| Non-Sterile, Powder Free Nitrile Examination Gloves, Tested for use with Chemotherapy Drugs (Original Blue, Cobalt Blue) (K162095) | Yty Industry (Manjung) Sdn Bhd | 2016-11-02 |
| Reprocessed Inquiry Optima Plus Steerable Diagnostic EP Catheter, Reprocessed Inquiry Optima Steerable Diagnostic EP Catheter (K160421) | Innovative Health, LLC | 2016-11-02 |
| CARDIOLINE touchECG (K160746) | Cardioline S.P.A | 2016-11-02 |
| Durepair Dura Regeneration Matrix (K161370) | Medtronic Neurosurgery | 2016-11-02 |
| T-PAL Spacer System, T-PAL Titanium Spacer System, SYNFIX Evolution System (K162358) | Synthes USA Products, LLC | 2016-11-01 |
| Xario 200 Diagnostic Ultrasound System V5.0 (K162155) | Toshibamedical Systems Corporation | 2016-11-01 |
| Z-Box/Z-Tilt Breast and Thoracic Positioning Device, Z-Square Indexing System, Z-Foam, Z-Bar Index Bar, Z-Pulls Patient Hand Grip Overlay (K162002) | Zdi, Solutions, LLC | 2016-11-01 |
| AVAmax Vertebral Balloon, AVAflex Vertebral Balloon (K162062) | Stryker Corporation | 2016-11-01 |
| 13G InterV Kyphoplasty Catheter (Micro) and 11G InterV Kyphoplasty Catheter (Mini-Flex) (K162453) | Pan Medical , Ltd. | 2016-11-01 |
| Initia Total Hip System & BIOCERAM AZUL(R) HEAD (K160895) | Kyocera Medical Corporation | 2016-11-01 |
| Propeller Sensor Model 2015-E (K161454) | Reciprocal Labs Corporation | 2016-11-01 |
| Anatomical Shoulder Domelock Dome centric (K161620) | Zimmer GmbH | 2016-11-01 |
| SLENDERTONE® Connect Abs, Type 570 (K161974) | Bio-Medical Research, Ltd. | 2016-11-01 |
| BreathID Hp Lab System (K162150) | Exalenz Bioscience , Ltd. | 2016-10-31 |
| Pleurx Pleural Catheter System (K160450) | Care Fusion | 2016-10-31 |
| Footmotion Plating System (K161448) | Newclip Technics | 2016-10-31 |
| Squirt Fluid Delivery System (K162777) | Merit Medical Systems, Inc. | 2016-10-31 |
| Unger Quad Injector (K161483) | Stradis Healthcare | 2016-10-31 |
| Glass Ionomer Cement (Luting) (K161851) | Shandong Huge Dental Material Corporation | 2016-10-31 |
| miraDry System (K160141) | Miramar Labs, Inc. | 2016-10-31 |
| AxoGuard Nerve Connector (K162741) | Cook Biotech Incorporated | 2016-10-31 |
| Disposable Pressure Transducer (K152472) | Zhejiang Haisheng Medical Device Co., Ltd. | 2016-10-31 |
| FlexStim Neurostimulation Electrodes Model Numbers: 5050ROC1S, 5050ROC1W, 5050ROC2S, 5050ROC2W, 5050SQC1S, 5050SQC1W, 5050SQC2S, 5050SQC2W (K161282) | Medico Electrodes International , Ltd. | 2016-10-30 |
| PaX-i3D Green Premium (Model: PCT-90LH) (K160882) | VATECH Co., Ltd. | 2016-10-28 |
| FRAXIS DUO (K160312) | Ilooda Co,., Ltd. | 2016-10-28 |
| FIREFLY® Pedicle Screw Navigation Guide (K162419) | Mighty Oak Medical, Inc. | 2016-10-28 |
| Sonata Breastpump Deluxe, Sonata Warranty Breastpump, Double pumping Tubing Kit, retail, Connector spare parts kit, Silicone Membrane, retail, Power Adaptor, retail (K161725) | Medela, Inc. | 2016-10-28 |
| Tuohy NRFit (K160297) | PAJUNK GmbH Medizintechnologie | 2016-10-28 |
| Arterys Software v2.0 (K162513) | Arterys, Inc. | 2016-10-28 |
| ELEOS Limb Salvage System (K161520) | Onkos Surgical, Inc. | 2016-10-28 |
| ClearVision ExamVue Flat Panel Detector (K160143) | Jpi Healthcare, Inc. | 2016-10-28 |
| Gammex Cut-Resistant Glove Liner (K160974) | Ansell Healthcare Products, LLC | 2016-10-28 |
