| VACUUM ASSISTED CORE BIOPSY DEVICE (K034021) | Suros Surgical Systems, Inc. | 2004-09-08 |
| ECHOSAMPLER (K041237) | Gynetics Medical Products NV | 2004-09-08 |
| STALIF TT (K041617) | Surgicraft , Ltd. | 2004-09-08 |
| MODIFICATION TO: CD HORIZON SPINAL SYSTEM (K042167) | Medtronic Sofamor Danek | 2004-09-08 |
| BIOPRO SUBTALAR IMPLANT (K041936) | Biopro, Inc. | 2004-09-08 |
| FOCUS MEDICAL NATURALASE LP AND NATURALIGHT FAMILY OF PRODUCTS (K041829) | Focus Medical, LLC | 2004-09-07 |
| PAJUNK TUOHY NEEDLES, QUINCKE NEEDLES, CHIBA NEEDLES & CRAWFORD NEEDLES (K040965) | Pajunk GmbH | 2004-09-07 |
| COMPASS F10 SYSTEM (K041904) | Medcare Flaga | 2004-09-07 |
| EN-BLOC BIOPSY SYSTEM MODEL#777-110,777-001,777-002,777-006,777-301,777-302,777-115,777-120 (K042170) | Neothermia Corporation | 2004-09-07 |
| SKINTACT MULTIFUNCTION ELECTRODES, MODEL DF 21 (K041883) | Leonhard Lang GmbH | 2004-09-07 |
| STRYKER MAESTRO SYSTEM (K041754) | Stryker Corp. | 2004-09-07 |
| MODEL 6416 TEMPORARY PACING LEAD SYSTEM (K042190) | Medtronic Vascular | 2004-09-07 |
| NEWPORT NEBSONIC N550 ULTRASONIC NEBULIZER (K041082) | Newport Medical Instruments, Inc. | 2004-09-07 |
| PHOT-X II, MODEL 303 (K042260) | Takara Belmont USA, Inc. | 2004-09-07 |
| ABRAM'S MULTI-DENSITY POLYURETHANE FOAM WOUND DRESSING SYSTEM (K033164) | Dr. Len'S Medical Products, LLC | 2004-09-07 |
| ULTRAVISUAL (K042008) | Emageon Uv, Inc. | 2004-09-03 |
| OUTOLOGOUS SPINAL FIXATION SYSTEM (K040493) | Orthopedic Sciences, Inc. | 2004-09-03 |
| PROTENS ELECTRODE (K042301) | Bio Protech, Inc. | 2004-09-03 |
| MODIFICATION TO CD HORIZON SPINAL SYSTEM (K041777) | Medtronic Sofamor Danek | 2004-09-03 |
| OTOGRAM (K041853) | Tympany, Inc. | 2004-09-03 |
| MANTRA TENS MODEL NT3 (K041520) | Mantra Intl. (Hk) , Ltd. | 2004-09-03 |
| MALLARD MODEL 3000 ANESTHESIA MACHINE (K033026) | Mallard Medical, Inc. | 2004-09-03 |
| ALL SAFE HUBER SAFETY INFUSION SETS (K041844) | Nexus Medical, LLC | 2004-09-03 |
| CYSTATIN C IMMUNOPARTICLES, CONTROL SET, CALIBRATOR (K041627) | Dako A/S | 2004-09-03 |
| STRYKER SWITCHPOINT INFINITY (K033132) | Stryker Communications Corp. | 2004-09-02 |
| ECHELON 10,45 TIP SHAPE MICRO CATHETER ECHELON 10,90 TIP SHAPE MICRO CATHETER, ECHELON 14,45 TIP SHAPE MICRO CATHETER,90 (K042187) | Micro Therapeutics, Inc. | 2004-09-02 |
| LOW FLOW OSV II HYDROCEPHALUS VALVE (K042192) | Integra Neurosciences Implants S.A. | 2004-09-02 |
| MPS MYOCARDIAL PROTECTION SYSTEM - MPS 2 CONSOLE, MODEL 5201260 (K041979) | Quest Medical, Inc. | 2004-09-02 |
| SYNTHETIC (BLUE) VINYL PATIENT EXAMINATION GLOVES - POWDER FREE (K042247) | Shijiazhuang Hongxiang Plastics Products Co., Ltd. | 2004-09-02 |
| PATHFINDER (K031788) | Massie Research Laboratories, Inc. | 2004-09-02 |
| DETECT SURGICAL PACING AND MAPPING TOOL (K040812) | Medtronic Vascular | 2004-09-02 |
| CADENCE, MODELS 2001 AND 2002 (K040903) | Edan Instruments, Inc. | 2004-09-02 |
| TARGETSCAN BIOPSY KIT (K041638) | Envisioneering, LLC | 2004-09-02 |
| SAMARITAN PAD PAK DEFIBRILLATION ELECTRODE, MODEL SPP-301 (K042088) | Heartsine Technologies, Inc. | 2004-09-02 |
| ASPIRATION PUMP, MODEL IMD-020 (K041405) | Industrial & Medical Design, Inc. | 2004-09-02 |
