| AEON Endoscopic Stapler (K182380) | Lexington Medical, Inc. | 2018-11-28 |
| Sildent Fast Light Body, Sildent Fast Heavy Body, Sildent Bite (K181604) | Hrs Co., Ltd. | 2018-11-28 |
| BGM014 Blood Glucose Monitoring System (K182992) | Apex BioTechnology Corp. | 2018-11-28 |
| Non-contact Infrared Thermometer (K180207) | Alicn Medical (Shenzhen), Inc. | 2018-11-28 |
| ATEC ALIF and LLIF Spacer System (K182746) | Alphatec Spine, Inc. | 2018-11-27 |
| EliA CENP Immunoassay, EliA U1RNP Immunoassay, EliA RNP70 Immunoassay (K182353) | Phadia AB | 2018-11-27 |
| gammaCore Sapphire (K182369) | Electrocore, Inc. | 2018-11-27 |
| Biop Digital Colposcope (K182764) | Biop Medical , Ltd. | 2018-11-27 |
| iFuse Implant System® (K182983) | SI-BONE, Inc. | 2018-11-27 |
| Codman Electrosurgical Irrigator, Codman Electrosurgical Irrigator Interconnecting Cable (K182801) | Integra LifeSciences Corporation | 2018-11-27 |
| AdVance XP Male Sling (K182169) | Boston Scientific Corporation | 2018-11-27 |
| ARiX RAD Radiographic System (K182134) | Compania Mexicana DE Radiologia Cgr, S.A. DE C.V. | 2018-11-26 |
| HEMOSTATIX MODEL P8400 DISPOSABLE HANDLE, HEMOSTATIX MODEL P8400 DISPOSABLE BLADES (K183009) | Hemostatix Medical Technologies, LLC | 2018-11-26 |
| FlexCath Advance Steerable Sheath and Dilator (K183174) | Medtronic Cryocath, LP | 2018-11-26 |
| Corin Optimized Positioning System (OPS) Plan (K183038) | Corin USA | 2018-11-26 |
| Selethru PTCA Balloon Dilatation Catheter (K182699) | Kossel Medtech (Suzhou) Co., Ltd. | 2018-11-26 |
| Vitrea Software Package, VSTP-001A (K183013) | Canon Medical Systems Corporation | 2018-11-26 |
| Plateau Spacer System (K182470) | Life Spine | 2018-11-26 |
| EkoSonic Endovascular System (K182324) | Btg International, Inc. | 2018-11-26 |
| Konicaminolta DI-X1 (K182431) | Konica Minolta, Inc. | 2018-11-26 |
| 3M Clarity Aligners (K183159) | 3M Company | 2018-11-26 |
| Orchestrate 3D (K181112) | Orchestrate 3D | 2018-11-26 |
| TRULIANT Porous Tibial Tray and Exactech Alteon Bone Screws (K182346) | Exactech, Inc. | 2018-11-26 |
| Low-frequency Multi-function physiotherapy instrument (K172837) | Shenzhen Osto Technology Co., Ltd. | 2018-11-26 |
| Steroid 21-Hydroxylase Antibody (21-OHAb) ELISA Kit (K180607) | Kronus, Inc. | 2018-11-23 |
| Hyper GP (tisilfocon A) Daily Wear Contact Lens (K182304) | Contamac, Ltd. | 2018-11-23 |
| MedCu Antibacterial Wound Dressings with Copper-Oxide (MedCu ABWDs) (K180643) | Medcu Technologies , Ltd. | 2018-11-23 |
| Motion Tracking and Compensation Feature for the Radixact Treatment Delivery System (K182687) | Accuray Incorporated | 2018-11-23 |
| Digistat Smart Central (K180430) | Ascom Ums Srl Unipersonale | 2018-11-23 |
| Responsive Arthroscopy Interference Screw System (K180573) | Responsive Arthroscopy, LLC | 2018-11-23 |
| A.B. Dental Devices Dental Implants System (K181381) | A.B. Dental Device , Ltd. | 2018-11-23 |
| Greene Renal Transplant Stent Set (K180557) | Cook Incorporated | 2018-11-23 |
| Visor System (K182967) | Cerebrotech Medical Systems, Inc. | 2018-11-23 |
| Accula RSV Test (K181443) | Mesa Biotech, Inc. | 2018-11-23 |
