| AXIEM IMAGELESS HIP MODULE FOR THE STEALTHSTATION SYSTEM (K061248) | Medtronic Navigation, Inc. | 2006-08-31 |
| BODY COMPOSITION ANALYZER, MODELS ZEUS 9.9 AND VENUS 5.5 (K053556) | Jawon Medical Co., Ltd. | 2006-08-31 |
| SENSITITRE HAEMOPHILUS / STREPTOCOCCUS PNEUMONIAE (HP) MIC PLATES (K062190) | Trek Diagnostic Systems, Inc. | 2006-08-31 |
| CONFORMIS, INC. TOTAL KNEE REPAIR SYSTEM (K052687) | Conformis, Inc. | 2006-08-31 |
| ELECSYS IGE II IMMUNOASSAY (K061970) | Roche Diagnostics | 2006-08-31 |
| EVIS EXERA 180 SYSTEM (K061313) | Olympus Medical Systems Corporation | 2006-08-31 |
| MR FIBER OPTIC INTUBATING LARYNGOSCOPE HANDLE, SHORT, MODEL 310002 (K062230) | Minrad, Inc. | 2006-08-31 |
| REPROCESSED ELECTROPHYSIOLOGY CATHETERS (K061045) | Alliance Medical Corp. | 2006-08-31 |
| RF LESION CANNULA, RF THERMOLESION CANNULA, THERMOLESION CANNULA, X-RAY CONTRAST CANNULA, CANNULA, FACET DENERATION NEED (K060397) | PAJUNK GmbH Medizintechnologie | 2006-08-31 |
| SYNTHES STERILE MANDIBLE EXTERNAL FIXATION KIT (K062299) | Synthes (Usa) | 2006-08-31 |
| ANCHOR LAPARSCOPIC TISSUE RETIEVAL SYSTEM (K061555) | Anchor Products Co. | 2006-08-31 |
| VITALSENSE XHR (K061870) | Respironics, Inc. | 2006-08-31 |
| MR FIBER OPTIC INTUBATING LARYNGOSCOPE HANDLE, STANDARD, MODEL 310001 (K062231) | Minrad, Inc. | 2006-08-31 |
| PRIMUS GPS BILIARY STENT SYSTEM (K061566) | Ev3, Inc. | 2006-08-31 |
| CALCITONIN IMMUNORADIOMETRIC ASSAY (IRMA) (COATED TUBE VERSION) (K060578) | Scantibodies Laboratory, Inc. | 2006-08-30 |
| SPACE CPSXL BONE CEMENT (K061531) | Dfine, Inc. | 2006-08-30 |
| TRINICA ANTERIOR LUMBAR PLATE SYSTEM (K061353) | Zimmer Spine, Inc. | 2006-08-30 |
| IDI-VANR ASSAY (K061686) | Geneohm Sciences Canada, Inc. | 2006-08-30 |
| V-808 ATOM TRANSCAPSULE (K061071) | Atom Medical, Inc. | 2006-08-29 |
| FLEXIFIT HC432 FULL FACE MASK (K061236) | Fisher & Paykel Healthcare, Ltd. | 2006-08-29 |
| DIMENSION VISTA DBIL FLEX REAGENT CARTRIDGE, MODEL K2125 (K061839) | Dade Behring, Inc. | 2006-08-29 |
| QUADRATENS, MODEL QT-42 (K061799) | Bio-Research Associates, Inc. | 2006-08-28 |
| AXIOM ORTHOPAEDICS SHOULDER RESURFACING SYSTEM (K061862) | Axiom Orthopaedics, Inc. | 2006-08-28 |
| LC SPRINT STAR (K062158) | Pari Innovative Manufacturers, Inc. | 2006-08-28 |
| DISTAL RADIUS LOCKING PLATING SYSTEM (K061917) | Newclip Technics | 2006-08-28 |
| DUPUY S-ROM STD HIP STEM PROSTHESIS (K061221) | DePuy Orthopaedics, Inc. | 2006-08-28 |
