| MC 300* Nebulizer (K173367) | Trudell Medical International | 2018-02-28 |
| P200TE (K173707) | Optos Plc. | 2018-02-28 |
| S Series Electrodes / Models S55105, S80120, SG4040, SG4368, SG50D, SG5050, SG5075, SG50100, SG5795, SG60147, SG7090, & SG75D (K173186) | Everyway Medical Instruments Co.,Ltd | 2018-02-28 |
| ALTA Anterior Cervical Interbody Spacer (K173324) | Astura Medical | 2018-02-27 |
| Zygomatic Implant System (K173343) | Southern Implants (Pty), Ltd. | 2018-02-27 |
| Cotton-Huibregtse Stent, Cotton-Leung Biliary Stent, Cotton-Leung Sof-Flex Biliary Stent, Soehendra Tannenbaum Biliary Stent, Zimmon Biliary Stent, Guiding Catheter, Pushing catheter, Fusion pushing catheter, Stent Introducer Set, Fusion Oasis One Action Sent Introduction System, Zimmon Biliary Stent Set, Oasis One Action Stent Introduction System, Solus Double Pigtail Stent and Introduction System, Cotton-Huibregtse Biliary Stent Set, Cotton-Leung Biliary Stent Set, Oasis One Action S (K172044) | Cook Ireland, Ltd. | 2018-02-27 |
| Rezum System (K180237) | Nxthera, Inc. | 2018-02-27 |
| ACE Hemoglobin A1c (HbA1c) Reagent (K170623) | Alfa Wassermann Diagnostic Technologies, LLC | 2018-02-27 |
| Activmotion Range (K173746) | Newclip Technics | 2018-02-27 |
| NeuroNav System, NeuroSmart System (K172042) | Alpha Omega Engineering , Ltd. | 2018-02-27 |
| LIAISON BRAHMS PCT II GEN, LIAISON Control BRAHMS PCT II GEN, LIAISON BRAHMS PCT II GEN Verifiers (K173683) | DiaSorin, Inc. | 2018-02-27 |
| SelectaLyte Electrolyte Analyzer (Na+, K+, Cl-) (K171476) | Awareness Technology, Inc. | 2018-02-27 |
| OMNICHROMA (K173275) | Tokuyama Dental Corporation | 2018-02-27 |
| Vygon PICCs (K172899) | Vygon USA | 2018-02-26 |
| TRYPTIK2 C-Plate Anterior Cervical Plate System (K171797) | Spineart | 2018-02-26 |
| Stryker iVAS 13g Bone Biopsy Kit (K180327) | Stryker Corporation | 2018-02-26 |
| Bluetooth blood pressure monitor (K171668) | Visiomed Group SA | 2018-02-26 |
| OpClear System (K171637) | Cipher Surgical, Ltd. | 2018-02-26 |
| ENDOSEAL MTA (K170175) | Maruchi | 2018-02-26 |
| Neurostructures Cavetto® Cervical Cage System (K172320) | Neurostructures, Inc. | 2018-02-26 |
| Trilor Disks, Blocks and Arches (K173643) | Bioloren S.R.L. | 2018-02-24 |
| Cavetto-SA Cervical Cage System (K173077) | Neurostructures, Inc. | 2018-02-23 |
| Ultraxx Nephrostomy Balloon Catheter (K171601) | Cook Incorporated | 2018-02-23 |
| InMode VLaze (K173677) | Inmode MD , Ltd. | 2018-02-23 |
| Ophthalmic Software Platform RX (K173689) | Canon Inc. -Medical Equipment Group | 2018-02-23 |
| SPIN-SWI (K173224) | Spintech, Inc. | 2018-02-23 |
| DM-Density (K170540) | Densitas, Inc. | 2018-02-23 |
| RTS Lesser MTP Implant System (K173491) | In2bones USA, LLC | 2018-02-23 |
| Ez3D-i /E3 (K173863) | Ewoosoft Co., Ltd. | 2018-02-23 |
| Ultrasound System 1300 (K173569) | Bk Medical Aps | 2018-02-23 |
| ELEOS™ Bipolar Acetabular System (K180130) | Onkos Surgical, Inc. | 2018-02-23 |
| Sutter CURIS RF Generator (K171869) | Sutter Medizintechnik GmbH | 2018-02-23 |
| Amsco Evolution Floorloader Steam Sterilizer HC-2000 and HC-3000 (K173493) | STERIS Corporation | 2018-02-23 |
| Aquilion Precision (TSX-304A/2) V8.6 with FIRST 3.0 (K173468) | Toshibamedical Systems Corporation | 2018-02-23 |
