| IV Administration (K142622) | Hospira, Inc. | 2015-01-15 |
| EVS 4343 (K142475) | DRTECH Corporation | 2015-01-15 |
| SUPER SHEATH (K141070) | Togo Medikit Co., Ltd. | 2015-01-15 |
| Powder-free PVC Vinyl Exam Gloves (K142703) | Hebei Grandeast Plastic Products Co., Ltd. | 2015-01-15 |
| SImmetry Sacroiliac Joint Fusion System (K141549) | Zyga Technology, Inc. | 2015-01-15 |
| truFreeze System (K143625) | CSA Medical, Inc. | 2015-01-15 |
| CI../..X liner for NOVAE Dual Mobility Acetabular Cup (K142675) | Serf | 2015-01-15 |
| CareEvent (K142935) | Philips Medical Systems | 2015-01-15 |
| GENASIS HIPATH IHC FAMILY (K140957) | Applied Spectral Imaging , Ltd. | 2015-01-15 |
| osteoSPAN Morpheus (K142828) | Biogennix | 2015-01-15 |
| OASYS System (K142741) | Stryker Corporation | 2015-01-15 |
| Erchonia Zerona Z6 OTC (K143007) | Erchonia Corporation | 2015-01-15 |
| Exilis XP (K143040) | BTL Industries, Inc. | 2015-01-15 |
| NEONATALIE RESUSCITATOR (K132172) | Laerdal Medical A/S | 2015-01-15 |
| IMPIX ALIF S/A (K141187) | Medicrea International SA | 2015-01-15 |
| Pre-vacuum Tabletop Autoclave (K143311) | Tuttnauer U.S.A Co, Ltd. | 2015-01-15 |
| ChoICE Guide Wire, Mailman Guide Wire, Luge Guide Wire, ChoICE PT Guide Wire, PT Graphix Wire (K143587) | Boston Scientific Corporation | 2015-01-15 |
| JIUYUAN POWDER-FREE YELLOW SYNTHETIC VINYL PATIENT EXAMINATION GLOVES (K141224) | Shijiazhunag Jiuyuan Plastic Co., Ltd. | 2015-01-15 |
| DISPOSABLE INJECTION NEEDLE (K142144) | Wilson Instruments (Shanghai) Company Limited | 2015-01-15 |
| PRO X OTC 5 (K140471) | La Lumiere, LLC | 2015-01-15 |
| SignosRT Bladder Ultrasound System (K143493) | Signostics, Ltd. | 2015-01-14 |
| Vivorte Trabexus EB (K143547) | Vivorte, Inc. | 2015-01-14 |
| AbbVie NJ (K142792) | AbbVie , Inc. | 2015-01-14 |
| AbbVie J (K142816) | AbbVie , Inc. | 2015-01-14 |
| IMMULITE 2000 Albumin Calibration Verification Material, IMMULITE 2000 Myoglobin Calibration Verification Material (K143504) | Siemens Healthcare Diagnostics, Inc. | 2015-01-14 |
| Medical Monofilament Sensory Screening Toool (K143068) | Medical Monofilament Manufacturing | 2015-01-14 |
| Vivorte Trabexus (K143549) | Vivorte, Inc. | 2015-01-14 |
| UNIEVER Disposable Epidural Anesthesia Needle, UNIEVER Disposable Nerve Blocked Needle (K142553) | Unisis Corp. | 2015-01-14 |
| NOBLUS DIAGNOSTIC ULTRASOUND SCANNER (K142368) | Hitachi Aloka Medical, Ltd. | 2015-01-14 |
| AbbVie PEG (K142793) | AbbVie , Inc. | 2015-01-14 |
| RapidVac Smoke Evacuator System (K142335) | Covidien | 2015-01-14 |
| ADROIT Guiding Catheter (K143412) | Cordis Corporation | 2015-01-14 |
| 3B Laser 500, 3B Laser 200, LA-X P 500, LA-X P 200 (K142722) | Livetec GmbH | 2015-01-13 |
| EXTERNAL PULSE OXIMETER (K141024) | Beijing Choice Electronic Technololgy Co., Ltd. | 2015-01-13 |
| Headless Compression Screw System (K143624) | Skeletal Dynamics, LLC | 2015-01-13 |
| CR3 Keyless Split Sample Cup Secobarbital- Methadone (K143535) | Guangzhou Wondfo Biotech Co., Ltd. | 2015-01-13 |
| Revolution Spinal Fixation System (K142939) | Intelligent Implant Systems, LLC | 2015-01-13 |
