| ALPCO MILENIA ANTI-TPO ELISA (K011201) | American Laboratory Products Co., Ltd. | 2001-05-24 |
| VIVA (K011480) | Richter Rubber Technology Sdn. Bhd. | 2001-05-24 |
| TC-PLUS POROUS FEMORAL COMPONENTS (K011258) | Plus Orthopedics | 2001-05-24 |
| TC-PLUS POROUS TIBIAL COMPONENTS (K011288) | Plus Orthopedics | 2001-05-24 |
| BIOSLING - BIOABSORBABLE POLYMER SLING & SURGICAL MESH (K010533) | Injectx, Inc. | 2001-05-24 |
| NEEDLELOK HYPODERMIC NEEDLE PROTECTION (K011004) | Diasol, Inc. | 2001-05-24 |
| DCM 1.0 (K011246) | Mds Nordion | 2001-05-23 |
| CAMBRIDGE HEART MODEL CH 2000 CARDIAC DIAGNOSTIC SYSTEM (K011324) | Cambridge Heart, Inc. | 2001-05-23 |
| CT SPACER (K010680) | Clinical Technologies, Inc. | 2001-05-23 |
| BIOCONNECT PATIENT MONITORING CABLES AND LEADWIRES, CAT# 1000 THRU CAT# 40000 (K010809) | Rf Industries, Ltd. | 2001-05-23 |
| VEGA ULTRASONIC NEBULIZER (K002831) | Vega Technologies, Inc. | 2001-05-23 |
| BCI ADVISOR VITAL SIGNS MONITOR (9200) (K011177) | Bci, Inc. | 2001-05-23 |
| ALOKA SSD-5500 WITH KI AND A-SMA (K011457) | Aloka Co., Ltd. | 2001-05-23 |
| BLEASE FRONTLINE PLUS RANGE, ANESTHESIA MACHINES, MODEL 440, 560 AND 690 (K003251) | Blease Medical Equipment , Ltd. | 2001-05-23 |
| WHITESIDE BIOMECHANICS LOW PROFILE STAINLESS STEEL CABLE SYSTEM, MODEL BIO-1-1014 (K003618) | Whiteside Biomechanics, Inc. | 2001-05-23 |
| LACTOSORB PLATES, MESHES, AND PANELS/SHEETS (K011237) | Biomet, Inc. | 2001-05-23 |
| CHEMWELL, MODEL 2900 (K010877) | Awareness Technology, Inc. | 2001-05-23 |
| SPECIALITY 42 UV (HEFILCON A) SOFT (HYDROPHILIC) CONTACT LENS FOR DAILY WEAR, SPECIALITY 42 UV TORIC (HEFILCON A) SOFT C (K011089) | Specialty Ultravision, Inc. | 2001-05-23 |
| MONARCH SPINE SYSTEM (K010576) | Depuyacromed | 2001-05-23 |
| SYNTHES ANTEROLATERAL CALCANEAL PLATE (K010518) | Synthes (Usa) | 2001-05-23 |
| ARTHREX TENODESIS SCREW 7MM, 8MM, 9MM (K010525) | Arthrex, Inc. | 2001-05-23 |
| KM-30 TENS ELECTRODE (K010543) | Katecho, Inc. | 2001-05-23 |
| POLVUE MULTIFOCAL (POLYMACON) SOFT CONTACT LENS FOR DAILY WEAR (CLEAR AND VISIBILITY TINTED, FULLY CAST-MOLDED LENS) (K004049) | Optech, Inc. | 2001-05-23 |
| ECOTRACT ADJUSTABLE WOUND PROTECTOR/RETRACTOR (K010711) | Advanced Surgical Concepts (Asc) | 2001-05-22 |
| VHF ULTRASONIC ARC-SCAN SYSTEM (K003890) | Ultralink, LLC | 2001-05-22 |
