| 1BD SOLOSHOT IX SYRINGE (K042934) | Becton, Dickinson & CO | 2004-10-28 |
| ATP (AUTO NON-CONTACT TONOMETER/PACHYMETER) (K042831) | Reichert, Inc. | 2004-10-28 |
| VITROS CHEMISTRY PRODUCTS DHDL SLIDES, VITROS CHEMISTRY PRODUCTS CALIBRATOR KIT 25, VITROS CHEMISTRY PRODUCTS PERFORMACE (K042006) | Ortho-Clinical Diagnostics, Inc. | 2004-10-28 |
| SIENET COSMOS (VERSION V15A) (K042832) | Siemens AG Medical Solutions | 2004-10-28 |
| KARATS MULTIPURPOSE SOLUTION (K031753) | Ciba Vision Corporation | 2004-10-28 |
| BIO-CHEM ANALYZER, MODEL 100 (K040750) | Clinical Analysis Corporation, Inc. | 2004-10-28 |
| STERNGOLD 3.25 ERA DENTAL IMPLANT SYSTEM (K041271) | Sterngold | 2004-10-28 |
| C-BOOT (K041659) | C-Boot , Ltd. | 2004-10-28 |
| RADIANT MEDICAL ENDOCATHETER TEMPERATURE PROBE (K042388) | Radiant Medical | 2004-10-28 |
| EMIT CAFFEINE ASSAY (K042407) | Dade Behring, Inc. | 2004-10-28 |
| VISTAKON (SENOFILCON A) SOFT CONTACT LENS (K042275) | Vistakon | 2004-10-28 |
| BD LOGIC BLOOD GLUCOSE MONITOR AND PARADIGM LINK BLOOD GLUCOSE MONITOR (K041478) | Becton Dickinson | 2004-10-28 |
| GLUCOSE TOLERANCE BEVERAGE (K042183) | Ever Scientific | 2004-10-27 |
| SYNTHES (USA) LCP WRIST FUSION PLATES (K042355) | Synthes (Usa) | 2004-10-27 |
| FRIADENT PLUS DENTAL IMPLANT SYSTEMS (K040170) | Friadent GmbH | 2004-10-27 |
| BITECH BIPOLAR SCISSORS (K042077) | Guenter Bissinger Medizintechnik GmbH | 2004-10-27 |
| ZODIAC POLYAXIAL SPINAL FIXATION SYSTEM (K042673) | Alphatec/Nexmed | 2004-10-27 |
| VERITAS DRY COLLAGEN MATRIX, VERITAS DRY OR VERITAS PSD (K041669) | Synovis Surgical Innovations | 2004-10-27 |
| SONOLINE G20 DIAGNOSTIC ULTRASOUND SYSTEMS (K042833) | Siemens Medical Solutions USA, Inc. | 2004-10-27 |
| EBI CAS SPINE SPACER SYSTEM (K042268) | Ebi, L.P. | 2004-10-27 |
| ANTI-SNORING/SLEEP APNEA DEVICE (K042161) | Rj & VK Bird Pty , Ltd. | 2004-10-27 |
| GALILEO GOLD (K040574) | Hamilton Medical, Inc. | 2004-10-27 |
| SELECT FABRICATORS, INC., AGMED TEX WOUND DRESSING (K040518) | Select Fabricators, Inc. | 2004-10-27 |
| ENDOREZ (K042756) | Ultradent Products, Inc. | 2004-10-26 |
| SMK, CX, CXE, RCN (K042375) | Technomed Europe | 2004-10-26 |
| GELATO PROPHYLAXIS PASTE (K042048) | Deepak Products, Inc. | 2004-10-26 |
| GE DATEX-OHMEDA ENGSTROM CARESTATION (K041775) | Datex-Ohmeda, Inc. | 2004-10-26 |
| QUILL SYNTHETIC ABSORBABLE BARBED SUTURE (K042075) | Quill Medical, Inc. | 2004-10-26 |
| H & L FULL AUTOMATIC (NIBP) BLOOD PRESSURE MONITOR, MODELS HL168H, HL168J & HL168Q (K042802) | Health & Life Co., Ltd. | 2004-10-26 |
| NUVASIVE MAXCESS LIGHT GUIDE (K042034) | Nuvasive, Inc. | 2004-10-26 |
| ACUMEN SHEATH, MODEL TTW7807 (K042376) | Acumen Medical, Inc. | 2004-10-26 |
| EXACTECH EQUINOXE SHOULDER SYSTEM (K042021) | Exactech, Inc. | 2004-10-26 |
| COOPER PROSTHETIC (K042435) | CooperVision, Inc. | 2004-10-26 |
| ZOLL AUTOCLAVABLE INTERNAL HANDLES, ZOLL AUTOCLAVABLE INTERNAL HANDLES WITH INTEGRATED ELECTRODES, ZOLL AUTOCLAVABLE (K042302) | Zoll Medical Corp | 2004-10-26 |
