| LAP-iX Suction Irrigation (K173111) | Sejong Medical Co., Ltd. | 2017-11-28 |
| 3.0T 16ch Breast Coil (K173377) | Neocoil, LLC | 2017-11-28 |
| PSLT for PASCAL Streamline (K171488) | Topcon Medical Laser Systems, Inc. | 2017-11-27 |
| Straumann Screw Retained Abutments (K171757) | Straumann USA, LLC (On Behalf of Institut Straumann Ag) | 2017-11-27 |
| Turbo-Power (2.0mm) Laser Atherectomy Catheters, Turbo-Power (2.3mm) Laser Atherectomy Catheters (K172687) | Spectranetics, Inc. | 2017-11-27 |
| LED Curing Light (K161855) | Monitex Industrial Co., Ltd. | 2017-11-27 |
| CoLink View Plating System (K172300) | In2bones USA, LLC | 2017-11-27 |
| HEALIX ADVANCE KNOTLESS Anchor (K171114) | Medos International SARL | 2017-11-27 |
| Devon 51 (K172030) | Devon Medical Products (Jiangsu), Ltd. | 2017-11-27 |
| Bausch + Lomb Boston Original Cleaner, Bausch + Lomb Boston Original Conditioning Solutions (K173089) | Bausch & Lomb, Incorporated | 2017-11-27 |
| Single Use Retrieval Nitinol Basket V (K170811) | Olympus Medical Systems Corp. | 2017-11-27 |
| VariAx 2 System (K173135) | Stryker GmbH | 2017-11-27 |
| Cerafix Dura Substitute (K172603) | Acera Surgical, Inc. | 2017-11-27 |
| THERMOPLASTIC ELASTOMER EXAMINATION (TPE) GLOVE (K172678) | Shen Wei USA, Inc. | 2017-11-24 |
| NuVasive AttraX Scaffold (K172497) | Nu Vasive, Incorporated | 2017-11-24 |
| FilmArray Respiratory Panel 2 plus (RP2plus) (DEN170017) | Biofire Diagnostics, LLC | 2017-11-24 |
| Skan-C Mobile C-Arm X-Ray System - 230V Variant, Skan-C Mobile C-Arm X-Ray System - 110V Variant (K170946) | Skanray Technologies Private Limited | 2017-11-24 |
| True Function Adjustable Herbst Appliances (K170578) | True Function Laboratory, Inc. | 2017-11-24 |
| FilmArray RP2/RP2plus Control Panel (K173171) | Maine Molecular Quality Controls, Inc. | 2017-11-24 |
| DIXI Medical Microdeep Depth Electrode (K170959) | Dixi Medical | 2017-11-24 |
| ExactechGPS Total Shoulder Application (K173372) | Blue Ortho | 2017-11-24 |
| SALUS - Hygiene Instrument Reprocessing Container (K172292) | Scican , Ltd. | 2017-11-24 |
| DENTCA DENTURE Teeth (K172398) | Dentca, Inc. | 2017-11-22 |
| I-Portal Portable Assessment System - Nystagmograph (I-PAS) (K171884) | Neuro Kinetics, Inc. | 2017-11-22 |
| Non Contact Infrared Forehead Thermometer (K170662) | Intrinity Global Limited | 2017-11-22 |
| EsoFLIP® ES-310 Balloon Catheter (K172128) | Crospon, Ltd. | 2017-11-22 |
| Firlit-Kluge Urethral Stent, Koyle Diaper Stent, Zaontz Urethral Stent (K172278) | Cook Incorporated | 2017-11-22 |
| OrthAlign Plus System (K172462) | Orthalign, Inc. | 2017-11-22 |
| GenePOC CDiff (K172569) | Genepoc, Inc. | 2017-11-22 |
| GC85A (K172229) | Samsung Electronics Co., Ltd. | 2017-11-22 |
| Azurion series R1.2 (K172822) | Philips Medical Systems Nederland B.V. | 2017-11-22 |
| BioHorizons Tapered Short Implants (K172576) | BioHorizons Implant Systems, Inc. | 2017-11-22 |
| The Wrist-Type Fully Automatic Digital Blood Pressure Monitors (K170666) | Joytech Healthcare Co. , Ltd. | 2017-11-22 |
| NIOX VERO (K170983) | Circassia AB | 2017-11-22 |
| AIR Anterior Array, AIR Posterior Array (K172695) | Ge Healthcare Coils (Usa Instruments, Inc.) | 2017-11-22 |
| CamX Triton HD Proxi Head (K172007) | Duerr Dental AG | 2017-11-22 |
| Velofix™ SA Cervical Cage (K172424) | U&I Corporation | 2017-11-22 |
