| TEETHMATE DESENSITZER SET TEETHMATE DESENSITIZER POWDER TEETHMATE DESENSITIZER LIQUID (K122421) | Kuraray Noritake Dental, Inc. | 2012-12-11 |
| AMBIENT TURBOFLASH 90 IFS (K120791) | Arthocare Corporation | 2012-12-11 |
| PROGRIP LAPAROSCOPIC SELF-FIXATING MESH (K123479) | Sofradim Production | 2012-12-11 |
| QUARK SERIES (K120146) | Cosmed Srl | 2012-12-11 |
| BPA-FREE MICROHYBID COMPOSITE (K120237) | Novocol, Inc. | 2012-12-11 |
| MAVRIC SL (K113394) | Ge Medical Systems, LLC | 2012-12-11 |
| MTA2 ROOT AND PULP MATERIALS (K122892) | Avalon Biomed, Inc. | 2012-12-11 |
| GLIDESHEATH SLENDER MODEL RM* ES6J10HQS, GLIDESHEATH SLENDER MODEL RM* ES6F16HQ, GLIDESHEATH SLENDER MODEL RM * RS6J10PQ (K122980) | Terumo Medical Corporation | 2012-12-11 |
| ANGLED XIVE MP ABUTMENT, ANGLED ANKYLOS (K122268) | Dentsply International | 2012-12-11 |
| NCS FISH-FIT MD SYSTEM FISH-FIT MD COMPASS MD (K120356) | Ncs Lab Srl | 2012-12-11 |
| PLEUR-EVAC SAHARA PLUS CONTINOUS REINFUSION AUTOTRANSFUSION SYSTEM (K120953) | Tlelflex Medical, Inc. | 2012-12-10 |
| POWDERED NITRILE EXAMINATION GLOVES, BLUE AND WHITE (K122874) | Nitrilist Gloves Manufacturing Sdn Bhd | 2012-12-10 |
| POWDER-FREE VINYL PATIENT EXAMINATION GLOVES, CLEAR(NON-COLORED) (K122828) | Shandong Hongxin Chemicals Co., Ltd. | 2012-12-10 |
| POWDER-FREE VINYL PATIENT EXAMINATION GLOVES, CLEAR(NON-COLORED) (K122835) | Yuanhang Plastic Co., Ltd. | 2012-12-10 |
| CARDNAV (K120282) | Paieon, Inc. | 2012-12-10 |
| OP300 (K122018) | Palodex Group OY | 2012-12-10 |
| INCLUSIVE TITANIUM ABUTMENTS FOR CAMLOG SCREW-LINE IMPLANTS (K121391) | Prismatik Dentalcraft, Inc. | 2012-12-10 |
| JETPREP FLUSHING DEVICE OL-103037, JETPREP FLUSHING DEVICE OL-133037, JETPREP FLUSHING DEVICE OL-168037, JETPREP FLUSHIN (K122740) | Jetprep, Ltd. | 2012-12-10 |
| EMERGE MEDICAL SOLID BONE SCREWS (K122489) | Emerge Medical | 2012-12-10 |
| TL-300 T-LINE NON-INVASIVE BLOOD PRESSURE MONITORING SYSTEM (K123446) | United States Gtm Medical Devices, Inc. | 2012-12-07 |
| OPELASER PRO II AND THE OPELASER LITE II (K120932) | The Yoshida Dental Mfg. Co., Ltd. | 2012-12-07 |
| REVERSE MEDICAL MICROCATHETER (K122684) | Reverse Medical Corporation | 2012-12-07 |
| SAFEAIR SMOKE PENCIL, (K120454) | Lna Medical Aps | 2012-12-07 |
| ES2 SPINAL SYSTEM MODEL 48280XXXX (K122845) | Stryker Spine | 2012-12-07 |
| PC-60NW FINGERTIP OXIMETER (K120502) | Shenzhen Creative Industry Co., Ltd. | 2012-12-07 |
| NUVASIVE BENDINI SPINAL ROD BENDING SYSTEM (K122742) | Nuvasive, Inc. | 2012-12-07 |
| VITESSE 3.0 (K123152) | Varian Medical Systems, Oncology Systems | 2012-12-07 |
| HOFFMANN'S CEMENT (PHOSPHATE, NORMAL) (K123273) | Temrex Corp. | 2012-12-07 |
| SUPERA VERITAS INTERWOVEN SELF-EXPANDING NITINOL STENT TRANSHEPATIC BILIARY SYSTEM (K122546) | Idev Technologies, Inc. | 2012-12-07 |
| OMNIPOD INSULIN MANAGMENT SYSTEM (K122953) | Insulet Corporation | 2012-12-07 |
| SMI CARDIOVASCULAR PATCH (K122105) | Solinas Medical, Inc. | 2012-12-07 |
| XTOOL (K122861) | Ouroboros Medical | 2012-12-07 |
| DENTAL X-RAY Z70 (W); DENTAL X-RAY Z70 (M); DENTAL X-RAY Z70 (C) (K122582) | Denterprise International, Inc. | 2012-12-07 |
