| Rotograph Prime (under trade mark Villa Sistemi Medicali), I-MAX (under trade mark Owandy Radiology) (K162190) | Villa Sistemi Medicali S.P.A. | 2017-07-06 |
| HPO Exotic, LP1, LP2, LP3, Mastersun 360, Mastersun 360 New Reflector, Vega Lux (K161394) | Sportarredo Group S.C. | 2017-07-06 |
| Philips BlueControl (K171055) | Philips Electronics Nederland B.V. | 2017-07-06 |
| On Call Ketone Reagent Strips for Urinalysis, Healthy Me Ketone Reagent Strips for Urinalysis (K170587) | ACON Laboratories, Inc. | 2017-07-06 |
| TOKUYAMA CUREGRACE (K170549) | Tokuyama Dental Corporation | 2017-07-05 |
| g.Nautilus PRO (K171669) | G.Tec Medical Engineering GmbH | 2017-07-05 |
| Eclipse Treatment Planning System (K170969) | Varian Medical Systems, Inc. | 2017-07-05 |
| Leica FL560 (K170239) | Leica Microsystems (Schweiz) AG | 2017-07-05 |
| NavLock Trackers (K171267) | Medtronic Navigation | 2017-07-03 |
| YOGA Microcatheter, 0.032, 150cm, Back Up and Extra Back Up (K171653) | Codman & Shurtleff, Inc. | 2017-07-03 |
| DigniCap Scalp Cooling System (K170871) | Dignitana AB | 2017-07-03 |
| BD FACSLyric Flow Cytometer (3-1, 4-2, 4-2-2 and 4-3-3 optical configurations), BD FACSuite Clinical Software, BD Multitest 6-Color Assays, BD Multitest 4-Color Assays, BD Multitest 6-Color TBNK (K170974) | Becton, Dickinson and Company | 2017-07-03 |
| Equashield Closed System drug Transfer Device (CSTD) (K170706) | Equashield Medical , Ltd. | 2017-07-03 |
| Enterprise Imaging XERO Viewer 8.1 (K170434) | Agfa Healthcare N.V. | 2017-07-03 |
| Medline ReNewal Reprocessed Sonicision Cordless Ultrasonic Dissector (K170955) | Surgical Instrument Service and Savings Inc.(Dba Medline Ren | 2017-07-03 |
| Gemini-C Hybrid Cervical Interbody System (K170844) | Osseus Fusion Systems, LLC | 2017-07-03 |
| ASAHI Neurovasulature Guide Wire: ASAHI CHIKAI black 18 soft tip (K171613) | Asahi Intecc Co., Ltd. | 2017-07-01 |
| Aquilion ONE (TSX-305A/3) V8.3 with FIRST 2.1 (K170177) | Toshibamedical Systems Corporation | 2017-06-30 |
| ACUITY Pro Lead Delivery System (K171612) | Boston Scientific Corporation | 2017-06-30 |
| D2 Dressing (DEN160012) | Z-Medica, LLC | 2017-06-30 |
| Welch Allyn Connex Vital Signs Monitor, Welch Allyn Connex Integrated Wall System, 901060 Vital Signs Monitor (K171621) | Welch Allyn, Inc. | 2017-06-30 |
| SpiralTech Dental Implant System (K170372) | Spiraltech Superior Dental Implants, Inc. | 2017-06-30 |
| NextDent Denture, E-Denture (K162572) | Vertex-Dental B.V. | 2017-06-30 |
| Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs (White) (K170794) | Hartalega NGC Sdn. Bhd. | 2017-06-30 |
| Infinity-Lock 3, Infinity-Lock 5 (K171680) | Xiros, Ltd. | 2017-06-30 |
| DePuy Synthes 4.0 mm and 5.0 mm Locking Screws – MR Conditional, DePuy Synthes Wrist Fusion Plate (WFP) – MR Conditional, DePuy Synthes Large Fragment Dynamic Compression Locking (DCL) System –MR Conditional, DePuy Synthes Small Fragment Dynamic Compression Locking (DCL) System – MR Conditional, DePuy Synthes Modular Foot System – MR Conditional, DePuy Synthes T-Plates – MR Conditional, DePuy Synthes One-third Tubular Plate with Collar (OTPC) – MR Conditional, DePuy Synthes Stainless S (K160553) | Synthes (Usa) Products, LLC / Depuy Orthopaedics, Inc. | 2017-06-30 |
| iVitri EZ (K162640) | Reprobitech Corp. | 2017-06-30 |
| GRAVITY™ Syndesmosis LP (K170249) | Wrightmedicaltechnologyinc | 2017-06-30 |
| Gelweave Vascular Grafts (K162794) | Vascutek, Ltd. | 2017-06-30 |