| IMMULISA ANTINUCLEAR ANTIBODY SCREEN ELISA (K041102) | Immco Diagnostics, Inc. | 2004-10-26 |
| SCB/VALLEYLAB FORCE FX INTERFACE UNIT (K041912) | KARL STORZ Endoscopy-America, Inc. | 2004-10-25 |
| GIVEN DIAGNOSTIC SYSTEM WITH M2A ESO CAPSULE (K041149) | Given Imaging , Ltd. | 2004-10-25 |
| URO PRO (K042457) | W.O.M. World of Medicine AG | 2004-10-25 |
| SILICONE BLOCK (K042380) | National Medical Devices, Inc. | 2004-10-25 |
| AMT INTRODUCER: MINI BUTTON DELIVERY SYSTEM (K042300) | Applied Medical Technology, Inc. | 2004-10-25 |
| VASOSTASIS VASCULAR CLOSURE SYSTEM (K041486) | Cardiva Medical, Inc. | 2004-10-22 |
| DIGITAL DETECTOR, MODEL GR17 (K042821) | Anrad Corp. | 2004-10-22 |
| CROMAX HIGH SPEED TURBINE HANDPIECE (K041755) | J.R. Medical Technologies, Inc. | 2004-10-22 |
| IDI-MRSA ASSAY (K042357) | Infectio Diagnostic (I.D.I.), Inc. | 2004-10-22 |
| VALLY FORGE SCIENTIFIC MALIS BIPOLAR DISPOSABLE FINGER OPERATED ELECTROSURGICAL INSTRUMENTS (K042604) | Valley Forge Scientific Corp. | 2004-10-22 |
| CAMINO SLIM-LINE INTRACRANIAL MONITORING SYSTEM (K042728) | Novus Monitoring, Ltd. | 2004-10-22 |
| POLYVAC INSTRUMENT DELIVERY SYSTEM (K040223) | Symmetry Medical USA, Inc. | 2004-10-22 |
| UNFORS PATIENT SKIN DOSIMETER (PSD) (K042698) | Unfors, Inc. | 2004-10-22 |
| QRS-CARD CARDIOLOGY SUITE (K042799) | Pulse Biomedical, Inc. | 2004-10-22 |
| MODIFICATION TO SILHOUETTE IC OR SILHOUETTE; LASER-LOK SURFACE TREATMENT -OPTIONAL SURFACE MODIFICATION TO IMPLANTS (K041136) | Bio-Lok Intl., Inc. | 2004-10-22 |
| SMARTMIX PRE-FILLED MIXING SYSTEM (K042591) | DePuy Orthopaedics, Inc. | 2004-10-22 |
| GYRUS PLASMACISION LAPAROSCOPIC SPATULA (K041633) | Gyrus Medical, Inc. | 2004-10-22 |
| RM3 RENAL PRESERVATION SYSTEM (K042224) | Waters Instruments, Inc. | 2004-10-22 |
| IPLAN! (K041703) | Brainlab AG | 2004-10-22 |
| POLYMEDCO OC AUTO MICRO 80 FOB TEST (K041408) | Polymedco, Inc. | 2004-10-21 |
| IV ADMINISTRATION SET B400 SP (K042693) | Codan US Corp. | 2004-10-21 |
| LITESTREAM 500E (K042444) | Pride Mobility Products Corp. | 2004-10-21 |
| HOVEROUND MPV-5 POWERCHAIR (K042545) | Hoveround Corp. | 2004-10-21 |
| CONTROL PLASMA N AND CONTROL PLASMA P (K042209) | Dade Behring, Inc. | 2004-10-21 |
| IMPLANTMASTER (K042212) | I-Dent | 2004-10-21 |
| RADIOTHERAPY SOLUTION BASED ON CR (K042779) | Agfa Corp. | 2004-10-21 |
| OSSAPLAST ORTHO, O.5ML, MODEL# 221 900, OSSAPLAST ORTHO, 1.0ML, MODEL# 221 901, OSSAPLAST ORTHO, 3.0ML, MODEL# 221 903 (K042305) | Ossacur AG | 2004-10-21 |
| COLLAGEN-ORC ANTIMICROBIAL MATRIX (K033523) | Johnson & Johnson Medical, Ltd. | 2004-10-21 |
| AMERICAN BANTEX, MODEL MS 3 (K042104) | American Bantex Corp. | 2004-10-21 |
| SYNESCOPE, EASYSCOPE, SYNECOM, HOLTERREADER (K042002) | Ela Medical, Inc. | 2004-10-20 |
| ARTHROTEK MENISCAL HYBRID DEVICE (K041988) | Biomet, Inc. | 2004-10-20 |