| CRYOCARE CN2 SYSTEM (K062175) | Endocare, Inc. | 2006-08-28 |
| HALO COAGULATION CATHETER (K062225) | Barrx Medical, Incorporated | 2006-08-28 |
| MICRUS MICROCOIL SYSTEM PRESIDIO-18, MODEL PC4 (K062036) | Micrus Endovascular Corporation | 2006-08-25 |
| DIMENSION VISTA TBIL FLEX REAGENT CARTRIDGE, AND DIMENSION VISTA TBIL/DBIL CALIBRATOR; MODELS K1167, KC212 (K061719) | Dade Behring, Inc. | 2006-08-25 |
| CURATIVE DENTAL ACRYLIC TEETH (K060720) | Curative, LLC | 2006-08-25 |
| TELAHEART DIGITAL RECORDER (K061293) | North East Monitoring, Inc. | 2006-08-25 |
| PREMIER 11 HOLTER (K062088) | Diagnostic Monitoring Software | 2006-08-25 |
| HIGH SPEED AIR TURBINE HANDPIECES, PAR-4HEX/4HX SERIES (TWIN POWER TURBINE 4H) (K061701) | J. Morita USA, Inc. | 2006-08-25 |
| DIMENSION VISTA SYSTEM CHEMISTRY 3 CALIBRATOR (CHEM 3 CAL - KC130) (K062122) | Dade Behring, Inc. | 2006-08-25 |
| DIMENSION VISTA SYSTEM DRUG 2 CALIBRATOR (DRUG 2 CAL - KC420) (K062121) | Dade Behring, Inc. | 2006-08-25 |
| DIMENSION VISTA ENZYME 1 CALIBRATOR (ENZ 1 CAL - KC310) (K061923) | Dade Behring, Inc. | 2006-08-25 |
| ALBERT BROWNE LTD. VERIFY STEAM AND EO LOAD RECORD CARD (K061738) | Albert Browne , Ltd. | 2006-08-25 |
| LIPOSAT (INFILTRATION PUMP), MODEL 00 002 274; VACUSAT (SUCTION UNIT), MODEL 00 002 252 (220 V), 00 002 318 (110 V); (K053451) | Moeller Medical GmbH & Co. KG | 2006-08-25 |
| N LATEX CDT (K060677) | Dade Behring, Inc. | 2006-08-25 |
| SURGIFROST XL CRYOSURGICAL DEVICE, MODEL 60SFXL; CRYOSURGICAL CONSOLE, MODEL 65CS1 (K062140) | Cryocath Technologies, Inc. | 2006-08-24 |
| CAPIOX RX OXYGENATOR WITH OR WITHOUT RESERVOIR (K062381) | Terumo Cardiovascular Systems Corp. | 2006-08-24 |
| MODIFICATION TO PHILIPS AVALON FETAL MONITORS FM20 AND FM30 (K062137) | Philips Medizin Systeme Boeblingen GmbH | 2006-08-24 |
| DIMENSION VISTA IGM FLEX REAGENT CARTRIDGE AND PROTEIN 1 CALIBRATOR AND CONTROL L, M AND H (K061845) | Dade Behring, Inc. | 2006-08-24 |
| ABX PENTRA 400: LIPOPROTEINS (K060854) | Horiba Abx | 2006-08-24 |
| AQUATINE EC ENDODONTIC CLEANSER (K061689) | Puricore, Inc. | 2006-08-24 |
| POWDER FREE LATEX EXAMINATION GLOVES, NATURAL OR BLUE COLOUR AND WITH PROTEIN CONTENT LABELING CLAIM (50 UG OR LESS) (K061551) | Medipure Corporation (M) Sdn. Bhd. | 2006-08-24 |
| STRAUMANN NARROW NECK IMPLANTS (K060958) | Straumann USA | 2006-08-24 |
| BODYGAURD PAIN MANAGER INFUSION SYSTEM (K061325) | Caesarea Medical Electronics , Ltd. | 2006-08-24 |
