| K183101 — Zenition 50 | Philips Medical Systems Nederland B.V. Dec 31, 2018 |
| K183000 — ViperCath XC Peripheral Exchange Catheter | Cardiovascular Systems, Inc. Dec 29, 2018 |
| K180204 — CranioMaxillofacial Fixation (CMF) System - CMF Visionare | Visionare, LLC Dec 28, 2018 |
| DEN170091 — EyeBOX | Oculogica, Inc. Dec 28, 2018 |
| K180867 — AmCAD-UO | Amcad Biomed Corporation Dec 28, 2018 |
| K183369 — COR12 ECG | Corscience GmbH & Co. Dec 28, 2018 |
| K182736 — OIC Suture Anchor System | The Orthopaedic Implant Company Dec 28, 2018 |
| K181703 — Straumann BLX Line Extension - Implants, SRAs and Anatomic Abutments | Institut Straumann AG Dec 28, 2018 |
| K182461 — LATITUDE EV Total Elbow Arthroplasty | Tornier, Inc. Dec 27, 2018 |
| K182045 — Lotus III Multi-Pulsed Er: Yag Laser System | Laseroptek Co., Ltd. Dec 27, 2018 |
| K182130 — iSchemaView RAPID | Ischemaview, Inc. Dec 27, 2018 |
| K182564 — Quantib ND | Quantib B.V. Dec 27, 2018 |
| K182404 — STERRAD VELOCITY Biological Indicator | Advanced Sterilization Products (Asp) Dec 27, 2018 |
| K183169 — Pulse 2.0, Pulse Pro 2.0 | NormaTec Industries, LP Dec 27, 2018 |
| K182845 — minisono | Alpinion Medical Systems Co., Ltd. Dec 27, 2018 |
| K182783 — DePuy Synthes Trauma Orthopedic Nail Implants | DePuy Synthes Dec 26, 2018 |
| K182698 — LIAISON Calprotectin, LIAISON Calprotectin Control Set, LIAISON Calprotectin Calibration Verifiers, LIAISON Q.S.E.T. Buffer, LIAISON Q.S.E.T. Device | DiaSorin, Inc. Dec 26, 2018 |
| K182709 — One-Step Suprapubic Introducer | Cook Incorporated Dec 26, 2018 |
| K182242 — VO200 NeurOs Cerebral Oximetry System | Mespere Lifesciences, Inc. Dec 26, 2018 |
| K182099 — Delta TT Pro | Lima Corporate S.P.A. Dec 26, 2018 |
| K181761 — Zimmer Biomet Select Ceramic Heads | Zimmer, Inc. Dec 26, 2018 |
| K181641 — QuikClot Radial | Z-Medica, LLC Dec 24, 2018 |
| K183007 — EliA SmDP Immunoassay | Phadia AB Dec 24, 2018 |
| K181412 — VITEK MS | bioMerieux, Inc. Dec 21, 2018 |
| K180014 — Creme de La Femme Feminine Lubricant | Cewal, Inc. Dba Premiere Enterprises Dec 21, 2018 |
| K180380 — vital signs monitor | Edan Instruments, Inc. Dec 21, 2018 |
| K181331 — JUVORA Oyster White Dental Disc, CERAMILL PEEK by JUVORA, Oyster White | Juvora, Ltd. Dec 21, 2018 |
| K182750 — 4D View | GE Medical Systems Ultrasound And Primary Care Diagnostics Dec 21, 2018 |
| K181752 — Stryker iVAS Elite Inflatable Vertebral Augmentation System (Stryker iVAS Elite Balloon Catheter) | Stryker Corporation Dec 21, 2018 |
| K181120 — 2.8 mm/3.3 mm PopLok Suture Anchors | Conmed Corporation Dec 21, 2018 |
| K182167 — The ICHOR Panacea Vascular Embolectomy Catheter System | Ichor Vascular, Inc. Dec 21, 2018 |
| K182755 — Disposable Temperature Probe | Shenzhen Caremed Medical Technology Co., Ltd. Dec 21, 2018 |
| K182012 — ADVIA Centaur Calcitonin (CALCT) assay | Axis-Shield Diagnostics Limited Dec 21, 2018 |
| K182776 — Neocis Guidance System | Neocis, Inc. Dec 21, 2018 |
| K180826 — Natrelle 133 Plus MICROCELL Tissue Expander | Allergan Dec 21, 2018 |
| K182032 — SterilContainer S System | Aesculap, Inc. Dec 21, 2018 |
| K183059 — 3nethra neo | Forus Health Pvt.Ltd Dec 21, 2018 |
| K183068 — Nitrile Glove Powder Free White | Haining Medical Products Co., Ltd. Dec 21, 2018 |
| K183012 — vascuCAP | Elucid Bioimaging, Inc. Dec 21, 2018 |
| K173036 — North-vision Multi-parameter Patient Monitor | North-Vision Tech., Inc. Dec 21, 2018 |
| K173747 — REXLENE | Sm Eng Co., Ltd. Dec 21, 2018 |
| DEN180007 — Miris Human Milk Analyzer | Miris AB Dec 21, 2018 |
| K181037 — DIO CAD/CAM Abutment | Dio Corporation Dec 21, 2018 |
| K182781 — PTS Professional Chemistry Kit | Polymer Technology Systems, Inc. D/B/A Pts Diagnostics Dec 21, 2018 |
| K182682 — OrthoGold 100 | Tissue Regeneration Technologies Dec 21, 2018 |
| K180821 — TruMatch Graft Cage - Long Bone | Synthes (Usa), LLC Dec 21, 2018 |
| K181690 — Clear-Jet Injection Catheter | Finemedix Co., Ltd. Dec 21, 2018 |
| K182690 — ePlex Blood Culture Identification Panel Fungal Pathogen (BCID-FP) Panel | Genmark Diagnostics, Incorporated Dec 21, 2018 |
| K181555 — Arthrex Fracture Adapter Hemi Shoulder Prosthesis | Arthrex, Inc. Dec 21, 2018 |
| K183328 — Pulse Rx 2.0, Pulse Pro Rx 2.0 | NormaTec Industries, LP Dec 21, 2018 |