| CEDIA Buprenorphine II Assay; CEDIA Buprenorphine II Calibrators; CEDIA Negative Calibrator II; CEDIA Buprenorphine II Control Set (K163101) | Microgenics Corporation | 2017-04-06 |
| UNO Negative Pressure Wound Therapy System (K161599) | Genadyne Biotechnologies, Inc. | 2017-04-06 |
| MIVI 6F 25cm Mi-EXT Extension Catheter, MIVI 5F 25cm Mi-EXT Extension Catheter, MIVI 4F 30cm Mi-EXT Extension Catheter, MIVI 3F 43cm Mi-EXT Extension Catheter (K163233) | Mivi Neuroscience, Inc. | 2017-04-06 |
| Optiflux dialyzer (K162488) | Fresenius Medical Care North America | 2017-04-06 |
| Atellica CH Phencyclidine (Pcp) (K163220) | Siemens Healthcare Diagnostics, Inc. | 2017-04-06 |
| FlowKeepers (K160323) | Dk Electronics, LLC | 2017-04-06 |
| ViziShot 2 FLEX (K163469) | Olympus Surgical Technologies America | 2017-04-06 |
| 23andMe Personal Genome Service (PGS) Genetic Health Risk Test for Hereditary Thrombophilia (DEN160026) | 23AndMe, Inc. | 2017-04-06 |
| Leva Anterior Expandable Spacer System (K163246) | Spine Wave, Inc. | 2017-04-06 |
| NobleStitch EL (K162617) | Nobles Medical Technologies Ii, Inc. | 2017-04-06 |
| Dual Mode Infrared Thermometer (K163256) | Intelliworks, LLC | 2017-04-06 |
| Inqwire Diagnostic Guide Wire (K170700) | Merit Medical Systems, Inc. | 2017-04-06 |
| Howell Biliary Aspiration Needle (K153763) | Wilson-Cook Medical, Inc. | 2017-04-06 |
| Synapse 3D Perfusion Analysis (K162287) | Fujifilm Medical Systems U.S.A, Inc. | 2017-04-06 |
| AcQGuide Steerable Sheath (K162925) | Acutus Medical, Inc. | 2017-04-06 |
| IOLMaster 700 (K170171) | Carl Zeiss Meditec, AG | 2017-04-06 |
| POGO Automatic Blood Glucose Monitoring System (K162203) | Intuity Medical, Inc. | 2017-04-06 |
| Invia Foam Dressing Kits with FitPad, Invia Foam Dressing Kits with FitPad, Invia Gauze Dressing Kits with FitPad, Invia FitPad, Invia Transparent Film (K170088) | Medela AG | 2017-04-06 |
| XprESS ENT Dilation System (K163509) | Entellus Medical, Inc. | 2017-04-05 |
| TipControl RF INSTRUMENT BIPO Ø 2.5MM WL 280MM, TipControl RF INSTRUMENT BIPO Ø 2.5MM WL 350MM (K170377) | Richard Wolf Medical Instruments Corporation | 2017-04-05 |
| Anzai Respiratory Gating System (K170719) | Anzai Medical Co., Ltd. | 2017-04-05 |
| Neurovision Nerve Locator Monitor (Nerveana), EMGView Software (K170677) | Neurovision Medical Product, Inc. | 2017-04-05 |
| HeartSpan Steerable Sheath Introducer (K170668) | Merit Medical Systems, Inc. | 2017-04-05 |
| LIFESYS PACS (K161341) | Lifetrack Medical Systems, Inc. | 2017-04-05 |
| Reprocessed HARMONIC FOCUS Shears + Adaptive Tissue Technology (K170456) | Stryker Sustainability Solutions | 2017-04-05 |
| ExactechGPS Total Shoulder Application, Equinoxe Planning Software (K162567) | Blue Ortho | 2017-04-05 |
| Segment CMR (K163076) | Medviso AB | 2017-04-05 |
| Arm automatic blood pressure monitor (K161712) | Shenzhen Pump Medical System Co., Ltd. | 2017-04-05 |
| NILE Proximal Fixation Spinal System (K161332) | K2m, Inc. | 2017-04-05 |
| Nio Color 3MP (MDNC-3421) (K170837) | Barco N.V. | 2017-04-05 |
| IQon Spectral CT (K163711) | Philips Medical Systems (Cleveland), Inc. | 2017-04-05 |
| Entellus Medical Reinforced Anesthesia Needle (K163435) | Entellus Medical, Inc. | 2017-04-05 |
| AggreGuide A-100 AA Assay, AggreGuide A-100 Instrument (K163274) | Aggredyne, Inc. | 2017-04-05 |
