| Normal Saline Flush (K150143) | Nurse Assist, Inc. | 2015-08-31 |
| ANAM Test System: Military Battery (K150154) | Vista Lifesciences, Inc. | 2015-08-28 |
| Eko Electronic Stethoscope System (K151319) | Eko Devices, Inc. | 2015-08-28 |
| Arthrex Fracture Plates (K151732) | Arthrex, Inc. | 2015-08-28 |
| Fingertip Pulse Oximeter (K151206) | Beijing Choice Electronic Technololgy Co., Ltd. | 2015-08-28 |
| UTAH CVX-RIPE (K143424) | Utah Medical Products, Inc. | 2015-08-28 |
| NuVasive Sterilization Trays (K143579) | Nu Vasive, Incorporated | 2015-08-28 |
| Dantec DCN Disposable Concentric Needle Electrodes-25mm, Dantec DCN Disposable Concentric Needle Electrodes-37mm, Dantec DCN Disposable Concentric Needle Electrodes-50mm, Dantec DCN Disposable Concentric Needle Electrodes-75mm (K143433) | Natus Manufacturing Limited | 2015-08-28 |
| S8 Exp/S9 Pro Portable Digital Color Doppler Ultrasound System (K152164) | Sonoscape Medical Corp. | 2015-08-28 |
| Optilite CH50 Reagent, Optilite CH50 Controls and Optilite CH50 Calibrator (K150412) | The Binding Site Group , Ltd. | 2015-08-28 |
| IcePearl 2.1 CX Cryoablation Needle, IcePearl 2.1 CX Prostate Cryoablation Kit Visual-ICE System, IceFORCE 2.1 CX Cryoablation Needle, IceFORCE 2.1 CX Prostate Cryoablation Kit Visual-ICE System (K152133) | Galil Medical , Ltd. | 2015-08-28 |
| Menicon Saline Rinse Solution (K151768) | Menicon Co, Ltd. | 2015-08-28 |
| VIA 21 Microcatheter (K150894) | Sequent Medical, Inc. | 2015-08-28 |
| PDO Absorbable Punctum Plug (K150288) | Riverpoint Medical | 2015-08-28 |
| Simplexa HSV 1 & 2 Direct, Simplexa HSV 1 & 2 Positive Control Pack (K150962) | Focus Diagnostics | 2015-08-28 |
| Sensititre 18-24 hours MIC or BP Susceptibility System with Ceftolozane/tazobactam (0.03/4- 64/4ug/mL) (K150556) | Thermo Fisher Scientific | 2015-08-28 |
| DMRC Bulk Fill (K151088) | Danville Materials, LLC | 2015-08-28 |
| Reprocessed Electrophysiology Diagnostic Catheters (K150357) | Sterilmed, Inc. | 2015-08-27 |
| Rezum System (K150786) | Nxthera, Inc. | 2015-08-27 |
| 16 ch Tx/Rx Knee SPEEDER (K151753) | Quality Electrodynamics, LLC | 2015-08-27 |
| DSS Sinusplasty Balloon Catheter (K143738) | Intuit Medical Products, LLC | 2015-08-27 |
| Respire Pink Series-Herbst-EF (K150572) | Respire Medical Holding | 2015-08-27 |
| PRCT2 (K143721) | Fx Solutions | 2015-08-27 |
| Advanced Perfusion System 1 (K151349) | Terumo Cardiovascular Systems Corporation | 2015-08-27 |
| CARDIOLINE HD+ (K150289) | Cardioline S.P.A | 2015-08-27 |
| SenSmart Model 8203CA Regional Oximetry Sensor (Adult/Pediatric, >40 kg, SenSmart Model 820CA Regional Oximetry Sensor (Adult/Pediatric, >40 kg) (K151305) | Nonin Medical, Inc. | 2015-08-27 |
| 5.5 F Worley Advanced LVI Lateral Vein Introducer (K152116) | Merit Medical Systems, Inc. | 2015-08-27 |
| COOK Sydney IVF Blastocyst Vitrification Kit, COOK Sydney IVF Blastocyst Warming Kit (K143724) | William A. Cook Australia Pty. , Ltd. | 2015-08-27 |
| Implanova (K150040) | Dental Evolutions, Inc. | 2015-08-27 |
| ProLite Mesh, ProLite Ultra Mesh, ProLoop Mesh Plug (K151437) | Atrium Medical Corporation | 2015-08-27 |
| JAZZ System (K151740) | Implanet, S.A. | 2015-08-27 |
| RxG Distraction System (K150771) | KLS Martin L.P. | 2015-08-27 |
| Pruitt F3-S Carotid Shunt (K143454) | LeMaitre Vascular, Inc. | 2015-08-27 |
| Optilite FreeLite Kappa Free Kit, Optilite Freelite Lambda Free Kit (K150658) | The Binding Site Group , Ltd. | 2015-08-26 |
