| ZyMot ICSI Sperm Separation Device, ZyMot Multi Sperm Separation Device (850µl, 3ml) (K173075) | Dxnow, Inc. | 2018-03-08 |
| PillCam Patency System (K180171) | Given Imaging , Ltd. | 2018-03-08 |
| Accutension Smartphone Auscultatory Blood (K180335) | Shanghai Hulu Devices Co., Ltd. | 2018-03-08 |
| SIROLaser Blue (K180044) | Dentsply Sirona | 2018-03-08 |
| icobrain (K180326) | Icometrix | 2018-03-08 |
| AnastoClip GC Closure System (K173323) | LeMaitre Vascular, Inc. | 2018-03-08 |
| AW-100 (K171150) | Micron Corporation | 2018-03-08 |
| iQMR (K173605) | Medic Vision - Imaging Solutions, Ltd. | 2018-03-08 |
| CD HORIZON™ Spinal System (K173249) | Medtronic Sofamor Danek USA, Inc. | 2018-03-08 |
| Gyrus ACMI – EZDilate 3-Stage Balloon Dilatation Catheter (K180086) | Gyrus Acmi, Inc. | 2018-03-08 |
| Navigated Instrument System (K172115) | Orthofix, Inc. | 2018-03-08 |
| Neuro Assessment System NAS-1000 (K172892) | Headsense Medical, Inc. | 2018-03-08 |
| Carriere SLX 3D Clear (K173440) | Ortho Organizers, Inc. | 2018-03-08 |
| NMF004A (K173500) | GC America, Inc. | 2018-03-08 |
| DMAX Coloring Liquid; Chang's Liquid; Confident Coloring Liquid; CAMeleon Coloring Liquid (K173769) | Dmax Co., Ltd. | 2018-03-08 |
| ARMAR / ARTIS Small Fragment and Calcaneal Plates & MBOSS / FIXION Screws, ARMAR/ ARTIS Humerus and Olecranon Plates & MBOSS/FIXION Screws, ARMAR / ARTIS Tibia and Buttress Plates & MBOSS/FIXION Screws, ARMAR / ARTIS 2.4mm Plates & MBOSS/FIXION Screws, ARMAR/ ARTISClavical Hook Plate & MBOSS/FIXION Screws, ARMAR/ ARTIS Metaphyseal Plate & MBOSS/FIXION Screws, ARMAR / ARTISCalcaneal Plate & MBOSS/FIXION Screws (K171320) | Meril Healthcare Pvt. , Ltd. | 2018-03-08 |
| Intellitorq (K180092) | Gauthier Biomedical, Inc. | 2018-03-08 |
| syngo.CT Clinical Extensions (K173625) | Siemens Medical Solutions USA, Inc. | 2018-03-08 |
| BreathID Hp System (K173772) | Exalenz Bioscience , Ltd. | 2018-03-08 |
| THD Anopress with THD SensyProbe (K180135) | Thd Spa | 2018-03-08 |
| BreathID Hp Lab System (K173777) | Exalenz Bioscience , Ltd. | 2018-03-08 |
| PORT-X IV (K172810) | Genoray Co., Ltd. | 2018-03-07 |
| On Call Express Mobile Blood Glucose Monitoring System (K180196) | ACON Laboratories, Inc. | 2018-03-07 |
| Cone Tip Ureteral Catheter, Rutner Universal Wedge Catheter (K171810) | Cook Incorporated | 2018-03-07 |
| ALEVE Direct Therapy (ALEVE Direct Therapy TENS Device) (K171802) | Bayer Healthcare, LLC | 2018-03-07 |
| ALVUE Balloon Dilation System (K171939) | Globus Medical, Inc. | 2018-03-07 |
| LMT-3000 (K172818) | Lameditech Co. , Ltd. | 2018-03-07 |
| primeMidline Catheters (K173114) | Pfm Medical, Inc. | 2018-03-07 |
| Dornier Medilas H Solvo 35 Laser (K180350) | Dornier Medtech America | 2018-03-07 |
| SP-Fix® Spinous Process Fixation Plate, RELIEVE® Laminoplasty Fixation System (K180156) | Globus Medical, Inc. | 2018-03-07 |
| Rotatable Snares, Non-Rotatable Snares (K172758) | Zhejiang Chuangxiang Medical Technology Co., Ltd. | 2018-03-07 |
| Aesculap Optilene Nonabsorbable Suture (K180321) | Aesculap, Inc. | 2018-03-07 |
| Digitimer DS7AP Constant Current Stimulator (K172381) | Digitimer , Ltd. | 2018-03-06 |
| Citric Complete Dry Citric Acid (45X) (K171750) | Dimesol USA, LLC | 2018-03-06 |