| PHOTON MULTI-PLATFORM SYSTEM, MODEL Z-12834-X & Z-13175-X (K003318) | Paradigm Medical Industries, Inc. | 2001-05-22 |
| PALOMAR SLP 1000 (K010580) | Palomar Medical Technologies, Inc. | 2001-05-22 |
| BIOSPHERE MEDICAL INFUSION CATHETER (K003105) | Biosphere Medical | 2001-05-22 |
| AFX MICROWAVE GENERATOR, FLEX ABLATION WAND, LYNX ABLATION WAND, MODEL SERIES 1000, P/N 102006, P/N 102007 (K003978) | Afx, Inc. | 2001-05-22 |
| PACING LEAD BIPOLAR ADAPTERS AND EXTENSIONS (K010787) | Oscor, Inc. | 2001-05-22 |
| CONCENTRIC RETRIEVER, MODEL 90030 (K003410) | Concentric Medical, Inc. | 2001-05-22 |
| OSCOR PERMANENT PACING LEAD RZ MODEL SERIES (K003918) | Oscor, Inc. | 2001-05-22 |
| GEN-PROBE APTIMA COMBO 2 ASSAY (K003395) | Gen-Probe, Inc. | 2001-05-21 |
| VACUCATH I.V. CATHETER INTRODUCTER (K003187) | Auto/Cath Vascular Access, Inc. | 2001-05-21 |
| HARMONE-SCHWARZER EEG SYSTEM (K010728) | Stellate Systems | 2001-05-21 |
| SCREW-VENT DENTAL IMPLANT SYSTEM (K011028) | Sulzer Dental, Inc. | 2001-05-21 |
| VECTORVISION CRANIAL, VECTORVISION SPINAL, VECTORVISION ENT (K003589) | Brainlab AG | 2001-05-21 |
| LYRA SERIES SURGICAL LASER SYSTEM & ACCESSORIES (K010834) | Laserscope | 2001-05-21 |
| PELVEX HOMETRAINER (K002043) | Purdue Technology Park | 2001-05-21 |
| MODIFICATION TO SEAMGUARD STAPLE LINE REINFORCEMENT MATERIAL (K010936) | W. L. Gore & Associates, Inc. | 2001-05-21 |
| CDMX (K010915) | Camsight Co., Inc. | 2001-05-21 |
| CARDIAC VIEW, MODEL 2001 (K010513) | Magna-Lab, Inc. | 2001-05-21 |
| ANALYST PANELS + ANALYTICAL TEST ROTOR (K010864) | Hemagen Diagnostics, Inc. | 2001-05-21 |
| SYMMETRY AORTIC CLIP SYSTEM (K003446) | St. Jude Medical Cardiovascular Group, Inc. | 2001-05-21 |
| QUANTA LITE ASCA (S. CEREVISIAE) IGA ELISA (K000733) | Inova Diagnostics, Inc. | 2001-05-21 |
| MODIFICATION TO GLUCOSURE BGM SYSTEM, MODEL 221100 (K011233) | Apex BioTechnology Corp. | 2001-05-18 |
| EQUINOX OCCULSION BALLOON SYSTEM MODEL # 104-4015, 104-4018, 104-4021, 104-4023, 104-4026 (K010162) | Micro Therapeutics, Inc. | 2001-05-18 |
| TINA-QUANT ALPHA-1 ANTITRYPSIN (K010978) | Rochdiag | 2001-05-18 |
| SEEDLING ENTERPRISES LLC, COOL TEC MONOPOLAR AND BIPOLAR REUSABLE ELECTRODES (K010710) | Seedling Enterprises., LLC | 2001-05-18 |
| ASCENT KNEE SYSTEM (K011219) | Biomet, Inc. | 2001-05-18 |
| GE LOGIQ 9, MODEL 2188900-X (K011188) | GE Medical Systems | 2001-05-18 |