| Dynamic Visualization II Image Processing Option for the FDX Console (DR-ID300CL of the DR-ID600) (K163624) | Fujifilm Medical Systems U.S.A, Inc. | 2017-06-30 |
| FIBERGRAFT BG Matrix Bone Graft Substitute (K171284) | Prosidyan, Inc. | 2017-06-30 |
| Smart External Drain (SED) System (K171586) | Aqueduct Critical Care, Inc. | 2017-06-30 |
| BioMonitor 2-AF, BioMonitor 2-S, FIT - Fast Insert Tool 1 + 2, Set (K171514) | Biotronik, Inc. | 2017-06-29 |
| SMR Hybrid Glenoid System (K163397) | Lima Corporate S.P.A. | 2017-06-29 |
| ADAMS A1c HA-8180V, CALIBRATOR 80 (K162822) | Arkray Factory, Inc. | 2017-06-29 |
| ClearLLab T1, ClearLLab T2, ClearLLab B1, ClearLLab B2, ClearLLab M (DEN160047) | Beckman Coulter | 2017-06-29 |
| SAGICO IBF SYSTEM – ARIA LUMBAR, SAGICO IBF SYSTEM – ARION CERVICAL (K161710) | Spinal Analytics & Geometrical Impant Co, LLC | 2017-06-29 |
| Reliance Solo Sterilization Wrap, Reliance Tandem Sterilization Wrap (K171533) | Ahlstrom Nonwovens, LLC | 2017-06-29 |
| Vessel Dilator (K163524) | Fetzer Medical GmbH & Co. KG | 2017-06-29 |
| Firebow Wire Torque Assist Device (K170684) | Vesatek, LLC | 2017-06-29 |
| Admira Fusion x-base (K170896) | Voco GmbH | 2017-06-29 |
| Parietene DS Composite Mesh (K163212) | Sofradim Production | 2017-06-29 |
| PHA S1 Spinal System (K163011) | Phamedica, Inc. | 2017-06-29 |
| Rickettsia Real-time PCR Assay (K170940) | Centers For Disease Control and Prevention (CDC) | 2017-06-29 |
| SupraSDRM Biodegradable Matrix Wound Dressing (K170213) | Polymedics Innovations, GmbH | 2017-06-28 |
| Livia (K163153) | Lifecare , Ltd. | 2017-06-28 |
| Delta III Lithotripter (K170122) | Dornier Medtech America | 2017-06-28 |
| TULA Tube Delivery System (K171239) | Tusker Medical | 2017-06-28 |
| Unison-C Anterior Cervical Fixation System (K170830) | Pioneer Surgical Technology, Inc., Dba Rti Surgical, Inc. | 2017-06-28 |
| Cannulated Screws Neoortho (K162874) | Neoortho Produtos Ortopedicos S/A | 2017-06-27 |
| Tranquil Interbody System (K170297) | Nexus Spine, LLC | 2017-06-27 |
| Distal Elbow Plating System (K171590) | Skeletal Dynamics, LLC | 2017-06-27 |
| Smith & Nephew 25 Fluid Management System (K171794) | Smith & Nephew, Inc. | 2017-06-27 |
| Powder-Free Clear Vinyl Patient Examination Gloves (K170735) | Zibo Yue Fan Medical Products Co, Ltd. | 2017-06-27 |
| RayStation (K171536) | RaySearch Laboratories AB (PUBL) | 2017-06-27 |
| Stellar LEAP (K163432) | Pdg Product Design Group, Inc. | 2017-06-27 |
| OWL RF INSULATED CANNULAE (K170708) | Diros Technology, Inc. | 2017-06-27 |
| Pinpoint GT Needles (K163216) | C.R. Bard, Inc. | 2017-06-27 |
| Contact Lens Case Round Glasses (K171163) | Fiftytwoways, Ltd. | 2017-06-27 |
| Halcyon (K170817) | Varian Medical Systems, Inc. | 2017-06-27 |
| Swedge™ Pedicle Screw Fixation System (K170045) | Spinal Resources, Inc. | 2017-06-26 |
| LZI Methadone Metabolite Enzyme Immunoassay, LZI Methadone Metabolite (100 and 300) Calibrators (K170416) | Lin-Zhi International, Inc. | 2017-06-26 |
| CardioLogs ECG Analysis Platform (K170568) | Cardiologs Technologies | 2017-06-26 |
| NuVasive® CoRoent® Thoracolumbar System (K170962) | Nu Vasive, Incorporated | 2017-06-26 |
| PROCOTYL® PRIME Acetabular Cup System (K170444) | Microport Orthopedics, Inc. | 2017-06-26 |
| Sprint System, Single Procedure Kit, Sprint System with Pad II, Single Procedure Kit, Sprint System, Multi-Procedure Kit, Sprint System, Sterile Components Kit, Sprint System, Stimulator Kit (K170902) | Spr Therapeutics, LLC | 2017-06-26 |
