| K181337 — Sypher Spacer System | Biogennix, LLC Sep 18, 2018 |
| K181320 — Caprolon | Resorba Medical GmbH Sep 18, 2018 |
| K181390 — Response Spine System, Response 5.5/6.0 Spine System, Response 4.5/5.0 Spine System | OrthoPediatrics Corp. Sep 18, 2018 |
| K181620 — Endoscopic Linear Cutting Staplers and Loading Units for Single Use | Ezisurg (Suzhou) Medical Co., Ltd. Sep 18, 2018 |
| K181653 — Ethicon Circular Stapler, Ethicon Circular Stapler -XL Sealed | Ethicon Endo-Surgery, LLC Sep 18, 2018 |
| K171904 — Tandry Locking Plate System | Microware Precision Co., Ltd. Sep 18, 2018 |
| K180933 — DenTek Ultimate Dental Guard | Medtech Products, Inc. Sep 17, 2018 |
| K182260 — PALACOS MV | Heraeus Medical GmbH Sep 17, 2018 |
| K181632 — Venacure 1470 Pro | Quanta System Spa Sep 17, 2018 |
| K181721 — Ceracell Ortho Foam | Curasan AG Sep 17, 2018 |
| K173871 — CalliSpheres Embolic Microspheres, 8Spheres Embolic Microspheres | Suzhou Hengrui Callisyn Biomedical Co., Ltd. Sep 17, 2018 |
| K181102 — ThermaCare Quick Therapy TENS | Pfizer, Inc. Sep 15, 2018 |
| K173910 — Impress SFS System | Cable Fix Medical, LLC Sep 14, 2018 |
| K173827 — LightScalpel | Lightscalpel, LLC Sep 14, 2018 |
| K173676 — A-FIT | Hironic Co., Ltd. Sep 14, 2018 |
| K182214 — DizzyDoctor System 1.0.0 | Dizzydoctor Systems, LLC Sep 14, 2018 |
| K182223 — Aquilion ONE Self-Propelled Scan Base Kit for IVR-CT, CGBA-034A | Canon Medical Systems, USA Sep 14, 2018 |
| K181874 — MX40 Mobile Digital X-ray System | Huestis Machine Corporation Sep 14, 2018 |
| K180182 — Dual Lumen Ureteral Access Catheter, Flexi-Tip Dual Lumen Ureteral Access Catheter | Cook Incorporated Sep 14, 2018 |
| K180369 — Intracept Intraosseous Nerve Ablation System (component Intracept RF Probe) | Relievant Medsystems Sep 14, 2018 |
| K180871 — Portable Nebulizer | Microbase Technology Corporation Sep 14, 2018 |
| K182213 — QT Ultrasound Breast Scanner - 1 | Qt Ultrasound, LLC Sep 14, 2018 |
| K173926 — DORADOnova MR3T | Lap GmbH Laser Applikationen Sep 14, 2018 |
| K180875 — POLY REJUV | Medtek Skincare, LLC Sep 14, 2018 |
| K181598 — Prime E-CLASS XLPE Liner | Microport Orthopedics, Inc. Sep 14, 2018 |
| K182206 — RiX70 DC | Trident S.R.L Sep 13, 2018 |
| K181594 — Spectralis HRA+OCT and variants with OCT Angiography Module | Heidelberg Engineering GmbH Sep 13, 2018 |
| K180215 — DYNA-LINK ELITE Stand-Alone Anterior Lumbar System | Life Spine, Inc. Sep 13, 2018 |
| K181821 — MOSS VRS Spinal System | Biedermann Motech GmbH & Co. KG Sep 13, 2018 |
| K181889 — MTS Penicillin 0.002- 32 µg/mL | Liofilchem S.R.L. Sep 13, 2018 |
| K172450 — TENS device-HeadaTerm, eEspress | Wat Medical Technology (Ningbo) Co., Ltd. Sep 13, 2018 |
| K181236 — HySil Impression Materials | Osstem Implant Co., Ltd. Sep 13, 2018 |
| K181000 — SelectFlex 072 Neurovascular Access System | Q'Apel Sep 13, 2018 |
| K173933 — Sorrento Bioglass Bone Graft Substitute | Xenco Medical, LLC Sep 13, 2018 |
| K181576 — Planmeca Viso | Planmeca Oy Sep 13, 2018 |
| K182275 — Seal Single Use Biopsy Valve | Boston Scientific Corporation Sep 13, 2018 |
| K180053 — Sof-Flex Ureteral Stent Set | Cook Incorporated Sep 13, 2018 |
| K181241 — KLS Martin Individual Patient Solutions (IPS) Planning System | KLS-Martin L.P. Sep 13, 2018 |
| K173424 — BioSphere Flex | Synergy Biomedical Sep 12, 2018 |
| K181748 — Magnesium | Abbott Laboratories Sep 12, 2018 |
| K181255 — PRODENSE Bone Graft Substitute | Wrightmedicaltechnologyinc Sep 12, 2018 |
| K182232 — Octane Mechanical Thrombectomy System | Vascular Solutions, Inc. Sep 11, 2018 |
| K181380 — LnK Lumbar Interbody Fusion Cage System | L&K BIOMED Co., Ltd. Sep 11, 2018 |
| K171532 — TruBase S | Truabutment, Inc. Sep 11, 2018 |
| K173822 — Anchor Tissue Retrieval System by CONMED | Conmed Corporation Sep 11, 2018 |
| DEN180044 — ECG App | Apple, Inc. Sep 11, 2018 |
| K181568 — IPL Salon Hair Reduction System | Medical Device Branch Of Zhangzhou Easepal Industrial Co.,Lt Sep 11, 2018 |
| K181655 — Renovis S180 Lateral Lumbar Interbody Fusion System | Renovis Surgical Technologies Sep 11, 2018 |
| K182226 — AirStrip RPM InvisionHeart Adapter | Airstrip Technologies, Inc. Sep 11, 2018 |
| DEN180042 — Irregular Rhythm Notification Feature | Apple, Inc. Sep 11, 2018 |