| INFLAMMA DRY (K132066) | Rapid Pathogen Screening, Inc. | 2013-11-21 |
| MISEQDX UNIVERSAL KIT 1.0 (DEN130042) | Illumina, Inc. | 2013-11-19 |
| BD VERITOR SYSTEM FOR THE RAPID DETECTION OF RSV (K133140) | Becton, Dickinson & CO | 2013-11-15 |
| MICROCYN SCAR MANAGEMENT HYDROGEL (K131672) | Oculus Innovative Sciences | 2013-11-15 |
| SHANGHAI PHOENIX MECHANICAL WHEELCHAIR (K130848) | Shanghai Phoenix Medical Equipment Co., Ltd. | 2013-11-12 |
| BYTECH (K130101) | Bytech Dongtai Co., Ltd. | 2013-11-08 |
| BD VERITOR (TM) SYSTEM FOR RAPID DETECTION OF RSV (K132456) | Becton, Dickinson and Company | 2013-11-07 |
| KIMBERLY-CLARK LAVENDER NITRILE POWDER-FREE EXAM GLOVE (K131841) | Kimberly-Clark Corp. | 2013-11-07 |
| STERILE NITRILE POWDER FREE EXAMINATION GLOVE(VBLU), STERLE NITRILE POWDER FREE EXAMINATION GLOVE(ABLU) (K132006) | Hartalega Sdn Bhd | 2013-11-07 |
| EM SINUS DILATION SYSTEM (K132297) | Medtronic Xomed, Inc. | 2013-11-05 |
| IMMULITE 2000; 3GALLERGY SPECIFIC IGE CONTROL VERIFICATION MATERIAL (CVM), TOTAL IGE CONTROL VERIFICATION MATERIAL (CVM) (K133122) | Siemens Healthcare Diagnostics, Inc. | 2013-10-30 |
| DIPLOMAT (K130534) | Diplomat Dental S.R.O. | 2013-10-30 |
| TX WHEELCHAIR CHASSIS (K131336) | Jcm Seating Solutions, Ltd. | 2013-10-28 |
| LIQUICHEK IMMUNOASSAY PREMIUM CONTROL-TRILEVEL, LIQUICHEK IMMUNOASSAY PREMIUM CONTROL-LEVEL I, LIQUICHEK IMMUNOASSAY (K132227) | Bio-Rad Laboratories | 2013-10-25 |
| IMMULITE 2000; TOTAL T3 CALIBRATION VERIFICATION MATERIAL, TOTAL T4 CALIBRATION VERIFICATION MATERIAL, TOTAL TBG CALIBRA (K133124) | Siemens Healthcare Diagnostics, Inc. | 2013-10-25 |
| RIGHTEST CONTROL SOLUTION (K133003) | Bionime Corporation | 2013-10-24 |
| RANDOX CSF CONTROLS LEVELS 2 AND 3 (K132156) | Randox Laboratories, Ltd. | 2013-10-23 |
| IMMULITE 2000; HCG CALIBRATION VERIFICATION MATERIAL, INSULIN CALIBRATION VERIFICATION MATERIAL, PYRILINKS-D CALIBRATION (K133128) | Siemens Healthcare Diagnostics, Inc. | 2013-10-22 |
| MULTICHEM S PLUS / S PLUS (ASSAYED) (K132751) | Techno-Path Manufacturing , Ltd. | 2013-10-22 |
| PURITAN AMIES MEDIUM COLLECTION AND TRANSPORT SYSTEM (K131630) | Puritan Medical Products, LLC | 2013-10-21 |
| LENSTEC LC INJECTION SYSTEM (K122848) | Lenstec, Inc. | 2013-10-18 |
| PEDIATRIC FOLDING WHEELCHAIR (K130644) | Columbia Medical Mfg, LLC | 2013-10-16 |
| MULTICHEM U (K131993) | Techno-Path Manufacturing , Ltd. | 2013-10-15 |
