| Persona Revision Knee System (K181947) | Zimmer, Inc. | 2018-10-25 |
| Solitare Platinum Revascularization Device (K181186) | Micro Therapeutics, Inc. d/b/a ev3 Neurovascular | 2018-10-25 |
| SMV Scientific K-Wire and Pins (K182171) | Summit Medventures | 2018-10-25 |
| Hybrid3D (K181468) | Hermes Medical Solutions AB | 2018-10-25 |
| SLENDERTONE CoreFit Abs 8, Type 734 (K180688) | Bio-Medical Research, Ltd. | 2018-10-25 |
| World Total Knee System (K181530) | Signature Orthopaedics Pty, Ltd. | 2018-10-24 |
| picoAMH ELISA (DEN180004) | Ansh Labs, LLC | 2018-10-24 |
| da Vinci Xi Surgical System, da Vinci X Surgical System (K182140) | Intuitive Surgical, Inc. | 2018-10-24 |
| Monarch Airway Clearance System (K173603) | Hill-Rom Holdings, Inc. | 2018-10-24 |
| GastroFlush (K180605) | Bionix Development Corporation | 2018-10-24 |
| Site~Rite 8 Ultrasound System with Cue Needle Tracking System and Pinpoint GT Needle Tech (K182281) | C. R. Bard | 2018-10-24 |
| Spine Wave Navigated Instruments (K181596) | Spine Wave, Inc. | 2018-10-24 |
| KODEX EPD System (K180940) | Philips Medical Systems Nederland B.V. | 2018-10-24 |
| Cios Alpha (K181560) | Siemens Medical Systems USA, Inc. | 2018-10-24 |
| GC70 (K182647) | Samsung Electronics Co., Ltd. | 2018-10-24 |
| Osteocera Resorbable Bone Substitute (K180758) | Wiltrom Corporation Limited | 2018-10-24 |
| VAMP Optima closed blood sampling system (K180275) | Edwards Lifesciences, LLC | 2018-10-24 |
| TempSure System (K182365) | Cynosure, Inc. | 2018-10-24 |
| Certus 140 2.45GHz Ablation System (K173756) | Neuwave Medical, Inc. | 2018-10-24 |
| Guardia™ Access Malleable Obturator, Guardia™ Obturator, Soft-Pass™ Obturator, Soft-Trans Malleable Obturator, Guardia™ ETS Embryo-Tested Syringe, Flushing Catheter (K180302) | Cook Incorporated | 2018-10-24 |
| Duo Lumbar Interbody Fusion Device (K182322) | Spineology, Inc. | 2018-10-24 |
| Retina Workplace (K182318) | Carl Zeiss Meditec, Inc. | 2018-10-24 |
| Gas Module 3 (K180788) | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 2018-10-24 |
| Cumulus Remover (K182002) | Kitazato Corporation | 2018-10-23 |
| FUSE Pedicle Screw System (K182283) | Black Box Medical | 2018-10-23 |
| Masimo Rad-97 and Accessories (K180046) | Masimo Corporation | 2018-10-23 |
| BD Single Use, Hypodermic Syringe (K172670) | Becton, Dickinson and Company | 2018-10-23 |
| Kangaroo Gastrostomy Feeding Tube with ENFit Y-Port (K180622) | Covidien | 2018-10-23 |
| Randox Calcium (Ca) (K182042) | Randox Laboratories, Ltd. | 2018-10-23 |
| BTL 799-2T (K182106) | BTL Industries, Inc. | 2018-10-23 |
| GU60A, GU60A-65 (K182622) | Samsung Electronics Co., Ltd. | 2018-10-23 |
| Xperius Ultrasound System (K182529) | Philips Ultrasound, Inc. | 2018-10-23 |
| Humeral Short Stem System (K173824) | Shoulder Innovations, Inc. | 2018-10-23 |
| JiveX (K181964) | Visus Health IT GmbH | 2018-10-23 |
| Sonendo Material A (K181922) | Sonendo, Inc. | 2018-10-22 |
