| ZIMMER AMBULATORY PUMP PAIN MANAGEMENT SYSTEM WITH PATIENT CONTROL MODULE (K052171) | Zimmer, Inc. | 2005-10-13 |
| IISIS, VERSION 1.0 (K052244) | Innovision Medical Technologies, LLC | 2005-10-13 |
| HYBRID ANTERIOR CERVICAL PLATE SYSTEM (K052552) | Depuy Spine, Inc. | 2005-10-13 |
| ETEST TIGECYCLINE GRAM POSITIVE AND GRAM NEGATIVE AEROBIC BACTERIA, STREPTOCOCCUS SPP. AND ANAEROBIC BACTERIA (K052366) | Ab Biodisk | 2005-10-13 |
| DATEX-OHMEDA S/5 NELLCOR COMPATIBLE SATURATION MODULE, E-NSAT (K052755) | GE Healthcare | 2005-10-13 |
| ZIMMER DENTAL HEX-LOCK PREPARED ABUTMENT (STRAIGHT & ANGLED) (K052600) | Zimmer Dental, Inc. | 2005-10-13 |
| ENTERAL FEEDING TUBE (K051480) | Biosearch Medical Products, Inc. | 2005-10-12 |
| AUTOCHECK6+ (K051928) | Radiometer Medical Aps | 2005-10-12 |
| SYNTHES UNIVERSAL LOCKING TROCHANTER STABILIZATION PLATE (ULTSP) (K052677) | Synthes (Usa) | 2005-10-12 |
| SCORPIO KNEE SYSTEM TIBIAL INSERTS AND PATELLAR COMPONENTS (K051977) | Howmedica Osteonics Corp. | 2005-10-12 |
| SELECTFLOW - INTRAVASCULAR ADMINISTRATION SET (K052658) | Renascence Medical, Inc. | 2005-10-12 |
| NEUROVASCULAR ARRAY COIL, MODEL NVA-127-16-A (K052497) | Invivo Corp. | 2005-10-12 |
| NV CORMED SOLAS SPINAL SYSTEM (K051959) | Nv Cormed | 2005-10-12 |
| ADVIA IMS GLUCOSE ASSAY (K052163) | Bayer Healthcare, LLC | 2005-10-11 |
| ATRILAZE MALLEABLE ABLATION PROBE (K052495) | Medical Cv, Inc. | 2005-10-11 |
| VNUS RFS, MODEL RFS-6-XX (XX = 10, 12, 13, & 15); VNUS RFS FLEX, MODEL RFX-6-XX (XX = 10, 20, 30 & 40) (K052003) | Vnus Medical Technologies, Inc. | 2005-10-11 |
| MENTOR SELF-CATH HYDROGEL INTERMITTENT CATHETER (K052440) | Mentor Corporation | 2005-10-11 |
| DYNATRON DX2 TRACTION UNIT (K051680) | Dynatronics Corp. | 2005-10-11 |
| UNICAP UNICOMPARTMENTAL KNEE RESURFACING PROSTHESIS (K050373) | Arthrosurface, Inc. | 2005-10-11 |
| COOL LINE CATHETER KIT, MODELS CL-2085B, CL-2295A; ICY CATHETER KIT, MODEL IC-3585A; FORTIUS CATHETER KIT, MOD. FR-5093B (K051912) | Alsius Corp. | 2005-10-11 |
| COOK IRELAND ECHOBRUSH (K052279) | Cook Ireland, Ltd. | 2005-10-11 |
| SPECTRAQUATTRO PULSED LIGHT SYSTEM (K052336) | Amjet Distribution, LLC | 2005-10-11 |
| AOC BONE WAX OSTENE, OSTEOTENE AND CERETENE (K052528) | Ceremed , Inc. | 2005-10-11 |
| TEH LOONG POWDERED SYNTHETIC VINYL PATIENT EXAMINATION GLOVES, WHITE (K052634) | Teh Loong Corp. | 2005-10-11 |
| MODIFICATION TO: XIA 4.5 SPINAL SYSTEM (K052761) | Stryker Spine | 2005-10-11 |
| ISE DILUENT, 1N KCL, INTERNAL REFERENCE AND ISE STANDARDS LOW AND HIGH (K051646) | Pointe Scientific, Inc., | 2005-10-07 |
| AJEX 9015/135H PORTABLE X-RAY (K052341) | Jpi America, Inc. | 2005-10-07 |
| GEMINI RAPTOR (K052640) | Philips Medical Systems (Cleveland), Inc. | 2005-10-07 |
| OOCYTE RETRIEVAL NEEDLE SET, MODELS 917-IH AND 917-SH (K051742) | Inntec, Inc. | 2005-10-07 |
| ANTHOLOGY HIP STEM (K052792) | Smith & Nephew, Inc. | 2005-10-07 |
| MODIFICATION TO: VERTE-STACK SPINAL SYSTEM (K052261) | Medtronic Sofamor Danek USA, Inc. | 2005-10-07 |
| EXPANSE VERTEBRAL BODY REPLACEMENT DEVICE (K050997) | Flexuspine, Inc. | 2005-10-07 |
