| Compressyn™ Staple (K171473) | Dallen Medical, Inc. | 2017-11-07 |
| Arthrex Knee Systems (K171365) | Arthrex, Inc. | 2017-11-07 |
| SPIRA-C Open Matrix Cervical Interbody (K172446) | Camber Spine Technologies | 2017-11-07 |
| Lateral Spinal Truss System (LSTS) Interbody Fusion Device (K172392) | 4Web, Inc. | 2017-11-07 |
| IV Administration Sets (K170595) | B.Braun Medical, Inc. | 2017-11-07 |
| UltraVision 2 Diagnostic Ultrasound System (K173265) | Winprobe Corporation | 2017-11-07 |
| Rooti Rx ECG Event Recorder, Rooti Link APP Software (K163694) | Rooti Labs , Ltd. | 2017-11-07 |
| Insulia Diabetes Management Companion (K172177) | Voluntis Sa. | 2017-11-07 |
| StatStrip Xpress Blood Glucose Monitoring System (K170464) | Nova Biomedical Corporation | 2017-11-07 |
| gentleheel Micro-Preemie, gentleheel Preemie, gentleheel Newborn, gentleheel Toddler (K172712) | Gri Medical & Electronic Technology Co., Ltd. | 2017-11-06 |
| EPIC Extremity Fracture Plate System (K172441) | Epic Extremity, LLC | 2017-11-06 |
| External Hex Implants (K163634) | Southern Implants (Pty), Ltd. | 2017-11-06 |
| Omni Foot Plating System (K172260) | Extremity Medical, LLC | 2017-11-06 |
| Nitrile Powder Free Examination Glove with Low Dermatitis Potential Claim and Tested for Use with Chemotherapy Drugs (Blue) (K172442) | Hartalega NGC Sdn. Bhd. | 2017-11-06 |
| NuVasive® Growth Rod Conversion Set (K172979) | Nu Vasive, Incorporated | 2017-11-06 |
| XW-100 Automated Hematology Analyzer for CLIA Waived Use (K172604) | Sysmex America, Inc. | 2017-11-06 |
| Aestiva 7900, Aestiva MRI, Aestiva 7100, Aestiva 7100 Compact, Aespire 100, Aespire 7100, Aespire 7900, Aespire View, Avance, Avance CS2, Aisys, Aisys CS2 (K172045) | Datex-Ohmeda, Inc. | 2017-11-03 |
| Fixed Patient Leads ECG Cable (Model 3153) (K172591) | Boston Scientific Corporation | 2017-11-03 |
| Geistlich Wound Matrix (K171842) | Geistlich Pharma AG | 2017-11-03 |
| Materialise Glenoid Positioning System (K172054) | Materialise NV | 2017-11-03 |
| Comet-PLUS (K172711) | Natus Medical Incorporated Dba Excel-Tech Ltd. (Xltek) | 2017-11-03 |
| Sandshark Injectable Anchor Kit, Injectroducer Handle, Loading Rod with Anchor, Loading Base (K172644) | Stimwave Technologies Incorporated | 2017-11-03 |
| CSMC Cardiac Suite (K172609) | Cedars-Sinai Medical Center | 2017-11-03 |
| Capio SLIM Suture Capturing Device (K172060) | Boston Scientific Corporation | 2017-11-03 |
| Reprocessed Halo XP Diagnostic Electrophysiology Catheter (K171788) | Innovative Health, LLC | 2017-11-03 |
| Fingertip Pulse Oximeter (K170965) | Shenzhen Jumper Medical Equipment Co., Ltd. | 2017-11-03 |
| PALLAS 308/311 Solid-State UV Laser System (K172639) | Laseroptek Co., Ltd. | 2017-11-03 |
| Surecan Safety II Needle, Surecan Safety II Needle, Surecan Safety II Needle with Caresite Luer Access Device and Y site (K170897) | B.Braun Medical, Inc. | 2017-11-03 |
| Phlebo Press DVT Model (K172277) | Mego Afek AC , Ltd. | 2017-11-03 |
| BIOSOFT DUO DOUBLE LOOP URETERAL STENTS (K170422) | Coloplast Corp. | 2017-11-02 |
| Neodent Implant System - CM Pro PEEK Abutment (K170080) | Jjgc Industria E Comercio DE Materiais Dentarios S.A. | 2017-11-02 |
| CONSTRUX® Mini PTC Spacer System, FORZA® PTC Spacer System, PILLAR® SA PTC Spacer System (K172437) | Orthofix, Inc. | 2017-11-02 |
| DynaNail TTC Fusion System (K171376) | MedShape, Inc. | 2017-11-02 |
