| SITZMARKS (K181750) | Konsyl Pharmaceuticals | 2018-11-15 |
| K2 Zirkon Blank white classic; K2 Zirkon Blank translucent; K2 Blanks extreme translucent (K173971) | Yeti Dentalprodukte GmbH | 2018-11-15 |
| PrimeSight™ UNITY 9000 Video Processor, PrimeSight™ UNITY 9100 Video Processor (K181292) | Cogentix Medical, Inc. | 2018-11-15 |
| CardioBand ECG Event Recorder (K181998) | Samsung Strategy and Innovation Center (Ssic) | 2018-11-15 |
| PathLoc-L MIS Spinal System (K183117) | L&K BIOMED Co., Ltd. | 2018-11-15 |
| Single Use Aspiration Needle NA-U401SX-4025/NA-U401SX-4025N (K180668) | Olympus Medical Systems Corp. | 2018-11-15 |
| Reprocessed Marinr Diagnostic EP Catheter (K181897) | Innovative Health, LLC | 2018-11-15 |
| IntelliVue Multi-Measurement Module MMX (K181831) | Philips Medizin Systeme Boeblingen GmbH | 2018-11-15 |
| Voluson E6, Voluson E8, Voluson E10 (K181985) | GE Healthcare | 2018-11-15 |
| CanGaroo Neuro Envelope (small) ; CanGaroo Neuro Envelope (medium) ; CanGaroo Neuro Envelope (large) ; CanGaroo Neuro Envelope (extra large) (K182255) | Aziyo Biologics, Inc. | 2018-11-15 |
| FilmArray Pneumonia Panel plus (K181324) | Biofire Diagnostics, LLC | 2018-11-15 |
| Nitrile Glove Powder Free Black (K182528) | Haining Medical Products Co., Ltd. | 2018-11-15 |
| Amsel Endo Occluder (K180650) | Amsel Medical Corporation | 2018-11-15 |
| Invacare® Solara® 3G and Solara® 3G Spree Manual Wheelchairs (K181090) | Invacare Corporation | 2018-11-14 |
| CrystalView Pro Irrigation Console, CrystalView Pro Autoclavable Remote Control (K182882) | Conmed Corporation | 2018-11-14 |
| Voyant Maryland Fusion Device (K182653) | Applied Medical Resources Corp. | 2018-11-14 |
| Riptide Aspiration System (React 71 Catheter) (K182101) | Micro Therapeutics, Inc. d/b/a ev3 Neurovascular | 2018-11-14 |
| New Era (K182604) | Step UP Skin Laser, LLC | 2018-11-14 |
| JO Naturalove Personal Lubricant, JO Naturalove Strawberry Fields Flavored Personal Lubricant (K182105) | United Consortium | 2018-11-14 |
| Miracu (K172602) | Feeltech Co., Ltd. | 2018-11-14 |
| Velofix TLIF Cage (K181829) | U&I Corporation | 2018-11-14 |
| VivaSight-DL System (K181886) | Etview , Ltd. | 2018-11-14 |
| React 71 Catheter (K182097) | Micro Therapeutics, Inc. d/b/a ev3 Neurovascular | 2018-11-14 |
| Inversa Implants (K181850) | Southern Implants (Pty), Ltd. | 2018-11-14 |
| Z6 Diagnostic Ultrasound System (K182603) | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 2018-11-14 |
| HPM-6000UF (K181497) | BTL Industries, Inc. | 2018-11-14 |
| ostaPek Interbody Fusion Cages (K181963) | Coligne AG | 2018-11-14 |
| Wearable Device ; Cradle ; Small Strap, Medium Strap, Large Strap ; Multiple Device Charger ; Hospital Starter Package (K182543) | Snap40, Ltd. | 2018-11-14 |
| SporView Rapid Read Biological Indicator SteamPlus Test Pack (K181434) | Crosstex/Spsmedical, A Division of Cantel Medical | 2018-11-14 |
| Apoller Flow Light Cure Flowable Composite (K180463) | Greenway Yw, LLC | 2018-11-14 |
| RectalPro 75 Endorectal Balloon (K180478) | Qlrad International , Ltd. | 2018-11-13 |
| Immucise Intradermal Injection System (K181369) | Terumo Corporation | 2018-11-13 |