| EDLENi Intra-Oral Sensor (K150823) | Edlen Imaging, LLC | 2015-08-26 |
| EAGLE EYE PLATINUM CATHETER, EAGLE EYE PLATINUM SHORT TIP CATHETER, VISIONS PV .014 PLATINUM (K143701) | Volcano Corporation | 2015-08-26 |
| UltraTENS (K142976) | Shenzhen Dongdixin Technology Co., Ltd. | 2015-08-26 |
| BioZorb LP Marker (K152070) | Focal Therapeutics | 2015-08-26 |
| PEEK Customized Cranial Implant, PEEK Customized Cranial Implant Priority (K152076) | Stryker | 2015-08-26 |
| ActiSpec Activity Monitor (K143512) | Sleep Modus, Inc. | 2015-08-26 |
| Weck Auto Endo5 Hem-o-lok Ligating Clip Applier (K152081) | Teleflexmedical, Inc. | 2015-08-26 |
| NovaBone MacroFORM MIS Composite - 2.5cc, NovaBone MIS Cartridge Delivery System (cartridge handle only) (K152071) | Novabone Products, LLC | 2015-08-26 |
| AveCure Microwave Coagulation-Ablation Generator, AveCure Microwave Large Antenna-Probe, AveCure Microwave Medium Antenna-Probe, AveCure Microwave Small Antenna-Probe, AveCure Microwave Mini Antenna-Probe (K143203) | Medwaves Incorporated | 2015-08-26 |
| S9 Portable Digital Color Doppler Ultrasound System (K152165) | Sonoscape Medical Corp. | 2015-08-26 |
| LINK® MEGASYSTEM-C® (K151008) | Waldemar Link GmbH & Co. KG | 2015-08-26 |
| GDH Professional Blood Glucose Monitoring System and GDH Professional LED Blood Glucose Monitoring System (K150274) | Infopia Co, Ltd. | 2015-08-26 |
| BioGuard Air/Water Valve, BioGuard Suction Valve (K151345) | United States Endoscopy Group, Inc. | 2015-08-25 |
| Zekang Self-adhesive Electrode (K150971) | Jiangsu Zekang Medical Technology Co., Ltd. | 2015-08-25 |
| Nuocande Plastic Manual Wheelchair Model NKD L07 (K151797) | Ningbo Lecount Medical Technology Co., Ltd. | 2015-08-25 |
| Retraction Aspirator (K152097) | Inari Medical | 2015-08-25 |
| Acuzone Acupuncture Needles, KSC DB Plus Acupuncture Needles (K142760) | K.S. Choi Corporation | 2015-08-25 |
| BD MAX Enteric Parasite Panel, BD MAX Instrument (K143648) | Becton, Dickinson and Company | 2015-08-25 |
| 25-Hydroxy Vitamin Ds EIA (K142351) | Immunodiagnostic Systems , Ltd. | 2015-08-25 |
| Nitrile Powder Free Examination Gloves Tested for Use with Chemotherapy Drugs (white, blue, orange) (K151343) | Hartalega NGC Sdn. Bhd. | 2015-08-24 |
| Skynector CPAP Mask (K150685) | Sky Wise Medical Instrument (Shen Zhen) Co., Ltd. | 2015-08-24 |
| LED Curing Light (K150205) | Monitex Industrial Co., Ltd. | 2015-08-24 |
| SALVATION® External Fixation System (K152045) | Wrightmedicaltechnologyinc | 2015-08-21 |
| Reform Pedicle Screw System (K151422) | Precision Spine, Inc. | 2015-08-21 |
| GranOSTM - beta tricalcium phosphate synthetic bone granules (K143692) | Tcm Associates, Ltd. | 2015-08-21 |
| UltraSmooth Lubricating Liquid, and Medline Lubricating Liquid and Vaginal Moisturizer (K143529) | Medline Industries, Inc. | 2015-08-21 |
| LightStim for Pain LED Belt (K151333) | Led Intellectual Properties, LLC | 2015-08-21 |
| Capillus82 (K151516) | Capillus, LLC | 2015-08-21 |
| STERISPINE LC CAGE (K151756) | Safe Orthopaedics | 2015-08-21 |
| PANAVIA V5: Standard Kit (Universal (A2)), Standard Kit (Clear), Introductory Kit (Universal (A2)), Introductory Kit (Clear), Sample Pack (Universal (A2)), Paste (Universal (A2)), Paste (Clear), Paste (Brown (A4)), Paste (White), Paste (Opaque), Try-in Paste (Universal (A2)), Try-in Paste (Clear), Try-in Paste (Brown (A4)), Try-in Paste (White), Try-in Paste (Opaque), Tooth Primer (K150704) | Kuraray Noritake Dental, Inc. | 2015-08-21 |
