| MACROPORE OS SPINAL SYSTEM (K010911) | Macropore Biosurgery, Inc. | 2001-07-20 |
| ROSSMAX MEDIPRO MODEL 100, MODEL 200, AND MODEL 300 BLOOD PRESSURE MONITORS (K011539) | Rossmax International , Ltd. | 2001-07-20 |
| SYSMEX AUTOMATED COAGULATION ANALYZER / MODEL # CA-1500 (K011235) | Dade Behring, Inc. | 2001-07-20 |
| LIVESURE PHENECYCLINE (PCP) SCREEN TESTS (K012107) | Pan Probe Biotech, Inc. | 2001-07-20 |
| NORMED EXTREMITY TITANIUM HAND AND SMALL FRAGMENT SYSTEM (K011118) | Osteomedics | 2001-07-20 |
| NIEN MADE NON-INVASIVE BLOOD PRESSURE MONITOR, MODELS HP-BPM0001; HP-BPM0002; HP-BPM0003; HP-BPM0003-1 (K011310) | Nien Made Electrnics Corp. | 2001-07-20 |
| BIOCHECK HIGH SENSITIVITY C-REACTIVE PROTEIN ENZYME IMMUNOASSAY TEST KIT, MODEL BC-1119 (K003851) | Biocheck, Inc. | 2001-07-20 |
| STRYKER TITANIUM CROSS-SCREW SYSTEM, MODEL 234-500-1XX (K011319) | Stryker Endoscopy | 2001-07-20 |
| ROSSMAX SMARTINFLATE CARDIOPRO, MODEL 1000I AND MODEL 3000I BLOOD PRESSURE MONITORS (K011352) | Rossmax International , Ltd. | 2001-07-20 |
| ARTHROSCOPES (K003831) | Global Endoscopy, Inc. | 2001-07-20 |
| MODIFICATION TO XIA SPINE SYSTEM (K012027) | Howmedica Osteonics | 2001-07-20 |
| BLOOD PRESSURE MONITOR (SPHYGMOMANOMETER), MODEL HT-110 (K012194) | Nihon Seimitsu Sokki Co., Ltd. | 2001-07-20 |
| MODIFICATION TO DEVICE LINK SYSTEM, MODEL M2376A (K012094) | Agilent Technologies, Inc. | 2001-07-20 |
| LIVESURE BARBITURATES SCREEN TEST (K012133) | Pan Probe Biotech, Inc. | 2001-07-20 |
| ALKALINE PHOSPHATASE LIQUID REAGENT (K011599) | Jas Diagnostics, Inc. | 2001-07-20 |
| LIVESURE BENZODIAZEPINES SCREEN TESTS (K012131) | Pan Probe Biotech, Inc. | 2001-07-20 |
| COLOR BUFFED (CB) DDH FEMORAL STEM (K012019) | Biomet, Inc. | 2001-07-20 |
| FADASIS MEDICAL FM-1 NO BLENDER (K011874) | Fadasis Medical, Inc. | 2001-07-20 |
| PRO OSTEON 200R WITH CALCIUM SULFATE, MODELS 2RCS038, 2RCS050, 2RCS075, 2RCS10, 2RCS15, 2RCS20, 2RCS225, 2RCS30 (K004003) | Interpore Cross Intl. | 2001-07-19 |
| SUPERIOR BATH, MODEL 6300 (K012061) | Penner Manufacturing, Inc. | 2001-07-19 |
| OHMEDA MEDICAL SPOT PT LITE PHOTOTHERAPY SYSTEM (K011549) | Ohmeda Medical | 2001-07-19 |
| CASCADE BATH, MODEL 6900 (K012057) | Penner Manufacturing, Inc. | 2001-07-19 |
| NEXGEN PRIMARY POROUS PATELLA, MODEL 04-211-IIII-5878-65-ZZ-(STANDARD),04-212-IIII-5878-61-ZZ-(MICRO) (K011904) | Implex Corp. | 2001-07-19 |
| MTP LAPAROMAT DISPOSABLE TUBING SET (K011360) | Mtp Medical Technical Promotion GmbH | 2001-07-19 |
| SYNTHES CERVIFIX SYSTEM (K011969) | Synthes (Usa) | 2001-07-19 |
| CAVEX STABISIL (K011452) | Cavex Holland BV | 2001-07-19 |
| ENDOPOUCH RETRIEVER (K011501) | Ethicon Endo-Surgery, Inc. | 2001-07-19 |
| ENTEC EVAC PLASMA WAND (K011279) | Arthrocare Corp. | 2001-07-19 |
| SPLITTABLE SHEATH INTRODUCER KIT (K004025) | Thomas Medical Products, Inc. | 2001-07-19 |
| INFINION ENHANCEMENT PACKAGE (K011296) | Philips Medical Systems (Cleveland), Inc. | 2001-07-19 |
| PVC FREE INTRAVASCULAR ADMINISTRATION SET (K011216) | Biometrix , Ltd. | 2001-07-18 |
| UROLOGICAL CATHETER (K011552) | Apogee Medical, Inc. | 2001-07-18 |
