| Model WP-3840 and WP-3040 (K173848) | Cnmc Co., Inc. | 2018-08-07 |
| Self-adhesive Electrode (K181234) | Dong Guan OU Kang Electronics Co., Ltd. | 2018-08-07 |
| CubeVue (K181962) | Curvebeam, LLC | 2018-08-07 |
| Volo 14 Guidewire, 200cm, Soft Profile, Volo 14 Guidewire, 200cm, Standard Profile, Volo 14 Guidewire, 300cm, Soft Profile, Volo 14 Guidewire, 300cm, Standard Profile (K181828) | Scientia Vascular, LLC | 2018-08-07 |
| EP Granules™ BVF (K180853) | Elute, Inc. | 2018-08-06 |
| Arthrex SwiveLock (K173845) | Arthrex, Inc. | 2018-08-06 |
| MINUET LCD, MINUET LCD eco (K180075) | Unimom.Co | 2018-08-06 |
| CystoSure Plus Catheter (K181346) | Emmy Medical, LLC | 2018-08-06 |
| VesoFlow Lite DVT Compression Device (K181217) | Caremed Supply, Inc. | 2018-08-05 |
| APTUS® Proximal Humerus System (K181425) | Medartis AG | 2018-08-05 |
| PHMB Foam Wound Dressing (K181197) | Advanced Medical Solutions, Ltd. | 2018-08-03 |
| ASK System (K181146) | L and K Biomed Corporation Limited | 2018-08-03 |
| K2M Expandable Interbody System (K180777) | K2m, Inc. | 2018-08-03 |
| HORIZON TMS Therapy System (K180907) | Magstim Company, Ltd. | 2018-08-03 |
| Ingenia Ambition S and Ingenia Ambition X (K181479) | Philips Medical Systems Nederland B.V. | 2018-08-03 |
| FreshLook Handling Tint, FreshLook Colors, FreshLook ColorBlends, FreshLook Dimensions (K181796) | Alcon Laboratories, Inc. | 2018-08-03 |
| Philips CT Big Bore Sliding Gantry Configuration (K181797) | Phillips Medical Systems (Cleveland), Inc. | 2018-08-03 |
| OptiPillows EPAP Mask (K181219) | Cpapnea Medical Supply | 2018-08-03 |
| Arm Type Blood Pressure Monitor (K180155) | Avita Corporation | 2018-08-03 |
| GRYPHON® Anchors with DYNACORD™ Suture (K181809) | Medos International SARL | 2018-08-03 |
| EasyTouch Safety Pen Needle (K163578) | Mhc Medical Products, LLC | 2018-08-03 |
| ECG recorder and Arrhythmia Detector (K173461) | Smart Solutions Technologies SL | 2018-08-03 |
| Atlas Gold PTA Dilatation Catheter (K181323) | C.R. Bard, Inc. | 2018-08-03 |
| BH Sterilization Pouch (K172280) | Bh Medical Products Co., Ltd. | 2018-08-03 |
| Fluent Fluid Management System (K180825) | Hologic, Inc. | 2018-08-03 |
| FUJIFILM 600 Series Endoscope EG-600WR v2 (K180341) | Fujifilm Corporation | 2018-08-03 |
| VirtuOst Vertebral Fracture Assessment (K171435) | O.N. Diagnostics, LLC | 2018-08-03 |
| Therm-X Pro, Therm-X AT, Therm-X Pro Athlete (K181149) | Zenith Technical Innovations | 2018-08-03 |
| Glidesheath Slender Tibial Pedal Kit (K181237) | Terumo Medical Corporation | 2018-08-03 |
| Curiteva Midline Anterior Cervical Plate System (or Curiteva Anterior Cervical Plate System) (K181549) | Curiteva, LLC | 2018-08-03 |
| Polydioxanone Surgical Scaffold (K181094) | Lntegra Lifesciences | 2018-08-02 |
| Temporary Cardiac Pacing Wire (K173923) | ETHICON, Inc. | 2018-08-02 |
| Azurion R2.0 (K181830) | Philips Medical Systems Nederland B.V. | 2018-08-02 |
| Qualisys Clinical System (K171547) | Qualisys AB | 2018-08-02 |
| DYNACORD Suture (K181182) | Medos International SARL | 2018-08-02 |
| Cianna Medical SAVI Scout Reflector and SAVI Scout System (K181007) | Cianna Medical, Inc. | 2018-08-02 |
