| 7D Surgical System (K180352) | 7D Surgical, Inc. | 2018-05-02 |
| Gold Standard Diagnostics Borrelia burgdorferi IgG/IgM ELISA Test Kit (K180264) | Gold Standard Diagnostics | 2018-05-02 |
| Drug Relief (K173861) | Dyansys, Inc. | 2018-05-02 |
| Non-Sterile Powder Free Blue Nitrile Examination Gloves Tested for Use with Chemotherapy Drugs (K172864) | Maxter Glove Manufacturing Sdn Bhd | 2018-05-02 |
| Lite (K172409) | Tzora Active Systems , Ltd. | 2018-05-02 |
| Alere i Strep A 2, Alere i instrument, Alere i Strep A 2 Control Swab Kit (K173653) | Alere Scarborough, Inc. | 2018-05-02 |
| Spineology Navigation Instruments (K180796) | Spineology, Inc. | 2018-05-02 |
| ADAPT for Gamma3 (K173946) | Stryker GmbH | 2018-05-02 |
| SAPPHIRE, ELEVARE SAPPHIRE (K172555) | Omm Imports, Inc. D/B/A Zero Gravity | 2018-05-01 |
| PeraServer and PeraTrend (K172959) | Perahealth, Inc. | 2018-05-01 |
| Liberty Cycler Set (K173718) | Fresenius Medical Care Renal Therapies Group, LLC | 2018-05-01 |
| ViaTherm BOOST (K173300) | Viatherm Therapeutics, LLC | 2018-05-01 |
| LUOFUCON Extra Silver Alginate Dressing, LUOFUCON Extra Antibacterial Alginate Dressing (K172554) | Huizhou Foryou Medical Devices Co., Ltd. | 2018-05-01 |
| AMBIENT Super MULTIVAC 50 Wand with Integrated Finger Switches (K180848) | ArthroCare Corporation | 2018-05-01 |
| BacterioScan 216Dx System (K172412) | Bacterioscan, Inc. | 2018-05-01 |
| Gordon Large-Bore Curved Drainage Catheter, Nephrostomy Pigtail Drainage Catheter, Percutaneous Nephrostomy Set, Pigtail Drainage Catheter Needle Set, Multipurpose Drainage Catheters and Sets (K173035) | Cook Incorporated | 2018-05-01 |
| BiliLux (K172656) | Draeger Medical Systems, Inc. | 2018-05-01 |
| ExactVu High Resolution Micro-Ultrasound System (K180636) | Exact Imaging, Inc. | 2018-04-30 |
| VitaMESH Macroporous PP Surgical Mesh (K172636) | Proxy Biomedical , Ltd. | 2018-04-30 |
| Mazor X (K180307) | Mazor Robotics , Ltd. | 2018-04-30 |
| Gas Sampling Line, Coextruded, 2m/7ft, 10/pkg, Disposable/ 100/pkg, Disposable, Gas Sampling Line, Coextruded, 2.5m/8ft, 10/pkg, Disposable, Gas Sampling Line, Coextruded, 3m/10ft, 10/pkg, Disposable/ 100/pkg, Disposable, Gas Sampling Line, Coextruded, 6m/20ft, 5/pkg, Disposable (K171678) | Vyaire Medical, Inc. | 2018-04-30 |
| EVIS EXERA III BRONCHOFIBERVIDEOSCOPE OLYMPUS BF-MP190F, Single Use Biopsy Forceps FB-433D (K172726) | Olympus Medical Systems Corp. | 2018-04-30 |
| Medline Green Ambidextrous Powder-Free Nitrile Examination Gloves with Colloidal Oatmeal (Tested for use with Chemotherapy Drugs) (K180696) | Medline Industries, Inc. | 2018-04-30 |
| Finessis Intense Polyisoprene Surgical Glove (K173304) | Lucenxia Prescience AG | 2018-04-30 |
| NeuroCap (K172866) | Memory MD, Inc. | 2018-04-27 |
| QiF Blood and Fluid Warmer (K180154) | Quality IN Flow , Ltd. | 2018-04-27 |
| Focus DAILIES / Focus DAILIES Toric / Focus DAILIES Progressives, DAILIES AquaComfort Plus (DACP) / DACP Toric / DACP Multifocal, FreshLook One-Day, DAILIES Total 1 / DAILIES Total 1 Multifocal (K180669) | Alcon Laboratories, Inc. | 2018-04-27 |
| HYALURONIC ACID TOPICAL WOUND CREAM (K172747) | Virchow Biotech Pvt, Ltd. | 2018-04-27 |
| HDR MRI Lumen Marker (K180069) | C4 Imaging, LLC | 2018-04-27 |
| TRACOE silcosoft Tracheostomy Tube (K172720) | Tracoe Medical GmbH | 2018-04-27 |
