| MICRO-6-SERIES (MR-6, MR-6L) URETEROSCOPES, MRO-6 SERIES (MR-633, MR-642) URETEROSCOPES, MRO-7 SERIES (MRO-733) URETEROS (K011849) | Circon Video | 2001-12-10 |
| REUNITE FUSION SCREW (K011451) | Biomet, Inc. | 2001-12-10 |
| DISPOSABLE POWDER FREE VINYL SYNTHETIC EXAM GLOVES, WHITE COLOR (K013753) | Canopus Medical Supply Co., Ltd. | 2001-12-10 |
| Z-NET (K001003) | Demite Limited | 2001-12-10 |
| SYNERGY FLOW (K013400) | Coltene/Whaledent, Inc. | 2001-12-10 |
| VIATRONIC V3D CALCIUM SCORING (K013146) | Viatronix, Inc. | 2001-12-07 |
| THE BIOPLATE BIOCLIP CRANIOTOMY FIXATION SYSTEM (K013055) | Bioplate, Inc. | 2001-12-07 |
| MASTER & FRANK SURGICAL GOWNS (STERILE) (K012186) | Master & Frank Ent. Co., Ltd. | 2001-12-07 |
| CYBERMED, INC., V-WORKS (K013878) | Cybermed, Inc. | 2001-12-07 |
| LIGHT SABER INTRODUCER NEEDLE (K013040) | Minrad, Inc. | 2001-12-07 |
| KODAK DIRECTVIEW TABLETOP CASSETTE (K013686) | Eastman Kodak Company | 2001-12-07 |
| BI-3M NEEDLE-FREE INJECTOR SYSTEM (K013256) | Felton International, Inc. | 2001-12-07 |
| STERILE POWDER FREE LATEX SURGICAL GLOVES WITH PROTEIN CLAIM LESS THAN 50 UG/G (K013727) | Smart Glove Corp. Sdn Bhd | 2001-12-07 |
| MAS LIPID CONTROL, LIQUID ASSAYED LIPID CONTROL, LEVEL 1 AND 2, DADE LIPID CONTROL, LIQUID ASSAYED LIPID CONTROL, LEVEL (K013734) | Medical Analysis Systems, Inc. | 2001-12-07 |
| KIMAX REMOTE VIEWING STATION (K013098) | Medical Metrics, Inc. | 2001-12-07 |
| EXCEL A.V FISUTAL NEEDLE SET (K013037) | Exelint Intl. Co. | 2001-12-07 |
| GUARDIAN LIMB SALVAGE SYSTEM (K013035) | Wrightmedicaltechnologyinc | 2001-12-07 |
| MOST OPTIONS SYSTEM (K013031) | Sulzer Orthopedics, Inc. | 2001-12-07 |
| METAPAK MULTI-PURPOSE INSTRUMENT TRAY (K993535) | Riley Medical, Inc. | 2001-12-07 |
| LATEX EXAMINATION GLOVES POWDERFREE POLYMER COATED WITH PROTEIN CONCENT LABEL CLAIM (K013333) | Innovative Gloves Co;, Ltd. | 2001-12-07 |
| ROYAL IMPERIAL POWDERED LATEX EXAMINATION GLOVES WITH PROTEIN CONTENT LABELING CLAIM (200 MICROGRAMS OR LESS) (K013537) | Koon Seng Sdn Bhd | 2001-12-07 |
| COMFORTCARE COMPRESSION SUPPORT WITIH MAGNETS AND AEGIS MICROBE SHIELD COMFORTCARE MAGNETIC INSOLES AND AEGIS MICROBE (K013244) | Med Gen, Inc. | 2001-12-07 |
| NOMOS MOTORIZED CRANE II (K013036) | Nomos Corp. | 2001-12-07 |
| DAYLITE XENON LIGHT SOURCES (K013880) | Designs For Vision, Inc. | 2001-12-07 |
| FOTONA DUALIS ND:YAG LASER SYSTEM, FOTONA TWINLIGHT ND:YAG LASER SYSTEM (K013047) | Mojca Valijavec | 2001-12-06 |
| MODIFICATION TO LEKSELL SURGIPLAN WITH ATLASPACE (K013861) | Elekta Instrument AB | 2001-12-06 |
