| DUS-7000 Digital Color Doppler Ultrasound System (K172055) | Advanced Instrumentations, Inc. | 2017-08-31 |
| Arctic Sperm Cryopreservation Medium (K171224) | Irvine Scientific Sales Co., Inc. | 2017-08-31 |
| Integrated Catch-up Freedom Syringe Driver Infusion System (K162613) | Repro-Med Systems, Inc. Dba Rms Medical Products | 2017-08-31 |
| SureFlo EVD Catheter (K170599) | Arkis Biosciences, Inc. | 2017-08-31 |
| MAGEC® System (K171791) | Nuvasive Specialized Orthopedics, Incorporated | 2017-08-31 |
| Pirouette High Pressure (HP) (K172033) | Arravasc, Ltd. | 2017-08-31 |
| MyndMove System, MyndMove Functional Electrical Stimulator (K170564) | Myndtec, Inc. | 2017-08-30 |
| Microlife Upper Arm Automatic Digital Blood Pressure Monitor (K170467) | Microlife Intellectual Property GmbH | 2017-08-30 |
| The Sensititre 20-24 hour Haemophilus influenzae/Streptococcus pneumoniae MIC or Breakpoint Susceptibility System with Delafloxacin in the dilution range of 0.00025-8µg/mL (K172274) | Thermo Fisher Scientific | 2017-08-30 |
| Astroglide O Oil Personal Lubricant & Massage Oil (K171985) | Biofilm, Inc. | 2017-08-30 |
| truFreeze System (K171626) | CSA Medical, Inc. | 2017-08-30 |
| LigaPASS (K172021) | Medicrea International SA | 2017-08-30 |
| SmartTouch (K163485) | Adherium (Nz), Ltd. | 2017-08-30 |
| K2M Navigation Instruments (K171321) | K2m | 2017-08-30 |
| Idylla Respiratory (IFV-RSV) Panel (K163628) | Janssen Pharmaceutica NV | 2017-08-30 |
| CryoIQ DERM, CryoIQ PRO, CryoIQ EquiMED (K172049) | Cry IQ AB | 2017-08-30 |
| Refobacin Bone Cement R (K171540) | Biomet, Inc. | 2017-08-30 |
| Assut Filbloc Permanent Sutures (K171039) | Assut Europe S.P.A. | 2017-08-29 |
| CrossFT™ Knotless Biocomposite Suture Anchor with Disposable Driver (K171592) | Conmed Corporation | 2017-08-29 |
| ChitoPulse 9in / 23 cm, ChitoPulse 12in / 30.5 cm, ChitoPulse 15in / 38 cm (K170958) | Tricol Biomedical, Inc. | 2017-08-29 |
| Feminine Personal Trainer (FPT) (K171896) | Ralston Group | 2017-08-29 |
| Laport (K171741) | Sejong Medical Co., Ltd. | 2017-08-29 |
| SyMRI (K162943) | Syntheticmr AB | 2017-08-29 |
| ambIT PCA*PIB, ambIT PIB, ambIT PIB*PCA, ambIT PIEB, and ambIT Programmable Intermittent Pump (K162165) | Summit Medical Products, Inc. | 2017-08-29 |
| Altus Spine Titanium Interbody Fusion System (K171329) | Altus Partners, LLC | 2017-08-29 |
| Cortex Dental Implant System (K163385) | Cortex Dental Implants Industries , Ltd. | 2017-08-29 |
| Easyscreen (K171506) | Maico Diagnostics GmbH | 2017-08-29 |
| PROCOTYL® PRIME E-CLASS™ XLPE Liner (K171181) | Microport Orthopedics, Inc. | 2017-08-28 |
| Moxxly Flow Collection System (K170722) | Moxxly, Inc. | 2017-08-28 |
| Salle Intraoperative Pyeloplasty Stent Set (K170010) | Cook Incorporated | 2017-08-28 |
| 2 Hole Lateral Plating System (K172131) | Life Spine, Inc. | 2017-08-28 |
| Reverse Pull Adjustable Facemask (K162543) | Sawbros Industries Pvt., Ltd. | 2017-08-28 |
| Captus Vascular Retrieval System (K170987) | Avantec Vascular Corporation | 2017-08-28 |
| Dextera MicroCutter 30 Blue Reload, Dextera MicroCutter 30 Curved Tip Blue Reload, Dextera MicroCutter 30 White Reload, Dextera MicroCutter 30 Curved Tip White Reload (K171561) | Dextera Surgical, Inc. | 2017-08-28 |
| IRIX-A Lumbar Integrated Fusion System (K171567) | X-Spine Systems, Inc. | 2017-08-28 |
