| Hybrid3D (K163394) | Hermes Medical Solutions AB | 2017-05-22 |
| Strep B Carrot Broth One-Step (K170586) | Hardy Diagnostics | 2017-05-22 |
| LT-300 SD Digital Video Colposcope (K170446) | Lutech Industries, Inc. | 2017-05-21 |
| Sol-Care Safety Blood Collection Needle with and without Pre-Attached Holder (K163073) | Sol-Millennium Medical, Inc. | 2017-05-19 |
| Stryker Universal Neuro III System AXS Screw (K171152) | Stryker | 2017-05-19 |
| DIVERGENCE-L ANTERIOR/OBLIQUE LUMBAR FUSION SYSTEM (K162212) | Medtronic Sofamor Danek USA, Inc. | 2017-05-19 |
| StealthStationTM S8 ENT Software (K170018) | Medtronic Navigation, Inc. | 2017-05-19 |
| Nihon Kohden QP-160AK EEG Trend Program (K163644) | Nihon Kohden Corporation | 2017-05-19 |
| OEC Elite (K170752) | Oec Medical Systems, Inc. | 2017-05-19 |
| PK AIM (K170908) | Gyrus Acmi, Inc. | 2017-05-19 |
| SLIT LAMP SL-2000 (K163564) | Nidek Co., Ltd. | 2017-05-19 |
| Thayer Medical LiteAire Dual-valved, Collapsible MDI Holding Chamber (K160109) | Thayer Medical Corporation | 2017-05-19 |
| BEAMSCAN (K161807) | Ptw-Freiburg Physikalisch Technische-Werksraetten | 2017-05-19 |
| OsteoMed PINNACLE Driver (K162542) | Osteomed | 2017-05-19 |
| BioPlex 2200 ToRC IgM, BioPlex 2200 ToRC IgM Calibrator Set, BioPlex 2200 ToRC IgM Control Set (K170509) | Bio-Rad Laboratories | 2017-05-19 |
| E5 Series Digital Color Doppler Ultrasound System (K170303) | Sonoscape Medical Corp. | 2017-05-19 |
| PIEZOTOME M+, PIEZOTOME M+ Handpiece (K163610) | Satalec-Acteon Group | 2017-05-19 |
| Catalys Precision Laser System (K170322) | Abbott Medical Optics, Inc. | 2017-05-19 |
| Eko Model E5 System (EME5), Eko DUO (K170874) | Eko Devices, Inc. | 2017-05-19 |
| AtriClip PRO, PRO2, and PRO V LAA Exclusion System devices with preloaded Gillinov-Cosgrove Clip (K163261) | AtriCure, Inc. | 2017-05-19 |
| Frova Intubating Introducer (K161813) | William Cook Europe Aps | 2017-05-19 |
| MICRORUPTOR 6 (K160677) | Meridian AG | 2017-05-19 |
| Lipogems System (K171135) | Lipogems International Spa | 2017-05-18 |
| HEALIX ADVANCE Anchor with PERMATAPE Suture (K170639) | Medos International SARL | 2017-05-18 |
| LaparoLight Veress Needle (K171139) | Buffalo Filter, LLC | 2017-05-18 |
| Barone Jejunostomy Catheter Set (K160567) | Cook Incorporated | 2017-05-18 |
| SmartByte Device (K171165) | Scientific Intake | 2017-05-18 |
| Tiger 2 Self-Advancing Nasal Jejunal Feeding Tube (K160509) | Cook Incorporated | 2017-05-18 |
| Supreme and Response Electrophysiology Catheters (K161272) | Surgical Instrument Service and Savings, Inc. | 2017-05-18 |
| bibag (K162716) | Fresenius Medical Care Renal Therapies Group, LLC | 2017-05-18 |
| The Solstice OCT System (K170804) | Life Spine, Inc. | 2017-05-18 |
| Vitamin D 200M Assay for the Topaz System (DEN170019) | Ab Sciex, LLC | 2017-05-18 |
| AirLife Misty Finity Nebulizer (K153748) | Care Fusion | 2017-05-17 |
| FREND PSA PLUS (reagent cartridge) (K162378) | Nanoentek USA, Inc. | 2017-05-17 |
| Test of Variables of Attention (T.O.V.A.) Version 9.0 (K170082) | The Tova Company | 2017-05-17 |
