| Performer Introducer (K173068) | Cook Incorporated | 2017-11-17 |
| SleepRight ProRx Custom Dental Guard (K172223) | Splintek, Inc. | 2017-11-17 |
| Bausch + Lomb Boston Scleral Lens Case (K173365) | Bausch & Lomb, Incorporated | 2017-11-17 |
| Endoform Silver Dermal Template (K172318) | Aroa Biosurgery | 2017-11-17 |
| Symbia T16, Symbia Intevo 16 and Symbia Intevo Bold (K173023) | Siemens Medical Solutions USA, Inc. | 2017-11-17 |
| Powder Free Pink Polychloroprene Copolymer Examination Gloves, Powder Free Black Polychloroprene Copolymer Examination Gloves (K171743) | Smart Glove Corporation Sdn. Bhd. | 2017-11-17 |
| Masimo Root Monitoring System and Accessories (K171121) | Masimo Corporation | 2017-11-17 |
| Compower CPR Mask With Oxygen Port, Compower CPR Mask Without Oxygen Port, Compower Infant CPR Mask, Compower Non-Rebreathing Valve (22mm/15mmOD), Non-Rebreathing Valve (22mm/18.5mm) (K171961) | Xiamen Compower Medical Tech. Co., Ltd. | 2017-11-17 |
| Intellijoint HIP System (Cart), Intellijoint HIP System (Portable), Intellijoint HIP Instrument Tray (K172849) | Intellijoint Surgical, Inc. | 2017-11-16 |
| Acrylic Herbst Appliance with Micro-Recorder (K170606) | Gergen'S Orthodontic Lab | 2017-11-16 |
| Menicon Progent Protein Remover for Rigid Gas Permeable Contact Lenses (K173136) | Menicon Co, Ltd. | 2017-11-16 |
| Merits Model R106/R136 Rehab Wheelchair (K170517) | Merits Healthcare Industries (Suzhou) Co., Ltd. | 2017-11-16 |
| MC3 QuickFlow Dual Lumen Catheter (K171610) | Mc3 Incorporated | 2017-11-16 |
| Renovis Surgical Hip Replacement System (K171543) | Renovis Surgical Technologies | 2017-11-16 |
| Reprocessed LigaSure Blunt Tip Laparoscopic Sealer/Divider (K172856) | Stryker Sustainability Solutions | 2017-11-16 |
| Klockner Vega TiBase for CEREC (K170022) | SOADCO, S.L. | 2017-11-16 |
| Bipolar applicator CELON ProCurve V (K172535) | Olympus Winter & Ibe GmbH | 2017-11-16 |
| Kardia Band System (K171816) | AliveCor, Inc. | 2017-11-16 |
| OptiCross HD, 60 MHz Coronary Imaging Catheter (Paper DFU); OptiCross HD, 60 MHz Coronary Imaging Catheter (e-DFU) (K173284) | Boston Scientific Corporation | 2017-11-16 |
| MobileDiagnost M50 (K173187) | Philips India Limited | 2017-11-16 |
| JOURNEY II XR Knee Instruments (K173331) | Smith & Nephew, Inc. | 2017-11-16 |
| Intra.Ox Handheld Tissue Oximeter (K163472) | Vioptix, Inc. | 2017-11-16 |
| LeEject 2 Dental Syringe and Needle System (K171254) | Advanced Technology and Capital, Inc. | 2017-11-16 |
| Triathlon® X3® UHMWPE Tibial Inserts and Patellar Components (K172634) | Howmedica Osteonics Corp. A.K.A. Stryker Orthopaedics | 2017-11-16 |
| NEPHROCHECK Test System (K171482) | Astute Medical, Inc. | 2017-11-16 |
| OEC Elite (K172550) | Ge Oec Medical Systems, Inc. | 2017-11-16 |
| Symetrex Long Term Hemodialysis Catheter (K171618) | Medcomp (Dba Medical Components, Inc.) | 2017-11-16 |
| LessRay System (K173314) | Nu Vasive, Incorporated | 2017-11-16 |
| Resorbable Mesh Device (K172130) | SeaSpine Orthopedics Corporation | 2017-11-16 |
| Minimally Invasive Bunion Plating System (K172178) | Trilliant Surgical, Ltd. | 2017-11-16 |
| SIRIO H3 (K163643) | Masmec Spa | 2017-11-16 |
| KaVo NOMAD Pro 2 Handheld X-ray System (K173319) | Aribex | 2017-11-16 |
| Orthofix MJ-FLEX THE NEW METAIZEAU NAIL (K173051) | Orthofix Srl | 2017-11-16 |
