| Classic ERCP Catheter and Huibregtse-Katon ERCP Catheter and Huibregtse-Katon Angled, Glo-Tip ERCP Catheter, Glo-Tip II Double Lumen ERCP Catheter & w/ Radiopaque Bands, Fusion ERCP Catheter with DomeTip and Fusion OMNI ERCP Catheter with DomeTip, Haber RAMP Catheter, Soehendra Universal Catheter (K171989) | Wilson-Cook Medical, Inc. | 2018-03-20 |
| ReConnex Pre-Sutured Tendon (K170957) | Allosource | 2018-03-20 |
| Anjon Bremer Halo System (K171863) | Anjon Holdings, LLC | 2018-03-19 |
| Moisyn Dry Mouth Oral Rinse, Moisyn Dry Mouth Oral Mist, Moisyn Free Dry Mouth Oral Rinse, Moisyn Free Dry Mouth Oral Mist (K173237) | Syendgen, Inc. | 2018-03-19 |
| Reprocessed DePuy Mitek Ablation Wand (K173740) | Renovo, Inc. | 2018-03-19 |
| Ezee Retrieval (K180579) | Genicon, Inc. | 2018-03-19 |
| PYTHON Plate Trial Instruments (K173930) | Treace Medical Concepts, Inc. | 2018-03-19 |
| Double Flexible Tip Wire Guides (K171912) | Cook Incorporated | 2018-03-19 |
| OTW Takeru PTCA Balloon Dilatation Catheter (K172264) | KANEKA Corporation | 2018-03-19 |
| Anchorage Bone Plating System (K172148) | Stryker GmbH | 2018-03-19 |
| PrimeStore MTM (DEN170029) | Longhorn Vaccines and Diagnostics, LLC | 2018-03-19 |
| Exeter V40 Femoral Stem Hip System, Orthinox V40 Femoral Heads (K173499) | Stryker Orthopaedics | 2018-03-19 |
| 3M Attest Super Rapid Readout Biological Indicator 1492V, 3M Attest Auto-reader 490, 3M Attest Auto-reader 490H (K173437) | 3M Company | 2018-03-19 |
| CapLOX II® / TowerLOX® MIS Pedicle Screw System (K180475) | Captiva Spine, Inc. | 2018-03-19 |
| AXS Catalyst Distal Access Catheter 058 x 115cm; AXS Catalyst Distal Access Catheter 058 x 132cm; AXS Catalyst Distal Access Catheter 060 x 132cm (K173841) | Stryker | 2018-03-18 |
| CCM Abutment System (K173120) | Innobiosurg Co., Ltd. | 2018-03-16 |
| Imbio Segmentation Editing Tool software (K180129) | Imbio, LLC | 2018-03-16 |
| Xpert CT/NG (K173840) | Cepheid | 2018-03-16 |
| TheraBreath Dry Mouth Oral Rinse, TheraBreath Dry Mouth Lozenges (K171542) | Dr. Harold Katz, LLC (Dba Therabreath | 2018-03-16 |
| Frigitronics adapter (K180195) | Phakos | 2018-03-16 |
| Acumen Hypotension Prediction Index (HPI) Feature Software (DEN160044) | Edwards Lifesciences, LLC | 2018-03-16 |
| ARTAS System (K173358) | Restoration Robotics, Inc. | 2018-03-16 |
| Empower H35 (K180426) | Quanta System Spa | 2018-03-16 |
| Portable X-ray System (K172928) | Rolence Enterprise, Inc. | 2018-03-16 |
| SI Screw System (K173752) | Zavation Medical Products, LLC | 2018-03-16 |
| SurgiQuest AIRSEAL iFS System (K172516) | Conmed Corporation | 2018-03-16 |
| ExSpiron 1Xi (K173181) | Respiratory Motion, Inc. | 2018-03-16 |
| Wrist Pulse Oximeter (K172366) | Beijing Choice Electronic Technology Co., Ltd. | 2018-03-16 |
| FluoroPerm 30 & Paragon Thin (paflufocon C) RGP contact lenses with Tangible Hydra-PEG; FluoroPerm 60 & Paragon HDS (paflufocon B) RGP contact lenses with Tangible Hydra-PEG; FluoroPerm 92 (paflufocon A) RGP contact lenses with Tangible Hydra-PEG; FluoroPerm 151 & Paragon HDS 100 (paflufocon D) RGP contact lenses with Tangible Hydra-PEG (K180172) | Paragon Vision Sciences | 2018-03-16 |
| syngo Application Software (K173611) | Siemens Medical Solutions USA, Inc. | 2018-03-16 |
