| Advanced Air System (K143704) | W&H Dentalwerk Buermoos GmbH | 2015-11-23 |
| Wondfo Propoxyphene Urine Test (K152495) | Guangzhou Wondfo Biotech Co., Ltd. | 2015-11-23 |
| Ceramax Skin Barrier Cream (K152055) | Oculus Innovative Sciences | 2015-11-23 |
| Ponto bone anchored hearing system (K152067) | Oticon Medical AB | 2015-11-23 |
| MedGyn Straight IUI Catheter, MedGyn Mini IUI Catheter, MedGyn curved, mini IUI Catheter (K143669) | Medgyn Products, Inc. | 2015-11-23 |
| Revision Femoral Stem (K151739) | Lima Corporate S.P.A. | 2015-11-23 |
| Arrow Endurance Extended Dwell Peripheral Catheter System (K152272) | Arrow International, Inc. (Subsidiary of Teleflex, Inc.) | 2015-11-23 |
| QuadraSphere Microspheres (K153102) | Biosphere Medical, S.A. | 2015-11-23 |
| Fogarty Occlusion Catheter (K152762) | Edwards Lifesciences, LLC | 2015-11-23 |
| PainKARE (K151034) | Triowave Technologies | 2015-11-21 |
| Cam Lock Plating System (K152282) | Life Spine, Inc. | 2015-11-20 |
| Power-Injectable Implantable Ports with ChronoFlex Polyurethane Catheters (K150514) | C.R. Bard, Inc. | 2015-11-20 |
| Parcus GFS Naked (K152711) | Parcus Medical, LLC | 2015-11-20 |
| e-1 etchants (K152110) | E Dental Products | 2015-11-20 |
| IQQA Guide (K151414) | Edda Technology | 2015-11-20 |
| ProFlu+ Assay (K153219) | Hologic, Inc. | 2015-11-20 |
| Pi Drive Plus Motor, Extender (K152641) | Stryker Corporation | 2015-11-20 |
| ArcCHECK (K142617) | Sun Nuclear Corporation | 2015-11-20 |
| CONCORDE Bullet Lumbar Interbody System (K151773) | Medos International SARL | 2015-11-20 |
| Libra Pedicle Screw System (K151770) | Spinal Balance, Inc. | 2015-11-20 |
| Single Use Aspiration Needle NA-U200H (K151738) | Olympus Medical Systems Corp. | 2015-11-20 |
| Gemini Sterilization Wrap (K150698) | Medline Industries, Inc. | 2015-11-20 |
| RX ACCUNET Embolic Protection System (K153086) | Abbott Vascular | 2015-11-20 |
| SPIES 3D Tip Cam, Image 1 SPIES CCU Image Connect, Image 1 SPIES CCU D-3 Link (K150525) | KARL STORZ Endoscopy-America, Inc. | 2015-11-20 |
| XprESS Multi-Sinus Dilation System (K152434) | Entellus Medical, Inc. | 2015-11-20 |
| PassAssist LED Light Fiber (K152435) | Entellus Medical, Inc. | 2015-11-20 |
| Collagen Dural Regeneration Matrix (K150825) | Collagen Matrix, Inc. | 2015-11-20 |
| RELIZORB (DEN150001) | Alcresta, Inc. | 2015-11-20 |
| Trinidad IM Thyroid Stimulating Hormone (TSH) Assay, Trinidad IM TSH Calibrators, Trinidad Immunoassay (IM) System (K151792) | Siemens Healthcare Diagnostics, Inc. | 2015-11-20 |
| BioArchitects Patient Specific Cranial/Craniofacial Plate (K151692) | Bioarchitects USA, LLC | 2015-11-20 |
| WALLSTENT RP Endoprosthesis Transhepatic Biliary, WALLSTENT Endoprosthesis Transhepatic Biliary (K152853) | Boston Scientific Corp | 2015-11-20 |
| 8MP Color LCD Monitor, RadiForce RX850, RX850-AR (K152713) | Eizo Corporation | 2015-11-20 |
| 3i T3 Short Implants (K150571) | Biomet 3i | 2015-11-20 |
| AN1087 Dosimeter (K150645) | Andersen Sterilizers, Inc. | 2015-11-19 |
