| Nerve Monitoring Cable System (K142438) | Pioneer Surgical Technology, Inc. (Rti Surgical, Inc.) | 2015-03-05 |
| MASTRO PLUS BALLOON IN-DEFLATION DEVICE (K140943) | Beijing Demax Medical Technology Co.,Ltd | 2015-03-05 |
| NP Cement HV Genta;NP Cement LV Genta;NP Cement HV System Genta;NP Cement LV System Genta (K143100) | Cossington, Ltd. | 2015-03-05 |
| SURGICAL GOWN (K141467) | Xuchang Zhengde Environstar Medical Products Co.,L | 2015-03-05 |
| Entriport (K142464) | Conmed Corporation | 2015-03-05 |
| FOXTROT NC PTCA Balloon Catheter (K143160) | Shanghai MicroPort Medical (Group) Co., Ltd. | 2015-03-05 |
| MR810 System, 900MR810 Adult Single Limb Circuit, 900MR810E Adult Dual Limb Circuit (K143646) | Fisher & Paykel Healthcare, Ltd. | 2015-03-05 |
| INFINITY (TM) TOTAL ANKLE SYSTEM; INBONE TOTAL ANKLE SYSTEM (K141740) | Wrightmedicaltechnologyinc | 2015-03-05 |
| Nellcor Bedside Respiratory Patient Monitoring System (K141518) | Covidien | 2015-03-05 |
| SALVATION External Fixation System (K150004) | Wrightmedicaltechnologyinc | 2015-03-04 |
| Hospira Blood Set (K143087) | Hospira, Inc. | 2015-03-04 |
| EsophyX® Z Fastener Delivery Device (K143645) | Endogastric Solutions, Inc. | 2015-03-04 |
| Zimmer Plates and Screws System (ZPS) - Non-sterile ZPS (K143331) | Zimmer, Inc. | 2015-03-04 |
| Healgen MDMA (Ecstacy) Test (Strip, Cassette, Cup, Dip Card), Healgen Phencyclidine Test (Strip, Cassette, Cup, Dip Card) (K150096) | Healgen Scientific,, LLC | 2015-03-04 |
| Consensus Knee System Modular Tibial Baseplate (K143725) | Consensus Orthopedics, Inc. | 2015-03-04 |
| DOLPHIN NEUROSTIM OTC (K133789) | Acumed Medical , Ltd. | 2015-03-04 |
| OCT-Camera (K142953) | Optomedical Technologies GmbH | 2015-03-04 |
| OSSEOSTAP Microdrill System (control unit and handpiece), OSSEOSTAP control unit (foot pedal), OSSEOSTAP handpiece (K143492) | Bien-Air Surgery SA | 2015-03-04 |
| ZONARE ZS3 and Z.Onepro Diagnostic Ultrasound System (K150249) | Zonare Medical Systems, Inc. | 2015-03-04 |
| Extremity Medical Calcaneal Osteotomy Device (K150309) | Extremity Medical, LLC | 2015-03-04 |
| CMOS Video Nasopharyngoscope System (K143673) | Schoelly Fiberoptic GmbH | 2015-03-04 |
| AngioSculpt PTA Scoring Balloon Catheter with HydroCross Coating (K142983) | Angioscore, Inc. | 2015-03-04 |
| T3 Software (K142732) | Etiometry, Inc. | 2015-03-04 |
| Simpliciti Shoulder System (K143552) | Tornier, Inc. | 2015-03-04 |
| SVED Wound Treatment System (K142916) | Cardinalhealth | 2015-03-04 |
| NIHON KOHDEN AE-918P NEURO UNIT (K130238) | Nihon Kohden Corp. | 2015-03-04 |
| Insta-Gard Surgical and Procedure Face Mask (K142990) | Cardinal Health200, LLC | 2015-03-04 |
| iGuide 2.1 (K143485) | Medical Intelligence Medizintechnik GmbH | 2015-03-04 |
| Vivid E80 Diagnostic Ultrasound Imaging System, Vivid E90 Diagnostic Ultrasound Imaging System, Vivid E95 Diagnostic Ultrasound Imaging System (K150087) | Ge Vingmed Ultrasound AS | 2015-03-04 |
| TightRail Rotating Dilator Sheath, TightRail Mini Rotating Dilator Sheath (K150360) | Spectranetics, Inc. | 2015-03-04 |
| ACCU-CHEK AVIVA CONNECT BLOOD GLUCOSE MONITORING SYSTEM (K141867) | Roche Diagnostics | 2015-03-03 |
| NewEra Small REVA Kit, NewEra Medium REVA Kit, NewEra Large REVA Kit (K143301) | Integrated Healing Technologies | 2015-03-03 |
