| K181978 — Zenius, Iliad and Kora Spinal Fixation Systems | Medyssey USA, Inc. Aug 13, 2018 |
| K173498 — Simplexa Bordetella Direct, Simplexa Bordetella Positive Control Pack | Diasorin Molecular, LLC Aug 13, 2018 |
| K181593 — Vantage Galan 3T, MRT-3020/A7, V5.0 | Canon Medical Systems Corporation Aug 13, 2018 |
| K173123 — Pulse Oximeter | Shenzhen Imdk Medical Technology Co., Ltd. Aug 13, 2018 |
| K181318 — ONIS-PACS | Digitalcore Co., Ltd. Aug 13, 2018 |
| K173549 — BIAFINE | Valeant Pharmaceuticals Aug 13, 2018 |
| K180539 — Deformity Analysis and Correction Software (DACS) and Instrumentation | Arrowhead Medical Device Technologies, LLC Aug 13, 2018 |
| K173248 — CARDIOSKIN | Bioserenity Sas Aug 11, 2018 |
| K181891 — Portable X-ray System (Model: MiniX-V, Mini X-S) | Digimed Co., Ltd. Aug 10, 2018 |
| K181584 — Redi-Spine | Innovative Surgical Designs, Inc. Aug 10, 2018 |
| K181253 — Bosley Revitalizer 272 Laser Cap, Bosley Revitalizer 164 Laser Cup | Pjm Worldwide, LLC D/B/A Phoenix Medical Technology, LLC Aug 10, 2018 |
| K180814 — CoreLink® M3 Stand-Alone Anterior Lumbar System | Corelink, LLC Aug 10, 2018 |
| K180834 — Altrix Precision Temperature Management System | Stryker Medical Aug 10, 2018 |
| K181151 — GYNECARE TVT Abbrevo Continence System; GYNECARE TVT Obturator Continence System | ETHICON, Inc. Aug 10, 2018 |
| K181627 — Bausch + Lomb Boston SimplusMulti-Action Solution, Bausch + Lomb Boston One Step Liquid Enzymatic Cleaner | Bausch & Lomb, Incorporated Aug 10, 2018 |
| K181849 — iStim S2 OTC Pain Relief TENS | Everyway Medical Instruments Co., Ldt. Aug 10, 2018 |
| K180234 — physiQ Heart Rhythm Module | Physiq, Inc. Aug 10, 2018 |
| K170110 — Diana Medication Transfer Set | Icu Medical, Inc. Aug 10, 2018 |
| K181130 — Powder Free Blue Nitrile Examination Gloves, Tested for Use with Chemotherapy Drugs | Hebei Titans Hongsen Medical Technology Co., Ltd. Aug 10, 2018 |
| DEN170052 — Natural Cycles | Natural Cycles Nordic AB Aug 10, 2018 |
| K180644 — Nitrile Powder Free Examination Gloves with Colloidal Oatmeal - Lemon Green | Hartalega Sdn Bhd Aug 10, 2018 |
| K173844 — Titan Ag 200 | Specialty Fibres And Materials, Ltd. Aug 9, 2018 |
| K173819 — MyPlant II Implant System | Hager& Meisinger GmbH Aug 9, 2018 |
| K181430 — LENSAR Laser System - fs 3D (LLS-fs 3D) | Lensar, Inc. Aug 9, 2018 |
| K181866 — MotoCLIP/HiMAX Step Staple Implant System | Crossroads Extremity Systems, LLC Aug 9, 2018 |
| K180759 — SECULOK Suture Anchor | U&I Corporation Aug 9, 2018 |
| K181557 — INFINITY Total Ankle System | Wrightmedicaltechnologyinc Aug 9, 2018 |
| K173407 — VT - 100, VT - 200 | Carilex Medical, Inc. Aug 9, 2018 |
| K181544 — Anchor Bolt (as an accessory to Depth Electrodes) | Ad-Tech Medical Instrument Corporation Aug 9, 2018 |
| K173505 — FORA GTel Blood Glucose Monitoring System | Foracare, Inc. Aug 9, 2018 |
| K180417 — Self-destruction Safety Syringes for Single Use; Sterile Hypodermic Syringes for Single Use; Sterile Hypodermic Needles for Single Use; Sterile Safety Hypodermic Needles for Single Use | Berpu Medical Technology Co., Ltd. Aug 9, 2018 |
| K181677 — Kodiak Spinal Fixation System | Alphatec Spine, Inc. Aug 9, 2018 |
| K181680 — ICONN Answer II Suture Anchor | Iconn Orthopedics, LLC Aug 9, 2018 |
| K181533 — EVOS Wrist Fracture Plating System | Smith & Nephew, Inc. Aug 9, 2018 |
| K171245 — Presygen/si-1 | Christie Medical Holdings, Inc. Aug 9, 2018 |
| K181041 — 7D Surgical System Cranial Application | 7D Surgical, Inc. Aug 8, 2018 |
| K180221 — Powder Free White, Green Sterilized Polychloroprene Copolymer Surgical Gloves - Tested for Use with Chemotherapy Drugs | Smart Glove Corporation Sdn. Bhd. Aug 8, 2018 |
| K181853 — Alere BinaxNOW Influenza A & B Card 2, Alere Reader | Alere Scarborough, Inc. Aug 8, 2018 |
| K180169 — EagleRay Long Sheath, 0.088 ID, 80cm, 90cm, 100cm and 110cm Lengths, EagleRay Access Catheter, 0.071 ID, 137cm Length, EagleRay Access Catheter, 0.055 ID, 137cm Length, EagleRay Access Catheter, 0.045 ID, 144cm Length, EagleRay Access Catheter, 0.035 ID, 158cm Length | Imperative Care, Inc. Aug 8, 2018 |
| K180598 — UNIQA Dental Implants System | Uniqa Dental, Ltd. Aug 8, 2018 |
| K173193 — F&P SleepStyle | Fisher & Paykel Healthcare, Ltd. Aug 8, 2018 |
| K180805 — Pure EP | Biosig Technologies Aug 8, 2018 |
| K181836 — 4F Infiniti Angiographic Catheter, 4F & 5F Nylex Angiography Catheters, 4F & 5F Tempo Angiography Catheters | Cordis, A Cardinal Health Company Aug 8, 2018 |
| K180734 — SmartLinx Vitals Plus Patient Monitoring System | Capsule Technologie Aug 8, 2018 |
| K181946 — Sensititre 18-24 hour MIC Breakpoint Susceptibility System with Plazomicin in the dilution range of 0.06-128 ug/mL | Thermo Fisher Scientific Aug 8, 2018 |
| K172508 — Ageless Health Medical Digital Thermometer | Ageless Health Industrial Co., Ltd. Aug 8, 2018 |
| K180351 — EndoWrist Mercury Bipolar Grasper | Intuitive Surgical, Inc. Aug 7, 2018 |
| K181218 — AlignRT Plus | Vision Rt, Ltd. Aug 7, 2018 |
| K180634 — Surgical Silver Post Operative Dressing | Advanced Medical Solutions, Ltd. Aug 7, 2018 |
| K180248 — VascuEase IC-1200-WH | Bio Compression Systems, Inc. Aug 7, 2018 |