| SL-PLUS STANDARD AND LATERAL FEMORAL STEM WITH TI/HA COATING (K120211) | Smith & Nephew, Inc. | 2012-07-19 |
| INSUFLOW SYNERGY PORT (K120640) | Lexion Medical, LLC | 2012-07-18 |
| U2 ACETABULAR CUP, PLASMA SPRAY (K121777) | United Orthopedic Corp. | 2012-07-18 |
| IO FIX, IO FIX PLUS, CARPALFIX, EXTREMITY MEDICAL SCREW AND WASHER (K121349) | Extremity Medical, LLC | 2012-07-18 |
| INTELLIVUE PATIENT MONITOR (K120366) | Philips Medizinsysteme Boeblingen GmbH, Cardiac AN | 2012-07-18 |
| WRIST-TYPE FULLY AUTOMATIC DIGITAL BLOOD PRESSURE MONITOR (K121355) | Sejoy Electronics & Instruments Co., Ltd. | 2012-07-18 |
| ZIO PATCH (K121319) | iRhythm Technologies, Inc. | 2012-07-18 |
| POLARIS Q-SWITCH RUBY SYSTEM (K121162) | Sandstone Medical Technologies, LLC | 2012-07-18 |
| PATHFINDER NXT MINIMALLY INVASIVE PEDICLE SCREW SYSTEM (K121671) | Zimmer Spine, Inc. | 2012-07-18 |
| CONNECTED CARE MOBILE APPLICATION (K120325) | Watermark Medical | 2012-07-18 |
| M.U.S.T PEDICLE SCREW SYSTEM (K121115) | Medacta International | 2012-07-18 |
| XMCP, HALLUX, TARSX, EXTREMITY MEDICAL SCREW SYSTEM (K121417) | Extremity Medical, LLC | 2012-07-18 |
| MEDICREA INTERNATIONAL ANTERIOR LUMBAR PLATE (K121323) | Medicrea International | 2012-07-18 |
| ST80I STRESS TEST SYSTEM (K121638) | Philips Health Care | 2012-07-18 |
| 3.9MM REELX STT SUTURE ANCHOR SYSTEM (K120824) | Stryker Corp. | 2012-07-18 |
| RESOLVE BILIARY LOCKING DRAINAGE CATHETER (K121832) | Merit Medical Systems, Inc. | 2012-07-17 |
| A&J 5L POCA SERIES OXYGEN CONCENTRATOR (K121531) | Zhongshan A&J Medical Equipment Co., Ltd. | 2012-07-17 |
| NON-CONTACT CLINICAL THERMOMETER (K121428) | Radiant Innovation, Inc. | 2012-07-17 |
| TIO2MESH TM (K113311) | Biocer Entwicklungs GmbH | 2012-07-17 |
| FASTEP HCG PREGANCY SERUM/URINE CASSETTE AND DIPSTICK TESTS (K112101) | Polymed Therapeutics, Inc. | 2012-07-17 |
| ACCU-CHECK COMBO SYSTEM (K111353) | Roche Diagnostics | 2012-07-17 |
| MERIDIAN CRANIAL PERFORATOR (K121253) | Adeor Medical Technologies GmbH | 2012-07-17 |
| NMI MICROCATHETER (K121954) | Navilyst Medical, Inc. | 2012-07-17 |
| PERFORMAX PEDIATRIC EE TOTAL FACE MASK (K120562) | Respironics, Inc. | 2012-07-17 |
| HEARTRAIL III GUIDING CATHETER (K113335) | Terumo Corporation | 2012-07-16 |
| VIGNET TELEHEALTH MANAGER (K113446) | Vignet, Inc. | 2012-07-16 |
| 3MP COLOR LCD MONITOR, RADIFORCE RX340 (K113562) | Eizo Nanao Corporation | 2012-07-16 |
| NUVASIVE BRIGADE ANTERIOR PLATE SYSTEM (K121837) | Nuvasive, Inc. | 2012-07-16 |
| OSTOMY IRRIGATION SET (K121833) | Coloplast A/S | 2012-07-16 |
| DISPOSABLE LINEAR STAPLER, DISPOSABLE LINEAR CUTTER (K121474) | Changzhou Kangdi Medical Stapler Co., Ltd. | 2012-07-16 |
| MAGNETOM SPECTRA (K121160) | Siemens Medical Solutions USA, Inc. | 2012-07-16 |
| CALYPSO SYSTEM (K120564) | Hogan Lovells US LLP | 2012-07-16 |
| ELCAM VITAL SIGNS WIRELESS SYSTEM (VSWS) (K120253) | Elcam Medical Acal | 2012-07-16 |
| ECHELON 60 ENDOSCPIC LINEAR CUTTER RELOAD, WHITE (K121600) | Ethicon Endo-Surgery, LLC | 2012-07-16 |
