| INTEGO Family and Accesories (K150909) | Sirona Dental Systems GmbH | 2015-07-17 |
| ADVIA Centaur Follicle Stimulating Hormone (FSH) Master Curve Material, ADVIA Centaur FT4 Master Curve Material, ADVIA Centaur T4 Master Curve Material, ADVIA Centaur T3 Master Curve Material (K143687) | Siemens Healthcare Diagnostics, Inc. | 2015-07-17 |
| Polychloroprene Powder-free Surgical Glove (White) Tested for Use with Chemotherapy Drugs; Polychloroprene Powder-free Surgical Glove (Green) Tested for Use with Chemotherapy Drugs (K142190) | Pt. Medisafe Technologies | 2015-07-14 |
| VIDAS H. pylori IgG, VIDAS 3, VIDAS Lyme IgG II, VIDAS RUB IgG, VIDAS TOXO M, VIDAS Human Chorionic Gonadotropin, VIDAS T4, VIDAS Testosterone, VIDAS TSH, and VIDAS D-Dimer Exclusion II (K141133) | BIOMERIEUX | 2015-07-09 |
| Powder Free Vinyl Patient Examination Gloves, Yellow Color (K143340) | Zibo Ling Yun Medical Products Co, Ltd. | 2015-07-09 |
| Endo 6:1, T1 Line Endo 6 L, SIRONiTi Apex, T1 Spray (K150750) | Sirona Dental Systems GmbH | 2015-07-02 |
| ST AIA-PACK SHBG, ST AIA-PACK SHBG Calibrator Set (K143075) | Tosoh Bioscience, Inc. | 2015-07-02 |
| TRAUS ENDO (K143411) | Saeshin Precision Co., Ltd. | 2015-06-29 |
| POWDER FREE Nitrile GLOVES (White), POWDER FREE Nitrile GLOVES (Cobalt Blue), POWDER FREE Nitrile GLOVES (Black), POWDER FREE Nitrile GLOVES (Ice Blue) (K150340) | Hebei Hongsen Plastics Technology Co, Ltd. | 2015-06-18 |
| Fusion Black Powder-Free Nitrile Exam Glove (K150113) | Halyard Health | 2015-06-18 |
| Edwards Suture Fastening System (K150882) | Edwards Lifesciences, LLC | 2015-06-16 |
| Midas Touch-Nitrile Examination Gloves- Powder free, Orange, XS, Model SNAEFT-240OR-XS; Midas Touch-Nitrile Examination Gloves -Powder free, Orange, XXL, Model SNAEFT-240OR-XXL (K150414) | Industrial Clothings (Pvt), Ltd. | 2015-06-12 |
| Nitrile Powder Free Examination Glove with Low Dermatitis Potential Claim (Blue) (K150593) | Hartalega Sdn Bhd | 2015-06-09 |
| Powder Free Vinyl Patient Examination Gloves, Clear (non-colored) (K143715) | Better Plastic Co., Ltd. | 2015-06-05 |
| Para-Fix C&S Medium (K150887) | Medical Chemical Corporation | 2015-05-29 |
| URISCAN OPTIMA (K141874) | Yd Diagnostics Corp. | 2015-05-28 |
| AEU-7000L-70V IMPLANT/ENDODONTIC DENTAL SYSTEM (LIGHTED VERSION) (K150129) | Aseptico, Inc. | 2015-05-28 |
| Rapid Aid Instant Disposable Infant Heel Warmer (K150627) | Rapid Aid Corp. | 2015-05-27 |
| Bausch + Lomb Injector System (K151102) | Bausch & Lomb, Inc. | 2015-05-22 |
| Rachel's Remedy (K150139) | Rachel'S Remedies, LLC | 2015-05-22 |
| Intelli-Ox (K143060) | Air Liquide Healthcare | 2015-05-21 |
| MDK HANDPIECES (K141886) | Modern Korea Co., Ltd. | 2015-05-13 |
| Hematocrit and Metabolite QUALICHECK (K150226) | Radiometer Medical Aps | 2015-05-13 |
