| HILL-ROM PRIMAVIEW MONITOR SYSTEM (K013709) | Hill-Rom, Inc. | 2001-11-16 |
| LACTOSORB CRANIOFACIAL ANCHOR-PUSH SCREW (K013557) | Walter Lorenz Surgical, Inc. | 2001-11-16 |
| WIENER LAB. AMILASA 405 CINETICA AA, WIENER LAB.AMILASA 405 CINETICA UNITEST,WIENER LAB.AMILASA CINETICA AA (K013101) | Wiener Laboratories Saic | 2001-11-16 |
| INTEX SCREW (K012798) | Biomet, Inc. | 2001-11-16 |
| POWERHEART CARDIAC RHYTHM MODULE (K012197) | Cardiac Science, Inc. | 2001-11-16 |
| RUSCH PERCUTANEOUS NEPHROSTOMY CATHETER SETS (K011121) | Rusch Intl. | 2001-11-16 |
| INTUITIVE SURGICAL BIPOLAR FORCEPS (K012833) | Intuitive Surgical, Inc. | 2001-11-16 |
| BIOSCANNER BEYOND GLUCOSE ANALYZER AND TEST STRIPS (K013203) | Polymer Technology Systems, Inc. | 2001-11-16 |
| VALIDATE CHEM 6 CALIBRATION VERIFICATION TEST SET MODEL # 10006 (K013119) | Maine Standards Co. | 2001-11-16 |
| FANELLI BILIARY STENT (K010601) | Cook, Inc. | 2001-11-16 |
| DIOMED 15 PLUS AND DIOMED 30PLUS LASERS (K013499) | Diomed, Inc. | 2001-11-16 |
| ISOBAR SPINAL SYSTEM (K013444) | Scien'Tx USA, Inc. | 2001-11-16 |
| SEMPERMED DERMA PLUS, SIZES 5.5,6,6.5,7,7.5,8,8.5,9 (K012819) | Semperit Technische Produkte Gesellshaft | 2001-11-16 |
| CYNOSURE PHOTOGENICA ER (K012790) | Cynosure, Inc. | 2001-11-16 |
| JOSTRA ARTERIAL PERFUSION CANNULAE (K012774) | Jostra AG | 2001-11-16 |
| TINA-QUANT APOLIPOPROTEIN B VER.2 (K013206) | Roche Diagnostics Corp. | 2001-11-16 |
| STERILE POWDER-FREE LATEX SURGICAL GLOVES (50 MICROGRAMS OR LESS) (K012880) | Ssn Gloves (M) Sdn Bhd | 2001-11-16 |
| ISOLA POLYAXIAL WASHER (K013441) | Depuyacromed | 2001-11-16 |
| DISCOVERY FACET SCREW FIXATION SYSTEM (K012773) | Depuyacromed | 2001-11-16 |
| SONOACE SA-8000 DIAGNOSTIC ULTRASOUND SYSTEM (K013627) | Medison America, Inc. | 2001-11-16 |
| STERILE POWDERED LATEX SURGICAL GLOVES WITH PROTEIN LABELING CLAIM (200 MICROGRAMS OR LESS) (K012896) | Ssn Gloves (M) Sdn Bhd | 2001-11-16 |
| MACS HMA ANTERIOR SPINAL STABILIZATION SYSTEM (K011556) | Aesculap, Inc. | 2001-11-16 |
| LONG LENGTH DYAX NAIL (K013468) | Howmedica Osteonics Corp. | 2001-11-16 |
| STERILE LATEX EXAMINATION GLOVES (POWDERED) WITH PROTEIN CLAIM LESS THAN 100UG/G (K012856) | Smart Glove Corp. Sdn Bhd | 2001-11-16 |
| WIENER LAB.FOSFATEMIA UV, MODELS 1X100 ML CAT.N 1382321, 4X20 ML CAT.N 1009311 (K013095) | Wiener Laboratories Saic | 2001-11-16 |
| AMEDITECH IMMUTEST DRUG SCREEN METHAMPHETAMINE (K012585) | Ameditech, Inc. | 2001-11-16 |
| BALLPEN SPINAL NEEDLE W/WO INTRODUCER (K011122) | Rusch Intl. | 2001-11-16 |
| MODIFICATION TO: STERILE COLLES CLASSIC FIXATOR (K013503) | DePuy Orthopaedics, Inc. | 2001-11-16 |
| SNAZZY2 (K011473) | Shoprider Intl., Inc. | 2001-11-16 |
| IRMA SL BLOOD ANALYSIS SYSTEM GL CARTRIDGE (K011586) | Diametrics Medical, Inc. | 2001-11-16 |
| COBE SMARXT OPTIMIN SURFACE MODIFIED HOLLOW FIBER MEMBRANE OXYGENATOR (K013480) | Cobe Cardiovascular, Inc. | 2001-11-16 |
| TWINTRODE ELC 134 ELECTRODE (K012785) | Healthtronics Surgical Services, Inc. | 2001-11-16 |
| SIGMA DIAGNOSTICS AUTO D-DIMER CONTROL, LEVEL 3, MODEL A8221 (K013545) | Sigma Diagnostics, Inc. | 2001-11-15 |
