| Zenition 50 (K183101) | Philips Medical Systems Nederland B.V. | 2018-12-31 |
| ViperCath XC Peripheral Exchange Catheter (K183000) | Cardiovascular Systems, Inc. | 2018-12-29 |
| Straumann BLX Line Extension - Implants, SRAs and Anatomic Abutments (K181703) | Institut Straumann AG | 2018-12-28 |
| EyeBOX (DEN170091) | Oculogica, Inc. | 2018-12-28 |
| OIC Suture Anchor System (K182736) | The Orthopaedic Implant Company | 2018-12-28 |
| AmCAD-UO (K180867) | Amcad Biomed Corporation | 2018-12-28 |
| CranioMaxillofacial Fixation (CMF) System - CMF Visionare (K180204) | Visionare, LLC | 2018-12-28 |
| COR12 ECG (K183369) | Corscience GmbH & Co. | 2018-12-28 |
| Lotus III Multi-Pulsed Er: Yag Laser System (K182045) | Laseroptek Co., Ltd. | 2018-12-27 |
| STERRAD VELOCITY Biological Indicator (K182404) | Advanced Sterilization Products (Asp) | 2018-12-27 |
| minisono (K182845) | Alpinion Medical Systems Co., Ltd. | 2018-12-27 |
| Quantib ND (K182564) | Quantib B.V. | 2018-12-27 |
| LATITUDE EV Total Elbow Arthroplasty (K182461) | Tornier, Inc. | 2018-12-27 |
| iSchemaView RAPID (K182130) | Ischemaview, Inc. | 2018-12-27 |
| Pulse 2.0, Pulse Pro 2.0 (K183169) | NormaTec Industries, LP | 2018-12-27 |
| Zimmer Biomet Select Ceramic Heads (K181761) | Zimmer, Inc. | 2018-12-26 |
| LIAISON Calprotectin, LIAISON Calprotectin Control Set, LIAISON Calprotectin Calibration Verifiers, LIAISON Q.S.E.T. Buffer, LIAISON Q.S.E.T. Device (K182698) | DiaSorin, Inc. | 2018-12-26 |
| DePuy Synthes Trauma Orthopedic Nail Implants (K182783) | DePuy Synthes | 2018-12-26 |
| Delta TT Pro (K182099) | Lima Corporate S.P.A. | 2018-12-26 |
| VO200 – NeurOs Cerebral Oximetry System (K182242) | Mespere Lifesciences, Inc. | 2018-12-26 |
| One-Step Suprapubic Introducer (K182709) | Cook Incorporated | 2018-12-26 |
| QuikClot Radial (K181641) | Z-Medica, LLC | 2018-12-24 |
| EliA SmDP Immunoassay (K183007) | Phadia AB | 2018-12-24 |
| Arthrex Fracture Adapter Hemi Shoulder Prosthesis (K181555) | Arthrex, Inc. | 2018-12-21 |
| VITEK MS (K181412) | bioMerieux, Inc. | 2018-12-21 |
| vital signs monitor (K180380) | Edan Instruments, Inc. | 2018-12-21 |
| Disposable Temperature Probe (K182755) | Shenzhen Caremed Medical Technology Co., Ltd. | 2018-12-21 |
| Miris Human Milk Analyzer (DEN180007) | Miris AB | 2018-12-21 |
| JUVORA Oyster White Dental Disc, CERAMILL PEEK by JUVORA, Oyster White (K181331) | Juvora, Ltd. | 2018-12-21 |
| LENSAR Laser System - fs 3D (LLS-fs 3D) (K182795) | Lensar, Inc. | 2018-12-21 |
| ADVIA Centaur Calcitonin (CALCT) assay (K182012) | Axis-Shield Diagnostics Limited | 2018-12-21 |
| ePlex Blood Culture Identification Panel Fungal Pathogen (BCID-FP) Panel (K182690) | Genmark Diagnostics, Incorporated | 2018-12-21 |
| SterilContainer S System (K182032) | Aesculap, Inc. | 2018-12-21 |
| Natrelle 133 Plus MICROCELL Tissue Expander (K180826) | Allergan | 2018-12-21 |
| TruMatch Graft Cage - Long Bone (K180821) | Synthes (Usa), LLC | 2018-12-21 |
| Stryker iVAS Elite Inflatable Vertebral Augmentation System (Stryker iVAS Elite Balloon Catheter) (K181752) | Stryker Corporation | 2018-12-21 |
