| Varaya Sport (K150716) | Varaya Photoceuticals, LLC | 2015-12-08 |
| higi Station (K151127) | Higi Sh, LLC | 2015-12-08 |
| High Speed Handpieces and Accessories (K152146) | Codent Technical Industry Co., Ltd. | 2015-12-08 |
| neoV980 & neoV1470 Diode Lasers (K152722) | G.N.S Neolaser , Ltd. | 2015-12-08 |
| EVO platform (K152012) | Quanta System Spa | 2015-12-08 |
| Cytal Wound Matrix (K152721) | Acell, Inc. | 2015-12-08 |
| Dignitana AB DigniCap System (DEN150010) | Dignitana AB | 2015-12-08 |
| Suntanning Lamps (K152436) | Interlectric Corporation | 2015-12-07 |
| Houdini Catheter (K151896) | Cruzar Medsystems, Inc. | 2015-12-07 |
| ROI-C Titanium-Coated Implant System (K151934) | Ldr Spine USA | 2015-12-07 |
| Merit 20 mL Syringe (K152783) | Merit Medical Systems, Inc. | 2015-12-07 |
| ABL80 FLEX and ABL80 FLEX CO-OX (K151639) | Sendx Medical, Inc. | 2015-12-07 |
| Respire Blue Series-EF (K152292) | Respire Medical Holding | 2015-12-07 |
| XSTAT 30, 3-PACK, XSTAT 30, 1-PACK (K152624) | Revmedx, Inc. | 2015-12-07 |
| Vital Connect Platform, HealthPatch MD, VitalPatch (K152139) | Vitalconnect, Inc. | 2015-12-06 |
| KIRO Set (K152441) | Kiro Robotics S.L. | 2015-12-04 |
| INEX Absorbable Nasal Implant (K152958) | Spirox, Inc. | 2015-12-04 |
| Stingray LP Catheter (K152401) | Boston Scientific Corporation | 2015-12-04 |
| HMB32 (K150966) | Haemopharm Biofluids S.R.L. | 2015-12-04 |
| Implant Studio 2015 (K152078) | 3Shape Medical A/S | 2015-12-04 |
| Steerable Intracardiac Catheter Introducer Kit and Transseptal Needle (K151936) | Synaptic Medical Limited | 2015-12-04 |
| EmbryoSlide Culture Dish (K150961) | Vitrolife A/S | 2015-12-04 |
| Upcera Dental Zirconia Blank for Aesthetic Restoration (K152175) | Liaoning Upcera Co., Ltd. | 2015-12-04 |
| COHITECH NON APPLICATOR ORGANIC COTTON TAMPONS;COHITECH COMPACT APPLICATOR ORGANIC COTTON TAMPONS (K152284) | Cotton High Tech S.L. | 2015-12-04 |
| FastFrame External Fixation System - Distal Radius (K152484) | Zimmer, Inc. | 2015-12-04 |
| iHealth Align Gluco-Monitoring System, iHealth BG5 wireless Smart Gluco-Monitoring System, iHealth BG5L wireless Smart Gluco-Monitoring System (K150833) | Andon Health Co, Ltd. | 2015-12-04 |
| kVue Encompass SRS Insert (Encompass Insert), Encompass SRS Standalone (Encompass Device), Encompass SRS MRI Immobilization device (Encompass MRI Device, Encompass Intracranial Fibreplast Variable Perf Head Only Open View System, Encompass Intracranial Fibreplast Variable Perf Head Only Open View with 119 mm opening (K152321) | Qfix | 2015-12-04 |
| NMI Port, NMI Port II (K153228) | Navilyst Medical, Inc. | 2015-12-04 |
| Capiox RX Hollow Fiber Oxygenator with/without Hardshell Reservoir (K153213) | Terumo Cardiovascular Systems Corporation | 2015-12-03 |
| CORE FM System, Patient Interface Module (OPIM), Hemodynamic Converter Box (K152582) | Volcano Corporation | 2015-12-03 |
| SYDNEY IVF EMBRYO BIOPSY MEDIUM (K152904) | William A. Cook Australia Pty. , Ltd. | 2015-12-03 |
| Xpert Flu+RSV Xpress, Xpert Nasopharyngeal Sample Collection Kit, GeneXpert Xpress System (GX-I) (K151226) | Cepheid | 2015-12-03 |
| Disposable Endoscope Valves Set A (K151714) | Wilson Instruments (Shanghai) Company Limited | 2015-12-03 |
| Portable X-ray System (Model: MINIX-V / MINIX-S) (K152859) | Digimed Co., Ltd. (Digimed Corporation Until 31/12/2012) | 2015-12-03 |
| Zero-P Natural Plate System (K152239) | Synthes (Usa), LLC | 2015-12-02 |
