| CG+ Arrow PICC powered by Arrow VPS Stylet PLUS and Arrow VPS Stylet PLUS (K153487) | Arrow International, Inc. (Subsidiary of Teleflex, Inc.) | 2016-02-04 |
| ENCOMPASS Eagle 3D CBCT/Panoramic/Cephalometric Dental X-Ray (K152489) | Panoramic Corp. | 2016-02-04 |
| CorMatrix Tyke (K152127) | Cormatrix Cardiovascular, Inc. | 2016-02-04 |
| Rampart A Lumbar Interbody Fusion Device (K153082) | Spineology, Inc. | 2016-02-04 |
| DermaScalp Laser Cap (K152587) | Dermascalp, LLC | 2016-02-04 |
| The Entasis Dual-Lead Sacroiliac Implant (K152237) | Corelink, LLC | 2016-02-04 |
| Comprehensive SRS/Nexel Elbow (K153398) | Biomet Manufacturing Corp | 2016-02-03 |
| Adaptivo (K152994) | Aurora Technology Development, LLC | 2016-02-03 |
| SUNTEC Mechanical Wheelchair, model ST-WL-1000 (K152878) | Danyang Suntec Auto Parts Co., Ltd. | 2016-02-03 |
| AIR-FLOW handy 3.0 PLUS (K151912) | E.M.S Electro Medical Systems S.A | 2016-02-03 |
| Navigation Instruments (K153203) | Globus Medical, Inc. | 2016-02-03 |
| Synapse PACS (K160108) | Fujifilm Medical Systems U.S.A, Inc. | 2016-02-03 |
| M-Fix Acromioclavicular Device (K153211) | Coracoid Solutions, Inc. | 2016-02-02 |
| HF1202H PowerPlus Portable X-ray Equipment (K153059) | Minxray, Inc. | 2016-02-02 |
| WS80A Diagnostic Ultrasound System (K153529) | Samsung Medison Co., Ltd. | 2016-02-02 |
| iHealth Track Blood Pressure Monitor (K160014) | Andon Health Co, Ltd. | 2016-02-02 |
| Top Fine Pen Needle (K152410) | Medexel Co.,Ltd | 2016-02-02 |
| ArcScan Insight 100 (K153416) | Arcscan, Inc. | 2016-02-02 |
| In2Bones Kirschner wire (K153204) | In2bones Sas | 2016-02-01 |
| Hansen Medical Magellan Robotic Catheter eKit (K153304) | Hansen Medical, Inc. | 2016-02-01 |
| Snowden-Pencer Ergonomic Take-Apart In-Line and Pistol Grip Laparoscopic Instruments (K151036) | Carefusion 2200, Inc. | 2016-02-01 |
| PacEndo EDTA (K153528) | Pac-Dent International, Inc. | 2016-02-01 |
| Image1 SPIES System (K160044) | Karl Storz Endoscopy America, Inc. | 2016-02-01 |
| YAHUA Spinal System (K152324) | Beijing Weigao Yahua Artificial Joint Development Co. , Ltd. | 2016-02-01 |
| C2 NerveMonitor System (K152505) | Inomed Medizintechnik GmbH | 2016-02-01 |
| Diazyme Fibrinogen Assay, Diazyme Fibrinogen Calibrator Set, Diazyme Fibrinogen Control Set (K143470) | Diazyme Laboratories | 2016-01-31 |
| ROSC-U Mini Chest Compressor (RMCC) (K153628) | Resuscitation International, LLC | 2016-01-30 |
| Firebird Spinal Fixation System, Phoenix MIS Spinal Fixation System (K153428) | Orthofix, Inc. | 2016-01-29 |
| URight Hemoglobin A1c system, FORA A1c System (K142664) | Taidoc Technology Corporation | 2016-01-29 |
| ScandiDos Delta4 Discover, Alternative Trade Name: ScandiDos Delta4 Discover+ (K151426) | Scandidos AB | 2016-01-29 |
| EYE-SYNC (K152915) | Syncthink, Inc. | 2016-01-29 |
| KLOCKNER DENTAL IMPLANT ABUTMENTS (II) (K151194) | SOADCO, S.L. | 2016-01-29 |
| ATLANTIS Crown (K152247) | Dentsply International, Inc. | 2016-01-29 |
