| LYRIC HEARING AID (K081136) | Insound Medical, Inc. | 2008-05-08 |
| MERETE TOEMOBILE ANATOMICAL GREAT TOE RESURFACING SYSTEM (K072251) | Merete Medical GmbH | 2008-05-08 |
| TEMPTOUCH DERMAL THERMOMETER (K081162) | Diabetica Solutions, Inc. | 2008-05-08 |
| DESARA MESH SLING, MODEL CAL-DS01 (K072456) | Caldera Medical, Inc. | 2008-05-08 |
| SMITH & NEPHEW MIS HIP STEM WITH STIKTITE (K080625) | Smith & Nephew, Inc. | 2008-05-08 |
| MICRUS MICROCOIL SYSTEM, DELTAPAQ 10 CERECYTE, MODEL CDF (K080437) | Micrus Endovascular Corporation | 2008-05-08 |
| TC MATRIX CLINICAL CHEMISTRY ANALYZER (K073370) | Teco Diagnostics | 2008-05-08 |
| PLATELIA LYME IGG ASSAY (K080012) | Bio-Rad | 2008-05-08 |
| POWDERED VINYL PATIENT EXAMINATION GLOVES, CLEAR (NON-COLORED) (K071999) | Tangshan Hongyun Plastic Products Co., Ltd. | 2008-05-08 |
| OLYMPUS ESG-100, MODEL WB991046; OLYMPUS AFU-100, MODEL WB950167 (K073207) | Celon AG Medical Instruments | 2008-05-08 |
| T-PUMP LOCALIZED TEMPERATURE THERAPY PUMP (K073675) | Gaymar Industries, Inc. | 2008-05-08 |
| POWDERED VINYL PATIENT EXAMINATION GLOVES, CLEAR (NON-COLORED) (K072084) | Zibo Hongye Shangqin Plastic Rubbert Co, Ltd. | 2008-05-08 |
| PAJUNK'S KIT FOR BALLOON AIDED LAPAROSCOPY (K080654) | PAJUNK GmbH Medizintechnologie | 2008-05-08 |
| MODIFICATION TO EXPEDIUM SPINE SYSTEM (K080313) | Depuy Spine, Inc. | 2008-05-08 |
| BIO-CONSOLE 560 (K080824) | Medtronic Perfusion Systems | 2008-05-07 |
| DUREX PLAY TINGLING AQUEOUS BASED LUBRICANT (K072236) | Ssl Americas | 2008-05-07 |
| TRAUMASTAT RAPID HEMOSTATIC WOUND DRESSING BANDAGE (K080648) | Ore-Medix, LLC | 2008-05-07 |
| SCOUTPRO CS LEAD INTRODUCER SYSTEM (K080988) | Biotronik, Inc. | 2008-05-07 |
| U-CLIP UNI-FIRE, MODEL M65 (K081082) | Medtronic, Inc. | 2008-05-07 |
| OPTISTAR ELITE INJECTION SYSTEM (K073592) | Mallinckrodt Inc., Liebel-Flarsheim Business | 2008-05-07 |
| LDR SPINE ROI-T IMPLANT (K080569) | Ldr Spine USA | 2008-05-07 |
| ESA BIOSCIENCES INC. VITAMIN D HPLC TEST (K072536) | Esa Biosciences, Inc. | 2008-05-07 |
| REVERA WOUND CARE, MODEL MDW0060 (K070463) | Revalesio Corporation | 2008-05-07 |
| PROLYTE ELECTROLYTE ANALYZER (K070104) | Diamond Diagnostics, Inc. | 2008-05-07 |
| ZIMMER M/L TAPER HIP PROSTHESIS WITH KINECTIV TECHNOLOGY SYSTEM (K081007) | Zimmer, Inc. | 2008-05-06 |
| SERIM HISENSE ULTRA 0.1, PART NUMBER 5167 (K080712) | Serim Research Corp. | 2008-05-06 |
| AOS PROXIMAL HUMERAL PLATE (K080590) | Advanced Orthopaedic Solutions, Inc. | 2008-05-06 |