| Pulse Rx 2.0, Pulse Pro Rx 2.0 (K183328) | NormaTec Industries, LP | 2018-12-21 |
| 4D View (K182750) | GE Medical Systems Ultrasound and Primary Care Diagnostics | 2018-12-21 |
| 3nethra neo (K183059) | Forus Health Pvt.Ltd | 2018-12-21 |
| PTS Professional Chemistry Kit (K182781) | Polymer Technology Systems, Inc. D/B/A Pts Diagnostics | 2018-12-21 |
| OrthoGold 100 (K182682) | Tissue Regeneration Technologies | 2018-12-21 |
| The ICHOR Panacea Vascular Embolectomy Catheter System (K182167) | Ichor Vascular, Inc. | 2018-12-21 |
| Clear-Jet Injection Catheter (K181690) | Finemedix Co., Ltd. | 2018-12-21 |
| vascuCAP (K183012) | Elucid Bioimaging, Inc. | 2018-12-21 |
| REXLENE (K173747) | Sm Eng Co., Ltd. | 2018-12-21 |
| DIO CAD/CAM Abutment (K181037) | Dio Corporation | 2018-12-21 |
| North-vision Multi-parameter Patient Monitor (K173036) | North-Vision Tech., Inc. | 2018-12-21 |
| MLL (KMT2A) Breakapart FISH Probe Kit; AML1 (RUNX1) Breakapart FISH Probe Kit, P53 (TP53) Deletion FISH Probe Kit; EVI1 (MECOM) Breakapart FISH Probe Kit, Del(20q) Deletion FISH Probe Kit; AML1/ETO (RUNX1/RUNXIT1)) Translocation, Dual Fusi, CBFB (CBFB) /MYH11 Translocation, Dual Fusion FISH Probe Kit,Del(5q)Deletion FISH Probe Kit; Del(7q)Deletion FISH Probe Kit (DEN170070) | Cytocell, Ltd. | 2018-12-21 |
| Neocis Guidance System (K182776) | Neocis, Inc. | 2018-12-21 |
| Nitrile Glove Powder Free White (K183068) | Haining Medical Products Co., Ltd. | 2018-12-21 |
| 2.8 mm/3.3 mm PopLok Suture Anchors (K181120) | Conmed Corporation | 2018-12-21 |
| Creme de La Femme Feminine Lubricant (K180014) | Cewal, Inc. Dba Premiere Enterprises | 2018-12-21 |
| ASAHI Corsair Pro XS (K182420) | Asahi Intecc Co., Ltd. | 2018-12-20 |
| Color Doppler Ultrasound System; Model: mEye1 and mEye2 (K182165) | Shenzhen Well.D Medical Electronics Co., Ltd. | 2018-12-20 |
| BD Contoured Base Pen Needle (K182320) | Becton, Dickinson and Company | 2018-12-20 |
| Embrace (K181861) | Empatica S.r.l. | 2018-12-20 |
| Enlight 1810 (DEN170072) | Timpel, Inc. | 2018-12-20 |
| 3DIEMME RealGUIDE (K173041) | 3Diemme , Ltd. | 2018-12-20 |
| SEM Scanner (Model 200) (DEN170021) | Bruin Biometrics, LLC | 2018-12-20 |
| Reuter Tip Deflecting Wire Guide (K180830) | Cook Incorporated | 2018-12-20 |
| Phoenix Atherectomy System (K182972) | Volcano Atheromed, Inc. | 2018-12-20 |
| microTargeting Guideline 4000 5.0 System (K183123) | FHC, Inc. | 2018-12-20 |
| Sinusway Dilation System (K181838) | 3nt Medical , Ltd. | 2018-12-20 |
| ePlex Blood Culture Identification Panel - Gram Positive (BCID-GP) Panel (K181663) | Genmark Diagnostics, Incorporated | 2018-12-20 |
| MTS Levofloxacin 0.002 - 32 µg/mL (K183115) | Liofilchem s.r.l. | 2018-12-20 |
| O2 Concepts Oxlife Independence Model 301-0001 (K182454) | O2 Concepts, LLC | 2018-12-20 |
| Dilator Sets (K183036) | Cook Incorporated | 2018-12-20 |
| FIBERGRAFT AERIDYAN Matrix Bone Graft Substitute (K182670) | Prosidyan, Inc. | 2018-12-20 |
| Natureplex Warm Touch Warming Jelly (K180828) | Natureplex, LLC | 2018-12-20 |
| Curiteva Lumbar Interbody Fusion System (K181589) | Curiteva, LLC | 2018-12-20 |