| CereTom Elite (K172539) | Neurologica Corporation, A Subsidiary of Samsung Electronics | 2017-11-22 |
| HemosIL D-Dimer HS 500 (K172903) | Instrumentation Laboratory CO | 2017-11-22 |
| CEDIA Heroin Metabolite (6-AM) Assay (K173183) | Microgenics Corporation | 2017-11-22 |
| Vevazz LED (K172111) | Vevazz, LLC | 2017-11-22 |
| Prosomnus [CA] Sleep and Snore Device and Prosomnus [CA] Sleep and Snore Device with Micro-recorder (K172859) | Prosomnous Sleep Technologies | 2017-11-22 |
| KLS Martin Individual Patient Solutions (K163579) | KLS Martin L.P. | 2017-11-21 |
| Parkell Universal Adhesive (K172176) | Parkell, Inc. | 2017-11-21 |
| Hermes Medical Imaging Suite v5.7 (K171681) | Hermes Medical Solutions AB | 2017-11-21 |
| MIM – Y90 Dosimetry (K172218) | Mim Software, Inc. | 2017-11-21 |
| Climax Personal Lubricant (K171044) | Wsm Investment, LLC, Dba Topco Sales | 2017-11-21 |
| Dental Low-speed Turbine Handpiece (K170236) | Guangdong Jinme Medical Technology Co., Ltd. | 2017-11-21 |
| Surgical Angle Handpiece, Surgical Straight Handpiece (K171155) | Nakanishi, Inc. | 2017-11-21 |
| TXM Hydrophilic Guidewire (K170915) | Texasmedical Technologies, Inc. | 2017-11-21 |
| LAP-iX (K173112) | Sejong Medical Co., Ltd. | 2017-11-21 |
| Follicle Aspiration Set, Reduced Single Lumen (K172050) | Vitrolife Sweden AB | 2017-11-21 |
| Altus Spine Cervical Interbody Fusion System (K172253) | Altus Partners, LLC | 2017-11-21 |
| Automatic Wrist Bluetooth Blood Pressure Monitor (K170545) | Truly Instrument , Ltd. | 2017-11-21 |
| Vertera Spine Cohere Cervical Interbody Fusion Device (K173030) | Nu Vasive, Incorporated | 2017-11-21 |
| Ultrasonic scaler (K163414) | Nanning VV Dental Co., Ltd. | 2017-11-21 |
| TXM Support Catheter (K170914) | Texasmedical Technologies, Inc. | 2017-11-21 |
| Visual-ICE MRI Cryoblation Console, Visual-ICE MRI Junction Box Assembly, Visual-ICE MRI Mobile Connection Panel (K173037) | Galil Medical, Inc. | 2017-11-21 |
| Alere Afinion HbA1c and ACR on Afinion 2 analyzer (K171650) | Abbott Rapid Diagnostics | 2017-11-21 |
| LiverMultiScan (K172685) | Perspectum Diagnostics, Ltd. | 2017-11-21 |
| S.I.N. Dental Implant System (K170398) | S.I.N. – Sistema DE Implante Nacional S.A. | 2017-11-21 |
| 3M Tegaderm Antimicrobial Transparent Dressing, 3M Tegaderm Antimicrobial I.V. Advanced Securement Dressing (K170754) | 3M Company, 3M Healthcare | 2017-11-21 |
| Smith & Nephew, Inc. REDAPT Augments (K171073) | Smith & Nephew, Inc. | 2017-11-21 |
| Hybrid3D (K171719) | Hermes Medical Solutions AB | 2017-11-21 |
| Microcyn Antimicrobial Skin and Wound Cleanser (K172622) | Sonoma Pharmaceuticals | 2017-11-21 |
| GentleCath Intermittent Urinary Catheter (K172924) | Convatec Limited | 2017-11-21 |
| Destination Carotid Guiding Sheath, Destination Peripheral Guiding Sheath, Destination Renal Guiding Sheath (K172995) | Terumo Medical Corporation | 2017-11-21 |
| ENSEAL X1 Tissue Sealer, Straight Jaw, 25 cm Shaft Length, ENSEAL X1 Tissue Sealer, Straight Jaw, 37 cm Shaft Length, ENSEAL X1 Tissue Sealer, Curved Jaw, 25 cm Shaft Length,ENSEAL X1 Tissue Sealer, Curved Jaw, 37 cm Shaft Length,ENSEAL X1 Tissue Sealer, Curved Jaw, 45 cm Shaft Length (K172580) | Ethicon Endo-Surgery, LLC | 2017-11-20 |
| LIA Pregnancy Test (K171136) | Lia Diagnostics | 2017-11-20 |
