| K181750 — SITZMARKS | Konsyl Pharmaceuticals Nov 15, 2018 |
| K181985 — Voluson E6, Voluson E8, Voluson E10 | GE Healthcare Nov 15, 2018 |
| K181831 — IntelliVue Multi-Measurement Module MMX | Philips Medizin Systeme Boeblingen GmbH Nov 15, 2018 |
| K181292 — PrimeSight UNITY 9000 Video Processor, PrimeSight UNITY 9100 Video Processor | Cogentix Medical, Inc. Nov 15, 2018 |
| K183117 — PathLoc-L MIS Spinal System | L&K BIOMED Co., Ltd. Nov 15, 2018 |
| K182255 — CanGaroo Neuro Envelope (small) ; CanGaroo Neuro Envelope (medium) ; CanGaroo Neuro Envelope (large) ; CanGaroo Neuro Envelope (extra large) | Aziyo Biologics, Inc. Nov 15, 2018 |
| K181998 — CardioBand ECG Event Recorder | Samsung Strategy And Innovation Center (Ssic) Nov 15, 2018 |
| K173971 — K2 Zirkon Blank white classic; K2 Zirkon Blank translucent; K2 Blanks extreme translucent | Yeti Dentalprodukte GmbH Nov 15, 2018 |
| K182528 — Nitrile Glove Powder Free Black | Haining Medical Products Co., Ltd. Nov 15, 2018 |
| K181689 — Nexcomp | Meta Biomed Co., Ltd. Nov 15, 2018 |
| K181324 — FilmArray Pneumonia Panel plus | Biofire Diagnostics, LLC Nov 15, 2018 |
| K181897 — Reprocessed Marinr Diagnostic EP Catheter | Innovative Health, LLC Nov 15, 2018 |
| K180650 — Amsel Endo Occluder | Amsel Medical Corporation Nov 15, 2018 |
| K182097 — React 71 Catheter | Micro Therapeutics, Inc. D/B/A Ev3 Neurovascular Nov 14, 2018 |
| K182882 — CrystalView Pro Irrigation Console, CrystalView Pro Autoclavable Remote Control | Conmed Corporation Nov 14, 2018 |
| K182101 — Riptide Aspiration System (React 71 Catheter) | Micro Therapeutics, Inc. D/B/A Ev3 Neurovascular Nov 14, 2018 |
| K182653 — Voyant Maryland Fusion Device | Applied Medical Resources Corp. Nov 14, 2018 |
| K182105 — JO Naturalove Personal Lubricant, JO Naturalove Strawberry Fields Flavored Personal Lubricant | United Consortium Nov 14, 2018 |
| K182603 — Z6 Diagnostic Ultrasound System | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. Nov 14, 2018 |
| K181434 — SporView Rapid Read Biological Indicator SteamPlus Test Pack | Crosstex/Spsmedical, A Division Of Cantel Medical Nov 14, 2018 |
| K181850 — Inversa Implants | Southern Implants (Pty), Ltd. Nov 14, 2018 |
| K181963 — ostaPek Interbody Fusion Cages | Coligne AG Nov 14, 2018 |
| K181886 — VivaSight-DL System | Etview , Ltd. Nov 14, 2018 |
| K181829 — Velofix TLIF Cage | U&I Corporation Nov 14, 2018 |
| K180463 — Apoller Flow Light Cure Flowable Composite | Greenway Yw, LLC Nov 14, 2018 |
| K182604 — New Era | Step UP Skin Laser, LLC Nov 14, 2018 |
| K181090 — Invacare® Solara® 3G and Solara® 3G Spree Manual Wheelchairs | Invacare Corporation Nov 14, 2018 |
| K181497 — HPM-6000UF | BTL Industries, Inc. Nov 14, 2018 |
| K182543 — Wearable Device ; Cradle ; Small Strap, Medium Strap, Large Strap ; Multiple Device Charger ; Hospital Starter Package | Snap40, Ltd. Nov 14, 2018 |
| K172602 — Miracu | Feeltech Co., Ltd. Nov 14, 2018 |
| K182674 — Largan U38 (Polymacon) Daily Wear Soft (hydrophilic) Contact Lens, Largan U38 (Polymacon) Daily Wear Soft (hydrophilic) Contact Lens for Astigmatism, Largan U38 (Polymacon) Daily Wear Soft (hydrophilic) Contact Lens for Presbyopia | Largan Medical Co., Ltd. Nov 13, 2018 |
| K180478 — RectalPro 75 Endorectal Balloon | Qlrad International , Ltd. Nov 13, 2018 |
| K172792 — Handheld Pulse Oximeter, Model SP-20 | Shenzhen Creative Industry Co., Ltd. Nov 13, 2018 |
| K181369 — Immucise Intradermal Injection System | Terumo Corporation Nov 13, 2018 |
| K182598 — VersaLink Fixation System | Premia Spine, Ltd. Nov 13, 2018 |
| K182248 — Aspire Venting Tube | Aspire Bariatrics, Inc. Nov 13, 2018 |
| K182508 — Saxxony Posterior Cervical Thoracic System | Nexxt Spine, LLC Nov 13, 2018 |
| K182195 — Arco-SA Lumbar Cage System | Neurostructures, Inc. Nov 9, 2018 |
| K182338 — Blue Sky Bio Computerized Orthodontic Bracket System | Blue Sky Bio Nov 9, 2018 |
| K182857 — EPIQ Diagnostic Ultrasound System, EPIQ 5 Diagnostic Ultrasound System, EPIQ 7 Diagnostic Ultrasound System, Affiniti 30 Diagnostic Ultrasound System, Affiniti 50 Diagnostic Ultrasound System, Affiniti 70 Diagnostic Ultrasound System | Philips Ultrasound, Inc. Nov 9, 2018 |
| K181890 — Brainlab Compatible K2M Navigation Instruments | K2M Nov 9, 2018 |
| K172907 — ELAN 4 Air Motor System | Aesculap, Inc. Nov 9, 2018 |
| K181559 — Neurosign V4 Intraoperative Nerve Monitor | Magstim Company, Ltd. Nov 9, 2018 |
| K180395 — EZ-IO Intraosseous Vascular Access System | Arrow International, Inc. (Subsidiary Of Teleflex, Inc.) Nov 9, 2018 |
| K181469 — Cryotop®US-flash and Cryotop®US-scoop | Kitazato Corporation Nov 9, 2018 |
| K182649 — Enteral Feeding Syringes with Enfit Connectors | Jiangsu Kangbao Medical Equipment Co., Ltd. Nov 9, 2018 |
| K180966 — FilmArray Pneumonia Panel | Biofire Diagnostics, LLC Nov 9, 2018 |
| K181759 — PowerDot PD-01MT | Smartmissimo Technologies Pte, Ltd. Nov 9, 2018 |
| K182808 — Aspida® Anterior Lumbar Plating System | Alphatec Spine, Inc. Nov 9, 2018 |
| K181992 — Heat Pain Pro | Omron Healthcare, Inc. Nov 9, 2018 |