| Hedgehog Cervical Interbody Fusion Device (K143685) | Vertera, Inc. | 2015-09-23 |
| Sydney IVF PVP (K152440) | Willam A. Cook Australia Pty, Ltd. | 2015-09-23 |
| iHealth View BP7S Wireless Blood Pressure Wrist Monitor (K152379) | Andon Health Co, Ltd. | 2015-09-23 |
| ImmuLisa Enhanced RF IgA Antibody ELISA, ImmuLisa Enhanced RF IgG Antibody ELISA, ImmuLisa Enhanced RF IgM Antibody ELISA, ImmuLisa Enhanced RF Antibody Screen ELISA (K143736) | Immco Diagnostics, Inc. | 2015-09-23 |
| Contour Next Control Solution (K151742) | Bayer Healthcare | 2015-09-23 |
| CrossRoads Screw System (K152072) | Crossroads Extremity Systems, LLC | 2015-09-23 |
| Uberlube (K151647) | Uberlube, LLC | 2015-09-23 |
| Universal Light Handle Cover, Light Handle Cover (K150532) | Key Surgical, Inc. | 2015-09-22 |
| ZELTIQ CoolSculpting System (K151179) | Zeltiq Aesthetics, Inc. | 2015-09-22 |
| Destino Reach (K151951) | Oscor, Inc. | 2015-09-22 |
| Permanent Sled Bag (K152403) | Boston Scientific | 2015-09-22 |
| HEARTWAY Power Mobility Scooter, BRIO S19 (K150987) | Heartway Medical Products Co., Ltd. | 2015-09-22 |
| Hummingbird Tympanostomy Tube (K151830) | Preceptis Medical | 2015-09-21 |
| Hyflex Heavy, Hyflex Mono, Hyflex Light (K151262) | Osstem Implant Co., Ltd. | 2015-09-21 |
| Simplexa Flu A/B & RSV Direct and Simplexa Flu A/B & RSV Positive Control Pack (K152408) | Focus Diagnostics, Inc. | 2015-09-21 |
| ZelanteDVT Thrombectomy Set (K151313) | Boston Scientific Corporation | 2015-09-21 |
| OsteoMed IMF Screw (K151195) | Osteomed | 2015-09-21 |
| QUANTA Flash CCP3, QUANTA Flash CCP3 Calibrators, and QUANTA Flash CCP3 (K143754) | Inova Diagnostics, Inc. | 2015-09-21 |
| Ceramill Zolid FX (K152383) | Emergo Europe Consulting | 2015-09-21 |
| Phoenix XL Dialysate Meter (K150657) | Mesa Laboratories, Inc. | 2015-09-21 |
| Chameleon PTA Balloon Catheter (K151678) | Av Medical Technologies, Ltd. | 2015-09-21 |
| Anker Dental Implant System - SB-III, ST and AT series (K142557) | Alliance Global Technology Co., Ltd. | 2015-09-21 |
| ACUSON NX3 Elite / NX3 Diagnostic Ultrasound System (K152469) | Siemens Medical Solutions, Inc., Ultrasound Division | 2015-09-21 |
| Prestige (K151514) | Danville Materials, LLC | 2015-09-21 |
| Hi-Torque Command 18 Guide Wire (K152404) | Abbott Vascular | 2015-09-21 |
| AVERT Contrast Modulation System;AVERT Contrast Modulation System;AVERT Contrast Modulation System (K152218) | Osprey Medical | 2015-09-21 |
| CARESTREAM Vue Motion (K151774) | Carestream Health, Inc. | 2015-09-21 |
| TM eCloud ECG Analysis System (K142349) | Telemed Solutions, Inc. | 2015-09-21 |
| Telio CAD Abutment Solutions (K151564) | Ivoclar Vivadent, AG | 2015-09-21 |
| Eclipse Treatment Planning System (K152393) | Varian Medical Systems, Inc. | 2015-09-18 |
| iLab Ultrasound Imaging System (K152316) | Boston Scientific | 2015-09-18 |
| Sensiflex Plus Sterile Latex Green Surgical Glove Powder Free with Protein Content Labeling Claim with 50ug/dm2 or less (K151392) | Terang Nusa Sdn Bhd | 2015-09-18 |
