| VARIAX 2 SYSTEM (K132502) | Stryker Trauma AG | 2013-10-23 |
| ENDO GIA RADIAL RELOAD WITH TRI-STAPLE TECHNOLOGY (K132493) | Covidien, LLC | 2013-10-23 |
| RANDOX CSF CONTROLS LEVELS 2 AND 3 (K132156) | Randox Laboratories, Ltd. | 2013-10-23 |
| INNERSENSE ESOPHAGEAL TEMPERATURE PROBE / FEEDING TUBE (K131590) | Philips Medical Systems | 2013-10-23 |
| RENASYS EZ MAX NEGATIVE PRESSURE WOUND THERAPY DEVICE (K132446) | Smith & Nephew, Inc. | 2013-10-23 |
| OPTUM TELEHEALTH APPLICATION (K130971) | Optumhealth Care Solutions, Inc. | 2013-10-23 |
| EVOLUTION MP ADAPTIVE PS TIBIAL INSERT (K131679) | Wrightmedicaltechnologyinc | 2013-10-23 |
| IMMULITE 2000; HCG CALIBRATION VERIFICATION MATERIAL, INSULIN CALIBRATION VERIFICATION MATERIAL, PYRILINKS-D CALIBRATION (K133128) | Siemens Healthcare Diagnostics, Inc. | 2013-10-22 |
| GEM FLOW COUPLER DEVICE AND SYSTEM (K132727) | Synovis Life Technologies, Inc. | 2013-10-22 |
| PERIFLUX 6000 (K131253) | Perimed AB | 2013-10-22 |
| 5F & 6F LAUNCHER GUIDE CATHETER, 5F SHERPA ACTIVE NX GUIDE CATHETER, 6F Z4 GUIDING CATHETER (K132673) | Medtronic, Inc. | 2013-10-22 |
| MEDCOMP VASCU-PICC WITH VALVE (K130897) | Medcomp ( Medical Components) | 2013-10-22 |
| RANFAC BONE MARROW ASPIRATION NEEDLE (K131157) | Ranfac, Corp. | 2013-10-22 |
| TAUTONA INJECTOR DEVICE (K131963) | Tautona Group, LLC | 2013-10-22 |
| MULTICHEM S PLUS / S PLUS (ASSAYED) (K132751) | Techno-Path Manufacturing , Ltd. | 2013-10-22 |
| VISCOELASTIC INJECTOR (K132494) | Sight Sciences, Inc. | 2013-10-22 |
| OCCLUSION BALLOON CATHETER (K132990) | Boston Scientific Corp | 2013-10-22 |
| LESSER METATARSAL HEAD IMPLANT SYSTEM (K131187) | Solana Surgical, LLC | 2013-10-22 |
| SMITH & NEPHEW GLOBAL FEMORAL HEAD TRIALS (K132435) | Smith & Nephew, Inc. | 2013-10-22 |
| PURITAN AMIES MEDIUM COLLECTION AND TRANSPORT SYSTEM (K131630) | Puritan Medical Products, LLC | 2013-10-21 |
| NEO DENTA ZIRCONIA (K130198) | Neo Group Limited | 2013-10-21 |
| SWIFT AIR (K132013) | Resmed, Ltd. | 2013-10-21 |
| BIOPLEX 2200 APLS IGM (K130528) | Bio-Rad Laboratories | 2013-10-21 |
| GYRUS ACMI URO-EZDILATE URETERAL BALLOON DILATION CATHETER (K132181) | Olympus Surgical Technologies America | 2013-10-21 |
| ELECSYS CK-MB STAT IMMUNOASSAY, ELECSYS CK-MB IMMUNOASSAY (K132571) | Roche Diagnostics | 2013-10-18 |
| ECHELON ENDOSCOPIC LINEAR CUTTER RELOAD, BLACK (K131663) | Ethicon Endo-Surgery, LLC | 2013-10-18 |
| REMSTAR AUTO A-FLEX HT (K131982) | Respironics, Inc. | 2013-10-18 |
| MULTIFUNCTIONAL SERIES (K131859) | Beijing Honkon Technologies Co., Ltd. | 2013-10-18 |
| NO-PROFILE SCREWS NO-PROFILE WASHER NO-PROFILE SCREWS WASHERLOC WASHERS (K122437) | Biomet Sports Medicine | 2013-10-18 |
| ASA ORAL APPLIANCES (K130504) | American Sleep Association | 2013-10-18 |
| DIREXION AND DIREXION HI-FLO TORQUEABLE MICROCATHETERS (K132947) | Boston Scientific Corp | 2013-10-18 |
| LENSTEC LC INJECTION SYSTEM (K122848) | Lenstec, Inc. | 2013-10-18 |
| PHILIPS HEARTSTART FR3 AUTOMATED EXTERNAL DEFIBRILLATOR (K130684) | Philips Medical Systems | 2013-10-18 |