| miPlatform medical imaging suite v3.0 (miPlatform v3.0), miPlatform ZFP Viewer (K171977) | Hinacom Software and Technology, Ltd. | 2018-08-02 |
| PL8 Wrist Reconstruction Plate (K180150) | Citieffe S.R.L. | 2018-08-02 |
| ProVectra 3D Prime with VistaSoft (K181432) | Durr Dental SE | 2018-08-02 |
| Alphenix, INFX-8000C/B, V8.0 (K181804) | Canon Medical Systems Corporation | 2018-08-02 |
| Neonatal ConchaSmart Breathing Circuits (K173280) | Teleflexmedical, Inc. | 2018-08-02 |
| Curiteva Anterior Cervical Plate System (K181562) | Curiteva, LLC | 2018-08-02 |
| Med-link Reusable Blood Pressure Cuff (K173869) | Shenzhen Med-Link Electronics Tech Co., Ltd. | 2018-08-02 |
| Lockbox for Perfusor Space PCA Infusion Pump (K173531) | B.Braun Medical, Inc. | 2018-08-02 |
| PlasmaBlade X 3.0S, PlasmaBlade X 4.0 (K181257) | Medtronic Advanced Energy | 2018-08-02 |
| MMD Tip (K181480) | Strata Skin Sciences, Inc. | 2018-08-01 |
| TrojanTM Azul Personal Lubricant (H2O Sensitive Touch Personal Lubricant) (K180764) | Church & Dwight Co., Inc. | 2018-08-01 |
| Propeller Sensor for Neohaler (K180770) | Reciprocal Labs Corporation | 2018-08-01 |
| VITA YZ ST and VITA YZ XT (K180703) | Vita Zahnfabrik H.Rauter GmbH Co. | 2018-08-01 |
| Smart One (K181666) | Mir Medical International Research | 2018-08-01 |
| Ultrasound Scanner System bk2300 (K180737) | Bk Medical Aps | 2018-08-01 |
| BriefCase (K180647) | Aidoc Medical , Ltd. | 2018-08-01 |
| SuperCable® Iso-Elastic™ Cerclage System (K181749) | Kinamed, Incorporated | 2018-08-01 |
| NovoStitch Pro Meniscal Repair System, CTX-A004 (size 0) (K181772) | Ceterix Orthopaedics, Inc. | 2018-08-01 |
| MTS Plazomicin 0.016-256 µg/mL (K181708) | Liofilchem s.r.l. | 2018-07-31 |
| SPRINT Peripheral Nerve Stimulation System, Extensa, SPRINT Peripheral Nerve Stimulation System, Endura, SPRINT Clinical Programmer Kit (K181422) | Spr Therapeutics, Inc. | 2018-07-31 |
| MolecuLight i:X (DEN180008) | MolecuLight, Inc. | 2018-07-31 |
| 3M High Performance Surgical Mask, 3M High Performance Surgical Mask with Face Shield (K180874) | 3M Healthcare | 2018-07-31 |
| Picocare Family (K181272) | Wontech Co., Ltd. | 2018-07-31 |
| Laser Ureteral Catheter (K181431) | Cook Incorporated | 2018-07-30 |
| CDC Human Influenza Virus Real-Time RT-PCR Diagnostic Panel: Influenza B Lineage Genotyping Kit, (K181736) | Centers For Disease Control and Prevention (CDC) | 2018-07-30 |
| Epiphany Cardio Server Mobile (K181720) | Epiphany Healthcare, LLC | 2018-07-30 |
| ADVIA Centaur CMV IgG and ADVIA Centaur CMV IgG Quality Control (K181213) | Siemens Healthcare Diagnostics, Inc. | 2018-07-30 |
| 308nm Excimer System (K172273) | Chongqing Peninsula Medical Technology Co., Ltd. | 2018-07-30 |
| IceSphere 1.5 CX Cryoablation Needle (K181741) | Galil Medical , Ltd. | 2018-07-30 |
| Proficient® Posterior Cervical Spine System (K181440) | Spine Wave, Inc. | 2018-07-30 |
| TE7/TE5 Diagnostic Ultrasound System (K180912) | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 2018-07-30 |
| RCT800 (K181452) | Ray Co., Ltd. | 2018-07-27 |