| Visions PV.014P RX Digital IVUS Catheter (K152829) | Volcano Corporation | 2015-11-19 |
| Gmate SMART Blood Glucose Monitoring System (K150299) | Philosys, Inc. | 2015-11-19 |
| Aerin Medical Wand Model FG011 (K150637) | Aerin Medical, Inc. | 2015-11-19 |
| MoisturemeterD (K143310) | Delfin Technologies, Ltd. | 2015-11-19 |
| SNaP Wound Care System (K151710) | Spiracur, Inc. | 2015-11-19 |
| Family of Radiofrequency System (Biorevital RF MED, ThermiSmooth 250) (K151296) | Bios S.R.L. | 2015-11-19 |
| Cytoflex Tefguard Ti-Enforced Membrane (K151344) | Unicare Biomedical, Inc. | 2015-11-19 |
| BladderScan Prime System (K153101) | Verathon Incorporated | 2015-11-19 |
| RT2 Trabeculite Titanium Cervical Cage System (K150455) | Rhausler, Inc. | 2015-11-19 |
| Good Clean Love Personal Lubricants Almost Naked and Natural Cinnamon Vanilla (K150094) | Good Clean Love, Inc. | 2015-11-19 |
| Puracyn(R) Plus Duo-Care(TM) Antimicrobial Wound & Skin Hydrogel, Puracyn(R) Plus Antimicrobial Hydrogel Professional Formula (K150799) | Innovacyn, Inc. | 2015-11-19 |
| TLC-2000 Therapeutic Medical Laser System (K151816) | Theralase, Inc. | 2015-11-19 |
| Terumo Capiox FX15 Advance Oxygenator with Integrated Arterial Filter and Reservoir, Terumo Capiox FX25 Advance Oxygenator with Integrated Arterial Filter and Reservoir (K151791) | Terumo Cardiovascular Systems Corporation | 2015-11-19 |
| Tritanium PL Cage (K152304) | Stryker | 2015-11-19 |
| InFill Interbody Fusion Device (K152259) | Pinnacle Spine Group, LLC | 2015-11-19 |
| Medihoney Wound Gel (K150985) | Derma Sciences, Inc. | 2015-11-19 |
| 8 CH Knee SPEEDER (K152695) | Quality Electrodynamics, LLC | 2015-11-18 |
| WASTON General Spinal System (K150684) | Changzhou Waston Medical Appliance Co., Ltd. | 2015-11-18 |
| Tyvek Sterilization Pouches with Chevron Seal (K152058) | Andersen Sterilizers, Inc. | 2015-11-18 |
| Venue 50 (K152758) | GE Medical Systems Ultrasound and Primary Care Diagnostics | 2015-11-18 |
| Invisalign System (K143630) | Align Technology, Inc. | 2015-11-18 |
| AN85/AN86 EO Indicators (K150644) | Andersen Sterilizers, Inc. | 2015-11-18 |
| Philips IntelliSpace Cardiovascular (K153022) | Philips Medical Systems Nethrlands BV | 2015-11-18 |
| R350 guidewire (K151234) | Vascular Solutions, Inc. | 2015-11-18 |
| EOGas 4 Ethylene Oxide Gas Sterilizer (K150646) | Andersen Sterilizers, Inc. | 2015-11-18 |
| Andersen EOGas 4 SteriTest (K151585) | Andersen Sterilizers, Inc. | 2015-11-18 |
| Clickfine AutoProtect Pen Needle (K152514) | Ypsomed AG | 2015-11-18 |
| DIVA ZSP5812CMI with QUBYX PerfectLum bundle (K152847) | Qubyx , Ltd. | 2015-11-17 |
| MD-2300S Ultrasonic A/B Scanner for Ophthalmology (K152318) | MEDA Co., Ltd. | 2015-11-17 |
| AUTOLAP SYSTEM (K152848) | M.S.T Medical Surgery Technologies, Ltd. | 2015-11-17 |
| Nanova Universal Composite (K152004) | Nanova Biomaterials, Inc. | 2015-11-17 |
| TYRX Neuro Antibacterial Envelope (K152678) | Tyrx, Inc. | 2015-11-17 |
| Renaissance X System (K152041) | Mazor Robotics , Ltd. | 2015-11-17 |
