| IRMA SL BLOOD ANALYSIS SYSTEM GL CARTRIDGE (K011586) | Diametrics Medical, Inc. | 2001-11-16 |
| VASCULAR ARCHITECTS ASPIRE COVERED STENT AND CONTROLLED EXPANSION DELIVERY SYSTEM (K012544) | Vascular Architects, Inc. | 2001-11-15 |
| ARTHROCARE ARTHRO WANDS, ENETEC EVAC PLASMA WAND (K013463) | Arthrocare Corp. | 2001-11-15 |
| SYMPHONY GRAFT DELIVERY SYSTEM (GDS) (K012738) | Depuyacromed | 2001-11-14 |
| VISULAS 532S (K013402) | Carl Zeiss, Inc. | 2001-11-14 |
| NORDIX INC RECHARGEABLE BATTERY PART NUMBER 2116 (K013133) | Nordix, Inc. | 2001-11-13 |
| MODIFICATION TO:MICRO TOUCH (R) POWDER FREE LATEX SURGICAL GLOVES , MODEL STYLE 65 (K013603) | Ansell Healthcare Products, Inc. | 2001-11-13 |
| MODIFICATION TO: ULTRALON (R) POWDER FREE LATEX SURGICAL GLOVES (K013604) | Ansell Healthcare Products, Inc. | 2001-11-13 |
| REPROCESSED LASER PROBE (K012682) | Sterilmed, Inc. | 2001-11-08 |
| REPROCESSED RF ARTHROSCOPY PROBES (K012679) | Sterilmed, Inc. | 2001-11-08 |
| TISSUE GRASPING FORCEPS, SCISSORS, CLAMPS AND DISSECTORS FOR LAPAROSCOPIC SURGERIES (K012725) | Endo-Therapeutics, Inc. | 2001-11-08 |
| REPROCESSED LAPAROSCOPIC ELECTRIC INSTUMENTS (K012598) | Sterilmed, Inc. | 2001-11-07 |
| PARADIGM-FONTONA PEROVSKITE ND: YAP LASER SYSTEM AND ACCESSORIES (K011174) | Fotona D.D. | 2001-11-07 |
| SURGITRON 120 IEC (ALSO KNOWN AS SURGITRON 4.0 DUAL RF (K013255) | Ellman Intl., Inc. | 2001-11-07 |
| VANGUARD REPROCESSED ENDOSCOPIC INSTRUMENTS (K012700) | Vanguard Medical Concepts, Inc. | 2001-11-07 |
| DRT4 LASER DOPPLER PERFUSION AND TEMPERATURE MONITOR (K011070) | Moor Instruments, Ltd. | 2001-11-07 |
| REPROCESSED AUTOSUTURE UNIPOLAR LAPAROSCOPIC/ENDOSCOPIC INSTRUMENTS (K012603) | Alliance Medical Corp. | 2001-11-07 |
| ARAMIS DERMATLOGIC LASER (K012545) | Lumedics, Ltd. | 2001-11-05 |
| SCITON IMAGE HAIR REMOVAL LASER (K012552) | Sciton, Inc | 2001-11-05 |
| W.O.M. LASER U100 (K011175) | W.O.M. World of Medicine GmbH | 2001-11-01 |
| CRYO-HIT, MODELS EP6T5, FP5T5, FP5T3, EP2T2, EP1T1, AND EP2T1 (K012497) | Galil Medical , Ltd. | 2001-10-30 |
| VANGUARD REPROCESSED ARTHROSCOPIC WANDS (K012695) | Vanguard Medical Concepts, Inc. | 2001-10-30 |
| THEKEN LARGE CEMENT RESTRICTOR (K012462) | Theken Surgical,Llc | 2001-10-29 |
| MODIFICATION TO: ERBE APC CONNECTOR HOSE AND PROBES, MODELS 20132-158, 20132-155, 20132-156, 20132-157, 20132-166 (K013348) | Erbe USA, Inc. | 2001-10-26 |
| GYNECARE TENSION-FREE VAGINAL TAPE SYSTEM (K012628) | Gynecare Center | 2001-10-26 |
| SPARC SLING SYSTEM (K013355) | American Medical Systems, Inc. | 2001-10-26 |
| TOURNIQUET CUFF; PNEUMATIC TOURNIQUET (K012632) | Medical Instruments Technology, Inc. | 2001-10-26 |
| SURGASSIST RIGHT ANGLE LINEAR CUTTER DLU - 45MM, MODEL RALC45 (K012809) | Power Medical Interventions, Inc. | 2001-10-26 |
| OXYGENATOR (K002632) | Adjunctive Therapeutics, Inc. | 2001-10-25 |
| ARTHROCARE ELECTROSURGERY WANDS (K012519) | Arthrocare Corp. | 2001-10-25 |
| CONFORM SHEETING, MODEL IGEL (K012419) | Implantech Associates, Inc. | 2001-10-24 |
| STONY BROOK SURGICAL INNOVAIONS STERNA-WIRE (STERNAL SUTURES) (K013059) | Stony Brook Surgical Innovations, Inc. | 2001-10-22 |
