| Polychloroprene Powder-free Surgical Glove (White) Tested for Use with Chemotherapy Drugs; Polychloroprene Powder-free Surgical Glove (Green) Tested for Use with Chemotherapy Drugs (K142190) | Pt. Medisafe Technologies | 2015-07-14 |
| Microlife Wrist Watch Blood Pressure Monitor (K151330) | Microlife Intellectual Property GmbH, Switzerland | 2015-07-14 |
| Shiley Adult Flexible Tracheostomy Tube Cuffless, Reusable Inner Cannula, Shiley Adult Flexible Tracheostomy Tube with TaperGuard Cuff, Reusable Inner Cannula (K150844) | Covidien | 2015-07-14 |
| Integre Pro Scan Green, Integre Pro Scan Yellow, Integre Pro Scan Red-Green, Integre Pro Scan Red-Yellow (K142398) | Ellex Medical Pty, Ltd. | 2015-07-14 |
| InFill Interbody Fusion Devices (K151184) | Pinnacle Spine Group, LLC | 2015-07-14 |
| Pyrenees Cervical Plate System (K150983) | K2m | 2015-07-14 |
| Rapid Hair Removal Pads (K150349) | Full Power Aed | 2015-07-14 |
| Nautilus Spinal System (K151196) | Life Spine, Inc. | 2015-07-14 |
| EVOS Lumbar Interbody System (K150321) | Cutting Edge Spine, LLC | 2015-07-13 |
| ArgenZ Esthetic Plus (K150919) | The Argen Corporation | 2015-07-13 |
| Aura DR 43C-AG flat panel detector (K151014) | Abyzr Co., Ltd. | 2015-07-13 |
| Argyle¿ Polyvinyl Chloride (PVC) and Kangaroo¿ Polyurethane (PU) Neonatal and Pediatric Feeding Tubes with ENFit connector (K150084) | Covidien | 2015-07-13 |
| Neodent Implant System (K150367) | Jjgc Industria E Comercio DE Materiais Dentarios S | 2015-07-13 |
| Vitrea Software Toshiba Package, VSTP-001A (K151091) | Toshibamedical Systems Corporation | 2015-07-13 |
| Stealth Monitor, Stealth Docking Cable, Stealth DSD Software Installation Disk, Stealth System (K142468) | Cardiac Insight, Inc. | 2015-07-11 |
| The Simple Locking IntraMedullary (SLIM) System (K143355) | Pega Medical, Inc. | 2015-07-10 |
| HARMONIC Focus Long Shears + Adaptive Tissue Technology (K151340) | Ethicon Endo-Surgery, LLC | 2015-07-10 |
| Atrax Anterior Cervical Plating System (K150834) | X-Spine Systems, Inc. | 2015-07-10 |
| IOLMaster700 (K143275) | Carl Zeiss Meditec, Inc. | 2015-07-10 |
| Aeroneb USB Contoller System (K143719) | Aerogen Limited | 2015-07-10 |
| Penumbra Smart Coil (K151572) | Penumbra, Inc. | 2015-07-10 |
| Houva-NET Control System (K150912) | National Biological Corporation | 2015-07-10 |
| SpineFab Vertebral Body Replacement (VBR) System (K142005) | Oxford Performance Materials | 2015-07-10 |
| CONTAFLEX 54 (hioxifilcon D) Spherical Soft Contact Lens for Daily Wear, CONTAFLEX 49 (hioxifilcon B) Spherical Soft Contact Lens for Daily Wear, (K150590) | Contamac, Ltd. | 2015-07-10 |
| Abbott ARCHITECT Total T4 Calibrators (K151566) | Abbott Laboratories | 2015-07-10 |
| INOmax DSIR Plus MRI (K143213) | Ino Therapeutics/Ikaria | 2015-07-10 |
| SIGNA Pioneer (K143345) | Ge Healthcare Japan Corporation | 2015-07-10 |
| Aplio 500/400/300 Diagnostic Ultrasound System V6.0 (K151451) | Toshibamedical Systems Corporation | 2015-07-09 |
| GraftMax Button, ALB with Cradle, GraftMax Button, BTB with Cradle (K151037) | Conmed Corporation | 2015-07-09 |
| BONGOLD BONE GRAFT MATERIAL (K141725) | Beijing Allgens Medical Science & Technology Co, L | 2015-07-09 |
| KYOLING CPR Mask with Oxygen Port and Without Oxygen Port (K142764) | Hangzhou Jinlin Medical Appliances Co., Ltd. | 2015-07-09 |