| IVENT 201 PORTABLE VENTILATOR (K011957) | Versamed , Ltd. | 2001-07-18 |
| BIOMET ONCOLOGY SALVAGE SYSTEM (OSS) TAPER STACKING ADAPTER (K011455) | Biomet, Inc. | 2001-07-18 |
| VIVO 200 DPS VIVOSCAN (K003364) | Vivosonic, Inc. | 2001-07-18 |
| PARALLAX BONE AND VERTEBRAL BODY BIOPSY AND INFUSION NEEDLES (K011206) | Parallax Medical, Inc. | 2001-07-18 |
| ADMIRA FLOW (K011756) | Voco GmbH | 2001-07-18 |
| SURGICAL DYNAMICS MESH CAGE SYSTEM (K003709) | United States Surgical, A Division of Tyco Healthc | 2001-07-18 |
| SUMMIT OCCIPITO-CERVICO-THORACIC (OCT) SPINAL SYSTEM (K010681) | Depuyacromed | 2001-07-18 |
| TRIDENT ALL POLY CUP (K012026) | Howmedica Osteonics Corp. | 2001-07-18 |
| DYNALINK .035 BILIARY SELF-EXPANDING STENT SYSTEM (K011881) | Guidant Corp. | 2001-07-18 |
| BLKS-303 MK MONOPLACE HYPERBARIC SYSTEM (K011312) | Khrunichev State Research & Production Space Centr | 2001-07-18 |
| 1.5MM BONE FIXATION KIT (K012000) | Bionx Implants, Ltd. | 2001-07-18 |
| OIL FOR EMBRYO CULTURE (K011938) | Irvine Scientific Sales Co., Inc. | 2001-07-18 |
| SMARTSCREW (K012001) | Bionx Implants, Ltd. | 2001-07-18 |
| UREA NITROGEN (BUN) LIQUID REAGENT (K011596) | Jas Diagnostic, Inc. | 2001-07-17 |
| 0.9% SODIUM CHLORIDE INJECTION, USP BD PRE-FILLED FLUSH SYRINGE (K011982) | Bd | 2001-07-17 |
| CYCLOSPORINE CALIBRATOR (K011112) | Dade Behring, Inc. | 2001-07-17 |
| TORIC LITE LENS (K011256) | Soflex Contact Lens Industries , Ltd. | 2001-07-17 |
| LATEX EXAMINATION GLOVES- POWDER FREE, BLUE (K011712) | Pt.Shamrock Manufacturing Corp. | 2001-07-17 |
| POWDERED SYNTHETIC (YELLOW) VINYL PATIENT EXAMINATION GLOVES (K011883) | Shijiazhuang Eversharp Plastic Products Co., Ltd. | 2001-07-17 |
| MESH URETERAL STENT (K011264) | Applied Medical Resources Corp. | 2001-07-17 |
| VISUALINE AMPHETAMINE DIPSTRIP ASSAY (K011499) | Sun Biomedical Laboratories, Inc. | 2001-07-17 |
| POWDERED SYNTHETIC VINYL PATIENT EXAMINATION GLOVES (K011884) | Shijiazhuang Eversharp Plastic Products Co., Ltd. | 2001-07-17 |
| AMERITEK BRACHYTHERAPY TEMPLATE (K011581) | Amertek Medical, Inc. | 2001-07-17 |
| WUNDCATH CONDUCTION CATHETER (K003966) | Micor, Inc. | 2001-07-17 |
| ABBOTT TUMORMARKER-MCC (LYOPHILIZED), LEVELS 1 AND 2, 2ML NO. 6E21-10 (K011853) | Bio-Rad | 2001-07-17 |
| DELTA PLUS MULTIACTION SOLUTION FOR RIGID GAS PERMEABLE CONTACT LENSES (K011456) | Sauflon Pharmaceuticals, Ltd. | 2001-07-17 |
| SYNTHETIC POWDER FREE VINYL PATIENT EXAMINATION GLOVES (K011885) | Shijiazhuang Eversharp Plastic Products Co., Ltd. | 2001-07-16 |
| CAVEX COLORCHANGE (K011419) | Cavex Holland BV | 2001-07-16 |
| AXXESS SPINAL CORD STIMULATION LEAD, MODEL 8000 SERIES, INCLUDING 80XX, 81XX, AND 82XX (K010008) | Micronet Medical, Inc. | 2001-07-16 |
| SAFE AT HOME TSH (THYROID STIMULATING HORMONE BLOOD COLLECTION AND TRANSPORT SYSTEM) (K011525) | Biosafe Laboratories, Inc. | 2001-07-16 |
| MODIFICATION TO:ACCUSONIC PLUS, MODEL AP-100 (K011955) | Metron Medical Australia, Pty, Ltd. | 2001-07-16 |
| CONCORD 82 (K011628) | Gateway Alloys, Inc. | 2001-07-16 |
| LORENZ STERNAL CLOSURE SYSTEM WITH MODULAR SCREW (K011076) | Walter Lorenz Surgical, Inc. | 2001-07-16 |
