| COMFY SERIES: EV-804, EV-805 & EV-806 (K071951) | Everyway Medical Instruments Co.,Ltd | 2007-09-05 |
| ISE MODULE AND BAR CODE READER ADDITION FOR THE DATAPRO CLINICAL CHEMISTRY ANALYZER (K070531) | Thermo Fisher Scientific | 2007-09-04 |
| ACME TALON PEDICLE SCREW (K071824) | Acme Spine, LLC | 2007-09-04 |
| OSTEOGRAF/N-300 (K071817) | Dentsply Interntional | 2007-09-04 |
| POWDER FREE VINYL PATIENT EXAMINATION GLOVES, CLEAR (NON-COLORED) (K072085) | Zibo Hongye Shangqin Plastic Rubbert Co, Ltd. | 2007-09-04 |
| DANA 3CC SYRINGE INSULIN RESERVOIR (K071418) | Sooil Development Co., Ltd. | 2007-09-04 |
| DEPUY RESTORE ORTHOBIOLOGIC SOFT TISSUE IMPLANT (K071016) | DePuy Orthopaedics, Inc. | 2007-09-04 |
| ACTIVAPIN, NEXFIX RFS PIN, NEXFIX RESORBABLE FIXATION SYSTEM (RFS) (K071863) | Bioretec, Ltd. | 2007-08-31 |
| IP SYSTEM, OCULAB IP, OPTOMIZE IP, RETASURE IP (K071299) | Digital Healthcare, Ltd. | 2007-08-31 |
| OASIS RELEASE 1.0 (K071584) | Segami Corporation | 2007-08-31 |
| DOMINATOR (K072127) | Biocomposites, Ltd. | 2007-08-31 |
| JOSTRA PEDIATRIC ARTERIAL PREFUSION CANNULAE (K072172) | Maquet Cardiopulmonary, AG | 2007-08-31 |
| STRAUMANN P.004 RC GOLD ABUTMENT (K070549) | Institut Straumann AG | 2007-08-31 |
| OPACIDEN OPA REAGENT STRIPS (K070419) | Hach Company | 2007-08-31 |
| IMPLANTECH EPTFE SHEETING, MODEL EPTFE-XXX (K071470) | Implantech Associates, Inc. | 2007-08-31 |
| BIOSIGN CENTRAL STATION (K071606) | Obs Medical | 2007-08-31 |
| PHARMAPAC LUBRICATING JELLY (K070623) | Pharmapac, LLC | 2007-08-31 |
| DENTAL MATRIX BAND (K071858) | Fly Cast Technologies, Inc. | 2007-08-31 |
| MOTIVA MONITOR DEVICE CONNECTIVITY, MODEL# 453564036921 (K071564) | Philips Medical Systems | 2007-08-31 |
| VISIONS PV 8.2 INTRAVASCULAR ULTRASOUND IMAGING CATHETER, MODEL 88900 (K071660) | Volcano Corporation | 2007-08-31 |
| DAR-9400F (K072006) | Shimadzu Corp. | 2007-08-31 |
| FLEX-NECK EXXTENDED PERITONEAL DIALYSIS CATHETER AND ACCESSORIES, MODEL CF-5560 (K071167) | Medigroup, Inc. | 2007-08-31 |
| TRABECULAR METAL VERTEBRAL BODY REPLACEMENT (VBR), MODEL# 06-115, 06-155 (K070754) | Zimmer Trabecular Metal Technology | 2007-08-31 |
| THE PORTABLE ANSISCOPE (K071168) | Dyansys, Inc. | 2007-08-31 |
| VISUALASE THERMAL THERAPY SYSTEM (K071328) | Biotex, Inc. | 2007-08-31 |
| INNOVASA STAT*SEAL TOPICAL HEMOSTAT (K071225) | Innovasa, Inc. | 2007-08-31 |
| ELECTROSURGICAL INFANT PATIENT RETURN ELECTRODE, DUAL PLATE WITH CORD, MODEL EP 211M (K071080) | E Surgical, LLC | 2007-08-31 |
| SPHYGMOCOR CARDIOVASCULAR MANAGEMENT SYSTEM (K070795) | Atcor Medical Pty, Ltd. | 2007-08-31 |
| HEALTH LINE INTERNATIONAL CORPORATION'S PRIMARY IV SOLUTION ADMINISTRATION SET WITH CHECK VALVE (K070630) | Health Line International Corporation (Hlic) | 2007-08-31 |
| MODIFICATION TO THERMOFOCUS 0800, 0900, 01500 AND 0700 SERIES (K072108) | Tecnimed S.R.L. | 2007-08-31 |
| VERTEFIX PEDICLE SCREW SPINAL SYSTEM (K063453) | Elite Surgical Supplies (Pty), Ltd. | 2007-08-30 |
| ALOKA SSD-ALPHA 7 ULTRASOUND SYSTEM (K072285) | Aloka Co., Ltd. | 2007-08-30 |
| LDR SPINE ROI-T SYSTEM (K072132) | Ldr Spine USA | 2007-08-30 |