| Prismaflex System 8.10 (K171671) | Baxter Healthcare Corporation | 2018-02-23 |
| KLS Martin L1 MMF System (K173320) | KLS Martin L.P. | 2018-02-23 |
| Axiostat Chitosan Hemostatic Dressing (K172324) | Advamedica, Inc. | 2018-02-23 |
| INSTANT-VIEW plus Multi-Drug of Abuse Urine Test - Simple Cup (OTC Use), INSTANT-VIEW plus Multi-Drug Urine Test - Simple Cup (Prescription Use) (K173303) | Alfa Scientific Designs, Inc. | 2018-02-23 |
| Orbitum Bone Staple Implant, X and VI (K173693) | Orthovestments, LLC | 2018-02-23 |
| LightForce LTS Model 1000, 1500, 2500, and 4000 (K173067) | Litecure, LLC | 2018-02-22 |
| Talon DistalFix Humeral Nail (K173255) | Orthopedic Designs North America, Inc. | 2018-02-22 |
| The Panthera Anti-Snoring X3 Device (K171576) | Panthera Dental, Inc. | 2018-02-22 |
| Osteotomy Truss System (OTS) (K172294) | 4Web, Inc. | 2018-02-22 |
| Amsco Evolution Medium Steam Sterilizer (K173485) | STERIS Corporation | 2018-02-22 |
| Natus Quantum (K180181) | Natus Medical Incorporated Dba Excel_Tech Ltd. (Xltek) | 2018-02-22 |
| Amsco Evolution Medium Steam Sterilizer (Models HC-800 and HC-1000) (K173490) | STERIS Corporation | 2018-02-22 |
| Neocis Guidance System (NGS) with Chairside Splint (K173402) | Neocis, Inc. | 2018-02-22 |
| Nexxis OR (K173381) | Barco N.V. | 2018-02-22 |
| Remedy Acetabular Cup (K173967) | Osteoremedies, LLC | 2018-02-22 |
| Sentry IVC Filter (K173236) | Novate Medical , Ltd. | 2018-02-22 |
| SurFuse Gel, SurFuse Putty, ExFuse Gel, ExFuse Putty (K171568) | Hans Biomed Corporation | 2018-02-22 |
| Menicon ASRB (asmofilcon A) Silicone Hydrogel Soft Contact Lens (K180004) | Menicon Co, Ltd. | 2018-02-22 |
| Straumann CARES M-Series CAD/CAM System (K171649) | Institut Straumann AG | 2018-02-22 |
| Medline Catheter Specimen Collector (K172541) | Medline Industries, Inc. | 2018-02-22 |
| KS Medicare Powder Free Nitrile Examination Gloves, Non-sterile, Tested for Use with Chemotherapy Drugs (Blue, Black) (K171171) | Koon Seng Sdn Bhd | 2018-02-22 |
| U&U Indicator tape and strip (K171823) | U&U Medical Technology Co, Ltd. | 2018-02-22 |
| Silicone Peripherally Inserted Central Venous Catheter Set/Tray (K171994) | Cook Incorporated | 2018-02-22 |
| SeaSpine Spinous Process System (K173334) | SeaSpine Orthopedics Corporation | 2018-02-22 |
| Scian Automatic Digital Blood Pressure Monitor, Model: LD-576, LD-575 & LD-579 (K170866) | Honsun (Nantong) Co., Ltd. | 2018-02-21 |
| Catasyn Advanced Technology Wound Hydrogel (K172338) | Synedgen, Inc. | 2018-02-21 |
| CELERITY 20 Steam Process Challenge Device for Gravity Cycles (K173629) | STERIS Corporation | 2018-02-21 |
| Reprocessed ArthroCare ENT Coblator (K172647) | Renovo, Inc. | 2018-02-21 |
| TSN Transseptal Needle (K172950) | Pressure Products Medical Device Manufacturing, LLC | 2018-02-21 |
| Celerity 20 Steam Process Challenge Device for Dynamic Air Removal Cycles (K173626) | STERIS Corporation | 2018-02-21 |
| DRI Benzodiazepine Assay (K173963) | Microgenics Corporation | 2018-02-21 |
| DEKA SMARTXIDE Family (Smartxide Touch, Smartxide Punto) (K180193) | El.En Electronic Engineering Spa | 2018-02-21 |
| PiCCO Catheter (K171620) | Pulsion Medical Systems SE | 2018-02-21 |
