with Soft Port; EZ PLUS/EZ MAX Canisters (K142979) | Smith & Nephew, Inc. | 2015-04-29 |
| Cardinal Health External Fixation System (K150579) | Cardinalhealth | 2015-04-29 |
| ULTRA Telescopes (K150633) | Olympus Winter & Ibe GmbH | 2015-04-29 |
| HUDSON RCI ADDIPAK UNIT DOSE VIAL, 0.9% FULL NORMAL SALINE SOLUTION, 3ML;5ML;15ML (K142153) | Teleflexmedical, Inc. | 2015-04-29 |
| NuVasive(R) CCX-L Interbody System (K143595) | Nu Vasive, Incorporated | 2015-04-29 |
| OUTBACK Elite Re-Entry Catheter (K150836) | Cordis Corporation, A Johnson & Johnson Co. | 2015-04-29 |
| iCase Contact Lens Case (K143351) | Novabay Pharmaceuticals, Inc. | 2015-04-29 |
| Reliance Posterior Cervical-Thoracic System (K142867) | Reliance Medical Systems, LLC | 2015-04-29 |
| PHALINX Hammertoe System (K150252) | Wrightmedicaltechnologyinc | 2015-04-29 |
| Zavation Posterior LEIF (K142392) | Zavation, LLC | 2015-04-29 |
| BD FlowSmart Set (K150059) | Becton, Dickinson Company | 2015-04-28 |
| Visage Ease Pro (K142196) | Visage Imaging GmbH | 2015-04-28 |
| Facet-Link Stabilization Platform (K150223) | Facet-Link, Inc. | 2015-04-28 |
| S30/S40 Digital Color Doppler Ultraound System (K150045) | Sonoscape Company Limited | 2015-04-28 |
| CAS-One Liver (K143024) | Cascination AG | 2015-04-28 |
| Compex Wireless USA (K143551) | Djo, LLC | 2015-04-28 |
| JUSHA-M53 Medical Display (K150842) | Nanjing Jusha Display Technology Co., Ltd. | 2015-04-28 |
| KYPHON (R) HV-R(R) Bone Cement (K150460) | Medtronic Sofamor Danck USA, Inc. | 2015-04-28 |
| Streamline OCT Occipito-Cervico-Thoracic System (K150254) | Pioneer Surgical Technology, Inc. (Dba Rti Surgical, Inc.) | 2015-04-28 |
| Medline Enteral Feeding Sets (K150286) | Medline Industries, Inc. | 2015-04-27 |
| Codent Low Speed Dental Handpieces and Accessories (K150798) | Codent Technical Industry Co., Ltd. | 2015-04-24 |
| KI-20 (K141482) | Saeyang Microtech Co., Ltd. | 2015-04-24 |
| Luminesse PMMA (K142371) | Talladium, Inc. | 2015-04-24 |
| Lipofina Laser System (K143741) | Yolo Medical, Inc. | 2015-04-24 |
| YARLAP (K141643) | International Trade Group, Inc. | 2015-04-24 |
| Artoura Breast Tissue Expander (K150777) | Mentor Worldwide, LLC | 2015-04-24 |
| SILHOUETTE INSTALIFT (K142061) | Silhouette Lift, Inc. | 2015-04-24 |
| EndoTool SubQ (K142918) | Monarch Medical Technologies | 2015-04-24 |
| Healgen Secobarbital Test(Strip, Cassette, Cup, Dip Card), Healgen Burprenorphine Test (Strip, Cassette, Cup, Dip Card), Healgen Methadone Test (Strip, Cassette, Cup, Dip Card) (K150791) | Healgen Scientific,, LLC | 2015-04-24 |
| Flexible 19G EBUS Needle (K142909) | Spiration, Inc. | 2015-04-24 |
| syngo®.via (version VB10A) (K150843) | Siemens AG | 2015-04-24 |
| C3 Wave (K143238) | Medcomp ( Medical Components) | 2015-04-24 |
| Neuromaster G1 MEE200 (K142624) | Nihon Kohden Corporation | 2015-04-24 |
| SpineFrontier SIJFuse Sacroiliac Joint Fusion Device System (K150017) | Spinefrontier, Inc. | 2015-04-24 |
| Aespire View (K143530) | Datex-Ohmeda, Inc. | 2015-04-24 |
| HUMMINGBIRD(TM) TYMPANOSTOMY TUBE SYSTEM (TTS) (K142282) | Preceptis Medical | 2015-04-23 |
