| System, Applicator, Radionuclide, Remote Controlled (K170203) | Kobold, LLC | 2017-06-01 |
| Celesteion, PCA-9000A/3 (K170490) | Toshibamedical Systems Corporation | 2017-06-01 |
| syngo Dynamics Version VA30 (K171053) | Siemens Healthcare GmbH | 2017-06-01 |
| Carbon Dioxide Reagent Set (K170200) | Teco Diagnostics, Inc. | 2017-06-01 |
| ARCHITECT B.R.A.H.M.S PCT, ARCHITECT B.R.A.H.M.S PCT Calibrators, ARCHITECT B.R.A.H.M.S PCT Controls (K170652) | Fisher Diagnostics | 2017-06-01 |
| PowerGlide ST Midline Catheter (K170158) | C.R. Bard, Inc. | 2017-06-01 |
| MATISSE Anterior Cervical Interbody Fusion Cage System (K162682) | Ctl Medical Corporation | 2017-06-01 |
| OARtrac System with Patient Specific Reusable Universal PSD Sensors (K162954) | Radiadyne, LLC | 2017-06-01 |
| GTK Disposable Needle Guides (K170741) | Geotek Medikal Ltd Sti | 2017-06-01 |
| ALLY(TM) Bone Screws (K170698) | Providence Medical Technology, Inc. | 2017-05-31 |
| B R A H M S PCT sensitive KRYPTOR (K171338) | Brahms GmbH | 2017-05-31 |
| Etest Ceftolozane/ Tazobactam (0.016-256 ug/ml) (K170670) | bioMerieux, Inc. | 2017-05-31 |
| Orthodontic Acrylic 2 (K163482) | Lang Dental Manufacturing Co., Inc. | 2017-05-31 |
| Empowr CR Knee Tibial Insert (K170573) | Encore Medical L.P. | 2017-05-31 |
| SL 220 (K162684) | Carl Zeiss Meditec, AG | 2017-05-31 |
| Infusion Set for Single Use (K162601) | Shinva Ande Healthcare Apparatus Co., Ltd. | 2017-05-31 |
| EMS100 Tri-Wave Combination Stimulator (K171387) | Elite Medical Supply of New York, LLC | 2017-05-31 |
| Reverse 021 Micro Catheter, Reverse 027 Micro Catheter (K171268) | Micro Therapeutics, Inc. d/b/a ev3 Neurovascular | 2017-05-31 |
| Acuity 58 (Enflufocon B) Rigid Gas Permeable Contact Lens (K170007) | Acuity Polymers, Inc. | 2017-05-31 |
| EndoWrist Stapler 45 System and Stapler 45 Reloads (K171388) | Intuitive Surgical, Inc. | 2017-05-31 |
| OptiFix AT Absorbable Fixation System with Articulating Technology - 30 Fasteners, OptiFix AT Absorbable Fixation System with Articulating Technology - 15 Fasteners (K170278) | C.R. Bard, Inc. | 2017-05-31 |
| Modified Alma Lasers Soprano XL Family of Multi-Application & Multi-Technology Platform, Soprano YAG Hand piece (K170626) | Alma Lasers, Inc. | 2017-05-31 |
| Lympha Press Optimal Plus (K170658) | Mego Afek AC , Ltd. | 2017-05-31 |
| 27HJ713S (K170899) | Lg Electronics | 2017-05-30 |
| QLAB Advanced Quantification Software (K171314) | Philips Health Care | 2017-05-30 |
| AmCAD-US (K162574) | Amcad Biomed Corporation | 2017-05-30 |
| gammaCore-S (K171306) | Electrocore, LLC | 2017-05-30 |
| Aplio i900/i800/i700 Diagnostic Ultrasound System, V2.1 (K163702) | Toshibamedical Systems Corporation | 2017-05-30 |
| ARIETTA PRECISION (K163505) | Hitachi , Ltd. | 2017-05-30 |
| TRINITY/3D PROSTATE SUITE (K170521) | Koelis | 2017-05-30 |
| Portable ECG Monitor (K170954) | Contec Medical Systems Co.,Ltd | 2017-05-30 |
| FilmArray Respiratory Panel 2 (RP2) (K170604) | Biofire Diagnostics, LLC | 2017-05-30 |
| VenaCure EVLT NeverTouch Direct Introducer Sheath (K170695) | AngioDynamics, Inc. | 2017-05-30 |