| 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 (K182674) | Largan Medical Co., Ltd. | 2018-11-13 |
| Aspire Venting Tube (K182248) | Aspire Bariatrics, Inc. | 2018-11-13 |
| Handheld Pulse Oximeter, Model SP-20 (K172792) | Shenzhen Creative Industry Co., Ltd. | 2018-11-13 |
| VersaLink™ Fixation System (K182598) | Premia Spine, Ltd. | 2018-11-13 |
| Saxxony™ Posterior Cervical Thoracic System (K182508) | Nexxt Spine, LLC | 2018-11-13 |
| Heat Pain Pro (K181992) | Omron Healthcare, Inc. | 2018-11-09 |
| FilmArray Pneumonia Panel (K180966) | Biofire Diagnostics, LLC | 2018-11-09 |
| VERITON CT whole body SPECT/CT system (K182484) | Spectrum Dynamics Medical, Ltd. | 2018-11-09 |
| Arco™-SA Lumbar Cage System (K182195) | Neurostructures, Inc. | 2018-11-09 |
| Aspida® Anterior Lumbar Plating System (K182808) | Alphatec Spine, Inc. | 2018-11-09 |
| HEM-6410T-ZM Wrist Blood Pressure Monitor (K182481) | Omron Healthcare, Inc. | 2018-11-09 |
| AtriCure cryoICE cryoSPHERE cryoablation probe (K182565) | AtriCure, Inc. | 2018-11-09 |
| Brainlab Compatible K2M Navigation Instruments (K181890) | K2m | 2018-11-09 |
| Neurosign V4 Intraoperative Nerve Monitor (K181559) | Magstim Company, Ltd. | 2018-11-09 |
| Catalys Precision Laser System (K182083) | Amo Manufacturing USA, LLC | 2018-11-09 |
| PowerDot PD-01MT (K181759) | Smartmissimo Technologies Pte, Ltd. | 2018-11-09 |
| ELAN 4 Air Motor System (K172907) | Aesculap, Inc. | 2018-11-09 |
| Enteral Feeding Syringes with Enfit Connectors (K182649) | Jiangsu Kangbao Medical Equipment Co., Ltd. | 2018-11-09 |
| Cryotop®US-flash and Cryotop®US-scoop (K181469) | Kitazato Corporation | 2018-11-09 |
| BIOEASY Multi-Drug Test Cup (K182530) | Shenzhen Bioeasy Biotechnology Co., Ltd. | 2018-11-09 |
| Teleport Microcatheter (K182360) | Orbusneich Medical Trading, Inc. | 2018-11-09 |
| EZ-IO Intraosseous Vascular Access System (K180395) | Arrow International, Inc. (Subsidiary of Teleflex, Inc.) | 2018-11-09 |
| 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 (K182857) | Philips Ultrasound, Inc. | 2018-11-09 |
| Blue Sky Bio Computerized Orthodontic Bracket System (K182338) | Blue Sky Bio | 2018-11-09 |
| VAMP Plus Venous/Arterial Blood Management Protection System (K181684) | Edwards Lifesciences, LLC | 2018-11-08 |
| ESOTEST MULTI Esophageal Temperature Probe and Temperature Monitoring System (K180047) | Fiab Spa | 2018-11-08 |
| CardioInsight Cardiac Mapping System (K181918) | Medtronic, Inc. | 2018-11-08 |
| SureCure Orthodontic Aligner System (K182329) | Digital Orthodontic Care | 2018-11-08 |
| Neurostructures Cavetto® [MAX] Cervical Cage System (K181590) | Neurostructures, Inc. | 2018-11-08 |
| Exactech Alteon Highly Polished Femoral Stem (K182462) | Exactech, Inc. | 2018-11-08 |
| MiroCam Capsule Endoscope System (K180732) | Intromedic Co., Ltd. | 2018-11-08 |
| neoClose PDS (K173917) | Neosurgical, Ltd. | 2018-11-08 |
| Wrist Blood Pressure Monitor Model BP4350 (K182166) | Omron Healthcare, Inc. | 2018-11-08 |
| Cepheid Xpert GBS LB Control Panel (K182472) | Microbiologics, Inc. | 2018-11-08 |
| Silk Voice (K180631) | Sofregen Medical, Inc. | 2018-11-08 |
