| CORDIS PALMAZ GENESIS TRANSHEPATIC BILIARY STENT (K012087) | Cordis Corp. | 2001-08-01 |
| PROTEGE SELF-EXPANDING NITINOL STENT WITH STARPORT DELIVERY TECHNOLOGY (K012066) | Sulzer Intratherapeutics, Inc. | 2001-08-01 |
| ORTHO VLC; ORTHO VLC CAPSULE (K011521) | First Scientific Limited | 2001-08-01 |
| MEDTRONIC SOFAMOR DANEK CEMENT RESTRICTOR (K012255) | Medtronic Sofamor Danek, Inc. | 2001-08-01 |
| NON-CHLORINATED, POLYMER COATED POWDER-FREE NITRILE PATIENT EXAMINATION GLOVES (K011792) | Latexx Partners Bhd. | 2001-08-01 |
| AESCULAP, INC. SAFIL QUICK SYNTHETIC ABSORBABLE SURGICAL SUTURE (K011372) | Aesculap, Inc. | 2001-08-01 |
| MODEL TOP END TERMINATOR TITANIUM MANUAL WHEELCHAIR (K012167) | Invacare Corp. | 2001-08-01 |
| MEDICON YASARGIL CLIP APPLYING FORCEPS (K010910) | Medicon EG | 2001-08-01 |
| NITRILE POWDER-FREE MEDICAL EXAMINATION GLOVE (BROWN) (K012166) | Best Manufacturing Company | 2001-08-01 |
| PROTECTIV ACUVANCE IV CATHETER SYSTEM (K012128) | Ethicon Endo-Surgery, Inc. | 2001-08-01 |
| ARTHREX BIO-POST AND WASHER (K011495) | Arthrex, Inc. | 2001-08-01 |
| 8100/8500 VITAL SIGNS MONITOR (K012059) | Criticare Systems, Inc. | 2001-08-01 |
| CORDIS PALMAZ GENESIS TRANSHEPATIC BILIARY STENT ON SLALOM .018 DELIVERY SYSTEM (K012056) | Cordis Europa, N.V. | 2001-08-01 |
| GIVEN DIAGNOSTIC IMAGING SYSTEM (DEN010002) | Given Imaging , Ltd. | 2001-08-01 |
| AUTOMATED WORKCELL CONTROL SOFTWARE (K010500) | Lab-Interlink, Inc. | 2001-08-01 |
| MEDICON TITANIUM YASARGIL ANEURYSM CLIPS (K010908) | Medicon EG | 2001-08-01 |
| OPTETRAK TOTAL KNEE SYSTEM, STRAIGHT STEM EXTENSIONS - ADDITIONAL SIZES (K012251) | Exactech, Inc. | 2001-07-31 |
| ACON AMP ONE STEP AMPHETAMINE TEST STRIP, ACON AMP ONE STEP AMPHETAMINE TEST DEVICE (K011673) | ACON Laboratories, Inc. | 2001-07-31 |
| MONOCHROME PERFECTLY FLAT PANEL DISPLAYS, ME SERIES (K012099) | Totoku Electric Co., Ltd. | 2001-07-31 |
| SUREVUE URINE HCG (K010522) | Sa Scientific, Inc. | 2001-07-31 |
| PASS SPINAL SYSTEM (K012175) | Encore Orthopedics, Inc. | 2001-07-31 |
| ZOLL M SERIES IBP OPERATION; ZOLL M SERIES TEMPERATURE OPTION (K011865) | Zoll Medical Corp | 2001-07-31 |
| UNITIP GASTROINTESTINAL PRESSURE SENSOR CATHETER (K003580) | Unisensor AG | 2001-07-31 |
| HIGH TIBIAL OSTEOTOMY PLATING SYSTEM (K011354) | Dj Orthopedics, LLC | 2001-07-31 |
| CALIBRATOR FOR AUTOMATED SYSTEMS (C.F.A.S.) LIPIDS (K011658) | Rochdiag | 2001-07-31 |
| ACON MAMP ONE STEP METHAMPHETAMINE TEST STRIP, ACON MAMP ONE STEP METHAMPHETAMINE TEST DEVICE (K011672) | ACON Laboratories, Inc. | 2001-07-31 |
| RESORBABLE BONE PINS (K011522) | Biomet, Inc. | 2001-07-31 |
| COPAN VIRAL TRANSYSTEM (K001780) | Copan Diagnostics, Inc. | 2001-07-31 |
| PREVISION CHEM (K010541) | Heraeus Kulzer, Inc. | 2001-07-31 |
| METHADONE MICROPLATE EIA URINE APPLICATION (K011131) | Cozart Bioscience , Ltd. | 2001-07-31 |
| POLYMER COATED LATEX MEDICAL EXAMINATION GLOVES WITH PROTEIN CONTENT LABELING CLAIM (50 MICROGRAMS OR LESS) (K011995) | Quality Latex Products Malaysia Sdn Bhd | 2001-07-31 |
| EFILM WORKSTATION (K012211) | Efilm Medical, Inc. | 2001-07-31 |
