| ViSi Mobile Monitoring System (K180472) | Sotera Wireless, Inc. | 2018-06-19 |
| Neutrogena Light Therapy Aging Mask+ (K180856) | Johnson & Johnson Consumer, Inc. | 2018-06-19 |
| sterEOS Workstation (K172346) | Eos Imaging | 2018-06-19 |
| Reprocessed DecaNav Diagnostic Electrophysiology Catheter (K180710) | Innovative Health, LLC | 2018-06-19 |
| Valleylab FT10 Energy Platform, Valleylab FX8 FX Series Energy Platform (K181389) | Covidien | 2018-06-19 |
| Neutrogena Light Therapy Acne Mask+ (K180847) | Johnson & Johnson Consumer, Inc. | 2018-06-19 |
| Surgic Pro, Surgic Pro+ (K173905) | Nakanishi, Inc. | 2018-06-19 |
| AGE Automatic Upper Arm Blood Pressure Monitor with models BA-815, BA-816, BA-818 and BA-819 (K172895) | Ageless Health Industrial Co., Ltd. | 2018-06-18 |
| GCE704 Breast Pump (K172842) | Globalcare | 2018-06-18 |
| Tecno Med, Tecno Med Mineral, Tecno Med Mineral Dentine, Tecno Med Mineral Tissue (K181484) | Zirkonzahn Srl | 2018-06-18 |
| SD LTM STIM Cortical Stimulator (K180761) | Micromed S.P.A. | 2018-06-18 |
| Sherlock 3CG+ T ip Confirmation System (K180560) | C.R. Bard, Inc. | 2018-06-18 |
| IU Implant System (K172345) | Warantec Co., Ltd. | 2018-06-18 |
| Savion DLVR Guidewire, Savion FLX Guidewire (K180726) | Boston Scientific, Inc. | 2018-06-18 |
| FlowTriever Retrieval/Aspiration System (K181325) | Inari Medical, Inc. | 2018-06-17 |
| CoLink™ Afx Plating System (K181113) | In2bones USA, LLC | 2018-06-15 |
| Medline Prevention CoolZone Gown (K172954) | Medline Industries, Inc. | 2018-06-15 |
| Prodiva 1.5T CX and Prodiva 1.5T CS R5.4 (K173507) | Philips Healthcare (Suzhou) Co., Ltd. | 2018-06-15 |
| Electro Antiperspirant, Electro Antiperspirant Sensitive, Electro Antiperspirant ELITE (K170835) | Hightech Development | 2018-06-15 |
| Natus Photic Stimulator (K173936) | Natus Medical Incorporated Dba Excel-Tech Ltd. (Xltek) | 2018-06-15 |
| Interlude and private label Unscented 3-piece compact applicator tampon (K173225) | Albaad Fem | 2018-06-15 |
| Trinity PLUS Acetabular Shell (K172551) | Corin U.S.A. Limited | 2018-06-15 |
| Life Spine SIMPACT Sacroiliac Joint Fixation System (K180749) | Life Spine, Inc. | 2018-06-15 |
| Scone Mask (K180497) | Resmed, Ltd. | 2018-06-15 |
| Fusion Bx 2.0 (K181290) | Focal Healthcare, Inc. | 2018-06-15 |
| DESS Dental Smart Solutions (K173908) | Terrats Medical SL | 2018-06-15 |
| LifeSignals WiPoint Biosensor_iOS Receiver_App System (LifeSignals WiPatch & WiApp System) (K172011) | Hmicro, Inc. | 2018-06-14 |
| Smart External Drain (SED) System (K181301) | Aqueduct Critical Care, Inc. | 2018-06-14 |
| Patello-Femoral Wave (Kahuna) Arthroplasty System (K181280) | Arthrosurface, Inc. | 2018-06-14 |
| POGO Automatic Blood Glucose Monitoring System (K181316) | Intuity Medical, Inc. | 2018-06-14 |
| Disposable Sterile Needle (K172938) | Jiangsu Caina Medical Co.,Ltd | 2018-06-14 |
| Access hsTnl (K172787) | Beckman Coulter, Inc. | 2018-06-14 |
| Ligation Device (K172985) | Leo Medical Co., Ltd. | 2018-06-14 |
| TiWAVE-C™ Porous Titanium Cervical Cage (K180401) | Kalitec Direct, LLC | 2018-06-14 |
| CARTO 3 EP Navigation System, Version 4.35 and Accessories with COHERENT MAP Module (K173977) | Biosense Webster, Inc. | 2018-06-14 |