| COAPTITE TISSUE MARKER AND COAPTITE FN TISSUE MARKER (K012955) | Bioform, Inc. | 2001-10-22 |
| REPROCESSED UNIPOLAR LAPAROSCOPIC/ENDOSCOPIC INSTRUMENTS (K012625) | Alliance Medical Corp. | 2001-10-22 |
| POWERPRO BATTERY SYSTEM (K012320) | Linvatec Corp. | 2001-10-19 |
| THEKEN SMALL CEMENT RESTRICTOR (K012278) | Theken Surgical,Llc | 2001-10-17 |
| MERTEX-PLUS REUSABLE SURGICAL DRAPE (K012237) | Mercan AB | 2001-10-15 |
| MERTEX-PLUS O.R./SURGEONS GOWN, NONSTERILE (K012240) | Mercan AB | 2001-10-15 |
| MENTOR ULTRASOUND-ASSISTED TISSUE REMOVAL SYSTEM (CURRENT), MENTOR CONTOUR GENESIS SYSTEM (PROPOSED) (K004005) | Mentor Corp. | 2001-10-12 |
| ULTRAFLEX ESOPHAGEAL STENT SYSTEM, ULTRAFLEX DIAMONDBILIARY STENT SYSTEM, ULTRAFLEX TRACHEOBRONCHIAL STENT SYSTEM (K012883) | Boston Scientific Corp | 2001-10-12 |
| MODIFICATION TO: COMPEL SURGICAL DRAPES (K012807) | Standard Textile Co., Inc. | 2001-10-11 |
| LEVEEN ELECTRODE (K012315) | Radiotherapeutics Corp. | 2001-10-11 |
| CANDELA CLEARBEAM PULSED DYE LASER (K013043) | Candela Corp. | 2001-10-11 |
| CRYOCARE SURGICAL SYSTEM (K003811) | Endocare, Inc. | 2001-10-11 |
| TITANIUM CEMENT RESTRICTOR MATERIAL PEEK (K010528) | Medtronic Sofamor Danek USA, Inc. | 2001-10-10 |
| LASER 20 (K011021) | Ya-Man, Ltd. | 2001-10-09 |
| AL-40 (K010715) | Ddc Technologies, Inc. | 2001-10-04 |
| BLOCK CEMENT RESTRICTOR (CR) - TITANIUM (K013014) | Medtronic Sofamor Danek, Inc. | 2001-10-04 |
| PULSEMASTER ERBIUM DENTAL LASER SYSTEM (K012127) | American Dental Technologies, Inc. | 2001-10-04 |
| ARTHREX FIBERWIRE, USP SIZE 5, MODEL AR-7201 (K012923) | Arthrex, Inc. | 2001-10-04 |
| URETEX SUP PUBOURETHRAL SLING (K012949) | Sofradim Production | 2001-10-04 |
| MEGABEAM/CERALAS REUSEABLE HANDPIECE AND DISPOSABLE TIPS (K010804) | Biolitec, Inc. | 2001-10-04 |
| MODIFICATION TO: THERMACOOL IIA (K013034) | Thermage, Inc. | 2001-10-04 |
| BIPOLAR IRRIGATION FORCEPS (K012986) | Aesculap, Inc. | 2001-10-03 |
| COOLTOUCH VARIZOOM (K012982) | New Star Lasers, Inc. | 2001-10-02 |
| STERILE NITRILE SURGICAL GLOVES (POWDERED) (K012479) | Smart Glove Corp. Sdn Bhd | 2001-09-26 |
| EASY GUIDE ELECTROSURGICAL ACCESS DEVICE (K012004) | Senorx, Inc. | 2001-09-25 |
| SUPERSTITCH VASCULAR SUTURING DEVICE (K012865) | Sutura, Inc. | 2001-09-25 |
| BREATHABLE IMPERVIOUS GOWNS (K012984) | Allegiance Healthcare Corp. | 2001-09-24 |
| MULTIFUNCTION ENDOSCOPIC INSTRUMENT (K012033) | Seedling Enterprises., LLC | 2001-09-20 |
| SURGICAL LIGHTSTIC 180, MODEL 180 L, MODEL 180 C (K011988) | Cardiofocus, Inc. | 2001-09-20 |
| KINETIC CANNULA (K012042) | Reliance Medical Corp. | 2001-09-20 |
| PREMICRON NONABSORBABLE PET SURGICAL SUTURE (K012201) | Aesculap, Inc. | 2001-09-19 |
| IMPRO VISE ABSORBABLE CEMENT FLOW RESTRICTOR (K011943) | Kensey Nash Corp. | 2001-09-19 |
| MERSILK BLACK SILK BRAIDED NON-ABSORBABLE SUTURE, USP (K012124) | Johnson & Johnson Medical (China) , Ltd. | 2001-09-19 |
| ADVANCE MEDICAL DESIGNS FLUID POUCH (K012168) | Advance Medical Designs, Inc. | 2001-09-18 |
| HANDPIECE SHEATH-MODEL #A910 (K011929) | Aaron Medical, Inc. | 2001-09-18 |