| EXACTECH NOVATION ELEMENT PRESS-FIT FEMORAL STEMS (K080980) | Exactech, Inc. | 2008-05-06 |
| OLYMPUS XCHF TYPE B180Y1 (K080586) | Olympus Medical Systems Corporation | 2008-05-06 |
| AMERICAN DENTAL IMPLANT ABUTMENT SYSTEM (K080397) | American Dental Implant Corporation | 2008-05-06 |
| SUCCESS CECAL INTUBATION ASSIST, MODEL: 4100 (K080764) | Max Endoscopy, Inc. | 2008-05-06 |
| NOVABONE PUTTY- BIOACTIVE SYNTHETIC GRAFT (K080009) | Novabone Products, LLC | 2008-05-06 |
| SPIRUS MEDICAL ENDO-EASE ENDOSCOPIC OVERTUBE (K080050) | Spirus Medical, Inc. | 2008-05-06 |
| HEPATOSTAT SET (K073493) | Vygon Corp. | 2008-05-06 |
| OPHTHALMOSCOPE F-10 (K072259) | Nidek Co., Ltd. | 2008-05-06 |
| ENDOSCOPIC CLIP APPLIERS WITH CLIP MAGAZINE (K081031) | Aesculap, Inc. | 2008-05-05 |
| BRACHYTHERAPY SOURCE DEVICE, MODEL 9011 (K081066) | Medi-Physics, Inc., Dba GE Healthcare | 2008-05-05 |
| SMART CO2 (SMART US 20D / ULTRASPEED, SMART CLINIC AND PERIOPULSE) SURGICAL LASER (K081181) | Cynosure, Inc. | 2008-05-05 |
| FINGERTIP PULSE OXIMETER, MODEL CMS-50C (K073454) | Contec Medical System Co., Ltd. | 2008-05-05 |
| CARDIOBLATE 68000 GNERATOR, BP2 SURGICAL ABLATION DEVICE, LP SURGICAL ABLATION DEVICE, GEMINI-SSURGICAL ABLATION DEVICE (K080509) | Medtronic, Inc. | 2008-05-05 |
| SURE-LOCK ELECTRODE CLIP, MODEL CL-34, CL-A60, CL-HW, CL-TL (K080605) | Curbell Electronics, Inc. | 2008-05-05 |
| AUTO SUTURE ENDO GIA STAPLERS WITH ENDO GIA SINGLE USE LOADING UNITS WITH STAPLE LINE REINFORCEMENT (K080898) | Tyco Healthcare Group LP | 2008-05-05 |
| ACL TOP (WITH SYSTEM SOFTWARE V3.0.0) (K073377) | Instrumentation Laboratory CO | 2008-05-04 |
| PROTECTISCOPE CS COLONOSCOPE, NON-INTRAPULL (K081004) | Stryker GI | 2008-05-02 |
| TRUFILL DCS ORBIT DETACHABLE COIL AND TRUFILL DCS SYRINGE OR TRUFILL DCS SYRINGE II, ALSO KNOWN AS THE TRUFILL DCS ORBIT (K080967) | Cordis Neurovascular, Inc. | 2008-05-02 |
| CAIS STAPLE (K073281) | Depuy Mitek, A Johnson & Johnson Company | 2008-05-02 |
| MEDIAID M960 SERIES, VITAL SIGNS MONITOR AND MEDIAID M900 SERIES, PULSE OXIMETER (K071642) | Mediaid, Inc. | 2008-05-02 |
| POWDERED VINYL PATIENT EXAMINATION GLOVES (K073192) | Shijiazhuang Prosperous Plastic Co., Ltd. | 2008-05-02 |
| SYSMEX UF-1000I, AUTOMATED URINE PARTICLE ANALYZER WITH URINALYSIS WAM SOFTWARE (K080887) | Sysmex America, Inc. | 2008-05-02 |
| NORAS MR-BI320-PA 1.5T (K081118) | Noras Mri Products GmbH | 2008-05-02 |
| MODIFICATION TO PROFLU+ ASSAY (K081030) | Prodesse, Inc. | 2008-05-02 |
