| RADREX-I, SW V4.00 MODEL DRAD-3000E (K122842) | Toshiba America Medical Systems, In.C | 2012-10-09 |
| REMSTAR SE (K122769) | Respironics, Inc. | 2012-10-09 |
| BRIGHTGLASS BRIGHTGLASS M (K122025) | Ktk Medical Supplies GmbH | 2012-10-09 |
| SHILEY NEONATAL TRACHEOSTOMY TUBE CUFFLESS, SHILEY PEDIATRIC TRACHEOSTOMY TUBE CUFFLESS, SHILEY PEDIATRIC TRACHEOSTOMY T (K122531) | Covidien | 2012-10-09 |
| VILEX EZ-STAPLE (MEMORY BONE FIXATION STAPLE) (K112837) | Vilex, Inc. | 2012-10-09 |
| CERNER FETALINK+(VERSION1.0) (K121758) | Cerner Corp. | 2012-10-09 |
| NEXTRA TI HAMMERTOE CORRECTION SYSTEM (K122031) | Nextremity Solutions, LLC | 2012-10-09 |
| BTL ELITE (K120093) | BTL Industries, Inc. | 2012-10-05 |
| TBS INSIGHT (K121716) | Medimaps Group SA | 2012-10-05 |
| EPOC CHLORIDE TEST AND EPOC CREATININE TEST (K113726) | Epocal, Inc. | 2012-10-05 |
| BENCOX II STEM, BENCOX METAL HEAD (K122099) | Corentec Co., Ltd. | 2012-10-05 |
| SMITH & NEPHEW RADIOPAQUE TRIAL NECKS (K113039) | Smith & Nephew, Inc. | 2012-10-05 |
| ACE CHOLESTEROL REAGENT, ACE HDL-C REAGENT, ACE LDL-C REAGENT, ACE TRIGLYCERIDES REAGENT (K122757) | Alfa Wassermann Diagnostic Technologies, Inc. | 2012-10-05 |
| DFP4343C7 (K122589) | Mdi Consultants, Inc. | 2012-10-05 |
| C1-6-D ULTRASOUND TRANSDUCER (K122921) | GE Healthcare | 2012-10-05 |
| MD211G3 21.3 DIAGNOSTIC IMAGING LCD MONITOR (K122843) | Prodigy Technology Consultant Co., Ltd. | 2012-10-05 |
| CVUE ADVANCED HYDRA VUE (K121652) | Unilens Corp., USA | 2012-10-05 |
| ALAMO T (K120401) | Alliance Partners, LLC | 2012-10-05 |
| ABTHERA OPEN ABDOMEN NEGATIVE PRESSURE THERAPY SYSTEM (K120499) | Kci USA, Inc. (Kinetic Concepts, Inc.) | 2012-10-05 |
| CORIN TRIFIT TS HIP (K121563) | Corin USA | 2012-10-05 |
| SIMPLE T NASAL MASK (K121631) | Respironics, Inc. | 2012-10-05 |
| REPROCESSED SURGICAL ELECTRIC INSTRUMENT (K120040) | Sterilmed, Inc. | 2012-10-05 |
| TIGER SPINE SYSTEM (K121728) | Corelink, LLC | 2012-10-05 |
| PORTA 100HF (K122697) | Job Corporation | 2012-10-05 |
| TRYPTIK CC ANTERIOR INTERSOMATIC CERVICAL CAGE (K122366) | Spineart | 2012-10-04 |
| STERRAD(R) CYCLESURE(R) 24 BIOLOGICAL INDICATOR (K122044) | Advanced Sterilization Products | 2012-10-04 |
| HERO II DENTAL IMPLANT SYSTEM, IS DENTAL IMPLANT SYSTEM (K121047) | Kj Meditech Co., Ltd. | 2012-10-04 |
| ELEGANT NITRILE POWDER FREE EXAMINATION GLOVE BLUE VIOLET (K120110) | Profit Point Manufacturing Sdn Bhd | 2012-10-04 |
| ACTIVE SCREW BONE SCREW (K121682) | Intelligent Implant Systems, LLC | 2012-10-04 |
| NIRVANA A PERSONAL LUBRICANT (K120706) | Church & Dwight Co., Inc. | 2012-10-04 |
| XPEED ANY RIDGE INTERNAL IMPLANT SYSTEM (K122231) | Megagen Implant Co., Ltd. | 2012-10-04 |
| MIXJECT WITH SPRAY HEAD (K122023) | Medimop Medical Projects, Ltd. | 2012-10-04 |
| Z-MED Z-MED II (K122012) | NuMED, Inc. | 2012-10-04 |
| MINISPIR (K122384) | Mir Medical Intl. Research Srl | 2012-10-04 |
| SMARTBUILDER SYSTEM (K120951) | Osstem Implant Co., Ltd. | 2012-10-03 |
| CD HORIZON SPINAL SYSTEM (K122862) | Medtronic Sofamor Danek USA, Inc. | 2012-10-03 |