| BLUE VINYL GLOVES POWDER FREE (K150224) | Zibo Sanying Trade Co., Ltd. | 2015-05-12 |
| Mission U120 Ultra Urine Analyzer, Mission Liquid Urine Controls, Mission Liquid Diptube Urine Control (K142543) | ACON Laboratories, Inc. | 2015-05-11 |
| One Series ULTRA Cartridge, The UNFOLDER Platinum 1 Series (K143434) | Abbott Medical Optics, Inc. | 2015-05-06 |
| Maxima PRO 45L (K141576) | Kavo DO Brasil Industria E Comercio Ltda | 2015-05-04 |
| Elecsys Progesterone III Cal Check 5 (K150955) | Roche Diagnostics | 2015-05-01 |
| 2D Mercy TAPE & 3D Mercy TAPE (K142469) | Children'S Mercy Hospital | 2015-05-01 |
| Invictus Medical GelShield (K150243) | Invictus Medical, Inc. | 2015-05-01 |
| Helio A7 Manual Wheelchair, Move Manual Wheelchair (K143101) | Motion Composites | 2015-05-01 |
| Mission Urinalysis Reagent Strips (Microalbumin/Creatinine) (K150330) | ACON Laboratories, Inc. | 2015-04-30 |
| VALIDATE Anemia Calibration Verification/ Linearity Test Kit (K142964) | Maine Standards Company, LLC | 2015-04-30 |
| Codent Low Speed Dental Handpieces and Accessories (K150798) | Codent Technical Industry Co., Ltd. | 2015-04-24 |
| KI-20 (K141482) | Saeyang Microtech Co., Ltd. | 2015-04-24 |
| Nitrile Powder Free Examination Gloves (Orange) Tested For Use With Chemotherapy Drugs (K150103) | Hartalega Sdn Bhd | 2015-04-23 |
| Nitrile Powder Free Examination Glove with Colloidal Oatmeal USP Skin Protectant - White, Nitrile Powder Free Examination Glove with Colloidal Oatmeal USP Skin Protectant - Dawn Blue, Nitrile Powder Free Examination Glove with Colloidal Oatmeal USP Skin Protectant - Dark Blue (DKBU), Nitrile Powder Free Examination Glove with Colloidal Oatmeal USP Skin Protectant - Dark Violet Blue (DVBU) (K150110) | Hartalega NGC Sdn. Bhd. | 2015-04-23 |
| Relieva SpinPlus Balloon Sinuplasty System (K143541) | Acclarent, Inc. | 2015-04-22 |
| Portrait GBS Assay (K143312) | Great Basin Corporation | 2015-04-21 |
| OXYTOTE INFINITY SERIES VIPR SYSTEMS (K142149) | Western/Scott Fetzer Co. | 2015-04-17 |
| UnicLine Mobile (K150490) | Heka Dental A/S | 2015-04-17 |
| Alcyone MEMS Cannula (AMC) System (K150660) | Alcyone Lifesciences, Inc. | 2015-04-16 |
| IMMULITE IGF Control Module, IMMULITE Gastrin Control Module (K150132) | Siemens Healthcare Diagnostics | 2015-04-13 |
| Lubricating Jelly (K142473) | Sion Biotext Medical , Ltd. | 2015-04-13 |
| ZM Powder Free Vinyl Patient Examination Gloves, Clear (non-colored) (K142911) | Huailai ZM Plastic Products Co., Ltd. | 2015-04-10 |
| COPAN FECALSWAB COLLECTION, TRANSPORT AND PRESERVATION SYSTEM (K142094) | Copan Italia Spa | 2015-04-10 |
| AlfaSight 9000 Thermographic System (K150457) | Alfa Thermodiagnostics, Inc. | 2015-04-10 |