| InMode Diolaze Device (K142952) | Inmode MD , Ltd. | 2015-01-13 |
| Triathlon Tritanium Cone Augments (K143393) | Stryker Orthopaedics | 2015-01-13 |
| PK Cutting Forceps for ESG-400 Workstation (K142759) | Gyrus Acmi, Inc. | 2015-01-13 |
| BIOSURE REGENESORB interference Screw (K142948) | Smith & Nephew, Inc. | 2015-01-13 |
| INFIX CANNULATED SCREW SYSTEM (K142057) | Infix Medical, LLC | 2015-01-13 |
| CGBA-032A, Aquilion PRIME Self-Propelled Scan Base Kit for IVR-CT (K143223) | Toshibamedical Systems Corporation | 2015-01-12 |
| Intelliwave4 (K142641) | Art Optical Contact Lens, Inc. | 2015-01-12 |
| Surefire Infusion System 021 (K143588) | Surefire Medical, Inc. | 2015-01-12 |
| DacryoCATH (K142914) | Armadillo Biomedical, LLC | 2015-01-12 |
| Presto Inflation Device (K143522) | C.R. Bard, Inc. | 2015-01-12 |
| TANGO3 WATER STORAGE TANK WITH OZONE DISINFECTION SYSTEM (K140984) | Tango3, LLC | 2015-01-12 |
| ILLUMINATED MEDIASTINOSCOPE (K141622) | Aegis Surgical, Ltd. | 2015-01-09 |
| NUSTAT, NUSTAT XR (K142363) | Beeken Biomedical | 2015-01-09 |
| INFX-8000V with Wireless Footswitch (K143225) | Toshibamedical Systems Corporation | 2015-01-09 |
| FOX MOBILE (K142059) | Vectura GmbH | 2015-01-09 |
| CARDIOGARD EMBOLI PROTECTION CANNULA (K141465) | Cardiogard Medical, Ltd. | 2015-01-09 |
| Medline Silicone Foley Catheter (K142635) | Medline Industries, Inc. | 2015-01-09 |
| Revolution Full Face Mask (K142554) | Respironics, Inc. | 2015-01-09 |
| Puritan OptiTranz Liquid Stuart Collection and Transport System (K142366) | Puritan Medical Products, LLC | 2015-01-09 |
| Straumann Variobase Abutment NNC, Straumann Variobase Abutment RN, Straumann Variobase Abutment WN, Straumann Variobase Abutment NC, Straumann Variobase Abutment RC, IPS e.max CAD MO Coping, IPS e.max CAD LT Crown, IPS e.max CAD HT Crown, coron CoCr Single Unit (K142890) | Straumann USA, LLC | 2015-01-09 |
| PASS LP SPINAL SYSTEM (K141398) | Medicrea International SA | 2015-01-09 |
| BIOPLEX(R) 2200 25-OH VITAMIN D KIT, BIOPLEX(R) 2200 25-OH VITAMIN D CALIBRATOR SET, AND BIOPLEX(R) 2200 25-OH VITAMIN D (K141114) | Bio-Rad Laboratories | 2015-01-09 |
| ASTROGLIDE TTC FERTILITY FRIENDLY PERSONAL LUBRICANT (K141132) | Biofilm, Inc. | 2015-01-09 |
| TDX SP2 POWER WHEECHAIR (K141783) | Invacare Corporation | 2015-01-09 |
| BEACON TIP TORCON NB ADVANTAGE CATHETER, TORCON NB ADVANTAGE CATHETER (K133130) | Cook, Inc. | 2015-01-09 |
| NEW ERA ORTHOPAEDICS POLYSCREW PEDICLE SCREW SYSTEM (K141253) | New Era Orthopaedics, LLC | 2015-01-09 |
| Extension Sets (K142974) | Hospira, Inc. | 2015-01-09 |
| MENNTOR X7 (K141441) | Mennen Medical , Ltd. | 2015-01-09 |
| SPINOUS PROCESS FUSION (SPF) PLATE (K140046) | Spinal Simplicity, LLC | 2015-01-09 |
| VaPro Pocket (K143594) | Hollister Incorporated | 2015-01-09 |
| t:flex Insulin Delivery System (K143189) | Tandem Diabetes Care, Inc. | 2015-01-09 |
| Range/Denali/Mesa Spinal System (K143334) | K2m, Inc. | 2015-01-09 |
| NUTRA STIM HAIR LASER COMB (K141588) | Nutra Luxe MD, LLC | 2015-01-08 |
