| BIOPSY SITE MARKER (K011402) | Senorx, Inc. | 2001-07-16 |
| MEDLINE GROUNDING PAD (K011515) | Medline Industries, Inc. | 2001-07-13 |
| SURGICAL DRAPES (K011422) | Advance Medical Designs, Inc. | 2001-07-10 |
| CANDELA SPTL-1E PULSED DYE LASER (K011092) | Candela Corp. | 2001-07-09 |
| WATERLASE, MILLENNIUM (K011041) | Biolase Technology, Inc. | 2001-07-03 |
| AESCULAP, INC., MONOSYN SYNTHETIC ABSORBABLE SURGICAL SUTURE (K011375) | Aesculap, Inc. | 2001-06-29 |
| LIPOMATIC; LIPOMATIC LIPOSUCTION DEVICE (K010311) | Euromi S.A | 2001-06-29 |
| AMS SLING FIXATION SYSTEM (K010990) | American Medical Systems, Inc. | 2001-06-22 |
| STRYKER T4 HYTREL (R) TOGAS (K011755) | Stryker Corp. | 2001-06-22 |
| MEDLITE Q-SWITCHED ND:YAG LASER REPLACED BY THE MEDLITE C3 Q-SWTICHED ND:YAG LASER (K011677) | Continuum Electro-Optics, Inc. | 2001-06-22 |
| PROCEDURE MASKS: PM4-301 AND PM4-304 (K011789) | Primeline Medical Products, Inc. | 2001-06-22 |
| CHESS HAND SURGERY SYSTEM (K010184) | Canica Design, Inc. | 2001-06-22 |
| MODIFICATION TO PROLITE PULSED LIGHT SYSTEM (K010927) | Medical Bio Care Sweden AB | 2001-06-19 |
| ARTHROCARE CONTROLLER, MODEL H2000; ARTHROCARE CABLE, MODEL H0970-02; FOOTSWITCH, MODEL H2000-04; POWERCORD, MODEL H2000 (K011634) | Arthrocare Corp. | 2001-06-19 |
| PROLITE VL PULSED LIGHT SYSTEM (K010928) | Medical Bio Care Sweden AB | 2001-06-19 |
| CRYOCARE CARDIAC SURGICAL SYSTEM (K011040) | Endocare, Inc. | 2001-06-15 |
| NTERO NOMAD SYSTEM (K010815) | Ntero Surgical, Inc. | 2001-06-15 |
| BARRIERPLUS POWDER-FREE SYNTHETIC POLYISOPRENE SURGICAL GLOVES (K011446) | Barriermed, Inc. | 2001-06-14 |
| SLT LASERPRO CTH HOLMIUM LASER SYSTEM (K011409) | Surgical Laser Technologies, Inc. | 2001-06-14 |
| TRUMPF SURGICAL LIGHTS, MODELS 301,501,701,1001 (K011693) | Trumpf Medical Systems, Inc. | 2001-06-13 |
| EN BLOC BIOPSY SYSTEM (K003190) | Neothermia Corp. | 2001-06-11 |
| ARDO SUCTION PUMP MASTER, MODEL 30.00.XX; ARDO SUCTION PUMP SENATOR, MODEL 31.00.XX (K011601) | Ardo Medical AG | 2001-06-08 |
| ULTRAFREE MAX STERILE LATEX POWEDER-FREE SURGICAL GLOVES WITH PROTEIN LABELING CLAIM, 50 PER GRAM OR LESS OF TOTAL WATER (K010862) | Allegiance Healthcare Corp. | 2001-06-07 |
| COMBOSAFE SURGICAL GOWNS, NON-STERILE (75X REUSABLE) (K010799) | Standard Textile Co., Inc. | 2001-06-07 |
| UNI-LASER 470 (K010885) | Medart Corp. | 2001-06-07 |
| SOLA 700,SOLA 500, SOLA 300 (K010724) | Drager Medizintechnik GmbH | 2001-06-07 |
| ESU HANDSWITCHING PENCIL (K001442) | Surgex, Inc. | 2001-05-31 |
| ENSIL FABRIC (K010675) | Gottfried Medical, Inc. | 2001-05-30 |
| VAL LUX 600 SURGICAL LIGHT (PLUS AND RS), MODEL ML600/S: SINGLE LIGHT HEAD, ML600/SS: SINGLE LIGHT HEAD, ML600/1D): DOUB (K010716) | Valmed Corp. | 2001-05-30 |
| FORTAFLEX SURGICAL SLING (K011027) | Organogenesis, Inc. | 2001-05-30 |
| SUTURTEK FASTCLOSE FASCIA CLOSURE DEVICE (K011105) | Qrc Consulting | 2001-05-30 |
| BIOSLING - BIOABSORBABLE POLYMER SLING & SURGICAL MESH (K010533) | Injectx, Inc. | 2001-05-24 |
| ECOTRACT ADJUSTABLE WOUND PROTECTOR/RETRACTOR (K010711) | Advanced Surgical Concepts (Asc) | 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 |
