| 0.9% Sodium Chloride Injection, USP BD PosiFlush SF Syringe (K153481) | Becton, Dickinson and Company | 2016-04-04 |
| Hydroven 12, Hydroven 12 Garments (K152228) | Huntleigh Healthcare , Ltd. | 2016-04-04 |
| Acclarix LX8 Diagnostic Ultrasound System (K160790) | Edan Instruments, Inc. | 2016-04-04 |
| S45 Digital Color Doppler Ultrasound System (K160283) | Sonoscape Medical Corp. | 2016-04-04 |
| Opticage(R) Expandable Interbody Fusion Device (K160464) | Interventional Spine, Inc. | 2016-04-04 |
| PRECICE Intramedullary Limb Lengthening System (K160325) | Ellipse Technologies, Inc. | 2016-04-04 |
| Centros Long-Term Hemodialysis Catheter, CentrosFLO Long-Term Hemodialysis Catheter (K151967) | Merit Medical Systems, Inc. | 2016-04-04 |
| SENTINEL CARDIOLOGY INFORMATION MANAGEMENT SYSTEM (K152881) | Spacelabs Healthcare, Ltd. | 2016-04-01 |
| Premier (K160320) | Shandong Weigao Orthopaedic Device Co., Ltd. | 2016-04-01 |
| Pulpdent Solo Flowable Composite with MCP (K153249) | Pulpdent Corporation | 2016-04-01 |
| Powder Free Blue Nitrile Examination Glove (K153562) | Vietglove Corporation | 2016-04-01 |
| Ekso™ (version 1.1) and Ekso GT™ (version 1.2) (K143690) | Ekso Bionics, Inc. | 2016-04-01 |
| X5 Digital Color Doppler Ultrasound System (K160258) | Sonoscape Medical Corp. | 2016-04-01 |
| Aquilion Lightning, TSX-035A/4 and /5, V7.0 (K153263) | Toshibamedical Systems Corporation | 2016-04-01 |
| FilmArray Gastrointestinal Panel (GI) for use with FilmArray Torch (K160459) | Biofire Diagnostics, LLC | 2016-04-01 |
| TRUE METRIX GO Self Monitoring Blood Glucose System (K143548) | Trividia Health, Inc. | 2016-04-01 |
| Fiagon Navigation System (K151156) | Fiagon GmbH | 2016-04-01 |
| BioVision Plus (K153583) | Faxitron Bioptics, LLC | 2016-04-01 |
| PlasmaFlow (K160318) | Manamed, Inc. | 2016-04-01 |
| Affirm Prone Biopsy System (K153486) | Hologic, Inc. | 2016-04-01 |
| Abutment for Bridges (K153779) | Altatec GmbH | 2016-03-31 |
| Infrared Ear Thermometer (K153146) | Sejoy Electronics & Instruments Co., Ltd. | 2016-03-31 |
| SICAT OPTISLEEP (K153291) | Sicat GmbH & Co. KG | 2016-03-31 |
| PRECICE Trauma Nail System (K160267) | Ellipse Technologies, Incorporated | 2016-03-31 |
| Halyard Black-Orange Powder-Free Nitrile Exam Glove (K153708) | Halyard Health | 2016-03-31 |
| Pure Tilt (K152021) | Proactive Comfort, LLC | 2016-03-31 |
| ENHANCE ALLOGRAFT WEDGE INSTRUMENT TRAY (K152969) | Conmed Corporation | 2016-03-31 |
| NOVATECH TALCAIR (K151832) | Novatech SA | 2016-03-31 |
| NewTom VGi evo (K151612) | Qr S.R.L. | 2016-03-31 |
| Avenue L Lateral Lumbar Cage, Avenue T TLIF Cage System, ROI-A ALIF Cage System, ROI-T Implant System (K153495) | Ldr Spine USA | 2016-03-31 |
| Liofilchem MIC Test Strip (MTS)-Vancomycin 0.016 -256 ug/mL (K153687) | Liofilchem s.r.l. | 2016-03-31 |
| Proxis Ureteral Access Sheath (K160861) | C.R. Bard, Inc. | 2016-03-31 |
| Nitrile Powder Free Examination Gloves Tested for Use with Chemotherapy Drugs-Violet Blue (VBLU) (K151997) | Hartalega NGC Sdn. Bhd. | 2016-03-31 |
