| ATEC ALIF Spacer System (K181453) | Alphatec Spine, Inc. | 2018-07-25 |
| FIXIT / ComposiTCP Threaded Anchor System (K180960) | S.B.M. Sas Sciences For Bio Materials | 2018-07-25 |
| TREND II Spinal Fixation System- STEP Series (K180226) | Paonan Biotech Co., Ltd. | 2018-07-25 |
| Exactech Equinoxe Small Reverse Shoulder System (K180632) | Exactech, Inc. | 2018-07-25 |
| Veloxion System, Veloxion Controller Kit, Veloxion Resecting Device Kit, Veloxion Fluid Control Set, Veloxion Saline Pole (K180752) | Corinth Medtech, Inc. | 2018-07-25 |
| Alphenix, INFX-8000V/B, V8.0 (K181670) | Canon Medical Systems Corporation | 2018-07-25 |
| Lumbar Interbody Fusion System (OLLIF) (K173947) | Advanced Research Medical, LLC | 2018-07-25 |
| CELERITY 20 Steam Biological Indicator (K181686) | STERIS Corporation | 2018-07-24 |
| Autokeeper (K172095) | Medexel Co.,Ltd | 2018-07-24 |
| S-mini active Fixture (K181178) | Neobiotech Co., Ltd. | 2018-07-24 |
| FIREFLY® Pedicle Screw Navigation Guide (K181399) | Mighty Oak Medical, Inc. | 2018-07-24 |
| TWBM Pump (K180115) | Taiwan Biomaterial Co., Ltd. | 2018-07-24 |
| CipherOx CRI M1 (K173929) | Flashback Technologies, Inc. | 2018-07-24 |
| I-Portal Neuro Otologic Test Center; I-Portal Video Nystagmography System; I-Portal Video Oculography Eye Tracking System (K181025) | Neuro Kinetics, Inc. | 2018-07-24 |
| RF-Relief (K181095) | El Global Trade, Ltd. | 2018-07-24 |
| MX40 Release C.01 (K180017) | Philips Medical Systems | 2018-07-24 |
| DePuy Synthes Static Staples (K180544) | Synthes (USA) Products, LLC | 2018-07-24 |
| Xpert Xpress Flu/RSV, Xpert Nasopharyngeal Sample Collection Kit, Xpert Nasal Sample Collection Kit, GeneXpert Xpress II, GeneXpert Xpress IV (K180218) | Cepheid | 2018-07-24 |
| Dental High-speed Handpiece and Accessories (K173943) | Microp Technology (Taiwan), Inc. | 2018-07-24 |
| Altus Spine Pedicle Screw System (K181339) | Altus Partners, LLC | 2018-07-24 |
| Portable ECG Monitor (ECG3) (K172862) | Andon Health Co, Ltd. | 2018-07-24 |
| DV-300 Aspirator (K181398) | Ding Hwa Co., Ltd. | 2018-07-23 |
| Quantitative Total Extensible Imaging (QTxI) (K173444) | Aiq Solutions, Inc. | 2018-07-23 |
| Non-contact infrared body thermometer (K171888) | Hetaida Technology Co., Ltd. | 2018-07-23 |
| JASPER Spinal Fixation System (K173645) | Gbs Commonwealth Co., Ltd. | 2018-07-23 |
| Voyager Trajectory Array Guide (V-TAG) (K180854) | Voyager Therapeutics, Inc. | 2018-07-23 |
| Braun BNT400 No Touch + Forehead Thermometer (K181242) | Kaz USA, Inc., A Helen of Troy Company | 2018-07-23 |
| GME LinScan Lite 808 Laser System (K180518) | Gme German Medical Engineering GmbH | 2018-07-23 |
| Stryker All-PEEK Knotless Anchor System (K181083) | Stryker | 2018-07-23 |
| JGH1 Core Deccompression Procedure Kit (K181585) | AgNovos Healthcare USA, LLC | 2018-07-20 |
| GR40CW (K181631) | Samsung Electronics Co., Ltd. | 2018-07-20 |
| The Graft Natural Bone Substitute (K173188) | Purgo Biologics, Inc. | 2018-07-20 |