| Nitrile Powder Free Examination Glove with Colloidal Oatmeal USP with Low-Dermatitis Potential Claim and Tested For Use with Chemotherapy Drugs (White) (K180505) | Hartalega Sdn Bhd | 2018-06-14 |
| ASI Evolution (K173376) | Arlington Scientific, Inc. (Asi) | 2018-06-14 |
| Natus Brain Monitor Amplifier (K180290) | Natus Medical Incorporated Dba Excel-Tech Ltd. (Xltek) | 2018-06-14 |
| BTL 799-2 (K180813) | BTL Industries, Inc. | 2018-06-14 |
| EchoMD Automated Ejection Fraction Software (K173780) | Bay Labs, Inc. | 2018-06-14 |
| SurgTech Bipolar Head System (K173455) | Surgtech, Inc. | 2018-06-14 |
| InMode Diolaze System (K180719) | Inmode MD , Ltd. | 2018-06-14 |
| Double Flexible Tipped Wire Guides (K181351) | Cook Incorporated | 2018-06-14 |
| COMPACTCATH Lubricated Intermittent UrinaryCatheter and OneCath Intermittent Urinary Catheter (K180738) | Compactcath, Inc. | 2018-06-14 |
| Portex® Lancet Point Spinal Needles with NRFit™ connectors, Portex® Pencil Point Spinal Needles with NRFit™ connectors (K172800) | Smiths Medical Asd, Inc. | 2018-06-14 |
| S128 Anterior Lumbar Interbody Fusion (ALIF) System (K180502) | Renovis Surgical Technologies, Inc. | 2018-06-14 |
| MRIaudio PREM System (K180100) | Mriaudio | 2018-06-14 |
| PEAK NS033CF, PEAK NS017CF (K180565) | Neosil Co., Ltd. | 2018-06-13 |
| Signature Orthodontic System (K181271) | Signature Orthodontics | 2018-06-13 |
| Ysio Max (K181279) | Siemens Medi Cal Solutions, Inc. | 2018-06-13 |
| HealthCCS (K172983) | Zebra Medical Vision, Ltd. | 2018-06-13 |
| PEDRA-17F Digital Flat Panel X-ray Detector (K180989) | Radisen, Inc. | 2018-06-13 |
| Desio (hioxifilcon D) Daily Wear Soft (hydrophilic) Contact Lenses (Clear and Tinted) (K181050) | Qualimed Srl | 2018-06-13 |
| CELERITY 20 HP Biological Indicator (K181429) | STERIS Corporation | 2018-06-13 |
| Aptima Combo 2 Assay (Panther System) (K180681) | Hologic, Inc. | 2018-06-13 |
| Catamaran Sacroiliac Joint Fixation System (CAT SIJ Fixation System) (K180818) | Tenon Medical, Inc. | 2018-06-13 |
| EcoVue Sterile and Non-Sterile Ultrasound Gels (K181363) | H R Pharmaceuticals, Inc. | 2018-06-13 |
| Harmony XL Multi-Application Platform (K181298) | Alma Lasers, Inc. | 2018-06-13 |
| Atlas Spine Expandable Cervical Interbody System (K180675) | Atlas Spine, Inc. | 2018-06-13 |
| VERIFY Assert Self-Contained Biological Indicator (K181442) | STERIS Corporation | 2018-06-13 |
| Case Medical SteriTite Reusable Rigid Sterilization Container System with MediTray accessories (K173259) | Case Medical, Inc. | 2018-06-13 |
| Vinyl Examination Glove (Clear, Non-Colored) (K180861) | Zhicheng Trading Co., Ltd. | 2018-06-13 |
| SyMRI (K181093) | Syntheticmr AB | 2018-06-12 |
| ZQuiet (K180124) | Sleeping Well, LLC | 2018-06-12 |
| E-XPE Acetabular Components and U-Motion II Acetabular Cup (K172833) | United Orthopedic Corporation | 2018-06-12 |
| Powder Free Vinyl Patient Examination Gloves (Yellow, White) (K180260) | Shanxi Hongjin Plastic Technology Co., Ltd. | 2018-06-12 |
| White Nitrile Examination Glove, Sterile with Chemotherapy Drugs Claim (K180452) | Riverstone Resources Sdn Bhd | 2018-06-12 |
| Perfusor® Space Syringe Infusion Pump System (K172831) | B.Braun Medical, Inc. | 2018-06-12 |