| Reaxon Plus (K143711) | Medovent GmbH | 2015-12-02 |
| Terumo Capiox SX18 Oxygenator/ Hardshell Reservoir, Terumo Capiox SX18 Oxygenator/ Hardshell Reservoir with Xcoating, Terumo Capiox SX25 Oxygenator/Hardshell Reservoir, Terumo Capiox SX25 Oxygenator/Hardshell Reservoir with Xcoating (K153140) | Terumo Cardiovascular Systems Corp. | 2015-12-02 |
| PEBA Anchor/Suture Combination, 2.0mm Mini-Tac Anchor, Model 10-1629-01, Modification to Twinfix Ti Quick-T, Twinfix FT PK, Twinfix Ultra Ti, Twinfix Ultra PK, Twinfix Ultra HA Suture Anchors, FOOTPRINT Ultra OK Suture Anchors, BIORAPTOR 2.9 Suture Anchor, BIORAPTOR 2.3 PK Suture Anchor, OSTEORAPTOR Suture Anchor, BIORAPTOR Knotless Suture Anchor, HEALICOIL PK Suture Anchor (formerly Next Generation Fully Threaded Suture Anchor), Bioraptor Curved 2.3 PK Suture Anchors (K152566) | Smith & Nephew, Inc. | 2015-12-02 |
| Capiox Advance Hardshell Reservoir (K153143) | Terumo Cardiovascular Systems Corporation | 2015-12-02 |
| Universal Spike (K150787) | B.Braun Medical, Inc. | 2015-12-02 |
| XIA 4.5 Spinal Fixation System, Power Adaaptor Instrument Accessory (K152632) | Stryker Corporation | 2015-12-02 |
| Attachable Cath Lab Hemostasis Valve (K152528) | Galt Medical Corp. | 2015-12-02 |
| EnFocus 2300, EnFocus 4400 (K150722) | Bioptigen, Inc. | 2015-12-02 |
| Lantern Delivery Microcatheter (K152840) | Penumbra, Inc. | 2015-12-02 |
| RX-FIX Mini Rail External Fixator (K150640) | Wrightmedicaltechnologyinc | 2015-12-01 |
| Biodenta Customized Abutment - Titanium (K151295) | Biodenta Swiss AG | 2015-12-01 |
| Gmate Origin Blood Glucose Monitoring System (K151658) | Philosys, Inc. | 2015-12-01 |
| Video Colposcope (K151878) | Edan Instruments, Inc. | 2015-12-01 |
| NuVasive Foundation-LL System (K152943) | Nu Vasive, Incorporated | 2015-12-01 |
| NuVent EM Sinus Dilation System (K152121) | Medtronic Xomed, Inc. | 2015-12-01 |
| PCT System (K152211) | Centinel Spine, Inc. | 2015-12-01 |
| CDC Human Influenza Virus Real- time RT-PCR Diagnostic Panel, Influenza A/H5 Subtyping (K153148) | Centers For Disease Control and Prevention (CDC) | 2015-12-01 |
| 3M Attest Rapid Readout Biological Indicator 1295 (K152060) | 3M Company | 2015-12-01 |
| Glidesheath (K152173) | Terumo Medical Corporation | 2015-12-01 |
| Adler MicroMed Laser Surgery Fibers (K152417) | Adler Micromed, Inc. | 2015-12-01 |
| Vonflex S Putty (K152518) | Vericom Co., Ltd. | 2015-11-30 |
| Aquilion ONE Vision with FIRST 1.0 (CCRS-001A) (K151673) | Toshibamedical Systems Corporation | 2015-11-27 |
| Rusch Safety Silk Pediatric Series Oral/Nasal Tracheal Tube (K150603) | Teleflexmedical, Inc. | 2015-11-27 |
| Stay Fresh Hydrocolloid dressing (K151186) | Sarasota Medical Products, Inc. | 2015-11-27 |
| Powder Free Vinyl Patient Examination Gloves, Clear (non-colored) (K151679) | Heze Yuze Glove Co., Ltd. | 2015-11-27 |
| SensiCare Sterile Powder-Free Polymer Coated Polyisoprene Surgical glove, With Aloe Vera (Tested of Use with Chemotherapy Drugs) -Natural Color (K150238) | Medline Industries, Inc. | 2015-11-27 |
| Picasso Plus, Picasso Lite Plus (K152939) | Amd Group, LLC | 2015-11-25 |
| VidiStar HeartView (K152822) | Vidistar, LLC | 2015-11-25 |
| SMV Scientific Bone Plate and Screw System (K152000) | Smv Scientific | 2015-11-25 |
| NET Brand Small Fragment and Large Fragment Osteosynthesis Plating System, NET Brand of DHS/DCS Plating System (K150561) | Narang Medical Limited | 2015-11-25 |
