| Beta-2-Microglobulin (K161297) | Beckman Coulter Ireland, Inc. | 2016-06-07 |
| DSM Biomedical Porcine Pericardium Dental Membrane (K160474) | Kensey Nash Corporation Dba Dsm Biomedical | 2016-06-07 |
| Contact Lens Case (multiple brand name) (K160005) | Danyang Chanxin Glasses Cases Factory | 2016-06-07 |
| SureFine Pen Needle (K152877) | Shina Med Corporation | 2016-06-07 |
| A Plus Internal Fixture System (K152786) | T-Plus Implant Tech. Co., Ltd. | 2016-06-07 |
| Getinge Series Warming Cabinet (K153713) | Getinge Sourcing, LLC | 2016-06-07 |
| IMPROSAFE Blood Collection Set with Pre-attached Holder, IMPROVACUTER Blood Collection Set Pre-attached Holder, IMPROSAFE Blood Collection Set, IMPROVACUTER Blood Collection Set, IMPROSAFE Multi Sample Needle, IMPROSAFE Multi Sample Needle (Flashback), IMPROVACUTER Multi Sample Needle (K153388) | Guangzhou Improve Medical Instruments Co., Ltd. | 2016-06-07 |
| EndoCure Model EUR078A (K161147) | Endocure Technologies, Inc. | 2016-06-07 |
| X-VIEW, IMAGEN (K151137) | Edlen Imaging, LLC | 2016-06-07 |
| Smart Set (K151250) | Top Spins, Inc. | 2016-06-07 |
| Disposable Barrier Sleeves and Covers (K160232) | Dentsply International, Inc. | 2016-06-07 |
| LATERAL Spine Truss System (K153436) | 4Web, Inc. | 2016-06-06 |
| NobelProcera HT ML Full Contour Zirconia Crown (K153534) | Nobel Biocare AB | 2016-06-06 |
| NMI DUAL PORT II (K151239) | Navilyst Medical, Inc. | 2016-06-06 |
| MICROPERIMETER MP-3 (K152729) | Nidek Co., Ltd. | 2016-06-06 |
| ORAL BOND (K142130) | Steiner Laboratories | 2016-06-06 |
| Thunderbolt™ Minimally Invasive and Lancer™ Open Pedicle Screw Systems (K160775) | Choicespine, LP | 2016-06-03 |
| Wing Smart FEVI and Peak Flow Meter (K152276) | Sparo, Inc. | 2016-06-03 |
| dynaMX(TM) Nitinol Compression Screw (K160427) | Mx Orthopedics, Corp. | 2016-06-03 |
| Sonendo GentleWave System (K160905) | Sonendo, Inc. | 2016-06-03 |
| Large Screws Range (K160617) | Newclip Technics | 2016-06-03 |
| LunulaLaser (K153164) | Erchonia Medical, Inc. | 2016-06-03 |
| Disposable Concentric Needle electrodes, Disposable Monopolar Needle electrodes, Disposable EP Needle electrodes, Disposable Hypodermic Needle electrodes (K152984) | Bio Protech, Inc. | 2016-06-03 |
| Communicator Surgical Facemask with Clear Window (K152561) | Prestige Ameritech , Ltd. | 2016-06-03 |
| Halo One Thin-Walled Guiding Sheath (K161183) | C.R. Bard, Inc. | 2016-06-03 |
| VALIDATE D-Dimer Calibration Verification/Linearity Test Kit (K152961) | Maine Standards Company, LLC | 2016-06-03 |
| Logical C-Series Acetabular Shell, Logical Constrained Liner, Logical Constrained Liner Collar, Logical 20° Hooded Acetabular Liner (K153131) | Signature Orthopaedics Pty, Ltd. | 2016-06-03 |
| Seal Rite Non-Rebreathing Valve (K152521) | The Lifeguard Store, Inc. | 2016-06-03 |
| Background Pattern Classification [BPc(TM)] (K152301) | Natus Medical Incorporated Dba Excel-Tech Ltd. (Xltek) | 2016-06-03 |
| Strive (K153704) | Djo, LLC | 2016-06-03 |
| Heat Pain Pro (K160115) | Omron Healthcare, Inc. | 2016-06-03 |
| LifeStream Management System, LifeStream Management Suite, LifeStream Patient Manager, LifeStream Manager, LifeStream Web Manager, LifeStream (K153719) | Honeywell Hommed, LLC | 2016-06-03 |
| HumaPen Savvio (K160668) | Eli Lilly and Company, Inc. | 2016-06-03 |