| A&D Medical UB-1100BLE UltraConnect Digital Blood Pressure Monitor (K170196) | A&D Company, Ltd. | 2017-05-17 |
| MRI Compatibility for Existing Zimmer Dental Implant Systems (K160398) | Zimmer Dental, Inc. | 2017-05-17 |
| QuantX (K170195) | Quantitative Insights, Inc. | 2017-05-17 |
| Dynamika (K161601) | Image Analysis Limited | 2017-05-17 |
| TinniLogic Mobile Tinnitus Management Device (K163094) | Jiangsu Betterlife Medical Co., Ltd. | 2017-05-17 |
| Humeris Shoulder (K163669) | Fx Solutions | 2017-05-17 |
| Nexus DR Digital X-ray Imaging System (K171138) | Varex Imaging Corporation | 2017-05-17 |
| Surefire Precision Infusion System (K171355) | Surefire Medical, Inc. | 2017-05-17 |
| Medisono Color Doppler Ultrasound System, models P11 Portable, P11 EXPERT Portable, P12 Trolley, P12 Expert, P25 Trolley, and P25 Expert Trolley (K170078) | Medisono, LLC | 2017-05-17 |
| Cardiac Trigger Monitor (K170828) | Ivy Biomedical Systems, Inc. | 2017-05-17 |
| iSR'obot Biopsy Kit (K163502) | Biobot Surgical Pte., Ltd. | 2017-05-16 |
| VerteFIT Corpectomy Cage System (K162133) | Ldr Spine USA, Inc. | 2017-05-16 |
| VITROS Immunodiagnostic Products Insulin Calibrators (K171168) | Ortho Clinical Diagnostics | 2017-05-16 |
| TRANSLACE™ Spinal Tethering System (K163181) | Medtronic Sofamor Danek USA, Inc. | 2017-05-16 |
| Disposable Powder Free Vinyl Exam Glove, Clear/Yellow (K170575) | Ever Global (Vietnam) Enterprise Corp | 2017-05-16 |
| Direxion and Direxion HI-FLO Torqueable Microcatheters (K163701) | Boston Scientific Corporation | 2017-05-16 |
| TEVADAPTOR Closed Drug Reconstitution and Transfer System (K170680) | Teva Medical Ltd., Migada Plant | 2017-05-16 |
| Strep B Carrot Broth Kit (K170481) | Hardy Diagnostics | 2017-05-16 |
| Kangaroo Feeding Tube with IRIS Technology (K163002) | Covidien (Dba Medtronic) | 2017-05-16 |
| A-View (K170338) | Stroke2prevent B.V. | 2017-05-16 |
| SIROLaser Advance+ (K170500) | Dentsply Sirona | 2017-05-16 |
| Xia® 3 Spinal System, Stryker Spine Power Adaptor Instrument Accessory (K170496) | Stryker Corporation | 2017-05-16 |
| Tyber Medical Wedge System (K171327) | Tyber Medical, LLC | 2017-05-16 |
| Arthrex Knotless SutureTak Anchor (K171020) | Arthrex, Inc. | 2017-05-16 |
| DSM Biomedical Dental Bone Graft (K170245) | Kensey Nash Corporation Dba Dsm Biomedical | 2017-05-16 |
| KARL STORZ ShuntScope (K170462) | KARL STORZ Endoscopy-America, Inc. | 2017-05-16 |
| EPIC Extremely Small Staple (K163226) | Epic Extremely, LLC | 2017-05-16 |
| SPiN Thoracic Navigation System (K170023) | Veran Medical Technologies, Inc. | 2017-05-15 |
| 3M Tegaderm CHG Chlorhexidine Gluconate I.V. Securement Dressing (K153410) | 3M Company | 2017-05-15 |
| ULTRASHAPE POWER SYSTEM (K170370) | Syneron Medical, Ltd. | 2017-05-15 |
| Dental 5 Multi Diode laser (K163638) | Bio-Med USA, Inc. | 2017-05-15 |
| PNEUMOCLEAR (K170784) | W.O.M. World of Medicine GmbH | 2017-05-15 |
| IPC systems, Legend EHS handpieces and Legend Stylus Touch handpiece, Microsaw handpieces,Triton electric high torque handpiece, Attachments and surgical dissecting tools (K170312) | Medtronic Powered Surgical Solutions | 2017-05-15 |