| Cortisol Saliva Luminescence Immunoassay (K150528) | Ibl International GmbH | 2015-11-25 |
| 4Sight (K152573) | Accutome, Inc. | 2015-11-25 |
| OT EQUATOR (K142211) | Rhein'83 Srl | 2015-11-25 |
| HEARTWAY Power Mobility Scooter (K151656) | Heartway Medical Products Co., Ltd. | 2015-11-25 |
| XIDF-AWS801, Angio Workstation, V6.20 (K152785) | Toshibamedical Systems Corporation | 2015-11-25 |
| SELF- COMPRESSIVE SCREW (K153182) | Neosteo | 2015-11-25 |
| LARIAT RS Suture Delivery Device (K153096) | Sentreheart, Inc. | 2015-11-25 |
| Contour Next USB Blood Glucose Monitoring System (K150942) | Bayer Healthcare | 2015-11-25 |
| Zimmer NexGen Complete Knee Solution Tibial and Femoral Augments (K152494) | Zimmer, Inc. | 2015-11-25 |
| SonicLift (K150077) | Pretika Corporation | 2015-11-25 |
| Tyber Medical MST Trauma Screw (K153180) | Tyber Medical, LLC | 2015-11-25 |
| Carestream DRX-1 System with DRX Plus 4343 Detectors (K153142) | Carestream Health, Inc. | 2015-11-25 |
| Permanent Beacon Transponder, Soft Tissue Beacon Transponder, Beacon Care Package - Soft Tissue (17G) (K152761) | Varian Medical Systems, Inc. | 2015-11-25 |
| DERMABOND PRINEO Skin Closure System (K152490) | ETHICON, Inc. | 2015-11-25 |
| CORVUS Radiation Therapy Planning System (K151469) | Best Nomos | 2015-11-25 |
| Avex CX2 (K152779) | Opal Orthodontics by Ultradent Products | 2015-11-25 |
| G3¿ Active Plate® Large Fragment System (K152242) | Genesis Fracture Care, Inc. | 2015-11-24 |
| Zimmer Plates and Screws System (ZPS) Sterile 2.7mm Cortical Screws (K152841) | Zimmer, Inc. | 2015-11-24 |
| OES ELITE Telescopes, Protective Tube (K151191) | Olympus Winter & Ibe GmbH | 2015-11-24 |
| OsteoCool V-3 RF Ablation System (K152057) | Baylis Medical Company, Inc. | 2015-11-24 |
| PENTAX Medical EPK-i7010 Video Processor with GI Family (K150618) | Pentax of America, Inc. | 2015-11-24 |
| AUTOLoader, and NOVA view with models: ALDR1000, AND NV2000 (K153150) | Inova Diagnostics, Inc. | 2015-11-24 |
| Edwards eSheath Introducer Set (K152225) | Edwards Lifesciences | 2015-11-24 |
| SD GlucoNFC Blood Glucose Monitoring System, SD GlucoNFC Multi Blood Glucose Monitoring System (K151265) | Sd Biosensor | 2015-11-24 |
| Lumipulse G HE4 Immunoreaction Cartridges, Lumipulse G HE4 Calibrators (K151378) | Fujirebio Diagnostics,Inc. | 2015-11-24 |
| Intelliwave4 with HPT, Silicone Hydrogel Daily Wear Soft Contact Lens (safrofilcon A) (K152046) | Art Optical Contact Lens, Inc. | 2015-11-24 |
| HardyDisk AST Ceftolozane/Tazobactam, (30/10ug)- C/T40 (K152846) | Hardy Diagnostics | 2015-11-24 |
| SilverCoat Silicone Foley Catheter (K150550) | Covalontechnologies, Inc. | 2015-11-24 |
| SOMATOM Force, SOMATOM Definition Flash, SOMATOM Definition Edge, SOMATOM Definition AS/AS+, SOMATOM Definition AS Open, SOMATON Emotion 6/16, SOMATOM Sensation 64/Sensation Cardiac , SOMATOM Perspective SOMATOM Scope/ Scope Power (K142955) | Siemens Medical Solutions USA, Inc. | 2015-11-24 |
| AVAflex Vertebral Balloon System (K151125) | Care Fusion | 2015-11-24 |
| LUXATOR LX HANDPIECE (K133178) | Directa AB | 2015-11-24 |
| HardyDisk AST Ceftazidime/Avibactam, (30/20ug)-CZA50 (K152838) | Hardy Diagnostics | 2015-11-24 |
| YAMAHACHI PMMA DISKS (K151764) | Yamahachi Dental Products USA, Inc. | 2015-11-23 |
| Star+ VPS Scannable Impression Material (K152349) | Danville Materials, LLC | 2015-11-23 |
| Arthrex Univers Apex, Size 5 Stem (K153115) | Arthrex, Inc. | 2015-11-23 |