| UNIPLAIN & UNICHROM (K042287) | United Medical Industries Co. , Ltd. | 2005-09-07 |
| CONNEXUS, .5CC, MODEL 023000-005 (K052098) | Isotis Orthobiologics, Inc. | 2005-09-07 |
| FIRST CHECK MULTI DRUG CUP 7 FOR MARIJUANA (THC), COCAINE (COC), AMPHETAMINE (AMP), METHAMPHETAMINE (MET), ECSTASY (K051966) | Worldwide Medical, LLC | 2005-09-07 |
| CALDYNE, INC. EXHALOMETER EX100, MODEL EX100 (K051279) | Caldyne, Inc. | 2005-09-07 |
| INFRARED EAR THEMOMETER, MODELS DX6603, DX66390 (K051251) | Shenzhen Dongdixin Technology Co., Ltd. | 2005-09-07 |
| EUGENONE (K051952) | Scientific Pharmaceuticals, Inc. | 2005-09-07 |
| BIO-STIM KIT (K050174) | Skylark Device & Systems Co., Ltd. | 2005-09-07 |
| VERTEBRON PSS PEDICLE SCREW SYSTEM (K051716) | Vertebron, Inc. | 2005-09-07 |
| REFIX INTERNAL FRACTURE FIXATION SCREWS (K050388) | Xtremi-T, LLC | 2005-09-07 |
| GEMINI SURGICAL CONTROL & DISPLAY SYSTEM (K051831) | Applied Surgical, LLC | 2005-09-07 |
| AIDA COMPACT II SYSTEM (K052159) | KARL STORZ Endoscopy-America, Inc. | 2005-09-07 |
| PARALLAX EZFLOW CEMENT DELIVERY SYSTEM (K051820) | Arthrocare Corp. | 2005-09-06 |
| PRAXAIR MEDICAL AIR MIXER (K051192) | Praxair, Inc. | 2005-09-06 |
| ACUMATCH A-SERIES CONNEXION GXL ENHANCED CROSSLINKED POLYTHYLENE (K051556) | Exactech, Inc. | 2005-09-06 |
| SBI WRISTFIT (K051747) | Small Bone Innovations, LLC | 2005-09-06 |
| E-STIM II (K050435) | Lhasa Oms, Inc. | 2005-09-06 |
| PREMIER TEMPORARY CEMENT (K051866) | Premier Dental Products Co. | 2005-09-06 |
| POROUS COATED DISCOVERY ELBOW (K051975) | Biomet, Inc. | 2005-09-06 |
| F-400 SYSTEM (K051585) | Mauna Kea Technologies | 2005-09-06 |
| FREELITE HUMAN KAPPA AND LAMBDA FREE KITS FOR USE ON THE BAYER ADVIA 1650 ANALYZER (K051915) | The Binding Site, Ltd. | 2005-09-06 |
| MBARESORB IMPLANT (K051611) | Kinetikos Medical, Inc. | 2005-09-06 |
| MIOT PLATING SYSTEM (K051945) | Orthofix Srl | 2005-09-06 |
| DESTINATION CAROTID GUIDING SHEATH (K052185) | Terumo Medical Corp. | 2005-09-06 |
| TAPERED COMPRESSION PIN (K051740) | Nexa Orthopedics, Inc. | 2005-09-06 |
| VANGUARD REPROCESSED EXTERNAL FIXATION DEVICES (K051616) | Vanguard Medical Concepts, Inc. | 2005-09-06 |
| SC CERAMIC BALL HEADS (K052237) | Orthopedic Alliance, LLC | 2005-09-06 |
| VCS DOPPLER TRANSCEIVER, MODEL 09-0023-01 (K052209) | Vascular Control Systems, Inc. | 2005-09-06 |
| OSTEOMIMETIC SYNTHETIC BONE MATRIX (K051775) | Biomimetic Pharmaceuticals, Inc. | 2005-09-06 |
| IMPLANT HANDPIECES (K051661) | Sirona Dental Systems GmbH | 2005-09-06 |
| R&R EXTERNAL FIXATION SYSTEM (K052005) | R&R Medical, Inc. | 2005-09-06 |
| MODIFICATION TO ACCU-CHEK GO SYSTEM (K051592) | Roche Diagnostics Corp. | 2005-09-02 |
| SYNERGEYES (PAFLUCON D HEM-IBERFILCON A) HYBRID CONTACT LENS (K051035) | Synergeyes | 2005-09-02 |
| POWDERED VINYL PATIENT EXAMINATION GLOVES, COLORED (WHITE, YELLOW) (K051924) | Shijiazhuang Manful Light Industrial Products Co., | 2005-09-02 |
| DAR-8000I (K052076) | Shimadzu Medical Systems | 2005-09-02 |