| BLOOD GLUCOSE MONITORING SYSTEM (K120813) | Andon Medical Co., Ltd. | 2012-12-07 |
| IBOND SELF ETCH BOTTLE ASSORTMENT, IBOND SELF ETCH BOTTLE VALUE PACK, IBOND SELF ETCH SINGLE DOSE ASSORTMENT, IBOND SELF (K123278) | Heraeus Kulzer, LLC | 2012-12-07 |
| RMGI LOW VISCOSITY (K123265) | Pulpdent Corporation | 2012-12-07 |
| AFFINITY AF100 ARTERIAL FILTER WITH BALANCE BIOSURFACE (K122760) | Medtronic, Inc. | 2012-12-07 |
| LOQTEQ PROXIMAL HUMERUS PLATE 3.5, SHORT LOQTEQ PROXIMAL HUMERUS PLATE 3.5, LONG (K121495) | Aap Implantate AG | 2012-12-07 |
| OCELOT CATHETER (K123462) | Avinger, Inc. | 2012-12-07 |
| ZQUIET PRO-PLUS (K122475) | Sleeping Well, LLC | 2012-12-07 |
| FLOWTRON FOOT GARMENT-REGULAR-STERILE FLOWTRON FOOT GARMENT-LARGE-STERILE (K122330) | Arjohuntleigh Polska SP Z.O.O. | 2012-12-07 |
| DDRVERSA MOTION (K123005) | Swissray Medical AG | 2012-12-07 |
| V2F ANTERIOR FIXATION SYSTEM (K122733) | Zimmer Spine, Inc. | 2012-12-07 |
| LIPOKIT WITH DISPOSABLE 50CC AFT SYRINGE (K121703) | Medi-Khan USA, Inc. | 2012-12-07 |
| PHYSIOSTAR NFC (K122852) | Candulor USA, Inc. | 2012-12-06 |
| COMFORT EZ (K122787) | Simple Diagnostics, Inc. | 2012-12-06 |
| QT GUARD PLUS ANALYSIS SYSTEM (K120770) | Ge Medical Systems Information Technologies | 2012-12-06 |
| EXACTECH EQUINOXE SHOULDER SYSTEM TORQUE DEFINING SCREW AND SHORT REPLICATOR PLATE (K121067) | Exactech, Inc. | 2012-12-06 |
| CAPILLARYS HEMOGLOBIN HBA1C CAPILLARYS 2 FLEX PIERCING CAPILLARYS HBA1C CONTROLS CAPILLARYS HBA1C C (K122101) | Sebia | 2012-12-06 |
| WESTMED, INC.'S BLOCKAIDE FILTER [21 CFR 807.87(A)] (K121382) | Westmed, Inc. | 2012-12-06 |
| MRJ 3300 (K122034) | Paramed S.R.L. | 2012-12-06 |
| PATRIOT SPACERS (K122097) | Globus Medical, Inc. | 2012-12-06 |
| PIEZOSURGERY TOUCH (K122322) | Mectron S.P.A. | 2012-12-06 |
| APEX MEDICAL XT AUTO CPAP WITH COMPLIANCE IMPROVEMENT ALGORITHM 9S-005720 (K112079) | Apex Medical Corp. | 2012-12-06 |
| FRESENIUS 2008T HEMODIALYSIS MACHINE WITH BIBAG SYSTEM (K121341) | Fresenius Medical Care North America | 2012-12-06 |
| IMPLANT BAR (K120858) | Prismatik Dentalcraft, Inc. | 2012-12-06 |
| ENCORE TONGUE SUSPENSION SYSTEM ENCORE REMOVAL-TITRATION KIT (K121440) | Siesta Medical, Inc. | 2012-12-06 |
| ADULT EVAQUA 2' DUAL HEATED BREATHING CIRCUITS (K122432) | Fisher & Paykel Healthcare, Ltd. | 2012-12-06 |
| VERIGENE C. DIFFICILE NUCLEIC ACID TEST (CDF) (K123197) | Nanosphere, Inc. | 2012-12-05 |
| ZIMMER PERSONA THE PERSONALIZED KNEE SYSTEM (K122745) | Zimmer, Inc. | 2012-12-05 |
| IGROW II HAIR GROWTH SYSTEM (K122248) | Apira Science, Inc. | 2012-12-05 |
| ELECSYS CA 15-3 II CALCHECK 5 (K122242) | Roche Diagnostics | 2012-12-05 |
| CLARITY (K121663) | Elekta , Ltd. | 2012-12-05 |
| IN:C2 SPINAL FIXATION SYSTEM (K122630) | Spine Smith Partners L.P. | 2012-12-05 |
| LESSRAY (K123226) | Saferay Spine, LLC | 2012-12-05 |
| MOBILE CAREGUIDE 2100 OXIMETER (K122645) | Reflectance Medical, Inc. | 2012-12-05 |
| MERIT ONE SNARE SYSTEM (K122088) | Merit Medical Systems, Inc. | 2012-12-05 |