| B7 2C Occlusion Balloon (K171492) | Spiration, Inc. | 2017-11-20 |
| Stryker Self-Punching ICONIX (K172921) | Stryker | 2017-11-20 |
| MDR17 Mobile Direct Radiographic System (K173018) | Del Medical, Inc. | 2017-11-20 |
| Affinity Pixie Oxygenator with Balance Biosurface, Affinity Pixie Oxygenator with Cardiotomy/Venous Reservoir and Balance Biosurface, Affinity Pixie Oxygenator with Cortiva BioActive Surface, Affinity Fusion Oxygenator with Cardiotomy/Venous Reservoir and Cortiva BioActive Surface (K172984) | Medtronic, Inc. | 2017-11-20 |
| Reusable Blood Pressure Cuff, Disposable Blood Pressure Cuff (K173044) | Ningbo Albert Novosino Co., Ltd. | 2017-11-20 |
| Materialise PKA Guide System (K172650) | Materialise NV | 2017-11-20 |
| Rapid Family (K173169) | Sharplight Technologies, Ltd. | 2017-11-20 |
| Modulift Vertebral Body Replacement (VBR) System (K172032) | Aesculap Implants Systems, Inc. | 2017-11-20 |
| syngo®.via protoNeo (Version VA20) (K173378) | Siemens Healthcare GmbH | 2017-11-20 |
| Gunther Tulip Vena Cava Filter Set for Femoral Vein Approach, Gunther Tulip Vena Cava Filter Set for Jugular Vein Approach, Gunther Tulip Vena Cava Filter Set for Femoral and Jugular Vein Approach (K172557) | William Cook Europe Aps | 2017-11-20 |
| Günther Tulip Vena Cava Filter Set for Femoral Vein Approach, Günther Tulip Vena Cava Filter Set for Femoral and Jugular Vein Approach (K172584) | William Cook Europe Aps | 2017-11-20 |
| Tyece OTC EMS System, Model EM35 (K172241) | Tyece , Ltd. | 2017-11-20 |
| DEKA SMARTXIDE ULTRASPEED (K172363) | El.En Electronic Engineering Spa | 2017-11-17 |
| Trak Plus Male Fertility Testing System (K172514) | Sandstone Diagnostics, Inc. | 2017-11-17 |
| Contour 24 (K173446) | Quality Electrodynamics, LLC | 2017-11-17 |
| N Latex FLC kappa assay, N Latex FLC Lambda assay, N FLC Standard SL, N FLC Control SL1 & SL2 (K171742) | Siemens Healthcare Diagnostics Products GmbH | 2017-11-17 |
| MR Wire Guide Wire Straight, MR Wire Guide Wire Angled (K173423) | Nano4imaging GmbH | 2017-11-17 |
| CMS600P2 B-Ultrasound Diagnostic System (K170856) | Contec Medical Systems Co.,Ltd | 2017-11-17 |
| Micro-MEC 1.8% Glutaraldehyde Monitor Strip (K172472) | STERIS Corporation | 2017-11-17 |
| Vantage Titan 3T, MRT-3010/A7, M-Power GX (K172878) | Toshiba Medical Systems Corporation, Japan | 2017-11-17 |
| SterilContainer with PrimeLine Pro Lid (K172850) | Aesculap, Inc. | 2017-11-17 |
| DEKA SMARTXIDE TOUCH (K172362) | El.En Electronic Engineering Spa | 2017-11-17 |
| Duravess bovine pericardial vascular patch (K172660) | Edwards Lifesciences, LLC | 2017-11-17 |
| Langston dual lumen catheter (K170544) | Vascular Solutions, Inc. | 2017-11-17 |
| NeuroBlate System (K173305) | Monteris Medical, | 2017-11-17 |
| Single Use Electrosurgical knife (K171158) | Olympus Medical Systems Corp. | 2017-11-17 |
| DIGITAL RADIOGRAPHY CXDI-410C WIRELESS (K171270) | Canon, Inc. | 2017-11-17 |
| New Century All-Ceramic Dental Zirconia Blocks (Un-Shaded & Pre-Shaded) (K172761) | Shanghai New Century Dental Materials Co., Ltd. | 2017-11-17 |
| Gastric Sizing Balloon Catheter (K173355) | Cook Incorporated | 2017-11-17 |
| Dr.MUSIC 3s (K172451) | Smartmedicaldevice Co., Ltd. | 2017-11-17 |
| AEON Endoscopic Stapler (K171589) | Lexington Medical, Inc. | 2017-11-17 |