| MONOBLOCK PRESS-FIT HIP STEM (K060072) | Omni Life Science, Inc. | 2006-08-24 |
| PORTEX NEEDLE-PRO EDGE SAFETY WITH SYRINGE, MODELS 432310, 432210, 432510, 432558 (K061194) | Smiths Medical Asd, Inc. | 2006-08-24 |
| MICROSCAN MICROSTREP PLUS PANEL CHLORAMPHENICOL (1 TO 32 MCG/ML) (K062293) | Dade Behring, Inc. | 2006-08-24 |
| ANGIODYNAMICS SOFT-VU AND MARINER HYDROPHILIC COATED ANGIOGRAPHIC CATHETER (K061733) | AngioDynamics, Inc. | 2006-08-24 |
| ARROW PRESSURE INJECTABLE PICC (K061289) | Arrow International, Inc. | 2006-08-24 |
| CELLVIZIO WITH CONFOCAL MINIPROBES, MODEL F-600; COLOFLEX AND GASTROFLEX (K061666) | Mauna Kea Technologies | 2006-08-24 |
| APPLIED LAPAROSCOPIC DISPOSABLE MONOPOLAR SCISSORS (K062169) | Applied Medical Resources Corp. | 2006-08-24 |
| ONLINE TDM PROCAINAMIDE (K060773) | Roche Diagnostics Corp. | 2006-08-23 |
| PROCERA ZIRCONIA ABUTMENT FOR CAMLOG IMPLANT SYSTEM (K061529) | Nobel Biocare AB | 2006-08-23 |
| RTA 5 & RTA MODEL E RETINAL THICKNESS ANALYZER (K061674) | Talia Technology , Ltd. | 2006-08-23 |
| APOLLO GAMMA CAMERA SYSTEM (K062298) | Adac Laboratories | 2006-08-23 |
| HARDY DISK AST TIGECYCLINE 15 UG, MODELZ936 (K062245) | Hardy Diagnostics | 2006-08-23 |
| ENDOSCOPIC SPINE SYSTEM (K061246) | Arthro Kinetics, Inc. | 2006-08-23 |
| MODIFIED ACUMEN LEAD DELIVERY SHEATH, MODELS LDS-10-57, LDS-10-57-90, LDS-10-64 AND LDS-10-64-90 (K062145) | Acumen Medical, Inc. | 2006-08-23 |
| MICROSCAN MICROSTREP PLUS PANEL (K061872) | Dade Behring, Inc. | 2006-08-23 |
| MICROSCAN DRIED GRAM-POSITIVE MIC/COMBO PANELS WITH ERYTHROMYCIN (0.25 - 16UG/ML) (K062179) | Dade Behring, Inc. | 2006-08-23 |
| MICROSCAN MICROSTREP PLUS PANEL (K062276) | Dade Behring, Inc. | 2006-08-23 |
| MODIFICATION TO BONE GRAFT SYRINGE (K062173) | Wrightmedicaltechnologyinc | 2006-08-23 |
| JOSTRA QUADROX D SAFELINE DIFFUSION MEMBRANE OXYGENATOR, MODEL HMOD 2030 (K061628) | Maquet Cardiopulmonary, AG | 2006-08-22 |
| TRIDENT LARGE DIAMETER HIP SYSTEM (K061434) | Howmedica Osteonics Corp. | 2006-08-22 |
| NANOTHERM, VASCUTHERM AND PROTHERMO THERAPY WRAPS (K061866) | Thermotek, Inc. | 2006-08-22 |
| VIGILEO ARTERIAL PRESSURE CARDIAC OUTPUT/OXIMETRY MONITOR (K062134) | Edwards Lifesciences, LLC | 2006-08-22 |
| TANDEM HEART ESCORT (T.H.E.) CONTROLLER, MODEL 5140-8500 (K061369) | Cardiacassist, Inc. | 2006-08-22 |
| ARX SPINAL SYSTEM (K061600) | Life Spine | 2006-08-22 |
| MYTECH / HAPPY LIFE / MAXIAIDS ARM BLOOD PRESSURE MONITOR, HPL-301, HPL-302, HPL-310, 180310 (K061959) | Mytech Technology Co., Ltd. | 2006-08-22 |