| Sonendo Gentle Wave System (K153157) | Sonendo, Inc. | 2016-01-29 |
| TriMed Humeral Supracondylar Fixation System (K151735) | TriMed, Inc. | 2016-01-29 |
| IntelliCuff (K150893) | Hamilton Medical AG | 2016-01-29 |
| PASS OCT Patient Specific Rods (K153169) | Medicrea International | 2016-01-29 |
| SD5 & SD6 Ultrasonic Tabletop Doppler (K153475) | Edan Instruments, Inc. | 2016-01-29 |
| COALITION Spacers (K151939) | Globus Medical, Inc. | 2016-01-29 |
| SPIWay Endonasal Access Guide (K153686) | Spiway, LLC | 2016-01-28 |
| Half Dome Posterior Lumbar Interbody System (K152512) | Astura Medical | 2016-01-28 |
| Adjustable Fixation Device (K153186) | Arthrocare Corp. | 2016-01-28 |
| TACVAC (K153459) | Athena Gtx | 2016-01-28 |
| PICO Single Use Negative Pressure Wound Therapy System (K151436) | Smith & Nephew Medical, Ltd. | 2016-01-28 |
| CG+ Arrow JACC powered by Arrow VPS Stylet, CG+ Arrow JACC (K153423) | Arrow International, Inc. (Subsidiary of Teleflex, Inc.) | 2016-01-28 |
| Seneka II Polyscrew Pedicle Fixation System (K153525) | Senecka Spine | 2016-01-28 |
| Cable-Ready Cable Grip System: Cable-Ready Bone Plate System (K151716) | Zimmer, Inc. | 2016-01-28 |
| VK-3 Verification Kit, VK-4 Verification Kit, VK-R5 Verification Kit, VK-R7 Verification Kit, VK-Crea Verification Kit (K153712) | Radiometer America, Inc. | 2016-01-28 |
| QUAD Dental Implants and Prostheses (K152188) | Dentack Impants, Ltd. | 2016-01-28 |
| dynaMX Tabbed Staple (K153129) | Mx Orthopedics, Corp. | 2016-01-28 |
| Total Bilirubin (K152344) | Randox Laboratories Limited | 2016-01-28 |
| BPhase, HPO Exotic, LPI, LP2, LP3, Mastersun 360, Mastersun 360 New Reflector, Vega Lux (K152233) | Sportarredo Group S.C. | 2016-01-27 |
| StatStrip Xpress 2 Glucose Hospital Meter System (K152986) | Nova Biomedical Corporation | 2016-01-27 |
| VistaCam iX Proof (K150672) | Durr Dental AG | 2016-01-27 |
| Holter System (K151787) | Edan Instruments, Inc. | 2016-01-27 |
| 8F FlowGate2 Balloon Guide Catheter (K153729) | Concentric Medical | 2016-01-27 |
| AtriClip LAA Exclusion System with preloaded Gillinov-Cosgrove PRO V Clip (K153500) | AtriCure, Inc. | 2016-01-27 |
| Sydney IVF Follicle Flush Buffer, Sydney IVF Fertilization Medium, Sydney IVF Cleavage Medium, Sydney IVF Blastocyst Medium (K153290) | William A. Cook Australia Pty. , Ltd. | 2016-01-27 |
| Cervello STIM (K151354) | Blackrock Neuromed | 2016-01-27 |
| Sydney IVF Hyaluronidase (K151367) | William A. Cook Australia Pty. , Ltd. | 2016-01-27 |
| PATIENT MONITORS VARIOUS MODELS (K151812) | Philips Medical Systems | 2016-01-26 |
| Discovery 24 (K150498) | Brainmaster Technologies, Inc. | 2016-01-26 |
| Antistatic Compact Space Chamber (K143615) | Medical Developments International Limited | 2016-01-26 |
| Vinyl patient examination glove, Powder Free (K153159) | Xingyuan Plastic Products Co., Ltd. | 2016-01-26 |
| Tenodesis screw system (K151701) | Normed Medizin-Technik GmbH | 2016-01-26 |
| Sysmex Automated Blood Coagulation Analyzer CS-2100i (K151259) | Siemens Healthcare Diagnostics Products GmbH | 2016-01-26 |
