| IUI, MODEL 4220; SMOOZE, MODEL 4225, L; SEMINOR, MODEL 4502 A, B (K013501) | Gynetics Medical Products NV | 2001-11-30 |
| KP + LFM (K013489) | Pds Healthcare Products, Inc. | 2001-11-29 |
| TINA-QUANT COMPLEMENT C3C TEST SYSTEM (K012361) | Roche Diagnostics Corp. | 2001-11-29 |
| MICRO STAMPING LIGATING CLIP (K013264) | Micro Stamping Corp. | 2001-11-29 |
| MODIFICATION TO: MAC-LINE O2/CO2 ORAL NASAL CANNULA SAMPLE LINE (K013845) | Oridion Medical 1987 , Ltd. | 2001-11-29 |
| DRYSTAR, MODEL 4500M (K012941) | Agfa Corp. | 2001-11-29 |
| HPI SENSI GRIP STERILE POWDERED LATEX SURGICAL GLOVE,WITH LABELED PROTEIN CONTENT AND MADE FROM ALLOTEX AN ENZYME TREAT (K013324) | Tillotson Healthcare Corp. | 2001-11-29 |
| RESECTION ABLATOR (K013117) | Linvatec Corp. | 2001-11-29 |
| TINA-QUANT COMPLEMENT C4 TEST SYSTEM (K012359) | Roche Diagnostics Corp. | 2001-11-29 |
| IGG ANTI-NDNA FLUORESCENT TEST SYSTEM; MODEL # 3040G (K013432) | Immuno Concepts, Inc. | 2001-11-29 |
| NORAD, NOCTURNAL ORAL AIRWAY DILATOR APPLIANCE (K013049) | Dennis R. Bailey, Dds | 2001-11-29 |
| MULTISTIM (K011308) | Pajunk GmbH | 2001-11-29 |
| POWDERED LATEX MEDICAL MEDICAL EXAMINATION GLOVES WITH 150 MICROGRAMS OR LESS OF TOTAL WATER EXTRACTABLE PROTEIN PER DM2 (K013443) | Maxter Glove Manufacturing Sdn Bhd | 2001-11-29 |
| NEPTUNE WASTE MANAGEMENT STSTEM (K012991) | Stryker Instruments | 2001-11-29 |
| MODIFICATION TO:PHILIPS M3000A/M3046A COMPACT PORTABLE PATIENT MONITOR, MODELS PHILIPS M3000A/M3046A (K013427) | Philips Medical Systems, Inc. | 2001-11-29 |
| MOTEX NITRILE EXAMINATION GLOVES POWDER-FREE (K013261) | Shanghai Motex Healthcare Co., Ltd. | 2001-11-29 |
| OXYGEN APPLIED SYMPTOM IMPROVEMENT SYSTEM (OASIS) (K001121) | Engineered Medical Technology, Inc. | 2001-11-29 |
| MED-RX IRRIGATION SET, MODEL 10-3001, 10-3002, 10-4000, 10-4001 (K010607) | Benlan, Inc. | 2001-11-28 |
| TCM ENDO III (K013185) | NOUVAG AG | 2001-11-28 |
| DYNAREX UMBILICAL CORD LAMP, MODELS 6833 AND 6833-B (K012917) | Dynarex Corp. | 2001-11-28 |
| DISPOSABLE STORAGE CAP (K010366) | Molded Products, Inc. | 2001-11-28 |
| TOTAL O2 (K013472) | Chad Therapeutics, Inc. | 2001-11-28 |
| BIOPLATE RESORBABLE BONE SCREW (K012908) | Bioplate, Inc. | 2001-11-28 |
| MOLDED CRANIAL HELMET (K012920) | Fairview Orthopedic Laboratory | 2001-11-28 |
| ULTRA-THIN SDS BALLOON DILATATION CATHETER (K011909) | Boston Scientific Corp | 2001-11-28 |
| MODIFICATION TO BASIC DENTAL IMPLANT SYSTEM (K013682) | Basic Dental Implant Systems, Inc. | 2001-11-28 |
| SILMED NASAL SEPTAL BUTTON (K013696) | Silmed, Inc. | 2001-11-28 |
| CORDIS AVIATOR PERIPHERAL DILATATION CATHETER (K013581) | Cordis, A Johnson & Johnson Co. | 2001-11-28 |
| PHILIPS COMPONENT COMPACT MONITOR,MODEL M1275B, PHILIPS COMPENENT RACK, MODEL M1276B (K013199) | Philips Medical Systems, Inc. | 2001-11-28 |
| EBI SPINELINK - II SPINAL FIXATION SYSTEM (K012516) | Ebi, L.P. | 2001-11-27 |
| FRONTIER ANTERIOR SCOLIOSIS SYSTEM (K012916) | Depuy Acromed, Inc. | 2001-11-27 |
| APEX MODULAR ALUMINA FEMORAL HEAD (K012918) | Apex Surgical, LLC | 2001-11-27 |