| PORTABLE ECSCOPE (K072353) | Dyansys Corp | 2007-08-30 |
| MODIFICATION TO EZ HUBER SAFETY INFUSION SET (K071846) | Pfm Medical, Inc. | 2007-08-30 |
| EASYRA CLINICAL CHEMISTRY ANALYZER (K070057) | Medica Corp. | 2007-08-30 |
| FORTAGEN ORAL MEMBRANE (K071555) | Organogenesis, Inc. | 2007-08-30 |
| ARROW, ARROWG+ARD AND ARROWG+ARD BLUE PLUS PRESSURE INJECTABLE CENTRAL VENOUS CATHETER (K071538) | Arrow International, Inc. | 2007-08-30 |
| IPS INLINE POM SYSTEM (K071848) | Ivoclar Vivadent, Inc. | 2007-08-30 |
| DIAGNOSTIC HYBRIDS D3 DFA VARICELLA-ZOSTER VIRUS IDENTIFICATION KIT, 01-020000 (K070206) | Diagnostic Hybrids, Inc. | 2007-08-30 |
| 150W CERALAS D 980NM DIODE LASER (K072106) | Biolitec, Inc. | 2007-08-30 |
| QUICKBRIDGE TM CYLINDER AND CAP (K071551) | Biomet 3i, Inc. | 2007-08-30 |
| STORZ SLX-F2 STORM TOUCH (K070579) | KARL STORZ Endoscopy-America, Inc. | 2007-08-30 |
| SHANGHAI CHINA STAR CORP. POWDER FREE BLUE NITRILE PATIENT EXAMINATION GLOVE (K071072) | Shanghai China Star Corp | 2007-08-30 |
| DIAMONDBACK 360 DEGREE ORBITAL ATHERECTOMY SYSTEM FOR TREATMENT OF A-V SHUNT STENOSIS (K071427) | Cardiovascular Systems, Inc. | 2007-08-30 |
| DEN TEK COMFORT FIT NIGHTGUARD (K072147) | Den Tek Oral Care, Inc. | 2007-08-30 |
| ECG-1250A SERIES CARDIOFAX S AND ECG-1350A SERIES CARDIOFAX M (K072217) | Nihon Kohden America, Inc. | 2007-08-30 |
| MODIFICATION TO GE LOGIQ A3 (K072075) | General Electric Co. | 2007-08-29 |
| SBI FOREFOOT SET (K063635) | Small Bone Innovations, Inc. | 2007-08-29 |
| ACUSON P50 DIAGNOSTIC ULTRASOUND SYSTEM (K072266) | Siemens Medical Solutions USA, Inc. | 2007-08-29 |
| VITALCOR FEATHERWEIGHT VASCULAR CLAMPS (K070661) | Vitalcor, Inc. | 2007-08-29 |
| FLEXIBLE TRANS-NASAL VIDEO ESOPHAGOSCOPE WITH DIGITAL VIDEO PROCESSOR AND DISPOSABLE ENDOSHEATH SYSTEMS (K072088) | Vision-Sciences, Inc. | 2007-08-29 |
| VISAGE PACS/CS, RELEASE VERSION 5.0 (K072205) | Mercury Computer Systems, Inc. | 2007-08-29 |
| FLEXCEL CAROTID SHUNT (INLYING), MODEL 2020-05 (K071367) | LeMaitre Vascular, Inc. | 2007-08-29 |
| MHI-TM2000 LINEAR ACCELERATOR SYSTEM (K072047) | Mitsubishi Heavy Industries, Ltd. | 2007-08-29 |
| VISION-SCIENCES ENT-5000 AND ENT-5100 VIDEO ENT SCOPE WITH ENDOSHEATH SYSTEM, DPU-5000/DPU-5050 VIDEO PROCESSOR (K072073) | Vision-Sciences, Inc. | 2007-08-29 |
| AAP APS SYSTEM (K071852) | Aap Implantate AG | 2007-08-29 |
| TPC ADVANCECAM INTRA ORAL CAMERA SYSTEM, MODEL AIC 888 (K071485) | Tpc Advanced Technology, Inc. | 2007-08-28 |
| FIRSTVIEW (K071492) | Riverain Medical Group,Llc | 2007-08-28 |
| RAINBOW, RAINBOW LIGHT,RAINBOW BLUE, RAINBOW PLUS (K070338) | Rainbow Communications, Inc. | 2007-08-28 |
| ECLOS COMPUTED TOMOGRAPHY X-RAY SYSTEM (K071806) | Hitachi Medical Systems America, Inc. | 2007-08-28 |
| LIFESYNC ADAPTER, MODEL LS-302 (K071751) | Lifesync Corporation | 2007-08-27 |
| SBI ARTFIX (K071656) | Small Bone Innovations, Inc. | 2007-08-27 |
| ANGIODYNAMICS, INC MORPHEUS PICC AND PROCEDURE KIT (K072196) | AngioDynamics, Inc. | 2007-08-27 |
| STRYKER SPINE XIA III SPINAL SYSTEM (K071373) | Stryker Spine | 2007-08-27 |