| IDEAL Locking Plate System (K141825) | Jiangsu Ideal Medical Science & Technology Co., LT | 2015-03-03 |
| TRILLIUM Oval MR System (K142734) | Hitachi Medical Systems America, Inc. | 2015-03-02 |
| Sensititre HP MIC Susceptibility Plate with Tedizolid (0.002-4 mcg/ml) (K142338) | Thermo Fisher Scientific | 2015-03-02 |
| Mpact Double Mobility System (K143453) | Medacta International | 2015-03-02 |
| GE EchoPAC (K150085) | Ge Vingmed Ultrasound AS | 2015-03-02 |
| EVO 500 SERIES HIGH SPEED HANDPIECES/TIGER 500/300/101 SERIES HIGH SPEED HANDPIECES (K141183) | Ttbio Corp. | 2015-02-27 |
| Single Use Biliary Balloon Dilator (K143303) | Olympus Medical Systems Corp. | 2015-02-27 |
| ALLIANCE SPINE RAAS CRANIAL PLATING SYSTEM (K141123) | Alliance Partners, LLC | 2015-02-27 |
| Exactech Ambassador (K143576) | Exactech, Inc. | 2015-02-27 |
| PROCOTYL L-O ACETABULAR SYSTEM (K142119) | Microport Orthopedics, Inc. | 2015-02-27 |
| LIGHTMED TRUSCAN 577 (K142172) | Lightmed Corp. | 2015-02-27 |
| V-GUIDE FOR VENTRICULOSTOMIES (K141559) | Arc Surgical, LLC | 2015-02-27 |
| BD FACSCanto II flow cytometer (4-2-2 and 5-3 configurations), BD FACSCanto flow cytometer (4-3-3 configuration) (K141468) | Bd Biosciences | 2015-02-27 |
| IRIS INTELLIGENT RETINAL IMAGING SYSTEM (K141922) | Intelligent Retinal Imaging Systems, LLC | 2015-02-27 |
| Progressive Orthopaedic Total Hip System (K143314) | The Progressive Orthopaedic Company, LLC | 2015-02-27 |
| KATANA Zirconia (K143439) | Kuraray Noritake Dental, Inc. | 2015-02-27 |
| Quick-Cross Extreme Support Catheter, Quick-Cross Select Support Catheter (K150201) | Spectranetics, Inc. | 2015-02-27 |
| HEARTWAY Electrically Powered Wheelchairs (K142731) | Heartway Medical Products Co., Ltd. | 2015-02-27 |
| EMS PIEZON 707 BIK AND PIEZON 707 BIK LED (K140990) | E.M.S Electro Medical Systems S.A | 2015-02-27 |
| OS2-V Varisation Staple (K143323) | In2bones Sas | 2015-02-26 |
| Spinal System (K142576) | Eisertech, LLC | 2015-02-26 |
| Ancora LLC Interbody Fusion Device (K143228) | Frontier Medical Devices, Inc. | 2015-02-26 |
| First Sign Drug of Abuse Dip Card Test, First Sign Drug of Abuse Cup Test (K150162) | W.H.P.M., Inc. | 2015-02-26 |
| NIOX VERO Airway Inflammation Monitor (K150233) | Aerocrine AB | 2015-02-26 |
| Vector PTA Balloon Dilatation Catheter (K143652) | Vector Corporation, LLC | 2015-02-26 |
| Air Bubble Based Infuser (ABBI) (K143415) | CooperSurgical, Inc. | 2015-02-26 |
| IntraTemp Solution Warmer (K150190) | Ecolab, Inc. | 2015-02-26 |
| EMMA (K150174) | Inrange Systems, Inc. | 2015-02-26 |
| UniCel DxC SYNCHRON System HDL Cholesterol reagent(HDL),Unicel DxC SYNCHRON System HDL Calibrator (K142985) | Beckman Coulter, Inc. | 2015-02-26 |
| IMMULITE® 2000 Calcitonin Calibration Verification Material , IMMULITE® 2000 Prostatic Acid Phosphatase (PAP) Calibration Verification Material (K143373) | Siemens Healthcare Diagnostics, Inc. | 2015-02-26 |
| MAGNIFY and MAGNIFY-S Spacers (K142498) | Globus Medical, Inc. | 2015-02-26 |
| PROROOT MTA WHITE, PROROOT MTA GRAY (K142178) | Dentsply International, Inc. | 2015-02-26 |
| PANAVIA SA Cement Plus Handmix (K142623) | Kuraray Noritake Dental, Inc. | 2015-02-26 |
