| WONDFO COCAINE URINE TEST MODEL W10-CU, W10-P, WONDFO METHAMPHETAMINE URINE TEST MODEL W11-CU, W11-P (K112071) | Guangzhou Wondfo Biotech Co., Ltd. | 2011-09-23 |
| LUMAGEM MOLECULAR BREAST IMAGING SYSTEM (K111791) | Gamma Medica-Ideas Incorporated | 2011-09-23 |
| ACQPOINT THERMAJADE MASSAGE TABLE (K102938) | Acqpoint, Inc. | 2011-09-23 |
| CORELEADER COLLA-ALGI FIBER MODEL CAW (K111578) | Coreleader Biotech Co., Ltd. | 2011-09-23 |
| VENUE 40 (K112122) | GE Healthcare | 2011-09-23 |
| UNITED 36MM CERAMIC FEMORAL HEAD, DELTA (K112463) | United Orthopedic Corporation | 2011-09-23 |
| ESTECH COBRA SURGICAL SYSTEM WITH THERMASHIELD ACCESSORY (K110913) | Endoscopic Technologies, Inc. D/B/A Estech | 2011-09-23 |
| CSMC CARDIAC SUITE- NUCLEAR MEDICINE SOFTWARE (K112474) | Cedars-Sinai Medical Center | 2011-09-23 |
| RHYTHMVIEW (TM) (K110878) | Topera, Inc. | 2011-09-23 |
| CORELEADER SCAR-DIMMER (K111733) | Coreleader Biotech Co., Ltd. | 2011-09-22 |
| DIGITAL ELECTROCARDIOGRAPH (K112431) | Shenzhen Biocare Electronics Co., Ltd. | 2011-09-22 |
| RADIFORCE LARGE MONITOR SYSTEM (K112645) | Eizo GmbH | 2011-09-22 |
| SENSITITRE OPTIREAD (K110583) | Trek Diagnostic Systems, Ltd. | 2011-09-22 |
| AIMING BLOCKS FOR VARIAX DISTAL RADIUS PLATES (K112455) | Howmedica Osteonics Corp., Dba Stryker Orthopaedics | 2011-09-22 |
| DUS-3000/DUS-3000PLUS DIGITAL ULTRASONIC DIAGNOSTIC IMAGING SYSTEM (K112022) | Advanced Instrumentations, Inc. | 2011-09-22 |
| PULSIOFLEX (K112448) | Pulsion Medical Systems, Inc. | 2011-09-22 |
| RAPID INTRAVASCULAR CATHETER START SYSTEM 22 GAUGE / 20 GAUGE / 18 GAUGE (K112347) | Vascular Pathways, Inc. | 2011-09-22 |
| PD-100 SERIES ULTRASONIC POCKET DOPPLER (K111934) | Advanced Instrumentations, Inc. | 2011-09-22 |
| CORONIS FUSION 4MP DL (K111989) | Barco N.V. | 2011-09-22 |
| OSTEOSYMBIONICS, ST TEMPORALIS IMPLANT (K111069) | Osteosymbionics, LLC | 2011-09-22 |
| 27 G X 1/2 K-PACK SURSHIELD NEEDLE (K111797) | Terumo Europe N.V. | 2011-09-22 |
| RHYTHMLINK MONOPOLAR STIMULATING INSTRUMENT (K112435) | Rhythmlink International, LLC | 2011-09-22 |
| ODALYS PEDICLE SCREW SYSTEM (K111370) | Kalitec Direct, LLC | 2011-09-21 |
| ORTHO DEVLOPMENT CERAMIC FEMORAL HEAD (K111936) | Ortho Development | 2011-09-21 |
| SYNTHETIC VINYL EXAMINATION GLOVE POWDER FREE (K111857) | Inmed Gloves Factory | 2011-09-21 |
| EASYGLUCO PLUS BLOOD GLUCOSE MONITORING SYSTEM (K110435) | U. S. Diagnostics, Inc. | 2011-09-21 |
| CVM, UNCONJUGATED ESTRIOL (UE3) CALIBRATION VERIFICATION MATERIAL (K110061) | Siemens Healthcare Diagnostics | 2011-09-21 |
| TRIPLE LUMEN PFM PICC (K110914) | Pfm Medical, Inc. | 2011-09-21 |
| FM-1000 PLUS FETAL MONITOR (K112187) | Advanced Instrumentations, Inc. | 2011-09-21 |
| CMS-1000FM CENTRAL MONITORING SYSTEM (K112159) | Advanced Instrumentations, Inc. | 2011-09-21 |
| Z BOND, PRELUDE ONE (K111876) | Danville Materials, Inc. | 2011-09-21 |
| VAGINAL CT / MR MULTI CHANNEL APPLICATOR SET (K111973) | Nucletron | 2011-09-21 |
| STERILE POLYISOPRENE POWDER-FREE BLUE SURGICAL GLOVES WITH NEU-THERA EMOLLIENT COATING (K111868) | Cardinal Health-Medical Products and Services | 2011-09-21 |
