| Apex Locator, DPEX III (K181087) | Guilin Woodpecker Medical Instrument Co., Ltd. | 2018-12-18 |
| BIO-VENTURE Rapid Amphetamine Test Cassette for OTC Use, BIO-VENTURE Rapid Oxazepam Test Cassette for OTC Use, BIO-VENTURE Rapid Cocaine Test Cassette for OTC Use, BIO-VENTURE Rapid Methamphetamine Test Cassette for OTC Use, BIO-VENTURE Rapid Morphine Test Cassette for OTC Use, BIO-VENTURE Rapid Marijuana Test Cassette for OTC Use, BIO-VENTURE Rapid Amphetamine Test Cassette for Rx Use, BIO-VENTURE Rapid Oxazepam Test Cassette for Rx Use, BIO-VENTURE Rapid Cocaine Test Cassette for Rx (K180878) | Shanghai Venture Bio-Tech Co., Ltd. | 2018-12-17 |
| Acucy Influenza A&B Test with the Acucy System (K182001) | SEKISUI Diagnostics, LLC | 2018-12-17 |
| NovoPen Echo Dial-A-Dose Insulin Delivery Device (Pen Injector) (K182387) | Novo Nordisk, Inc. | 2018-12-17 |
| Handheld VitalSigns Monitoring System (K172965) | Visiomed Technology Co.,Ltd | 2018-12-17 |
| FlowTriever Retrieval/Aspiration System (K183198) | Inari Medical | 2018-12-17 |
| Reusable Silicone Cover CPRmeter 2 (K183348) | Laerdal Medical AS | 2018-12-17 |
| Met One Czar Anterior Cervical Plate System (K180772) | Met One Technologies | 2018-12-17 |
| Tyto Stethoscope (OTC) (K181612) | Tyto Care , Ltd. | 2018-12-17 |
| Reusable Blood Pressure Cuff, Disposable Blood Pressure Cuff (K182433) | Shenzhen Caremed Medical Technology Co., Ltd. | 2018-12-17 |
| Phoenix 2.4mm Atherectomy Plus System (K181877) | Volcano Atheromed, Inc. | 2018-12-17 |
| Cardio-TriTest v6.5 (K182790) | Cardio-Phoenix, Inc. | 2018-12-14 |
| SureClip Repositionable Hemostasis Clip (K182556) | Micro-Tech (Nanjing) Co., Ltd. | 2018-12-14 |
| Tono Vue Non-Contact Tonometer (K180820) | Crystalvue Medical Corporation | 2018-12-14 |
| Xcess Guiding Catheter (K180797) | Curatia Medical Co. | 2018-12-14 |
| MTS Omadacycline 0.002-32 µg/mL (K182922) | Liofilchem s.r.l. | 2018-12-14 |
| UV Active Implant System (K182194) | Dio Corporation | 2018-12-14 |
| HyperFil-LV (K182296) | Parkell, Inc. | 2018-12-14 |
| 3880 MRI Patient Monitoring System (K182900) | Iradimed Corporation | 2018-12-14 |
| AC5 Topical Gel (K182681) | Arch Therapeutics, Inc. | 2018-12-14 |
| UniPulse (K182905) | Seaward Group | 2018-12-14 |
| Vitrea Software Package, VSTP-001A (K182601) | Canon Medical Systems Corporation | 2018-12-14 |
| RCT800 (K182805) | Ray Co., Ltd. | 2018-12-14 |
| SCIg60 Infusion System (K173783) | Emed Technologies Corporation | 2018-12-14 |
| Arthrex SwiveLock Anchors (K180768) | Arthrex, Inc. | 2018-12-14 |
| SafeAir Telescopic Smoke Pencil (K182354) | Lina Medical Aps | 2018-12-14 |
| NRFit Syringe (K181374) | Jiangsu Caina Medical Co.,Ltd | 2018-12-14 |
| TR90BH (K182207) | Minxray, Inc. | 2018-12-14 |
| Affixus Hip Fracture Nail (K183162) | Biomet, Inc. | 2018-12-14 |
| C.T.M Mobility Scooter (K181344) | Chien TI Enterprise Co., Ltd. | 2018-12-14 |
| Affixus Natural Nail System Humeral Nail (K181827) | Zimmer GmbH | 2018-12-14 |
| Acu-sInQ Complete Endoscope Cleaning Aid System (K181865) | STERIS Corporation | 2018-12-14 |
| Phasix ST Mesh with Echo 2 Positioning System (K182008) | C.R. Bard, Inc. | 2018-12-14 |
