| Philips IntelliVue GuardianSoftware (K161767) | Philips Medizin Systeme Boeblingen GmbH | 2017-01-27 |
| Universa Firm Ureteral Stents and Stent Sets (K161236) | Cook Incorporated | 2017-01-27 |
| MAGNETOM Sempra with syngo MR E11S (K163211) | Siemens Medical Solutions USA, Inc. | 2017-01-27 |
| ASAHI PTCA Guide Wire ASAHI SUOH 03 (K162842) | Asahi Intecc Co., Ltd. | 2017-01-27 |
| nordicBrainEx (K163324) | Nordicneurolab AS | 2017-01-27 |
| CSX-30 Flat Panel Detector (K162909) | Canon, Inc. – Medical Equipment Group | 2017-01-27 |
| Vado Bi-Directional Steerable Sheath (K162427) | Kalila Medical, Inc. | 2017-01-27 |
| MAGNETOM Aera and MAGNETOM Skyra with syngo MR E11C - AP02 Software (K163312) | Siemens Medical Solutions USA, Inc. | 2017-01-27 |
| chromID Strepto B agar (K163042) | bioMerieux, Inc. | 2017-01-27 |
| Ecomed Disposable Angiographic Syringes (K162088) | Ecomed Solutions, LLC | 2017-01-27 |
| Allura Xper R9 (K163715) | Philips Medical Systems Nederland B.V. | 2017-01-26 |
| FITBONE TAA (K163368) | Wittenstein Intens GmbH | 2017-01-26 |
| Zmaxx T Series (K161219) | Maxx Digm, Inc. | 2017-01-26 |
| ROCCIA® ACIF (K162587) | Silony Medical GmbH | 2017-01-26 |
| Pantera LEO (K163660) | Biotronik, Inc. | 2017-01-26 |
| FastStroke (K163281) | Gef Medical Systems Scs | 2017-01-26 |
| KARL STORZ ICG Imaging System (K162882) | KARL STORZ Endoscopy-America, Inc. | 2017-01-26 |
| Onli Intermittent Catheter (K163179) | Hollister Incorporated | 2017-01-26 |
| IntraClude Intra-Aortic Occlusion Device (K163693) | Edwards Lifesciences, LLC | 2017-01-26 |
| ORTHOLOC® 3Di Ankle Fracture Plating System (K163044) | Wrightmedicaltechnologyinc | 2017-01-26 |
| dynaMX™ Compression Plate (K161303) | Mx Orthopedics, Corp. | 2017-01-26 |
| V.A.C.ULTA Negative Pressure Wound Therapy System (K162790) | Kci USA, Inc. (Kinetic Concepts, Inc.) | 2017-01-26 |
| Multi Modality Viewer (K163574) | Vital Images, Inc. | 2017-01-26 |
| PreludeSYNC Radial Compression Device (K162988) | Merit Medical Systems, Inc. | 2017-01-25 |
| CrossFT Knotless Suture Anchor with Disposable Driver (K163258) | Conmed Corporation | 2017-01-25 |
| PASS LP Spinal System (K162786) | Medicrea International SA | 2017-01-25 |
| Altus Spine Interbody Fusion System (K160976) | Altus Partners, LLC | 2017-01-25 |
| Reliant Multistage Dilatation Balloon Catheter (K162226) | Micro-Tech (Nanjing) Co., Ltd. | 2017-01-25 |
| StageOne Disposable Cement Spacer Molds for Temporary Knee Prosthesis (K161273) | Biomet, Inc. | 2017-01-25 |
| ORTHOFIX CHIMAERA Hip Fracture System - Trochanteric Nailing System (K161466) | Orthofix Srl | 2017-01-24 |
| Nitrile Powder Free Examination Gloves Tested for Use with Chemotherapy Drugs (White); Dark Violet Blue (DVBU); Dark Blue (DKBU) (K162924) | Hartalega Sdb. Bhd. | 2017-01-24 |
| nvc (K170074) | Nvision Biomedical Technologies, LLC | 2017-01-24 |
| eLyx-PRO (K162851) | Intelligent Sensory Concept SA | 2017-01-24 |
| Barrx Anorectal RFA Wand (K162802) | Covidien, LLC | 2017-01-24 |