| ShenDa Sinuscope (K161298) | Shenyang Shenda Endoscope Co., Ltd. | 2017-08-25 |
| Sapphire Sets (K171346) | Icu Medical | 2017-08-25 |
| Sirius MRI Marker NS (K171487) | C4 Imaging, LLC | 2017-08-25 |
| Hi-Torque Command 18 Guide Wire (K172073) | Abbott Vascular | 2017-08-25 |
| Revolve Envi 600 Advanced Adipose System (K163647) | Lifecell Corporation | 2017-08-25 |
| OTIS Optical Coherence Tomography System (K171560) | Perimeter Medical Imaging, Inc. | 2017-08-25 |
| Hexagen Derm (K171191) | Global Health Solutions, LLC | 2017-08-25 |
| SKR 3000 (K171716) | Konica Minolta, Inc. | 2017-08-25 |
| Standard Supreme Sterilization Wrapper (K172207) | Standard Textile Co., Inc. | 2017-08-25 |
| VMA™ System version 3.0 (K172327) | Ortho Kinematics, Inc. | 2017-08-25 |
| Nihon Kohden Wireless Input Unit WEE-1200 (K171124) | Nihon Kohden Corporation | 2017-08-25 |
| Locking Cage, Full XPE Cup (K163441) | United Orthopedic Corporation | 2017-08-25 |
| Catalys Precision Laser System (K172002) | Amo Manufacturing USA, LLC | 2017-08-25 |
| Synthetic Nitrile Patient Examination Gloves, Powder Free, Blue Color, and Tested for Use with Chemotherapy Drugs (K170136) | Shandong Feiyang Professional Gloves Co., Ltd. | 2017-08-25 |
| Non-Sterile, Powder Free Nitrile Examination Gloves, Tested for use with Chemotherapy Drugs (Blue, Cobalt Blue) (K171104) | Yty Industry (Manjung) Sdn Bhd | 2017-08-25 |
| BRH-A2 Combined Ultrasound and Electric Field Stimulation (CUSEFS) (K160378) | Brh Medical , Ltd. | 2017-08-25 |
| Entrada™ hip stem (K171249) | Ortho Development Corporation | 2017-08-24 |
| RS80A Diagnostic Ultrasound System (K171048) | Samsung Medison Co., Ltd. | 2017-08-24 |
| Liver Access and Biopsy Sets (K171853) | Cook Incorporated | 2017-08-24 |
| MagnetOs Putty (K171563) | Kuros Biosciences B.V | 2017-08-24 |
| PRECICE UNYTE System (K172061) | Nuvasive Specialized Orthopedics, Inc. | 2017-08-24 |
| Nivairo RT045 Non-Vented Hospital Full Face Mask Anti-Asphyxiation Valve - Large, Nivairo RT045 Non-Vented Hospital Full Face Mask Anti-Asphyxiation Valve - Medium, Nivairo RT045 Non-Vented Hospital Full Face Mask Anti-Asphyxiation Valve - Small, Nivairo RT045 Non-Vented Hospital Full Face Mask Anti-Asphyxiation Valve - Extra Small (K170367) | Fisher and Paykel Healthcare Limited | 2017-08-24 |
| Fixone Biocomposite Anchor (K171299) | Aju Pharm Co., Ltd. | 2017-08-24 |
| RT Elements, Cranial SRS, Spine SRS, Multiple Brain Mets SRS, RT QA, Adaptive Hybrid Surgery Analysis, Dose Review (K170750) | Brainlab AG | 2017-08-24 |
| F1 Mothership Wireless Transducers for Fetal Ultrasonic and Tocodynamometer Monitoring (K171865) | Farus, LLC | 2017-08-24 |
| OrthoPediatrics Titanium PediPlates® System (K171173) | OrthoPediatrics Corp. | 2017-08-24 |
| Stryker Self-Punching ICONIX (K171465) | Stryker | 2017-08-24 |
| NxStage System One (K171331) | Nxstage Medical, Inc. | 2017-08-24 |
| CADD®- Solis Ambulatory Infusion Pump with Wireless Communication; CADD®-Solis Infusion Pump, Model 2110; PharmGuard® Administrator Medication Safety Software; CADD® Administration Sets; Wireless Communication Module (CM) (K170982) | Smiths Medical Ads, Inc. | 2017-08-24 |
| VenaCure EVLT NeverTouch Procedure Kit (K171921) | AngioDynamics, Inc. | 2017-08-24 |