| IMMULITE 2000 ACTH CALIBRATION VERIFICATION MATERIAL (K131662) | Siemens Healthcare Diagnostics, Inc. | 2013-10-10 |
| VIDAS C DIFFICILE GDH (K132010) | Biomerieux S.A. | 2013-10-09 |
| INTEL-GE CARE INNOVATIONS QUIETCARE (K131585) | Intel-Ge Care Innovations, LLC | 2013-10-08 |
| V8 SP NORMAL CONTROL, ABNORMAL CONTROL (K131479) | Helena Laboratories | 2013-10-07 |
| THORATRAK MICS RETRACTOR SYSTEM, RACK, BLADES (K132645) | Medtronic, Inc. | 2013-10-04 |
| SINUS DILATION SYSTEM WITH CANNULATED INSTRUMENT (K131709) | Arthrocare Corp. | 2013-10-04 |
| XPRESS MULTI-SINUS DILATION TOOL (K132440) | Entellus Medical, Inc. | 2013-10-04 |
| MOTEX POWDER-FREE NITRILE SURGICAL GLOVES (K122557) | Shanghai Motex Healthcare Co., Ltd. | 2013-10-03 |
| COLONGLIDE(R) LUBRICANT (K131617) | Pediatric Pharmaceuticals, Inc. | 2013-10-03 |
| WIRED MOUTH PROTECTOR (WMP) (K131396) | Elba Laboratories, Inc. | 2013-09-30 |
| MASTERTORQUE LUX 8900 L (K130560) | Kaltenbach & Voigt GmbH | 2013-09-27 |
| FINESSIS VIOLET ELEMENT POLYISOPRENE POWDERFREE STERILE SURGICAL GLOVES (K131751) | Lucenxia Prescience AG | 2013-09-25 |
| MULTICHEM P (K131992) | Techno-Path Manufacturing , Ltd. | 2013-09-25 |
| 430 SWL 45 AND 430 SW 45 HIGH-SPEED HANDPIECES (K130455) | Dentalez Group, Stardental Division | 2013-09-25 |
| POWDER FREE NITRILE PATIENT EXAMINATION GLOVES, BLUE (K131440) | Hebei Hongsen Plastics Technology Co, Ltd. | 2013-09-25 |
| SHENGGUANG MANUAL WHEELCHAIR (K131529) | Pingdingshan Shenxing Healthcare Technology Co., L | 2013-09-24 |
| MULTICHEM WBT (K132174) | Techno-Path Manufacturing , Ltd. | 2013-09-20 |
| MULTICHEM IA AND IA PLUS (K132091) | Techno-Path Manufacturing , Ltd. | 2013-09-20 |
| IMMULITE 2000 ANTI-TG AB CALIBRATION VERIFICATION MATERIAL, IMMULITE 2000 ANTI-TPO AB CALIBRATION VERIFICATIN MATERIAL (K132391) | Siemens Helathcare Diagnostics, Inc. | 2013-09-20 |
| SINUFLUSH LAVAGE SYSTEM (K131177) | Hedgepath, LLC | 2013-09-20 |
| CRYSTALSERT DELIVERY SYSTEM (K132593) | Bausch & Lomb | 2013-09-17 |
| IPROPHY MOBILE (K131578) | Nakanishi, Inc. | 2013-09-12 |
| POWER FREE VINYL EXAMINATION GLOVES (K122102) | Wang Tong Xinghua Co., Ltd. | 2013-09-09 |
| POWDER FREE NATURAL RUBBER LATEX EXAMINATION GLOVES (K121844) | Worldmed Manufacturing Sdn. Bhd. | 2013-09-06 |
| PICTZAR DIGITAL PLANIMETRY SOFTWARE APPLICATION 7.0 (K130165) | Advanced Planimetric Services, LLC | 2013-08-30 |