| ACCU-CHEK AVIVA PLUS BLOOD GLUCOSE MONITORING SYSTEM (K101299) | Roche Diagnostics | 2011-09-21 |
| VIRTUE (K111833) | Diagnosoft, Inc. | 2011-09-21 |
| TANDEMHEART PUMP (K110493) | Cardiacassist, Inc. | 2011-09-20 |
| Spacer-G and Spacer-K (K101356) | Tecres S.P.A. | 2011-09-20 |
| AMSCO CHIMERON SMALL STEAM STERILIZER (K111223) | STERIS Corporation | 2011-09-20 |
| NEXWAVE COMBO MUSCLE STIMULATOR SYSTEM (K111279) | Zynex Medical, Inc. | 2011-09-20 |
| CERALAS 147NM DIODE LASER SYSTEM (K112253) | Biolitec, Inc. | 2011-09-20 |
| NT 2000 LESIONING GENERATOR (K111576) | Neuro Therm, Inc. | 2011-09-20 |
| SORIN CENTRIFUGAL PUMP 5 (CP5) (K112225) | Sorin Group Deutschland GmbH | 2011-09-20 |
| NUCLEIC ACID DETECTION IMMUNOASSAY (NADIA) PSA ASSAY (K101185) | Iris Molecular Diagnostics | 2011-09-20 |
| BIOGEL PI ORTHOPRO BROWN SURGICAL GLOVE (K112257) | Molnlycke Health Care Us, LLC | 2011-09-20 |
| FULL AUTO TONOMETER MODEL TX-20 (K111710) | Canon Inc. -Medical Equipment Group | 2011-09-20 |
| MICROPLEX COIL SYSTEM-VECTOR MODEL 030606XXX-V, 030610XXX-V, 30615XXX-V, 061020XXX-V, 061030XXX-V, 101530XXX-V, 101540XX (K111451) | MicroVention, Inc. | 2011-09-20 |
| EDLEN IMAGING - GEMINI DUSB (K103290) | Edlen Imaging, LLC | 2011-09-19 |
| NXSTAGE PUREFLOW SL (K111174) | Nxstage Medical, Inc. | 2011-09-19 |
| GLUCOSE METER-CHECK CONTROL SOLUTION FOR AGAMATRIX WAVESENSE (K112356) | Bionostics, Inc. | 2011-09-19 |
| PROCEDURAL STRECHER WITH INTELLIDRIVE P8000 (K112502) | Hill-Rom Co. | 2011-09-19 |
| WONDFO METHYLENEDIOXYMETHAMPHETAMINE URINE TEST, WONDFO MORPHINE URINE TEST (K112236) | Guangzhou Wondfo Biotech Co., Ltd. | 2011-09-19 |
| MOBILETT MIRA (K111912) | Siemens Medical Solutions USA, Inc. | 2011-09-19 |
| BEAUTISEALANT (K111782) | Shofu Dental Corporation | 2011-09-16 |
| ECHOBRIGHT (K111355) | Life-Tech, Inc. | 2011-09-16 |
| CELLAVISION DM1200 WITH THE BODY FLUID APPLICTION (K102778) | CellaVision AB | 2011-09-16 |
| MARKSMAN CATHETER, *REFERS TO DIFFERENT CATHETER WORKING LENGHTS, DISTAL SINGLE COILED LENGTHS AND DISTAL SHAFT LENGTHS (K111490) | Ev3, Inc. | 2011-09-16 |
| PERMASHADE VENEER CEMENT (K111836) | Ultradent Products, Inc. | 2011-09-16 |
| SURGICAL MASKS (K111559) | Shanghai Neo-Medical Import & Export Co., Ltd. | 2011-09-16 |
| S8 DIAGNOSTIC ULTRASOUND SYSTEM (K112451) | Sonoscape Company Limited | 2011-09-16 |
| Z10 WHEELCHAIR PUSH AND BRAKE ASSIST DEVICE (K111278) | Otto Bock Healthcare LP | 2011-09-16 |
| PICASSO/ PICASSO LITE/ PICASSO PERIO (K102359) | Amd Lasers, LLC | 2011-09-16 |
| JOURNEY II BCS KNEE SYSTEM (K111711) | Smith & Nephew, Inc. | 2011-09-16 |
| TURON RSP SOCKET SHELL-NEUTRAL MODEL 508-02-000, TURON RSP SOCKET SHELL-OFFSET MODEL 508-02-001 (K111629) | Encore Medical L.P. | 2011-09-16 |
| NAVIGATOR DELIVERY SYSTEM (NAVIGATOR DS) (K112067) | Carticept Medical, Inc. | 2011-09-16 |
| DIACHECK BLOOD GLUCOSE MONITORING SYSTEM MODEL: PREMIUM (K100806) | Delbio Incorporation | 2011-09-16 |
| EMV3 SELF MONITORING BLOOD GLUCOSE SYSTEM, EMV3 PRO SELF MONITORING BLOOD GLUCOSE SYSTEM (K111728) | Eps Bio Technology Corp. | 2011-09-16 |