| MODIFICATION TO BLUE SKY BIO DENTAL IMPLANT SYSTEM (K051507) | Blue Sky Bio, LLC | 2005-09-02 |
| SEDLINE SEDATION MONITOR WITH FRONTAL PSI AND SEDTRACE EEG ELECTROSE SET (K051874) | Physiometrix, Inc. | 2005-09-02 |
| IMAGER II ANGIOGRAPHIC CATHETER (K050863) | Boston Scientific Corp | 2005-09-02 |
| ACCU-LEAD (K050443) | Kentec Medical, Inc. | 2005-09-02 |
| RADIANCY SKINSTATION WITH MODIFIED LIGHT UNIT ADDEMBLY (K051671) | Radiancy (Israel) , Ltd. | 2005-09-02 |
| UROPASS URETERAL ACCESS SHEATH, MODEL 61224 (K051593) | Acmi Corporation | 2005-09-02 |
| INTERMEZZO IMPLANT SYSTEMS (K051018) | Megagen Co., Ltd. | 2005-09-02 |
| CLIRPATH TURBO EXCIMER LASER CATHETERS (K052296) | Spectranetics Corp. | 2005-09-02 |
| MANIPUSEAL (K051160) | Insitu Systems | 2005-09-02 |
| CAVITRON RF ULTRASONIC SCALER SYSTEM WITH STERIMATE HANDPIECE, MODEL G-131 (K052334) | Dentsply Intl. | 2005-09-02 |
| YI XIN STERILE SYRINGE FOR SINGLE USE (K050999) | Jiangxi Sanxin (Eversincere) Medical Devices Group | 2005-09-02 |
| ZIMMER A.T.S. 3000 AUTOMATIC TOURNIQUET SYSTEM (K050411) | Zimmer, Inc. | 2005-09-02 |
| ANGIOSCULPT SCORING BALLOON CATHETER (K050629) | Angioscore, Inc. | 2005-09-02 |
| MAXISONIC FAMILY AND SWIFT ULTRASONIC SCALER (K051910) | D.B.I. America Corp. | 2005-09-02 |
| EDWARDS PERIPHERAL DILATION CATHETER (K052149) | Edwards Lifesciences, LLC | 2005-09-02 |
| MCCARTNEY ACCESS TUBE (K051594) | Gynetech Pty. , Ltd. | 2005-09-02 |
| DOLOTENS DENTAL TM 1 (K043373) | Neuromuscular Technologies, Inc. | 2005-09-02 |
| SEER MC (K042782) | Ge Medical Systems Information Technologies | 2005-09-02 |
| DUAL MODE UP-GRADE FOREHEAD/UNDERARM THERMOMETER DEVICE (K051422) | Medisim, Ltd. | 2005-09-01 |
| CYCLOSPORINE EXTENDED RANGE ASSAY (CSAE) FLEX REAGENT CARTRIDGE, CATALOG # DF108 (K052017) | Dade Behring, Inc. | 2005-09-01 |
| COMFORT AND INSET SUBCUTANEOUS INFUSION SETS FOR USE WITH ABBOTT INFUSION PUMPS (K051264) | Unomedical A/S | 2005-09-01 |
| SYNTHOGRAFT (K051091) | Bicon, Inc. | 2005-09-01 |
| MODEL 2800 PFT FILTER (K051712) | Air Safety, Ltd. | 2005-09-01 |
| AVANA DENTAL IMPLANT SYSTEM (K051576) | Osstem Co., Ltd. | 2005-09-01 |
| TEVADAPTOR CLOSED DRUG RECONSTITUTION AND TRANSFER SYSTEM (K051669) | Migada Plant | 2005-09-01 |
| JSZ-STAT-TREE, AND JSZ-STAT-OR, CLEANING, DISINFECTING AND STORING SOLUTIONS; JSZ-WET-TREE AND JSZ-WET-OR, WETTING, (K052074) | Szabocsik and Associates | 2005-09-01 |
| INSTRU-SAFE INSTRUMENT PROTECTION SYSTEMS (K051157) | Micromedics, Inc. | 2005-09-01 |
| IN-VITRO DIAGNOSTIC VAGINITIS TEST KIT (K050352) | Ameritek Research, LLC | 2005-09-01 |
| MODIFIED CONCENTRIC RETRIEVER, MODEL 90039 (K051838) | Concentric Medical, Inc. | 2005-09-01 |
| NON-STERILE POWDER FREE MULTICOLOR - RED, BLUE, PURPLE AND YELLOW LATEX EXAMINATION GLOVES WITH PROTEIN CONTENT LABELING (K052016) | Sgmp Co., Ltd. | 2005-09-01 |
| MODIFIED ACUMEN SHEATH, MODEL TTW 10-65 (K051515) | Acumen Medical, Inc. | 2005-09-01 |
| CANADY PLASMA PROBES (K052035) | Canady Technology, LLC | 2005-08-31 |
| TRIABSORB COMPOSITE SCREW (K050468) | Advanced Biomaterials | 2005-08-31 |
