| SOMNODENT HERBST; CLASSIC, FLEX (K130558) | Somnomed, Inc. | 2013-05-17 |
| SCOPEVALET DISPOSABLE BIOPSY VALVE (K122417) | The Ruhof Corp. | 2013-05-17 |
| NEODENT IMPLANT SYSTEM (K123022) | Jjgc Industria E Comercio DE Materiais Dentarios S | 2013-05-17 |
| ERCHONIA VERJU LASER SYSTEM WITH MASSAGER (K130922) | Erchonia Medical, Inc. | 2013-05-17 |
| BREATHE CPAP SYSTEM (K130037) | Breathe Technologies, Inc. | 2013-05-17 |
| SALTO TALARIS TOTAL ANKLE PROSTHESIS, RHS (K130533) | Tornier S.A.S. | 2013-05-17 |
| MAGNETOM SKYRA (K123510) | Siemens Medical Solutions USA, Inc. | 2013-05-17 |
| OEC BRIVO 865 ADVANCE, OEC BRIVO 785 ESSENTIAL, AND OEC BRIVO 715 PRIME (K123603) | Ge Healthcare Surgery GE Oec Medical Systems, Inc. | 2013-05-17 |
| AESCULAP HISTOACRYL FLEXIBLE TOPICAL SKIN ADHESIVE (K121976) | Aesculap, Inc. | 2013-05-17 |
| HUMAN IGM CSF KIT (K120750) | The Binding Site Group , Ltd. | 2013-05-17 |
| PORTABLE X-RAY SYSTEM (K122124) | Osstem Implant Co., Ltd. | 2013-05-16 |
| FORACARE GD20 BLOOD GLUCOSE MONITORING SYSTEM (K124040) | Taidoc Technology Corporation | 2013-05-16 |
| ARTIS ZEE/ZEEGO WITH CSX-10 DETECTOR SW VC21 (K122644) | Siemens Medical Solutions USA, Inc. | 2013-05-16 |
| SHARPOINT POLYPROPYLENE SURGICAL SUTURE, LOOK POLYPROPYLENE SURGICAL SUTURE, QUILL POLYPROPYLENE KNOTLESS TISSUE-CLOSURE (K131224) | Surgical Specialties Corp. Dba Angiotech | 2013-05-16 |
| ELITE-I (BI) DUAL LUMEN CATHETER; ELITE-I (RA) DUAL LUMEN CATHETER; ELITE-I (BIX)DUAL LUMEN CATHETER (K130639) | Maquet Cardiopulmonary, AG | 2013-05-16 |
| MOBILECT VIEWER (K123082) | Nephosity, Inc. | 2013-05-16 |
| GATEWAY ADVANAGE Y-ADAPTER (K130909) | Boston Scientific Corp | 2013-05-16 |
| VINTAGE MP PRESS OVER (K122614) | Shofu Dental Corporation | 2013-05-16 |
| CRYSTALSERT DELIVERY SYSTEM (K123736) | Bausch & Lomb | 2013-05-16 |
| 4D VIEW (K131118) | GE Healthcare | 2013-05-16 |
| AEROBIKA POSITIVE EXPIRATORY PRESSURE DEVICE (K123400) | Trudell Medical Intl. | 2013-05-16 |
| BRUXZIR SHADED (K130924) | Prismatik Dentalcraft, Inc. | 2013-05-16 |
| PASCAL SYNTHESIS (532NM/577NM) OPTHALMIC LASER (K123542) | Topcon Medical Laser Systems, Inc. | 2013-05-15 |
| EASYRA CREATININE REAGENT (K123586) | Medica Corporation | 2013-05-15 |
| WRIST AUTOMATIC BLOOD PRESSURE MONITOR (K123800) | Little Doctor Electronic (Nantong)Co.,Ltd | 2013-05-15 |
| VITROS CHEMISTRY PRODUCTS HCY 2 REAGENT, CALIBRATOR KIT 27, HCY 2 PERFORMANCE VERIFIERS I, II AND III (K123930) | Ortho-Clinical Diagnostics, Inc. | 2013-05-15 |
| BARD DENALI FILTER SYSTEM- FEMORAL DELIVERY KIT AND JUGULAR DELIVERY KIT (K130366) | C.R. Bard, Inc. | 2013-05-15 |
| UCP HOME DRUG SCREENING TEST; CARDS, CUPS (K130463) | Ucp Biosciences, Inc. | 2013-05-15 |
| GENESISPLUS (K122493) | Cutera, Inc. | 2013-05-15 |
| NBX - NON BRIDGING EXTERNAL FIXATOR HAND (K122777) | Nutek Orthopaedics, Inc. | 2013-05-15 |
| SAUFLON MULTIPURPOSE SOLUTION (K130734) | Sauflon Pharmaceuticals, Ltd. | 2013-05-15 |
| ALERE CHOLESTECH LDX ANALYZER, ALERE CHOLESTECH LDX LIPID PROFILE - GLU CASSETTE (K120615) | Alere San Diego Inc. Dba Biosite,Innovacon,Hemosen | 2013-05-15 |