| AESKULISA ANA HEP-2, REF 30-7115US (K081104) | Aesku Diagnostics | 2008-05-02 |
| LB MEDICAL INFLATABLE TISSUE ELEVATOR/EXPANDER SYSTEM (K080158) | Lb Medical LLC | 2008-05-02 |
| PKS PLASMA MORCELLATOR, MODELS 962000PK, 3620PK (K080093) | Gyrus Acmi, Inc. | 2008-05-02 |
| DSS STABILIZATION SYSTEM (K080963) | Paradigm Spine | 2008-05-02 |
| OEC 9900 ELITE (K073543) | Ge Oec Medical Systems | 2008-05-02 |
| OSFERION (K080065) | Olympus Terumo Biomaterials Corporation | 2008-05-02 |
| EAR THERMOMETER, MODELS ST66 AND ST67 (K080981) | Mesure Technology Co., Ltd. | 2008-05-02 |
| P.004 NC CARES TITANIUM AND CERAMIC ABUTMENTS (K081005) | Institut Straumann AG | 2008-05-02 |
| ANT ANGIOGRAPHIC SYRINGES, MODEL(S) 100101,102,103,100201,202,203,204,100301,200101,201,202, 203,200301,101,102,202,301 (K072696) | Shenzhen Ant Hi-Tech Industrial Co., Ltd. | 2008-05-02 |
| MOBLVAC W.C. (K081185) | Ohio Medical Corporation | 2008-05-02 |
| UNIVERSAL VIAL ACCESS SPIKE (K080989) | Icu Medical, Inc. | 2008-05-02 |
| ZELTIQ AESTHETICS CLN1 DERMAL COOLING DEVICE (K080118) | Zeltiq Aesthetics | 2008-05-02 |
| BIOMERS TRANSLUCENT ORTHODONTIC WIRE (K081143) | Biomers Product, LLC | 2008-05-02 |
| AQUACEL HYDROFIBER WOUND DRESSING AND AG HYDROFIBER DRESSING (K080383) | Convatec, A Division of E.R. Squibb & Sons, LLC | 2008-05-02 |
| ARTBLOC TEMP, DIMENSION: 15.5 X19.39 MM V-CLASSIC SHADES AND BLEACH SHADES (K080556) | Merz Dental GmbH | 2008-05-02 |
| C-TEK MAXAN ANTERIOR CERVICAL PLATE SYSTEM (K080646) | Biomet Spine | 2008-05-02 |
| CONTURA MLB SOURCE APPLICATOR FOR BRACHYTHERAPY (K081079) | Senorx, Inc. | 2008-05-02 |
| VARIANT NBS SICKLE CELL PROGRAM REAGENT KIT, VARIANT NBS NEWBORN SCREENING SYSTEM AND VARIANT NBS WORKSTATION WITH (K080911) | Bio-Rad Laboratories Inc., Clinical Systems Divisi | 2008-05-02 |
| CORONIS 5MP MAMMO SL, MODEL MDMG 6121 (K081109) | Barcoview, Medical Imaging Systems | 2008-05-02 |
| STD MED PRIMO PORT POLY (K080645) | Std Med, Inc. | 2008-05-02 |
| PATHWAY (K080281) | Custom Spine, Inc. | 2008-05-01 |
| AESCULAP PEEK INTERVERTEBRAL BODY FUSION SYSTEM: A SPACE, CESPACE, PROSPACE, T-SPACE (K071983) | Aesculap Implant Systems, Inc. | 2008-05-01 |
| DISPOSABLE ADHESIVE SURFACE ELECTRODES, DISC ELECTRODES (K073532) | Technomed Europe | 2008-05-01 |
| X-MESH EXPANDABLE CAGE SYSTEM (K080568) | Depuy Spine, Inc. | 2008-05-01 |
| FUTAR (FUTAR, FUTAR D, FUTAR D FAST, FUTAR D SLOW, FUTAR SCAN BITE REGISTRATION MATERIALS (K081120) | Kettenbach GmbH & Co. KG | 2008-05-01 |