| POWDERED LATEX SURGEON'S GLOVE (K121925) | Suzhou Colour-Way Enterprise Development Co., Ltd. | 2013-08-28 |
| LATEX SURGEON'S GLOVES (POWDERED AND POWDER FREE) (K130301) | Elimedical Devices (Fujian), Inc. | 2013-08-22 |
| POWDERED VINYL EXAMINATION GLOVES (K122100) | Wang Tong Xinghua Co., Ltd. | 2013-08-22 |
| SAS FLUALERT A & B, SAS INFLUENZA A TEST (K132352) | Sa Scientific , Ltd. | 2013-08-22 |
| ENDO E CLASS (K123608) | Saeyang Microtech Co., Ltd. | 2013-08-16 |
| QUICKIE & ZIPPIE SERIES (K123975) | Sunrise Medical | 2013-08-16 |
| ENDO A CLASS (K123582) | Saeyang Microtech Co., Ltd. | 2013-08-16 |
| DYNASENSE SYSTEM (K130752) | Centauri Medical, Inc. | 2013-08-15 |
| SOFIA(R) RSV FIA (K130398) | Quidel Corp. | 2013-08-13 |
| IMMULITE 2000 PSA CALIBRATION VERIFICATION MATERIAL (K131536) | Siemens Healthcare Diagnostics, Inc. | 2013-08-12 |
| PANA SPRAY PLUS (K131014) | Nsk America Corp. | 2013-08-12 |
| PROFTHAND MECHANICAL WHEELCHAIR (K123076) | Harmony Hill International | 2013-08-09 |
| ZIMMER A.T.S. 4000TS AUTOMATIC TOURNIQUET SYSTEM (K123553) | Zimmer, Inc. | 2013-08-09 |
| MIDAS TOUCH, NITRILE EXAMINATION GLOVES, POWDER FREE, GREEN (K130846) | Industrial Clothings, Ltd. | 2013-08-08 |
| BD FACS SAMPLE PREP ASSISTANT III (K131301) | Becton, Dickinson & CO | 2013-08-02 |
| HBA1C CONTROL, LEVEL 1 AND LEVEL 2 (K131999) | Randox Laboratories, Ltd. | 2013-07-26 |
| CAPILLARYS IMMUNOTYPING, CAPILLARYS 2 INSTRUMENT, IT/IF CONTROL, CAPILLARYS 2 FLEX PIERCING INSTRUMENT (K130500) | Sebia | 2013-07-26 |
| DENTAL UNIT WITH CHAIR (K130410) | Xianyang North West Medical Instrument (Group) Co. | 2013-07-26 |
| EUROTROL GAS-ISE HCT QC AND EUROTROL GAS-ISE HCT LVM (K131595) | Eurotrol B.V. | 2013-07-26 |
| POWDERFREE LATEX EXAMINATION GLOVES COATED WITH ALLOGEL (K130667) | Preventive Care, Inc. | 2013-07-24 |
| GRAM-NEGATIVE QUICKFISH BC (K123418) | Advandx, Inc. | 2013-07-21 |
| ALDOLASE CONTROLS LEVEL 2, AND ALDOLASE CONTROL LEVEL 3 (K131776) | Randox Laboratories, Ltd. | 2013-07-18 |
| TQ-PREP WORKSTATION, PREPPLUS 2 WORKSTATION (K130253) | Beckman Coulter, Inc. | 2013-07-15 |
| DENTEK EASY BRUSH WITH FLUORIDE (K130186) | Den Tek Oral Care, Inc. | 2013-07-15 |
| REMEL XPECT FLU A&B (K131804) | Remel, Inc. | 2013-07-12 |
| DERMA HOOD (K131338) | Globalmedia Group, LLC | 2013-07-10 |
| NITRILE POWDER FREE EXAMINATION GLOVE (ABLU) (K130473) | Hartalega Sdn Bhd | 2013-07-05 |