| PKS BILL (K122605) | Gyrus Acmi, Inc. | 2012-12-05 |
| ZIMMER PATIENT SPECIFIC INSTRUMENTS SYSTEM (K121640) | Materialise NV | 2012-12-05 |
| CALYPSO SYSTEM (K123137) | Varian Medical Systems | 2012-12-05 |
| OMEGA LABORATORIES HAIR DRUG SCREENING ASSAY CARDOXY-THC (THCA) (K122759) | Omega Laboratories, Inc. | 2012-12-05 |
| ACUSON (K123622) | Siemens Medical Solutions USA, Inc. | 2012-12-05 |
| ERAD PACS/ERAD RIS/PACS/ERAD EPVLITE VIEWER SOFTWARE PRODUCT (K120995) | Erad, Inc. | 2012-12-03 |
| BWF-5 MEDICAL LASER SERIES (K123031) | Litecure, LLC | 2012-12-03 |
| RESOLUTION CLIP MODEL M00522600, M00522601, M00522602, M00522610, M00522611, M00522612 (K122660) | Boston Scientific Corporation | 2012-12-03 |
| ZIMMER TRABECULAR METAL REVERSE SHOULDER SYSTEM, NON-POROUS HUMERAL STEMS (K122692) | Zimmer, Inc. | 2012-12-03 |
| POLARIS SPINAL SYSTEM - BALLISTA II RODS (K123451) | Biomet Spine (Aka Ebi, LLC) | 2012-12-03 |
| LENSAR LASER SYSTEM - FS 3D FOR CORNEAL INCISIONS (K122829) | Lensar, Inc. | 2012-12-03 |
| GALLEON PEDICLE SCREW SYSTEM (K122814) | Everest Spine, LLC | 2012-12-03 |
| INTUITIVE SURGICAL DA VINCI SI SURGICAL SYSTEM SMARTPEDALS (K123463) | Intuitive Surgical, Inc. | 2012-12-03 |
| FIREBIRD SPINAL FIXATION SYSTEM, PHOENIX MIS SPINAL FIXATION SYSTEM (K122901) | Orthofix | 2012-12-03 |
| POWDER FREE NITRILE EXAMINATION GLOVES, TESTED FOR USE WITH CHEMOTHERAPY DRUGS (K122999) | Top Glove Sdn. Bhd. | 2012-11-30 |
| SMARTTOOLS KNEE SYSTEM (K122326) | Zimmer | 2012-11-30 |
| POWDER-FREE VINYL PATIENT EXAMINATION GLOVES, CLEAR(NON-COLORED) (K122893) | Geenli Plastic Co, Ltd. | 2012-11-30 |
| CURALINE POLYURETHANE FOAM AWC DRESSING (K121361) | Curaline, Inc. | 2012-11-30 |
| SOLITAIRE 2 REVASCULARIZATION DEVICE (K123378) | Micro Therapeutics Dba Ev3 Neurovascular | 2012-11-30 |
| GENSTRIP TEST STRIP MODEL 100-201 (K103542) | Shasta Technologies, LLC | 2012-11-30 |
| TARGET DETACHABLE COIL (K123377) | Stryker Neurovascular | 2012-11-30 |
| ACCULIS ACCU21 PMTA MICROWAVE TISSUE ABLATION APPLICATOR (K122762) | Microsulis Medical Limited | 2012-11-30 |
| POWDER FREE VINYL PATIENT EXAMINATION GLOVES, COLORED (YELLOW) (K122920) | Hebei Leader Plastic Co., Ltd. | 2012-11-30 |
| DIMENSION VISTA VITAMIN B12 (VB12) FLEX REAGENT CARTRIDGE, DIMENSION VISTA LOCI 4 CALIBRATOR (K121994) | Siemens Healthcare Diagnostics, Inc. | 2012-11-30 |
| HYLATOPICPLUS LOTION (K121559) | Precision Dermatology Incorporated | 2012-11-30 |
| HARD SHELL VENTED NASAL MASK (K121321) | Sleepnet Corporation | 2012-11-30 |
| UCP HOME DRUG SCREENING TEST CUPS (K122419) | Ucp Biosciences, Inc. | 2012-11-30 |
| NAVIOPFS (K121936) | Blue Belt Technologies, Inc. | 2012-11-30 |
| ARROW JUGULAR AXILLO-SUBCLAVIAN CENTRAL CATHETER (JACC) (K121501) | Arrow International (Subsidiary of Teleflex Inc.) | 2012-11-29 |
| CHEMTRUE SINGLE/MULTI-PANEL DRUG SCREEN DIP CARD/ CASSETTE TESTS (K123080) | Chemtron Biotech, Inc. | 2012-11-29 |
| PLANER BT37 INCUBATOR (K121566) | Planer Plc | 2012-11-29 |
| TITAN (K121847) | Interacoustics A/S | 2012-11-29 |
| LIGHTSCALPEL (K123037) | Lightscalpel, LLC | 2012-11-29 |