| Pulse* Spray Infusion System, Uni*Fuse Infusion System (K163356) | AngioDynamics, Inc. | 2017-05-30 |
| T3 Software (K163065) | Etiometry, Inc. | 2017-05-26 |
| MIS V3 Conical Connection Dental Implant System (K163349) | Mis Implants Technologies , Ltd. | 2017-05-26 |
| SPINEL 12HD Interventional Fluoroscopic Mobile X-ray System (K163140) | Gemss Medical Systems Co., Ltd. | 2017-05-26 |
| Ultravision Visual Field Clearing System (K170178) | Alesi Surgical, Ltd. | 2017-05-26 |
| Flexitouch System (K170216) | Tactile Systems Technology, Inc. (Dba Tactile Medical) | 2017-05-26 |
| AcceleDent Optima (K170093) | Orthoaccel Technology, Inc. | 2017-05-26 |
| Creatine Kinase-MB (K162526) | Roche Diagnostics | 2017-05-26 |
| DyeVert Plus Contrast Reduction System, DyeVert NG Contrast Reduction System (K171217) | Osprey Medical, Inc. | 2017-05-26 |
| FFR V2.5 (K170133) | Philips Volcano | 2017-05-26 |
| Masimo O3 Regional Oximeter System (K162603) | Masimo Corporation | 2017-05-26 |
| My Dose Coach (K171230) | Sanofi | 2017-05-26 |
| White Sizing Catheter, Aurous Centimeter Sizing Catheter, Cava Vessel Sizing Catheter (K162448) | Cook Incorporated | 2017-05-26 |
| Mistral-Air Warming Unit (K171234) | The Surgical Company International BV (As the 37company) | 2017-05-26 |
| Respire Pink Series with DentiTrac (K170692) | Respire Medical Holding | 2017-05-26 |
| da Vinci X Surgical System (K171294) | Intuitive Surgical, Inc. | 2017-05-26 |
| RAPID Web (K170839) | Given Imaging , Ltd. | 2017-05-26 |
| SutureTape (K171296) | Arthrex, Inc. | 2017-05-26 |
| IQ Technologies (K170659) | Iq Technologies, Inc. | 2017-05-26 |
| DELL UP3017 with QUBYX PerfectLum bundle (K171229) | Qubyx Software Technologies, Inc. | 2017-05-26 |
| Nova StatSensor Creatinine Hospital Meter System (K171059) | Nova Biomedical Corporation | 2017-05-26 |
| MultiGen™ 2 RF Generator System (K170242) | Stryker Corporation | 2017-05-25 |
| M.U.S.T. Pedicle Screw System Extension - Straight Connectors and Additional Screws (K171170) | Medacta International S.A. | 2017-05-25 |
| TruAbutment DS (K170259) | Truabutment | 2017-05-25 |
| LCD Monitor (MD310C, MD310G, MD210G) (K170944) | Benq Corporation | 2017-05-25 |
| CATHTONG II PICC Catheter (K170486) | L&Z Us, Inc. | 2017-05-25 |
| SETx Pedicle Screw System (K170611) | Xenco Medical, LLC | 2017-05-25 |
| PicoWay Laser System (K170597) | Syneron Candela Corporation | 2017-05-25 |
| KARL STORZ ICG Imaging System (K171238) | KARL STORZ Endoscopy-America, Inc. | 2017-05-25 |
| Liofilchem MIC Test Strip (MTS)- Tedizolid 0.002 - 32 µg/mL (K170892) | Liofilchem s.r.l. | 2017-05-25 |
| GenePOC GBS LB (K170557) | Genepoc, Inc. | 2017-05-25 |
| revogene (K170558) | Genepoc, Inc. | 2017-05-25 |
| Streamline 6491 Unipolar Pediatric Temporary Pacing Lead, Streamline 6492 Unipolar Temporary Pacing Lead, Streamline 6495 Bipolar Temporary Myocardial Pacing Lead, Streamline 6500 Unipolar Temporary Myocardial Pacing Lead (K171253) | Medtronic | 2017-05-25 |