| Faros Mobile (K182030) | Bittium Biosignals , Ltd. | 2018-11-08 |
| Geistlich Derma-Gide (K182838) | Geistlich Pharma AG | 2018-11-08 |
| Steribite (K180949) | Rjr Surgical, Inc. | 2018-11-08 |
| Powder Free Vinyl Patient Examination Gloves (K180381) | Shanxi Hongjin Plastic Technology Co., Ltd. | 2018-11-07 |
| Certa Dose Pediatric Midazolam 5mg/mL IM Syringe (K180683) | Certa Dose, Inc. | 2018-11-07 |
| Simplexa GBS Direct, Simplexa GBS Positive Control Pack (K182467) | Diasorin Molecular, LLC | 2018-11-07 |
| uWS-CT (K173001) | Shanghai United Imaging Healthcare Co., Ltd. | 2018-11-07 |
| uWS-MR (K172999) | Shanghai United Imaging Healthcare Co., Ltd. | 2018-11-07 |
| OptiBond eXTRa Universal (K182162) | Kerr Corporation | 2018-11-07 |
| Curbell branded Patient Monitoring Cables (K182220) | Curbell Medical Products, Inc. | 2018-11-07 |
| SMARTRELEASE Endoscopic Soft Tissue Release System (K181819) | Microaire Surgical Instruments, LLC | 2018-11-06 |
| Günther Tulip® Vena Cava Filter Retrieval Set (K181757) | Cook Incorporated | 2018-11-06 |
| ImaJin Silicone Hydro-Coated Double Loop Ureteral Stent (K180469) | Coloplast Corp. | 2018-11-06 |
| MAGNETOM Avanto, MAGNETOM Verio with software syngo MR E11D (K181613) | Siemens Medical Solutions USA, Inc. | 2018-11-06 |
| Vivid T8, Vivid T9 (K181934) | GE Medical Systems Ultrasound & Primary Care Diagnostics, LLC | 2018-11-06 |
| Innovo (DEN170049) | Bio-Medical Research, Ltd. | 2018-11-06 |
| icobrain (K181939) | Icometrix NV | 2018-11-06 |
| W Zirconia Implants (K172668) | Tav Medical , Ltd. | 2018-11-06 |
| Finapres Nova Noninvasive Hemodynamic Monitor (K173916) | Finapres Medical Systems B.V. | 2018-11-06 |
| Merit Syringe (K182216) | Merit Medical Systems, Inc. | 2018-11-06 |
| Merit Syringe (K182279) | Merit Medical Systems, Inc. | 2018-11-06 |
| Universal Mesh - Sterile (K182425) | Stryker Leibinger GmbH & Co KG | 2018-11-06 |
| ERBEFLO Olympus Scope Port Connector (K182444) | Erbe USA, Inc. | 2018-11-06 |
| ASSURE Anterior Cervical Plate System, PROVIDENCE Anterior Cervical Plate System, VIP Anterior Cervical Plate System, XTEND Anterior Cervical Plate System, UNIFY Dynamic Anterior Cervical Plate System, CITADEL Anterior Lumbar Plate System, TRUSS Thoracolumbar Plate System, PLYMOUTH Thoracolumbar Plate System, SP-Fix Spinous Process Fixation Plate, RELIEVE Laminoplasty Fixation System (K181846) | Globus Medical, Inc. | 2018-11-06 |
| MiniGuard Arterial Safety Valve (K182442) | Quest Medical, Inc. | 2018-11-06 |
| Elecsys Tacrolimus (K173857) | Roche Diagnostics | 2018-11-06 |
| SaliPen (K180838) | Saliwell , Ltd. | 2018-11-06 |
| BiZact Tonsillectomy Device Advanced Bipolar Tissue Sealer/Divider (K182451) | Covidien, LLC | 2018-11-06 |
| DynaClipTM Bone Staple (K181781) | MedShape, Inc. | 2018-11-05 |
| Tina-quant Transferrin ver.2 (urine application) (K182095) | Roche Diagnostics Operations (Rdo) | 2018-11-05 |
| PREMIER Platinum HpSA PLUS (K182559) | Meridian Bioscience, Inc. | 2018-11-05 |
| ConnectedOR Hub with Device and Voice Control (K181258) | Stryker | 2018-11-05 |
| Athelas One (K181288) | Athelas, Inc. | 2018-11-05 |