| Internal Joint Stabilizer - Elbow (K153208) | Skeletal Dynamics, LLC | 2015-12-31 |
| Visions PV .035 Digital IVUS Catheter (K153094) | Volcano Corporation | 2015-12-31 |
| Ascent 3D (K150585) | CAO Group, Inc. | 2015-12-31 |
| Giraffe Incubator Carestation CS1 (K152809) | Ohmeda Medical, A Division of Datex-Ohmeda, Inc. | 2015-12-31 |
| KEELER DISPOSABLE TONOMATE, KEELER DISPOSABLE TONOMATE, BOX OF 100 (K152644) | Keeler Limited | 2015-12-31 |
| Ageless Health Medical Digital Thermometer (K152508) | Dongguan Ageless Health Industrial Co., Ltd. | 2015-12-31 |
| Bio2 Fusion Implant System (K151876) | Bio2 Technologies, Inc. | 2015-12-30 |
| MedActive Oral Gel and Spray (K152201) | Medactive Oral Pharmaceuticals, LLC | 2015-12-30 |
| Beacon Fine Needle Fiducial System (K152586) | Covidien, LLC | 2015-12-30 |
| CD HORIZON Spinal System, IPC POWEREASE System (K153463) | Medtronic Sofamor Danek USA, Inc. | 2015-12-30 |
| Arsenal Spinal Fixation System (K152968) | Alphatec Spine, Inc. | 2015-12-30 |
| SONILASE BLUE, SONILASE BLUE-CLEAN, SONILASE BLUE-UV CLEAN PLUS (K152889) | Biorenew Labs, LLC | 2015-12-30 |
| VITA VM LC Flow (K152373) | Vita Zahnfabrik H.Rauter GmbH & Co. | 2015-12-30 |
| HumanPen Ergo II (K151686) | Eli Lilly and Company, Inc. | 2015-12-30 |
| Cable-Ready® Cable Grip System: Cable-Ready® GTR System, Cable-Ready® 1.8mm Cerclage Cables (K151907) | Zimmer, Inc. | 2015-12-30 |
| Navigator Aesthetic Delivery System (K151255) | Carticept Medical, Inc. | 2015-12-30 |
| iHearTest (K151025) | Ihear Medical, Inc. | 2015-12-29 |
| HELIXAR ELECTROSURGICAL GENERATOR WITH ARGON BEAM COAGULATION, HELIXAR MOBILE PEDESTAL (K152860) | Conmed Corporation | 2015-12-29 |
| SpectraShield 9500 Surgical N95 Respirator (K150729) | Nexera Medical, Inc. | 2015-12-29 |
| Traxcess Pro 14 Guidewire (K153053) | MicroVention, Inc. | 2015-12-29 |
| VisualEyes (K152112) | Interacoustics A/S | 2015-12-29 |
| Luvena Enhanced Personal Moisturizer, Luvena Enhanced Personal Lubricant (K150841) | Laclede, Inc. | 2015-12-29 |
| PediatrOS RigidTack/FlexTack (K151762) | Merete Medical GmbH | 2015-12-28 |
| Advanced Imaging Modality (AIM) Sterilization Tray, Endoscope and Camera Sterilization Tray, Camera Sterilization Tray (K152951) | Paragon Medical, Inc. | 2015-12-28 |
| Asnis JFX System (K153154) | Stryker Trauma AG | 2015-12-28 |
| Solution Administration Sets with 0.2 Micron Filter (K153158) | Baxter Healthcare Corporation | 2015-12-28 |
| Intellijoint HIP(tm) System (K151364) | Intellijoint Surgical, Inc. | 2015-12-28 |
| Myray- HYPERION X5 (K152162) | Cefla S.C. | 2015-12-24 |
| Powder Free Nitrile Examination Glove (Blue) With Low Dermatitis Potential Claim and with tested for Use with Chemotherapy Drugs (K152542) | Riverstone Resources Sdn Bhd | 2015-12-24 |
| MAGNETOM Amira (K152283) | Siemens Medical Solutions USA, Inc. | 2015-12-24 |
| BrainPort V100 (K152851) | Wicab, Inc. | 2015-12-24 |
| CareView 1800L (K153492) | Careray Digital Medical System Co., Ltd. | 2015-12-24 |
| cNEP Airway (DEN140024) | Sommetrics | 2015-12-23 |
| 2-in-1 Abdominal Muscle Training & Back Pain Relief System (K152128) | Tohkai Precision Electrical Manufactory (Shenzhen) Limited | 2015-12-23 |