| SeaSpine Spacer System- Hollywood NanoMetalene, Hollywood VI NanoMetalene, Ventura NanoMetalene; SeaSpine Cambria NanoMetalene (K162715) | SeaSpine Orthopedics Corporation | 2016-10-28 |
| Klassic Knee System (K162422) | Total Joint Orthopedics, Inc. | 2016-10-28 |
| Codman EDS3 CSF External Drainage System (K162437) | Codman & Shurtleff, Inc. | 2016-10-28 |
| Dental Implants and Abutments (K161497) | Ditron Precision, Ltd. | 2016-10-28 |
| Cutera enlighten III Laser System (K160488) | Cutera, Inc. | 2016-10-28 |
| Link Abutment for CEREC (K160519) | Osstem Implant Co., Ltd. | 2016-10-28 |
| BD MAX Vaginal Panel, BD MAX Instrument (DEN160001) | Geneohm Sciences Canada, Inc. (Bd Diagnostics) | 2016-10-28 |
| Xonrid Gel (K152533) | Helsinn Healthcare SA | 2016-10-28 |
| Klassic Femur, Porous, Klassic Tibial Baseplate, Porous (K162256) | Total Joint Orthopedics, Inc. | 2016-10-27 |
| ColpoWave™ Colpotomizer and CerviGrip™ Uterine Manipulator (K161065) | Surgitools Pty , Ltd. | 2016-10-27 |
| SPROTTE SPECIAL NRFit (K160296) | PAJUNK GmbH Medizintechnologie | 2016-10-27 |
| Torcon NB Advantage Catheters (K161822) | Cook Incorporated | 2016-10-27 |
| SemiCut Semi-automatic Biopsy Needle, Themy Automatic Disposable Biopsy Device, Palium Automatic Reusable Biopsy Device, EasyCut Semi-automatic Biopsy Needle, MDL Biopsy and Coaxial Introducer Needles (K160316) | M.D.L. S.R.L. | 2016-10-27 |
| SPROTTE NRFit, Quincke NRFit (K160295) | PAJUNK GmbH Medizintechnologie | 2016-10-27 |
| CorPath GRX System (K160121) | Corindus, Inc. | 2016-10-27 |
| MaxBlend 2, MaxBlend Lite (K161718) | Maxtec, LLC | 2016-10-27 |
| HemosIL D-Dimer HS (K160885) | Instrumentation Laboratory CO | 2016-10-27 |
| Libra Pedicle Screw System (K162750) | Spinal Balance, Inc. | 2016-10-27 |
| EdgeOne CO2 Laser (K162169) | Jeisys Medical, Inc. | 2016-10-27 |
| Erisma® LP MIS (K162367) | Clariance, Sas | 2016-10-27 |
| Smart External Drain (SED) System (K161605) | Aqueduct Critical Care, Inc. | 2016-10-27 |
| ETIII SA Fixture System (O3.2mm) (K153332) | Hiossen, Inc. | 2016-10-27 |
| NanoBone SBX Putty (K161351) | Artoss GmbH | 2016-10-26 |
| REFINITY Rotational IVUS Catheter, REFINITY Rotational IVUS Catheter, Short Tip (K160583) | Volcano Corporation | 2016-10-26 |
| NeuroBlate System (K162762) | Monteris Medical, Inc. | 2016-10-26 |
| Reprocessed Orbiter ST Steerable Diagnostic EP Catheter (K161393) | Innovative Health, LLC | 2016-10-26 |
| Multichem A1c (K162514) | Technopath Manufacturing | 2016-10-26 |
| PLEX Elite 9000 SS-OCT (K161194) | Carl Zeiss Meditec, Inc. | 2016-10-26 |
| FortiBridge Anterior Cervical Plate System (K162250) | Nanovis Spine, LLC | 2016-10-26 |
| NuVasive CoRoent Small Ti-C System (K162138) | Nu Vasive, Incorporated | 2016-10-26 |
| Zimmer M/L Taper Hip Prosthesis (K161830) | Zimmer, Inc. | 2016-10-26 |
| CODMAN VersaTru Standard Disposable Non-Stick Bipolar Forceps, CODMAN VersaTru Slim Disposable Non-Stick Bipolar Forceps (K162469) | Medos International SARL | 2016-10-26 |
| G-scan Brio, S-scan (K161973) | Esaote, S.p.A. | 2016-10-25 |
| Solana Strep Complete Assay (K162274) | Quidel Corporation | 2016-10-25 |
| Biograph Horizon PET/CT and Biograph mCT PET/CT and Biograph mCT Flow PET/CT (K162736) | Siemens Medical Solutions USA, Inc. | 2016-10-25 |