| VASCULAR ARCHITECTS ASPIRE COVERED STENT AND CONTROLLED EXPANSION DELIVERY SYSTEM (K012544) | Vascular Architects, Inc. | 2001-11-15 |
| DIGITAL RADIOGRAPHY SYSTEM, MODEL DFP-8000D (K013608) | Toshiba America Medical Systems, In.C | 2001-11-15 |
| SORIN BIOMEDICA SMART BCD VANGUARD,SURFACE MODIFIED BLOOD CARDIOPLEGIA SYSTEM (K012763) | Cobe Cardiovascular, Inc. | 2001-11-15 |
| PASS SPINAL SYSTEM (K013431) | Encore Orthopedics, Inc. | 2001-11-15 |
| DIMENSION HAIC ASSAY, MODEL DF105 (K011852) | Dade Behring, Inc. | 2001-11-15 |
| CAPIOX RX HARDSHELL RESERVOIR (K013526) | Terumo Cardiovascular Systems Corp. | 2001-11-15 |
| WALLSTENT RX BILIARY ENDOPROSTHESES, MODELS 6961-6972 INCLUSIVE (K012752) | Boston Scientific Corp | 2001-11-15 |
| ARTHROCARE ARTHRO WANDS, ENETEC EVAC PLASMA WAND (K013463) | Arthrocare Corp. | 2001-11-15 |
| TINA-QUANT APOLIPOPROTEIN A-1 VER.2 (K013278) | Roche Diagnostics Corp. | 2001-11-15 |
| SIGMA DIAGNOSTICS AUTO D-DIMER CONTROL, LEVEL 2, MODEL A8096 (K013544) | Sigma Diagnostics, Inc. | 2001-11-15 |
| BITEM ANGEL RELINE KIT, BITEM LABORATORY KIT, MODELS 120110, 120060 (K012882) | Thermoelastic Technologies, Inc. | 2001-11-14 |
| TRI-FIX SPINAL FIXATION SYSTEM (K013403) | Endius, Inc. | 2001-11-14 |
| RELISA MPO-ANCA TEST SYSTEM FOR ANTIBODIES TO MYELOPEROXIDASE, MODEL # 7096-15 (K013285) | Immuno Concepts, Inc. | 2001-11-14 |
| ICE BATON (K012746) | Behive, Ltd. | 2001-11-14 |
| MODIFICATION TO HANDMASTER (K012823) | Ness-Neuromuscular Electrical Stimulation Systems | 2001-11-14 |
| CONVERGE ACETABULAR SYSTEM (K012739) | Sulzer Orthopedics, Inc. | 2001-11-14 |
| SYMPHONY GRAFT DELIVERY SYSTEM (GDS) (K012738) | Depuyacromed | 2001-11-14 |
| TROCAR SLEEVE AND ACCESSORIES, MODELS 1287-XX-XX (K012771) | Pajunk GmbH | 2001-11-14 |
| MICROSTREAM O2/CO2 ORAL NASAL FILTERLINE (K011536) | Oridion Medical 1987 , Ltd. | 2001-11-14 |
| HEALOS BONE GRAFT MATERIAL (K012751) | Orquest, Inc. | 2001-11-14 |
| TROCHANTERIC DYAX NAIL SYSTEM (K013524) | Howmedica Osteonics Corp. | 2001-11-14 |
| MODIFICATION TO M2376A DEVICELINK SYSTEM (K013470) | Philips Medical Systems, Inc. | 2001-11-14 |
| ALTAIR MODEL, DEI SYSTEM (DIFFRACTIVE ENERGY IMAGING SYSTEM) (K013291) | Advanced Diagnostics, Inc. | 2001-11-14 |
| CAROTID GUIDING SHEATH (K012812) | Terumo Medical Corp. | 2001-11-14 |
| VISULAS 532S (K013402) | Carl Zeiss, Inc. | 2001-11-14 |
| ADC PEDIATRIC (K012750) | Agfa Corp. | 2001-11-14 |
| RELISA PR3-ANCA TEST SYSTEM FOR ANTIBODIES TO PROTEINASE 3, MODEL # 7096-16 (K013283) | Immuno Concepts, Inc. | 2001-11-14 |
| N2000 BASE STATION, N2001 NURSE STATION (K012801) | Neptec Design Group, Ltd. | 2001-11-14 |
| AUTOJECT 2 (K013362) | Owen Mumford USA, Inc. | 2001-11-13 |
| NORDIX INC RECHARGEABLE BATTERY PART NUMBER 2116 (K013133) | Nordix, Inc. | 2001-11-13 |
| SCANTAC MEMBRANE OR SCANTAC STRIP (K013170) | Sonotech, Inc. | 2001-11-13 |
| SSA-770A, APLIO ULTRASOUND SYSTEM (K013633) | Toshiba America Medical Systems, In.C | 2001-11-13 |
| BSM BONE SUBSTITUTE MATERIAL (K011048) | DePuy Orthopaedics, Inc. | 2001-11-13 |
| SORING GMBH SONOCA 180/190 (K012753) | Soring GmbH Medizintechnik | 2001-11-13 |