| QUICKPROFILE SINGLE DRUG OF ABUSE DEVICE AND QUICK PROFILE MULTI-DRUGS OF ABUSE SCREEN DEVICE (K130213) | Lumiquick Diagnostics, Inc. | 2013-10-18 |
| CRANIAL MAP NEURO (K131214) | Stryker Corporate | 2013-10-18 |
| PROVOX VEGA PUNCTURE SET (K131947) | Atos Medical AB | 2013-10-18 |
| RAPIDFRET ORAL FLUID ASSAY FOR THC, THC CALIBRATOR SET, THC CONTROL SET, COLLECTOR (K132096) | Biophor Diagnostics, Inc. | 2013-10-18 |
| TRANSCEND AUTO (K132127) | Somnetics International, Inc. | 2013-10-17 |
| TRUE SPINAL FIXATION SYSTEM (K130958) | Innovative Surgical Designs | 2013-10-17 |
| DYONICS PLAN HIP IMPINGEMENT PLANNING SYSTEM (K132636) | Smith & Nephew, Inc. | 2013-10-17 |
| UNIVERSAL NEURO 3 SYSTEM (K131775) | Stryker | 2013-10-17 |
| BIOROOT RCS (K130601) | Novocol, Inc. | 2013-10-17 |
| NBM-200MP (K124041) | Orsense, Ltd. | 2013-10-17 |
| GLOOKO DEVICE SYSTEM FOR GLOOKO APPLICATION (K132272) | Glooko, Inc. | 2013-10-17 |
| FOCUS BLOOD GLUCOSE MONITORING SYSTEM, FOCUS PRO BLOOD GLUCOSE MONITORING SYSTEM (K131013) | Nova Biomedical Corporation | 2013-10-17 |
| LEGACY MEDICAL ECO-CHOICE DISPOSABLE BLOOD PRESSURE CUFF (K130942) | Legacy Medical, Inc. | 2013-10-17 |
| SOMNOLYZER 24X7 (K131994) | Respironics, Inc. | 2013-10-17 |
| INTELLIVUE PATIENT MONITOR MX500, INTELLIVUE PATIENT MONITOR MX550 (K131872) | Philips Medizinsysteme Boeblingen GmbH, Cardiac AN | 2013-10-17 |
| STERLING OVER-THE-WIRE (OTW) PTA BALLOON DILATATION CATHETER (K132430) | Boston Scientific Corp | 2013-10-17 |
| RESPIGUIDE DELIVERY SYSTEM (K130378) | Respicardia | 2013-10-17 |
| MRSA/SA ELITE MGB, ELITE MGB SOFTWARE (K132468) | Elitechgroup Epoch Biosciences | 2013-10-17 |
| SAPPHIRE INFUSION PUMP (K123049) | Q Core Medical , Ltd. | 2013-10-17 |
| HARMONIC ACE+ SHEARS 23 CM LENGTH WITH ADVANCED HEMOSTASIS, HARMONIC ACE + LAPAROSCOPIC SHEARS 36 CM LENGTH WITH ADVANCE (K132612) | Ethicon Endo-Surgery, LLC | 2013-10-17 |
| APTIMA COMBO 2 ASSAY (PANTHER SYSTEM) (K132251) | Hologic / Gen-Probe Incorporated | 2013-10-17 |
| AAP K-WIRE, STEINMANN PIN, CERCLAGE WIRE (K131459) | Aap Implantate AG | 2013-10-17 |
| IMAGENET 5 PC SOFTWARE SYSTEM (K132438) | Topcon Medical Systems, Inc. | 2013-10-17 |
| TVC IMAGING SYSTEM, TVC INSIGHT CATHETER (K130719) | Infraredx, Inc. | 2013-10-17 |
| SITE-RITE VISION II ULTRASOUND SYSTEM (K132942) | C.R. Bard, Inc. | 2013-10-17 |
| UNIVATION (K131167) | Aesculap Implant Systems, LLC | 2013-10-17 |
| VANTAGE TITAN 3T (K132160) | Toshibamedical Systems Corporation | 2013-10-16 |
| SMOOTH OR THREADED METALLIC BONE FASTENER (K131640) | Biomedical Ent., Inc. | 2013-10-16 |
| OVATION 10/12 HIP STEM (K131022) | Ortho Development Corp. | 2013-10-16 |
| FINGERTIP PULSE OXIMETER (K131047) | Beijing Choice Electronic Technololgy Co., Ltd. | 2013-10-16 |
| PROW FUSION (K130254) | Nlt Spine, Ltd. | 2013-10-16 |
| AEQUALIS SHOULDER FRACTURE SYSTEM, AEQUALIS REVERSED SHOULDER PROSTHESIS, AEQUALIS REVERSED FRACTURE SHOULDER PROTHESIS (K131231) | Tornier S.A.S. | 2013-10-16 |
| MEDLINE SUCTION COAGULATOR (K122949) | Medline Industries, Inc. | 2013-10-16 |