| SurgTech Thoracolumbosacral (TLS) Posterior Fixation System (K163363) | Surgtech, Inc. | 2017-04-05 |
| C-Reactive Protein Kit for use on SPAPLUS (K161982) | The Binding Site Group | 2017-04-05 |
| UltraScan 650 (K161919) | Cyberlogic, Inc. | 2017-04-05 |
| Acuson SC2000 Diagnostic Ultrasound System (K170315) | Siemens Medi Cal Solutions, Inc. | 2017-04-04 |
| System, X-Ray, Extra oral Source, Digital, PaX-i Plus, PaX-i Insight (K170731) | VATECH Co., Ltd. | 2017-04-04 |
| BePOD Cannulated Arthrodesis Screws (K170040) | Fournitures Hospitalieres Industrie | 2017-04-04 |
| MX50N(MX50YQS) (K170781) | Wide Corporation | 2017-04-04 |
| ER-REBOA Catheter (K170411) | Prytime Medical Devices, Inc. | 2017-04-04 |
| Bluephase Style 20i (K163613) | Ivoclar Vivadent, AG | 2017-04-04 |
| Mazor X (K163221) | Mazor Robotics , Ltd. | 2017-04-04 |
| SAGE Vitrification Kit and SAGE Vitrification Warming Kit (K170560) | CooperSurgical, Inc. | 2017-04-04 |
| OsteoMed ExtremiFix Mid and Large Screw System (K163303) | Osteomed, LLC | 2017-04-04 |
| iHelmet Hair Growth System (K162782) | Slinph Technologies Co., Ltd. | 2017-04-04 |
| Zavation IBF (K162206) | Zavation, LLC | 2017-04-04 |
| OsteoMed PINNACLE Driver (K162544) | Osteomed | 2017-04-04 |
| Beta-CrossLaps CalCheck 5 (K170678) | Roche Diagnostics | 2017-04-04 |
| CD HORIZON™ Fenestrated Screw Set (K170347) | Medtronic Sofamor Danek USA | 2017-04-04 |
| Nihon Kohden Vital Sign Telemeter (K163459) | Nihon Kohden Corporation | 2017-04-04 |
| Zenysis Short-Term Dialysis Catheter (K163458) | C.R. Bard, Inc. | 2017-04-04 |
| ESTELITE BULK FILL Flow (K161353) | Tokuyama Dental Corporation | 2017-04-03 |
| TITAN 3-D™ Wedge System (K162241) | Paragon 28 | 2017-04-03 |
| AeroForm Tissue Expander (v3.0), AeroForm Dosage Controller (v1.5) (K170075) | Airxpanders, Inc. | 2017-04-03 |
| ASAHI PTCA, Peripheral, and Neurovascular Guide Wires, ASAHI Guide Wire Extension (K163426) | Asahi Intecc Co., Ltd. | 2017-04-03 |
| AC3 Series IABP System (K162820) | Arrow International, Inc. | 2017-03-31 |
| AMIStem-H Proximal Coating (K161635) | Medacta International S.A. | 2017-03-31 |
| Multibase Abutments EV and ATLANTIS Suprastructures (K163350) | Dentsply Sirona | 2017-03-31 |
| AMSCO V-PRO 1 Low Temperature Sterilization System, AMSCO V-PRO 1 Plus Low Temperature Sterilization System, V-PRO maX Low Temperature Sterilization System, V-PRO 60 Low Temperature Sterilization System (K162413) | STERIS Corporation | 2017-03-31 |
| Bakri Postpartum Balloon, Bakri Postpartum Balloon with Rapid Instillation Component (K170622) | Cook Incorporated | 2017-03-31 |
| BRIGHTWAY BRAND NITRILE EXAMINATION GLOVES 12”, POWDER FREE, [STERLING/GREY] WITH CHEMOTHERAPY CLAIM (K162186) | Brightway Holdings Sdn. Bhd. | 2017-03-31 |
| BioMonitor 2-AF, BioMonitor 2-S (K170628) | Biotronik, Inc. | 2017-03-31 |
| GPC BRAND Posterior, Non cervical Pedicle Screw Spinal System (K163096) | Gpc Medical Limited | 2017-03-31 |
| Autoclavable Suction Jar with Luer Lock extension - 250, 500, 1,000, 2,000 and 3,000 ml, Autoclavable Suction Jar without Luer Lock extension - 1,500 and 2,500 ml, Sterile 1,500 and 2,500 Lids with Conical patient connection 6-10 and overflow protection (K170449) | Millennium Medical Technologies, Inc. | 2017-03-31 |
| EnsoSleep (K162627) | Ensodata, Inc. | 2017-03-31 |