| HT-WEDGE (K121287) | D.T. Davis Enterprises Ltd. T/A Hovertech Int'L | 2012-10-03 |
| MHI-TM2000 LINEAR ACCELERATOR SYSTEM VERO IMAVIS (K122450) | Mitsubishi Heavy Industries, Ltd. | 2012-10-03 |
| SOFT-CUF, CLASSIC-CUF, DURA-CUF, SENSA-CUF (K120125) | Ge Medical Systems Information Technologies, Inc. | 2012-10-03 |
| ORTHOFIX SCREW (K113650) | Bonafix Surgical and Dental Implants, LLC | 2012-10-03 |
| GEMINUS FOSSA SPECIFIC PLATE SYSTEM (K122737) | Skeletal Dynamics, LLC | 2012-10-03 |
| NIRVANA B PERSONAL LUBRICANT (K120751) | Church & Dwight Co., Inc. | 2012-10-03 |
| STERRAD SEALSURE CHEMICAL INDICATOR TAPE MODEL 14202 (K111519) | Advanced Sterilization Products | 2012-10-03 |
| AIDA VI.8 DIAGNOSTIC ULTRASOUND GM-72P00A, L13-5V1 TRANSDUCER (K122009) | Panasonic Healthcare Co., Ltd. | 2012-10-03 |
| EK DELIVERY DEVICE (K121579) | Tdak Medical, Inc. | 2012-10-03 |
| LOGIQ S7 EXPERT, LOGIQ S7 PRO (K122114) | GE Healthcare | 2012-10-03 |
| STERRAD CHEMIAL INDICATOR STRIP MODEL 14100 (K111518) | Advanced Sterilization Products | 2012-10-03 |
| LIGAFIX INTERFERENCE SCREW (K122228) | Sbm Sciences For Bio Materials | 2012-10-03 |
| ELTECH CHINICAL SYSTEM AMYLASE SL ELITECH CLINICAL SYSTEMS ELICAL2 ELTECH CLINICAL SYSTEMS ELITROL I AND ELITROL II (K122858) | Elitechgroup | 2012-10-03 |
| ADVIA CHEMISTRY MYOGLOBIN REAGENT, ADVIA CHEMISTRY MYOGLBIN CALIBRATOR (K122599) | Siemens Healthcare Diagnostics, Inc. | 2012-10-03 |
| SHIGA TOXIN CHEK (K121411) | Techlab Inc., Corporate Research Center | 2012-10-02 |
| SPEEDICATH COMPACT SET (12 FR) (K121457) | Coloplast Corp. | 2012-10-02 |
| GIRAFFE AND PANDA WARMERS (K122267) | Ohmeda Medical, A Division of Datex-Ohmeda, Inc. | 2012-10-02 |
| ESON NASAL MASK (K121597) | Fisher & Paykel Healthcare Limited | 2012-10-02 |
| PENUMBRA PUMP MAX (110VAC), PENUMBRA PUMP MAX (230VAC), PENUMBAR PUMP MAX CANISTER/TUBING (K122756) | Penumbra, Inc. | 2012-10-02 |
| AIRSTRIP REMOTE PATIENT MONITORING (RPM) REMOTE DATA VIEWING (K122133) | Airstrip Technologies, LP | 2012-10-02 |
| 6-8MM X 30 MM INTRAFIX PEEK TAPERED SCREW 7-9MM X 30MM INTRAFIX PEEK TAPERED SCREW 8-10MM X 30 MM INTRAFIX PEEK TAPERED (K122123) | Depuy Mitek, Inc., A Johnson and Johnson Company | 2012-10-02 |
| ULTHERA SYSTEM (K121700) | Ulthera, Inc. | 2012-10-02 |
| SHIGA TOXIN QUIK CHEK (K121364) | Techlab Inc., Corporate Research Center | 2012-10-02 |
| AOS SOLID LOCKING LAG SCREW, AOS TELESCOPING LAG SCREW (K120148) | Advanced Orthopaedic Solutions, Inc. | 2012-10-02 |
| EPIX IRRIGATION PUMP, EPIX SUCTION IRRIGATION TUBING SET (K122619) | Applied Medical | 2012-10-02 |
| SPEEDICATH COMPACT SET (12/18 FR) (K121458) | Coloplast A/S | 2012-10-01 |
| SMARTLUX (K120460) | Medmix Co., Ltd. | 2012-10-01 |
| REVERE STABILIZATION SYSTEM (K122226) | Globus Medical, Inc. | 2012-10-01 |
| AXSOS DISTAL LATERAL FEMUR TS LONG PLATES (K122308) | Howmedica Osteonics Corp., Dba Stryker Orthopaedics | 2012-10-01 |
| SERF ABLATION SYSTEM SERF ABLATION NEEDLE (K120116) | Thermedical | 2012-10-01 |
| SOLSTICE CROSS CONNECTOR (K120998) | Life Spine | 2012-10-01 |