| .DECIMAL PROTON APERTURE (K132236) | .Decimal, Inc. | 2013-10-16 |
| PEDIATRIC FOLDING WHEELCHAIR (K130644) | Columbia Medical Mfg, LLC | 2013-10-16 |
| A.I.M. SUTURE ANCHOR (K132461) | Anchor Innovation Medical, Inc. | 2013-10-16 |
| NASAL COMFORT FREEDOM (K130686) | Lakeview Sleep Center | 2013-10-16 |
| IFUSE IMPLANT SYSTEM (K131405) | SI-BONE, Inc. | 2013-10-16 |
| BRAEMAR CARDIOKEY HOLTER RECORDER (K130294) | Braemar Manufacturing, LLC | 2013-10-16 |
| ADVIA CHEMISTRY ALBUMIN BCP REAGENT (ALBP), ADVIA CHEMISTRY ALBUMIN BCP CALIBRATOR (K132664) | Siemens Healthcare Diagnostics, Inc. | 2013-10-16 |
| ENDOCHOICE HOT BIOPSY FORCEPS (K131991) | Endochoice, Inc. | 2013-10-15 |
| NON-CONTACT INFRARED THERMOMETER (K130231) | Jinxinbao Electronic Co.,Ltd | 2013-10-15 |
| MULTICHEM U (K131993) | Techno-Path Manufacturing , Ltd. | 2013-10-15 |
| LUNGPOINT TOOLS (LUNGPOINT SHEATH, LUNGPOINT DILATION BALLOON) (K131234) | Broncus Medical, Inc. | 2013-10-15 |
| ACUSON S2000 AND S3000 (K130881) | Siemens Medical Solutions USA, Inc. | 2013-10-11 |
| MODIFIED CONCENTRIC MICROCATHETER (K131437) | Concentric Medical, Inc. | 2013-10-11 |
| REVERSE MEDICAL MICROCATHETER (K130858) | Reverse Medical Corporation | 2013-10-11 |
| SEATTLE - PAP (K131502) | Seattle Childrens Hospital | 2013-10-11 |
| KATANA ZIRCONIA (K131534) | Kuraray Noritake Dental, Inc. | 2013-10-11 |
| PRECICE INTRAMEDULLARY LIMB LENGTHENING SYSTEM (K131677) | Ellipse Technologies, Inc. | 2013-10-11 |
| 2008T HEMODIALYSIS MACHINE WITH OPTIONAL CRIT-LINE MONITOR (CLIC) (K131908) | Fresenius Medical Care Renal Therapies Group, LLC | 2013-10-11 |
| ACCU-CHEK AVIVA EXPERT BLOOD GLUCOSE MONITORING SYSTEM (K131366) | Roche Diagnostics Operations, Inc. | 2013-10-11 |
| OPTETRAK LOGIC PS 17MM & 19MM THICK INSERTS, OPTETRAK LOGIC PSC 17MM & 19MM THICK INSERTS (K132161) | Exactech, Inc. | 2013-10-11 |
| CLASSIC INTERMITTENT CATHETER (K132619) | Flexicare Medical, Ltd. | 2013-10-11 |
| IMDX C.DIFFICILE FOR ABBOTT M2000 (K132235) | Intelligent Medical Devices, Inc. | 2013-10-11 |
| BASIC AND DOMINANT FLEX SUCTION PUMPS (K130123) | Medela AG | 2013-10-11 |
| MTM(R) CLEAR ALIGNER (K132145) | Dentsply International, Inc. | 2013-10-11 |
| HIGH ENERGY LINEAR ACCELERATOR (K131807) | Varian Medical Systems, Inc. | 2013-10-11 |
| BALANCED KNEE SYSTEM HIGH FLEX VITAMIN E PS TIBIAL INSERT AND PATELLA (K131337) | Ortho Development Corp. | 2013-10-11 |
| THERAFLOW SINGLE LUMEN AND THERAFLOW DUAL LUMEN (K131023) | Medical Products, LLC | 2013-10-11 |
| AUDICOR CPAM WITH SDB (SINGLE SENSOR) (K130660) | Inovise Medical, Inc. | 2013-10-11 |
| PPA/BT-RB STETHOSCOPE (K132405) | Rnk Products, Inc. | 2013-10-11 |
| TURBO-JECT PERIPHERALLY INSERTED CENTRAL VENOUS CATHETER (PICC) SET (K132885) | Cook Incorporated | 2013-10-11 |
| PCP-USB STETHOSCOPE (K132560) | Rnk Products, Inc. | 2013-10-11 |
| IDYS LIF CAGES (K131178) | Clariance | 2013-10-10 |
| INERTIA MIS PEDICLE SCREW SYSTEM (K132412) | Nexxt Spine, LLC | 2013-10-10 |
| IMMULITE 2000 ACTH CALIBRATION VERIFICATION MATERIAL (K131662) | Siemens Healthcare Diagnostics, Inc. | 2013-10-10 |