| MODIFICATION TO GIRAFFE AND PANDA WARMERS (GIRAFFE AND PANDA UNINTERRUPTIBLE POWER SUPPLY) (K072157) | Ohmeda Medical | 2007-08-27 |
| CARDIODRIVE CATHETER ADVANCEMENT SYSTEM (CAS) (K071029) | Stereotaxis, Inc. | 2007-08-24 |
| CHISON, MODEL 8300 (K072210) | Chison Medical Imaging Co., Ltd. | 2007-08-24 |
| GSO GS1 SPACER (K071274) | Gold Standard Orthopedics, LLC | 2007-08-24 |
| SYNTHES (USA) 2ND GENERATION PELVIC C-CLAMP (K071476) | Synthes (Usa) | 2007-08-24 |
| ANGIOJET XPEEDIOR RHEOLYTIC THROMBECTOMY CATHETER, MODEL 104307 (K071336) | Possis Medical, Inc. | 2007-08-24 |
| ETOH FLEX REAGENT CARTRIDGE (DF22) (K071811) | Dade Behring, Inc. | 2007-08-24 |
| KARL STORZ VIDEO FLEXIBLE VIDEO ENT ENDOSCOPE SYSTEM (K071530) | KARL STORZ Endoscopy-America, Inc. | 2007-08-24 |
| TIZIAN CERAMIC, FLOW, PLATE, FIX & ZR BLANKS (K071010) | Schutz-Dental GmbH | 2007-08-24 |
| LORENZ BIOTECH APTIVA, VERSION 2.13 (K061828) | Lorenz Biotech S.P.A. | 2007-08-24 |
| PMAX NEWTRON XS (K071424) | Satelec - Acteon Group | 2007-08-24 |
| IMMUNOCAP ALLERGEN F338, SCALLOP WITH MODEL(S): 14-4895-01 (K071913) | Phadia AB | 2007-08-24 |
| NXSTAGE TRAVEL WARMER, MODELS TW-400 & FWS-500 (K071263) | Nxstage Medical, Inc. | 2007-08-24 |
| LATITUDE ELBOW PROTHESIS (K070787) | Tornier | 2007-08-24 |
| AMS MINIARC SLING SYSTEM (K071902) | American Medical Systems, Inc. | 2007-08-24 |
| SPINEASSIST SYSTEM (K063607) | Mazor Surgical Technologies , Ltd. | 2007-08-23 |
| PEDI CO2 EASY (K072220) | Westmed, Inc. | 2007-08-23 |
| WOUNDSTAT, MODEL TC1001 (K071936) | Traumacure, Inc. | 2007-08-23 |
| SC PROFI FINE PEN NEEDLE, MODELS; 5MM, 8MM, 12.7MM (28G, 29G, 30G, 31G) (K070988) | Shinchang Medical Co., Ltd. | 2007-08-23 |
| SMALL VOLUME SYRINGE (K062865) | Alcon Laboratories | 2007-08-23 |
| R-PORT LAPAROSCOPIC ACCESS DEVICE (K070158) | Advanced Surgical Concepts | 2007-08-23 |
| DOCTOR'S LIGHT LED DENTAL CURING LIGHT (K071908) | Good Doctors Co., Ltd. | 2007-08-23 |
| DURAGEN XS DURAL REGENERATION MATRIX (K072207) | Integra Lifesciences Corp. | 2007-08-23 |
| THROMCAT THROMBECTOMY CATHETER SYSTEM (K072195) | Kensey Nash Corp. | 2007-08-23 |
| THERMOGARD XP THERMAL REGULATION SYSTEM (K072234) | Alsius Corp. | 2007-08-23 |
| POWDERED VINYL PATIENT EXAMINATION GLOVES (K071686) | Langfang Huilong Plastic Product Co., Ltd. | 2007-08-22 |
| AXIOM LUMINOS DRF (K062623) | Siemens Medical Solutions USA, Inc. | 2007-08-22 |
| 4DDOME (K070918) | Cousin Biotech | 2007-08-22 |
| MODIFICATION TO CYBERKNIFE ROBOTIC RADIOSURGERY SYSTEM (K071531) | Accuray Incorporated | 2007-08-22 |
| EXTENDSURE LYOPHILIZED HBA1C LINEARITY CONTROLS (K071648) | Canterbury Scientific , Ltd. | 2007-08-22 |
| ELTA SILVER ANTIMICROBIAL WOUND GEL DRESSING, WOUND AND BURN, HYDROGEL W/DRUG AND/OR BIOLOGIC (K071703) | Swiss American Products, Inc. | 2007-08-22 |
| 15.5F HEMO-STREAM HEMODIALYSIS CATHETER SET (K071422) | Rex Medical | 2007-08-22 |
| MODIFIED MERCI RETRIEVER, MODEL 90060 (K071172) | Concentric Medical, Inc. | 2007-08-22 |
| REFLEXION SPIRAL VARIABLE RADIUS CATHETER (K072012) | St Jude Medical | 2007-08-22 |
| VELASHAPE (K071872) | Syneron Medical, Ltd. | 2007-08-22 |