| BIO-VENTURE Rapid Multi-Drug Test Easy Cup for OTC Use, BIO-VENTURE Rapid Multi-Drug Test Split Key Cup for OTC Use, BIO-VENTURE Rapid Multi-Drug Test Easy Cup for Rx Use, BIO-VENTURE Rapid Multi-Drug Test Split Key Cup for Rx Use (K180879) | Shanghai Venture Bio-Tech Co., Ltd. | 2018-12-14 |
| Rapid Reboot Compression Therapy System (K182668) | Rapid Reboot Recovery Products, LLC | 2018-12-14 |
| Honda Walking Assist Device (K181294) | Honda Motor Company, Ltd. | 2018-12-14 |
| Centricity Universal Viewer (K182419) | GE Healthcare | 2018-12-14 |
| CAPI 3 HEMOGLOBIN(E) (K180762) | Sebia | 2018-12-14 |
| iCertainty (K181269) | Rfpi | 2018-12-14 |
| HipCheck (K182359) | Stryker Corp. | 2018-12-13 |
| Argos (K181372) | Retia Medical, LLC | 2018-12-13 |
| StatStrip Xpress Glucose Hospital Meter System (K182552) | Nova Biomedical Corporation | 2018-12-13 |
| DuraSheath Introducer Sheath System (K181463) | Contract Medical International, GmbH | 2018-12-13 |
| ROCCIA® PLIF (K181899) | Silony Medical GmbH | 2018-12-13 |
| LaparoGuard (K182434) | Mariner Endosurgery, Inc. | 2018-12-13 |
| Diamondback 360 Peripheral Orbital Atherectomy System Exchangeable Series (K182397) | Cardiovascular Systems, Inc. | 2018-12-13 |
| PYRAMIDION Dental Implants and Prostheses (K180859) | Dentack Implants, Ltd. | 2018-12-13 |
| CBT Screw Fixation System (K181824) | U&I Corporation | 2018-12-13 |
| IlluminOss Photodynamic Bone Stabilization System (K183145) | Illuminoss Medical, Inc. | 2018-12-13 |
| Accu-Chek Guide Me Blood Glucose Monitoring System (K181131) | Roche Diabetes Care | 2018-12-13 |
| neoBLUE blanket LED Phototherapy System (K182178) | Natus Medical Incorporated | 2018-12-13 |
| Selectra Catheters, Selectra Accessory Kit (K183265) | Biotronik, Inc. | 2018-12-13 |
| BTL-FR2000 (K180359) | BTL Industries, Inc. | 2018-12-13 |
| EVOLUX CAD/CAM PMMA BLOCKS (K182065) | Blue Dent Dental | 2018-12-13 |
| Erran Dental Zirconia (K182068) | Hangzhou Erran Technology Co., Ltd. | 2018-12-13 |
| StatStrip Xpress 2 Glucose Hospital Meter System (K182549) | Nova Biomedical Corporation | 2018-12-13 |
| Harvest Dental Polymer Blocks (K180578) | Harvest Dental Products, LLC | 2018-12-12 |
| ANAX™ OCT Spinal System (K183383) | U&I Corporation | 2018-12-12 |
| On1 Universal Abutment (K181869) | Nobel Biocare AB | 2018-12-12 |
| enlighten III Laser System (K182997) | Cutera, Inc. | 2018-12-12 |
| Medline Cautery Electrode (SILICONE) (K182812) | Medline Industries, Inc. | 2018-12-12 |
| EnSite Velocity Cardiac Mapping System v5.2, EnSite Precision Cardiac Mapping System v2.2 (K183128) | Abbott | 2018-12-12 |
| Salvo™ Spine System (K182954) | Spine Wave, Inc. | 2018-12-12 |
| LEUCADIA AUTOLOK™ Pedicle Screw System (K182339) | Clearview Orthopedic Development, LLC | 2018-12-12 |
| PYRENEES Cervical Plate System, BLUE RIDGE Cervical Plate System, OZARK Cervical Plate System, CAYMAN Thoracolumbar and Buttress Plate Systems (K182473) | K2m, Inc. | 2018-12-12 |
| Retrograde Intubation Set (DEN170055) | Cook Incorporated | 2018-12-12 |
| Precision1 (K182902) | Alcon Laboratories, Inc. | 2018-12-11 |
| Invacare TDX SP2-HD with Captain's Seat (K182946) | Invacare Corporation | 2018-12-11 |