| GM Implant Tubes, Length Cutting Gauge (K172533) | Varian Medical Systems, Inc. | 2018-10-22 |
| Nutrifill (K181566) | Contamac, Ltd. | 2018-10-22 |
| ANTHEM Fracture System (K180554) | Globus Medical, Inc. | 2018-10-22 |
| PIP Fix (K181192) | Hand Biomechanics Lab, Inc. | 2018-10-22 |
| Quadra P (K181254) | Medacta International S.A. | 2018-10-22 |
| TD-1035 Thermometer (K172733) | Taidoc Technology Corporation | 2018-10-22 |
| Comarch e-Care Platform (K181248) | Comarch Healthcare SA | 2018-10-22 |
| ImPACT (K181223) | Impact Applications, Inc. | 2018-10-20 |
| Vantage Orian 1.5T, MRT-1550, V4.5 (K182282) | Canon Medical Systems Corporation | 2018-10-19 |
| Paragonix SherpaPak Cardiac Transport System (K182735) | Paragonix Technologies | 2018-10-19 |
| Straumann cerabone (K173594) | Institut Straumann AG | 2018-10-19 |
| EchoS (K180516) | Echolight S.P.A | 2018-10-19 |
| Histofluor Rodent LKS Fluorescent Antibody Test System, Image Navigator by Immuno Concepts (K180202) | Immuno Concepts, N.A. , Ltd. | 2018-10-19 |
| 1.5T AIR MP M, 1.5T AIR MP L, 1.5T 16ch AIR AA, 1.5T 30ch AIR AA (K182590) | GE Healthcare | 2018-10-19 |
| DLP Aortic Root Cannula, DLP Aortic Root Cannula with Vent Line, DLP Pressure Monitoring Extension Line Adapter, DLP Cardioplegia Adapter with Pressure Port (K182586) | Medtronic, Inc. | 2018-10-19 |
| UroNav (Version 3.0) (K182561) | Invivo Corporation | 2018-10-19 |
| MAGNETOM Vida (K181433) | Siemens Medical Solutions USA, Inc. | 2018-10-19 |
| ICONN Revolution Knotless Suture Anchor (K182264) | Iconn Orthopedics, LLC | 2018-10-19 |
| Vivid S60N, Vivid S70N (K182450) | GE Medical Systems Ultrasound and Primary Care Diagnostics | 2018-10-19 |
| Titanium TomoFix Medial High Tibia Plate Anatomical (K180213) | Synthes (USA) Products, LLC | 2018-10-19 |
| EnSite Velocity Cardiac Mapping System v5.2, EnSite Precision Cardiac Mapping System v2.2 (K182644) | Abbott | 2018-10-19 |
| AVELLE Negative Pressure Wound Therapy System (K180205) | Convatec Limited | 2018-10-19 |
| Stable-C Interbody System (K181621) | Nexus Spine, LLC | 2018-10-19 |
| OLYMPIC Posterior Spinal Fixation System (K182239) | Astura Medical, LLC | 2018-10-18 |
| Extended Lipid Panel Assay (K181373) | Laboratory Corporation of America Holdings | 2018-10-18 |
| Spectralis HRA+OCT and variants with High Magnification Module (K182569) | Heidelberg Engineering GmbH | 2018-10-18 |
| Reprocessed Torqr Diagnostic EP Catheter (K181618) | Innovative Health, LLC | 2018-10-18 |
| Swift System (K181941) | Emblation , Ltd. | 2018-10-18 |
| Medax Biopsy Systems III (K181803) | Medax Srl Unipersonale | 2018-10-18 |
| QuickScreen Pro Multi Drug Screening Test, Model 9395Z (K181945) | Phamatech, Inc. | 2018-10-18 |
| 14HK701G-W (K182348) | Lg Electronics.Inc | 2018-10-18 |
| TNI softFlow 50 (K180474) | Tni Medical AG | 2018-10-18 |
| BD FlowSmart Set/MiniMed Pro-Set (K181718) | Becton, Dickinson and Company | 2018-10-18 |