| VITALCAREGIVING SYSTEM (K051544) | Advanced Monitoring Caregiving, Inc. | 2005-10-07 |
| PROASIA, MODEL L4501 (K052486) | Proasia Limited | 2005-10-07 |
| PROASIA, MODEL L3402 (K052378) | Proasia Limited | 2005-10-07 |
| SYNTHES LCP PROXIMAL TIBIA PLATES LINE EXTENSION (K052390) | Synthes (Usa) | 2005-10-07 |
| GLUCODR SUPERSENSOR SYSTEM (K050985) | All Medicus Co., Ltd. | 2005-10-07 |
| EQUATOR PLUS ACETABULAR CUP SYSTEM (K051844) | Portland Orthopaedics Pty. , Ltd. | 2005-10-07 |
| S-BONE HIP TOOL (K052538) | Orthopedic Sciences, Inc. | 2005-10-07 |
| ARCTEC SEMIRIGID PLATING SYSTEM (K051044) | Altiva Corp. | 2005-10-07 |
| LANX VBR SYSTEM (K052384) | Lanx, LLC | 2005-10-07 |
| 1.5T 16 CHANNEL BRAIN-SPINE ARRAY COIL (K052621) | Usa Instruments, Inc. | 2005-10-07 |
| NEOBLUE COZY LED PHOTOTHERAPY SYSTEM (K051869) | Natus Medical, Inc. | 2005-10-07 |
| NOVASPINE CEMENT RESTRICTOR NSCR (K051607) | Novaspine, LLC | 2005-10-07 |
| WIDE 5MP (MAMMO) LCD MONITOR SYSTEM (K052312) | Wide Corporation | 2005-10-07 |
| 1.5T 12 CHANNEL BODY ARRAY (K052584) | Usa Instruments, Inc. | 2005-10-07 |
| SORING GMBH SONOCA LIPO (K052183) | Soring GmbH Medizintechnik | 2005-10-07 |
| INSCOPE MULTI-CLIP APPLIER, MODELS IN22321, IN23321 (K051950) | Ethicon Endo-Surgery, Inc. | 2005-10-07 |
| AXYA MODEL 6500 AXYALOOP SELF-TAPPING BONE ANCHOR (K052491) | Axya Medical, Inc. | 2005-10-07 |
| THERATEST EL-ANA PROFILES (K051066) | Theratest Laboratories, Inc. | 2005-10-07 |
| STRYKER STILETTO ELECTROSURGICAL PROBE (K052141) | Stryker Endoscopy | 2005-10-06 |
| 14.5 FR CHRONIC HEMODIALYSIS CATHETER WITH INSERTION STYLETS ACCESSORY (K051584) | Kendall | 2005-10-06 |
| FLEXISKIN POLYMER COATED LATEX EXAMINATION GLOVES, POWDER FREE, NON-STERILE (K051987) | Pt. Mandiri Inti Buana | 2005-10-06 |
| RUBICOR ENCAPSULE BREAST BIOPSY DEVICE, MODEL 31108 (K052506) | Rubicor Medical, Inc. | 2005-10-06 |
| START FAMILY OF MANUAL WHEELCHAIRS (BASIC, PLUS, MULTI AND HEMI) (K052681) | Otto Bock Healthcare LP | 2005-10-06 |
| LEADCARE II BLOOD LEAD TESTING SYSTEM (K052549) | Esa Biosciences, Inc. | 2005-10-06 |
| DEPUY GLOBAL SHOULDER CROSSLINK GLENOID (K052472) | DePuy Orthopaedics, Inc. | 2005-10-06 |
| KOWA VX-10 (K043213) | Kowa Co. , Ltd. | 2005-10-06 |
| PLEURX PLEURAL CATHETER KIT, MODEL 50-7000 (K052436) | Denver Biomedical, Inc. | 2005-10-06 |
| ETIAM STAR PACS COMPONENTS (K052358) | Etiam, S.A. | 2005-10-05 |
| SCIENT'X CEMENT RESTRICTOR (K052367) | Scient'X | 2005-10-05 |
| BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM - CEFUROXIME (STREP) 0.125 - 4UG/ML (K052270) | Becton, Dickinson & CO | 2005-10-05 |
| PHILIPS HEARTSTART FR2+ AUTOMATED EXTERNAL DEFIBRILLATOR, MODELS M3860A, M3861A, M3840A, M3841A (K051632) | Philips Medical Systems | 2005-10-05 |
| CARDIOLINE AR 600, AR 1200, AR 2100 (K051534) | Et Medical Devices Spa | 2005-10-05 |
| SYNTHES (USA) POROUS POLYETHYLENE IMPLANTS (K051879) | Synthes (Usa) | 2005-10-05 |
| MED FLASH II INTENSE PULSED LIGHT SYSTEM. (K051508) | General Project S.R.L. | 2005-10-05 |
| ARTHROCARE ARTHROWANDS (K052686) | Arthrocare Corp. | 2005-10-05 |
