| ManoScan System (K151086) | Given Imaging , Ltd. | 2016-04-28 |
| Blockade Surgical Gown (K150598) | Medline Industries, Inc. | 2016-04-28 |
| Endopath Electrosurgery Probe Plus II (K160128) | Ethicon Endo-Surgery, LLC | 2016-04-28 |
| 3Shape Ortho System (K152086) | 3Shape A/S | 2016-04-28 |
| Syzygy Stabilization System (K153152) | Amendia, Inc. | 2016-04-27 |
| EYEPRINTPRO (ROFLUFOCON D) SCLERAL GP LENSES (K152724) | Advanced Vision Technologies | 2016-04-27 |
| Dual Pump Pack (K160236) | Abbott Medical Optics, Inc. | 2016-04-27 |
| Pyrenees Cervical Plate System (K153526) | K2m | 2016-04-27 |
| Wet Original Personal Lubricant (K160211) | Trigg Laboratories D/B/A Wet International | 2016-04-27 |
| OmniPod Insulin Management System (K160252) | Insulet Corporation | 2016-04-27 |
| Trinidad CH Vancomycin (Vanc), Trinidad CH Drug 3 Calibrator (DRUG3 CAL) (K160202) | Siemens Healthcare Diagnostics, Inc. | 2016-04-27 |
| Elecsys Cortisol II, Cortisol II CalSet (K152227) | Roche Diagnostics | 2016-04-27 |
| Signia Stapler (K160176) | Covidien | 2016-04-26 |
| Rapid Single/Multi-drug Test Cup, Rapid Single/Multi-drug Test Dipcard (K153050) | Co-Innovation Biotech Co., Ltd. | 2016-04-26 |
| PASS OCT Spinal System (K160756) | Medicrea International SA | 2016-04-26 |
| Inertia Pedicle Screw and Deformity Correxxion System (K153453) | Nexxt Spine, LLC | 2016-04-26 |
| White Pearl Preferred Angle Anterior Cervical Plate (K160522) | Osseus Fusion Systems, LLC | 2016-04-26 |
| ISEN-Goggles (K152727) | Isen Tech & Trading Company, Ltd. | 2016-04-26 |
| Materialise Glenoid Positioning System (K153602) | Materialise NV | 2016-04-26 |
| StarFuse Interphalangeal Pin (K160194) | Phalanx Innovations | 2016-04-26 |
| Genesys Spine Apache Interbody Fusion System (K153123) | Genesys Spine | 2016-04-26 |
| 2008K2 Hemodialysis Machine (K153449) | Fresenius Medical Care Renal Therapies Group, LLC | 2016-04-26 |
| CompactCath Intermittent Urinary Catheter (K160858) | Compactcath, Inc. | 2016-04-26 |
| Voluson P6, Voluson P8 (K160162) | GE Healthcare | 2016-04-26 |
| MMS PTA Balloon Catheter (K152934) | Micro Medical Solutions, Inc. | 2016-04-25 |
| Stryker Neptune 3 Waste Management System (K153407) | Stryker Corporation | 2016-04-25 |
| KRONUS Aquaporin-4 Autoantibody (AQP4Ab) ELISA Assay (DEN150030) | Kronus, Inc. | 2016-04-25 |
| maxFit II Dental Implant System (K151588) | Taiwan Implant Technology Company, Ltd. | 2016-04-25 |
| POGO Automatic Blood Glucose Monitoring System (K152493) | Intuity Medical, Inc. | 2016-04-25 |
| Capillus272 Pro, Capillus272 OfficePro, Capillus82, Capillus202 (K160285) | Capillus, LLC | 2016-04-25 |
| MIM-Thin Client (mobile) (K151913) | Mim Software, Inc. | 2016-04-25 |
| Gridlock Ankle Plating System (K160177) | Trilliant Surgical, Ltd. | 2016-04-22 |
| Cascadia Interbody System (K160125) | K2m | 2016-04-22 |
| G3(TM) Active Plate(R) Small Fragment System (K160633) | Genesis Fracture Care, Inc. | 2016-04-22 |