| Revitive Medic; Revitive MV; Revitive LV (K152480) | Actegy , Ltd. | 2016-03-31 |
| Stryker CrossFlow Day-Use Inflow Cassette Tubing and Patient-Use Tubing (K151932) | Stryker Corporation | 2016-03-31 |
| ECHELON Oval V 5.1 MRI System (K153547) | Hitachi Medical Systems America, Inc. | 2016-03-31 |
| JAZZ LOCK (K153348) | Implanet, S.A. | 2016-03-31 |
| MAGNETOM Spectra (K153447) | Siemens Medical Solutions USA, Inc. | 2016-03-31 |
| SensiCare PI Surgical Gloves (K152428) | Medline Industries, Inc. | 2016-03-31 |
| T3 Software (K152258) | Etiometry, Inc. | 2016-03-31 |
| AssureTech Amphetamine Tests (Strip, Dip Card, Quick Cup, Turn-Key Split Cup), AssureTech Cocaine Tests (Strip, Dip Card, Quick Cup, Turn-Key Split Cup), AssureTech Morphine Tests (Strip, Dip Card, Quick Cup, Turn-Key Split Cup) (K153465) | Assure Tech. (Hangzhou) Co, Ltd. | 2016-03-31 |
| Corin TriFit TS Hip (K153772) | Corin U.S.A. Limited | 2016-03-31 |
| da Vinci Surgical System, Model IS4000 (K152578) | Intuitive Surgical, Inc. | 2016-03-30 |
| Flight 60 Ventilator (K143035) | Flight Medical Innovations , Ltd. | 2016-03-30 |
| BrightMatter Guide with Surface Trace Registration (K153281) | Synaptive Medical, Inc. | 2016-03-30 |
| Rotatable Snares (K160637) | Boston Scientific Corporation | 2016-03-30 |
| Elysiom Polychromatic LED Light Therapy (PLLT) System (Elysiom) (K153389) | In Light Wellness Systems, Inc. | 2016-03-30 |
| AVIVO Mobile Patient Management (MPM) System (K153160) | Medtronic, Inc. | 2016-03-30 |
| Visaris Vision® (Vision C, Vision U. Vision V, Vision X) (K160620) | Visaris D.O.O. Belgrade | 2016-03-30 |
| SIGNAPioneer (K160621) | GE Healthcare | 2016-03-29 |
| Rocket IPC Insertion Set, Rocket IPC Mini Insertion Set (K152105) | Rocket Medical Plc | 2016-03-29 |
| Full Automatic (NIBP) Blood Pressure Monitor (K160336) | Health & Life Co., Ltd. | 2016-03-29 |
| Puritan Bennett 840 Series Ventilator System (K151252) | Covidien LP | 2016-03-29 |
| X-cera Zirconia Blanks (K153767) | Shenzhen Xiangtong Photoelectricity Technology Co., Ltd. | 2016-03-29 |
| Synaptive ImageDrive Pro (K153284) | Synaptive Medical, Inc. | 2016-03-29 |
| PURE CRYOGEN (K153564) | Air Liquide Healthcare America Corporation | 2016-03-29 |
| Infrared Thermometer (FT-F11-BT, FT-F21-BT, FT-31-BT, FT-F41-BT) (K152640) | Fudakang Industries Co., Ltd. | 2016-03-28 |
| Sonicision Cordless Ultrasonic Dissection Device (K153371) | Covidien, LLC | 2016-03-28 |
| SMV Scientific Schanz Screws (K160603) | Smv Scientific | 2016-03-28 |
| ANATOMIC PEEK PTC Cervical Fusion System (K160528) | Medtronic Sofamor Danek USA, Inc. | 2016-03-28 |
| ACUVUE (senofilcon C) Soft Contact Lens (K160212) | Johnson & Johnson Vision Care, Inc. | 2016-03-28 |
| TRYPTIK2C-plate Anterior Cervical Plate System (K153042) | Spineart | 2016-03-28 |
| Amplichek II, Negative and Amplichek II, Negative MiniPak, Amplichek II, Level 1 and Amplichek II, Level 1 MiniPak, Amplichek II, Level 2 and Amplichek II, Level 2 MiniPak, Amplichek II, Level 3 and Amplichek II, Level 3 MiniPak (DEN150058) | Bio-Rad Laboratories | 2016-03-28 |