| SalivaMAX (K152406) | Forward Science, LLC | 2015-12-23 |
| Solitaire Platinum Revascularization Device (K153071) | Micro Therapeutics, Inc. d/b/a ev3 Neurovascular | 2015-12-23 |
| INTEGRA TITAN Modular Total Shoulder System Fin-Lock Glenoid (K152047) | Ascension Orthopedics | 2015-12-23 |
| L-Mesitran Dressing Family II- Soft and Tulle (K150676) | Theo Manufacturing BV | 2015-12-23 |
| BTM Wound Dressing (K142879) | Polynovo Biomaterials Pty, Ltd. | 2015-12-23 |
| Medical Diode Laser Systems (K151890) | Wuhan Gigaa Optronics Technology Co., Ltd. | 2015-12-23 |
| Expression MR400 MRI Patient Monitoring System (K152330) | Invivo Corporation | 2015-12-23 |
| ENDOPLUS hand-held laparoscopic instruments (K151567) | Endoplus | 2015-12-23 |
| MammoGRIP (K152038) | Women'S Imaging Solutions Enterprises, LLC | 2015-12-22 |
| Cellvizio 100 Series System with Confocal Miniprobes (K150831) | Mauna Kea Technologies | 2015-12-22 |
| Rectangular Corpectomy Cage (K152460) | Amendia, Inc. | 2015-12-22 |
| PRECICE Trauma Nail System (K152370) | Ellipse Technologies, Incorporated | 2015-12-22 |
| SW v3.5 Install Kit, CORE Mobile, SW v3.5 Install Kit, CORE, SW v3.5 Install Kit, s5iz (K153369) | Volcano Corporation | 2015-12-22 |
| Philips Eleva Workspot with SkyFlow (K153318) | Philips Medical Systems Dmc GmbH | 2015-12-22 |
| Nexodyn AOS Wound Care Solution (K151168) | Apr Applied Pharma Research SA | 2015-12-22 |
| ALEVE Direct Therapy (ALEVE Direct Therapy TENS device) (K152852) | Bayer Healthcare, LLC | 2015-12-22 |
| RUBY STAR (K150997) | Bison Medical Co, Ltd. | 2015-12-22 |
| Pacifier Activated Lullaby (PAL®) (K151050) | Power Medical Devices, LLC | 2015-12-22 |
| BONDEASE TOPICAL SKIN ADHESIVE (K141157) | Optmed, Inc. | 2015-12-22 |
| New Medax Biopsy Systems (K142125) | Medax Srl Unipersonale | 2015-12-22 |
| NeoLas (K150664) | Sheaumann Laser, Inc. | 2015-12-22 |
| ADVIA Centaur Toxoplasma M (Toxo M) (K142826) | Siemens Healthcare Diagnostics, Inc. | 2015-12-22 |
| Magnetic Reasonance Imaging System (K151074) | Jiangsu Magspin Instrument Co.,Ltd | 2015-12-22 |
| Powder Free Vinyl Patient Examination Glove (Non?-Sterile) (K150934) | Lpl (Hui Zhou) Glove | 2015-12-21 |
| Sahara Stabilization System (K151481) | K2m, Inc. | 2015-12-21 |
| SERVO-U Ventilator System, SERVO-n Ventilator System (K151814) | Maquet Critical Care AB | 2015-12-21 |
| AXI+LINE Proximal Bunion Correction System (K152548) | Nextremity Solutions, Inc. | 2015-12-21 |
| Cardinal Health Sterilization Wrap (K151445) | Cardinal Health200, LLC | 2015-12-21 |
| Cerner CareAware Event Management (K151672) | Cerner Corporation | 2015-12-21 |
| Apex Revision Knee System (K153437) | Omnilife Science | 2015-12-21 |
| GR40CW (K153401) | Samsung Electronics Co., Ltd. | 2015-12-21 |
| HydroPearl Microspheres, HydroPearl Microspheres (K150870) | MicroVention, Inc. | 2015-12-21 |
| QUANTA Flash B2GP1-Domain1, QUANTA Flash B2GP1-Domain1 Controls, HemosIL AcuStar Anti-B2GPI Domain 1, HemosIL AcuStar Anti-B2GPI Domain 1 Controls (K152875) | Inova Diagnostics, Inc. | 2015-12-21 |
| SYDNEY IVF SPERM MEDIUM, SYDNEY IVF SPERM GRADIENT KIT, SYDNEY IVF SPERMIENT (K152782) | William A. Cook Australia Pty. , Ltd. | 2015-12-21 |