| BRUSH&BOND PLUS (K151518) | Parkell, Inc. | 2015-09-18 |
| AF541 SE Full Face Mask (K150638) | Respironics, Inc. | 2015-09-18 |
| Dimension Vista MMB Assay (K143720) | Siemens Healthcare Diagnostics | 2015-09-18 |
| ECHO 2.0 LAP SYSTEM with VENTRALIGHT ST MESH (K143743) | C.R. Bard, Inc. | 2015-09-18 |
| STARband, STARlight (K151979) | Orthomerica Products, Inc. | 2015-09-18 |
| Recovr Rehabilitation System (K151446) | Recovr,Inc | 2015-09-18 |
| AF541 EE Full Face Mask (K150639) | Respironics, Inc. | 2015-09-18 |
| CoStorSol plus G (K151728) | Preservation Solutions, Inc. | 2015-09-18 |
| PROPEL device (K150392) | Propel Orthodontics, LLC | 2015-09-18 |
| Rapidfret Oral Fluid Assay for Methamphetamine, Rapidfret Oral Fluid Methamphetamine Calibrators, Rapidfret Oral Fluid Methamphetamine Controls (K142293) | Biophor Diagnostics, Inc. | 2015-09-18 |
| Clinpro Varnish (K151302) | 3M Company | 2015-09-18 |
| Spirit (K143696) | Pelton & Crane | 2015-09-18 |
| Thoratec CentriMag Drainage (Venous) Cannula Kit (K152190) | Thoratec Corporation | 2015-09-18 |
| Circumplast Circumcision Device (K151095) | Novadien Healthcare | 2015-09-18 |
| DeVilbiss Intellipap2/DeVilbiss BLUE (K143677) | Devilbiss Healthcare, LLC | 2015-09-18 |
| Thoratec CentriMag Return (Arterial) Cannula Kit (K152161) | Thoratec Corporation | 2015-09-18 |
| Nitrile Powder Free Examination Glove with Low Dermatitis Potential Claim(Blue) (K151684) | Hartalega NGC Sdn. Bhd. | 2015-09-18 |
| Cirona 6300 Disposable Deep Vein Thrombosis (DVT) Prevention System (K151189) | Devon Medical Products | 2015-09-18 |
| Export Advance Aspiration Catheter (K152335) | Medtronic, Inc. | 2015-09-18 |
| Radifocus Glidewire Endoscopic Wire (K151471) | Terumo Medical Corporation | 2015-09-17 |
| LDR Spine ROI-C Cervical Cage System (K150765) | Ldr Spine USA | 2015-09-17 |
| LifePearl Microshperes (K150958) | MicroVention, Inc. | 2015-09-17 |
| FreeStyle InsuLinx Blood Glucose Monotioring System (K152328) | Abott Laboratories | 2015-09-17 |
| DEFENDO Bronchoscopy Suction Valve (K151522) | Medivators, Inc. | 2015-09-17 |
| Everest Spinal System (K151727) | K2m, Inc. | 2015-09-17 |
| ODALYS Pedicle Screw System (K152098) | Kisco International | 2015-09-17 |
| KSEA CMOS Camera System (C-cam) (K143640) | KARL STORZ Endoscopy-America, Inc. | 2015-09-17 |
| LeForte System II (K150965) | Jeil Medical Corporation | 2015-09-17 |
| BodyGuardian Remote Monitoring System (K151188) | Preventice | 2015-09-17 |
| New Deantronics Smoke Evacuation Adapter with 10mm connector. New Deantronics Smoke Evacuation Adapter with 22mm connector. New Deantronics Button Switch Electrosurgical Pencil with SA01 Adapter. New Deantronics Button Switch Electrosurgical Pencil with SA02 Adapter. (K152031) | New Deantronics Taiwan , Ltd. | 2015-09-17 |
| Reliance Spinal Screw System (K152131) | Reliance Medical Systems, LLC | 2015-09-17 |
| SmartLinx Vitals Plus Patient Monitoring System (K151071) | Capsule Technologie Sas | 2015-09-17 |