| CARDIO 7 (K113306) | Bionet Co., Ltd. | 2012-07-16 |
| HSINER CPAP SILICONE NASAL MASK SIZE XS/PETITE HSINER NASAL PILLOW MASK HSINER INFANT CPAP CANNULA (K120920) | Hsiner Company | 2012-07-16 |
| INFILL INTERVERTEBRAL BODY FUSION DEVICE (K121733) | Pinnacle Spine Group, LLC | 2012-07-13 |
| CAPNODURA COMBI & CAPNODURA PEDI CO2 DETECTOR (K112840) | Seebreath AB | 2012-07-13 |
| CAPNOGRAPHY PAD (92516) (K121017) | Spacelabs Healthcare | 2012-07-13 |
| EMPTY EVA SOLUTION CONTAINER EMPTY EVA DUAL CHAMBER SOLUTION CONTAINER (K121161) | Acta Medical, LLC | 2012-07-13 |
| SIMPLEXA FLU A/B & RSV DIRECT, SIMPLEXA FLU A/B & RSV POSITIVE CONTROL PACK (K120413) | Focus Diagnostics, Inc. | 2012-07-13 |
| CONGRUENT BONE PLATE SYSTEM: ACU-LOC 2 PLATE (K120903) | Acumed, LLC | 2012-07-13 |
| CRUX VENA CAVA FILTER SYSTEM (K120402) | Crux Biomedical | 2012-07-13 |
| QUILL PDO KNOTLESS TISSUE-CLOSURE DEVICE (POLYDIXANONE) (K120827) | Angiotech | 2012-07-13 |
| ACE ALBUMIN REAGENT ACE TOTAL PROTEIN REAGENT ACE CALCIUM-ARSENAZO REAGENT ACE PHOSPHORUS U.V. REAGENT (K113374) | Alfa Wassermann Diagnostic Technologies, Inc. | 2012-07-13 |
| RESIN 11 (K121170) | Respinnovation Sas | 2012-07-13 |
| FLEXITIME MONOPHASE PRO SCAN (K113574) | Heraeus Kulzer, LLC | 2012-07-13 |
| HEALTHPRO BLOOD GLUCOSE MONITORING SYSTEM (K113192) | Infopia Co, Ltd. | 2012-07-13 |
| MONICA AN24 (K112390) | Monica Healthcare, Ltd. | 2012-07-13 |
| PLANCET (K113513) | Micropoint Technologies Pte, Ltd. | 2012-07-13 |
| CARDIOBLATE GEMINI SURGICAL ABLATION DEVICE (K121767) | Medtronic, Inc. | 2012-07-13 |
| LIL-LETS SILK COMFORT COMPACT, PLASTIC APPLICATOR, LITE, REGULAR, SUPER, SUPER PLUS AND ULTRA LIL-LETS NON APPLICATOR, (K120481) | Tosama, D.O.O. | 2012-07-13 |
| MANTARAY GUIDEWIRES (K121745) | Bridgepoint Medical | 2012-07-13 |
| RI MSC (MIGRATION SEDIMENTATION CHAMBER) (K112413) | Research Instruments , Ltd. | 2012-07-13 |
| LSI SOLUTIONS FORNISEE SYSTEM UTERINE MANIPULATOR AND ACCESSORIES (K111014) | Lsi Solutions, Inc. | 2012-07-13 |
| ARROW REVERSE SHOULDER SYSTEM (K112193) | Fournitures Hospitalieres Industrie | 2012-07-12 |
| MYRIAN 1.11 (K113620) | Intrasense | 2012-07-12 |
| BLACK NITRILE POWDER-FREE EXAMINATION GLOVES (K121529) | Northstar Healthcare Holdings | 2012-07-12 |
| 0.9% SODIUM CHLORIDE FLISH SYRINGE (K120836) | Am USA | 2012-07-12 |
| BIOPSY SCIENCES, INC. HYDROMARK BREST BIOSY SITE MARKER (K121113) | Biopsy Sciences, LLC | 2012-07-12 |
| BW685, BW685S (K121198) | Biegler GmbH | 2012-07-12 |
| CS1000 LIGHT THERAPY DEVICE (K110558) | Genesis Health Light Corporation | 2012-07-12 |
| SMARTSTITCH M-CONNECTOR ULTRA SMARTSTITCH SUTURE DEVICE HANDLE SMARTSTITCH SUTURE DEVICE HANDLE (K121306) | Arthocare Corporation | 2012-07-12 |
| PRESSON ELECTRODE (K121347) | Rhythmlink International, LLC | 2012-07-12 |
| ACE ALKALINE PHOSPHATASE REAGENT, ACE AMYLASE REAGENT, ACE LDH-L REAGENT (K113436) | Alfa Wassermann | 2012-07-12 |
| RENAISSANCE (K120812) | Mazor Robotics , Ltd. | 2012-07-12 |