| WIENER LAB. GOT (AST) UV AA. WEINER LAB. GOT (AST) UV UNITEST, MODELS 10 * 20 ML CAT. NR. 1751302 AND 20 * 2 ML CAT NR. (K013145) | Wiener Laboratories Saic | 2001-11-27 |
| RUSCH POLYFLEX STENT KIT (K013266) | Rusch Intl. | 2001-11-27 |
| CARDIOVASCULAR ARRAY (K013810) | W. L. Gore & Associates, Inc. | 2001-11-27 |
| GIMMI ALPHA SINUSCOPES MODEL # E.8282.01/31/71 + E.8284.01/31/71; GIMMI ALPHA BRONCHOSCOPES MODEL # E.8189.00/01/02/03 (K013731) | Gimmi GmbH | 2001-11-27 |
| PERIOLASE ND:YAG DENTAL LASER SYSTEM (K010771) | Millennium Dental Technologies, Inc. | 2001-11-27 |
| ORALLITE COMPREHENSIVE EXAM TRAY (K012070) | Trylon Corp. | 2001-11-27 |
| RAPIDONE-ECSTASY TEST (K013180) | American Bio Medica Corp. | 2001-11-26 |
| LIVESURE METHADONE SCREEN TESTS (K013796) | Pan Probe Biotech, Inc. | 2001-11-26 |
| COMPRESSIBLE LIMB SLEEVE (K011192) | Alliance Medical Corp. | 2001-11-26 |
| ANEURYSM CLIPS (K013136) | Gistlstrasse | 2001-11-26 |
| SENSITITRE HAEMOPHILUS/STREPTOCOCCUS PNEUMONIAE (HP) MIC PLATE (K013075) | Trek Diagnostic Systems, Inc. | 2001-11-26 |
| BACTI-SWAB DRY (K013711) | Remel Co. | 2001-11-26 |
| C3 ANTERIOR CERVICAL PLATE SYSTEM (K012881) | Spine Vision, Inc. | 2001-11-26 |
| MODIFICATION TO HEARTWAVE ALTERNANS PROCESSING SYSTEM, MODEL APS (K013564) | Cambridge Heart, Inc. | 2001-11-21 |
| CARDIO CARE EKG-2000 12-CHANNEL ELECTROCARDIOGRAPH (K011328) | Bionet Company, Ltd. | 2001-11-21 |
| RENAL GUIDING SHEATH (K012854) | Terumo Medical Corp. | 2001-11-21 |
| CORRESTORE PATCH, MODELS 1.5P2, 2P3, 3P4; CORRESTORE SIZER, MODEL CRPS (K011487) | Somanetics Corp. | 2001-11-21 |
| MODIFICATION TO: 1.5 BONE FIXATION KIT, MODELS BXS6114, BXS6214 (K013546) | Bionx Implants, Inc. | 2001-11-21 |
| RUSCH BRONCHUS BLOCKER KIT (K010596) | Rusch Intl. | 2001-11-21 |
| HIGH GOLD PALLADIUM FREE CERAMIC SOLDER (K012877) | Ivoclar USA, Inc. | 2001-11-21 |
| STENT SUPPORT GUIDE CATHETER (K010579) | Medtronic Vascular | 2001-11-21 |
| CARTO XP EP NAVIGATION SYSTEM (K013083) | Biosense Webster, Inc. | 2001-11-21 |
| CARDIAC DIAGNOSTIC SYSTEM, MODEL CH2000 (K013565) | Cambridge Heart, Inc. | 2001-11-21 |
| EBI XFIX ACCESS PELVIC FIXATOR (K013540) | Ebi, L.P. | 2001-11-20 |
| HELICAL COMPRESSION ANCHOR SYSTEM, CANNULATED SINGLE HELIX (K012818) | Triage Medical, Inc. | 2001-11-20 |
| CLIRANS E-SERIES DIALYZER (K013550) | Terumo Medical Corp. | 2001-11-20 |
| DISETRONIC PENFINE INSULIN INJECTION PEN NEEDLE (K013782) | Disetronic Medical Systems | 2001-11-20 |
| POWER DRIVE (K012944) | Mediteam AB | 2001-11-20 |
| VALIDATE CHEM 7 CALIBRATION VERIFICATION TEST SET, MODEL 10007 (K013265) | Maine Standards Co. | 2001-11-20 |
| SIGNA OPENSPEED MAGNETIC RESONANCE SYSTEM (K012875) | GE Medical Systems | 2001-11-20 |
| ZIPPY, MODEL I88WA (K012846) | Pillar Technology, Inc. | 2001-11-20 |
| DUO PAL 6, ORDER-NO.: 2154 (K012841) | Wieland Edelmetalle GmbH & Co. | 2001-11-20 |
| EYE-Q (XYLOFILCON A) SOFT (HYDROPHILIC) MULTIFOCAL CONTACT LENS FOR DAILY WEAR (K013469) | Soflex Contact Lens Industries , Ltd. | 2001-11-20 |
| HNC-63-INT NEUROVASCULAR ARRAY COIL (K013602) | Mri Devices Corp. | 2001-11-20 |
| HD/HDT, PV/PVT (POLYMACON) SOFT CONTACT LENS FOR DAILY WEAR (CLEAR AND TINTED, FULLY CAST-MOLDED LENS) (K013220) | Poly Vue Technolgies, Inc. | 2001-11-20 |