| PULLUP® Adjustable Juxtacortical Fixation Device (K151004) | Sbm Sciences For Bio Materials | 2015-11-17 |
| RANGE/DENALI/MESA Spinal System (K153031) | K2m, Incorporated | 2015-11-17 |
| Powder Free Vinyl Patient Examination Gloves, Clear (non-colored) (K151682) | Daxwell, LLC | 2015-11-17 |
| KYPHON XPEDE Bone Cement (K151227) | Medtronic | 2015-11-16 |
| Finessis Zero Flexylon Powder Free Sterile White Surgical Glove (K151607) | Lucenxia Prescience AG | 2015-11-16 |
| EVOLUTION BIOFOAM Tibial Base, EVOLUTION Modular Keels, ADVANCE Modular Keels, ADVANCE Bullet-Tipped Keels, ADVANCE BIOFOAM Tibial Base (K152298) | Microport Orthopedics, Inc. | 2015-11-16 |
| HICAT Air (K152661) | Hicat GmbH | 2015-11-16 |
| REDAPT Porous Acetabular Shell and Cemented Liner (K150790) | Smith & Nephew, Inc. | 2015-11-16 |
| GUS ASTRA TEE Transesophageal Probe Reprocessor, GUS ASTRA VR Endovaginal/Endorectal Probe Reprocessor (K150504) | Pci Medical, Inc. | 2015-11-16 |
| Arthrex iBalance TKA System (K152252) | Arthrex, Inc. | 2015-11-16 |
| Viradius Neurowire (K151825) | Mivi Neuroscience, Inc. | 2015-11-16 |
| ICS Impulse (K151504) | Gn Otometrics | 2015-11-16 |
| Inclusive Titanium Abutments compatible with: Straumann synOcta Implant System (K151798) | Prismatik Dentalcraft, Inc. | 2015-11-16 |
| BoneCam Suture Anchors (K152255) | Valeris Medical | 2015-11-16 |
| Finessis Corium Flexylon Powder Free Sterile Green Surgical Gloves (K151605) | Lucenxia Prescience AG | 2015-11-16 |
| Annuy Latex Patient Examination Glove (powdered and powder-free); Annuy Nitrile Patient Examination Glove (powdered and powder-free) (K150612) | Anhui Anyu Latex Products Co., Ltd. | 2015-11-16 |
| Annuy Latex Surgeon's Gloves (Powdered and Powder Free) (K150609) | Anhui Anyu Latex Products Co., Ltd. | 2015-11-16 |
| UroNav (Version 2.0) (K153073) | Invivo Corporation | 2015-11-16 |
| HairMD (K152019) | Trophy Skin, Inc. | 2015-11-16 |
| Radifocus Glidewire (K152740) | Ashitaka Factory of Terumo Corp. | 2015-11-16 |
| LithoVue System (K153049) | Boston Scientific Corporation | 2015-11-13 |
| MAKO Device (K151275) | Nvision Medical | 2015-11-13 |
| Phenom 17 Catheter, Phenom 21 Catheter, Phenom 27 Catheter, Phenom Plus Catheter (K151638) | Cathera, Inc. | 2015-11-13 |
| Myosure Hysteroscopic Tissue Removal System and Myosure Tissue Removal Devices (K152723) | Hologic, Inc. | 2015-11-13 |
| Klassic Knee System (K153075) | Total Joint Orthopedics, Inc. | 2015-11-13 |
| ComboRehab (K150436) | Shenzhen Dongdixin Technology Co., Ltd. | 2015-11-13 |
| Denture base resin (K152270) | Korea Engineering Plastics Co., Ltd. | 2015-11-13 |
| BTL-4000 (K150353) | BTL Industries, Inc. | 2015-11-13 |
| SIGN Hip Construct (SHC) (K152757) | Sign Fracture Care International | 2015-11-13 |
| Polaris Spinal System (K151974) | Biomet Spine | 2015-11-13 |
| Sirius Max Dental Diode Curing Light (K152936) | National Dental, Inc. | 2015-11-13 |
| Multitom Rax (K152928) | Siemens Medical Solutions USA, Inc. | 2015-11-13 |
| PIVOX(tm) Oblique Lateral Spinal System (K152277) | Medtronic Sofamor Danek USA, Inc. | 2015-11-13 |