| 3F PRO-PICC (K123617) | Medical Components, Inc. | 2013-05-15 |
| EXTRA CORPOREAL SHOCKWAVE LITHOTRIPTER (K130729) | Dornier Medtech Systems | 2013-05-14 |
| SPEED SHIFT (K124022) | Biomedical Enterprises, Inc. | 2013-05-14 |
| SENSUS HEALTHCARE SUPERFICIAL RADIOTHERAPY SYSTEM SRT-100 (K123985) | Sensus Healthcare | 2013-05-14 |
| ATRICLIP GILLINOV-COSGROVE LAA CLIP (K131107) | AtriCure, Inc. | 2013-05-14 |
| VASCULAR CLAMPS (K123077) | Hebumedical GmbH | 2013-05-14 |
| KOBOLD FLETCHER TYPE APPLICATOR SET, KOBOLD HENSCHKE TYPE APPLICATOR SET (K123912) | Spencer Fillmore | 2013-05-14 |
| HYDROSIL; MAGIC; PERSONAL CATHETER (K122785) | Rochester Medical Corp. | 2013-05-14 |
| ITCLAMP 50 (K123551) | Innovative Trauma Care, Inc. | 2013-05-14 |
| ILIZAROV DRILL TIP WIRES (K130479) | Smith & Nephew, Inc. | 2013-05-14 |
| LSH (MANGOFILCON A) SPHERE SOFT (HYDROPHILIC) CONTACT LENS, LSH (MANGOFILCON A) MULTIFOCAL SOFT (HYDROPHILIC) CONTACT LE (K120756) | The Lagado Corp. | 2013-05-13 |
| LATIS SPACER (K123913) | Globus Medical, Inc. | 2013-05-13 |
| MICROLIFE UPPER ARM AUTOMATIC DIGITAL BLOOD PRESSURE MONITOR, CARDIO+ (BP4GAPO-2M) (K122013) | Microlife Corp. | 2013-05-13 |
| QLAB QUANTIFICATION SOFTWARE HEART MODEL (K130159) | Philips Health Care | 2013-05-13 |
| FINESSIS POLYISOPRENE POWDERFREE SURGICAL GLOVES (K123629) | Lucenxia Prescience AG | 2013-05-13 |
| CREO STABILIZATION SYSTEM (K124058) | Globus Medical, Inc. | 2013-05-13 |
| BACTEC Lytic/10 Anaerobic/F Culture Vials (plastic) (K123903) | Becton, Dickinson & CO | 2013-05-13 |
| REMINGTON MEDICAL CENTREFIRE 22 BIOPSY INSTRUMENT (K130282) | Remington Medical, Inc. | 2013-05-13 |
| IMSE P-TLIF (K130506) | Institute of Musculoskeletal Science & Education | 2013-05-13 |
| AG MASS (K131099) | Hospitech Respiration , Ltd. | 2013-05-13 |
| TORNIER INSITE FT BIOCOMPOSITE SUTURE ANCHOR (K122635) | Tornier, Inc. | 2013-05-13 |
| EUROTROL HEMATOCRIT CONTROL (K121467) | Eurotrol B.V. | 2013-05-10 |
| FINGERTIP PULSE OXIMETER (K123871) | Beijing Choice Electronic Technololgy Co., Ltd. | 2013-05-10 |
| STINGRAY BIPOLAR FORCEPS (K123478) | Stingray Surgical Products | 2013-05-10 |
| RAYSTATION (K130617) | Raysearch Laboratories AB | 2013-05-10 |
| HYPERION X9 (K123381) | Cefla S.C. | 2013-05-10 |
| TRC-NW8 NON-MYDRIATIC RETINAL CAMERA (K130289) | Topcon Corp. | 2013-05-10 |
| BOSTON KERATOPROSTHESIS OR BOSTON KPRO (K121203) | Massachusetts Eye & Ear Infirmary | 2013-05-10 |
| SM TENS & PMS (K121719) | Hong Qiangxing (Shenzhen) Electronics Limited | 2013-05-10 |
| ZX-I POWER ADD ON (K123769) | Spinergy, Inc. | 2013-05-10 |
| NEXTSTEP RETROGRADE (K130192) | Arrow International, Inc. | 2013-05-10 |
| VITAL SYNC INFORMATICS MANAGER & VIRTUAL PATIENT MONITORING PLATFORM (K130796) | Covidien | 2013-05-09 |
| TEMPERATURE SENSOR CATHETER (K131020) | Degania Silicone , Ltd. | 2013-05-09 |
| VARIANT(TM) II TURBO HBA1C KIT - 2.0 (K130990) | Bio-Rad Laboratories, Inc., Clinical Systems Divis | 2013-05-09 |