| AvaDent Denture Base Material (K153590) | Global Dental Science | 2016-04-22 |
| sterEOS Workstation (K160914) | Eos Imaging, Inc. | 2016-04-22 |
| PASS LP Spinal System (K153413) | Medicrea International SA | 2016-04-22 |
| MIRI TL (K151357) | At Medical Uab | 2016-04-22 |
| Revolution Spinal Fixation System (K160216) | Intelligent Implant Systems, LLC | 2016-04-22 |
| OSTEOPAL plus (K153737) | Heraeus Medical GmbH | 2016-04-22 |
| ACCENTO / HWA Dual/Single laser (K160227) | Bison Medical Co, Ltd. | 2016-04-22 |
| CueSee Hypoxic (K152553) | Eurotrol B.V. | 2016-04-22 |
| U80 Series Upper Arm Electronic Blood Pressure Monitor (K160019) | Shenzhen Urion Technology Co., Ltd. | 2016-04-22 |
| MotoBand(TM) CP Implant System (K160300) | Crossroads Extremity Systems, LLC | 2016-04-22 |
| Sydney IVF Sperm Cryopreservation Buffer (K160814) | William A. Cook Australia Pty. , Ltd. | 2016-04-22 |
| MX50N(MX50YQS) (K160353) | Wide Corporation | 2016-04-22 |
| Reveal LINQ (K160689) | Medtronic, Inc. | 2016-04-22 |
| Matrix Mini ECG Monitor (K152701) | Global Instrumentation, LLC | 2016-04-22 |
| Anzai Respiratory Gating System (K160432) | Anzai Medical Co., Ltd. | 2016-04-22 |
| Disposable General Electrode (K152059) | Modern Medical Equipment Manufacturing Limited | 2016-04-21 |
| Ventix Suture Anchor (K153558) | Biomet Manufacturing Corp | 2016-04-21 |
| MINERAL OIL (K160142) | Kitazato Biopharma Co., Ltd. | 2016-04-21 |
| NITRILE BLUE POWDER FREE EXAMINATION GLOVES tested for use with Chemotheraphy Drugs (K152222) | Gmp Medicare Sdn Bhd (F25) | 2016-04-21 |
| Zavation Spinal System (K153404) | Zavation, LLC | 2016-04-21 |
| AgaMatrix Jazz Wireless 2 Blood Glucose Monitoring System (K152365) | Agamatrix, Inc. | 2016-04-21 |
| Pantheris Catheter (K160827) | Avinger, Inc. | 2016-04-21 |
| Dropper hsCRP High Sensitivity CRP Control (K152117) | Quantimetrix Corporation | 2016-04-21 |
| VirtuoSaph Plus Endoscopic Vessel Harvesting System (K160206) | Terumo Cardiovascular Systems Corporation | 2016-04-21 |
| MaxiGen (K152077) | Hans Biomed Corp. | 2016-04-21 |
| Dash-Topic Plus Cream (K150914) | Founders Science Group, LLC | 2016-04-21 |
| PROBEAT-V and accessories (K153614) | Hitachi, Ltd., Health Care Company | 2016-04-21 |
| Laparoscope Lens Shield Device (K160172) | Medeon Biodesign, Inc. | 2016-04-21 |
| ULTRA Telescopes (K160249) | Olympus Winter & Ibe GmbH | 2016-04-21 |
| Leksell Gamma Knife Icon (K160440) | Elekta Instrument AB | 2016-04-20 |
| NuVasive® Interfixated Interbody System (K160051) | Nu Vasive, Incorporated | 2016-04-20 |
| Elite SPK, Compasso, Elite SPK Kit (K160500) | Ncs Lab Srl | 2016-04-20 |
| Penumbra Smart Coil (K160832) | Penumbra, Inc. | 2016-04-20 |
| GLAUCOMA COMPANION (DEN140022) | Innovatex, Inc. | 2016-04-20 |
| Icare ic100 (K153694) | Icare Finland OY | 2016-04-19 |
| AIRO Computed Tomography (CT) X-ray System (K160126) | Mobius Imaging | 2016-04-19 |