| Digital Diagnostic Mobile X-ray System (K181626) | Samsung Electronics Co., Ltd. | 2018-07-20 |
| Aurora (K181636) | Sodium Systems, LLC | 2018-07-20 |
| GC85A (K181629) | Samsung Electronics Co., Ltd. | 2018-07-20 |
| TruDi NAV Suction Instruments (K180948) | Acclarent, Inc. | 2018-07-20 |
| Bandit guidewire (K181647) | Vascular Solutions, Inc. | 2018-07-20 |
| GuardianTM Burr Hole Cover System (K181382) | St Jude Medical | 2018-07-20 |
| AQUACEL Ag+ EXTRA Enhanced Hydrofiber Dressing with Silver and Strengthening Fiber (K173675) | Convatec Limited | 2018-07-20 |
| NicoletOne (K173366) | Natus Neurology Incorporated | 2018-07-20 |
| Free Testosterone AccuBind ELISA Test System (K181017) | Monobind, Inc. | 2018-07-20 |
| WATCHMAN TruSeal Access System (K180864) | Boston Scientific | 2018-07-20 |
| Bonebridge (DEN170009) | Med-El Elektromedizinische Geraete GmbH | 2018-07-20 |
| Athena Cervical Plate System (K180022) | Medyssey USA, Inc. | 2018-07-20 |
| EcoFit Vit E Acetabular System (K180263) | Implantcast GmbH | 2018-07-20 |
| TV-100 (K173973) | Bio-Med Devices, Inc. | 2018-07-20 |
| CuffLink Implant System Biocomposite (K180763) | Conmed Corporation | 2018-07-19 |
| Medline Burn and Wound Dressing (K173911) | Medline Industries, Inc. | 2018-07-19 |
| DentiqGuide (K180629) | 3D Industrial Imaging Co., Ltd. | 2018-07-19 |
| Atellica IM High-Sensitivity Troponin I (TNIH) (K171566) | Siemens Healthcare Diagnostics, Inc. | 2018-07-19 |
| da Vinci Xi Surgical System, da Vinci X Surgical System (K173585) | Intuitive Surgical, Inc. | 2018-07-19 |
| Latitud Hip Replacement System (K172857) | Meril Healthcare Pvt. , Ltd. | 2018-07-19 |
| Image Filing Software NAVIS-EX (K181345) | Nidek Co., Ltd. | 2018-07-19 |
| Disposable Electrosurgical Pencils (K170369) | Cathay Manfacturing Corp. | 2018-07-19 |
| Ultrasonic Doppler (Model YM-2T8) (K180419) | Shenzhen Imdk Medical Technology Co., Ltd. | 2018-07-19 |
| Clarifi Imaging System (K181623) | Modulated Imaging, Inc. | 2018-07-19 |
| Ultimax-i, DREX-UI80 (V1.60) (K181834) | Canon Medical Systems Corporation | 2018-07-19 |
| JGH1 Bone Graft Substitute (K181342) | AgNovos Healthcare USA, LLC | 2018-07-19 |
| Power Infuser (K172653) | ZOLL Medical Corporation | 2018-07-18 |
| ATLANTIS Conus Structure (K181189) | Dentsply Sirona | 2018-07-18 |
| PENTAX Medical VIVIDEO ENT Videoscope Solution (K171011) | Pentax Medical | 2018-07-18 |
| ePTFE-Coated Auricular Implant (K172389) | Implantech Associates, Inc. | 2018-07-18 |
| SeaSpine Regatta Lateral System (K181079) | SeaSpine Orthopedics Corporation | 2018-07-18 |
| Ultra Facial Toning System (K181062) | Micro Current Technology, Inc. | 2018-07-18 |
| ASAHI PTCA Guide Wire ASAHI Gladius Mongo 14, ASAHI Gladius Mongo 14 ES (K180784) | Asahi Intecc Co., Ltd. | 2018-07-18 |
| Capnograph and Oximeter (K170820) | Cmi Health, Inc. | 2018-07-18 |
| Tritanium PL Cage (K181014) | Stryker Spine | 2018-07-18 |