| FLEXIBLE VIDEO CYSTOSCOPE/CHOLEDOCHOSCOPE, MODELS 7308.061 AND 7308.066 (K051176) | Richard Wolf Medical Instruments Corp. | 2005-10-05 |
| SMARTSUCTION HARMONY DEVICE (K052626) | Haemonetics Corp. | 2005-10-05 |
| YK9000 SERIES MANUAL WHEELCHAIR (K052468) | Intco Metal Products (Zhenjiang) Co., Ltd. | 2005-10-05 |
| ARTSANA PEN NEEDLES, ARTSANA INJECTION NEEDLES (K051783) | Artsana S.P.A | 2005-10-04 |
| QUANTA LITE GLIADIN IGA II (K052143) | Inova Diagnostics, Inc. | 2005-10-04 |
| QUANTA LITE GLIADIN IGG II (K052142) | Inova Diagnostics, Inc. | 2005-10-04 |
| FETAL MONITOR, MODELS BT-300 AND BT-200 (K052190) | Bistos Co., Ltd. | 2005-10-04 |
| MAGNETOM SYSTEMS WITH SOFTWARE SYNGO MR 2006A (K052164) | Siemens Medical Solutions USA, Inc. | 2005-10-04 |
| CARDIUS-1, CARDIUS-2, CARDIUS-3, 2020TC SPECT IMAGING SYSTEM (K052430) | Digirad Corp. | 2005-10-04 |
| HBA1C LINEARITY SET (K052010) | Cone Bioproducts | 2005-10-04 |
| POROUS COATED ACETABULAR COMPONENTS (K050124) | Biomet, Inc. | 2005-10-04 |
| SUREFLOW SAFETY INFUSION DEVICE (K051943) | Intrasafe Medical, LLC | 2005-10-04 |
| MASTEL LASER CLEAN ROOM, MODEL EBS-100 (K043494) | Mastel Precision Surgical Instruments, Inc. | 2005-10-04 |
| 3T HD BREAST ARRAY (K052585) | Usa Instruments, Inc. | 2005-10-04 |
| IMMUNALYSIS METHAMPHETAMINE ELISA FOR ORAL FLUIDS (K051577) | Immunalysis Corporation | 2005-10-04 |
| ASSURE PRO BLOOD GLUCOSE MONITORING SYSTEM, MODEL 460002 (K051514) | Hypoguard USA, Inc. | 2005-10-04 |
| ADVIA CHEMISTRY MICROALBUMIN CONTROLS (K052242) | Bayer Healthcare, LLC | 2005-10-03 |
| BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM -CIPROFLOXACIN GN (K052269) | Becton, Dickinson & CO | 2005-10-03 |
| MK-DENT LOW SPEED HANDPIECES AND ACCESSORIES INCLUDING SPARE PARTS, TUBINGS, AND LIGHT POWER SYSTEM, MODELS: LS2011 (K051872) | Mk-Dent GmbH | 2005-10-03 |
| STERITEC CONTAINER CORD - CI 135, STERITEC PROCESS INDICATOR LABELS - CI 140, STERITEC PROCESS INDICATOR DOTS - CI 137 (K052516) | Steritec Products, Inc. | 2005-10-03 |
| TRICAT RIA (ADRENALIN/NORADRENALIN/DOPAMINE); KATCOMBI RIA (ADRENALIN/NORADRENALIN); NORADRENALIN RIA (K051969) | Ibl GmbH | 2005-10-03 |
| FIDIS CONNECTIVE 8 (K050286) | Biomedical Diagnostics (Bmd) SA | 2005-10-03 |
| ISE COMPENSATOR (K052193) | Roche Diagnostics | 2005-10-03 |
| CARE FECAL OCCULT BLOOD TEST, MODEL KT313 (K051806) | Epitope Diagnostics, Inc. | 2005-10-03 |
| IBL CORTISOL LIA TEST KIT (K052359) | Lehnus & Associates Consulting | 2005-10-03 |
| DEVON STANDARD SYRINGE, HYPODERMIC NEEDLE AND INSULIN SYRINGE (K052551) | Devon Safety Products, Inc. | 2005-09-30 |
| ANDROFLOW - RESPIRATORY RATE MONITOR (K051779) | Andromed, Inc. | 2005-09-30 |
| COLOR CORONIS 2MP-21 AND MFCD 2321 (K052352) | Barcoview | 2005-09-30 |
| E-2320 PA S (K052529) | Barcoview | 2005-09-30 |
| TECHNO-SCOPE VISUAL STETHOSCOPE (K050097) | Techtrade, LLC | 2005-09-30 |
| TINA-QUANT HEMOGLOBIN A1C GEN.2 TEST (K052464) | Roche Diagnostics Corp. | 2005-09-30 |
| HEMOR-RITE CRYOTHERAPHY (K042564) | Fama Holdings International Corp | 2005-09-30 |
| POWDERED LATEX PATIENT EXAMINATION GLOVES (K051913) | Shinemound Enterprise, Inc. | 2005-09-30 |