| TANGORS MULTIFUNCTIONAL POSTERIOR SYSTEM (K120891) | Ulrich GmbH & Co. KG | 2012-10-01 |
| AFT PROXIMAL HUMERUS FRACTURE PLATE (K121672) | Shoulder Options, Inc. | 2012-10-01 |
| INVIA MOTION NEGATIVE PRESSURE WOUND THERAPY SYSTEM (K113678) | Medela AG | 2012-10-01 |
| NOVATION LPI PRIME FEMORAL STEM (K121684) | Exactech, Inc. | 2012-10-01 |
| ENDOPATH XCEL BLADELESS TROCAR WITH OPTIVIEW TECHNOLOGY ENDOPATH XCEL BLUNT TIP TROCAR WITH OPTIVIEW TECHNOLOGY ENDOPATH (K122511) | Ethicon Endo-Surgery, LLC | 2012-10-01 |
| ORTHOLOC 3DI ANKLE FUSION PLATING SYSTEM (K121425) | Wrightmedicaltechnologyinc | 2012-10-01 |
| PEERSCOPE SYSTEM (K120289) | Peermedical | 2012-09-28 |
| GMK NARROW (K122232) | Medacta International | 2012-09-28 |
| NIPRO BLOOD TUBING SET WITH TRANSDUCER PROTECTOR AND PRIMING SET (K112628) | Nipro Medical Corporation | 2012-09-28 |
| BAUSCH & LOMB IOL INJECTOR (K113852) | Bausch & Lomb, Inc. | 2012-09-28 |
| EXACTRAC VERO (K122451) | Brainlab AG | 2012-09-28 |
| EZ-BLOCKER (K121462) | Ez-Blocker B.V. | 2012-09-28 |
| BRIGHT RESTORATIVE MATERIALS (K121915) | Dmp, Ltd. | 2012-09-28 |
| WALLFLEXTM BILIARY RX STENT SYSTEM (UNCOVERED, PARTIALLY COVERED, AND FULLY COVERED) WALLFLEXTM BILIARY TRANSHEPATIC STE (K122072) | Boston Scientific Corporation | 2012-09-28 |
| OVERTUBE ENDOSCOPIC ACCESS SYSTEM (K122270) | Apollo Endosurgery, Inc. | 2012-09-28 |
| MPACT EXTENSION (K122641) | Medacta International | 2012-09-28 |
| ACUSON (K122825) | Siemens Medical Solutions USA, Inc. | 2012-09-28 |
| DIGITAL EYE-FUNDUS CAMERA (K120982) | Medimaging Integrated Solutions, Inc. (Miis) | 2012-09-28 |
| 14.5-16.0 FRENCH CUFFED CATHETER REMOVAL DEVICE, SYMMETRY SURGICAL SINGEL USE (K122263) | Symmetry Medical | 2012-09-28 |
| BESIDE RESPIRATORY PATIENT MONITORING SYSTEM BESIDE RESIRATORY PATIENT MONITORING SYSTEM WITH RESPIRATION RATE SOFTWARE (K121806) | Covidien | 2012-09-28 |
| EPIC 10 (K121286) | Biolase Technology, Inc. | 2012-09-28 |
| CD HORIZON SPINAL SYSTEM (K122433) | Medtronic Sofamor Danek, Inc. | 2012-09-28 |
| SOMNOGUARD SP SOFT (K121761) | Tomed Dr. Toussaint GmbH | 2012-09-28 |
| EASYONE PRO RESPIRATORY TESTING DEVICE (K120635) | Ndd Medizitechnik AG | 2012-09-27 |
| ITOTAL CRUCIATE RETAINING (CR) KNEE REPLACEMENT SYSTEM (K122033) | Conformis, Inc. | 2012-09-27 |
| SUPER SHEATH INTRODUCER SHEATH AND SUPER SHEATH INTRODUCER SHEATH SETS (K121504) | Togo Medikit Co., Ltd. | 2012-09-27 |
| FREEDOM ND: YAG LASER SYSTEM (K113843) | Lutronic Corporation | 2012-09-27 |
| WITHINGS, SMART BODY SCALE (K121971) | Zhongshan Transtek Electronics Co., Ltd. | 2012-09-27 |
| TYPE 1077 ACCUSCREEN (K122067) | Gn Otometrics | 2012-09-27 |
| POWDER-FREE VINYL PATIENT EXAMINATION GLOVES, CLEAR (NON-COLORED) (K122266) | Shandong Junfeng Industries Co., Ltd. | 2012-09-27 |
| PMT BONE SCREWS (K121713) | Providence Medical Technology, Inc. | 2012-09-27 |
| RAPICIDE OPA-28 (K120306) | Minntech Corp. | 2012-09-27 |
| KARL STORZ NAVIGATIONPANEL UNIT (NPU) SYSTEM (K122096) | KARL STORZ Endoscopy-America, Inc. | 2012-09-27 |