| Mandril Wire Guide (K171997) | Cook Incorporated | 2018-03-30 |
| Nipro Syringe (K173029) | Nipro Medical Corporation | 2018-03-30 |
| eego amplifiers (K172312) | Eemagine Medical Imaging Solutions GmbH | 2018-03-30 |
| UF(II) Implant System (K170608) | Dio Corporation | 2018-03-30 |
| Dr’s Finder NEO (K171867) | Good Doctors Co., Ltd. | 2018-03-30 |
| ImmuLisa Enhanced RNA POL III Antibody ELISA (K172078) | Immco Diagnostics, Inc. | 2018-03-30 |
| Vitrea Software Package; VSTP-001A (K180323) | Canon Medical Systems Corporation | 2018-03-30 |
| Arthrex Shoulder System (K171841) | Arthrex, Inc. | 2018-03-29 |
| Atellica IM Total hCG (ThCG) (K172322) | Siemens Healthcare Diagnostics, Inc. | 2018-03-29 |
| NaviCross 0.018 (K173799) | Terumo Corporation | 2018-03-29 |
| Voluson P6 and Voluson P8 (K180535) | GE Healthcare | 2018-03-29 |
| TwitchView System (K172843) | Blink Device Corporation | 2018-03-29 |
| Terumo Capiox NX19 Oxygenator with Reservoir (east orientation ), Terumo Capiox NX19 Oxygenator with Reservoir (west orientation ), Terumo Capiox NX19 Oxygenator (east orientation ), Terumo Capiox NX19 Oxygenator (west orientation) (K172071) | Terumo Cardiovascular Systems Corporation | 2018-03-29 |
| Zimmer Knee Joint Replacement Prostheses MR Labeling (K173057) | Zimmer, Inc. | 2018-03-29 |
| CorPath GRX System (K180517) | Corindus, Inc. | 2018-03-29 |
| Bloom2 Programmable Electrophysiology Stimulator (K173439) | Fischer Medical | 2018-03-29 |
| IXOS Radius Plate System (K171624) | Stuckenbrock Medizintechnik GmbH | 2018-03-29 |
| Arco™-SA Lumbar Cage System (K173082) | Neurostructures, Inc. | 2018-03-29 |
| NovoStitch Pro Meniscal Repair System (K180531) | Ceterix Orthopaedics, Inc. | 2018-03-29 |
| OLYMPUS URF-P6/P6R (K172298) | Olympus Medical Systems Corp. | 2018-03-29 |
| Duette 100% Silicone Dual-Balloon, Temperature-Sensing Catheter (K173533) | Poiesis Medical, LLC | 2018-03-29 |
| Mission Lipid Panel Monitoring System (K180504) | ACON Laboratories, Inc. | 2018-03-28 |
| GYN-Pump PH304 (K173489) | W.O.M. World of Medicine GmbH | 2018-03-28 |
| Ambu aScope 3 Slim 3.8/1.2 and Ambu aScope 4 Broncho Slim 3.8/1.2; Ambu aScope 3 Regular 5.0/2.2 and Ambu aScope 4 Broncho Regular 5.0/2.2; Ambu aScope 3 Large 5.8/2.8 and Ambu aScope 4 Broncho Large 5.8/2.8; Ambu aView Monitor (K173727) | Ambu A/S | 2018-03-28 |
| Quantum Diagnostic Module, Quantum Diagnostic Module - No Gas (K173591) | Spectrum Medical , Ltd. | 2018-03-28 |
| Genesys Spine AIS-C Cervical Anchored Interbody System (K180056) | Genesys Spine | 2018-03-28 |
| Web II Memory Extraction Basket or Memory II Double Lumen Extraction Basket, Memory 5 Fr. Soft Wire Baskets or Memory Helical Stone Extractor, Memory Eight Wire Baskets or Memory Hard Wire Baskets, Fusion Wire Guided Extraction Basket, Non-Lithotripsy Extraction Basket (K171969) | Wilson-Cook Medical, Inc. | 2018-03-28 |
| CoreHip® System (K172235) | Aesculap Implants Systems, LLC | 2018-03-28 |
| ROSA BRAIN (v3.0.0.5) (K172444) | Medtech S.A | 2018-03-28 |
| David Home Pregnancy Test Cassette, David Professional Pregnancy Test Cassette (K172627) | Runbio Biotech Co.,Ltd | 2018-03-28 |
| Concentrix MX-AC High-Speed Handpiece (K173465) | Dentalez, Inc. | 2018-03-28 |