| ACCUSYTE 3D Fiducial Marker (K180027) | Radiation Products, LLC | 2018-07-18 |
| KARL STORZ New Generation Trocars (K180977) | KARL STORZ Endoscopy-America, Inc. | 2018-07-18 |
| ARIETTA 65 (K181376) | Hitachi Healthcare Americas Corporation | 2018-07-18 |
| DIP/U.S. Urine Analysis Test System (K173327) | Healthy.Io, Ltd. | 2018-07-18 |
| CarboClear® Pedicle Screw System (K173487) | CarboFix Orthopedics , Ltd. | 2018-07-18 |
| AngioDynamics, Inc. Soft-Vu and Mariner Angiographic Catheters (K173762) | AngioDynamics, Inc. | 2018-07-18 |
| NeoLSD MSMS kit (K173829) | Wallac Oy, A Subsidiary of Perkinelmer | 2018-07-18 |
| Braun BFH175 Infrared Forehead Thermometer (K181015) | Kaz USA, Inc., A Helen of Troy Company | 2018-07-18 |
| Stat Profile Prime Plus Analyzer System (K173797) | Nova Biomedical Corporation | 2018-07-17 |
| Cadwell Apollo System (K180269) | Cadwell Industries, Inc. | 2018-07-17 |
| Apex Femoral Nailing System (K181375) | Orthoxel | 2018-07-17 |
| Sonicision Reusable Sterilization Tray (K180915) | Covidien | 2018-07-17 |
| Rubicon Lumbar Interbody Fusion System (K181030) | Rubicon Spine, LLC | 2018-07-17 |
| Field Orthopaedics Micro Screw System (K180348) | Field Orthopaedics Pty, Ltd. | 2018-07-17 |
| Cook-Swartz Doppler Flow Probe (K171272) | Cook Incorporated | 2018-07-17 |
| Ureteral Dilator Sets, Ureteral Dilators (K173654) | Cook Incorporated | 2018-07-17 |
| Straumann Variobase for Bridge/Bar Cylindrical (K173968) | Institut Straumann AG | 2018-07-17 |
| Atellica IM BRAHMS Procalcitonin (PCT) (K181002) | Siemens Healthcare Diagnostics, Inc. | 2018-07-16 |
| EIDON FA (K180526) | Centervue S.P.A. | 2018-07-16 |
| Embosphere Microspheres (K181300) | Biosphere Medical, S.A. | 2018-07-16 |
| CxHA PEEK Cervical IBF System (K181115) | Innovasis, Inc. | 2018-07-16 |
| Welch Allyn RetinaVue Network REF 901108 PACS Medical Image System (K181016) | Welch Allyn, Inc. | 2018-07-16 |
| Philips IntelliVue GuardianSoftware (K180534) | Philips Medizin Systeme Boeblingen GmbH | 2018-07-16 |
| MC3 Jugular Dual Lumen Catheter (K180151) | Mc3 Incorporated | 2018-07-16 |
| PathLoc-SI Joint Fusion System (K181600) | L&K BIOMED Co., Ltd. | 2018-07-16 |
| Diode Laser System (K181019) | Guangzhou Huafei Tongda Technology Co., Ltd. | 2018-07-16 |
| Solana Bordetella Complete Assay (K181029) | Quidel Corporation | 2018-07-15 |
| Yikang Latex Foley Catheter (K173340) | Jiangxi Yikang Medical Instrument Group Co., Ltd. | 2018-07-13 |
| EliA M2 Immunoassay (K181556) | Phadia AB | 2018-07-13 |
| Kestrel™ Buttress Plate System (K181063) | Innovasis, Inc. | 2018-07-13 |
| Aquarius 8600 Digital Radiography Sensor (K181565) | Biokinemetrics, Inc. | 2018-07-13 |
| Surgical gown (AE1001, AE2001, AE3001); Surgical Gown (AG1001, AG2001, AG3001) (K172987) | Gmax Industries, Inc. | 2018-07-13 |
| Sterile Latex Surgical Gloves, Powder Free (K171550) | Sanrea Healthcare Products Pvt, Ltd. | 2018-07-13 |