| DreaMed Advisor Pro (DEN170043) | DreaMed Diabetes, Ltd. | 2018-06-12 |
| HeartSee Cardiac P.E.T. Processing Software (K181343) | Bracco Diagnostics, Inc. | 2018-06-12 |
| Portex NRFit Epidural Needles (K172823) | Smiths Medical Asd, Inc. | 2018-06-12 |
| Access hs Tnl (K172783) | Beckman Coulter, Inc. | 2018-06-12 |
| Pollogen Legend System (K173503) | Pollogen, Ltd. | 2018-06-11 |
| Phenom 27 Catheter (K180959) | Cathera, Inc. | 2018-06-11 |
| CAPERE Thrombectomy System (K180722) | Kp Medcure, Inc. | 2018-06-11 |
| SOFIA Plus Aspiration Catheter (K173200) | MicroVention, Inc. | 2018-06-11 |
| X-MESH® Expandable Cage System, OCELOT® Stackable Cage System, Stackable Cage System, Surgical Titanium Mesh System, BENGAL Stackable Cage System, BENGAL System, CONCORDE® System, CONCORDE® Inline Lumbar Interbody System, CONCORDE® Curve Lumbar Interbody System, CONCORDE® Bullet Lumbar Interbody System, COUGAR® System, COUGAR® LS Lateral Cage System, DEVEX® System, LEOPARD® System, DePuy PULSE Cervical Cage System, DePuy PULSE Lumbar Cage System, LUMBAR I/F CAGE® System (K173787) | Medos International SARL | 2018-06-11 |
| Endiscope, Endiscope Cervical (K180766) | Elliquence, LLC | 2018-06-11 |
| Altus Spine Pedicle Screw System (K181281) | Altus Partners, LLC | 2018-06-11 |
| BeautiCem Veneer Kit (K180649) | Shofu Dental Corporation | 2018-06-11 |
| Ti-one 101 TS Dental Implant System (K172821) | Hung Chun Bio-S Co., Ltd. | 2018-06-11 |
| Vinyl Examination Glove (Clear, Non-Colored) (K180849) | Huifu Trading Co., Ltd. | 2018-06-11 |
| LIAC HWL (K172961) | Sit Sordina Iort Technologies Spa | 2018-06-11 |
| GRI-Alleset Veress Needle (K172835) | Gri Medical and Electronic Technology Co., Ltd. | 2018-06-11 |
| Omnican fine (K173803) | B.Braun Medical, Inc. | 2018-06-11 |
| Disposable Powder Free Nitrile Examination Glove, White/ Blue/ Black/ Pink Color (K171422) | Ever Global (Vietnam) Enterprise Corp | 2018-06-11 |
| 17HK700G-W (K180332) | Lg Electronics | 2018-06-08 |
| Acuity 18 (enflufocon A) Rigid Gas Permeable Contact Lens, Acuity 58 (enflufocon B) Rigid Gas Permeable Contact Lens, Acuity 85 (Oprifocon A) Rigid Gas Permeable Contact Lens, Acuity 100 (hexafocon A) Rigid Gas Permeable Contact Lens (K180988) | Acuity Polymers, Inc. | 2018-06-08 |
| VT Dressing Kits (K172725) | Carilex Medical, Inc. | 2018-06-08 |
| Aveo (omafilcon A) Soft (Hydrophilic) Contact Lenses (K180985) | Supervision Optimax Sdn Bhd | 2018-06-08 |
| Single Use Aspiration Needle NA-U200H (K180449) | Olympus Medical Systems Corp. | 2018-06-08 |
| Piccolo Implants and Accessories (K173706) | Southern Implants (Pty), Ltd. | 2018-06-08 |
| Integrated CardioRespiratory System (K173156) | Sensydia, Inc. | 2018-06-08 |
| Nexy (K180306) | Next Sight Srl | 2018-06-08 |
| Lumfuse TP (K173189) | Precifit Medical, Ltd. | 2018-06-08 |
| Sniper Infusion Catheter with Balloon Occlusion (K180904) | Embolx, Inc. | 2018-06-08 |
| HSW Resection Instruments (K173070) | Henke-Sass, Wolf GmbH | 2018-06-08 |
| Avanti (K180660) | Optovue, Inc. | 2018-06-08 |
| Reusable SpO2 Sensors, Disposable SpO2 Sensors (K172981) | APK Technology Co., Ltd. | 2018-06-08 |
| ELEVARE, PERFECTIO 4 (K172909) | Omm Imports D/B/A Zero Gravity | 2018-06-07 |