| DyeVert™ NG Contrast Reduction System, DyeVert™ PLUS EZ Contrast Reduction System, DyeTect™ Contrast Monitoring Disposable Kit, Smart Syringe, DyeVert™ PLUS EZ Contrast Reduction System (K183267) | Osprey Medical, Inc. | 2018-12-20 |
| AirSpiral Heated Breathing Tube (K162553) | Fisher & Paykel Healthcare | 2018-12-20 |
| FORA NAS100 Electronic Nasal Aspirator, Electronic Nasal Aspirator (K180863) | Taidoc Technology Corporation | 2018-12-19 |
| TruShot with Y-Knot All-Suture Anchor (K182446) | Conmed Corporation | 2018-12-19 |
| Modified BrainScope One (K181785) | Brainscope Company, Inc. | 2018-12-19 |
| BA310 Abutment, BIA310 Implant/Abutment (K182116) | Cochlear Americas | 2018-12-19 |
| FFRangio System (K182149) | Cathworks, Ltd. | 2018-12-19 |
| Simplexa Bordetella Direct, Simplexa Bordetella Positive Control Pack (K183223) | Diasorin Molecular, LLC | 2018-12-19 |
| CoreLink F3D™ Lateral System (K183239) | Corelink, LLC | 2018-12-19 |
| Fetal Doppler (K182190) | Shenzhen AOJ Medical Technology Co., Ltd. | 2018-12-19 |
| Valleylab FT10 Electrosurgical Platform, Cardioblate BP2 Surgical Ablation Device, Cardioblate LP Surgical Ablation Device (K182610) | Medtronic | 2018-12-19 |
| VivaChek Ino Smart Blood Glucose Monitoring System, VivaChek Ino Sync Blood Glucose Monitoring System, VivaChek Ino Sound Blood Glucose Monitoring System, VivaChek Ino Plus Blood Glucose Monitoring System, VivaChek Ino Sound Simple Blood Glucose Monitoring System, VivaChek Ino Sound Bright Blood Glucose Monitoring System (K173140) | Vivachek Laboratories, Inc. | 2018-12-19 |
| Arterial Pressure Monitoring Set/Tray (K180846) | Cook Incorporated | 2018-12-19 |
| HERA W10 Diagnostic Ultrasound System (K182595) | Samsung Medison Co., Ltd. | 2018-12-18 |
| MIM - MRT Dosimetry (K182624) | Mim Software, Inc. | 2018-12-18 |
| REVEL Spacers (K180909) | Globus Medical, Inc. | 2018-12-18 |
| VINTAGE PRO (K181496) | Shofu Dental Corporation | 2018-12-18 |
| KET-1 Blood Ketone Monitoring System (K182593) | Apex BioTechnology Corp. | 2018-12-18 |
| Emission Computed Tomography System (K182938) | Shanghai United Imaging Healthcare Co., Ltd. | 2018-12-18 |
| Gangi-SoftGuard Coaxial Needle, Gangi-HydroGuard Coaxial Needle (K181756) | Apriomed AB | 2018-12-18 |
| NuFACE FIX Skin Toning Device (K182424) | Carol Cole Company Dba Nuface | 2018-12-18 |
| Lucitone Denture Base Materials (K182422) | Dentsply Sirona | 2018-12-18 |
| Integra Salto Total Ankle System (K182878) | Ascension Orthopedics | 2018-12-18 |
| Devon 52 Sequential Compression Device (K182150) | Devon Medical Products (Jiangsu), Ltd. | 2018-12-18 |
| AURORA™ Screw System (K182989) | MiRus, LLC | 2018-12-18 |
| ValPro 2 Plus, VaPro 2 Plus Pocket (K183253) | Hollister Incorporated | 2018-12-18 |
| EliA RF IgM Immunoassay (K182747) | Phadia AB | 2018-12-18 |
| SKR 3000 (K182688) | Konica Minolta, Inc. | 2018-12-18 |
| Riptide Aspiration System (Riptide Large Bore Aspiration System) (K183185) | Micro Therapeutics, Inc. d/b/a ev3 Neurovascular | 2018-12-18 |
| Arthrex Compression FT Screws (K182361) | Arthrex, Inc. | 2018-12-18 |