| U50 Diagnostic Ultrasound System (K173003) | Edan Instruments, Inc. | 2017-11-15 |
| uMEC Series Patient Monitors (including uMEC6, uMEC7, uMEC10, uMEC12, uMEC15, uMEC15S) (K171901) | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 2017-11-15 |
| Beacon Tip Torcon NB Advantage Catheter, Slip-Cath Beacon Tip Catheter and Shuttle Select Slip-Cath Catheter, Beacon Tip Centimeter Sizing Catheter, Beacon Tip Cava Vessel Sizing Catheter, Beacon Tip White Vessel Sizing Catheter (K173289) | Cook Incorporated | 2017-11-15 |
| NSS-2 System (DEN170018) | Innovative Health Solutions (Ihs), Inc. | 2017-11-15 |
| Registrado Scan (K171815) | Voco GmbH | 2017-11-15 |
| jFit Surgical Planner (K173329) | Jointvue, LLC | 2017-11-15 |
| Kindguard Powder Free Vinyl Patient Examination Gloves, Light Yellow Color (K173016) | Anhui Kindguard Medical Supplies Technology Co., Ltd. | 2017-11-15 |
| Microcyn Plus Antimicrobial Wound Care Solution (K172851) | Sonoma Pharmaceuticals, Inc. | 2017-11-15 |
| MSK-IMPACT (Integrated Mutation Profiling of Actionable Cancer Targets):a Hybridization-Capture Based Next Generation Sequencing Assay (DEN170058) | Memorial Sloan-Kettering Cancer Center | 2017-11-15 |
| Arthrex FiberTape Cerclage (K170206) | Arthrex, Inc. | 2017-11-15 |
| VORTEK HYDRO-COATED DOUBLE LOOP URETERAL STENTS (K170362) | Coloplast Corp. | 2017-11-15 |
| Powder Free Nitrile Patient Examination Glove, Blue Colored, Non Sterile, Tested for Use with Chemotherapy Drugs (K171873) | Zhonghong Pulin Medical Products Co., Ltd. | 2017-11-15 |
| OverStitch SX Endoscopic Suturing System (ESS) (K171886) | Apollo Endosurgery, Inc. | 2017-11-15 |
| Geri Embryo Incubator and Geri Dish (K171736) | Genea Biomedx Pty, Ltd. | 2017-11-15 |
| Biograph mMR with mMR Angio Transfer Option (K172531) | Siemens Medical Solutions USA, Inc. | 2017-11-14 |
| n!ce for Planmill (K173410) | Institut Straumann AG | 2017-11-14 |
| Smart External Drain (SED) System (K172759) | Aqueduct Critical Care, Inc. | 2017-11-14 |
| Straumann PURE Ceramic Implants (K171769) | Straumann USA, LLC (On Behalf of Institut Straumann Ag) | 2017-11-14 |
| FibroScan® Family of Products (Models: 502 Touch, 530 Compact, and 430 Mini+) (K173034) | Echosens | 2017-11-14 |
| DePuy Synthes Femoral Recon Nail System (K172157) | Synthes (USA) Products, LLC | 2017-11-14 |
| Planmeca Romexis (K171385) | Planmeca Oy | 2017-11-14 |
| AP 50/30 Insufflator with Insuflow Port (K170799) | Lexion Medical, LLC | 2017-11-14 |
| Dolphin/IQ and Dolphin/4D (K170859) | Viasonix , Ltd. | 2017-11-14 |
| Blue Non Sterile Powder Free Nitrile Examination Gloves Tested for Use with Chemotherapy Drugs (K172525) | Central Medicare Sdn Bhd | 2017-11-13 |
| Medax Biopsy Systems II (MEDONE, MEDCUT, MEDEM, MEDBONE, MEDLOCK) (K172344) | Medax Srl Unipersonale | 2017-11-13 |
| CXI TriForce Peripheral Crossing Set (K170931) | Cook Incorporated | 2017-11-13 |
| IMPIX 3D Print Cages (K163595) | Medicrea International SA | 2017-11-13 |
| Pekkton Ivory (K170102) | Cendres+Metaux SA | 2017-11-13 |
| Access AMH (K170524) | Beckman Coulter, Inc. | 2017-11-13 |
| ANTHEM Fracture System (K173166) | Globus Medical, Inc. | 2017-11-13 |
| Stryker Universal Mesh (K170725) | Stryker | 2017-11-13 |
| Disposable Snap Electrode (K172703) | Embla Systems | 2017-11-13 |
| A1AT Genotyping Test (K171868) | Progenika Biopharma S.A., A Grifols Company | 2017-11-11 |