| VASOVIEW HemoPro Endoscopic Vessel Harvesting System (K153194) | Maquet Cardiovascular, LLC | 2016-04-19 |
| Fujifilm Sonosite Vevo MD Imaging System (K160674) | FUJIFILM Sonosite, Inc. | 2016-04-19 |
| Arthrex Univers Revers CA Heads and Adapters (K151527) | Arthrex, Inc. | 2016-04-19 |
| Microcyn Plus Skin and Wound Hydrogel (K153648) | Oculus Innovative Sciences | 2016-04-19 |
| Bicortical Fixation Screw & Washer Nut System (K153638) | First Ray, LLC | 2016-04-19 |
| LumenR Tissue Retractor System (K153698) | Lumenr, LLC | 2016-04-19 |
| Chemtrue Multi-Panel Drug Screen Dip Card/Cup Tests, Chemtrue Multi-Panel Drug Screen Dip Card/Cup with OPI 2000 Tests (K153192) | Chemtron Biotech, Inc. | 2016-04-18 |
| Pulse Oximeter (MD300M/MD300K2) (K152563) | Beijing Choice Electronic Technology Co., Ltd. | 2016-04-18 |
| Forma System, Forma Light System (K160195) | Formatk Systems , Ltd. | 2016-04-15 |
| Bullfrog Micro-Infusion Device (K153501) | Mercator Medsystems, Inc. | 2016-04-15 |
| Accuryn Monitoring System (K153655) | Potrero Medical, Inc. | 2016-04-15 |
| Applanation Tonometer (K142263) | Shanghai Mediworks Precision Instruments Co. , Ltd. | 2016-04-15 |
| MAGNETOM Aera, MAGNETOM Skyra, MAGNETOM Prisma, MAGNETOM Prisma fit (K153343) | Siemens Medi Cal Solutions, Inc. | 2016-04-15 |
| Spectra S1Plus and Spectra S2 Plus (K150476) | Uzinmedicare Co. | 2016-04-15 |
| VITEK 2 AST-Gram Negative Ertapenem (<=0.12 - >=8 ug/mL) (K152075) | bioMerieux, Inc. | 2016-04-15 |
| Rainbow Paste Stain (K151731) | Genoss | 2016-04-15 |
| ACCU NEWS Drug Screening Test Card/Urine Cup (K152590) | Coretests, Inc. | 2016-04-15 |
| Neodent Implant System (K153624) | Jjgc Industria E Comercio DE Materiais Dentarios S | 2016-04-15 |
| Simple T Pediatric Nasal Mask (K151120) | Respironics, Inc. | 2016-04-15 |
| CRIT-LINE III Blood Chamber II (K160749) | Fresenius Medical Care Renal Therapies Group, LLC | 2016-04-15 |
| Leva Spacer System (K153222) | Spine Wave, Inc. | 2016-04-15 |
| StimSox(TM) System (K151922) | Stimmed, LLC | 2016-04-15 |
| VERASENSE Knee System (K150372) | Orthosensor, Inc. | 2016-04-15 |
| BiNAPS Nasal Airflow and Snore Transducer; ThermiSense Oral/Nasal Thermal AirFlow Sensor with Airflow Pressure Cannulas, Nasal and Oral/Nasal (K151874) | Salter Labs | 2016-04-15 |
| RIOScan (RPS500) (K160788) | Ray Co., Ltd. | 2016-04-15 |
| SLI Endoprobe, SLI DENT Bare Fiber, SLI HO Bare Fiber, SLI HCS Bare Fiber, SLI Lateral Firing Fiber (K151855) | Surgical Laser Incorporated | 2016-04-15 |
| Morpheus RealTime Ultrasound, Pathway RealTime Ultrasound, QuickScan Bladder Ultrasound (K160792) | The Prometheus Group | 2016-04-15 |
| Lumipulse G 25-OH Vitamin D, Lumipulse G 25-OH Vitamin D Calibrators (K153361) | Fujirebio Diagnostics,Inc. | 2016-04-15 |
| CX30N (CX30PQX) (K160348) | Wide Corporation | 2016-04-14 |
| Symmetry Surgical Quad-Lock Container System (K152111) | Symmetry Surgical, Inc. | 2016-04-14 |