| HUMAN CH50 REAGENT PACK FOR USE ON THE SPAPLUS, HUMAN CH50 CALIBRATOR SET FOR USE ON THE SPAPLUS, HUMAN CH50 CONTROLS FO (K113349) | The Binding Site Group , Ltd. | 2012-07-11 |
| SLIMPLICITY SOLO ANTERIOR CERVICAL PLATE SYSTEM (K112748) | Spinal USA, LLC | 2012-07-11 |
| MINICAT (K113421) | Xoran Technologies, Inc. | 2012-07-11 |
| AC LENS BRANDED CONTACT LENS CASE (K120969) | Arlington Contact Lens Services,Inc. | 2012-07-11 |
| MEDSOURCE IV ADMINSTRATION SET (K120424) | Medsource International, LLC | 2012-07-11 |
| LIQUICHEK URINE CHEMISTRY CONTROL (K121794) | Bio-Rad, Diagnostics Grp. | 2012-07-11 |
| GYMFORM DUAL FLEX BELT MODEL WB-162 (K111781) | Well Brain International , Ltd. | 2012-07-11 |
| ULTRAVERSE 014 AND 018 PTA BALLOON DILATATION CATHETERS LINE EXTENSION (K121856) | C.R. Bard, Inc. | 2012-07-11 |
| MONGOOSE ANGIOGRAPHIC CATHETER (K113819) | Pediacath, Inc. | 2012-07-11 |
| RANDOX MICROALBUMIN CONTROL LEVEL 1 AND CONTROL LEVEL 2 (LIQUID) (K121746) | Randox Laboratories, Ltd. | 2012-07-11 |
| POISE PERSONAL LUBRICANT (K120650) | Kimberly-Clark Corporation | 2012-07-11 |
| M/29TM - PRESSURE INJECTABLE (K111939) | Flexicath , Ltd. | 2012-07-11 |
| AEROCHAMBER PLUS FLOW-VU ANTI-STATIC VALVED HOLDING CHAMBER (VHC) (K112010) | Trudell Medical Intl. | 2012-07-11 |
| LIEBEL-FLARSHEIM DIRECT DIGITAL IMAGING SYSTEM (K121838) | Liebel-Flarsheim | 2012-07-11 |
| POWER FREE STRETCH VINYL PATIENT EXAMINATION GLOVES (K120584) | Wealth on (Jiangsu) Co., Ltd. | 2012-07-10 |
| DIRECTPATH (K121449) | Cybernet Systems Co., Ltd. | 2012-07-10 |
| PERFORMAX PEDIATRIC SE TOTAL FACE MASK (K120639) | Respironics, Inc. | 2012-07-10 |
| VOLUX 21C, DIGITAL EXTRAORAL SOURCE X-RAY SYSTEM (K120263) | Genoray Co., Ltd. | 2012-07-10 |
| CARESENS N VOICE BLOOD GLUCOSE MONITORING SYSTEM (K121133) | I-Sens, Inc. | 2012-07-10 |
| STATIM 2000 G4 CASSETTE (K112872) | Scican , Ltd. | 2012-07-10 |
| NELLCOR BEDSIDE SPO2 PATIENT MONITORING SYSTEM (K120773) | Covidien, LLC | 2012-07-10 |
| PROTEUS INGESTION CONFINMATION SYSTEMS (DEN120011) | Proteus Biomedical, Inc. | 2012-07-10 |
| GYRUS ACMI TELESCOPE STORAGE-STERILIZATION TRAY (K120474) | Gyrus Acmi, Inc. | 2012-07-10 |
| V5MS TRANSDUCER (K121807) | Siemens Medical Solutions USA, Inc. | 2012-07-10 |
| AYNERGETICS DISPOSABLE SPETZLER-MALIS STANDARD BIPOLAR FORCEPS (K121426) | Synergetics, Inc. | 2012-07-10 |
| LIGHTSCALPEL FAMILY OF HANDPIECE TIPS FOR CO2 SURGICAL LASERS (K121471) | Lightscalpel, LLC | 2012-07-10 |
| OXYBAND WOUND DRESSING (K121407) | O2s, LLC | 2012-07-09 |
| S-SCAN (K121650) | Esaote, S.p.A. | 2012-07-09 |
| ANA-SCREEN WITH MDSS (K113610) | Bio-Rad Laboratories | 2012-07-09 |
| THINKINGNET, THINKINGPACS/RIS - PROPRIETARY NAME FRO THINKINGNET, THINKINGARCHIVE (OR NUPAX) - THE MANAGEMENT AND ARCHIV (K120305) | Thinking Systems Corp. | 2012-07-09 |
| SEVIIN REVERSE SHOULDER (K120374) | Ingen Orthopedics, LLC | 2012-07-09 |
| SMARTDRIVE WHEELCHAIR POWER-ASSIST (K113621) | Max Mobility, LLC | 2012-07-06 |
| NAVIS TORQUER (K112674) | Navis Medical,Inc | 2012-07-06 |
| SYNTHES MULTILOC HUMERAL NAILING SYSTEM (K120807) | Synthes USA Products, LLC | 2012-07-06 |