| ORCA (tm) - Operational Rescue Containment Apparatus (K163223) | Isovac Products, LLC | 2017-11-02 |
| Mako Partial Knee Application (K172301) | Mako Surgical Corp. | 2017-11-02 |
| Duracetal (K172407) | The Myerson Company Limited | 2017-11-02 |
| SOVEREIGN™ Spinal System (K172328) | Medtronic Sofamor Danek USA, Inc. | 2017-11-02 |
| VitalPatch® VitalConnect Platform (K163453) | Vitalconnect, Inc. | 2017-11-02 |
| myMerlin(TM) Mobile Application Model APP1001 (K173232) | St Jude Medical | 2017-11-02 |
| Compound W Nitro-Freeze (K172373) | Medtech Products, Inc. | 2017-11-02 |
| Terragene Bionova(R) SCBI (BT220, BT221, BT222, BT223), Terragene Bionova (R) PCD (PCD220-C, PCD220-2, PCD222-C, PCD222-2), and Terragene Bionova(R) IC10/20FR Reader Incubator (K163646) | Terragene S.A. | 2017-11-02 |
| PixoTest Blood Glucose Monitoring System (K163087) | Ixensor Company , Ltd. | 2017-11-02 |
| InnoSpire Go (K170853) | Respironics Respiratory Drug Delivery (Uk) , Ltd. | 2017-11-02 |
| Medussa-PL Cage (K170341) | Medyssey USA, Inc. | 2017-11-02 |
| Vivid E80, Vivid E90, Vivid E95 (K173341) | GE Medical Systems | 2017-11-02 |
| Valleylab FX8 Electrosurgical Platform (K172757) | Covidien, LLC | 2017-11-02 |
| Sapphire Cervical Implant System (K172674) | Sapphire Medical Group | 2017-11-02 |
| BD Curve Ascites Shunt (K170405) | Care Fusion | 2017-11-02 |
| ABX MICROS ES 60 OT and ABX MICROS ES 60 CT (K170353) | HORIBA ABX SAS | 2017-11-01 |
| Surgical Stainless Steel Suture, Stainless Steel Suture (K170767) | ETHICON, Inc. | 2017-11-01 |
| Sterisheet Sterilization Wrap (K170437) | Andersen Sterilizers, Inc. | 2017-11-01 |
| Unomedical Comfort Subcutaneous Infusion Set, Unomedical Comfort Short Subcutaneous Infusion Set, Unomedical Neria Soft Subcutaneous Infusion Set, Medtronic Silhouette Subcutaneous Infusion Set, Medtronic Silhouette Paradigm Subcutaneous Infusion Set, Roche Accu-Chek Tender Subcutaneous Infusion Set, Asante Comfort Subcutaneous Infusion Set, Abbott Comfort Subcutaneous Infusion Set (K162812) | Unomedical A/S | 2017-11-01 |
| Mytens Model: BW-TSX (K171026) | Bewell Connect Corp. | 2017-11-01 |
| GMK Hinge, GMK Revision (K172347) | Medacta International S.A. | 2017-11-01 |
| Paramount Anterior Cervical Cage System (K173175) | Spine Wave, Inc. | 2017-11-01 |
| CoolSculpting System (K172144) | Zeltiq Aesthetics | 2017-11-01 |
| AN87 Dosimeter (K170439) | Andersen Sterilizers, Inc. | 2017-11-01 |
| IMAGEnet 6 Ophthalmic Data System (K171370) | Topcon Corporation | 2017-11-01 |
| Monitor B125, Monitor B105 (K171580) | Ge Medical Systems (China) Co., Ltd. | 2017-11-01 |
| Spectralis HRA + OCT and variants, Spectralis FA+OCT, Spectralis ICGA+OCT, Spectralis OCT Blue Peak, Spectralis OCT with Multicolor (K172649) | Heidelberg Engineering GmbH | 2017-11-01 |
| MAUSER PG II Sharps Container (K170513) | Mauzer USA, LLC | 2017-11-01 |
| Sysmex CS-5100 (K172333) | Siemens Healthcare Diagnostics Products GmbH | 2017-10-31 |
| Anprolene SteriTest (K170427) | Andersen Sterilizers, Inc. | 2017-10-31 |
| iFuse Implant System- iFuse Navigation (K172268) | SI-BONE, Inc. | 2017-10-31 |
| Anprolene AN75 Ethylene Oxide Gas Sterilizer (K170432) | Andersen Sterilizers, Inc. | 2017-10-31 |
| Rapid HB, Rapid LB, Rapid MB (K173318) | 3M Deutschland GmbH | 2017-10-31 |
| Stryker Upper-Face AXS screws and Mid-Face AXS screws (K172572) | Stryker | 2017-10-31 |