| 1.8mm X 149cm Phoenix Atherectomy System, 2.2mm X 149cm Phoenix Atherectomy System, 2.4mm X 130cm Phoenix Atherectomy System (K172386) | Volcano Atheromed, Inc. | 2017-08-24 |
| Passport Series Patient Monitors(Passport 12m, Passport 17m) (K170876) | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 2017-08-23 |
| LG BEAUTY LED MASK (K170984) | Lg Electronics | 2017-08-23 |
| Ozark(tm) Cervical Plate System (K172104) | K2m, Inc. | 2017-08-23 |
| Endoscopic Injection Needle (K172227) | Carbon Medical Technologies, Inc. | 2017-08-23 |
| EVOS Small Fragment Plating System (K172262) | Smith & Nephew, Inc. | 2017-08-23 |
| Physiotrace (K171244) | Nimbleheart, Inc. | 2017-08-23 |
| Modified Winch Kyphoplasty (15 and 20 mm) 11 Gauge Balloon Catheters (K172214) | G-21 S.R.L. | 2017-08-23 |
| OKI Surgical Planning Software (K171617) | Ortho Kinematics, Inc. | 2017-08-22 |
| Stryker Integrated Bipolar Cord and Tubing Sets (K172367) | Stryker Instruments | 2017-08-22 |
| Matrixx System (K171140) | Nexxt Spine, LLC | 2017-08-22 |
| VERIFY Assert VH2O2 Self-Contained Biological Indicator (K171504) | STERIS Corporation | 2017-08-22 |
| i-STAT Hematocrit test with i-STAT Alinity System (K163342) | Abbott Laboratories | 2017-08-22 |
| Grivamax Hair Growth System (K171895) | Leana Orders, Inc. | 2017-08-22 |
| EzDent-i / E2 / Prora View (K172364) | Ewoosoft Co., Ltd. | 2017-08-22 |
| INNOVANCE(r) Heparin Reagents, INNOVANCE(r) Heparin Calibrator, INNOVANCE(r) Heparin UF and Heparin LMW Controls (K162540) | Siemens Healthcare Diagnostics Prodcts GmbH | 2017-08-22 |
| Borrelia B31 ViraChip IgM Test Kit (K163695) | Viramed Biotech AG | 2017-08-22 |
| Monopolar Single Use Laparoscopic Instrument (K171523) | Getsch+Hiller Medizintechnik GmbH | 2017-08-22 |
| VERIFY Incubator for Assert VH2O2 Self-Contained Biological Indicator (K171587) | STERIS Corporation | 2017-08-22 |
| SilverSeal (K171041) | Alliqua Biomedical, Inc. | 2017-08-22 |
| NEOCERA Advanced Barrier Cream (K170911) | Exeltis USA Dermatology, LLC | 2017-08-22 |
| GRAVITY™ Soft Tissue Repair System (K170642) | Wrightmedicaltechnologyinc | 2017-08-22 |
| MAMBA and MAMBA FLEX Microcatheters (K171452) | Boston Scientific Corporation | 2017-08-21 |
| Approach CTO Microwire Guide (K171897) | Cook Incorporated | 2017-08-21 |
| Ceribell Instant EEG Headband (K171459) | Ceribell, Inc. | 2017-08-21 |
| Sterile Polyisoprene Surgical Powder Free Glove Tested for Use with Chemotherapy Drugs (K171276) | Tg Medical Sdn. Bhd. | 2017-08-21 |
| RIDA GENE Norovirus GI/GII (K171511) | R-Biopharm AG | 2017-08-21 |
| Threshold™ V2 Pedicular Fixation System, Threshold™ Pedicular Fixation System, Fortress™ Pedicular Fixation System, Palisade™ Pedicular Fixation System (K172107) | Spineology, Inc. | 2017-08-21 |
| Sorbact Wound Dressing-Ribbon Gauze (K171225) | Abigo Medical AB | 2017-08-21 |
| ShockPulse-SE Lithotripsy System (K171024) | Cybersonics, Inc. | 2017-08-21 |
| INFINITY™ OCT System (K163375) | Medtronic Sofamor Danek USA, Inc. | 2017-08-21 |
| Zenius™, lliad™ and Kora™ Spinal Fixation Systems (K171526) | Medyssey USA, Inc. | 2017-08-21 |
| Streamline OCT Occipito-Cervico-Thoracic System (K172139) | Pioneer Surgical Technology, Inc. (Dba Rti Surgical, Inc.) | 2017-08-18 |
| NuVasive LessRay with Enhanced Tracking (K170800) | Nu Vasive, Incorporated | 2017-08-18 |
| Connector System (K172194) | Orthofix, Inc. | 2017-08-18 |