| EndoLIF On-Cage (K151143) | Joimax GmbH | 2015-07-09 |
| VIDAS H. pylori IgG, VIDAS 3, VIDAS Lyme IgG II, VIDAS RUB IgG, VIDAS TOXO M, VIDAS Human Chorionic Gonadotropin, VIDAS T4, VIDAS Testosterone, VIDAS TSH, and VIDAS D-Dimer Exclusion II (K141133) | BIOMERIEUX | 2015-07-09 |
| OIC Intramedullary Nail System (K150655) | Orthopaedic Implant Company | 2015-07-09 |
| Ablation Confirmation (K150313) | Neuwave Medical, Inc. | 2015-07-09 |
| StarCeram® Z-Nature, StarCeram® Z-Smile (K143656) | H.C. Starck Ceramics GmbH | 2015-07-09 |
| Penguin In-Line Warmer (K150484) | Creche Innovations | 2015-07-09 |
| Powder Free Vinyl Patient Examination Gloves, Yellow Color (K143340) | Zibo Ling Yun Medical Products Co, Ltd. | 2015-07-09 |
| Leva Spacer System (K151581) | Spine Wave, Inc. | 2015-07-09 |
| OASYS(r) System (K151755) | Stryker Corporation | 2015-07-09 |
| Model BT-220L and BT-220C (K142799) | Bistos Co., Ltd. | 2015-07-09 |
| NavSuite3 Kit (K150301) | Stryker Leibinger GmbH & Co. KG - Navigation | 2015-07-08 |
| JO H20 Water Based Personal Lubricant (K150480) | United Consortium, Inc. | 2015-07-08 |
| I-Portal NOTC, VNG and VOG (K143607) | Neuro Kinetics, Inc. | 2015-07-08 |
| ELITech Clinical Systems ELICAL 2, ELITech Clinical Systems ELITROL I, ELITech Clinical Systems ELITROL II (K151552) | Elitechgroup | 2015-07-08 |
| SmartTwist MRII Hand Drill, SmartTip MRII Drill bit Kit, 4.5mm, 6.0mm (K151536) | Mri Interventions, Inc. | 2015-07-08 |
| EXPAZEN (K150423) | Produits Dentaires Pierre Rolland (Acteon Group) | 2015-07-08 |
| Arrow Endurance Extended Dwell Peripheral Catheter System (K151513) | Arrow Internation, Inc. (Subsidiary of Teleflex Inc.) | 2015-07-08 |
| SterilContainer S System (K142970) | Aesculap, Inc. | 2015-07-08 |
| Monaco (K151233) | Impac Medical Systems, Inc. | 2015-07-07 |
| Reform Pedicle Screw System (K150856) | Precision Spine, Inc. | 2015-07-07 |
| iBond Universal & iBond Ceramic Primer (K150933) | Heraeus Kulzer, LLC, Mitsui Chemicals Group | 2015-07-07 |
| CardioChek Plus Test System (K151530) | Polymer Technology Systems, Inc. | 2015-07-07 |
| Coldplay Full CryoBalloon Ablation System and Coldplay Swipe CryoBalloon Ablation System (K151054) | C2 Therapeutics, Inc. | 2015-07-07 |
| Disposable Safety Self-destructive Syringes, 5 ML (K143070) | Jiangsu Yile Medical Article Co., Ltd. | 2015-07-07 |
| ANGIO-PRESS DVT Compression Device Model Name: IPCS (K143202) | Pegasus Medical Supply, Inc. | 2015-07-07 |
| mcompass Biofeedback Anorectal Manometry System (K143031) | Medspira, LLC | 2015-07-07 |
| Ellipse Nordlys/Ellipse Nordlys+, Ellipse Sirius, Ellipse Infinity, Ellipse Mjolner, Ellipse Nordlys Ultra (K150907) | Ellipse A/S | 2015-07-07 |
| ST.A.R. 90 F4 External Fixation Screws With Hydroxyapatite (K150661) | Citieffe S.R.L. | 2015-07-07 |
| Firebird Spinal Fixation System/Phoenix MIS Spinal Fixation System (K151488) | Orthofix, Inc. | 2015-07-07 |
| Graft Delivery Device with Integrated Stylet (K151543) | Micromedics, Inc. (D/B/A Nordson Medical) | 2015-07-07 |
| LeadCare Plus Blood Lead Testing System (K142705) | Magellan Diagnostics | 2015-07-07 |
| Dentrix Ascend Imaging (K151438) | Realcloud Imaging, Inc. | 2015-07-07 |