| CG-6108 ARRHYTHMIA ECG EVENT RECORDER (K060911) | Card Guard Scientific Survival , Ltd. | 2006-08-22 |
| BIOKNOTLESS AND LUPINE PLUS ANCHORS (K062170) | Depuy Mitek, A Johnson & Johnson Company | 2006-08-22 |
| UNI KNEE SURGETICS NAVIGATION SYSTEM (K062146) | Praxim S.A | 2006-08-21 |
| DIMENSION VISTA SYSTEM DRUGS OF ABUSE POSITIVE AND NEGATIVE CONTROLS, MODELS KC515 AND KC516 (K062191) | Dade Behring, Inc. | 2006-08-21 |
| DIMENSION VISTA CYCLOSPORINE (CSA) FLEX REAGENT CARTRIDGE (K062236) | Dade Behring, Inc. | 2006-08-21 |
| BIOPRO MEMORY STAPLE (K061798) | Biopro, Inc. | 2006-08-21 |
| ATTAIN 6227DEF DEFLECTABLE CATHETER DELIVERY SYSTEM (K061480) | Medtronic, Ireland | 2006-08-21 |
| UCP RAPID DRUG SCREENING TRICYCLIC ANTIDEPRESSANT, PROPOXYPHENE TESTS (K061457) | Ucp Biosciences, Inc. | 2006-08-21 |
| VANGUARD ANATOMIC PATELLA GROOVE (APG) / VANGUARD V GROOVE (K061433) | Biomet Manufacturing, Inc. | 2006-08-21 |
| NOVAPACS, NOVAVIEW, NOVACARDIO, NOVAQC AND NOVAER (K061920) | Novarad Corp. | 2006-08-21 |
| Z-BLOCK, MODELS 20/19, 40/19, 55/19 (K062389) | Foundation Milling Centre | 2006-08-21 |
| VITREAACCESS, VERSION 1.0 (K062328) | Vital Images, Inc. | 2006-08-21 |
| KSEA BIPOLAR ELECTROTOME (K061541) | Ksea | 2006-08-21 |
| VECTORVISION HIP (K060727) | Brainlab AG | 2006-08-21 |
| ULTRASONIC SCALER, MODELS UDS-N1, UDS-N2. UDS-J, UDS-K, UDS-L (K053555) | Guilin Woodpecker Medical Instrument Co., Ltd. | 2006-08-21 |
| DIMENSION VISTA CHEMISTRY 1 CALIBRATOR, MODEL KC110 (K061838) | Dade Behring, Inc. | 2006-08-21 |
| LEKSELL GAMMA KNIFE PERFEXION, MODEL 715000 (K061941) | Elekta Instrument AB | 2006-08-21 |
| THE DIMENSION VISTA FLEX REAGENT CARTRIDGES / KIT ASSAYS (K062128) | Dade Behring, Inc. | 2006-08-21 |
| PROCERA TITANIUM ABUTMENT FOR ASTRATECH AND CAMLOG IMPLANT SYSTEMS (K061478) | Nobel Biocare AB | 2006-08-21 |
| EXCIA (K061699) | Aesculap, Inc. | 2006-08-18 |
| CORONIS 2MP AND MDCG 2121 - CB (K061926) | Barcoview | 2006-08-18 |
| 7F ACUMEN CORONARY SINUS VISUALIZATION SYSTEM, MODEL CSVS-7-67 (K062084) | Acumen Medical, Inc. | 2006-08-18 |
| SONOMARK (K061560) | Medical Products Manufacturing, Inc. | 2006-08-18 |
| LD-578 FULLY AUTOMATIC DIGITAL BLOOD PRESSURE MONITOR (K061279) | Little Doctor (Shanghai) Electronic | 2006-08-18 |
| VERT-X (K061873) | Direx Systems Corp. | 2006-08-18 |
| HHF1 ECHELON MULTI-PURPOSE COIL (K061950) | Hitachi Medical Systems America, Inc. | 2006-08-18 |