| AUTION CHECK PLUS (K142262) | Quantimetrix Corp. | 2015-04-10 |
| MASTERmatic LUX (K143465) | Kaltenbach & Voigt GmbH | 2015-04-09 |
| LIOLI IOL DELIVERY SYSTEM (K142056) | Ast Products, Inc. | 2015-04-09 |
| ACCLARENT SE Inflation Device (K150172) | Acclarent, Inc. | 2015-04-07 |
| IDS-iSYS CTX-I Calibration Verifiers (K143324) | Immunodiagnostic Systems , Ltd. | 2015-03-30 |
| Powder-free Clear Vinyl Patient Examination Gloves (K142892) | Shenyi (Shandong) Plastic Products Co., Ltd. | 2015-03-25 |
| BIOGEL PS SURGICAL GLOVE SERIES, BIOGEL SKINSENSE SURGICAL GLOVE SERIES (K140477) | Molnlycke Health Care Us, LLC | 2015-03-23 |
| myVision Track Model 005 (K143211) | Vital Art and Science Incorporated | 2015-03-20 |
| MCARE PF POWDER FREE LATEX EXAMINATION HIGH RISK GLOVES (K141042) | Mercator Medical (Thailand), Ltd. | 2015-03-19 |
| TULIP Natural Rubber Latex Surgeon's Glove (Powdered) (K142992) | Shanghai Jinxiang Latex Products Co., Ltd. | 2015-03-18 |
| Liquichek Maternal Serum II Control (K143379) | Bio-Rad Laboratories | 2015-03-13 |
| Dental Unit (K142206) | Zhuhai Siger Medical Equipment Co., Ltd. | 2015-03-13 |
| Patient Examination Gloves (K143419) | Hartalega NGC Sdn. Bhd. | 2015-03-06 |
| EVO 500 SERIES HIGH SPEED HANDPIECES/TIGER 500/300/101 SERIES HIGH SPEED HANDPIECES (K141183) | Ttbio Corp. | 2015-02-27 |
| IntraTemp Solution Warmer (K150190) | Ecolab, 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 |
| MCC Para-Fix CARY BLAIR MEDIUM (K141506) | Medical Chemical Corporation | 2015-02-25 |
| IMMULITE 2000 Androstenedione Calibration Verification Material, IMMULITE 2000 Troponin I Calibration Verification Material (K143636) | Siemens Healthcare Diagnostics, Inc. | 2015-02-25 |
| T-8000 THEROZONE UNIT (K141504) | Therozone USA, Inc. | 2015-02-24 |
| IntelliSense Drill (K143191) | Mcginley Innovations | 2015-02-20 |
| Osstell IDx (K142358) | Osstell AB | 2015-02-19 |
| Maxima XTEND Handpiece Maintenance System (K143183) | Handpiece Headquarters | 2015-02-17 |
| Powder Free Nitrile Patient Examination Glove, Black Colored, Non-Sterile (K143131) | Kossan International Sdn Bhd | 2015-02-12 |
| Non-Sterile, Powder Free Scented Blue Nitrile Examination Gloves - Grape, Apple, Peppermint, Vanilla (K143055) | Yty Industry (Manjung) Sdn Bhd | 2015-02-12 |
| NITRILE EXAMINATION GLOVES WITH ALOE & VITAMIN E, POWDER- FREE (K142685) | Siam Sempermed Corp., Ltd. | 2015-02-11 |
| POWDER FREE NITRILE EXAMINATION GLOVE, WHITE (colored) (K142858) | Careplus (M) Sdn Bhd | 2015-02-09 |
| DERMAGRIP POWDER FREE BLUE NITRILE PATIENT EXAMINATION GLOVES, NON-STERILE, TESTED FOR USE WITH CHEMOTHERAPY DRUGS (K141982) | Wrp Asia Pacific Sdn. Bhd. | 2015-02-05 |
| LDLC3 LDL-Cholesterol Gen.3 (K143691) | Roche Diagnostics Operations (Rdo) | 2015-01-28 |