| Gems Vitrification Set, Gems Warming Set (K162409) | Genea Biomedx Pty, Ltd. | 2017-05-24 |
| ACTION II Laser System (K163196) | Lutronic Corporation | 2017-05-24 |
| GCE Zen-O Portable Oxygen Concentrator (K162433) | Oxus, Inc. | 2017-05-24 |
| Tao Brush I.U.M.C. Endometrial Sampler (K170603) | Cook Incorporated | 2017-05-24 |
| RA-308 Excimer Laser System, Excimer Laser Catheter (K170349) | Ra Medical Systems,Inc | 2017-05-24 |
| UNiD Spine Analyzer (K170172) | Medicrea International | 2017-05-24 |
| AS-10, CXDI-401RF (K171194) | Canon, Inc. | 2017-05-24 |
| Cook Holmium Laser Fiber (K163197) | Cook Incorporated | 2017-05-24 |
| INDIGO Aspiration System (K163618) | Penumbra, Inc. | 2017-05-24 |
| VitreOx Anti-fog Solution (K163257) | Sio2 Nanotech, LLC | 2017-05-24 |
| HemoDraw Plus Closed Blood Sampling System with LogiCal Transducer Kit, HemoDraw Plus Closed Blood Sampling System with Transtar Transducer Kit (K163172) | Smiths Medical Asd, Inc. | 2017-05-24 |
| Dental Implants OKTAGON Bone Level Tapered Design (K170287) | Hager& Meisinger GmbH | 2017-05-24 |
| Mako Partial Knee Application (K170891) | Mako Surgical Corp. | 2017-05-24 |
| truFreeze System (K163244) | CSA Medical, Inc. | 2017-05-24 |
| FIBERGRAFT BG Putty Bone Graft Substitute (K170306) | Prosidyan, Inc. | 2017-05-24 |
| vascuCAP (K163071) | Elucid Bioimaging, Inc. | 2017-05-24 |
| Central Monitoring System (K170514) | Guangdong Biolight Meditech Co., Ltd. | 2017-05-24 |
| Nugard Black Powder Free Latex Examination Glove, Polymer Coated, Contains 50 Micrograms or less of water extractable protein (K170779) | Terang Nusa Sdn Bhd | 2017-05-24 |
| Powder Free Nitrile Exam Glove w/pH coating, White-Black color, Tested for Use with Chemo dr (K170290) | Shen Wei USA, Inc. | 2017-05-24 |
| Matrix Data Management System (K162463) | Global Instrumentation, LLC | 2017-05-24 |
| Fortilink™-C with TETRAfuse™ 3D Technology (K163673) | Rti Surgical, Inc. | 2017-05-23 |
| Skylit Phototherapy System (K170489) | Skylit Medical | 2017-05-23 |
| LATEX EXAMINATION GLOVE POWDER FREE (K161833) | Careglove Global Sdn. Bhd. | 2017-05-23 |
| ADVIA Centaur Intact Parathyroid Hormone (PTH) Assay (K163658) | Siemens Healthcare Diagnostics, Inc. | 2017-05-23 |
| Plasma Edge System (K163090) | Chirurgie Innovation | 2017-05-23 |
| HAPI Seal (K162598) | Bisco, Inc. | 2017-05-23 |
| Prontosan Wound Gel (K163430) | B.Braun Medical, Inc. | 2017-05-23 |
| Lumenis Family of Holmium Surgical Lasers and Delivery Devices and Accessories (K170121) | Lumenis, Ltd. | 2017-05-22 |
| Smith & Nephew VISIONAIRE Adaptive Guides (K170282) | Smith & Nephew, Inc. | 2017-05-22 |
| OSSTEM Implant System - Abutment (K161689) | Osstem Implant Co., Ltd. | 2017-05-22 |
| Pinpoint GT Needle Guide Kits (K171348) | C.R. Bard, Inc. | 2017-05-22 |
| Powder Free Nitrile Patient Examination Gloves, Blue (K163553) | Hebei Titans Medical Supply Technology Group., Ltd. | 2017-05-22 |
| SMV Scientific Cannulated Screws (K170021) | Smv Scientific | 2017-05-22 |
| Dymaxeon Spine System (K170989) | Back 2 Basics Direct, LLC | 2017-05-22 |