| 23andMe PGS Genetic Health Risk Report for BRCA1/BRCA2 (Selected Variants) (DEN170046) | 23AndMe, Inc. | 2018-03-06 |
| IRENE Thoracolumbar Fixation System (K172267) | Tianjin Zhengtian Medical Instrument Co., Ltd. | 2018-03-06 |
| Reprocessed ViewFlex Xtra Ice Diagnostic Ultrasound Catheter (K173262) | Innovative Health, LLC | 2018-03-06 |
| OrthoSteady G Bone Cement (K173494) | G21, S.R.L. | 2018-03-06 |
| Ingenia Elition S and Ingenia Elition X R5.4 (K173356) | Philips Medical Systems Nederland B.V. | 2018-03-06 |
| Cytology Brush (K172663) | Micro-Tech (Nanjing) Co., Ltd. | 2018-03-05 |
| Valeo® C+CSC with Lumen Interbody Fusion Device (K173453) | Amedica Corp. | 2018-03-05 |
| LEGION Knee System (K180334) | Smith & Nephew, Inc. | 2018-03-05 |
| EMPOWR Universal Tibial Baseplate (K173723) | Encore Medical L.P. | 2018-03-05 |
| MiniMed Mio Advance infusion set (K173879) | Unomedical A/S | 2018-03-05 |
| DePuy Synthes Femoral Neck System (K172872) | DePuy Synthes | 2018-03-05 |
| Blue Non Sterile powder free Nitrile Examination Gloves Tested for Use with Chemotherapy Drugs (K173942) | Central Medicare Sdn Bhd | 2018-03-05 |
| HammerTube System (K171715) | Paragon 28 | 2018-03-05 |
| AllergiEnd ST-9 Multiple Skin Test Applicator, AllergiEnd ST-9 Multiple Well Test Tray (K172062) | Medscience Science Research Group, Inc. | 2018-03-05 |
| Reprocessed ArthoCare Ablation Wand (K173741) | Renovo, Inc. | 2018-03-05 |
| ProBx Software (K173312) | Harmonus, Inc. | 2018-03-02 |
| Next Generation iBOT (K172601) | Deka Research & Development Corp. | 2018-03-02 |
| System 1 endo Liquid Chemical Sterilant Processing System (K173256) | STERIS Corporation | 2018-03-02 |
| SoftVue (K172256) | Delphinus Medical Technologies | 2018-03-02 |
| Phoenix Wound Matrix (K173544) | Nanofiber Solutions, Inc. | 2018-03-02 |
| CO Check Pro, CO Screen (K171129) | MD Diagnostics Limited | 2018-03-02 |
| SAGE Vitrification Kit (ART-8025 and ART-8026) / SAGE Vitrification Warming Kit (ART-8030 and ART-8031) (K173731) | CooperSurgical, Inc. | 2018-03-02 |
| COMPACT TOUCH Ophthalmic Ultrasound System (K180265) | Quantel Medical | 2018-03-02 |
| ologen Collagen Matrix (K173223) | Aeon Astron Europe B.V. | 2018-03-02 |
| Footmotion HammerToe (K172485) | Newclip Technics | 2018-03-02 |
| Spectra Optia Apheresis System (K172590) | Terumobct, Inc. | 2018-03-02 |
| Wrist Type Automatic Blood Pressure Monitor (K172972) | Shenzhen Jiacom Technology CO ., Ltd. | 2018-03-02 |
| Type I, Type II, Type III, Type IV (K172331) | Lepu Medical Technology (Beijing) Co., Ltd. | 2018-03-02 |
| LENSAR Laser System - fs 3D (LLS-fs 3D) (K173346) | Lensar, Inc. | 2018-03-02 |
| ORIGIO® Handling™ without phenol red (Cat. No. 8310), ORIGIO® Handling™ with phenol red (Cat. No. 8311) (K173624) | Origio A/S | 2018-03-02 |
| Flowtron DVT5 Small Calf Garment (K172103) | Getinge (Suzhou) Co., Ltd. | 2018-03-02 |
| cobas m 511 integrated hematology analyzer (K171655) | Roche Diagnostics Hematology, Inc. | 2018-03-02 |
| Infrared Thermometer (K171214) | Shenzhen Brav Electronic Technologies Co., Ltd. | 2018-03-02 |
| LigaSure Exact Dissector, Nano-coated (K173281) | Covidien | 2018-03-02 |