| Microlife Upper Arm Automatic Digital Blood Pressure Monitor (K171937) | Microlife Intellectual Property GmbH | 2018-03-16 |
| SOFTXIL (K171851) | Bistool | 2018-03-16 |
| MIS CONNECT Conical Connection Abutment (K173326) | Mis Implants Technologies , Ltd. | 2018-03-16 |
| XCelliStem Wound Powder (K172593) | Stemsys | 2018-03-16 |
| BD BACTEC Peds Plus/F Culture Vials Soybean-Casein Digest Broth with Resins in a Plastic Vial (K173873) | Becton, Dickinson and Company | 2018-03-16 |
| 3M Clarity Ultra Self-Ligating Brackets and Adhesive Coated Appliance System (K180404) | 3M Healthcare | 2018-03-16 |
| MEMO 4D (K180411) | Sorin Group Italia S.R.L. | 2018-03-16 |
| X-spine Cortical Bone Screw System (K180153) | X-Spine Systems, Inc. | 2018-03-15 |
| Polaris Spinal Growth System (K180227) | Zimmer Biomet Spine, Inc. | 2018-03-15 |
| miraDry System (K180396) | Miramar Labs, Inc. | 2018-03-15 |
| Liofilchem MIC Test Strip (MTS)- Linezolid 0.016 - 256ug/mL (K180330) | Liofilchem s.r.l. | 2018-03-15 |
| AIRO Computed Tomography (CT) X-ray System (K180393) | Mobius Imaging, LLC | 2018-03-15 |
| FUJIFILM Endoscope Models EC-600HL and EC-600LS (K180405) | Fujifilm Corporation | 2018-03-15 |
| Incontinence Treatment Device, Model LT2061 (K171430) | Shenzhen Dongdixin Technology Co., Ltd. | 2018-03-15 |
| NuVasive® VuePoint® II OCT System (K180198) | Nu Vasive, Incorporated | 2018-03-15 |
| Ellipse Ydun (K180406) | Ellipse A/S | 2018-03-15 |
| TRIWAY Tibiotalocalcaneal (TTC) Arthrodesis System (K173811) | In2bones Sas | 2018-03-15 |
| ELEMENT-TL (K180224) | Elemenic Co., Ltd. | 2018-03-15 |
| TDM Plate and Screw System (K171808) | Tdm Co., Ltd. | 2018-03-15 |
| INSPIRE 6M Hollow Fiber Oxygenator; INSPIRE 6F M Hollow Fiber Oxygenator with Integrated Arterial Filter; INSPIRE 8M Hollow Fiber Oxygenator; INSPIRE 8F M Hollow Fiber Oxygenator with Integrated Arterial Filter (K180448) | Sorin Group Italia S.R.L. | 2018-03-15 |
| Tissue of Origin Test Kit-FFPE (K173839) | Cancer Genetics, Inc. | 2018-03-15 |
| Mega Plus Spine System (K173180) | Bk Meditech, Co., Ltd. | 2018-03-15 |
| Empower H65 (K180423) | Quanta System Spa | 2018-03-15 |
| Cardiovascular Analzyer (K172431) | Physiowave, Inc. | 2018-03-14 |
| Natus NeuroWorks (K180421) | Natus Medical Incorporated Dba Excel-Tech Ltd. (Xltek) | 2018-03-14 |
| MR Wireless Gating System, Model WGS-100 (K171778) | Ivy Biomedical Systems, Inc. | 2018-03-14 |
| Simplexa HSV 1 & 2 Direct, Simplexa HSV 1 & 2 Positive Control Pack (K173798) | Diasorin Molecular, LLC | 2018-03-14 |
| Advincula Delineator Uterine Manipulator (K180429) | CooperSurgical, Inc. | 2018-03-14 |
| AMIStem-H Proximal Coating, AMIStem-P and AMIStem-P Collared (K173794) | Medacta International S.A. | 2018-03-14 |
| Trojan Chain Reaction Natural Rubber Latex Condom with Sensate Lubricant (K180104) | Church & Dwight Co., Inc. | 2018-03-14 |
| star RF Electrode, VIVA RF Electrode (K172012) | Starmed Co., Ltd. | 2018-03-14 |
| Dynarex Three-Way Stopcock (K172266) | Dynarex Corporation | 2018-03-14 |
| Infrared Thermometer (K172795) | Shenzhen Jumper Medical Equipment Co., Ltd. | 2018-03-14 |
| Athena GTX Device Management Suite (ADMS) Software (K173203) | Athena Gtx | 2018-03-14 |
| Specular Microscope CEM-530 (K173980) | Nidek Co., Ltd. | 2018-03-14 |