| Captura Disposable Bronchoscope Biopsy Forceps (K163377) | Wilson-Cook Medical, Inc. | 2018-02-21 |
| HydroPICC (K172885) | Access Vascular, Inc. | 2018-02-20 |
| Tri-Staple 2.0 Reinforced Reload (K173270) | Covidien | 2018-02-20 |
| Aesculap Video Assisted Thoracic Surgery (VATS) INstruments (K170683) | Aesculap, Inc. | 2018-02-20 |
| SeaSpine NewPort Spinal System (K180176) | SeaSpine Orthopedics Corporation | 2018-02-20 |
| U-MED Powder Free Polyethylene Examination Gloves,Blue Color (K173228) | Jiangsu U-Med Rubber & Plastic Products Co., Ltd. | 2018-02-20 |
| WS80A Diagnostic Ultrasound System (K173513) | Samsung Medison Co., Ltd. | 2018-02-20 |
| Elecsys CA 15-3 II (K171605) | Roche Diagnostics | 2018-02-20 |
| PediaSat Oximetry Catheter, PreSep Oligon Oximetry Catheter, Edwards Oximetry Central Venous Catheter (previously PreSep Oximetry Catheter) (K172423) | Edwards Lifescience, LLC | 2018-02-20 |
| Optima Coil System (K172390) | Blockade Medical, LLC (D.B.A. Balt Usa) | 2018-02-18 |
| NeVap Aspire Subglottic Suction Endotracheal Tube (ASSET) with Preloaded Stylet (K172208) | Nevap, Inc. | 2018-02-16 |
| DUS R-50S (Urine Chemistry system) (K171521) | DFI Co., Ltd. | 2018-02-16 |
| Renal Access Cobra Catheter, Kumpe Access Catheter (K171600) | Cook Incorporated | 2018-02-16 |
| ACISTCVi® Contrast Delivery System (K171646) | Acist Medical Systems, Inc. | 2018-02-16 |
| Wireless Audio System (K173409) | Neocoil, LLC | 2018-02-16 |
| SPIWay Endonasal Access Guide (K180141) | Spiway, LLC | 2018-02-16 |
| Magseed Magnetic Marker Systtem (K173587) | Endomagnetics Ltd., | 2018-02-16 |
| Breast BI 7 MR Coil 1.5T Mammavention (K180123) | Noras Mri Products GmbH | 2018-02-16 |
| NeuroEEG (K173460) | Memory MD, Inc. | 2018-02-16 |
| Needle Free Transseptal Cannula (K172934) | Pressure Products Medical Device Manufacturing, LLC | 2018-02-16 |
| AESKUSLIDES nDNA (Crithidia luciliae), AESKUSLIDES nDNA (Crithidia luciliae) Demo Kit, AESKUSLIDES nDNA (Crithidia luciliae) Bulk kit x5, AESKUSLIDES nDNA (Crithidia luciliae) Bulk kit x10 (K172348) | Aesku.Diagnostics GmbH & Co. KG | 2018-02-16 |
| EEA Circular Stapler with Tri-Staple Technology (K172361) | Covidien | 2018-02-16 |
| Warrior 14 guidewire (K180128) | Vascular Solutions, Inc. | 2018-02-16 |
| Optilite Hevylite IgG Kappa Kit, Optilite Hevylite IgG Lambda Kit (K172613) | The Binding Site Group , Ltd. | 2018-02-15 |
| Instant-view-PLUS immunochemical Fecal Occult Blood Test (K173212) | Alfa Scientific Designs, Inc. | 2018-02-15 |
| Gazelle Polypropylene Suture and Delivery Device (K173644) | Dura Tap, LLC | 2018-02-15 |
| Prelude IDeal Hydrophilic Sheath Introducer (K173750) | Merit Medical Systems, Inc. | 2018-02-15 |
| BOWA Neutral Electrodes (K173877) | Bowa-Electronics GmbH & Co. KG | 2018-02-15 |
| Vinyl Patient Examination Glove (Yellow) (K173580) | Nature Medical Products Co., Ltd. | 2018-02-15 |
| AtriCure cryoICE cryo-ablation probe (CRYO2) (K180138) | AtriCure, Inc. | 2018-02-15 |
| Velocity (K173636) | Varian Medical Systems, Inc. | 2018-02-15 |
| SURGICAL ISOLATION GOWN (K171535) | Jingzhou Haixin Green Cross Medical Products Co., Ltd. | 2018-02-15 |
| Trevo Pro Vue Retriever and Trevo XP Pro Vue Retriever (Trevo Retriever) (K173352) | Concentric Medical, Inc. | 2018-02-15 |