| CenterCross Ultra Catheter (K152456) | Roxwood Medical, Inc. | 2016-01-26 |
| Medline ReNewal Reprocessed Harmonic ACE + Shears without Adaptive Tissue Technology (K151405) | Surgical Instrument Services and Savings(Dba Medline Renewal | 2016-01-26 |
| Fusion Bx (K153166) | Focal Healtcare, Inc. | 2016-01-25 |
| FacetBRIDGE System (K152137) | Ldr Spine USA | 2016-01-25 |
| Perla Posterior Cervico-Thoracic Fixation system (K153386) | Spineart | 2016-01-25 |
| ImagenSPECT (K152503) | Cardiovascular Imaging Technologies | 2016-01-25 |
| Ellipse Supplemental Instrument Trays (K151594) | Ellipse Technologies, Incorporated | 2016-01-25 |
| DG PACS (K152977) | Dicom Grid, Inc. | 2016-01-25 |
| Magicore System (K152520) | Innobiosurg Co., Ltd. | 2016-01-25 |
| Evogue Dental Unit (K152100) | Takara Belmont Corporation | 2016-01-22 |
| ASAHI Caravel (K152447) | Asahi Intecc Co., Ltd. | 2016-01-22 |
| Solo-Dex Fascile Continuous Peripheral Nerve Block Catheter and Needle Kit (K151072) | Solo-Dex, Inc. | 2016-01-22 |
| SonarMed AirWave, Airway Monitoring System (K143042) | Sonarmed, Inc. | 2016-01-22 |
| FD TENS 2090, FD TENS 2095 (K152676) | Fuji Dynamics , Ltd. | 2016-01-22 |
| PW Guidewires (K152497) | Tatara Vascular, LLC | 2016-01-22 |
| CT Expres 3D Contrast Media Delivery System, Bottle Spike Type B, Day Set III HP, Patient Set (K151048) | Bracco Injeneering | 2016-01-22 |
| DirectLink ICP Module, DirectLink ICP Extension Cable, Patient Monitor Interface Cables (K152670) | Medos International SARL | 2016-01-22 |
| TAURUS C1 (K151996) | Shinhung Company, Ltd. | 2016-01-22 |
| Ponto Bone Anchored Hearing System (K152820) | Oticon Medical AB | 2016-01-22 |
| Crosperio RX PTA Balloon Dilatation Catheter (K152887) | KANEKA Corporation | 2016-01-22 |
| VersaOne Bladed Trocar 5mm (K152149) | Covidien | 2016-01-22 |
| MicroPlex Coil System (MCS), Hydrocoil Embolic System (HES) (K153594) | MicroVention, Inc. | 2016-01-22 |
| Stryker Neptune E-SEP Smoke Evacuation Pencil (K153679) | Stryker Corporation | 2016-01-22 |
| General & Plastic Surgery Instruments (K152400) | Sontec Instruments, Inc. | 2016-01-22 |
| Livewire Electrophysiology Catheter (K151617) | Surgical Instrument Service and Savings Inc.(Dba Medline Ren | 2016-01-22 |
| Crosstella RX Balloon Dilatation Catheter (K152873) | KANEKA Corporation | 2016-01-22 |
| POCKET NEB (K142541) | Microvaper Devices | 2016-01-22 |
| Mepiseal Soft Silicone Sealant (K152741) | Molnlycke Health Care Us, LLC | 2016-01-22 |
| Discovery NM/CT 670 CZT (K153402) | GE Healthcare | 2016-01-21 |
| Grasping Forceps (K152802) | Micro-Tech (Nanjing) Co., Ltd. | 2016-01-21 |
| AirLife Infant Heated Wire Circuit (K151303) | Care Fusion | 2016-01-21 |
| Shape-HF Cardiopulmonary Testing System (K150888) | Shape Medical Systems, Inc. | 2016-01-21 |
| Carestation 620/650/650C (K151570) | Datex-Ohmeda, Inc. | 2016-01-21 |
| HI VISION ASCENDUS, HV ASCENDUS, ASCENDUS (K153421) | Hitachi Aloka Medical America, Inc. | 2016-01-21 |