| ADVIA Centaur IgE Master Curve Material (K143680) | Siemens Healthcare Diagnostics, Inc. | 2015-01-27 |
| IMMULITE 2000 CEA Calibration Verification Material (K143639) | Siemens Healthcare Diagnostics | 2015-01-23 |
| Audit MicroControls Linearity LQ Cystatin-C (K143571) | Aalto Scientific, Ltd. | 2015-01-23 |
| Powder Free Nitrile Examination Gloves, Nonsterile,(Blue,Black, and White Colored) (K143247) | Central Medicare Sdn Bhd | 2015-01-22 |
| Audit MicroControls Linearity FD Tumor Markers II (K143573) | Aalto Scientific, Ltd. | 2015-01-16 |
| Non-Sterile, Powder Free Nitrile Examination Gloves (Blue, Black and White Color) (K142283) | Yty Industry (Manjung) Sdn Bhd | 2015-01-16 |
| POWDER FREE NITRILE EXAMINATION GLOVE, BLUE (Colored). (K142862) | Careplus (M) Sdn Bhd | 2015-01-16 |
| Powder-free PVC Vinyl Exam Gloves (K142703) | Hebei Grandeast Plastic Products Co., Ltd. | 2015-01-15 |
| JIUYUAN POWDER-FREE YELLOW SYNTHETIC VINYL PATIENT EXAMINATION GLOVES (K141224) | Shijiazhunag Jiuyuan Plastic Co., Ltd. | 2015-01-15 |
| 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 |
| Puritan OptiTranz Liquid Stuart Collection and Transport System (K142366) | Puritan Medical Products, LLC | 2015-01-09 |
| S200, S300 (K133412) | Cefla S.C. | 2015-01-08 |
| ZX-27 (K133088) | M&M Dental Studio, Inc. | 2015-01-02 |
| AEU-6000 IMPLANT / ENDODONTIC DENTAL SYSTEM (K142124) | Aseptico, Inc. | 2014-12-31 |
| NON-STERILE ORS-400N SCOPE PILLOW WARMER DRAPE (K142173) | Ecolab, Inc. | 2014-12-30 |
| HONGYUN POWDER-FREE YELLOW VINYL PATIENT EXAMINATION GLOVES (K141878) | Tangshan Hongyun Plastic Products Co., Ltd. | 2014-12-24 |
| IMMULITE 2000 Ferritin Calibration Verification Material, IMMULITE 2000 IGFBP-3 Calibration Verification Material (K143352) | Siemens Healthcare Diagnostics, Inc. | 2014-12-24 |
| ADIVA Centaur Progesterone Master Curve Material (MCM), ADIVA Centaur Ferritin Master Curve Material (K143376) | Siemens Healthcare Diagnostics, Inc. | 2014-12-23 |
| POWDER FREE NITRILE SURGICAL GLOVES, WHITE COLOR (BRAND NAME: TITANFINE) (K140989) | Hebei Hongsen Plastics Technology Co, Ltd. | 2014-12-22 |
| Xuanye Powder Free Vinyl Patient Examination Gloves, Clear (non-colored) (K142771) | Xuanhua Metallurgical Industry Co., Ltd. | 2014-12-22 |
| Powder Free Yellow Vinyl Patient Examination Gloves (K142508) | Zibo Huaqi Trading Co., Ltd. | 2014-12-19 |
| MEDLINE RENEWAL REPROCESSED GYRUS-DIEGO SINUS APPLICATION BLADES (K142022) | Medline Renewal | 2014-12-19 |
| NacrousPowder Free Vinyl Patient Examination Gloves, Clear (non-colored) (K142342) | Nacrous Plastic Co., Ltd. | 2014-12-18 |
| Nitrile Powder Free Examination Glove with Colloidal Oatmeal USP Skin Protectant Drug- Dark Violet Blue (DVBU) (K142805) | Hartalega Sdb. Bhd. | 2014-12-18 |