| PROCHEM INDICATOR TAPE (K080307) | Raven Laboratories | 2008-05-01 |
| SYNTHES 6.5MM MIDFOOT FUSION BOLT (K081071) | Synthes (Usa) | 2008-05-01 |
| 3-D IMAGING WORKSTATION (K081093) | Eigen, LLC | 2008-05-01 |
| SUPRASORB A +AG (K071442) | Specialty Fibres and Materials, Ltd. | 2008-05-01 |
| XIA SPINAL SYSTEM, STAINLESS STEEL UNI-PLANAR SCREWS (K080928) | Stryker Spine | 2008-04-30 |
| DEMETECH ABSORBABLE SURGICAL SUTURE PLAIN & CHROMIC GUT (K072930) | Demetech Corp. | 2008-04-30 |
| EndoWave Infusion System (K080392) | Ekos Corp. | 2008-04-30 |
| CONTURA MULTI-LUMEN BALLOON SOURCE APPLICATOR FOR BRACHYTHERAPY, MODELS B001-45 AND B011-45 (K080791) | Senorx, Inc. | 2008-04-30 |
| P.004 ABUTMENTS, P.004 TEMPORARY COPINGS, P.004 PROTECTIVE CAPS, P.004 PERMANENT COPINGS (K080239) | Straumann Manufacturing, Inc. | 2008-04-30 |
| SYNTHES CRANIOFACIAL PLATE AND SCREW SYSTEM (K080331) | Synthes (Usa) | 2008-04-30 |
| EMAX 2 PLUS SYSTEM, MODEL EMAX 2 PLUS MOTOR, EMAX 2 CONSOLE>FIRMWARE UPGRADE, EMAX 2 FP FOOT PEDAL (K080802) | The Anspach Effort, Inc. | 2008-04-30 |
| EMU-GRAPH EMULATOR, MODEL CI 131 (K072408) | Steritec Products Mfg Co, Inc. | 2008-04-30 |
| VANTAGECATH INTRAVASCULAR CATHETER (K073471) | Advantage Medical Device | 2008-04-30 |
| OSSEOSPEED NARROW (K080396) | Astra Tech AB | 2008-04-30 |
| MAS TOX CONTROL (K080085) | Thermo Fisher Scientific | 2008-04-30 |
| MODIFICATON TO: PYRAMID +4 ANTERIOR LUMBAR PLATE SYSTEM (K080429) | Medtronic Sofamor Danek USA, Inc. | 2008-04-30 |
| MOND RVOT STYLET MODELS 4140, 4141, 4150, 4151 (K080924) | St. Jude Medical, Cardiac Rhythm Management Divisi | 2008-04-30 |
| VITEK 2 GRAM POSITIVE INDUCIBLE CLINDAMYCIN RESISTANCE (K080201) | bioMerieux, Inc. | 2008-04-30 |
| ORWELL FLUID COLLECTION AND DISPOSAL SYSTEM (K080845) | Cardinalhealth | 2008-04-30 |
| NON STERILE, POWDER FREE NITRILE EXAMINATION GLOVE, BLUE, POLYMER COATING WITH CHEMOTHERAPY CLAIM (K080520) | Siam Sempermed Corp., Ltd. | 2008-04-30 |
| WG-SURGICAL SUTURES WITH NEEDLE (K073614) | Foosin Medical Supplies, Inc. | 2008-04-30 |
| REGENAFIL, REGENAFORM, ALRIVA DBM PASTE, SLTIVA DM WITH CORTICAL CANCELLOUS SHIPS, BIOSET, SIOSET IC, RTI ALLOGRAFT PAST (K080418) | Regeneration Technologies, Inc. | 2008-04-30 |
| MPS OXIPORT AND MPS OXIPORT PLUS (K072379) | Innerspace, Inc. | 2008-04-29 |
| FASTLOCK, MODEL PC175M01, PC175MCE, PC005R01 (K080621) | European Custom Manufacturing BV | 2008-04-29 |