| PressureWire X (K180558) | St. Jude Medical (Now Part of Abbott Medical) | 2018-03-28 |
| AEON Retrieval Bag (K180114) | Lexington Medical, Inc. | 2018-03-27 |
| OCM-G1 Attachment (K180063) | The Anspach Effort, Inc. | 2018-03-27 |
| Zavation Buttress Plate System (K180537) | Zavation Medical Products, LLC | 2018-03-27 |
| Mpact® 3D Metal™ Implants and Augments 3D Metal™ (K171966) | Medacta International S.A. | 2018-03-27 |
| LenSx Laser System (K173660) | Alcon Laboratories, Inc. | 2018-03-27 |
| NES Reprocessed RF Stylet (RFS) (K173214) | Northeast Scientific, Inc. (Nes) | 2018-03-27 |
| Pulse Oximeter (K171241) | Hunan Accurate Bio-Medical Technology Co., Ltd. | 2018-03-27 |
| Upper Arm Type Electronic Blood Pressure Monitor Series, Electronic Blood Pressure Monitor: YE650A, YE650D, YE660B, YE670A and YE670D (K170605) | Jiangsu Yuyue Medical Equipment & Supply Co., Ltd. | 2018-03-27 |
| FORTRESS™ Radiopaque Bone Cement (FORTRESS™ and FORTRESS-Plus™), CREO® Fenestrated Screw System, REVLOK® Fenestrated Screw System (K172269) | Globus Medical, Inc. | 2018-03-27 |
| Bausch + Lomb Boston Advance Cleaner, Bausch + Lomb Boston Advance Conditioning Solution (K180319) | Bausch and Lomb, Incorporated | 2018-03-27 |
| Dexcom G6 Continuous Glucose Monitoring System (DEN170088) | Dexcom, Inc. | 2018-03-27 |
| Prelude (K180308) | Medcom GmbH | 2018-03-27 |
| REST EAZY Appliance (K172760) | Insert Molding Solutions, Inc. | 2018-03-26 |
| ThermoNeuroModulation Device, TNM Device (DEN170023) | Scion Neurostim, LLC | 2018-03-26 |
| Sonicision Reusable Generator, Sonicision Reusable Battery Pack, Sonicision Curved Jaw Dissectors (multiple lengths), Sonicision Battery Charger, Sonicision Battery Insertion Guide (K180149) | Covidien, LLC | 2018-03-26 |
| DISKOM (K180315) | Biopsybell S.R.L. | 2018-03-26 |
| SmartTouch (K173310) | Adherium (Nz), Ltd. | 2018-03-26 |
| OssBuilder System (K172354) | Osstem Implant Co., Ltd. | 2018-03-26 |
| C-PTFETM Surgical Suture (K173922) | Cp Medical, Inc. | 2018-03-26 |
| Black Silicone Filiform Double Pigtail Stent Set (K172017) | Cook Incorporated | 2018-03-26 |
| EKOS ultrasound EVD Device, EVD Control Unit (K172035) | Btg International, Inc. | 2018-03-24 |
| ANYVIEW DR SERIES FPD Fluoroscopic Mobile C-arm ANYVIEW-240DR, ANYVIEW-320DR, ANYVIEW-500DR (K180473) | Ecotron Co., Ltd. | 2018-03-23 |
| Longeviti PMMA Static Cranial Implant (K170410) | Longeviti Neuro Solutions, LLC | 2018-03-23 |
| UriSwab-Urine Collection, Transport and Preservation System (K180052) | Copan Italia Spa | 2018-03-23 |
| SRT-100+ (K173425) | Sensus Healthcare, Inc. | 2018-03-23 |
| CPRmeter 2 CPR Feedback Device (K173886) | Laerdal Medical AS | 2018-03-23 |
| Acculoc Total Knee System (K170753) | Rootloc Co., Ltd. | 2018-03-23 |
| SUPERCATH 5 (26G) (K172496) | Togo Medikit Co., Ltd. | 2018-03-23 |
| Dario LC Blood Glucose Monitoring System (K172723) | Labstyle Innovation, Ltd. | 2018-03-23 |
| Drive DeVilbiss iGo 2 Portable Oxygen Concentrator (K172648) | Devilbiss Healthcare, LLC | 2018-03-23 |
| MED-TAB (K173241) | Plum Medical Solutions GmbH | 2018-03-23 |
| AESKUSLIDES ANCA Ethanol, AESKUSLIDES ANCA Formalin (K172461) | Aesku.Diagnostics GmbH & Co. KG | 2018-03-23 |