| HammerTechTM Fixation System (K182684) | Fusion Orthopedics, LLC | 2018-11-23 |
| Sunkingdom Slit Lamp (K182306) | Chongqing Sunkingdom Medical Instrument Co., Ltd. | 2018-11-22 |
| DAILIES AquaComfort Plus, DAILIES AquaComfort Plus FreshTech, DAILIES AquaComfort Plus Toric and DAILIES AquaComfort Plus Multifocal (K181454) | Alcon Laboratories, Inc. | 2018-11-21 |
| DePuy Synthes 2.0 mm Quick Insertion Screws (K180541) | Synthes USA Products, LLC | 2018-11-21 |
| Isolette 8000 Plus (K182977) | Draeger Medical Systems, Inc. | 2018-11-21 |
| Wet Organics Personal Lubricant (K182027) | Trigg Laboratories Dba Wet International | 2018-11-21 |
| MATRx Plus (K181996) | Zephyr Sleep Technologies | 2018-11-21 |
| Transpara (K181704) | Screenpoint Medical B.V. | 2018-11-21 |
| DENTIOIII series (DENTIOIII, DENTIOIII-S) (K181297) | Hdx Will Corp. | 2018-11-21 |
| Jet Power Injectable PICC (K180546) | Jet Medical, Inc. | 2018-11-21 |
| ApnoDent Appliance (K181123) | Apnomed, Inc. | 2018-11-21 |
| PlayMakar Sport Muscle Stimulator, Model PRO-500 (K182581) | Playmakar, Inc. | 2018-11-21 |
| PINPOINT Endoscopic Fluorescence Imaging System (K182606) | Novadaq Technologies Ulc. (Now A Part of Stryker) | 2018-11-21 |
| Versana Premier (K182277) | GE Medical Systems Ultrasound and Primary Care Diagnostics | 2018-11-21 |
| SP-LINK™ System (K182352) | Medical Designs, LLC | 2018-11-21 |
| Roth Net Retriever Product Line (K182909) | United States Endoscopy Group, Inc. | 2018-11-21 |
| Heli-FX EndoAnchor System (K182957) | Medtronic Vascular, Inc. | 2018-11-21 |
| ProFuse CAD (K173744) | Eigen | 2018-11-21 |
| ARK EDDP Assay (K182779) | Ark Diagnostics, Inc. | 2018-11-21 |
| MR Compatible Aspiration Kit (K181731) | Mri Interventions, Inc. | 2018-11-20 |
| COCET Digital Thermometer (Models KFT-01/KFT-02/KFT-03/KFT-04/KFT-05/KFT-06/KFT-07/KFT-08/KFT-09/KFT-10 (K182652) | Kangfu Medical Equipment Factory | 2018-11-20 |
| Orbit Subretinal Delivery System (K182274) | Orbit Biomedical, Inc. | 2018-11-20 |
| TPH Spectra ST Flowable Composite Restorative (K182288) | Dentsply Sirona | 2018-11-20 |
| 6MP Color LCD Monitor (C61W+) (K182291) | Shenzhen Beacon Display Technology Co., Ltd. | 2018-11-20 |
| Infrared Thermometer (K182133) | Shenzhen AOJ Medical Technology Co., Ltd. | 2018-11-20 |
| Vitrea CT Brain Perfusion (K181247) | Vital Images, Inc. | 2018-11-20 |
| GC Acrylic Primer (K180917) | GC America, Inc. | 2018-11-20 |
| Telepack X LED (K182696) | KARL STORZ Endoscopy-America, Inc. | 2018-11-20 |
| CodMan Certas Plus Programmable Valve (K182265) | Integra Lifesciences Corp. | 2018-11-20 |
| Piloter Exp/Piloter/Piloter P Diagnostic Ultrasound System (K182715) | Shenzhen Wisonic Medical Technology Co. , Ltd. | 2018-11-20 |
| VERIFY All-In-One STEAM Reusable Test Pack, VERIFY All-In-One STEAM Reusable Test Pack with Step Counter, VERIFY All-In-One STEAM Reusable Test Pack with Tracker Tag (K182931) | Steris Corporations | 2018-11-20 |
| ARIX Sternal System (K181806) | Jeil Medical Corporation | 2018-11-20 |
| NuVasive Monolith Cervical Corpectomy System (K180550) | Nu Vasive, Incorporated | 2018-11-20 |