| FISTULOK FISTULA NEEDLE PROTECTION (K010958) | Diasol, Inc. | 2001-05-18 |
| ADVANTA SST GRAFT (<6MM) (K010517) | Atrium Medical Corp. | 2001-05-18 |
| CINCH-TYPE DISPOSABLE LIMB HOLDERS, MODEL 912025 (K010644) | Skil-Care Corp. | 2001-05-18 |
| HARDKYDISK NEOMYCIN, 30 MCG (K011385) | Hardy Diagnostics | 2001-05-18 |
| MONOGRAMS SYNTHETIC MONOFILAMENT ABSORBABLE SUTURE (K010672) | Gramsmed, LLC | 2001-05-18 |
| MEGABEAM/CERALAS NON STERILE FIBER OPTIC LASER DELIVERY SYSTEMS, MODEL 200,320,400 OR 600UM (K010689) | Biolitec, Inc. | 2001-05-18 |
| K-ASSAY D-DIMER WITH CALIBRATOR SET AND CALIBRATOR DILUENT (K002948) | Kamiya Biomedical Co. | 2001-05-18 |
| HSCRP CONTROL LEVEL 1, HSCRP CONTROL LEVEL 2, AND HSCRP CONTROL LEVEL 3 (K011169) | International Enzymes, Inc. | 2001-05-18 |
| ADVANTA SST GRAFT (>_6MM) (K010516) | Atrium Medical Corp. | 2001-05-18 |
| SYNTHES TITANIUM MULTI-VECTOR DISTRACTOR (K010690) | Synthes (Usa) | 2001-05-18 |
| VENA TECH VENA CAVA FILTER; VENA TECH 30D VENA CAVA FILTER; VENA TECH LP CAVE FILTER (K010485) | Bbraun | 2001-05-18 |
| VASO PRESS DVT FOOT GARMENT #VP 520 (K003828) | Britt Corp., Inc. | 2001-05-18 |
| VISUALINE II (ALSO KNOWN AS SUNLINE) AMPHETAMINE ASSAY (K010177) | Sun Biomedical Laboratories, Inc. | 2001-05-17 |
| RADCALC, MODEL V.4.0 (K010464) | Lifeline Software, Inc. | 2001-05-17 |
| EMIT 2000 PHENYTOIN ASSAY, MODEL 0SR4A229 (K011347) | Syva Co. | 2001-05-17 |
| EBI DYNAFIX VS OSTEOTOMY SYSTEM (K010551) | Ebi, L.P. | 2001-05-17 |
| ENDOSCOPIC STAPLE REMOVAL INSTRUMENT (K010620) | Onux Medical, Inc. | 2001-05-17 |
| SENICARE ADVANTIX POWDER FREE POLYURETHANE MEDICAL EXAMINATION GLOVE, SENSICARE ADVANTIX POWDER FREE POLYURETHANE DENTAL (K011198) | Maxxim Medical, Inc. | 2001-05-17 |
| EMIT II PLUS CANNABINOID ASSAY, MODEL OSR9N229 (K011300) | Syva Co., Dade Behring, Inc. | 2001-05-17 |
| STEREOTACTIC FRAME BASED SYSTEM (K003486) | Stryker Instruments | 2001-05-17 |
| CLASSIC CEM (K011064) | S & C Polymer GmbH | 2001-05-17 |
| GEM POSTERIOR STABILIZED TOTAL KNEE SYSTEM (K010101) | Kinamed, Inc. | 2001-05-17 |
| XSE (K011167) | 3M Company | 2001-05-17 |
| TETHER ACFS (K010466) | Theken Surgical,Llc | 2001-05-16 |
| N-MID OSTEOCALCIN ONE STEP ELISA MODEL 30SC4000 (K003609) | Osteometer Biotech A/S | 2001-05-16 |
| POWDER-FREE NITRILE EXAM GLOVE, BLUE (K011286) | Ningbo Yujiang Plastic & Rubber Co. , Ltd. | 2001-05-16 |