| SCANDIUS ABSORBABLE ACL RECONSTRUCTION SYSTEM (K041961) | Scandius Biomedical, Inc. | 2004-10-20 |
| ERA 3000 PACING SYSTEM ANALYZER (K042708) | Biotronik, Inc. | 2004-10-20 |
| OSSATURA DENTAL (K042706) | Isotis Orthobiologics, Inc. | 2004-10-20 |
| WEST NILE VIRUS IGG INDIRECT ELISA (K041068) | Panbio Limited | 2004-10-20 |
| RSA-CMS (K042383) | Medis Medical Imaging Systems BV | 2004-10-20 |
| MEGA PURE CART (K031832) | Mega Services | 2004-10-20 |
| OPTIMA MX (K042759) | Bien-Air SA Switzerland | 2004-10-20 |
| PROCERA ABUTMENT BRANEMARK, MODELS 10-4001, 10-4004, 10-5001, 10-5004, 10-6001, 10-6004 (K042658) | Nobel Biocare Uas, Inc. | 2004-10-20 |
| IONOFIL PLUS AC (K042669) | Voco GmbH | 2004-10-20 |
| IBD-SCAN (K042071) | Techlab, Inc. | 2004-10-20 |
| MODIFICATION TO ACUSON CV70 CARDIOVASCULAR SYSTEM (K042770) | Siemens Medical Solutions USA, Inc. | 2004-10-20 |
| NAI TECH PRODUCTS MEDICAL DIGITAL RECORDER (K042484) | Nai Technology Products | 2004-10-20 |
| SONOSCAPE ULTRASOUND SYSTEM SSI-1000/SSI-5000 (K042369) | Sonoscape Company Limited | 2004-10-20 |
| AMERICAN BANTEX HUMIDIFIER, DRY, BUBBLE, MODELS B9000, 3 PSI AND B9100, 6 PSI (K041963) | American Bantex Corp. | 2004-10-20 |
| MI PASTE (K042200) | GC America, Inc. | 2004-10-20 |
| COMPLETE BLINK-N-CLEAN LENS DROPS (K040839) | Advanced Medical Optics, Inc. | 2004-10-19 |
| RETIC-CHEX FOR CELL-DYN (K042587) | Streck Laboratories, Inc. | 2004-10-19 |
| EC-3870CILK, CONFOCAL VIDEO COLONOSCOPE (K042741) | Pentax Medical Company | 2004-10-19 |
| SITE-RITE NEEDLE GUIDE KITS AND PROBE COVER KIT (K042445) | Bard Access Systems, Inc. | 2004-10-19 |
| KOLIBRI IMAGE GUIDED SURGERY SYSTEM (K042391) | Brainlab AG | 2004-10-19 |
| PS MEDICAL STRATA II VALVE (K042465) | Medtronic Neurosurgery | 2004-10-19 |
| AURORA DS (K041969) | Syneron Medical, Ltd. | 2004-10-19 |
| OPUS SPEEDSTITCH SUTURE DEVICE (K042031) | Opus Medical, Inc. | 2004-10-19 |
| DYNACT (K042646) | Siemens Medical Systems, Inc. | 2004-10-19 |
| GDC-10 360 DEGREE COIL SR; GDC-10 360 DEGREE SOFT COIL SR; GDC-18 360 DEGREE COIL (K042539) | Boston Scientific Corp | 2004-10-19 |
| HAND STC, MODEL 60MM (K042492) | Niti Medical Technologies , Ltd. | 2004-10-19 |
| ISC-1000 PENTAX CONFOCAL LASER SYSTEM (K042740) | Pentax Medical Company | 2004-10-19 |
| VITROS CHEMISTRY PRODUCTS C3 AND CR REAGENT, CALIBRATOR KIT 20, PROTEIN PERFORMANCE VERIFIERS I, II, AND III (K042494) | Ortho-Clinical Diagnostics | 2004-10-19 |
| IPACS CARDIO (K042781) | Realtimeimage, Inc. | 2004-10-19 |
| COLON CAR 1.2 (K042674) | Medicsight | 2004-10-19 |
| FIRST RESPONSE ONE-STEP DIGITAL PREGNANCY TEST (K040866) | Armkel, LLC | 2004-10-19 |
| ALPHA METASUL 28MM AND 32MM ACETABULAR INSERTS, STANDARD AND HOODED (K033943) | Centerpulse Orthopedics, Inc. | 2004-10-18 |
| PURPLE/BLACK HEPARIN ASSAY CONTROL (K042206) | Medtronic Vascular | 2004-10-18 |
| CUTERA TABLETOP AESTHETIC PRODUCT (K042165) | Cutera, Inc. | 2004-10-18 |