| Powder Free Nitrile Patient Examination Glove, Blue Colored, Non-Sterile, Low Dermatitis Potential. Tested for Use with Chemotherapy Drugs and Fentanyl Citrate (K181857) | Kossan International Sdn Bhd | 2018-11-20 |
| R3 Anteverted Liners (K182535) | Smith & Nephew, Inc. | 2018-11-19 |
| SAFECARE Multi-Drug Urine Test Cup, SAFECARE Multi-Drug Urine Test Dip Card (K182654) | Safecare Biotech (Hangzhou) Co., Ltd. | 2018-11-19 |
| Valleylab Smoke Evacuation Rocker Switch Pencil , Valleylab Telescoping Smoke Evacuation Rocker Switch Pencil (K182772) | Covidien | 2018-11-19 |
| QMS Plazomicin Immunoassay (DEN180030) | Microgenics Corporation | 2018-11-19 |
| AI-ECG Platform (K180432) | Shenzhen Carewell Electronics., Ltd. | 2018-11-19 |
| LensHooke X1 Pro Semen Quality Analyzer, LensHooke X1 Semen Quality Analyzer (K180343) | Bonraybio Co., Ltd. | 2018-11-16 |
| Pruitt F3 Carotid Shunt, 10 Fr, Pruitt F3 Carotid Shunt, 9 Fr, Pruitt F3 Carotid Shunt, 8 Fr (K182916) | Lemaitre Vascular | 2018-11-16 |
| Celesteion, PCA-9000A/3, V6.5 (K181646) | Canon Medical Systems Corporation | 2018-11-16 |
| hemochroma PLUS System (K182298) | Immunostics Inc., | 2018-11-16 |
| Serenity Piezo Sensor, Serenity Thermocouple Sensor (K181709) | Neurotronics, Inc. | 2018-11-16 |
| REDAPT Modular Acetabular Shell (K182109) | Smith & Nephew, Inc. | 2018-11-16 |
| PureFlex Arterial Cannulae (K180979) | Sorin Group Italia S.R.L. | 2018-11-16 |
| AposTherapy System (K182090) | Apos Medical Assets , Ltd. | 2018-11-16 |
| AdvantageRib Anterior System (K182179) | Sig Medical Corp. | 2018-11-16 |
| Solidity Vertebral Body Replacement (K181921) | Ulrich Medical USA | 2018-11-16 |
| Hair Boom 69 (K182562) | Wontech | 2018-11-16 |
| OEC One (K182626) | Ge Hualun Medical Systems Co. , Ltd. | 2018-11-16 |
| Zilver 518 Biliary Stent, Zilver 635 Biliary Stent (K182980) | Cook Ireland, Ltd. | 2018-11-16 |
| 1.5T 16ch Breast Coil (K182958) | Neocoil, LLC | 2018-11-16 |
| SafeT T-Piece Resuscitator (K173373) | Ventlab, LLC | 2018-11-16 |
| Stratum™ Foot Plating System (K182201) | Nextremity Solutions, Inc. | 2018-11-16 |
| Axis Chena Cervical PEEK Spacer System (K181140) | Axis Orthopaedics | 2018-11-16 |
| InstruSafe(R) Sterilization Container (K180528) | Summit Medical, Inc. | 2018-11-16 |
| 1.5T 16Ch Diagnostic Breast Coil, 3.0T 16Ch Diagnostic Breast Coil (K181948) | Rapid Biomedical GmbH | 2018-11-16 |
| HemoSphere Advanced Monitor, HemoSphere Pressure Cable (K180881) | Edwards Lifesciences, LLC | 2018-11-16 |
| Oral Device OA, Oral Device S (K181396) | Passion For Life Healthcare (Uk) Limited | 2018-11-16 |
| Zeramex(R) XT Dental Implant System, NobelPearl Dental Implant System (K180184) | Dentalpoint AG | 2018-11-16 |
| Powder Free Examination Gloves with Colloidal Oatmeal USP and Tested for Use with Chemotherapy Drugs - (Lemon Green) (K180645) | Hartalega Sdn Bhd | 2018-11-16 |
| IT-III active System (K181137) | Neobiotech Co., Ltd. | 2018-11-16 |
| SmartBag (SmartPouch) (K181643) | 11 Health Technologies Limited | 2018-11-16 |
| Nexcomp (K181689) | Meta Biomed Co., Ltd. | 2018-11-15 |
| YUKON OCT Spinal System (K182182) | K2m | 2018-11-15 |