| F&P InfoSmart (K161686) | Fisher & Paykel Healthcare, Ltd. | 2017-01-24 |
| VITEK 2 AST-GN Tigecycline (<0.5->8 ug/mL) (K163006) | bioMerieux, Inc. | 2017-01-24 |
| EzRay Air W (K163705) | VATECH Co., Ltd. | 2017-01-24 |
| AOS Small Bone Nailing System (K163014) | Advanced Orthopaedic Solutions, Inc. (Aos) | 2017-01-24 |
| OrthAlign Plus System (K162962) | Orthalign, Inc. | 2017-01-23 |
| CONCORD Plus Radiopaque Bone Cement (K162618) | Globus Medical, Inc. | 2017-01-23 |
| Facilis™ Spinal System (K161231) | Baui Biotech Co., Ltd. | 2017-01-23 |
| D.O.R.C. Disposable Cryo Probe (K160591) | Dutch Ophthalmic Research Center International BV | 2017-01-23 |
| Elecsys TSH assay, cobas e 801 Immunoassay analyzer (K162606) | Roche Diagnostics | 2017-01-23 |
| EZ-Tip Singles, EZ-Tip Vial of 20, EZ-Grip (K161275) | Research Instruments Limited | 2017-01-23 |
| Powder Free Nitrile Surgical Glove, Sterile, Tested for use with Chemotherapy Drugs (K161823) | Wrp Asia Pacific Sdn. Bhd. | 2017-01-23 |
| Lifestyles Zero Lubricated Latex Male Condom (K163107) | Ansell Healthcare Products, LLC | 2017-01-23 |
| Digital Automatic Wrist Blood Pressure Monitor SWBPM22 Series (K163113) | Grandway Technology (Shenzhen) Limited | 2017-01-19 |
| Ranfac Fat Aspiration Cannula (K162932) | Ranfac, Corp. | 2017-01-19 |
| Anatomic Total Knee System (K161414) | Amplitude | 2017-01-19 |
| NC Gallant PTCA Catheter (K162434) | Medinol, Ltd. | 2017-01-19 |
| Cardinal Health NPWT Irrigation Tubing Set, Cardinal Health NPWT Irrigation Delivery Set (K161418) | Cardinalhealth | 2017-01-19 |
| Medline Waste Station (K160660) | Medline Industries, Inc. | 2017-01-19 |
| GMI Frontier Dental Implant System (K161593) | Ilerimplant S.L | 2017-01-19 |
| Reprocessed Kendall SCD Express Compression Sleeves, Reprocessed Kendall SCD Comfort Compression Sleeves (K163620) | Covidien | 2017-01-19 |
| Cranial PSI (K161090) | Ossdsign AB | 2017-01-19 |
| TrueBeam-TrueBeam STx-Edge (K162472) | Varian Medical Systems, Inc. | 2017-01-19 |
| JAZZ FRAME SYSTEM (K162764) | Implanet, S.A. | 2017-01-19 |
| OLYMPUS SMALL INTESTINAL CAPSULE ENDOSCOPE SYSTEM (K163069) | Olympus Medical Systems Corp. | 2017-01-19 |
| Comfort Flo Humidification System (K162242) | Teleflexmedical, Inc. | 2017-01-19 |
| LEDEX WL070+ (K163605) | Dentmate Technology Co. , Ltd. | 2017-01-19 |
| Certa Dose PD Epinephrine 1mg/mL IM/SC Syringe (K160589) | Certa Dose, Inc. | 2017-01-19 |
| da Vinci Xi Surgical System (K161178) | Intuitive Surgical, Inc. | 2017-01-19 |
| Fever Scout™ Continuous Monitoring thermometer (K162137) | VivaLNK, Inc. | 2017-01-19 |
| Titan 3 Low Speed Angle Attachments (K162397) | Dentalez, Inc. | 2017-01-19 |
| Atellica CH Magnesium (Mg) (K162399) | Siemens Healthcare Diagnostics, Inc. | 2017-01-19 |
| Juno VPAP ST-A (K161492) | Resmed, Ltd. | 2017-01-19 |
| Polysmith Sleep System, Model NTI7593 (K161650) | Neurotronics, Inc. | 2017-01-19 |
| meso-relle (AAL34, AAL36, AM30G) (K161255) | Biotekne Srl | 2017-01-19 |