| RadiForce RX360, RX360-AR (K182591) | Eizo Corporation | 2018-10-18 |
| Quantum Ventilation Module (K181942) | Spectrum Medical , Ltd. | 2018-10-18 |
| Entuit LP Gastrostomy BR Low Profile Balloon Retention Feeding Tube, Entuit LP Gastrostomy BR Low Profile Balloon Retention Feeding Tube with ENFit Connection, Entuit LP Patient Care Kit, Entuit LP Patient Care Kit with ENFit Connection, PromaX Low Profile Gastrostomy Feeding Tube, PromaX LP Patient Care Kit with ENFit (K180708) | Xeridiem Medical Devices, A Spectrum Plastics Group Company | 2018-10-18 |
| Full Automatic(NIBP) Blood Pressure Monitor (K180240) | Health & Life Co., Ltd. | 2018-10-17 |
| Wireless Digital Flat Panel Detector (K182550) | Iray Technology Taicang , Ltd. | 2018-10-17 |
| Youlaser CO2 (K182669) | Quanta System Spa | 2018-10-17 |
| PASS LP Spinal System (K182240) | Medicrea International SA | 2018-10-17 |
| Uroject12 Syringe Lever (K180345) | Urogen Pharma, Ltd. | 2018-10-17 |
| ELAN 4 Electro Motor System Tools (K172709) | Aesculap, Inc. | 2018-10-17 |
| Wireless Digital Flat Panel Detector (K182551) | Iray Technology Taicang , Ltd. | 2018-10-17 |
| Arterys MICA (K182034) | Arterys, Inc. | 2018-10-17 |
| Alphenix, INFX-8000H/B, V8.0 (K182546) | Canon Medical Systems Corporation | 2018-10-17 |
| OsteoBridge™ IDSF System (K181026) | Merete GmbH | 2018-10-17 |
| Ortho System (K180941) | 3Shape A/S | 2018-10-17 |
| Muscle Trainer (K181728) | Shenzhen Kentro Medical Electronics Co., Ltd. | 2018-10-17 |
| NvisionVLE Imaging System, NvisionVLE Optical Probe (K182261) | Ninepoint Medical, Inc. | 2018-10-16 |
| RCT700 (K182614) | Ray Co., Ltd. | 2018-10-16 |
| QUANTA Flash Calprotectin and Fecal Extraction Device (K180971) | Inova Diagnostics, Inc. | 2018-10-16 |
| Depuy Synthes Femoral Neck System (K182154) | Synthes (USA) Products, LLC | 2018-10-16 |
| KidCap (K180568) | Eastern Cranial Affiliates, LLC | 2018-10-16 |
| Pump In Style Advanced, Advanced Personal Double Breastpump (K181937) | Medela, LLC | 2018-10-16 |
| DynaBridge (K181815) | Fusion Orthopedics, LLC | 2018-10-15 |
| Reliant(TM) Multistage Dilatation Balloon Catheter (K180418) | Micro-Tech (Nanjing) Co., Ltd. | 2018-10-15 |
| FlowTriever Retrieval/Aspiration System (K182233) | Inari Medical | 2018-10-15 |
| BracePaste MTP Light Cure Primer (K181910) | American Orthodontics | 2018-10-15 |
| NeuroBlate System (K182036) | Monteris Medical, | 2018-10-15 |
| MAGNETOM Sola (K182129) | Siemens Medical Solutions USA, Inc. | 2018-10-12 |
| Penumbra System (Modified 110 Aspiration Tubing) (K182522) | Penumbra, Inc. | 2018-10-12 |
| Radial Medical Compression System (K181651) | Radial Medical, Inc. | 2018-10-12 |
| ILICON (ocufilcon D) Soft (Hydrophilic) Daily Wear Contact Lenses (Tinted, Color) (K182247) | Vizionfocus, Inc. | 2018-10-12 |
| 3.0T Air MP M, 3.0T Air MP L (K182504) | Ge Healthcare Coils (Usa Instruments, Inc.) | 2018-10-12 |
| Endophys Pressure Sensing Sheath Kit (K180620) | Endophys Holdings, LLC | 2018-10-12 |