| LINICAL PROTEIN I CALIBRATION VERIFIERS LEVELS A=E FOR BECKMAN COULTER IMMAGE (K013332) | Cliniqa Corporation | 2001-11-20 |
| HAEMOPHILUS/STREPTOCOCCUS PNEUMONIAE (HP) MIC PLATE (K013368) | Trek Diagnostic Systems, Inc. | 2001-11-20 |
| INFUSION IV SET (K001879) | Nirvi Intl. USA | 2001-11-20 |
| SEREINE EXTRA STRENGTH DAILY CLEANER (K011561) | Wilsa, Inc. | 2001-11-20 |
| LERMAN & SON CRANIAL ORTHOSIS HELMET (K012830) | Lerman & Son | 2001-11-20 |
| EFILM VIDEO (K013631) | Efilm Medical, Inc. | 2001-11-20 |
| RESORBABLE SCREW ANCHOR (K012872) | Arthrotek, Inc. | 2001-11-20 |
| THE BIOPLATE MANDIBLE FIXATION SYSTEM (K012910) | Bioplate, Inc. | 2001-11-20 |
| IMMULITE INTACT PTH, IMMULITE 2000 INTACT PTH, MODELS LKPP1 (100 TESTS), LKPP5 (500 TESTS), L2KPP2 (200 TESTS), L2KPP6 (K013566) | Diagnostic Products Corp. | 2001-11-20 |
| BIOSCANNER 2000 (K013068) | Polymer Technology Systems, Inc. | 2001-11-20 |
| HRH-127-ALLEGRA HEAD ARRAY COIL (K013508) | Mri Devices Corp. | 2001-11-20 |
| HELICAL COMPRESSION ANCHOR SYSTEM, NON-CANNULATED (K012817) | Triage Medical, Inc. | 2001-11-20 |
| CYBERCASES BY BAUSCH & LOMB (K013232) | Bausch & Lomb, Inc. | 2001-11-20 |
| 'RAPIDONE'-METHADONE TEST (K012164) | American Bio Medica Corp. | 2001-11-20 |
| COMFORTCARE COMPRESSION SUPPORT WITH MAGNETS COMFORTCARE MAGNETIC INSOLES (K013239) | Med Gen, Inc. | 2001-11-20 |
| MEDSTAR 150 (K013081) | Mednet Services, Inc. | 2001-11-20 |
| TORIC EYE-Q (XYLOFILCON A) SOFT (HYDROPHILIC) TORIC MULTIFOCAL CONTACT LENS FOR DAILY WEAR (K013467) | Soflex Contact Lens Industries , Ltd. | 2001-11-20 |
| ADVIA 1650 GLUCOSE HEXOKINASE 11 ASSAY (K011963) | Bayer Corp. | 2001-11-20 |
| RECORDING AND STIMULATING ELECTRODE (K012850) | Radionics, A Division of Tyco Healthcare Group LP | 2001-11-19 |
| HSG CATHETER SET, 5F MODEL RGS0947, HSG CATHETER SET, 7F, MODEL R65-948 (K013491) | A & A Medical, Inc. | 2001-11-19 |
| STARS2000 POWER CANNULA (K012236) | Kmi Kolster Methods, Inc. | 2001-11-19 |
| FLEXIBLE PEDIATRIC CYSTOURETEROSCOPE, MODEL AUR- 735 (K012929) | Circon Video | 2001-11-19 |
| DOCUMENTING LASER SLIT LAMP, DP 2010 (K012873) | Bausch & Lomb, Inc. | 2001-11-19 |
| SF SH CATHETER, MODEL R65-945 (K013437) | A & A Medical, Inc. | 2001-11-19 |
| SCREW VENT IMPLANT; TAPERED SCREW VENT IMPLANT (K013227) | Sulzer Dental, Inc. | 2001-11-19 |
| DORNIER SAPPHIREERBIUM HANDPIECE, DORNIER SAPPHIRESPOT HANDPIECE (K011322) | Dornier Medtech America, Inc. | 2001-11-19 |
| CYNOSURE PHOTOGENICA VL (K012806) | Cynosure, Inc. | 2001-11-19 |
| ISOBAR SPINAL SYSTEM (K013440) | Scien'Tx USA, Inc. | 2001-11-16 |
| TINA-QUANT APOLIPOPROTEIN VER.2 (K013249) | Roche Diagnostics Corp. | 2001-11-16 |
| MEDSTAR 100 INTERFERENTIAL STIMLATOR (K013082) | Mednet Services, Inc. | 2001-11-16 |
| MONO-DOX, SYNTHETIC ABSORBABLE POLYDIOXANONE SURGICAL SUTURE,STERILE (K013274) | Cp Medical | 2001-11-16 |
| DURACON CONSTRAINED POSTERIOR STABILIZED (PS) TIBIAL INSERT (K012776) | Howmedica Osteonics Corp. | 2001-11-16 |
| SMART GLOVE STERILE NITRILE EXAM GLOVE (K012853) | Smart Glove Corp. Sdn Bhd | 2001-11-16 |