| ACUSON S2000 DIAGNOSTIC ULTRASOUND SYSTEM (K112596) | Siemens Medical Solutions USA, Inc., Ultrasound DI | 2011-09-16 |
| AVIAFIT (K111720) | Flowmedic , Ltd. | 2011-09-16 |
| ASTRA (K111694) | Candelis, Inc. | 2011-09-15 |
| VORTRAN AIRWAY PRESSURE MONITOR (VAPM)-ADULT, VORTRAN AIRWAY PRESSURE MONITOR (VAPM)- PEDIATRIC (K103639) | Vortran Medical Technology 1, Inc. | 2011-09-15 |
| KOLPLUX SYSTEM (K110766) | Kolplast CI Ltda | 2011-09-15 |
| GAL-1C BLOOD GLUCOSE MONITORING SYSTEM, GAL-1C TEST STRIPS (K102816) | Apex BioTechnology Corp. | 2011-09-15 |
| EQUAL DOSE (K103515) | Nucletron Corporation | 2011-09-15 |
| SEVEN IMPLANTS; BIOCOM IMPLANTS; LANCE IMPLANTS (K103089) | Mis - Implant Technologies , Ltd. | 2011-09-15 |
| TRAGET DETACHABLE COIL (K112385) | Stryker Neurovascular | 2011-09-15 |
| SURE LOK MINI POSTERIOR CERVICAL/UPPER THORACIC SYSTEM (K112025) | Spinal USA | 2011-09-15 |
| FEEL-DRCS (K110033) | Imfou Co., Ltd. | 2011-09-15 |
| VITEK 2 STRPTOCOCCUS AMPICILLIN (K112075) | bioMerieux, Inc. | 2011-09-15 |
| NESS H200 WIRELESS HAND REHABILITATION SYSTEM USER KIT AND CLINICAN KIT (K111767) | Ness-Neuromuscular Electrical Stimulation Systems | 2011-09-15 |
| SILICONE SPHERES (K112176) | Oculo Plastik, Inc. | 2011-09-15 |
| QUADROX-I MICROPORPOROUS MEMBRANE OXGENATOR SERIES AND QUDROX-ID DIFFUSION MEMBRANE OXYGENATORS SERIES (K112360) | Maquet Cardiopulmonary, AG | 2011-09-15 |
| CARDIOSAVE HYBRID INTRA-AORTIC BALLOON PUMP (K112372) | Cardiac Assist, Maquet Cardiovascular, LLC | 2011-09-15 |
| 4CH FLEX SPEEDER (K112366) | Toshiba Medical Systems Coporation, Japan | 2011-09-15 |
| MOLECULAR BREAST IMAGING SOFTWARE (K111731) | Gamma Medica-Ideas Incorporated | 2011-09-15 |
| CD HORIZON SPINAL SYSTEM (K111457) | Medtronic Sofamor Danek | 2011-09-15 |
| PATHASSIST LIGHT FIBER (K111763) | Entellus Medical, Inc. | 2011-09-15 |
| PROCLEAR, PROCLEAR TORIC, PROCLEAR MULTIFOCAL, PROCLEAR 1DAY, PROCLEAR XC (K111966) | CooperVision, Inc. | 2011-09-15 |
| BIODENTA DENTAL IMPLANT SYSTEM - BONE LEVEL (K111003) | Biodenta Swiss AG | 2011-09-15 |
| Q-CLEAR (K110370) | Light Age, Inc. | 2011-09-15 |
| R4 ACERT ULTRASOUND REPORTING SYSTEM (K101898) | R4, LLC | 2011-09-15 |
| CD HORIZON SPINAL SYSTEM (K111510) | Medtronic Sofamor Danek, Inc. | 2011-09-15 |
| ELITECH CLINICAL SYSEMS ISE CONTROL 1 AND 2 (K111996) | Elitechgroup | 2011-09-14 |
| CHEMTRUE SINGLE/MULTI-PANEL DRUG SCREEN CASSETTE/DIPCARD (K111322) | Chemtron Biotech, Inc. | 2011-09-14 |
| EXPECT ENDOSCOPIC ULTRASOUND ASPIRATION NEEDLE (K112198) | Boston Scientific Corporation | 2011-09-14 |
| SHEAUMANN PL-980 (K111360) | Sheaumann Lasers | 2011-09-14 |
| LITE PELVIC FLOOR REPAIR KITS (K103426) | Boston Scientific Corp | 2011-09-14 |
| VITAL SIGNS MONITOR (K112465) | Advanced Instruments, Inc. | 2011-09-14 |
| FOB ONE STEP RAPID TEST (K110309) | Orient Gene Biotech | 2011-09-14 |
| THE INSYNC CERAMIC SYSTEM (K111743) | Jensen Industries, Inc. | 2011-09-14 |
| KJ SUBMERGED SYSTEM (K103810) | Kj Meditech Co., Ltd. | 2011-09-14 |