| Bio2 CLM BG Bioactive Scaffold (K152589) | Bio2 Technologies, Inc. | 2016-01-12 |
| ImplantMax Software (K151152) | Saturn Imaging, Inc. | 2016-01-12 |
| MUSE Cardiology Information System (K152993) | Ge Medical Systems Information Technologies, Inc. | 2016-01-12 |
| INFX-8000V, V6.20 (K152696) | Toshibamedical Systems Corporation | 2016-01-12 |
| Endoscope Sterilization Tray (K151450) | Intuitive Surgical, Inc. | 2016-01-12 |
| K-Y Marilyn Pleasure Gel (K151884) | Reckitt Benckiser, LLC | 2016-01-11 |
| Universa Soft Ureteral Stents and Stent Sets (K151051) | Cook Incorporated | 2016-01-11 |
| Fortress Introducer Sheath SYstem (K153197) | Contract Medical International, GmbH | 2016-01-11 |
| Sysmex Automated Blood Coagulation Analyzer CS-5100 (K150678) | Siemens Healthcare Diagnostic Products GmbH | 2016-01-11 |
| PURE Ceramic Implants (K151328) | Straumann USA | 2016-01-11 |
| Sapphire (K152356) | Respironics, Inc. | 2016-01-08 |
| MyGlucoHealth Wireless System (K143169) | Entra Health Systems | 2016-01-08 |
| VINTAGE LD (K152392) | Shofu Dental Corporation | 2016-01-08 |
| Unidrive S III ENT 40701601-1 with KARL STORZ-SCB, DrillCut-X II Shaver Handpiece, High Speed EC Micromotor II for use with INTRA Drill Handpieces (K150969) | Karl Storz Endoscopy America, Inc. | 2016-01-08 |
| Direct HDL Cholesterol (HDL) (K153435) | Randox Laboratories, Ltd. | 2016-01-08 |
| BioBridge Collagen Matrix (K151083) | Fibralign Corporation | 2016-01-08 |
| LONG SHEATH OR LS, 70 CM, LONG SHEATH OR LS, 80 CM, LONG SHEATH OR LS, 90 CM (K152876) | Tni Manufacturing, Inc. | 2016-01-08 |
| MRI Dynamic Analysis Plus (K153039) | Esaote, S.p.A. | 2016-01-08 |
| Embryo Biopsy Pipette, Polar Body Biopsy Pipette, Testicular Sperm Extraction Pipette (K151018) | Cook Incorporated | 2016-01-08 |
| ONLINE TDM Vancomycin Gen.3 (K152245) | Roche Diagnostics Operations (Rdo) | 2016-01-08 |
| VuePoint OCT System (K153336) | Nu Vasive, Incorporated | 2016-01-07 |
| Treace Medical Concepts (TMC) Plating System (K153531) | Treace Medical Concepts, Inc. | 2016-01-07 |
| Coldplay CryoBalloon® Ablation System (K153541) | C2 Therapeutics, Inc. | 2016-01-07 |
| ConforMIS iTotal Posterior Stabilized Knee Replacement System (K153217) | Conformis, Inc. | 2016-01-07 |
| Volpara Imaging Software (K153427) | Matakina Technology, Ltd. | 2016-01-07 |
| Tellos ISQ Buddy (K143445) | Tellos Medical AB | 2016-01-07 |
| Full Automatic (NIBP) Blood Pressure Monitor (K153214) | Health & Life Co., Ltd. | 2016-01-07 |
| Sterile High-pressure Angiographic Syringes for Single-use (K151960) | Shenzhen Baoan Medical Supplies Co., Ltd. | 2016-01-07 |
| TIVA¿ (K152924) | Velano Vascular | 2016-01-07 |
| Edwards Balloon Catheter (K153069) | Edwards Lifesciences | 2016-01-07 |
| Well Lead Ureteral Access Sheath (K151084) | Well Lead Medical Co., Ltd. | 2016-01-07 |
| ClariVein IC (K153502) | Vascular Insights, LLC | 2016-01-06 |
| Amendia Interbody Fusion Devices (K151310) | Amendia, Inc. | 2016-01-06 |
| Fingertip Pulse Oximeters M70, M70A, M70B, M70C, M70D (K151287) | Guangdong Biolight Meditech Co., Ltd. | 2016-01-06 |
| Galaxy UNYCO System (K153233) | Orthofix Srl | 2016-01-06 |
| KYPHON HV-R Fenestrated Screw Cement, CD HORIZON Fenestrated Screw Set (K152604) | Medtronic Sofamor Danek USA, Incorporated | 2016-01-06 |
| iRestore (K151662) | Freedom Laser Therapy, Inc. | 2016-01-06 |
| Medline ReNewal Reprocessed Endopath Endoscopic Instruments (K152313) | Surgical Instrument Services and Savings, Inc. | 2016-01-06 |
| Xscribe Stress Exercise Testing Systems, Q-Stress Stress Exercise Testing Systems (K152944) | Mortara Instrument, Inc. | 2016-01-06 |
| OTELO LL (K151104) | Spineart | 2016-01-06 |
| VasoStat Hemostasis Device (K153259) | Forge Medical, Inc. | 2016-01-06 |
| Piccolo Composite® Nailing System (K153536) | CarboFix Orthopedics , Ltd. | 2016-01-06 |
| Quell (K152954) | Neurometrix, Inc. | 2016-01-05 |
| VENTURI MiNO TG600/14 (K143004) | Talley Group, Ltd. | 2016-01-05 |
| K2M Fenestrated Tap System (K152872) | K2m | 2016-01-05 |
| FloSure Ventilation Patch (K150459) | Simex Medizintechnik GmbH | 2016-01-05 |
| New Deantronics Disposable Laparoscopic Electrodes, non-coated, and coated (K153265) | New Deantronics Taiwan , Ltd. | 2016-01-05 |
| Zenysis Short-Term Dialysis Catheter (K153190) | C.R. Bard, Inc. | 2016-01-05 |
| SoloPath Re-Collapsible Access System (K152498) | Onset Medical Corporation | 2016-01-05 |
| Immunalysis Benzodiazepines Urine Enzyme Immunoassay, Immunalysis Multi-Drug Calibrators (K151771) | Immunalysis Corporation | 2016-01-05 |
| MyOn HC Manual Wheelchair (K152536) | Invacare Corporation | 2016-01-05 |
| Erchonia PL Touch (K153052) | Erchonia Corporation | 2016-01-04 |
| ROSA Spine (K151511) | Medtech S.A | 2016-01-04 |
| LOGIQ V1/ LOGIQ V2 (K153037) | GE Medical Systems Ultrasound & Primary Care Diagnostics, LLC | 2016-01-04 |
| InMode FRF Applicator (K151273) | Inmode MD , Ltd. | 2016-01-04 |
| Ez3D Plus (K152746) | Ewoosoft Co., Ltd. | 2016-01-03 |