| LEARDO, AVANTICARE ELECTRICAL SCOOTERSM3021 (K051473) | Lerado China Limited | 2005-08-31 |
| O'MY NATURAL LUBRICANT, O'MY NATURAL FLAVORED LUBRICANT (K042915) | O'My Products Incorporated | 2005-08-31 |
| OPTI-AMP DC-POWERED (K052060) | Intelligent Hearing Systems | 2005-08-31 |
| ENCORE REVERSE SHOULDER PROSTHESIS HUMERAL STEM ADAPTER (K052086) | Encore Medical, Inc. | 2005-08-31 |
| DRYSTAR MODEL 5500 (K052251) | Agfa Corporation | 2005-08-31 |
| REGENSIS PERICARDIAL PATCH (K051405) | Cormatrix Cardiovascular, Inc. | 2005-08-31 |
| RELIEVA SINUS BALLOON INFLATION DEVICE (K052198) | Acclarent, Inc. | 2005-08-31 |
| TSRH SPINAL SYSTEM (K052144) | Medtronic Sofamor Danek | 2005-08-31 |
| MS 4/5 HEMATOLOGY ANALYZER (K050421) | Melet Schloesing Laboratories USA | 2005-08-31 |
| TRIATHLON PRESS-FIT TOTAL KNEE SYSTEM (K051380) | Howmedica Osteonics Corp. | 2005-08-30 |
| PROXIMATE PPH HEMORRHOIDAL CIRCULAR STAPLER AND ACCESSORIES (K051301) | Ethicon Endo-Surgery, Inc. | 2005-08-30 |
| LUMENIS 1000 INTEGRATED SLIT LAMP (K052129) | Lumenis, Inc. | 2005-08-30 |
| A-DEC SELF-CONTAINED WATER SYSTEM (K051657) | A-Dec, Inc. | 2005-08-30 |
| CAREVENT CA AND DRA (K051889) | O-Two Medical Technologies, Inc. | 2005-08-30 |
| INTER V BRAND V-MARK BREAST BIOPSY SITE MARKER WITH TITANIUM ANCHOR (K051421) | Medical Device Technologies, Inc. | 2005-08-30 |
| ORS MODEL 6000 ENDOSCOPE HOLDER (K051979) | O.R. Solutions, Inc. | 2005-08-30 |
| POLYTECH PULMONARY FUNCTION FILTER (K042758) | Polytechnic Resources, Inc. | 2005-08-29 |
| THE SC-ACUFIX ANT-CER DYNAMIC CERVICAL PLATE SYSTEM SINGLE LEVEL PLATES (K052072) | Abbott Spine, Inc. | 2005-08-29 |
| PVC AND SILICONE MANUAL RESUSCITATORS (K051177) | David Medical Products Co.,Ltd | 2005-08-29 |
| ISIS IQ DUO TWIN ELECTRONIC BREAST PUMP, MODEL 100 (K051413) | Avent America, Inc. | 2005-08-29 |
| DOPPLER GUIDED PROCTOSCOPE, MODEL 500H (K052067) | Multigon Industries, Inc. | 2005-08-29 |
| U1 HIP SYSTEM - BIPOLAR (K050269) | United Orthopedic Corp. | 2005-08-29 |
| MODIFICATION TO: RECOVERY FILTER SYSTEM, MODEL RF-210F (K050558) | C.R. Bard, Inc. | 2005-08-29 |
| UROPLASTY RIGID ENDOSCOPIC NEEDLE (K051905) | Uroplasty, Inc. | 2005-08-29 |
| LUMIWAVE 1X4 INFRARED THERAPY DEVICE (K051816) | Biocare Systems, Inc. | 2005-08-26 |
| PHILIPS 12-LEAD ALGORITHM (K052049) | Philips Medical Systems | 2005-08-26 |
| C.F.A.S. (CALIBRATOR FOR AUTOMATED SYSTEMS) HBA1C (K052101) | Roche Diagnostics | 2005-08-26 |
| CEEGRAPH/SLEEPSCAN NETLINK TRAVELER (K052066) | Bio-Logic Systems Corp. | 2005-08-26 |
| MRI COMPATIBLE PATIENT MONITORING SYSTEM, MODEL 3160 (K050399) | Invivo Research, Inc. | 2005-08-26 |
| FORTOSS VITAL BONE GRAFT SUBSTITUTE (K050170) | Biocomposites, Ltd. | 2005-08-26 |
| STINGRAY EPIDURAL CATHETER CONNECTOR (K051171) | Epimed International, Inc. | 2005-08-26 |
| NIPRO DISPOSABLE SYRINGE WITH OR WITHOUT NEEDLE (K051574) | Nipro Medical Corp. | 2005-08-26 |
| FIBRIN ANALYSIS SYSTEM ENDOLUMINAL BRUSH (K050889) | Crs Medical Diagnostics, Inc. | 2005-08-26 |