| INTEGRA LAMINOPLASTY SYSTEM (K130830) | Seaspine, Inc. | 2013-05-09 |
| X-RAY ATTENUATING CREAM (DEN120022) | Bloxr Corporation | 2013-05-09 |
| ZIMMER TRABECULAR METAL REVERSE SHOULDER SYSTEM (K130661) | Zimmer, Inc. | 2013-05-09 |
| SAKURA STEAM STERILIZAER MODEL ASSV-AH06; SAKURA STEAM STERILIZER MODEL ASSV-AH06E; SKYTRON INTEGRITY 175; SKYTRON INTEG (K122774) | Sakura Seiki Co., Ltd. | 2013-05-09 |
| NMI PICC MAXIMAL BARRIER NURSING KITS (K131038) | Navilyst Medical, Inc. | 2013-05-09 |
| NELLCOR OXIMAX N-600X PULSE OXIMETER, NELLCOR BEDSIDE RESPIRATORY PATIENT MONITORING SYSTEM, NELLCOR BEDSIDE SPO2 PATIEN (K123581) | Covidien, Formerly Nellcor Puritan Bennett, Inc. | 2013-05-09 |
| RANGE SPINAL SYSTEM (K131030) | K2m, Inc. | 2013-05-09 |
| UNITOX BOTOX SYRINGE (K123710) | Bio-Med USA, Inc. | 2013-05-09 |
| BEACON TISSUE MARKER (K130763) | Scion Medical Technologies, LLC | 2013-05-08 |
| OLYMPIC BRAINZ MONITOR (K123079) | Excel-Tech Ltd. (Xltek) | 2013-05-08 |
| RESPONSE SPINE SYSTEM (K130655) | OrthoPediatrics Corp. | 2013-05-08 |
| SOL-CARE SAFETY NEEDLE (K123684) | Sol-Millennium Medical | 2013-05-08 |
| RANGE SPINAL SYSTEM, SMALL STATURE (K122877) | K2m, Inc. | 2013-05-08 |
| VOLISTA 400; VOLISTA 600 (K130513) | Maquet S.A.S. | 2013-05-08 |
| MEDLINE BLOOD PRESSURE TRANSDUCER (K123095) | Medline Industries, Inc. | 2013-05-08 |
| GRIDLOCK PLATING SYSTEM (K130964) | Trilliant Surgical, Ltd. | 2013-05-08 |
| TEPHAFLEX MELTBLOWN CONSTRUCT (K130326) | Tepha, Inc. | 2013-05-07 |
| DILATOR TUBE SET (K120590) | Koros USA, Inc. | 2013-05-07 |
| HOVEROUND TEKNIQUE (K122741) | Hoveround Corp. | 2013-05-07 |
| PROTEUS PATCH, INGESTIBLE SENSOR (ACCESSORY) (K131009) | Proteus Digital Health, Inc. | 2013-05-07 |
| ABL90 FLEX (K123748) | Radiometer Medical Aps | 2013-05-07 |
| FORSURE ONE STEP BUPRENORPHINE CUP TEST DEVICE (K122064) | Tianjin New Bay Bioresearch Co., Ltd. | 2013-05-07 |
| QUANTA FLASH ENA7 (K122923) | Inova Diagnostics, Inc. | 2013-05-07 |
| HOVERROUND TEKNIQUE (K122707) | Hoveround Corp. | 2013-05-07 |
| PUREFLUX-H HEMODIALYZER (K122343) | Nipro Medical Corporation | 2013-05-07 |
| CONI (K130624) | Globalmed | 2013-05-07 |
| LATEX POWDER FREE EXAMINATION GLOVES WITH COLLOIDAL OATMEAL USP SKIN PROTECTANT (K123368) | Hartalega Sdn Bhd | 2013-05-07 |
| AZURE ANTERIOR CERVICAL PLATE SYSTEM (K130825) | Orthofix, Inc. | 2013-05-07 |
| UNITRON TINNITUS MASKER FEATURE (K130494) | Unitron Hearing | 2013-05-07 |
| EMPI PHOENIX (K124016) | Djo, LLC | 2013-05-06 |
| ORTHOCOR ACTIVE DEVICE ORTHOCOR GENERAL USE ACTIVE DEVICE (K121702) | Orthocor Medical | 2013-05-06 |
| MODEL NUMBER: RMS1-2604, RMS1-2614, RMS1-2404, RMS1-2414, RMS2-2604, RMS2-2614, RMS2-2404, RMS2-2414, RMS3-2604, RMS3-26 (K122404) | Repro-Med Systems, Inc. Dba Rms Medical Products | 2013-05-06 |
| LIQUICHEK PEDIATRIC CONTROL, LEVEL 1; LIQUICHEK PEDIATRIC CONTOL, LEVEL 2; LIQUICHEK PEDIATRIC CONTROL, BILEVEL MINIPAK (K130963) | Bio-Rad Laboratories, Inc. | 2013-05-06 |
| BIODENTA DENTAL IMPLANT SYSTEM - ABUTMENTS (K122559) | Biodenta Swiss AG | 2013-05-03 |