| Powder Free Vinyl Patient Examination Gloves (Green) (K152692) | Supermax Plastic Products Co., Ltd. | 2015-12-21 |
| Ally Uterine Positioning System (K153092) | CooperSurgical, Inc. | 2015-12-21 |
| OsteoMed ExtremiLOCK Wrist Plating System (K152145) | Osteomed | 2015-12-21 |
| FreezeKit Cleave , ThawKit Cleave (K150950) | Vitrolife Sweden AB | 2015-12-21 |
| Quanta Forte (K152714) | Quanta System Spa | 2015-12-21 |
| Monster BITE Screw System (K153378) | Paragon 28 | 2015-12-21 |
| The Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with Ceftazidime/Avibactam in the dilutions range of 0.015/4 - 32/4 ug/mL (K152774) | Thermo Fisher Scientific | 2015-12-21 |
| HM70A Diagnostic Ultrasound System (K153408) | Samsung Medison Co., Ltd. | 2015-12-21 |
| Defibrillator Analyzer Variable Load (K153210) | Bc Group International, Inc. | 2015-12-21 |
| FastFrame External Fixation System-Ankle Spanning (K152755) | Zimmer, Inc. | 2015-12-21 |
| Q Series Diagnostic Ultrasound System (K153085) | Chison Medical Imaging Co., Ltd. | 2015-12-21 |
| Electric Double Breast Pumps (K151284) | Wuxi Xinzhongrui Baby Supplies Co., Ltd. | 2015-12-21 |
| Dario Blood Glucose Monitoring System (K150817) | Labstyle Innovations, Ltd. | 2015-12-21 |
| Flexipet Denuding Pipette, Flexipet Manipulation Pipette (K150748) | Cook Incorporated | 2015-12-18 |
| Deployable Oxygen Generation System-Smaill (DOGS-S) (K150930) | Airsep Corporation | 2015-12-18 |
| Fluent Inflation Device (K152387) | Vascular Solutions, Inc. | 2015-12-18 |
| LiquoGuard 7, LiquoGuard 7 Drainage Set, Lenght 2000mm (K150898) | Moller Medical GmbH | 2015-12-18 |
| O-RING Condom (K150828) | O-Ring Products, LLC | 2015-12-18 |
| MReye Embolization Coils (K150931) | Cook Incorporated | 2015-12-18 |
| Imbibe Needle (K153306) | Orthovita, Inc. | 2015-12-18 |
| ST AIA-PACK PROG III Calibrator Set (K153417) | Tosoh Bioscience, Inc. | 2015-12-18 |
| Optilite Hevylite IgM Kappa Kit; Optilite Hevylite IgM Lambda Kit (K152389) | The Binding Site Group , Ltd. | 2015-12-18 |
| TRI Dental Implant System (K151916) | Tri Dental Implants Int. AG | 2015-12-18 |
| MReye Flipper Detachable Embolization Coil and Delivery System (K150964) | Cook Incorporated | 2015-12-18 |
| ADVIA Chemistry Enzyme 1 Calibrator, ADVIA Chemistry Enzyme 2 Calibrator (K153365) | Siemens Healthcare Diagnostics, Inc. | 2015-12-18 |
| TOMCAT Cervical Spinal System (K152515) | Choicespine, LP | 2015-12-18 |
| AERO -C Cervical Cage System (K152532) | Stryker Spine | 2015-12-18 |
| Breathing circuit bacterial/viral filter (K151498) | Zhejiang Haisheng Medical Device Co., Ltd. | 2015-12-18 |
| Always/Tampax bladder supports (K151413) | Procter & Gamble | 2015-12-18 |
| ROSA Brain (K151359) | Medtech S.A | 2015-12-18 |
| EDGE Arthroscopic Energy System, Arthroscopic Energy System Probes, Arthroscopic Energy System Wireless Footswitch, Arthroscopic Energy System Corded Footswitch, Arthroscopic Energy System Foot Control, Extension (K153499) | Conmed Corporation | 2015-12-18 |
| Digital Electrocardiograph (K152384) | Shenzhen Biocare Bio-Medical Equipment Co., Ltd. | 2015-12-18 |