| truFreeze System (K162695) | CSA Medical, Inc. | 2016-10-25 |
| chromID MRSA (K162076) | bioMerieux, Inc. | 2016-10-25 |
| Tempo Temporary Pacing Lead (K160260) | Biotrace Medical, Inc. | 2016-10-25 |
| t:slim Insulin Delivery System, t:flex Insulin Delivery System, Tandem Device Updater (K162080) | Tandem Diabetes Care, Inc. | 2016-10-25 |
| KATOR Suture Anchor (K162386) | Kator, LLC | 2016-10-25 |
| vRad PACS with Mammography (K162145) | Virtual Radiologic Corporation | 2016-10-25 |
| NIRO-200NX DP (K162117) | Hamamatsu Photonics K.K. | 2016-10-25 |
| CLEARFIL Universal Bond Quick Bottle Standard Kit, CLEARFIL Universal Bond Quick Bottle Refill, CLEARFIL Universal Bond Quick Bottle Value pack (K161042) | Kuraray Noritake Dental, Inc. | 2016-10-25 |
| PowerPICC Provena Catheters (K162443) | C.R. Bard, Inc. | 2016-10-25 |
| syngo.via RT Image Suite (K162370) | Siemens Medical Solutions USA, Inc. | 2016-10-25 |
| Relieva UltirraNav Sinus Balloon Catheter (K161698) | Acclarent, Inc. | 2016-10-24 |
| Acclarent NavWire Sinus Navigation Guidewire (K161697) | Acclarent, Inc. | 2016-10-24 |
| Standard Clamp (K161720) | Standard Bariatrics | 2016-10-24 |
| Caremed patient cable and leadwires (K153188) | Shenzhen Caremed Medical Technology Co., Ltd. | 2016-10-24 |
| Visco (olifilcon A) soft contact lens (K160245) | Visco Vision, Inc. | 2016-10-24 |
| CARTO ENT System (K161701) | Biosense Webster | 2016-10-24 |
| Capo Hybrid, Capo Slow Flow, Capo Flow, Capo Natural, Capo Universal, Nano Paq, Nano Paq Flow (K151399) | Schutz Dental GmbH | 2016-10-24 |
| Ahmed Glaucoma Valve (K162060) | New World Medical, Inc. | 2016-10-24 |
| Automatic Arm Bluetooth Blood Pressure Monitor (K161846) | Truly Instrument Limited | 2016-10-24 |
| NeoSpan Compression Staple Impant w/instruments (K161426) | In2bones USA, LLC | 2016-10-24 |
| TRAcelet Compression Device (K162027) | Medtronic Vascular | 2016-10-21 |
| Ambient HipVac 50 Wand with Integrated Finger Switches (K161481) | ArthroCare Corporation | 2016-10-21 |
| KJ Mini Implant System (K151970) | Kj Meditech Co., Ltd. | 2016-10-21 |
| Saview-Colors Aqua 42 UV (hefilcon A) Soft (Hydrophilic) Contact Lens, Saview-Colors Aqua 42 UV Toric (hefilcon A) Soft (Hydrophilic) Contact Lens, Saview-Colors Aqua 42 UV Multifocal (hefilcon A) Soft (Hydrophilic) Contact Lens (K162317) | St. shine Optical Co., Ltd. | 2016-10-21 |
| Xenco Medical Cervical Interbody System (K160313) | Xenco Medical, LLC | 2016-10-21 |
| Artemis (K162474) | Eigen | 2016-10-21 |
| Paragon 2 (K162687) | Meridian Medical Systems, LLC | 2016-10-21 |
| CapsoCam Plus (SV-3) Capsule Endoscope System (K161773) | CapsoVision, Inc. | 2016-10-21 |
| Lucid M1 Transcranial Doppler Ultrasound System (Lucid M1 System) with 2MHz Transducers (K160442) | Neural Analytics, Inc. | 2016-10-21 |
| Gentrix Surgical Matrix (K162554) | Acell, Inc. | 2016-10-21 |
| MAGEC® Spinal Bracing and Distraction System (K160352) | Nuvasive Specialized Orthopedics, Inc. | 2016-10-21 |
| SPROTTE NRFit, Quincke NRFit Lumbar Puncture needles (K160294) | PAJUNK GmbH Medizintechnologie | 2016-10-21 |
| Automated Immunoassay System HISCL -800, HISCL TSH Assay Kit, HISCL TSH Calibrator, HISCL Immuno Multi Control (K160541) | Sysmex America, Inc. | 2016-10-21 |