| TINA-QUANT APOLIPOPROTEIN B VER.2 (K013207) | Roche Diagnostics Corp. | 2001-11-13 |
| MODIFICATION TO COROMETRICS MODEL 120IS MATERNAL/FETAL MONITORING SYSTEM. (K012718) | Ge Medical Systems Information Technologies | 2001-11-13 |
| WIENER LAB. FER-COLOR TRANSFERRINA, MODEL AUX. REAGENTS FOR 25 SAMPLES CAT. 1492002 (K013102) | Wiener Laboratories Saic | 2001-11-13 |
| MODEL MES-9000/EMG SYSTEM (K013399) | Myotronics-Noromed, Inc. | 2001-11-13 |
| WIENER LAB.FER-COLOR AA, MODEL 5X 20 ML CAT.N 1492003 (K013097) | Wiener Laboratories Saic | 2001-11-13 |
| MODIFICATION TO:MICRO TOUCH (R) POWDER FREE LATEX SURGICAL GLOVES , MODEL STYLE 65 (K013603) | Ansell Healthcare Products, Inc. | 2001-11-13 |
| SINGLE DOSE DISPENSING PIN, MODEL 2201 (K013087) | Alaris Medical Systems, Inc. | 2001-11-13 |
| SAFESKIN HEALTHTOUCH POWDER-FREE EXAM GLOVE WITH VITAMIN E AND ALOE (K012815) | Kimberly-Clark Corp. | 2001-11-13 |
| MODIFICATION TO: ULTRALON (R) POWDER FREE LATEX SURGICAL GLOVES (K013604) | Ansell Healthcare Products, Inc. | 2001-11-13 |
| VANGUARD REPROCESSED PHACOEMULSIFICATION (K012698) | Vanguard Medical Concepts, Inc. | 2001-11-09 |
| DOTTED CONDOM, MALE NATURAL RUBBER LATEX CONDOM (K012962) | Innolatex Sdn. Bhd | 2001-11-09 |
| APN-2 USA SERIES FLEXIBLE CHOLEDOCHOSCOPE (K012951) | Circon Video | 2001-11-09 |
| CLIP PARTIAL PROSTHESIS-TITANIUM DRESDEN, MODEL 1002 250-257 (K013573) | Heinz Kurz GmbH Medizintechnik | 2001-11-09 |
| BCS SYSTEM (K013114) | Dade Behring, Inc. | 2001-11-09 |
| SE-100 VACUUM ERECTION DEVICE (K012662) | Vts, Inc. | 2001-11-09 |
| N LP(A) STANDARD SY (K013126) | Dade Behring, Inc. | 2001-11-09 |
| ULTRA THIN MALE LATEX CONDOM WITH SILICONE LUBRICANT (K012665) | Innolatex Sdn. Bhd | 2001-11-09 |
| BOSS 2000-3 VACUUM ERECTION DEVICE (K012670) | Pos-T-Vac, Inc. | 2001-11-09 |
| REPROCESSED LINVATEC ARTHROSCOPIC BURS (K012630) | Alliance Medical, Inc. | 2001-11-09 |
| VT-1 (K012619) | Vts, Inc. | 2001-11-09 |
| TONOPORT V (K012647) | Par Medizintechnik GmbH | 2001-11-09 |
| HEPARIN COATED MINIATURE CENTRIFUGAL BYPASS PUMP SYSTEM;MODEL #CP-1H (K013393) | A-Med Systems, Inc. | 2001-11-09 |
| ATAC PAK DIRECT HDL REAGENT AND ATAC DIRECT HDL CALIBRATOR KITS (K013152) | Elan Holdings, Inc. | 2001-11-09 |
| ACON BAR ONE STEP BARBITURATES TEST STRIP, ACON BAR ONE STEP BARBITURATES TEST DEVICE (K012824) | ACON Laboratories, Inc. | 2001-11-09 |
| ULTRA THICK MALE LATEX CONDOM WITH SILICONE LUBRICANT (K012664) | Innolatex Sdn. Bhd | 2001-11-09 |
| 56MM CONDOM,MALE NATURAL RUBBER LATEX CONDOM (K012964) | Innolatex Sdn. Bhd | 2001-11-09 |
| BOSS-2000-2 VACUUM ERECTION DEVICE (K012672) | Pos-T-Vac, Inc. | 2001-11-09 |
| SE-300 VACUUM THERAPY SYSTEM (K012639) | Vts, Inc. | 2001-11-09 |
| FAS SET #4551 (K013497) | Gynetics Medical Products NV | 2001-11-09 |
| SE-200 (K012620) | Vts, Inc. | 2001-11-09 |
| CLEARBLUE EASY EARLY RESULT PREGNANCY TEST (K013372) | Unipath , Ltd. | 2001-11-09 |
| STANDARD IMAGING IVB 1000 WELL CHAMBER (K013548) | Standard Imaging, Inc. | 2001-11-09 |
| REPROCESSED LASER PROBE (K012682) | Sterilmed, Inc. | 2001-11-08 |