| DATEX-OHMEDA TRUSAT PULSE OXIMETER AND ACCESSORIES, MODEL 3500 (K040831) | Datex-Ohmeda, Inc. | 2004-09-02 |
| FLEXI-STAT REUSABLE FINGER CLIP SPO2 SENSORS (NELLCOR-COMPATIBLE),(BCI-COMPATIBLE), (DATEX-COMPATIBLE) (K041647) | Elekon Industries U.S.A., Inc. | 2004-09-02 |
| ORALIEF THERAPY FOR SENSITIVE TEETH (K040858) | Novamin Technology, Inc. | 2004-09-02 |
| TARGETSCN TRANSRECTAL ULTRASOUND SYSTEM (K041639) | Envisioneering, LLC | 2004-09-02 |
| SOMATOM RADIATION TREATMENT PLANNING (RTP) PACKAGE (K042229) | Siemens Medical Solution, Inc. USA | 2004-09-01 |
| SHINMED MODE SW-988 UNTRASONIC NEBULIZER (K031370) | Shining World Health Care Co., Ltd. | 2004-09-01 |
| SYNTHES (USA) [SYNTHES} PERI-PROSTHETIC SCREWS (K041533) | Synthes (Usa) | 2004-09-01 |
| Y CLAVE CONNECTOR WITH INTEGRATED CHECK VALVE, MODEL XI-3432 (K042182) | Icu Medical, Inc. | 2004-09-01 |
| TARGETSCAN TRANSRECTAL ULTRASOUND SYSTEM (K041637) | Envisioneering, LLC | 2004-09-01 |
| ZIMMER TRABECULAR METAL HUMERAL STEM (K041549) | Zimmer, Inc. | 2004-09-01 |
| R&D CBC-XE HEMATOLOGY CONTROL (K042094) | R&D Systems, Inc. | 2004-09-01 |
| POWER SCOOTER, MODEL TL-688 (K042010) | Teh Lin Prosthetic & Orthopaedic, Inc. | 2004-09-01 |
| INFINITY TRIDENT NMT POD (K042003) | Draeger Medical Systems, Inc. | 2004-09-01 |
| RESOLUTION THROMBECTOMY SYSTEM, MODEL EV-2 (K041705) | Omnisonics Medical Technologies | 2004-09-01 |
| THROMBELASTOGRAPH (TEG) PLATELET MAPPING ASSAY (K041502) | Haemoscope Corp. | 2004-09-01 |
| ROCHE DIAGNOSTICS CARDIAC D-DIMER RAPID ASSAY; ROCHE DIAGNOSTICS CARDIAC D-DIMER CONTROLS (K033491) | Roche Diagnostics Corp. | 2004-09-01 |
| FABIUS GS ANESTHESIA SYSTEM; FABIUS TIRO ANESTHESIA SYSTEM (K042086) | Draeger Medical, Inc. | 2004-08-31 |
| SKIN LEVEL GASTROSTOMY TUBE KIT (ECSL) (K041034) | Entracare, LLC | 2004-08-31 |
| OSS BONE GRAFT SYSTEM AND OSS RAPIDSET BONE GRAFT SYSTEM (K041089) | Biomet Manufacturing, Inc. | 2004-08-31 |
| ACCUNET EMBOLIC PROTECTION SYSTEM, RX ACCUNET EMBOLIC PROTECTION SYSTEM (K042218) | Guidant Corp. | 2004-08-31 |
| PRE-POWDERED VINYL EXAM GLOVES (K041379) | Shijiazhuang Wally Plastics Co., Ltd. | 2004-08-31 |
| ACCLAIM (K042266) | Air Techniques, Inc. | 2004-08-31 |
| HC604 CPAP HUMIDIFIER (K041900) | Fisher & Paykel Healthcare, Ltd. | 2004-08-31 |
| FULL AUTOMATIC (NIBP) BLOOD PRESSURE MONITOR MODEL# HL888 (K042265) | Health & Life Co., Ltd. | 2004-08-31 |
| LIFECLINIC, MODEL 2400 (K040562) | Lifeclinic International, Inc. | 2004-08-31 |
| REIZEN TALKING BLOOD PRESSURE MONITOR, MODEL #SF860T (K041778) | Maxi-Aids, Inc. | 2004-08-31 |
| SD360 DIGITAL RECORDER/SD360 HOLTER DIGITAL RECORDER (K041901) | North East Monitoring, Inc. | 2004-08-31 |
| GE DATEX-OHMEDA AISYS CARESTATION (K042154) | Datex-Ohmeda, Inc. | 2004-08-31 |
| MODIFICATION TO HEALTH BUDDY WITH DEVICE CONNECTIVITY (K042273) | Health Hero Network, Inc. | 2004-08-31 |
| PRO 2 MONITOR, PRO 2 SENSOR, PRO2 HOLDER, PRO2 NEONATE HOLDER, MODELS, PRO- 200, ANS-200, AHL-200, NHL-200 (K032831) | Conmed Corporation | 2004-08-31 |
| MULTI-DRIP INFUSION CATHETER (K042246) | Advanced Infusion, Inc. | 2004-08-31 |