| OLYMPIC Navigated Instruments (K172166) | Astura Medical | 2018-04-27 |
| Novasight Hybrid System (K172258) | Conavi Medical, Inc. | 2018-04-27 |
| ACRON™ TLIF System (K171151) | Spinemed Ges.M.B.H | 2018-04-27 |
| ADHEAR System (K172460) | Med-El Elektromedizinische Geraete GmbH | 2018-04-27 |
| hipEOS (K173390) | Onefit Medical | 2018-04-27 |
| Keymill (K172764) | Mycone Dental Supply Company, Inc. (Aka Keystone Industries) | 2018-04-27 |
| Astral 100/150 (K172875) | Resmed, Ltd. | 2018-04-26 |
| ENNOVATE® (K180433) | Aesculap Implant Systems, LLC | 2018-04-26 |
| Summit Hip System (K170339) | DePuy Orthopaedics, Inc. | 2018-04-26 |
| Intuitive Surgical EndoWrist Vessel Sealer Extend (K173337) | Intuitive Surgical, Inc. | 2018-04-26 |
| INFINITY Total Ankle System (K172633) | Wrightmedicaltechnologyinc | 2018-04-26 |
| P50 Series Dental Operative Unit and Accessories (K171872) | Pelton & Crane | 2018-04-26 |
| 2 Face / Face Evolution (K171821) | Heat IN A Click | 2018-04-26 |
| LungVision Tool (K172955) | Bodyvision Medical , Ltd. | 2018-04-26 |
| UNITY Sacroiliac Joint Fixation System (K173201) | Huvexel Co. , Ltd. | 2018-04-26 |
| Nitrile Examination Powder Free Glove, White, Black, Orange, Nitrile Examination Powder Free Gloves Tested For Use With Chemotherapy Drugs, Blue (K172923) | Top Glove Sdn. Bhd. | 2018-04-26 |
| ESG-300, APU-300, Pressure Reducer, MAPC Probes (K180200) | Olympus Winter & Ibe GmbH | 2018-04-26 |
| 3F Single Lumen and 4F Dual Lumen PowerPICC Provena Catherers; 3F Single Lumen and 4F Dual Lumen PowerPICC Provena Catherters with SOLO Valve Technology (K180548) | C.R. Bard, Inc (Bard Has Joined Bd) | 2018-04-26 |
| Beacon EUS Access System (K180037) | Covidien, LLC | 2018-04-26 |
| Cala ONE (DEN170028) | Cala Health, Inc. | 2018-04-26 |
| Xpert Xpress Strep A (K173398) | Cepheid | 2018-04-26 |
| Oniko nail brace (K162525) | Begum Saglik Hizmetleri Tibbi Malzemeler Danismanlik Lsti | 2018-04-25 |
| InCore® Lapidus System (K180257) | Nextremity Solutions, Inc. | 2018-04-25 |
| Rampart One Lumbar Interbody Fusion Device (K180002) | Spineology, Inc. | 2018-04-25 |
| VERITON NM (K180514) | Spectrum Dynamics Medical, Ltd. | 2018-04-25 |
| StimuQuik 21G x 9cm (3.5”) Peripheral Nerve Block Needle, StimuQuik Echo 21G x 9cm (3.5”) Peripheral Nerve Block Needle, StimuQuik 21G x 15cm (6”) Peripheral Nerve Block Needle, StimuQuik Echo 21G x 15cm (6”) Peripheral Nerve Block Needle, StimuQuik 21G x 2.5cm (1”) Peripheral Nerve Block Needle (K173321) | Teleflex Medical | 2018-04-25 |
| UNiD Patient Specific 3D printed cage (K173782) | Medicrea International SA | 2018-04-25 |
| RayStation 7 (K180379) | RaySearch Laboratories AB (PUBL) | 2018-04-25 |
| Phasix ST Mesh (K173143) | C.R. Bard, Inc. | 2018-04-25 |
| syngo.plaza (K180563) | Siemens Healthcare GmbH | 2018-04-25 |
| OPTIMUM GP (roflufocon D, roflurocon E) Daily Wear Contact Lens, HEXA100 (hexafocon A) Daily Wear Contact Lens (K180616) | Contamac, Ltd. | 2018-04-25 |
| IMACTIS CT-Navigation system (K162314) | Imactis, Sas | 2018-04-24 |
| ZOOM (K172768) | Zetta Medical Technologies, LLC | 2018-04-24 |
| GSI Viewer with GSI Fat Option (K180225) | GE Medical Systems SCS | 2018-04-24 |
| neuromate Gen III (K180206) | Renishaw Mayfield Sarl | 2018-04-24 |