| SureSigns VS3; SureSigns VS4 (K163649) | Philips Medical Systems | 2017-03-31 |
| Great Basin Bordetella Direct Test (K170284) | Great Basin Scientific, Inc. | 2017-03-31 |
| Bluetooth blood pressure monitor (K161530) | Shenzhen Kingyield Technology Co., Ltd. | 2017-03-31 |
| Caphosol Artifical Saliva Tablets (K162167) | Eusa Pharma (Uk) Limited | 2017-03-31 |
| MEP Monitor (K162873) | Tonica Elektronik A/S | 2017-03-31 |
| Move Forward 3D Motion Simulation Service (K162559) | Biomet, Inc. | 2017-03-31 |
| LOSPA IS TLIF & DLIF Cages (K170243) | Corentec Co., Ltd. | 2017-03-31 |
| StealthStation S8 System Platforms and StealthStation Cranial Software (K162309) | Medtronic Navigation, Inc. | 2017-03-31 |
| Multichem IA Plus (K162530) | Techno-Path Manufacturing | 2017-03-31 |
| THERMOPLASTIC POLYETHYLENE EXAMINATION (TPE) GLOVE (K162626) | Top Quality Glove Sdn. Bhd | 2017-03-31 |
| ICONIX TT All Suture Anchor (K170098) | Stryker | 2017-03-31 |
| MultiPulse HoPLUS (K161257) | Asclepion Laser Technologies GmbH | 2017-03-31 |
| CX50N(CX50YQS) (K170783) | Wide Corporation | 2017-03-31 |
| Chameleon PTA Balloon Catheter (K170635) | Av Medical Technologies, Ltd. | 2017-03-30 |
| Parcus SLiK Anchors (K170327) | Parcus Medical | 2017-03-30 |
| Alians Clavicle range (K170310) | Newclip Technics | 2017-03-30 |
| Hach CM130 Chlorine Monitoring System (K162471) | Hach Company | 2017-03-30 |
| Esophageal Cooling Device (K170009) | Advanced Cooling Therapy, LLC | 2017-03-30 |
| AngioDynamics Total Abscession Biliary Drainage Catheter (K170743) | AngioDynamics, Inc. | 2017-03-30 |
| Ibis® Pedicle Screw System (K162995) | Ortho Development Corporation | 2017-03-30 |
| NuVasive(r) Monolith Corpectomy System (K170271) | Nu Vasive, Incorporated | 2017-03-30 |
| LUOFUCON Silicone Ag Foam Dressing with Border (K170077) | Huizhou Foryou Medical Devices Co., Ltd. | 2017-03-30 |
| VertebraLINK Fusion Platform (K162693) | Facetlink Dba Linkspine | 2017-03-29 |
| FLOW-i Anesthesia System C20, FLOW-i Anesthesia System C30, FLOW-i Anesthesia System C40 (K160665) | Maquet Critical Care AB | 2017-03-29 |
| Bodycad Unicompartmental Knee System (K163700) | Bodycad Laboratories, Inc. | 2017-03-29 |
| Brevera Biopsy System with Corlumina Imaging Technology (K163052) | Hologic, Inc. | 2017-03-29 |
| V-Grip Detachment Controller for use with Hydrocoil Embolic System and MicroPlex Coil System, AZUR Detachment Controller for use with AZUR Peripheral Coil System (K162999) | MicroVention, Inc. | 2017-03-29 |
| USS System (K170654) | Synthes USA Products, LLC | 2017-03-29 |
| ReliaTect Post-Op Dressing with CHG (8cm x 15cm), ReliaTect Post-Op Dressing with CHG (10cm x 25cm) (K163529) | Avery Dennison Corporation | 2017-03-29 |
| Synthes 4.5mm VA-LCP Curved Condylar Plate System Line Extension, Variable Angle Positioning Pins (K162124) | DePuy Synthes | 2017-03-29 |
| New Deantronics E Green™ Electrosurgical Monopolar Pencils (K170161) | New Deantronics Taiwan , Ltd. | 2017-03-29 |
| Palm-Pro Chemo-Guard Nitrile Powder Free Examination Glove (K161929) | Dipped Products (Thailand) Limited | 2017-03-29 |
| Foresight Intracardiac Echocardiology (ICE) System (K162789) | Conavi Medical, Inc. | 2017-03-28 |
| HS50 / HS60 Diagnostic Ultrasound System (K170493) | Samsung Medison Co., Ltd. | 2017-03-28 |