| SynePure Wound Cleanser (K143444) | Synedgen, Inc. | 2015-08-21 |
| Lifelines iEEG (K143487) | Kvikna Ehf | 2015-08-21 |
| BC-3600 Auto Hematology Analyzer (K143348) | Mindray Bio-Medical Electronics Co., Ltd. | 2015-08-21 |
| SYNFIX Evolution Secured Spacer System (K150673) | Synthes (USA) Products, LLC | 2015-08-21 |
| CS 8100SC, CS8100SC Access (K151087) | Trophy | 2015-08-21 |
| UCP Drug Test Mini Cups (K151213) | Ucp Biosciences, Inc. | 2015-08-21 |
| STRYKER INFRARED ILLUMINATION SYSTEM (IRIS) [AIM Light Source and IRIS Ureteral Kit] (K151243) | Stryker Endoscopy | 2015-08-20 |
| Turbo High-Flow Non-coring Needle (K151341) | Norfolk Medical | 2015-08-20 |
| OC-Light S FIT (K143325) | Eiken Chemical Co., Ltd. | 2015-08-20 |
| HealthMyne PACS (K152186) | Healthmyne, Inc. | 2015-08-20 |
| Arthrex DX SwiveLock SL with Forket Eyelet 3.5 x 8.5mm, Arthrex DX SwiveLock Suture Anchor, 3.5 x 13.5mm (K150648) | Arthrex, Inc. | 2015-08-20 |
| Fujifilm Double Balloon Endoscopes Models EN-530T and EN-580T (K143556) | Fujifilm Medical Systems U.S.A, Inc. | 2015-08-20 |
| Natrelle 133 Plus Tissue Expander (K143354) | Allergan, Inc. | 2015-08-20 |
| Frontier Medical Devices Posterior Cable Screw System (K151346) | Frontier Medical Devices, Inc. | 2015-08-20 |
| Pirouette 018 (K151153) | Arravasc Limited | 2015-08-20 |
| HA Minuteman G3 MIS Fusion Plate (K151741) | Spinal Simplicity, LLC | 2015-08-20 |
| Laparoscope Lens Shield Device (K151117) | Medeon Biodesign, Inc. | 2015-08-20 |
| PREVENA INCISION MANAGEMENT SYSTEM WITH PEEL & DRESSING, PREVENA INCISION MANAGEMENT SYSTEM WITH CUSTOMIZABLE DRESSING, (K141017) | Kci USA, Inc. (Kinetic Concepts, Inc.) | 2015-08-20 |
| Cascadia Interbody System (K150481) | K2m, Inc. | 2015-08-20 |
| FUJIFILM SonoSite X-Porte Ultrasound System (K152209) | FUJIFILM Sonosite, Inc. | 2015-08-19 |
| CS 3D Imaging (K151837) | Trophy | 2015-08-19 |
| Corporate Dental Imaging (CDI) Application (K151371) | U.S. Army Dental Command (Dencom) | 2015-08-19 |
| ManipulatOR PRO, ManipulatOR (K150519) | Gynetech Pty. , Ltd. | 2015-08-19 |
| STM 9000 Basic, STM 9000 Standard, STM 9000 Fast, STM 9000 Ultra-Fast (K150220) | Eb Neuro S.P.A. | 2015-08-19 |
| Cook ECM Powder (K152033) | Cook Biotech Incorporated | 2015-08-19 |
| ScandiDos Delta4 Phantom+ (K151180) | Scandidos AB | 2015-08-19 |
| TraceIT Tissue Marker - 3mL (K151998) | Augmenix, Inc. | 2015-08-19 |
| Instru-Safe Instrument Protection System (K151166) | Summit Medical, Inc. | 2015-08-18 |
| LnK Lumbar Interbody Fusion Cage System (K151140) | L&K BIOMED Co., Ltd. | 2015-08-18 |
| Full Automatic (NIBP)Blood Pressure Monitor (K150311) | Health & Life Co., Ltd. | 2015-08-18 |
| OsteoSelect PLUS Demineralized Bone Matrix Putty (K150621) | Bacterin International, Inc. | 2015-08-18 |
| Volk Disposable Iridotomy Lens, Volk Disposable Capsulotomy Lens (K151961) | Volk Optical, Inc. | 2015-08-18 |
| SterilContainer S (K143729) | Aesculap, Inc. | 2015-08-18 |
| Healgen Propoxyphene Test (Strip, Cassette, Cup, Dip Card), Healgen Nortriptyline Test (Strip, Cassette, Cup, Dip Card), Healgen EDDP (Methadone Metabolite) Test (Strip, Cassette, Cup, Dip Card) (K151348) | Healgen Scientific,, LLC | 2015-08-18 |
| NON-STERILE, POWER FREE NITRILE EXAMINATION GLOVES-ORANGE, GREEN, BLUE AND VIOLET COLOR (K143289) | Yty Industry (Manjung) Sdn Bhd | 2015-08-18 |
| Nexus Suture (K151009) | Baylis Medical Company, Inc. | 2015-08-18 |