| CLINCARE LATEX SURGEON'S GLOVE (K012067) | Ttk Healthcare , Ltd. | 2001-09-17 |
| STERILE LATEX SURGICAL GLOVES (POWDERED) WITH PROTEIN CONTENT LABELING CLAIM (100 MICROGRAMS OR LESS) (K011066) | Smart Glove Corp. Sdn Bhd | 2001-09-11 |
| PALOMAR DERMALUX PULSED LIGHT SYSTEM (K010618) | Palomar | 2001-09-10 |
| CYNOSURE ACCLAIM DERMATOLOGY LASER (K011828) | Cynosure, Inc. | 2001-09-07 |
| AMS SOFT-TISSUE APPROXIMATION SYSTEM (K012342) | American Medical Systems, Inc. | 2001-09-05 |
| ES-2000 SHAPE SELECT ELECTROSURGICAL SCALPEL (K012799) | Senorx, Inc. | 2001-09-04 |
| COALESCENT SURGICAL U-CLIP (K012317) | Coalescent Surgical | 2001-08-31 |
| OLYMPUS SUCTION PUMP, MODEL KV-5 (K011725) | Keymed (Medical & Industrial Equipment), Ltd. | 2001-08-31 |
| MODIFICATION TO:ENDIUS BIPOLAR SHEATH (K012488) | Endius, Inc. | 2001-08-30 |
| PALOMAR LC 100 DIODE LASER (K011747) | Palomar Medical Technologies, Inc. | 2001-08-30 |
| OPUS 10 (WITH TOOTH WHITENING APPLICATION), MODEL 2ND (K011769) | Opusdent , Ltd. | 2001-08-30 |
| ATRICURE BIPOLAR COAGULATION SYSTEM (K011722) | AtriCure, Inc. | 2001-08-30 |
| LUMENIS VERSAPULSE POWERSUITE HOLMIUM (HO:YAG) AND DUAL WAVELENGTH (HO:YAG/ND:YAG) SURGICAL LASERS AND DELIVERY DEVICES (K011703) | Lumenis | 2001-08-29 |
| POLY-TAPES (VARIOUS SIZES AND WOVEN CONSTRUCTION VARIANTS) (K002172) | Xiros Plc | 2001-08-28 |
| FORTAFLEX SURGICAL MESH (K011025) | Organogenesis, Inc. | 2001-08-24 |
| MODIFICATION TO VASCULAR CLOSURE DEVICE (K012362) | Std Mfg., Inc. | 2001-08-23 |
| ORTHO DEVELOPMENT ORION-I EMF SYSTEM (K012129) | Ortho Development Corp. | 2001-08-22 |
| RADIOGRAPHIC MARKERS (K011856) | Encore Orthopedics, Inc. | 2001-08-22 |
| CRYOPLAN SYSTEM (K011073) | Cryomedical Sciences, Inc. | 2001-08-22 |
| SNOW LOTUS POWDER-FREE LATEX SURGEON'S GLOVES (K012104) | Beijing Reagent Latex Products Co., Ltd. | 2001-08-21 |
| ESTEEM STERILE POLYISOPRENE SURGICAL GLOVES (K011721) | Allegiance Healthcare Corp. | 2001-08-14 |
| INSTRUMENTS FOR ONE TIME USE - DISPOSABLE (K011514) | Kencap , Ltd. | 2001-08-13 |
| INTRALASE 600C LASER KERATOME (K002890) | Intra Lase Corp. | 2001-08-09 |
| INPULSE DENTAL LASER (K011423) | Incisive, LLC | 2001-08-07 |
| THREADED CEMENT RESTRICTOR (CR) TITANIUM (K011443) | Medtronic Sofamor Danek USA, Inc. | 2001-08-03 |
| XTRAC EXCIMER LASER SYSTEM, MODEL AL 7000 (K011382) | Photo Medex, Inc. | 2001-08-02 |
| POWDER FREE BROWN LATEX SURGICAL GLOVES WITH PROTEIN CONTENT LABELING CLAIM (50 MICROGRAMS OR LESS) (K012135) | Wrp Asia Pacific Sdn. Bhd. | 2001-08-01 |
| SPARC SLING SYSTEM (K011251) | American Medical Systems, Inc. | 2001-08-01 |
| MEDTRONIC SOFAMOR DANEK CEMENT RESTRICTOR (K012255) | Medtronic Sofamor Danek, Inc. | 2001-08-01 |
| AESCULAP, INC. SAFIL QUICK SYNTHETIC ABSORBABLE SURGICAL SUTURE (K011372) | Aesculap, Inc. | 2001-08-01 |
| METRONIC SOFAMOR DANEK CEMENT RESTRICTOR (K011998) | Medtronic Sofamor Danek, Inc. | 2001-07-26 |
| LASER PERIPHERALS REUSABLE HOLMIUM FIBER (K011207) | Laser Peripherals, LLC | 2001-07-24 |
| ENTEC EVAC PLASMA WAND (K011279) | Arthrocare Corp. | 2001-07-19 |