| V.A.C.VIA 7 Day Therapy System Kit, V.A.C.VIA Therapy Starter Kit, V.A.C.VIA Negative Pressure Wound Therapy Unit (K173447) | Kci USA, Inc. | 2018-03-02 |
| Omega VL (K162366) | Ov World Co., Ltd. | 2018-03-02 |
| uCT Computed Tomography X-ray System (K172135) | Shanghai United Imaging Healthcare Co., Ltd. | 2018-03-02 |
| ImmunoCAP Tryptase, ImmunoCAP Tryptase Calibrators, ImmunoCAP Tryptase Curve Control, ImmunoCAP Tryptase Conjugate 50, ImmunoCAP Tryptase Calibrator Strip, ImmunoCAP Tryptase Curve Control Strip (K173704) | Phadia AB | 2018-03-02 |
| VERIFY Chemical Indicator for S40 Sterilant (K173428) | STERIS Corporation | 2018-03-02 |
| Astell UMB 220, UMB 230, UMB 240 Autoclaves/sterilizers (K170304) | Astell Scientific Limited | 2018-03-02 |
| FUJIFILM Endoscope Models EG-760R, EG-760Z, EC-760R-V/L and EC-760ZP-V/L, and FUJIFILM Water Tank Model WT-603 (K172916) | Fujifilm Corporation | 2018-03-01 |
| PUMA System (K171703) | Panther Orthopedics, Inc. | 2018-03-01 |
| Arthrex Corkscrew FT (K173788) | Arthrex, Inc. | 2018-03-01 |
| Sapphire II PRO (K173680) | Orbusneich Medical Trading, Inc. | 2018-03-01 |
| SkinPen Precision System (DEN160029) | Bellus Medical, LLC | 2018-03-01 |
| Technoweb Surgical Mask (K172500) | Yts Global, Inc. | 2018-03-01 |
| CorPath GRX System (K173806) | Corindus, Inc. | 2018-03-01 |
| CELERITY 20 HP Challenge Pack (K173488) | STERIS Corporation | 2018-03-01 |
| Microscope Navigation Software (K172820) | Brainlab AG | 2018-03-01 |
| Nathanson Transcystic Bile Duct Stone Exploration Pack (K171915) | Cook Incorporated | 2018-03-01 |
| STARband, STARlight, St. Louis Band (K180109) | Orthomerica Products, Inc. | 2018-03-01 |
| Diode Laser Cap (K173678) | Cosmo Far East Technology Limited | 2018-02-28 |
| VERIFY All-In-One STEAM Reusable Test Pack, VERIFY All-In-One STEAM Reusable Test Pack with Step Counter, VERIFY All-In-One STEAM Reusable Test Pack with Tracker Tag (K173633) | STERIS Corporation | 2018-02-28 |
| REVIAN RED (K173729) | Photonmd, Inc. | 2018-02-28 |
| TrackX (K173736) | Track X Technology, LLC | 2018-02-28 |
| EnsoETM (K180244) | Advanced Cooling Therapy, Inc. D/B/A Attune Medical | 2018-02-28 |
| HeRO Symphony, HeRO ES, HeRO solo/duet (K180242) | Medical Predictive Science Corporation | 2018-02-28 |
| Wireless Probe Type Ultrasound Scanner (Model:UProbe-C; UProbe-L; BProbe) (K172750) | Guangzhou Sonostar Technologies Co., Ltd. | 2018-02-28 |
| ECG Cable/Leadwires (K172797) | Shenzhen Coreray Technology, Ltd. | 2018-02-28 |
| Sofia Lyme FIA, Sofia 2 analyzer, Sofia 2 Installation Pack (K173691) | Quidel Corporation | 2018-02-28 |
| CereMetrix Silver (K173145) | Ceremetrix Corp | 2018-02-28 |
| Liofilchem MIC Test Strip (MTS), Ceftazidime-avibactam 0.016/4 - 256/4 µg/mL (K173817) | Liofilchem s.r.l. | 2018-02-28 |
| Optilite C-Reactive Protein Reagent,Optilite C-Reactive Protein Calibrator,Optilite C-Reactive Protein Controls (K172868) | The Binding Site Group , Ltd. | 2018-02-28 |
| iovera system (K173763) | Myoscience, Inc. | 2018-02-28 |
| ALOKA ARIETTA 850 (K173739) | Hitachi Healthcare Americas Corporation | 2018-02-28 |
| CLUNGENE Multi-Drug Test Dip Card, CLUNGENE Multi-Drug Test Easy Cup (K180255) | Hangzhou Clongene Biotech Co., Ltd. | 2018-02-28 |