| VIADUCT MICROENDOSCOPE AND ACCESSORIES (K011189) | Acueity, Inc. | 2001-07-16 |
| OPTETRAK TOTAL KNEE SYSTEM SIZE 0/1 DELTA (LINE EXTENSION) (K011976) | Exactech, Inc. | 2001-07-16 |
| BIOPSY SITE MARKER (K011402) | Senorx, Inc. | 2001-07-16 |
| CONCORD 72 (K011626) | Gateway Alloys, Inc. | 2001-07-16 |
| MEDLINE GROUNDING PAD (K011515) | Medline Industries, Inc. | 2001-07-13 |
| ZYNERGY Z5000 ELECTROPHYSIOLOGY CATHETER WITH Z9000 ACCESSORY CABLE (K011847) | Zynergy Cardio Vasular (Zcv), Inc. | 2001-07-13 |
| QUANTUM BLAST (K011993) | Pride Mobility Products Corp. | 2001-07-13 |
| MODEL 100 ACTIVITY MONITOR (K011429) | Telecom Medical, Inc. | 2001-07-13 |
| MALLEABLE SHAFT CLAMP (K011078) | Allegiance Healthcare Corp. | 2001-07-13 |
| IMAGER II UROLOGY TORQUE CATHETER, MODEL 40030X1, 40040X1, AND 40050X1 (K011965) | Boston Scientific Corp | 2001-07-13 |
| METAL TRANSCEND ARTICULATION SYSTEM (K004043) | Wrightmedicaltechnologyinc | 2001-07-13 |
| POLY-TAPES WITH THE FASTLOK FIXATION DEVICE (K010051) | Xiros Plc | 2001-07-13 |
| LIFECARD CF 7 DAY (K011837) | Reynolds Medical , Ltd. | 2001-07-13 |
| HOFFMAN II HYBRID RING CLAMP (K011948) | Howmedica Osteonics Corp. | 2001-07-13 |
| AEQUALIS PRESS-FIT SHOULDER PROSTHESIS (K011942) | Tornier | 2001-07-13 |
| AVIDCARE SERIES 100 TELEMANAGEMENT SYSTEM (K011779) | Avid Care Corp. | 2001-07-13 |
| ENDOPATH NON-BLADED OBTURATOR TROCAR SYSTEM (5 MM) (K011257) | Ethicon Endo-Surgery, Inc. | 2001-07-13 |
| RAMBLER (K011401) | Rambler Mobility, Inc. | 2001-07-13 |
| SUPREMA POWERED WHEELCHAIR (K010600) | Luigi Chinetti | 2001-07-13 |
| MEDICAL DEPOT POWER NEB 1 (K012006) | Medical Depot, Inc. | 2001-07-13 |
| IN-FAST BONE SCREW SYSTEM (K011910) | American Medical Systems, Inc. | 2001-07-13 |
| LIFESOURCE MODELS UA-787, UA 787PC, UA-787T (K012013) | A&D Engineering, Inc. | 2001-07-13 |
| TRUBYTE DENTURE BASE RESIN SYSTEM (K011560) | Dentsply Intl. | 2001-07-12 |
| PURESPERM BUFFER (K011606) | Nidacon International AB | 2001-07-12 |
| HA-TI (HAND TITANIUM SCREW) IMPLANT (K003045) | Hati Dental Ag. | 2001-07-12 |
| INTERSTRAND 125 & INTERSTRAND 103, MODEL NUMBERS 1251S AND 1031S (K011155) | Ibt, Inc. | 2001-07-12 |
| DENVER ASCITES SHUNT AND PERCUTANEOUS ACCESS KIT WITH ASCITIES SHUNT (K011862) | Denver Biomedical, Inc. | 2001-07-12 |
| TEMPORALSCANNER THERMOMETER, SENSORTOUCH (K011291) | Exergen Corp. | 2001-07-12 |
| PRIMARY CARE SOLUTIONS STERILE SALINE-0.9% SODIUM CHLORIDE FOR DEVICE IRRIGATION (K000266) | Primary Care Solutions, Inc. | 2001-07-12 |
| PRIMARY CARE SOLUTIONS STERILE WATER DEVICE IRRIGATION (K000265) | Primary Care Solutions, Inc. | 2001-07-12 |
| PROTON THERAPY SYSTEM (K983024) | Ion Beam Applications S.A. | 2001-07-12 |
| STIMULAN - CALCIUM SULFATE BONE VOID FILLER KIT (K003954) | Biocomposites, Ltd. | 2001-07-12 |
| HYPODERMIC NEEDLE-PRO NEEDLE WITH NEEDLE PROTECTION DEVICE; HYPODERMIC NEEDLE-PRO SYRINGE & NEEDLE WITH NEEDLE PROTECTIO (K011925) | Sims Portex, Inc. | 2001-07-12 |
| VOXAR VC, MODEL 1.0 (K012072) | Voxar Limited | 2001-07-12 |
| VARISEED 7.0 (K012017) | Varian Medical Systems | 2001-07-12 |