| WallFlex Biliary RX Fully Covered Stent System RMV (DEN150040) | Boston Scientific | 2016-06-03 |
| iFUSE Implant System (K160652) | SI-BONE, Inc. | 2016-06-03 |
| Coated VICRYU (Polyglactin 91O)Sterile Synthetic Absorbable Suture Cartridges, ETHIBOND Polybutilate Coated Polyester Sterile Synthetic Non-Absorbable Suture Cartridges, PROXISURE Suturing Device (K153611) | Ethicon, LLC | 2016-06-03 |
| Medipure Oxygen-LC System (K153518) | Praxair Distribution, Incorporated. | 2016-06-03 |
| OrthoButton CL (K160655) | Riverpoint Medical | 2016-06-03 |
| Corin Optimized Positioning System (OPS) (K152893) | Corin USA | 2016-06-03 |
| VARIOunite (K160244) | Thommen Medical AG | 2016-06-02 |
| Helios III (K152856) | Laseroptek Co., Ltd. | 2016-06-02 |
| NobelSpeedy Groovy (K160119) | Nobel Biocare AB | 2016-06-02 |
| NobelDesign Software (K153036) | Nobel Biocare AB | 2016-06-02 |
| LENS Camera Control Unit-WiFi, LENS Camera Unit-Non-WiFi, LENS camera head, Camera Coupler, Tablet Application (K153606) | Smith & Nephew | 2016-06-02 |
| Gun Oil, Pink, Gun Oil H2O, Pink Water (K152918) | Empowered Products, Inc. | 2016-06-02 |
| O-pel Laser and families of probe delivery devices (K160012) | Precise Light Surgical | 2016-06-02 |
| Anker II Dental Implant System (K152576) | Alliance Global Technology Co., Ltd. | 2016-06-02 |
| CEREC SpeedGlaze (K160099) | Sirona Dental Systems GmbH | 2016-06-02 |
| ABC D-FLEX PROBE (K151229) | Conmed Corporation | 2016-06-02 |
| 16ch Tx/Rx Knee SPEEDER (K161193) | Quality Electrodynamics, LLC | 2016-06-02 |
| PowerGlide Pro Midline Catheter (K153280) | C.R. Bard, Inc. | 2016-06-02 |
| MTR550 (Tentative) Antimicrobial Silver Wound Gel (K152519) | Medical Technology Research, Inc. | 2016-06-02 |
| NEPHROCHECK Test Kit, ASTUTE140 Meter, NEPHROCHECK Liquid Controls Kit, NEPHROCHECK Calibration Verification (Cal Vers) Kit (K153165) | Astute Medical, Inc. | 2016-06-01 |
| FirstSense Breast Exam (K160573) | First Sense Medical, LLC | 2016-06-01 |
| EV1000 Clinical Platform with ClearSight Finger Cuff or ClearSight System, EV1000 Clinical Platform (K160552) | Edwards Lifesciences, LLC | 2016-06-01 |
| DCI Edge Dental Chair with Operative Unit (K151987) | Dci | 2016-06-01 |
| Hermes Medical Imaging Suite v5.6 (K153056) | Hermes Medical Solutions AB | 2016-06-01 |
| Hospira Administration Sets (K160870) | Hospira, Inc. | 2016-06-01 |
| VERIFY VH2O2 Indicator Tape (K160485) | STERIS Corporation | 2016-06-01 |
| AGE Automatic Upper Arm Blood Pressure Monitor (K153552) | Ageless Health Industrial Co., Ltd. | 2016-06-01 |
| Voyant Open Fusion Device (K153288) | Applied Medical Resources | 2016-06-01 |
| Additive Orthopaedics Hammertoe Correction System (K160264) | Additive Orthopaedics, LLC | 2016-06-01 |
| QUANTA Flash Scl-70, QUANTA Flash Scl-70 Calibrators, QUANTA Flash Scl-70 Controls (K152635) | Inova Diagnostics, Inc. | 2016-06-01 |
| Gemini Bonded Sterilization Wrap (K152458) | Medline Industries, Inc. | 2016-06-01 |
| NAR Sharps Shuttle; NAR Sharps Shuttle Pack of six (K152340) | North American Rescue, LLC | 2016-05-31 |
| Acclarix AX8 Diagnostic Ultrasound System (K161300) | Edan Instruments, Inc. | 2016-05-31 |
| Cirona 6400 (K161209) | Devon Medical Products | 2016-05-31 |
| IMMULITE 2000 Third Generation TSH, IMMULITE 2000 Free T4 (K160647) | Siemens Healthcare Diagnostics, Inc. | 2016-05-31 |