| Hypervisor IX Monitoring System (K150632) | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 2015-07-06 |
| Electronic Pulse Stimulator (K150995) | Shenzhen Jingkehui Electronic Co.., Ltd. | 2015-07-06 |
| Armada 18 PTA Catheter (K151317) | Abbott Vascular | 2015-07-06 |
| FUJIFILM Endoscope Models EC-600HL and EC-600LS (K143732) | Fujifilm Medical Systems U.S.A, Inc. | 2015-07-06 |
| HemosIL D-Dimer HS (K151534) | Instrumentation Laboratory CO | 2015-07-06 |
| Lariat snare (K151197) | United States Endoscopy Group, Inc. | 2015-07-06 |
| Endo 6:1, T1 Line Endo 6 L, SIRONiTi Apex, T1 Spray (K150750) | Sirona Dental Systems GmbH | 2015-07-02 |
| ST AIA-PACK SHBG, ST AIA-PACK SHBG Calibrator Set (K143075) | Tosoh Bioscience, Inc. | 2015-07-02 |
| Arthrex Corkscrew and SwiveLock Suture Anchors (K143745) | Arthrex, Inc. | 2015-07-02 |
| Biodenta Customized Abutment-Hybrid (K150296) | Biodenta Swiss AG | 2015-07-02 |
| ECVUE Mapping System (K150990) | Cardioinsight Technologies, Inc. | 2015-07-02 |
| VersaOne Bladed Trocar, VersaOne Bladeless Trocar (K151548) | Covidien | 2015-07-02 |
| Theranos Herpes Simplex Virus-1 IgG Assay (K143236) | Theranos, Inc. | 2015-07-02 |
| MicroScan Dried Gram Positive MIC/Combo Panels with vancomycin (0.25-64 mcg/mL) (K150039) | Siemens Healthcare Diagnostics, Inc. | 2015-07-02 |
| AUTOMATIC BLOOD PRESSURE MONITOR (K140762) | Jawon Medical Co., Ltd. | 2015-07-02 |
| CARDIOSAVE Hybrid Intra-Aortic Balloon Pump (K151254) | Datascope Corp. | 2015-07-02 |
| LTM-Perforated Surgical Mesh (K150712) | Lifecell Corporation | 2015-07-02 |
| STRATAFIX Spiral PDS Plus Knotless Tissue Control Device (K150670) | ETHICON, Inc. | 2015-07-02 |
| BruxZir Anterior Milling Blanks (K150872) | Prismatik Dentalcraft, Inc. | 2015-07-02 |
| 3M Comply Indicator Tape for Ethylene Oxide (EO) Sterilization (K150477) | 3M Company | 2015-07-02 |
| SpeediCath Compact Eve (K150935) | Coloplast A/S | 2015-07-02 |
| PLEURX PLEURAL CATHETER SYSTEM, PLEURX CATHETER ACCESS KIT (K141965) | Care Fusion | 2015-07-02 |
| Admira Fusion (K150784) | Voco GmbH | 2015-07-02 |
| Tosama 100% Organic Cotton Menstrual Tampon (K151170) | Tosama, D.O.O. | 2015-07-02 |
| Suture Wires and Wire Loops (K150889) | Zimmer, Inc. | 2015-07-01 |
| STARband, STARlight (K151147) | Orthomerica Products, Inc. | 2015-07-01 |
| SILKPRO laser hair removal system (K142845) | Wuhan Lotuxs Technology Co., Ltd. | 2015-07-01 |
| ASFORA ANTERIOR CERVICAL PLATE SYSTEM (K143688) | Medical Designs, LLC | 2015-07-01 |
| CyberKnife M6 FI Sytem, CyberKnife M6 FM System, CyberKnife M6 FIM System (K150873) | Accuray Incorporated | 2015-07-01 |
| Fetal & Maternal Monitor, models F6, F6 Express, F9, F9 Express (K150901) | Edan Instruments, Inc. | 2015-07-01 |
| SculpSure (K150724) | Cynosure, Inc. | 2015-07-01 |
| CastleLoc-P Anterior Cervical Plate System (K143271) | L&K BIOMED Co., Ltd. | 2015-07-01 |
| Wondfo CR3 Keyless Split Sample Cup (K151478) | Guangzhou Wondfo Biotech Co., Ltd. | 2015-07-01 |
| EN Snare Endovascular Snare System (K151497) | Merit Medical Systems, Inc. | 2015-07-01 |
| Magellan Robotic System, Magellan Robotic Catheter 10Fr (K143227) | Hansen Medical, Inc. | 2015-07-01 |
| COMPASS (K150320) | Centervue S.P.A. | 2015-06-30 |
| V60 Anesthetic Vaporizer (K150167) | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 2015-06-30 |