| CrossTie Intraosseous Fixation System (K141857) | Orthodiscovery Group, LLC (D.B.A. Crossroads Extrem | 2015-01-08 |
| SIDEKICK EZ FRAME External Fixation System (K143220) | Wrightmedicaltechnologyinc | 2015-01-08 |
| IntellaMap Orion High Resolution Mapping Catheter (K143481) | Rhythmia Medical, Inc. | 2015-01-08 |
| EnteraLite Infinity Enteral Pump Delivery Set, 1200 mL Enteral Feeding Delivery Set (K142539) | Zevex, Inc. | 2015-01-08 |
| FREERIDER FR1, models FR1-13, FR1-15, FR1-17 (K133187) | Freerider Corp | 2015-01-08 |
| BI-FUNNEL GASTROSTOMY FEEDING TUBE, TRI-FUNNEL GASTROSTOMY FEEDING TUBE (K142075) | Xeridiem (Formerly Mri) | 2015-01-08 |
| OMEGA LABORATORIES HAIR DRUG SCREENING ASSAY FOR OPIATES, OXYCODONE AND HYDROCODONE (K140671) | Omega Laboratories, Inc. | 2015-01-08 |
| PK J-HOOK (K142350) | Gyrus Acmi, Inc. | 2015-01-08 |
| MINICAP Immunotyping using the MINICAP and the MINICAP FLEX-PIERCING (K143483) | Sebia | 2015-01-08 |
| ACCUCATH MIDLINE CATHETER SYSTEM (K142136) | Vascular Pathways, Inc. | 2015-01-08 |
| NUTRA STIM HAIR LASER COMB (K141596) | Nutra Luxe MD, LLC | 2015-01-08 |
| TIVA (K142946) | Velano Vascular, Inc. | 2015-01-08 |
| 3M STERI-VAC STERILIZER/AERATOR (K142034) | 3M Company | 2015-01-08 |
| Dental Collagen Wound Dressing (Nova Tape and NovaPlug) (K142712) | Novabone Products, LLC | 2015-01-08 |
| DISPOSABLE NEBULIZER SET (K140237) | Suzhou Weikang Medical Apparatus Co., Ltd. | 2015-01-08 |
| Genesis Reusable Rigid Container System (K142529) | Carefusion 2200, Inc. | 2015-01-08 |
| S200, S300 (K133412) | Cefla S.C. | 2015-01-08 |
| BioHorizons Tapered Internal Implants (K143022) | BioHorizons Implant Systems, Inc. | 2015-01-08 |
| ANUTRA Feedback Aspiration Syringe (K143757) | Anutra Medical, Inc. | 2015-01-08 |
| CONSTRUX MINI PEEK; SPACER SYSTEM, TI SPACER SYSTEM, CERVICAL STAND ALONE SYSTEM (K142152) | Orthofix, Inc. | 2015-01-08 |
| Endo Vive 3S Low Profile Balloon Kit, Endo Vive 3S Bolus Extension Sets, Endo Vive 3S Continuous Extension Sets, Endo Vive 3S Medication Extension Set (K142297) | Xeridiem (Formerly Mri) | 2015-01-08 |
| AED HYSTEROSCOPE AND ACCESSORIES (K141515) | National Advanced Endoscopy Devices, Inc. | 2015-01-07 |
| Ufi Gel hard C (K143486) | Voco GmbH | 2015-01-07 |
| PERI-GUARD Repair Patch & SUPPLE PERI-GUARD Repair Patch (K142447) | Synovis Life Technologies, Inc. | 2015-01-07 |
| Stern AC 3.3x10mm, Stern AC 3.3x11.5mm, Stern AC 3.3x13mm, Stern AC 4.0x8.5mm, Stern AC 4.0x10mm (K142667) | Sterngold Dental, LLC | 2015-01-07 |
| ENDOPHYS BLOOD PRESSURE MONITOR (K141615) | Endophys, Inc. | 2015-01-07 |
| Applied BioPhotonics Phototherapy System ABPT1003 (K142256) | Applied Biophotonics , Ltd. | 2015-01-07 |
| FastPack High Sensitivity C-Reactive Protein Immunoassay, High Sensitivity C-Reactive Protein Calibrator Kit, FastPack High Sensitivity C-Reactive Protein Controls, FastPack High Sensitivity C-Reactive Protein Method Verification Kit (K141689) | Qualigen, Inc. | 2015-01-07 |
| Unity Network ID (K142840) | GE Healthcare | 2015-01-07 |
| HILTHERA 4.0 (K141861) | Jeisys Medical, Inc. | 2015-01-07 |