| CT/MR Compatible M.A.C. Interstitial GYN Template (K150979) | Mick Radio-Nuclear Instruments, Inc. | 2016-05-31 |
| Ez3D-i / E3 (K161246) | Ewoosoft Co., Ltd. | 2016-05-31 |
| FILASILK - Natural Non-absorbable Silk Surgical Suture, FILAMIDE - Non Absorbable polyamide surgical Sutures, MERICRON XL - Non Absorbable Polyester Surgical Suture, FILAPROP - Non Absorbable Polypropylene surgical Suture (K160623) | M/s. Meril Endo Surgery Private Limited. | 2016-05-31 |
| KARL STORZ Endoscopic ICG Imaging System (K152583) | KARL STORZ Endoscopy-America, Inc. | 2016-05-31 |
| CapSure Fixation System - Straight 5mm x 37 cm – 30 Permanent fasteners, CapSure Fixation System - Straight 5mm x 37 cm – 15 Permanent fasteners (K160900) | C.R. Bard, Inc. | 2016-05-31 |
| Cardiac Trigger Monitor, Cardiac & Regulatory Synchronization Monitor (K151781) | Ivy Biomedical Systems, Inc. | 2016-05-27 |
| BD Eclipse Hypodermic Needle (K161170) | Becton, Dickinson and Company | 2016-05-27 |
| NoCord (K152826) | Centrix, Inc. | 2016-05-27 |
| Glocyte Automated Cell Counter System (K152776) | Advanced Instruments, Inc. | 2016-05-27 |
| Digital Thermometer, Models MT-1027, MT-4127, MT-1032, MT-4132, MT-4333, MT-4326, MT-4726, MT-4335, MT-4735, MT-09, MT-30, MT-31, MT-36 (K153149) | Sejoy Electronics & Instruments Co., Ltd. | 2016-05-27 |
| 3mensio Workstation (K153736) | Pie Medical Imaging BV | 2016-05-27 |
| BIJOU Orthodontic Ceramic Bracket (K152167) | World Bio Tech Co., Ltd. | 2016-05-27 |
| neoBLUE® LED Phototherapy System (K160305) | Natus Medical Incorporated | 2016-05-27 |
| O-PEP (K150044) | Pari Respiratory Equipment, Inc. | 2016-05-27 |
| Si-Hy (olifilcon B) sperical silicone hydrogel soft contact lens, Si-Hy (olifilcon B) multifocal silicone hydrogel soft contact lenses, Si-Hy (olifilcon B) toric silicone hydrogel soft contact lens2/16/2016 (K160344) | Visco Vision, Inc. | 2016-05-26 |
| Stealth-Midas System (K160713) | Medtronic Powered Surgical Solutions | 2016-05-26 |
| ORAcollect.Dx (K152464) | DNA Genotek, Inc. | 2016-05-26 |
| Reveal LINQ (K160809) | Medtronic, Inc. | 2016-05-26 |
| Mariner Pedicle Screw System (K160902) | SeaSpine Orthopedics Corporation | 2016-05-26 |
| Stivax (K152571) | Biegler GmbH | 2016-05-26 |
| eSensor Warfarin Sensitivity Saliva Test (K152612) | Genmark Diagnostics, Incorporated | 2016-05-26 |
| Radiance Ultra Series ZeroWire Embedded (K161228) | Nds Surgical Imaging, LLC | 2016-05-26 |
| Yongchang Powder-Free Yellow Vinyl Patient Examination Gloves (K152818) | Ideal Plastic Co., Ltd. | 2016-05-26 |
| Auris Robotic Endoscopy System (ARES) (K152319) | Auris Surgical Robotics, Inc. | 2016-05-26 |
| Noxilizer Surgical Ruler (K160501) | Noxilizer, Inc. | 2016-05-26 |
| AxSOS 3Ti (K153379) | Stryker GmbH | 2016-05-26 |
| AdTec (K160393) | Aesculap, Inc. | 2016-05-26 |
| Biodesign Sling, Biodesign Plastic Surgery Matrix, Biodesign Anal Fistula Plug (K161221) | Cook Biotech Incorporated | 2016-05-26 |
| Seal Single-Use Biopsy Valve (K161167) | Endochoice, Inc. | 2016-05-26 |
| Z5 Slit lamp microscope, Z2 Slit lamp microscope (K152535) | Takagi Seiko Co., Ltd. | 2016-05-26 |
| MC BIO Supertack Tack 3mm, 4mm and 5mm (K151540) | Eli-Ka Technologies | 2016-05-26 |
| Threshold Pedicular Fixation System, Palisade Pedicular Fixation System (K160980) | Spineology, Inc. | 2016-05-26 |