| MCC Para-Fix CARY BLAIR MEDIUM (K141506) | Medical Chemical Corporation | 2015-02-25 |
| ANAX 5.5 Spinal System (K143417) | U&I Corporation | 2015-02-25 |
| Biomet Microfixation Thoracic Fixation System (K142823) | Biomet Microfixation | 2015-02-25 |
| Palladian Lumbar Pedicle Screw System (K143230) | Neurostructures, Inc. | 2015-02-25 |
| Irritrol, EDS Combo-Rinse (K150020) | Essential Dental Systesm, Inc. | 2015-02-25 |
| CR3 Keyless Split Sample Cup Oxycodone - Cannabinoids (K150179) | Guangzhou Wondfo Biotech Co., Ltd. | 2015-02-25 |
| GastriSail Gastric Positioning System (K143088) | Covidien | 2015-02-25 |
| CD HORIZON Growth Rod Conversion Set (K150200) | Medtronic Sofamor Danek USA, Incorporated | 2015-02-25 |
| IMMULITE 2000 Androstenedione Calibration Verification Material, IMMULITE 2000 Troponin I Calibration Verification Material (K143636) | Siemens Healthcare Diagnostics, Inc. | 2015-02-25 |
| Baide (K150009) | Jiangsu Baide Medical Intrument Co., Ltd. | 2015-02-25 |
| Nile Alternative Fixation (K143350) | K2m, Inc. | 2015-02-25 |
| Hospira Primary Sets (K143015) | Hospira, Inc. | 2015-02-25 |
| Shiley Adult Flexible Tracheostomy Tube Cuffless, Disposable Inner Cannula; Shiley Adult Flexible Tracheostomy Tube with TaperGuard Cuff, Disposable Inner Cannula (K142296) | Covidien | 2015-02-24 |
| T-8000 THEROZONE UNIT (K141504) | Therozone USA, Inc. | 2015-02-24 |
| Photonica Professional (K150336) | Ward Photonics, LLC | 2015-02-24 |
| AESCULAP ORTHOPILOT NEXT GENERATION (K141694) | Aesculap Implant Systems, LLC | 2015-02-24 |
| Syngo X-workplace SW VD10 (K143319) | Siemens Medi Cal Solutions, Inc. | 2015-02-24 |
| THD REVOLUTION (K141657) | Thd Spa | 2015-02-24 |
| Synergetics PHOTON EX (K143123) | Synergetics | 2015-02-24 |
| MEGNA BREAST PUMPS (K142479) | Wuxi Xinzhongrui Baby Supplies Co., Ltd. | 2015-02-24 |
| NewEra Small Dome Kit, NewEra Medium Dome Kit, NewEra Large Dome Kit (K142956) | Integrated Healing Technologies | 2015-02-24 |
| EAZY PRIMER (K142848) | Parkell, Inc. | 2015-02-24 |
| Endoscope Sterilization Tray (K142937) | Intuitive Surgical, Inc. | 2015-02-24 |
| Zimmer Periarticular Plating System (K150121) | Zimmer, Inc. | 2015-02-23 |
| DentiAnn Smart Sil (K143382) | Seilglobal Co., Ltd. | 2015-02-23 |
| Otoport OAE +ABR Advance, Otoport OAE+ABR DP+TE, Otoport OAE+ABR Screener-Otocheck OAE+ABR, Otocheck OAE+ABR LE, Otocheck ABR Screener-Otodynamics ABR Upgrade Kit (K143395) | Otodynamics, Ltd. | 2015-02-23 |
| Reprocessed Covidien LigaSure 5mm, Blunt Tip, Laparoscopic Sealer/Divider (K143260) | Sterilmed, Inc. | 2015-02-23 |
| KANGAROO ENTERAL FEEDING SYRINGES WITH ENFIT CONNECTOR (K142128) | Covidien | 2015-02-23 |
| Extremity Medical Suture Anchor (K150166) | Extremity Medical, LLC | 2015-02-23 |
| SORRENTO BONE GRAFT SUBSTITUTE (K141429) | Haider Biologics, LLC | 2015-02-23 |
| SCARLET® AC-T Secured Anterior Cervical Cage (K143214) | Spineart | 2015-02-23 |
| Picosure Workstation (K143105) | Cynosure, Inc. | 2015-02-23 |
| Talos-C(HA) Cervical Intervertebral Body Fusion Devices (K142345) | Meditech Spine, LLC | 2015-02-22 |
| LIFE SPINE SACROILIAC JOINT FIXATION SYSTEM (K141246) | Life Spine, Inc. | 2015-02-22 |
| PJ'S SERENITY (K132220) | Limerick, Inc. | 2015-02-20 |