| IntraNovo 25 Microcatheter (K142817) | Texasmedical Technologies, Inc. | 2015-04-23 |
| PULSE OXIMETER CMS50EW (K141362) | Contec Medical Systems Co.,Ltd | 2015-04-23 |
| ConMed Mixing and Delivery Kit (K142535) | Conmed Corporation | 2015-04-23 |
| Galt Tork, 0.010 to 0.020 inches (yellow), Galt Tork, 0.025 to 0.040 inches (orange) (K143252) | Needle Tech Products, Inc. | 2015-04-23 |
| SOLSTICE OCT System (K142253) | Life Spine, Inc. | 2015-04-23 |
| Aequalis PerFORM+ Shoulder System (K150583) | Tornier, Inc. | 2015-04-23 |
| Zimmer Nexel Total Elbow Ulnar Cement Diverter (K150501) | Zimmer, Inc. | 2015-04-23 |
| Noblex Long Pulse Alexandrite Laser (K143666) | Finemec Co., Ltd. | 2015-04-23 |
| iBreastExam (K142926) | Ue Lifesciences, Inc. | 2015-04-23 |
| Nitrile Powder Free Examination Gloves (Orange) Tested For Use With Chemotherapy Drugs (K150103) | Hartalega Sdn Bhd | 2015-04-23 |
| Stryker Elite Attachments, Stryker Heavy Duty (HD) Attachments (K143320) | Stryker Corp. | 2015-04-23 |
| Nitrile Powder Free Examination Glove with Colloidal Oatmeal USP Skin Protectant - White, Nitrile Powder Free Examination Glove with Colloidal Oatmeal USP Skin Protectant - Dawn Blue, Nitrile Powder Free Examination Glove with Colloidal Oatmeal USP Skin Protectant - Dark Blue (DKBU), Nitrile Powder Free Examination Glove with Colloidal Oatmeal USP Skin Protectant - Dark Violet Blue (DVBU) (K150110) | Hartalega NGC Sdn. Bhd. | 2015-04-23 |
| INTERBODY CAGE (K140348) | Eisertech, LLC | 2015-04-23 |
| BHV VIVID (etafilcon A) Soft (Hydropholic) Contact Lens (K143280) | Brien Holden Vision Pty , Ltd. | 2015-04-23 |
| PRECICE Intramedullary Limb Lengthening System (K150656) | Ellipse Technologies, Incorporated | 2015-04-23 |
| STARBAND, STARLIGHT (K142141) | Orthomerica Products, Inc. | 2015-04-23 |
| Otowave 202 Portable Tympanometer (K150163) | Amplivox, Ltd. | 2015-04-23 |
| NICO TRIOwand (K150993) | Nico Corporation | 2015-04-23 |
| Neodent Implant System- CM Drive Implants (K150182) | Jjgc Industria E Comercio DE Materiais Dentarios S | 2015-04-23 |
| NuVasive Reline System (K143684) | Nu Vasive, Incorporated | 2015-04-23 |
| Jintronix (K143034) | Jintronix, Inc. | 2015-04-22 |
| Relieva SpinPlus Balloon Sinuplasty System (K143541) | Acclarent, Inc. | 2015-04-22 |
| Reverse Medical Micro Vascular Plug System (K150108) | Reverse Medical Corporation | 2015-04-22 |
| RAYSCAN A-EXPERT (K142058) | Ray Co., Ltd. | 2015-04-22 |
| ADVIA CENTAUR TSH (K141999) | Siemens Healthcare Diagnostics, Inc. | 2015-04-22 |
| CLEARSIGN II Amplifier, 40 channels, CLEARSIGN II Amplifier, 80 channels, CLEARSIGN II Amplifier, 120 channels, CLEARSIGN II Amplifer, 160 channels (K150235) | Boston Scientific Corporation | 2015-04-22 |
| LUNA CPAP AND AUTO-CPAP SYSTEM (K141770) | 3B Medical, Inc. | 2015-04-22 |
| VENUS Spinal Fixation System (K143363) | L&K BIOMED Co., Ltd. | 2015-04-22 |
| Tranberg CLS Thermal Therapy System (K142216) | Clinical Laserthermia Systems, AB | 2015-04-21 |
| IDS-iSYS Aldosterone,IDS iSYS Aldosterone Control Set, and IDS iSYS Aldosterone Calibration Verifiers (K142994) | Immunodiagnostic Systems , Ltd. | 2015-04-21 |