| SpringTMS (K162797) | Eneura, Inc. | 2017-06-26 |
| LASEMD Laser System (K171009) | Lutronic Corporation | 2017-06-23 |
| hypodermic Pinpoint™ GT Needle (K163437) | C.R. Bard, Inc. | 2017-06-23 |
| Gemini Sterilization Wrap (K162993) | Medline Industries, Inc. | 2017-06-23 |
| Elecsys Toxo IgM, Elecsys Toxo IgM PreciControl (K162678) | Roche Diagnostics | 2017-06-23 |
| Babyleo TN500 (K162821) | Draegerwerk AG & CO Kgaa | 2017-06-23 |
| POWDER FREE LATEX EXAMINATION GLOVE, POLYMER COATED (K170094) | Vietglove Corporation | 2017-06-23 |
| ReBOSSIS85 (K170620) | Orthorebirth Co., Ltd. | 2017-06-23 |
| Navios EX Flow Cytometer, 6 Color/2 Laser, Navios EX Flow Cytometer, 8 Color/2 Laser, Navios EX Flow Cytometer, 10 Color/3 Laser (K162897) | Beckman Coulter | 2017-06-23 |
| Arrow Seldinger Arterial Catheterization Device 18 ga., Arrow Seldinger Arterial Catheterization Device 20 ga., Arrow Seldinger Arterial Catheterization Device 22 ga., Arrow Seldinger Arterial Catheterization Device 24 ga. (K171146) | Arrow International, Inc. (Subsidiary of Telelflex Inc.) | 2017-06-23 |
| Ossler Exam Scope (K171188) | Lr Med, Inc. | 2017-06-23 |
| Aqua Care & Accu-Rinse, Sterile Water & Sterile Normal Saline (K170270) | Ls Scientific Inc. D.B.A. Kse Scientific | 2017-06-23 |
| Medline ReNewal Reprocessed ArthroCare ArthroWands and Smith & Nephew Dyonics (K171324) | Surgical Instrument Service and Savings, Inc. | 2017-06-23 |
| YELLOW LASER PHOTOCOAGULATOR YLC-500 (K170302) | Nidek Co., Ltd. | 2017-06-23 |
| Cerdak Basic (K153138) | Bu Polysciences Equipment & Trading, LLC | 2017-06-23 |
| HumiGard Surgical Humidification System, HumiGard Humdified Insufflation Kit (K162582) | Fisher & Paykel Healthcare | 2017-06-23 |
| HyPHo Laser System (K163449) | Hyper Photonics Srl | 2017-06-23 |
| SUITESTENSA (K163668) | Ebit Srl | 2017-06-23 |
| CRE Pulmonary Balloon Dilatation Catheter (K170759) | Boston Scientific Corporation | 2017-06-23 |
| AOS Anterolateral Proximal Humeral Plate (K171606) | Advanced Orthopaedic Solutions, Inc. (Aos) | 2017-06-22 |
| Tria Firm Ureteral Stent (K163399) | Boston Scientific Corporation | 2017-06-22 |
| VITRUVIAN INFILTRATION PUMP (K170629) | Black & Black Surgical, Inc. | 2017-06-22 |
| Girgis Scope Video 200 Double Bladed Laryngoscope (GSV200.DBL) (K163412) | Girgis Scope, LLC | 2017-06-22 |
| Spiral Shape Dental Implant System (K162299) | Gp Implants | 2017-06-22 |
| CoVa Monitoring System 2 (K160899) | Tosense, Inc. | 2017-06-22 |
| Merit Hydrophilic Guide Wire (K170933) | Merit Medical Systems, Inc. | 2017-06-22 |
| CUBEScan™ BioCon-900 (Bladder Volume Measurement System) (K171591) | Mcube Technology Co., Ltd. | 2017-06-22 |
| Sterile Polyisoprene Powder Free Surgical Gloves (K171047) | Better Care Plastic Technology Co., Ltd. | 2017-06-22 |
| Ion PGM Dx System (K170299) | Life Technologies Corporation | 2017-06-22 |
| Multi-Link X2 ECG Adapter and Direct Connect Lead Wire System (K163316) | Carefusion 303, Inc. | 2017-06-22 |
| FilmArray NGDS Warrior Panel (K170883) | Biofire Defense, LLC | 2017-06-22 |
| VariAx 2 Compression Plating System (K170727) | Stryker GmbH | 2017-06-22 |
| Reprocessed Webster CS Bi-Directional Diagnostic EP Catheter, Reprocessed Webster CS Bi-Directional Diagnostic EP Catheter (with Auto ID) (K170922) | Innovative Health, LLC | 2017-06-22 |
| TransFix/EDTA Vacuum Blood Collection Tubes (K162723) | Caltag Medsystems, Ltd. | 2017-06-22 |