| AFX MICROWAVE GENERATOR, FLEX ABLATION WAND, LYNX ABLATION WAND, MODEL SERIES 1000, P/N 102006, P/N 102007 (K003978) | Afx, Inc. | 2001-05-22 |
| LYRA SERIES SURGICAL LASER SYSTEM & ACCESSORIES (K010834) | Laserscope | 2001-05-21 |
| MODIFICATION TO SEAMGUARD STAPLE LINE REINFORCEMENT MATERIAL (K010936) | W. L. Gore & Associates, Inc. | 2001-05-21 |
| SYMMETRY AORTIC CLIP SYSTEM (K003446) | St. Jude Medical Cardiovascular Group, Inc. | 2001-05-21 |
| SEEDLING ENTERPRISES LLC, COOL TEC MONOPOLAR AND BIPOLAR REUSABLE ELECTRODES (K010710) | Seedling Enterprises., LLC | 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 |
| MODIFICATION TO IMPLANTABLE CLIP (K011236) | Applied Medical Resources Corp. | 2001-05-14 |
| DENSTAT (K010465) | Elmed, Inc. | 2001-05-14 |
| ARTHREX FIBERWIRE, MODEL SPU-02NB-3800 (K010673) | Arthrex, Inc. | 2001-05-14 |
| BIOKNOTLESS ANCHOR (K002639) | Mitek Products | 2001-05-11 |
| ENDOSCOPIC MONOPOLAREECTRODE, MODEL EME- 1000 TO 1999 (K003403) | Highland / Marietta, Inc. | 2001-05-07 |
| XPS 3000 SYSTEM WITH RECIPROCATING ADAPTER AND SUCTION CANNULAE (K010666) | Medtronic Xomed, Inc. | 2001-05-07 |
| TANTALUM BEADS - RADIOGRAPHIC MARKER (K010348) | Biomet, Inc. | 2001-05-03 |
| MODIFICATION TO TISSUELINK BIPOLAR FORCEPS (K010661) | Tissuelink Medical, Inc. | 2001-05-03 |
| TISSUE MARKER (K001807) | Advanced Uroscience, Inc. | 2001-05-03 |
| SEEDNET, MODELS FP6T5, FP5T5, FP5T3 (K010991) | Galil Medical , Ltd. | 2001-05-03 |
| BIPOLAR PENCIL, MODEL 3901-002, 3900-002 (K010487) | Medtronic PS Medical | 2001-05-03 |
| MAXITEX DUPLEX POWDER FREE LATEX STERILE SURGEON GLOVES PROTEIN LABELING CLAIM (50 MICRGRAMS OR LESS) (K010438) | Terang Nusa Sdn Bhd | 2001-05-01 |
| COOLTOUCH VARIA ND:YAG LASER SYSTEM; COOLTOUCH VARIA-II ND:YAG LASER SYSTEM (K010316) | Cooltouch Corp. | 2001-05-01 |
| MAXITEX DUPLEX STERILE LATEX POWDERED SURGEON GLOVES WITH PROTEIN LABELING CLAIM (100 MICROGRAMS OR LESS) (K010439) | Terang Nusa Sdn Bhd | 2001-05-01 |
| LYRA G SERIES SURGICAL LASER SYSTEM (SL SERIES Q-SWITCHED ND:YAG CONFIGURATION) (K010284) | Laserscope | 2001-05-01 |
| PROLENE (POLYPROPYLENE) 3D PATCH, NONABSORBABLE SYNTHETIC SURGICAL MESH (K010722) | ETHICON, Inc. | 2001-04-27 |
| MODIFICATION TO TISSUELINK MONOPOLAR FLOATING BALL (K010662) | Tissuelink Medical, Inc. | 2001-04-27 |
| ACTIVHEAL SCAR MANAGEMENT DRESSING (K010245) | Advanced Medical Solutions, Ltd. | 2001-04-25 |
| ACTI-GARD ANTIMICROBIAL FILM, MODELS D6635, D6640, D6648, D6650,D6651, D66XX (K000442) | Medical Concepts Development, Inc. | 2001-04-24 |
| SYNPLUG (K010840) | Isotis NV | 2001-04-20 |
| SOFTLASE - SURGICAL DIODE LASER SYSTEM (K003440) | Zap Lasers, Inc. | 2001-04-20 |
| COBRA 1/2 FLEX SURGICAL PROBE, MODEL 1593X; COBRA FLEX SURGICAL PROBE MODEL 1594X (K010956) | Boston Scientific Corp | 2001-04-13 |
| LASER MECHANISMS LASER SCANNING SYSTEM (K010113) | Laser Mechanisms, Inc. | 2001-04-12 |
| CANDELA LONG PULSE ND:YAG (K010104) | Candela Corp. | 2001-04-11 |
| BIPOLAR TRIGGER-FLEX PROBE (K003126) | Ellman Intl., Inc. | 2001-04-11 |
| MULTIFUCTION SUCTION IRRIGATION SYSTEM, EXISTING OF SUCTION IRRIGATION HANDLES, SUCTION IRRIGATION TUBES, AND TUBE SETS; (K002000) | Richard Wolf Medical Instruments Corp. | 2001-04-10 |