| SCALPFIX CLIP SYSTEM (K012219) | Aesculap, Inc. | 2001-07-31 |
| R STENT BILIARY ENDOPROSTHESIS (K010107) | Orbus Medical Technologies | 2001-07-31 |
| QCU ANALYTICAL SOFTWARE PACKAGE (K011582) | Medis Medical Imaging Systems BV | 2001-07-31 |
| SUMMIT DUOFIX HIP PROSTHESIS (K011489) | DePuy Orthopaedics, Inc. | 2001-07-31 |
| BISTITE II DC (K011685) | Tokuyama America, Inc. | 2001-07-31 |
| EXAC TRAC 2.0 (NOVALIS BODY MODULE) (K003285) | Brainlab AG | 2001-07-31 |
| GLUCOSE (HEXOKINASE) (K011900) | Jas Diagnostics, Inc. | 2001-07-31 |
| MININEPH A-1 ANTITRYPSIN ANTISERUM, HIGH AND LOW SERUM CONTROLS (K011663) | The Binding Site, Ltd. | 2001-07-30 |
| RADS (K011054) | Chason Healthcare, LLC | 2001-07-30 |
| ACON OPI ONE STEP OPIATES TEST STRIP, ACON OPI ONE STEP OPIATES TEST DEVICE (K011353) | ACON Laboratories, Inc. | 2001-07-30 |
| BRANAN MEDICAL CORPERATION MONITECT TCA DRUG SCREEN TEST, MODEL MC21 AND MD21 (K010734) | Branan Medical Corp. | 2001-07-30 |
| OSTEOMARK NTX POINT OF CARE PRESCRIPTION HOME USE (K011052) | Ostex Intl., Inc. | 2001-07-30 |
| MININEPH A-1 TRANSFERRIN ANTISERUM, HIGH AND LOW SERUM CONTROL (K011662) | The Binding Site, Ltd. | 2001-07-30 |
| MITYVAC (K011532) | Prism Enterprises, Inc. | 2001-07-30 |
| QUANTA PLEX ENA PROFILE 4 (K011140) | Inova Diagnostics, Inc. | 2001-07-27 |
| KLS-MARTIN TEMPORARY CONDYLAR IMPLANT (K990667) | KLS-Martin L.P. | 2001-07-27 |
| MODIFICATION TO:HU-FRIEDY BRAND SATIN SWIVEL ULTRASONIC INSERT (K012060) | Hu-Friedy Mfg. Co., Inc. | 2001-07-27 |
| SYNTHS ONE-THIRD TUBULAR DCL PLATE (K011335) | Synthes (Usa) | 2001-07-27 |
| DRIED GRAM-NEGATIVE AND GRAM-POSITIVE MIC/COMBO PANELS (K010159) | Dade Microscan, Inc. | 2001-07-27 |
| SYNTHES CURVED RECONSTRUCTION PLATE (K011334) | Synthes (Usa) | 2001-07-27 |
| ALLIGER ULTRASONIC SURGICAL SYSTEM MODEL AUSS-5 (K012028) | Misonix, Inc. | 2001-07-27 |
| WELL-TENS (K002874) | Well-Life Consultant | 2001-07-27 |
| BRAUN PRECISION SENSOR PRO, MODEL BP 2590 (K012035) | Braun GmbH | 2001-07-27 |
| MS104A, NEWMINI II (EMS-II), MODEL AP-101050T AND MEDTRIM (EMS-V), MODEL AP-102050T (K002336) | Apex Medical Corp. | 2001-07-27 |
| HYDRO2, HS-75 (K011914) | Innovision, Inc. | 2001-07-27 |
| RF-IVD WIRELESS DOSIMETER-MODEL 1133 (K011332) | Sun Nuclear Corp. | 2001-07-26 |
| THE LPS - CONTINUUM TM HYBRID TIBIA, MODELS 32-5886-2Y-XX (ZIMMER) AND 05-119-XXYY1-0 (IMPLEX) (K012095) | Implex Corp. | 2001-07-26 |
| VIKING OPTIMA GUIDING CATHETER (K012002) | Guidant Corp. | 2001-07-26 |
| METRONIC SOFAMOR DANEK CEMENT RESTRICTOR (K011998) | Medtronic Sofamor Danek, Inc. | 2001-07-26 |
| GSI AUDERA (K011135) | Nicolet Biomedical | 2001-07-26 |
| MODIFICATION TO THERMAL ANGEL (K012031) | Estill Medical Technologies, Inc. | 2001-07-26 |
| TERATECH MODEL 2000 HANDHELD ULTRASOUND SYSTEM WITH DOPPLER AND HARMONIC IMAGING MODES (K012191) | Teratech Corp. | 2001-07-26 |
| LIPOPRINT SYSTEM, LDL SUBFRACTIONS (K010337) | Quantimetrix Corp. | 2001-07-25 |
| BAUSCH & LOMB SOFLENS ONE DAY DISPOSABLE (HILAFILCON A) VISIBILITY TINTED CONTACT (K011718) | Bausch & Lomb, Inc. | 2001-07-25 |