| Custom Clear Aligner System (K173785) | Derby Dental Laboratory | 2018-03-13 |
| ThinkQA (K180106) | Dosisoft | 2018-03-13 |
| Olympus Small Intestinal Capsule Endoscope System (K173459) | Olympus Medical Systems Corp. | 2018-03-13 |
| Biodesign Diaphragmatic Hernia Graft (K171817) | Cook Biotech Incorporated | 2018-03-13 |
| EliA PR3s Immunoassay; EliA MPOs Immunoassay; EliA GBM Immunoassay (K173792) | Phadia AB | 2018-03-13 |
| STERIZONE VP4 Sterilizer (K173694) | Tso3, Inc. | 2018-03-13 |
| Voluson S8/ Voluson S10/ Voluson S10 Expert (K180374) | GE Healthcare | 2018-03-13 |
| SICAT Endo (K180262) | Sicat GmbH & Co. KG | 2018-03-12 |
| REXMONO, PDREX (K173779) | Sm Eng Co., Ltd. | 2018-03-12 |
| RocaJJ Soft Stents (K173734) | Promepla Sam | 2018-03-12 |
| Corvocet Biopsy System (K180450) | Merit Medical Systems, Inc. | 2018-03-12 |
| Preview Digital Pregnancy Test (K173229) | Guangzhou Wondfo Biotech Co., Ltd. | 2018-03-12 |
| Exactech® Novation® and AcuMatch® E-HXL Acetabular Liners (K173583) | Exactech, Inc. | 2018-03-12 |
| Acclarent ENT Navigation System (K173628) | Acclarent, Inc. | 2018-03-10 |
| UltraCor Twirl Breast Tissue Marker (K180061) | Bard Peripheral Vascular, Inc. | 2018-03-09 |
| Exactech Equinoxe Stemless Shoulder (K173388) | Exactech, Inc. | 2018-03-09 |
| VORTEK URETERAL DOUBLE LOOP STENT (K180057) | Coloplast Corp. | 2018-03-09 |
| Grass TWin (K173690) | Natus Medical Incorporated Dba Excel-Tech Ltd. (Xltek) | 2018-03-09 |
| Klassic® Knee System (K180159) | Total Joint Orthopedics, Inc. | 2018-03-09 |
| BrightMatter Plan 1.6.0 (K180394) | Synaptive Medical, Inc. | 2018-03-09 |
| Quantib Brain (K173939) | Quantib B.V. | 2018-03-09 |
| Powder-free Clear Vinyl Patient Examination Gloves (K173078) | Yongsheng Medical Products Co., Ltd. | 2018-03-09 |
| PREVENA PLUS Incision Management System, PREVENA PLUS DUO Incision Management System (K173426) | Kci USA, Inc. | 2018-03-09 |
| CATS Tonometer Prism (K173904) | Cats Tonometer, LLC | 2018-03-09 |
| L300 Go System (K173682) | Bioness, Inc. | 2018-03-09 |
| Zimmon Pancreatic Stents/Stent sets, Geenen Pancreatic Stents/Stent Sets, Pushing Catheter and Guiding Catheter, Johlin Pancreatic Wedge Stent and Introducer Set (K172057) | Cook Ireland, Ltd. | 2018-03-09 |
| Transjugular Liver Access Sets (K171820) | Cook Incorporated | 2018-03-09 |
| Wrist Type Blood Pressure Monitor (K162616) | Xuzhou Yongkang Electronic Science Technology Co., Ltd. | 2018-03-09 |
| Parietex Surgical Mesh (modified into Parietex Hydrophilic 2D, 3D, Anatomical Mesh), Parietex Composite Mesh (PCO and PCO-OS references), Parietex Optimized Composite Mesh (PCO-X, PCO-FX and PCO-OSX references) (K173796) | Sofradim Production | 2018-03-09 |
| Fixed Core Wire Guides (K171764) | Cook Incorporated | 2018-03-09 |
| Amsco Evolution Medium Steam Sterilizer (K173481) | STERIS Corporation | 2018-03-09 |
| Catalyst CSR 3 Peg Glenoids (K173812) | Catalyst Orthoscience, Inc. | 2018-03-09 |
| Positional Sleep Assessment System (PoSAS) software (K172799) | Advanced Brain Monitoring | 2018-03-09 |
| Indigo Aspiration System - Penumbra Engine Pump, Indigo Aspiration System - Penumbra Engine Pump Canister (K180105) | Penumbra, Inc. | 2018-03-08 |
| HS70A Diagnostic Ultrasound System (K173713) | Samsung Medison Co., Ltd. | 2018-03-08 |