| Alamo® C (K173128) | Alliance Partners, LLC | 2018-03-22 |
| Arthrex UNIVERS REVERS COATED BASEPLATE (K172371) | Arthrex, Inc. | 2018-03-22 |
| HemosIL Factor XII Deficient Plasma (K180486) | Instrumentation Laboratory CO | 2018-03-22 |
| Diazyme Lipoprotein (a) Assay (K180074) | Diazyme Laboratories, Inc. | 2018-03-22 |
| Granada Medium (K173903) | Hardy Diagnostics | 2018-03-22 |
| Tumark Vision (K180443) | Somatex Medical Technologies GmbH | 2018-03-22 |
| Bio-Medicus Adult Cannulae and Introducer (K180453) | Medtronic, Inc. | 2018-03-22 |
| Cortina [MAX] Lumbar Cage System (K180431) | Neurostructures, Inc. | 2018-03-22 |
| Endoscopic Cap, Check-Flo Adapter, Side-arm Adapter, Tuohy-Borst Adapter (K173105) | Cook Incorporated | 2018-03-22 |
| Bio-Medicus Adult Cannulae Kit (K180456) | Medtronic, Inc. | 2018-03-22 |
| Monarch Endoscopy Platform (Monarch Platform) (K173760) | Auris Surgical Robotics, Inc. | 2018-03-22 |
| Test of Variables of Attention (T.O.V.A.) (K173915) | The Tova Company | 2018-03-22 |
| SENTIO MMG Pedicle Access Needles (K173134) | Medos International SARL | 2018-03-22 |
| Mimics inPrint (K173619) | Materialise NV | 2018-03-21 |
| cobas CT/NG for use on cobas 6800/8800 systems (K173887) | Roche Molecular Systems, Inc. | 2018-03-21 |
| Universal Cylinder Applicator Family, Universal Segmented Cylinder Applicator Set, Universal Stump Applicator Set, Universal Cervix Probe Sets, odd lengths and even lengths, Universal Titanium Cervix Probe Sets, odd lengths and even lengths (K172611) | Varian Medical Systems, Inc. | 2018-03-21 |
| DROPLET PEN NEEDLE (K171982) | Htl-Strefa S.A | 2018-03-21 |
| Mammomat Revelation (K173408) | Siemens Medi Cal Solutions, Inc. | 2018-03-21 |
| ATS Thermal Imaging Probe, ATS Patient Interface Unit (K180148) | Securus Medical Group, Inc. | 2018-03-21 |
| WillCeph (K172168) | Hdx Will Corp. | 2018-03-21 |
| DermaScalp Laser Cap (K173846) | Dermascalp, LLC | 2018-03-21 |
| WIRION (K180023) | Gardia Medical , Ltd. | 2018-03-21 |
| SOMATOM Edge Plus (K173607) | Siemens Medical Solutions USA, Inc. | 2018-03-21 |
| Emprint Ablation Visualization Application (K180192) | Covidien, LLC | 2018-03-21 |
| Captura® Disposable Hot Biopsy Forceps (K171973) | Wilson-Cook Medical, Inc. | 2018-03-21 |
| P-140-Flex Coil, Na-140-Flex Coil, C-140-Flex Coil (K163661) | Rapid Biomedical GmbH | 2018-03-21 |
| Element System with IBT Electrodes (K173571) | Infinite Biomedical Technologies, LLC | 2018-03-21 |
| Freezpoint (K180211) | Bovie Medical Corp. | 2018-03-21 |
| Ventix Link Knotless Anchor with Inserter (K180274) | Cayenne Medical, Inc. | 2018-03-21 |
| Philips Incisive CT (K180015) | Philips Healthcare (Suzhou) Co., Ltd. | 2018-03-20 |
| Ingenia Elition S and Ingenia Elition X (K173451) | Philips Medical Systems Nederland B.V. | 2018-03-20 |
| Home Use IPL Beauty Device (K180016) | Shenzhen Mismon Technology Co., Ltd. | 2018-03-20 |
| Single Use Hemoclip (K172762) | Zhejiang Chuangxiang Medical Technology Co., Ltd. | 2018-03-20 |
| Habib EndoHPB (K180165) | Emcision , Ltd. | 2018-03-20 |
| BD Veritor System for Rapid Detection of Flu A + B CLIA waived kit (K180438) | Bd | 2018-03-20 |
| HX Device (K173919) | Human Extension , Ltd. | 2018-03-20 |