| MEDIFIX URETEROSCOPE (K011325) | Medifix, Inc. | 2001-07-25 |
| TACKER, MODEL R65-933 (K003949) | A & A Medical, Inc. | 2001-07-25 |
| HOMOGENEOUS ENZYMIC HOMOCYSTEINE REAGENT (K011692) | Intersect Systems, Inc. | 2001-07-25 |
| STREERABLE PTCA GUIDEWIRE (K011968) | Lake Region Mfg., Inc. | 2001-07-25 |
| TREMOROMETER (K010270) | Flexable Systems, Inc. | 2001-07-25 |
| LASERSKIN DRESSING (K001508) | Fidia Advanced Biopolymers Srl | 2001-07-25 |
| XENF-DP RHINO-LARYNGOFIBERSCOPE, ITS ACCESSORIES AND ANCILLARY EQUIPMENT (K011869) | The Olympus Optical Co. | 2001-07-25 |
| DRAINAGE CATHETER OR FOLEY CATHETER (K010006) | Applied Medical Resources Corp. | 2001-07-25 |
| RAPID DRUG SCREEN (K012159) | American Bio Medica Corp. | 2001-07-25 |
| EBI XFIX DFS SYSTEM (K012024) | Ebi, L.P. | 2001-07-25 |
| K-ASSAY C1-INA (K011780) | Kamiya Biomedical Co. | 2001-07-25 |
| HOMOGENEOUS ENZYMIC HOMOCYSTEINE REAGENT (K011689) | Catch, Inc. | 2001-07-25 |
| MODIFICATION TO ALARMVIEW WIRELESS DATA NETWORK SYSTEM (K012005) | Data Critical Corp. | 2001-07-24 |
| MODIFICATION TO: SIPAP INFANT NASAL CPAP CIRCUIT (K012034) | Sensor Medics Corp. | 2001-07-24 |
| MODIFICATION TO: ARGUS SYSTEM-CONTINUOUS EXPERT CARE NETWORK W/SMART ALRAMS (K012171) | Visicu, Inc. | 2001-07-24 |
| INTUITIVE SURGICAL ULTRASONIC SHEARS (K011281) | Intuitive Surgical, Inc. | 2001-07-24 |
| LASER PERIPHERALS REUSABLE HOLMIUM FIBER (K011207) | Laser Peripherals, LLC | 2001-07-24 |
| VACUUM ASSISTED CORE BIOPSY DEVICE (K010400) | Promex, Inc. | 2001-07-24 |
| MODIFICATION TO FLEXVIEW CLINICAL MONITORING SYSTEM (K011999) | Data Critical Corp. | 2001-07-24 |
| BILATERAL FITTING OF THE BRANEMARK BONE-ANCHORED HEARING AID (BAHA) SYSTEM. (K011438) | Entific Medical Systems, Inc. | 2001-07-23 |
| TOOTH SHADE RESIN MATERIAL (K011453) | Rite-Dent Manufacturing Corp. | 2001-07-23 |
| RESTORE-X (K011520) | First Scientific Limited | 2001-07-23 |
| AV 800 VENTILATOR (K010317) | Penlon , Ltd. | 2001-07-23 |
| TRI-FIX SPINAL FIXATION SYSTEM (K011830) | Endius, Inc. | 2001-07-23 |
| ADVANTAGE NASAL MASK, SMALL, ADVANTAGE NASAL MASK. REGULAR, MODELS TMS-2520, TMS 2530 (K012207) | Tiara Medical Systems, Inc. | 2001-07-23 |
| FRESENIUS C.A.T.S; ATI AUTOTRANSFUSION SET; PSQ PLASMA SEQUESTRATION SET; PSQ-DD PLASMA SEQUESTRATION DIRECT DRAW (K012178) | Fresenius Hemotechnology, Inc. | 2001-07-23 |
| PRIMA OXYGEN MONITOR (K010318) | Penlon , Ltd. | 2001-07-23 |
| ISODAN (K010415) | Specialites Septodont | 2001-07-23 |
| HYSTEROSCOPES (K003802) | Global Endoscopy, Inc. | 2001-07-22 |
| GYNECOLOGICAL LAPAROSCOPES (K003805) | Global Endoscopy, Inc. | 2001-07-22 |
| FLAVORED MALE LATEX CONDOM (K011253) | Thai Nippon Rubber Industry Co., Ltd. | 2001-07-20 |
| CARDIONAVIGATOR INFORMATION MANAGEMENT SYSTEM (K011345) | Reynolds Medical , Ltd. | 2001-07-20 |
| INFINITY SC 8000 WITH ADVANCED COMMUNICATION OPTION II (K012016) | Siemens Medical Solutions USA, Inc. | 2001-07-20 |
| NORTHEAST PROTON THERAPY CENTER (K983332) | Massachusetts General Hospital | 2001-07-20 |