| QUICK VUE INFLUENZA (K131599) | Quidel Corporation | 2013-07-05 |
| SOFIA INFLUENZA A+B FIA (K131606) | Quidel Corp. | 2013-07-05 |
| QUICKVUE INFLUENZA A+B (K131619) | Quidel Corp. | 2013-06-28 |
| LYRIC2 (K130790) | Phonak, LLC | 2013-06-27 |
| SPOTCHECK NEONATAL TOTAL GALACTOSE MICROPLATE REAGENT KIT (K121101) | Astoria-Pacific, Inc. | 2013-06-20 |
| RANDOX SPECIALITY CONTROL (I) LEVELS 1, 2 AND 3 (K130337) | Randox Laboratories Limited | 2013-06-19 |
| SOFIA STREP A FIA (K123793) | Quidel Corporation | 2013-06-17 |
| VINYL EXAMINATION POWDER FREE GLOVES, CLEAR (K123590) | Weilin Plastic and Rubber Products Co., Ltd. | 2013-06-17 |
| VALIDATE PSA CALIBRATION VERIFICATION/ LINEARITY TEST KIT MODEL 406 (K123127) | Maine Standards Co. | 2013-06-14 |
| PATHASSIST LED LIGHT FIBER (K130503) | Entellus Medical, Inc. | 2013-06-11 |
| HITACHI CLINICAL ANALYZER S TEST REAGENT CARTRIDGE ALT, HITACHI CLINICAL ANALYZER S TEST REAGENT CARTRIDGE AST (K120945) | Hitachi Chemical Diagnostics, Inc. | 2013-06-07 |
| VITROS CHEMISTRY PRODUCTS TRIG SLIDES (K130332) | Ortho-Clinical Diagnostics, Inc. | 2013-05-31 |
| GLUCOSE METER-CHECK SOLUTION FOR TAIDOC (K131136) | Bionostics, Inc. | 2013-05-31 |
| MEDIENT MIDDLE TURBINATE IMPLANT; (SINGLE PACK-1 PAIR, FOUR PACK-4 PAIR) (K130354) | Entrigue Surgical, Inc. | 2013-05-29 |
| STAY FRESH SKIN FOLD MANAGEMENT TEXTILE (K121898) | Quick-Med Technologies, Inc. | 2013-05-24 |
| BREATHID HP SYSTEM (K130524) | Exalenz Bioscience , Ltd. | 2013-05-22 |
| AIO HD OTOSCOPE (K123821) | Blue Focus | 2013-05-17 |
| CRYSTALSERT DELIVERY SYSTEM (K123736) | Bausch & Lomb | 2013-05-16 |
| FINESSIS POLYISOPRENE POWDERFREE SURGICAL GLOVES (K123629) | Lucenxia Prescience AG | 2013-05-13 |
| BACTEC Lytic/10 Anaerobic/F Culture Vials (plastic) (K123903) | Becton, Dickinson & CO | 2013-05-13 |
| LATEX POWDER FREE EXAMINATION GLOVES WITH COLLOIDAL OATMEAL USP SKIN PROTECTANT (K123368) | Hartalega Sdn Bhd | 2013-05-07 |
| LIQUICHEK PEDIATRIC CONTROL, LEVEL 1; LIQUICHEK PEDIATRIC CONTOL, LEVEL 2; LIQUICHEK PEDIATRIC CONTROL, BILEVEL MINIPAK (K130963) | Bio-Rad Laboratories, Inc. | 2013-05-06 |
| AUDIT MICROCV THERAPEUTIC DRUG (TDM) LINEARITY SET (K130762) | Aalto Scientific, Ltd. | 2013-04-29 |
| PAS ALCOVISOR MARS, PAS ALCOVISOR SATELLITE (K123470) | Pas Systems International, Inc. | 2013-04-29 |
| AUDIT MICROCV VITAMIN D LINEARITY SET (K130764) | Aalto Scientific, Ltd. | 2013-04-26 |