| AMS SACRAL COLPOPEXY SLING, MODEL 72403501 (K010931) | American Medical Systems, Inc. | 2001-04-09 |
| ULTRACISION HARMONIC SCALPEL COAGULATING SHEARS, MODEL LCSC5,LCSC1,CS23C,CS231,CS14C,CS141,LCSB5,LCSK5,LCS15,LCS16,CS150 (K002981) | Ethicon Endo-Surgery, Inc. | 2001-04-09 |
| NONABSORBABLE POLYPROPYLENE SURGICAL SUTURE (K010909) | Tyco Healthcare Group LP | 2001-04-09 |
| RITA MODEL 2500 ELECTROSURGICAL RF GENERATOR (K003676) | Rita Medical Systems | 2001-04-09 |
| BAYLIS MEDICAL RF PERFORATION PROBE, MODEL RFP-265 (K010265) | Baylis Medical Co., Inc. | 2001-04-09 |
| NUVOLASE 532 MEDICAL LASER SYSTEM (K010046) | American Laser Corp. | 2001-04-05 |
| IVS TUNNELLER (K010035) | United States Surgical, A Division of Tyco Healthc | 2001-04-04 |
| WHITE KNIGHT MASKS (21 MODELS, VARIOUS COLORS WITH AND WITHOUT FACE SHIELDS) (K001892) | White Knight Healthcare, Inc. | 2001-04-03 |
| WHITE KNIGHT MASKS, BLUE, PINK, YELLOW, WHITE MASKS (13 MODELS) (K001893) | White Knight Healthcare, Inc. | 2001-04-02 |
| WHITE KNIGHT BLUE, GREEN FACE MASK, (4 MODELS) (K001997) | White Knight Healthcare, Inc. | 2001-04-02 |
| CYNOSURE PHOTOGENICA DL (K010005) | Cynosure, Inc. | 2001-04-02 |
| BIPOLAR COAGULATION SYSTEM (K010112) | Enable Medical Corp. | 2001-04-02 |
| VALLEYLAB LIGASURE PRECISE INSTRUMENT VESSEL SEALING SYSTEM-MODEL # LS1200 & SLIGAURE GENERATOR (K010010) | Valleylab, Inc. | 2001-04-02 |
| ENDOSCOPIC TUBE SHAFT INSTRUMENTS FOR MONOPLAR COAGULATION (K010192) | Antyllos Medizintechnik GmbH | 2001-04-02 |
| CYNOSURE PHOTOGENICA NEO-V (K004039) | Cynosure, Inc. | 2001-03-29 |
| F1 DIODE LASER SYSTEM (K004021) | Opus Medical, Inc. | 2001-03-27 |
| AMS FASCIAL-ANCHORING SYSTEM (K010277) | American Medical Systems, Inc. | 2001-03-26 |
| DORNIER MEDILAS D SKINPULSE LASER SYSTEM (SKINPULSE) (K003993) | Dornier Surgical Products, Inc. | 2001-03-26 |
| SELECTA 7000 FREQUENCY DOUBLED, Q-SWITCHED ND:YAG OPHTHALMIC LASER (K004006) | Lumenis, Inc. | 2001-03-26 |
| LIGASURE LAPAROSCOPIC SEALER DIVIDER MODEL LS1100 (K010013) | Valleylab, Inc. | 2001-03-26 |
| ENDIUS BIPOLAR SHEATH (K003897) | Endius, Inc. | 2001-03-22 |
| MEDTRADE PRODUCTS SILICON SCAR MANAGEMENT PAD (K003979) | Medtrade Products , Ltd. | 2001-03-19 |
| MICROWAVAE DELIVERY SYSTEM #MW2000 (K010589) | Mw Medical, Inc. | 2001-03-19 |
| INDIGO DIFFUSER-TIP FIBEROPTIC WITH TEMPERATURE SENSING OPTION, MODEL LF001 (K003953) | Ethicon Endo-Surgery, Inc. | 2001-03-16 |
| MD 30 COMPACT (K004014) | General Project | 2001-03-16 |
| MRI SAFE INSTRUMENTS (K003965) | Aesculap, Inc. | 2001-03-16 |
| INDIGO LASEROPTIC TREATMENT SYSTEM (K003952) | Ethicon Endo-Surgery, Inc. | 2001-03-16 |
| LASEREX INTEGRE, MODEL LP2532 (K003955) | Ellex Medical Pty, Ltd. | 2001-03-15 |
| WISEBANDS SKIN CLOSURE DEVICE (K002315) | Wisebands , Ltd. | 2001-03-15 |
| LIGHTSHEER PULSED DIODE ARRAY LASER SYSTEM (K003614) | Coherent Star | 2001-03-13 |
| GRAMSORB SYNTHETIC ABSORBABLE SUTURE (K003017) | Gramsmed, LLC | 2001-03-13 |
| ASPIRE COVERED STENT AND DELIVERY CATHETER (K003173) | Vascular Architects, Inc. | 2001-03-13 |