| E-Z EM PERCUPUMP 2001 CT INJECTOR (K011160) | E-Z-Em, Inc. | 2001-05-16 |
| OPC OXYGEN CONSERVING REGULATOR, MODEL AHG 1968, LIN-7005, MDL-7609, MEM-7612, OPC-830 (K010747) | Western Ent. | 2001-05-16 |
| CONCENTRIC HYDROPHILIC GUIDEWIRE, MODELS 90011, 90012 (K003084) | Concentric Medical, Inc. | 2001-05-16 |
| SEA-LONG MEDICAL TREATMENT HOOD (K010659) | Sea-Long Medical Systems, Inc. | 2001-05-16 |
| HORIZONS INTERNATIONAL VARICES INJECTION NEEDLES (K010448) | Horizons Intl. Corp. | 2001-05-16 |
| ACTIVEECG (K010587) | Active Corp. | 2001-05-16 |
| MODIFICATION TO FLOW 7000 PERIPHERAL VASCULAR COIL (K010730) | Usa Instruments, Inc. | 2001-05-16 |
| CARDIONET AMBULATORY ECG MONITOR, MODEL CN1000A (K003707) | Cardionet | 2001-05-16 |
| EMIT II PLUS BENZODIAZEPINE ASSAY, MODEL 0SR9F229 (K011306) | Syva Co., Dade Behring, Inc. | 2001-05-16 |
| K-ASSAY HS-CRP CONTROLS (K011079) | Kamiya Biomedical Co. | 2001-05-16 |
| UNIGLOVE POLYMER COATED POWDER-FREE LATEX EXAMINATION GLOVES WITH PROTEIN CONTENT LABELING CLAIM (50 MICROGRAMS OR LESS) (K010881) | N.S. Uni-Gloves Sdn. Bhd. | 2001-05-16 |
| CLEAR OR BRAIDED CONTRAST MEDIA INJECTION LINE WITH OR WITHOUT ROTATOR, CATH LAB KIT (K011217) | Abbott Laboratories | 2001-05-16 |
| ACUMATCH L-SERIES CEMENTED FEMORAL STEM, MODEL SIZE 1 (K011218) | Exactech, Inc. | 2001-05-16 |
| CONCENTRIC MICRO CATHETER, MODELS 90001 TO 90008 (K003086) | Concentric Medical, Inc. | 2001-05-16 |
| BRAUN PRECISION SENSOR, MODEL BP 2000 SERIES (K003732) | Braun GmbH | 2001-05-16 |
| MODIFIED MOSS MIAMI 4.35MM DIAMETER POLYAXIAL SCREWS (K011182) | Depuyacromed | 2001-05-16 |
| LIFECORE BIOMEDICAL DENTAL IMPLANT SYSTEMS (K002037) | Lifecore Biomedical, Inc. | 2001-05-16 |
| MODIFICATION TO MALE TO MALE LUER ADAPTER (K003712) | Molded Products, Inc. | 2001-05-16 |
| CONCENTROC HD GUIDE CATHETER, MODELS 90017 (4F), 90019 (5F), 90021 (6F), 90022 (7F), 90023 (8F), 90024 (9F) (K003880) | Concentric Medical, Inc. | 2001-05-16 |
| ELIPAR FREELIGHT (K011154) | Espe Dental AG | 2001-05-16 |
| BALLOON CANNULA, SHORT, MODEL R65-985; BALLOON CANNULA, LONG, MODEL R65-985-1 (K010510) | A & A Medical, Inc. | 2001-05-16 |
| MODIFICATION TO SYNCHRON LX 20 CLINICAL CHEMISTRY SYSTEM (K011213) | Beckman Coulter, Inc. | 2001-05-16 |
| MODIFICATION TO THE EMIT II PLUS PHENCYCLIDINE ASSAY, MODEL OSR9J229 (K011161) | Syva Co., Dade Behring, Inc. | 2001-05-15 |