| Panther Fusion GBS Assay (K181156) | Diagenode | 2018-07-27 |
| Ti 3Z Interbody System (K180076) | Zavation Medical Products, LLC | 2018-07-27 |
| FlowTriever Retrieval/Aspiration System (K181694) | Inari Medical | 2018-07-27 |
| OIC Intramedullary Nail System (K181184) | The Orthopaedic Implant Company | 2018-07-27 |
| Universal Cannula Seal (5-12 mm) (K181395) | Intuitive Surgical, Inc. | 2018-07-27 |
| Stowe Pedicle Screw System (K181554) | Black Box Medical | 2018-07-27 |
| EPIQ , EPIQ 5, EPIQ 7, Affiniti 30, Affiniti 50 and Affiniti 70 Diagnostic Ultrasound System (K181485) | Philips Ultrasound, Inc. | 2018-07-27 |
| Pulse Oximeter (K172616) | Beijing Safe Heart Technology , Ltd. | 2018-07-27 |
| RetiCapture (K173474) | Ilooda Co,., Ltd. | 2018-07-27 |
| Argyle Peritoneal Dialysis Catheter and Kits, Argyle Presternal Peritoneal Dialysis Catheter and Kits, Argyle Peritoneal Dialysis Accessory Two Part Titanium Luer Adapter, Argyle Adult Peritoneal Dialysis Accessory Titanium Catheter Extender (K180485) | Covidien, LLC | 2018-07-27 |
| FUJIFILM Ultrasonic Endoscope (K181763) | Fujifilm Corporation | 2018-07-27 |
| Medline ReNewal Reprocessed Smith & Nephew Jet-X External Fixation Devices (K180580) | Surgical Instrument Service and Savings, Inc. | 2018-07-27 |
| OsteoFab Patient Specific Cranial Device (K180064) | Oxford Performance Materials, Inc. | 2018-07-27 |
| Corelink Foundation 3D Anterior Lumbar System (K180556) | Corelink, LLC | 2018-07-27 |
| Macroduct Advanced Model 3710 (K180627) | Elitechgroup, Inc. | 2018-07-27 |
| Voutia™ (K173808) | Jeffrey Ward Cash, Dds | 2018-07-27 |
| CLUNGENE Multi-Drug Test Dip Card, CLUNGENE Multi-Drug Test Easy Cup (K181790) | Hangzhou Clongene Biotech Co., Ltd. | 2018-07-26 |
| RxSight Insertion Device (K181401) | Rxsight, Inc. | 2018-07-26 |
| eLens Rigid Gas Permeable Contact Lens for Daily Wear, eLens Rigid Gas Permeable Contact Lens for Daily Wear Ortho-K (K181579) | E&E Optics, Inc. | 2018-07-26 |
| PROLENE (Polypropylene) 3D Patch (K181268) | ETHICON, Inc. | 2018-07-26 |
| Vios Central Station Monitor Software, Vios Central Server Software (K173107) | Vios Medical, Inc. | 2018-07-26 |
| Level 1 Convective Warmer (K181699) | Smiths Medical Asd, Inc. | 2018-07-26 |
| RadialSeal Introducer Kit (K181855) | Great Batch Medical | 2018-07-26 |
| Avologi ENEO (K181659) | Premier North America, Inc. | 2018-07-26 |
| neuromate Gen III (K181706) | Renishaw Mayfield Sarl | 2018-07-26 |
| Saniclave 250 (K180272) | Revolutionary Science | 2018-07-26 |
| Shockwave M5 Peripheral Intravascular Lithotripsy (IVL) Catheter, lntravascular Lithotripsy (IVL) Generator And Connector Cable, Intravascular Lithotripsy (IVL) Connector Cable (K180958) | Shockwave Medical, Inc. | 2018-07-26 |
| San Antonio Stopcock (K181712) | Cook Incorporated | 2018-07-26 |
| Arthrex FibuLock Nail (K173656) | Arthrex, Inc. | 2018-07-26 |
| Smartinhaler (K180407) | Adherium (Nz), Ltd. | 2018-07-25 |
| Republic Spine Dark Star Spinal System (K181495) | Republic Spine, LLC | 2018-07-25 |
| RHYTHMIA HDx Mapping System (with software Version 2.0) (K173837) | Boston Scientific Corporation | 2018-07-25 |