| RECON system - MPJ-Plates (K152142) | Normed Medizin-Technik GmbH | 2015-09-16 |
| MicroScan Dried Gram Positive MIC/Combo Panels - Vancomycin (0.25-64 ug/mL) (K152346) | Beckman Coulter, Inc. | 2015-09-16 |
| Hisense 2MP/3MP LCD Monitor (HMD2C21/HMD3C21) (K152030) | Qingdao Hisense Medical Equipment Co., Ltd. | 2015-09-16 |
| ArgenIS Titanium Abutments (K143051) | The Argen Corporation | 2015-09-16 |
| Partial Knee Application (PKA) (K142530) | Mako Surgical Corporation | 2015-09-16 |
| XP3000 (K150720) | BTL Industries, Inc. | 2015-09-16 |
| SupaScoota Motorized vehicle (K143557) | Eurogreen International, Inc. | 2015-09-16 |
| Gynomunal (K143349) | Polichem S.A | 2015-09-16 |
| Ackermann Intervertebral Body Fusion Device (K143450) | Ackermann Instrumente GmbH | 2015-09-16 |
| syngo VSim (K151887) | Siemens Medical Solutions USA, Inc. | 2015-09-16 |
| Radio Therapy Treatment Chair (K150382) | Radiation Products Design, Inc. | 2015-09-16 |
| ELUMI 810 + 980 Soft Tissue Laser (K152032) | Azena Medical, LLC | 2015-09-16 |
| OTSC Proctology (K150067) | Ovesco Endoscopy AG | 2015-09-16 |
| Straumann CARES Titanium Alloy (TAN) Abutment (K150899) | Straumann USA, LLC | 2015-09-16 |
| Ergoline, Sun Angel, Soltron, Sundash and Palm Beach Tan Sunlamp Products (K151400) | Jk Holding GmbH | 2015-09-16 |
| Biodesign Otologic Repair Graft (K150594) | Cook Biotech Incorprated | 2015-09-16 |
| Ultrasound Scanner System bk2300 (K152052) | Bk Medical Aps | 2015-09-16 |
| Rhythm View Workstation (non-streaming, steaming option) (K151245) | Topera, Inc. | 2015-09-15 |
| VITALA PORCINE DERIVED COLLAGEN MEMBRANE (K141177) | Osteogenics Biomedical, Inc. (Formerly Obi Biologi | 2015-09-15 |
| Apex Medical Corp. iCH CPAP with PVA 9S-007XXX Series (K150111) | Apex Medical Corp. | 2015-09-15 |
| G.o.c.c.l.e.s. (K151630) | Pierrel Pharma S.R.L. | 2015-09-15 |
| Occlusion Perfusion Catheter (K151554) | Advanced Catheter Therapies, Inc. | 2015-09-15 |
| CO2RE System (K151655) | Syneron Medical, Ltd. | 2015-09-15 |
| SuPro 100 (K151144) | 3M Deutschland GmbH | 2015-09-14 |
| Premium Surgiclip¿; Endo Clip¿; AcuClip¿ (K143644) | Covidien | 2015-09-14 |
| Powder Free Nitrile Examination Glove (K151208) | Vrg Khai Hoan Joint Stock Company | 2015-09-14 |
| MAMMOMAT Fusion (K151645) | Siemens Medical Solutions USA, Inc. | 2015-09-14 |
| LOGIQ E9, LOGIQ E9 XDClear 2.0 (K152309) | GE Medical Systems Ultrasound and Primary Care Diagnostics | 2015-09-14 |
| XEROSTOM SALIVA SUBSTITUTE GEL (K142657) | Bio Cosmetics, S.L. | 2015-09-14 |
| KleenGel Dispenser (K143177) | Kleengel, LLC | 2015-09-14 |
| Straumann Variobase for CEREC (K151324) | Straumann USA, LLC | 2015-09-11 |
| CT Sim Laser System (K152303) | Gammex, Inc. | 2015-09-11 |
| AQUA CLEANSE (K150381) | Quality Medical Supply, Inc. | 2015-09-11 |
| Tissue Removal System (K151990) | Boehringer Laboratories, LLC | 2015-09-11 |
| QuickPlan (K151560) | Siris Medical | 2015-09-11 |
| J+PRAS YOUNG'S Thread (K143413) | Y. Jacobs Medical, Inc. | 2015-09-11 |