| IVA Cage Ti (ACIF, PLIF, TLIF, DLIF, and ALIF) (K173080) | Huvexel Co. , Ltd. | 2017-10-31 |
| JO Gelato Flavored Personal Lubricants (K172447) | United Consortium | 2017-10-31 |
| Cianna Medical SAVI Scout Reflector and SAVI Scout System (K171767) | Cianna Medical, Inc. | 2017-10-31 |
| ALOKA ARIETTA 850 (K171708) | Hitachi Healthcare Americas Corporation | 2017-10-31 |
| Trinity™ Dual Mobility System (K170359) | Corin U.S.A. Limited | 2017-10-31 |
| Stethee Pro (K172296) | M3Dicine Pty , Ltd. | 2017-10-30 |
| Flex-Thread Fibula Pin System (K172943) | Intrafuse, LLC | 2017-10-30 |
| Bi-Ostetic Bioactive Glass Foam (K170917) | Berkeley Advanced Biomaterials | 2017-10-30 |
| Triathlon Total Knee System, Triathlon PKR System, Restoris MCK Knee System (K172326) | Stryker Orthopaedics | 2017-10-30 |
| Pantheris Catheter (8F), Pantheris Catheter (7F), Lightbox HS Imaging Console, Lightbox Sled (K172236) | Avinger, Inc. | 2017-10-30 |
| Anorganic Bone Mineral with Collagen in Delivery Applicator (K171008) | Collagen Matrix, Inc. | 2017-10-30 |
| Crystal Vision (K163659) | I.C Medical, Inc. | 2017-10-30 |
| XIDF-AWS801, Angio Workstation, V7.0 (K172646) | Toshibamedical Systems Corporation | 2017-10-30 |
| ARIES Group A Strep Assay, ARIES Group A Strep Assay Protocol File Kit (K172402) | Luminex Corporation | 2017-10-30 |
| AltiVate Reverse Humeral Stem, AltiVate Reverse Small Spacer, Altivate Reverse, Small Hemi-Adapter, AltiVate Reverse, Small Socket Insert (K172351) | Encore Medical L.P. | 2017-10-30 |
| AN85/AN86 EO Indicators (K170426) | Andersen Sterilizers, Inc. | 2017-10-30 |
| Intellijoint HIP Generation 2B System (K171525) | Intellijoint Surgical, Inc. | 2017-10-30 |
| SenoBright HD (K172404) | GE Healthcare | 2017-10-30 |
| Geistlich Bio-Gide Shape, Geistlich Bio-Gide Compressed (K171643) | Geistlich Pharma AG | 2017-10-30 |
| Cutera enlighten III Laser System (K172077) | Cutera, Inc. | 2017-10-27 |
| SANGRAY (K172087) | Hitachi , Ltd. | 2017-10-27 |
| Automatic Blood Pressure Monitor Model LD-518 & LD-537 (K170466) | Honsun (Nantong) Co., Ltd. | 2017-10-27 |
| Puritan Bennett 980 Ventilator System (K162738) | Covidien | 2017-10-27 |
| 2MP LCD Monitor (G22S+, G22SP+, C22S+, C22SP+) (K172815) | Shenzhen Beacon Display Technology Co., Ltd. | 2017-10-27 |
| Tubing Pack (K171979) | Medtronic, Inc. | 2017-10-27 |
| VENTANA anti-MLH-1(M1) Mouse Monoclonal Primary Antibody, VENTANA anti-PMS2 (A16-4) Mouse Monoclonal Primary Antibody, VENTANA anti-MSH2 (G219-1129) Mouse Monoclonal Primary Antibody, VENTANA anti-MSH6 (SP 93) Mouse Monoclonal Primary Antibody, VENTANA anti-BRAF V600E (VE1) Mouse Monoclonal Primary Antibody (DEN170030) | Ventana Medical Systems | 2017-10-27 |
| Klassic HD® Hooded Acetabular Insert with E-Link® Poly, Klassic HD® Low Profile Acetabular Insert with E-Link® Poly (K173104) | Total Joint Orthopedics, Inc. | 2017-10-27 |
| SOFTDISO (K170345) | Best Nomos | 2017-10-27 |
| Tyvek Sterilization Pouches with Chevron Seal (K170429) | Andersen Sterilizers, Inc. | 2017-10-27 |
| Infinitt PACS 7.0 (K172803) | Infinitt Healthcare Co., Ltd. | 2017-10-27 |
| Biim Diagnostic Ultrasound System (K173138) | Biim Ultrasound AS | 2017-10-27 |
| LINACwatch, LinacView (K172534) | Qualiformed Sarl | 2017-10-27 |
| C5 Diagnostic Ultrasound System (K171926) | Guangzhou Sonostar Technologies Co., Ltd. | 2017-10-27 |