| EVS 2430W, EVS 2430GW (K171137) | DRTECH Corporation | 2017-05-15 |
| SS SA Fixture (K163557) | Osstem Implant Co., Ltd. | 2017-05-15 |
| Wondfo One Step Fecal Occult Blood (FOB) Test (K162333) | Guangzhou Wondfo Biotech Co., Ltd. | 2017-05-14 |
| Belimed Steam Sterilizer MST-H TOP 5000 (K170228) | Belimed AG | 2017-05-12 |
| GM85 (K171119) | Samsung Electronics Co., Ltd. | 2017-05-12 |
| iChemVELOCITY Automated Urine Chemistry System (K171083) | Iris Diagnostics, A Division of Iris International, Inc. | 2017-05-12 |
| Gems Geri Medium, Gems Fertilisation Medium, Gems Cleavage Medium, Gems Blastocyst Medium, Gems VitBase (K161261) | Genea Biomedx Pty, Ltd. | 2017-05-12 |
| Avazzia (K162392) | Avazzia, Inc. | 2017-05-12 |
| Piccolo Composite® Plate System (K170401) | CarboFix Orthopedics , Ltd. | 2017-05-12 |
| Unity Network ID (K170199) | GE Healthcare | 2017-05-12 |
| N Latex Cystatin C; N Protein Standard UY (K171072) | Siemens Healthcare Diagnostics Products GmbH | 2017-05-12 |
| AIK Sterile Acupuncture Needles for Single Use (K162566) | Changchun Aik Medical Devices Co., Ltd. | 2017-05-11 |
| Common Type Insulin Pen Needle, Safety Type Insulin Pen Needle (K161950) | Promisemed Hangzhou Meditech Co., Ltd. | 2017-05-11 |
| TREFOIL System (K170135) | Nobel Biocare AB | 2017-05-11 |
| GORE SYNECOR Preperitoneal Biomaterial (K163576) | W. L. Gore & Associates, Inc. | 2017-05-11 |
| Mako Total Knee Application (K170581) | Mako Surgical Corp. | 2017-05-11 |
| Winner Transfer Wheelchair (K162328) | Winner SG Pte, Ltd. | 2017-05-11 |
| A-dec NLZ Electric Motor System (K163131) | Nakanishi, Inc. | 2017-05-11 |
| UniTex Non-Sterile, Powder-Free, Latex Examination Glove (K161961) | Ug Global Resources Sdn. Bhd. | 2017-05-11 |
| ANTHEM CR Total Knee System (K170648) | Smith & Nephew, Inc. | 2017-05-11 |
| SurgiCase Viewer (K170419) | Materialise NV | 2017-05-11 |
| Connector System (K170647) | Orthofix, Inc. | 2017-05-11 |
| BioPlex 2200 Syphilis Total & RPR, BioPlex 2200 Syphilis Total & RPR Calibrator Set, BioPlex 2200 Syphilis Total & RPR Control Set (K170413) | Bio-Rad Laboratories | 2017-05-11 |
| Solana C. difficile Assay (K170491) | Quidel Corporation | 2017-05-11 |
| Arthrex Compression Screws (K170382) | Arthrex, Inc. | 2017-05-11 |
| Low-Frequency Therapy Instrument /Model: KTR-201, KTR-202, KTR-203 (K170205) | Shenzhen Kentro Medical Electronics Co., Ltd. | 2017-05-11 |
| Lung Vision (K163622) | Bodyvision Medical , Ltd. | 2017-05-11 |
| Longitudinal Brain Imaging (LoBI) application (K163250) | Philips Medical Systems Nederland B.V. | 2017-05-11 |
| GMR40 (K171085) | Neurologica Corporation, A Subsidiary OF | 2017-05-11 |
| Active Needle Endoscopic Treatment (ANET) Electrosurgical Applicator (K170990) | Spiration, Inc. | 2017-05-11 |
| Kitazato IUI Catheter (K162667) | Kitazato Corporation | 2017-05-11 |
| Fully Automatic Electronic Blood Pressure Monitor (K163276) | Andon Health Co, Ltd. | 2017-05-11 |