| MRII Cranial Drill and Accessories (K160129) | Mri Interventions, Inc. | 2016-03-26 |
| truFreeze System (K160273) | Csa Medial, Inc. | 2016-03-25 |
| VibraPEP (K153441) | Medica Holdings, LLC | 2016-03-25 |
| LOGIQ F8 Expert, LOGIQ F8, LOGIQ F6 (K160277) | GE Medical Systems Ultrasound and Primary Care Diagnostics | 2016-03-25 |
| Corvocet Biopsy System (K153337) | Merit Medical Systems, Inc. | 2016-03-25 |
| iTotal Cruciate Retaining (CR) Knee Replacement System (K153721) | Conformis, Inc. | 2016-03-25 |
| VITEK 2 AST-Yeast Micafungin (0.06-8 mcg/mL) (K151923) | bioMerieux, Inc. | 2016-03-25 |
| Great Basin Staph ID/R Blood Culture Panel (K152470) | Great Basin Scientific, Inc. | 2016-03-25 |
| SurgTech Interbody System (K152200) | Surgtech, Inc. | 2016-03-25 |
| Corin TaperFit Hip Stem (K153725) | Corin U.S.A. Limited | 2016-03-25 |
| MSCB-001 (K152274) | GC America, Inc. | 2016-03-25 |
| Vas-Q-Clip (K151943) | Nanova Biomaterials, Inc. | 2016-03-25 |
| Align Anterior Ankle Fusion Plate (K160191) | Extremity Medical, LLC | 2016-03-25 |
| DeRoyal Angiography Kits (K152978) | Deroyal Industries, Inc. | 2016-03-25 |
| EliA anti-TG Immunoassay, EliA anti-TPO Immunoassay, EliA Thyroid Positive Control 250, EliA Thyroid Positive Control 2500/5000 (K151799) | Phadia AB | 2016-03-25 |
| Optetrak Logic Metaphyseal Cones (K153595) | Exactech, Inc. | 2016-03-25 |
| SOMATOM Perspective (K151765) | Siemens Medical Solutions USA, Inc. | 2016-03-25 |
| U&U Insulin Syringe with/without Safety Retractable Device (K152808) | U&U Medical Technology Co, Ltd. | 2016-03-25 |
| iMESH Tacker (K153202) | Thd Lap | 2016-03-24 |
| Biomet Microfixation RibFix Blu Thoracic Fixation System (K152253) | Biomet Microfixation | 2016-03-24 |
| STERIZONE VP4 Sterilizer (K153392) | Ts03, Inc. | 2016-03-24 |
| Arthrex SwiveLock Anchors (K151342) | Arthrex, Inc. | 2016-03-24 |
| NuVasive® Lumbar Interbody Implants (K153782) | Nu Vasive, Incorporated | 2016-03-24 |
| TRUESPAN Meniscal Repair System (K153667) | Medos International SARL | 2016-03-24 |
| Cascadia Interbody System (K160547) | K2m | 2016-03-24 |
| EV Insite System (K152716) | Psp Corporation | 2016-03-24 |
| Solex 7 Intravascular Heat Exchange Catheter, ZOLL Start-Up Kit (K153226) | Zoll Circulation, Inc. | 2016-03-24 |
| Exceed Tx (K150702) | Great Lakes Orthodontics, Ltd. | 2016-03-24 |
| Hybernite RT (K151461) | Plastiflex Group NV | 2016-03-24 |
| X-Fix Line Additions (K151881) | Vilex IN Tennessee, Inc. | 2016-03-24 |
| Cardinal HealthTM Sterile Latex Powder-Free Orthopedic Surgical Gloves with Hydrogel Coating (K151778) | Cardinal Health 200, Inc. | 2016-03-24 |
| Response 5.5 Spine System (K160466) | OrthoPediatrics Corp. | 2016-03-23 |
| MPO Total Knee Systems MR Labeling (K152631) | Microport Orthopedics, Inc. | 2016-03-23 |
| PointerShell Universal, PointerShell LS (K160479) | Fiagon GmbH | 2016-03-23 |
| Reprocessed Steerable Introducer (K152090) | Sterilmed, Inc. | 2016-03-23 |
| Vesalius (K152933) | Telea Electronic Engineering Srl | 2016-03-23 |
| ZELTIQ CoolSculpting System (K160259) | Zeltiq Aesthetics, Inc. | 2016-03-23 |