| Intuitive Surgical Vessel Sealer Extend (K183107) | Intuitive Surgical, Inc. | 2018-12-11 |
| Clariti 1 day (somofilcon A) Soft (Hydrophilic) Daily Disposable Contact Lens with UV Blocker (K181920) | CooperVision, Inc. | 2018-12-11 |
| Magma Spark Pro (Magma Spark Plus, Alpha) (K183307) | Formatk Systems , Ltd. | 2018-12-11 |
| OpenLoc-L Spinal Fixation System (K183168) | L&K BIOMED Co., Ltd. | 2018-12-11 |
| Cardinal Health Sterilization Wrap (K181174) | Cardinal Health200, LLC | 2018-12-11 |
| Mygen V-1000 RF System (K180999) | RF Medical Co., Ltd. | 2018-12-11 |
| Life Spine Resolute™ Threaded Cage System (K181625) | Life Spine, Inc. | 2018-12-11 |
| BI-MENTUM dual mobility system (K181744) | Serf | 2018-12-11 |
| URiSCAN 10ACR urine strips on the URiSCAN Optima urine analyzer (K182038) | Yd Diagnostics Corporation | 2018-12-10 |
| FORA MD6 Uric Acid Monitoring System, FORA MD6 Pro Uric Acid Monitoring System (K181675) | Taidoc Technology Corporation | 2018-12-10 |
| SabreLine and SabreGuard Laser Fibers (K182831) | Coloplast Corp. | 2018-12-10 |
| CelerityTM 10 STEAM Chemical Indicator (K182724) | STERIS Corporation | 2018-12-10 |
| Glenoid Polyaxial Non-locking Screws (K181826) | Medacta International S.A. | 2018-12-10 |
| X-ray Imaging System for the McLaren Proton Treatment System (K181498) | Ehmetdx, LLC | 2018-12-10 |
| Mega Plus Spine System (K183080) | Bk Meditech, Co., Ltd. | 2018-12-10 |
| Lucent® XP (K182584) | Spinal Elements, Inc. | 2018-12-10 |
| reSET-O (K173681) | Pear Therapeutics, Inc. | 2018-12-10 |
| Applanation tonometer AT-2 (K182491) | Takagi Seiko Co., Ltd. | 2018-12-10 |
| Distal Radius Plating System (K182810) | Miami Device Solutions, LLC | 2018-12-10 |
| Procellera Composite Antibacterial Wound Dressing (K180533) | Vomaris Wound Care, Inc. | 2018-12-10 |
| BeneVision N Series Patient Monitors (Including BeneVision N12, BeneVision N15, BeneVision N17, BeneVision N19. BeneVision N22, BeneVision N1) (K182075) | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 2018-12-10 |
| Hailie Sensor (K181405) | Adherium (Nz), Ltd. | 2018-12-10 |
| VITEK 2 AST-Gram Positive Inducible Clindamycin Resistance (K181766) | bioMerieux, Inc. | 2018-12-10 |
| ARK Tramadol Assay (K182280) | Ark Diagnostics, Inc. | 2018-12-10 |
| LipiScan Dynamic Meibomian Imager (K182506) | Tearscience, Inc. | 2018-12-10 |
| Disposable Temperature Probe (K181967) | Shenzhen Launch Electrical Co., Ltd. | 2018-12-10 |
| Route 92 Medical Delivery Catheter (K182512) | Route 92 Medical, Inc. | 2018-12-10 |
| CATSmart (K180831) | Fresenius Kabi AG | 2018-12-10 |
| LUTRONIC GENIUS Radiofrequency System (K180945) | Lutronic Corporation | 2018-12-10 |
| Tractus Crossing Support Catheter (K180889) | Tractus Vascular, LLC | 2018-12-07 |
| CitriCon Liquid and Powder (Acid Concentrate acidified with Citric Acid), AcetiCon Liquid and Powder (Acid Concentrate acidified with Acetic Acid or Na Di Acetate), BicarboCon Liquid and Powder (Bicarb Concentrate), RenaCon Liquid and Powder (Acetate Concentrate with Na Acetate) (K180679) | Global Scientific Technologies, LLC | 2018-12-07 |
| ICONN Campbell Interference Screw (K180670) | Iconn Orthopedics, LLC | 2018-12-07 |