| DOLPHIN MEDICAL DOLPHIN ONE ADULT REUSABLE FOREHEAD SENSOR, MODEL 420 (K040380) | Dolphin Medical, Inc. | 2004-08-31 |
| VAPOTHERM MODEL#2000I, 200H (K042245) | Vapotherm, Inc. | 2004-08-30 |
| EV APAN DIGITAL, MODEL K1VSM2000 (K041120) | Afp Imaging Corp. | 2004-08-30 |
| ACON MULTI-CLIN DRUG SCREEN TEST DEVICE (K041685) | ACON Laboratories, Inc. | 2004-08-30 |
| ORTHODONTIC CERAMIC BRACKETS (K042178) | Dentsply Intl. | 2004-08-30 |
| COMPOSITE/COMPOMER REPAIR KIT (K041960) | Dmg USA, Inc. | 2004-08-30 |
| THERMO ELECTRON ANGIOTENSIN CONVERTING ENZYME INFINITY (ACE) REAGENT (K041657) | Thermo Electron Corporation | 2004-08-30 |
| CARRIAZO PENDULAR (K032910) | Schwind Eye-Tech-Solutions GmbH & Co. KG | 2004-08-30 |
| NXSTAGE PUREFLOW-B SOLUTION (K042045) | Nxstage Medical, Inc. | 2004-08-27 |
| EXPANDABLE PEEK VBR IMPLANT (K040928) | Interpore Cross Intl. | 2004-08-27 |
| PICC (K042126) | Arrow Intl., Inc. | 2004-08-27 |
| ENDOTINE FOREHEAD TRIPLE DEVICE (K042078) | Coapt Systems, Inc. | 2004-08-27 |
| SYNTHES (USA) TITANIUM WIRE (K041333) | Synthes (Usa) | 2004-08-27 |
| BARCOVIEW CORONIS 5MP HD MEDICAL FLAT PANEL DISPLAY SYSTEM (K041508) | Barco NV Barcoview | 2004-08-27 |
| B. BRAUN BICARBONATE DIALYSATE (K041683) | B.Braun Medical, Inc. | 2004-08-27 |
| SURFIX KNEE OSTEOTOMY SYSTEM (K041601) | Surfix Technologies | 2004-08-27 |
| ACHTUNG TD-4207, CLEVER CHEK TD-4209, CLEVER CHEK TD-4222 (K042005) | Taidoc Technology Corporation | 2004-08-27 |
| XLTEK TREX MODEL#10309 (K042150) | Excel Tech. , Ltd. | 2004-08-27 |
| OASIS DRY MOUTH RELIEF DISCS OR OASIS MOUTH MOISTURIZING DISCS (K041563) | Glaxosmithkline Consumer Healthcare, L.P. | 2004-08-27 |
| MYOHEALTH CLENCHING INHIBITOR (K040315) | Mci-Myohealth Systems | 2004-08-27 |
| ACCUSOL DIALYSIS SOLUTION (K041428) | Baxter Healthcare Corp | 2004-08-27 |
| CASHMERE POWDER FREE NITRILE EXAMINATION GLOVES (K042101) | Seal Polymer Industries Bhd. | 2004-08-27 |
| USFILTER BICARBONATE MIXING AND DISPENSING (BICARB) SYSTEM (K031502) | Usfilter | 2004-08-27 |
| RADIONICS XKNIFE RT 3 WITH NON STEREOTACTIC MODULE (K041997) | Radionics, A Division of Tyco Healthcare Group LP | 2004-08-27 |
| DURASUL BIPOLAR (K040947) | Centerpulse Orthopedics, Inc. | 2004-08-27 |
| MODIFICATION TO MAC 5000 ECG ANALYSIS SYSTEM (K042177) | Ge Medical Systems Information Technologies | 2004-08-27 |
| INNOVA 4100, INNOVA 3100 (K042053) | Ge Medical Systems, Inc. | 2004-08-26 |
| SPECTRUM AND SPECTRUM WITH MASTER DRUG LIBRARY (K042121) | Sigma Intl. | 2004-08-26 |
| AUTOFUSER AMBULATORY INFUSION PUMP (K041585) | Algos, LC | 2004-08-26 |
| LIGHTFORCE LF 20/30 980NM SURGICAL DIODE LASER SYSTEM (K041419) | Medical Energy, Inc. | 2004-08-26 |
| ALEXIS WOUND RETRACTOR, MODELS C8312, C8301, C8302, C8303, C8304 (K041711) | Applied Medical Resources Corp. | 2004-08-26 |
| ANKYLOS DENTAL IMPLANT SYSTEM (K041509) | Friadent GmbH | 2004-08-26 |
| 0.9% SODIUM CHLORIDE INJECTION, USP BD POSTFLUSH SF FLUSH SYRINGE (K042061) | Becton Dickinson | 2004-08-26 |
| MAMMOSITE II RADIATION THERAPY SYSTEM (RTS) TRAY, MAMMOSITE HDR AFTERLOADER ACCESSORIES TRAY (K041929) | Proxima Therapeutics, Inc. | 2004-08-26 |