| XD880A Ultrasonic Osteotomy Surgical System (K172464) | Morley Research Consortium | 2018-04-24 |
| trophon2 (K173865) | Nanosonics Limited | 2018-04-24 |
| Crown Dental Zirconia Blank & Crown Dental Zirconia Pre-Shaded Blank (K180252) | Crown Porcelain Dental Technology Co., Ltd. | 2018-04-24 |
| TYRX Absorbable Antibacterial Envelope (medium), TYRX Absorbable Antibacterial Envelope (large) (K180030) | Medtronic, Inc. | 2018-04-24 |
| Smith & Nephew SURESHOT Distal Targeting System V4.0 Targeter (K180277) | Smith & Nephew, Inc. | 2018-04-24 |
| Reaxon Plus (K180222) | Medovent GmbH | 2018-04-24 |
| EnSite Velocity Cardiac Mapping System v5.2 (K172396) | St Jude Medical | 2018-04-23 |
| Sysmex UF-5000 Fully Automated Urine Particle Analyzer (K171883) | Sysmex America, Inc. | 2018-04-23 |
| Patient Status Engine (K172329) | Isansys Lifecare, Ltd. | 2018-04-23 |
| Advisor HD Grid Mapping Catheter, Sensor Enabled (K172393) | St. Jude Medical, Inc. | 2018-04-23 |
| AlertWatch:OB (K173715) | Alertwatch, Inc. | 2018-04-23 |
| Cure™ Lumbar Plate System (K180090) | Meditech Spine, LLC | 2018-04-23 |
| Frova Intubating Introducer (K171917) | Cook Incorporated | 2018-04-23 |
| da Vinci Xi Surgical System, da Vinci X Surgical System (K173842) | Intuitive Surgical, Inc. | 2018-04-23 |
| Reprocessed LigaSure Maryland Jaw Sealer/Divider (K180499) | Stryker Sustainability Solutions | 2018-04-23 |
| Agile Nail (K172699) | Orthofix Srl | 2018-04-23 |
| 3M Attest Super Rapid Readout Steam Challenge Pack, 3M Attest Super Rapid 5 Steam-Plus Chaallenge Pack, 3M Attest Auto-reader, 3M Attest Auto-reader (K173519) | 3M Company | 2018-04-23 |
| Polychloroprene Powder Free Sterile Surgical Gloves, White, Tested for Use with Chemotherapy (K173258) | Pt. Medisafe Technologies | 2018-04-20 |
| Etherea MX (K171443) | Vydence Medical Industria E Comercio Ltda | 2018-04-20 |
| EUROIMMUN IFA: Crithidia luciliae sensitive (anti-dsDNA) EUROPattern (K172252) | Euroimmun Us, Inc. | 2018-04-20 |
| Si-Hy (olifilcon B) color silicone hydrogel soft contact lens (K180322) | Visco Vision, Inc. | 2018-04-20 |
| Geri Embryo Incubator and Geri Dish (K180304) | Genea Biomedx Pty, Ltd. | 2018-04-20 |
| ProFlex Laser Fibers (K180140) | Innovaquartz, LLC | 2018-04-20 |
| Arthrex Univers Revers Modular Glenoid System (K173900) | Arthrex, Inc. | 2018-04-20 |
| Aria (K180782) | GE Medical Systems Ultrasound & Primary Care Diagnostics, LLC | 2018-04-20 |
| Televere Podiatry X-Ray System HF (K180765) | Televere Systems, Inc. | 2018-04-20 |
| MALDI Biotyper CA System (DEN170081) | Bruker Daltonik GmbH | 2018-04-20 |
| Viz CTP (K180161) | Viz. Ai, Inc. | 2018-04-20 |
| Sharpsite AC Rigid Endsocope (K173855) | Medtronic Xomed, Inc. | 2018-04-20 |
| World Knee System (K180750) | Signature Orthopaedics Pty, Ltd. | 2018-04-20 |
| Viamo c100 TUS-VC100 Diagnostic Ultrasound System (K173962) | Toshibamedical Systems Corporation | 2018-04-20 |
| JO H2O Flavored Personal Lubricants (K180219) | United Consortium | 2018-04-20 |
| LZI Carisoprodol Metabolite (Meprobamate) Enzyme Immunoassay (DEN170010) | Lin-Zhi International, Inc. | 2018-04-20 |
| Hickman TriFusion Catheter (K172511) | C.R. Bard, Inc. | 2018-04-20 |
| Neodent Implant System – GM Line (K173902) | Jjgc Industria E Comercio DE Materiais Dentarios S.A. | 2018-04-20 |