| UniStrip1 Generic Blood Glucose Test Strips (K162430) | Ok Biotech Co., Ltd. | 2017-01-19 |
| NovaBone IRM (K163310) | Novabone Products, LLC | 2017-01-18 |
| F&P Brevida™ Nasal Pillows Mask (K161412) | Fisher & Paykel Healthcare, Ltd. | 2017-01-18 |
| Bondiloxs Topical Hemostatic Granules (K161274) | Medtrade Products , Ltd. | 2017-01-18 |
| EndoClot (K162197) | Endoclot Plus Co., Ltd. | 2017-01-18 |
| GEO Bone Screw System (K161904) | Gramercy Extremity Orthopeidics, LLC | 2017-01-18 |
| Quantum Workstation (K163657) | Spectrum Medical , Ltd. | 2017-01-18 |
| STIMPOD NMS460 Nerve Stimulator (K161091) | Xavant Technology (Pty), Ltd. | 2017-01-18 |
| Multi-Link X2 ECG Cable and Lead Wire System (K162432) | Carefusion 2200, Inc. | 2017-01-18 |
| Acuity 18 (enflufocon A) Rigid Gas Permeable Contact Lens (K163254) | Acuity Polymers, Inc. | 2017-01-18 |
| Elecsys Troponin T Gen 5 STAT Assay, Elecsys Troponin T Gen 5 STAT CalSet, Elecsys PreciControl Troponin, Elecsys Troponin T Gen 5 CalCheck 5 (K162895) | Roche Diagnostics | 2017-01-18 |
| Siconus SI Joint Fixation System (K162121) | Camber Spine Technologies | 2017-01-18 |
| SurgiCase Orthopaedics, SurgiCase Connect, SurgiCase Guides (K163156) | Materialise NV | 2017-01-18 |
| Noddle(TM) (K162817) | Iowa Adaptive Technologies, Inc. Dba Voxello, Inc. | 2017-01-18 |
| Breast BI 7 MR Coil Mammavention 3T (K162651) | Moras Mri Products GmbH | 2017-01-18 |
| Taps for Resorbable Screws (K153587) | Synthes (USA) Products, LLC | 2017-01-18 |
| Humelock Reversed Shoulder (K162455) | Fx Solutions | 2017-01-17 |
| Precision Thin Reciprocating Blade, 0.010in. (K161514) | Stryker Corporation | 2017-01-17 |
| Chameleon PTA Balloon Catheter (K163231) | Av Medical Technologies, Ltd. | 2017-01-17 |
| WELL LIFE Rx Wireless TENS/EMS Stimulator, model WR-2603/2603A, WR-2604/2604A and WR-2605/2605A (K162663) | Well-Life Healthcare Limited | 2017-01-17 |
| hema-screen ER XCEL Enhanced Readability Fecal Occult Blood Test (K163554) | Immunostics Inc., | 2017-01-17 |
| Legion Cone System (K162775) | Smith & Nephew, Inc. | 2017-01-13 |
| Lumipulse G FSH-N Calibrators (K163534) | Fujirebio Diagnostics,Inc. | 2017-01-13 |
| LELO RESPECT HEX Natural Rubber Latex Condom (K162511) | Lelo, Inc. | 2017-01-13 |
| RED Light Device (K162489) | Zhongshan Bisen Plastic Electronic Products Co., Ltd. | 2017-01-13 |
| RX DC (K163519) | Cefla S.C. | 2017-01-13 |
| SuperLine (K160965) | Dentium Co., Ltd. | 2017-01-13 |
| Magseed Magnetic Marker System (K163541) | Endomagnetics Ltd., | 2017-01-13 |
| DynaMatrix/Dynamatrix Plus (K161762) | Cook Biotech Incorporated | 2017-01-13 |
| GingiKnit+, GingiBraid+, and Shortcut with GingiBraid+ Non-Impregnated Retraction Cord (K162164) | Kerr Corporation | 2017-01-13 |
| PANPAC DISPOSABLE VACUUM CURETTES (K161106) | Panpac Medical Corporation | 2017-01-13 |
| Cantab Mobile (K161328) | Cambridge Cognition , Ltd., US Agent: Clementi Associates , Ltd. | 2017-01-13 |