| Nexstim Navigated Brain Therapy (NBT) System 2 (K171902) | Nexstim Plc | 2017-11-10 |
| Aesculap Slim Clip Applier Forceps (K173271) | Aesculap, Inc. | 2017-11-10 |
| SGS ECCOVISIONTM Pharyngometer, SGS ECCOVISIONTM Rhinometer, SGS ECCOVISIONTM Rhino/Pharyngometer (K170071) | Sleep Group Solutions | 2017-11-09 |
| MX40 Release B.07 (K172226) | Philips Medical Systems | 2017-11-09 |
| HemoDraw Plus Closed Blood Sampling System with LogiCal Transducer Kit, HemoDraw Plus Closed Blood Sampling System with Transtar Transducer Kit (K172458) | Smiths Medical Asd, Inc. | 2017-11-09 |
| Geistlich Fibro-Gide (K171050) | Geistlich Pharma AG | 2017-11-09 |
| Odyssey Micro Catheter (K170664) | Heraeus Medical Components, LLC | 2017-11-09 |
| FORTIFY Corpectomy Spacers (K162315) | Globus Medical, Inc. | 2017-11-09 |
| PROLIXUS TOTAL KNEE SYSTEM (K170534) | Otis Biotech Co., Ltd. | 2017-11-09 |
| Televere Podiatry Digital Imaging System (K172124) | Televere Systems | 2017-11-09 |
| J2A SLA Dental Implant System (K161923) | Kj Meditech Co., Ltd. | 2017-11-09 |
| Philips CT Big Bore (K171850) | Philips Medical Systems (Cleveland), Inc. | 2017-11-09 |
| Alivio Ventricular Catheter and Flusher System (Alivio System) (K172006) | Alcyone Lifesciences, Inc. | 2017-11-09 |
| Aquarius 8600 1417WCI; Aquarius 8600 1717WCI (K173273) | Imaging Dynamics Company , Ltd. | 2017-11-09 |
| BioZorb Marker GOLD / LP Marker GOLD (K171467) | Focal Therapeutics | 2017-11-09 |
| DASH 6 NRFit Lock Syringe + Accessories, DASH 6 NRFit Slip Syringe + Accessories, DASH 6 NRFit Plastic LOR Syringe + Accessories (K170900) | Intervene Group, Ltd. | 2017-11-09 |
| OEC One (K172700) | Ge Hualun Medical Systems Co. , Ltd. | 2017-11-09 |
| Medline ReNewal Reprocessed Synthes External Fixation Systems (K171911) | Surgical Instrument Service and Savings, Inc. | 2017-11-09 |
| WATCHDOG Hemostasis Valve Kit (K172453) | Boston Scientific Corporation | 2017-11-09 |
| ulrichINJECT CT motion (K171392) | Ulrich GmbH & Co. KG | 2017-11-09 |
| Stryker Universal Mesh (K170773) | Stryker | 2017-11-08 |
| Idys™ ALIF System (K172083) | Clariance, Sas | 2017-11-08 |
| Dental High-speed Turbine Handpiece (K170229) | Guangdong Jinme Medical Technology Co., Ltd. | 2017-11-08 |
| CereLink ICP Sensor Basic Kit, CereLink ICP Sensor Metal Skull Bolt Kit, CereLink ICP Sensor Plastic Skull Bolt Kit, CereLink ICP Sensor Ventricular Catheter Kit (K173192) | Codman & Shurtleff, Inc. | 2017-11-08 |
| Surgical Planning Software version 1.1 (K173247) | Ortho Kinematics, Inc. | 2017-11-08 |
| C2 femoral stem (K170473) | Lima Corporate S.P.A. | 2017-11-08 |
| SyndesMetrics Syndesmosis Repair System (K172620) | Mortise Medical, LLC | 2017-11-08 |
| RadiForce RX560, RX560-AR (K172738) | Eizo Corporation | 2017-11-08 |
| MHC Standard and NRFit Tip Syringes (K171131) | Mazza Healthcare, LLC | 2017-11-08 |
| ER-REBOA Catheter (K172790) | Prytime Medical Devices, Inc. | 2017-11-08 |
| SurgicalPreview (K171534) | Endo Vantage, LLC | 2017-11-08 |
| NaturalVue (etafilcon A) Daily Disposable Soft (Hydrophilic) Contact Lenses (K173086) | Visioneering Technologies, Inc. | 2017-11-07 |
| Hintermann Series H2 Total Ankle System (K171004) | Dt Medtech, LLC | 2017-11-07 |
| NCompass Nitinol Stone Extractors (K173009) | Cook Incorporated | 2017-11-07 |