| PLASMA SPRAYED SHOULDER (K003324) | Encore Orthopedics, Inc. | 2001-12-06 |
| REPROCESSED SOFT TISSUE ABLATORS (K012631) | Alliance Medical Corp. | 2001-12-06 |
| MISTER NEB NEBULIZER COMPRESSOR, WITH NEBULIZER, MODEL HS123 (K013027) | Respironics Healthscan, Inc. | 2001-12-06 |
| AT HOME DRUG TEST, MODEL 9084 (K013407) | Phamatech, Inc. | 2001-12-06 |
| ORTHOPHOS DS/DC CEPH, ORTHOPHOS 5/PLUS/CD (K013650) | Sirona Dental Systems GmbH | 2001-12-06 |
| MEDIGROUP KEY TUBE (K013017) | Janin Group, Inc. | 2001-12-06 |
| AT HOME DRUG TEST, MODEL 9074 (K013409) | Phamatech, Inc. | 2001-12-06 |
| EXCELSIOR SL-10 MICROCATHETER, MODELS 168581, 168381, 168181, 168189 (K013789) | Boston Scientific, Target | 2001-12-06 |
| PALOMAR SLP 1000 (K013028) | Palomar Medical Products, Inc. | 2001-12-06 |
| COSMETICA (POLYMACON) SOFT (HYDROPHILIC) CONTACT LENSES (K011893) | Contact Color Srl | 2001-12-06 |
| BAYER ADVIA IMS SYSTEM; C-REACTIVE PROTEIN SYSTEM (K012337) | Bayer Corp. | 2001-12-06 |
| MODIFICATION TO SIDEXIS DIGITAL RADIOGRAPHY IMAGING SYSTEM (K013659) | Sirona Dental Systems GmbH | 2001-12-06 |
| AT HOME DRUG TEST, MODEL 9064 (K013410) | Phamatech, Inc. | 2001-12-06 |
| AT HOME DRUG TEST, MODEL 9079 (K013408) | Phamatech, Inc. | 2001-12-06 |
| AT HOME DRUG TEST, MODEL 9069 (K013412) | Phamatech, Inc. | 2001-12-06 |
| MEDLINE EXCEL RECLINCER WHEELCHAIR (K013761) | Medline Industries, Inc. | 2001-12-06 |
| MODIFICATION TO: ABBOTT VASCULAR SUTURE ANASTOMOSIS DEVICE (K013683) | Abbott Vascular, Inc. | 2001-12-06 |
| CEMENT RESTRICTOR (K013663) | Medtronic Sofamor Danek, Inc. | 2001-12-05 |
| TCI-31 LIFELONG OVULATION TESTER (K013323) | Tci New York | 2001-12-05 |
| AUTOGENESIS AUTOMATOR, MODEL M1000 (K013818) | Autogenesis, Inc. | 2001-12-05 |
| MODIFICATION TO BLOOD GLUCOSE MONITORING SYSTEM (K012014) | Abbott Diabetes Care, Inc. | 2001-12-05 |
| MODIFICATION TO XIA SPINAL SYSTEM (K013688) | Howmedica Osteonics Corp. | 2001-12-05 |
| MEDTRONIC INVISX BURR HOLE LOCK, MODEL 60520 (K013000) | Medtronic Neurosurgery | 2001-12-05 |
| FOCAL SIM (K013112) | Computerized Medical Systems, Inc. | 2001-12-05 |
| TRIDENT HEMISPHERICAL ACETABULAR SHELLS (K013676) | Howmedica Osteonics Corp. | 2001-12-05 |
| ACCU-CHEK ACTIVE TEST SYSTEM (K012324) | Roche Diagnostics Corp. | 2001-12-05 |
| ISITE RADIOLOGY (K013630) | Stentor, Inc. | 2001-12-05 |
| MODIFICATION TO: ACUMATCH L-SERIES BIPOLAR ENDOPROSTHESIS (K013211) | Exactech, Inc. | 2001-12-05 |
| MODIFICATION TO REFLECTION CROSS-LINKED UHMWPE ACETABULAR COMPONENTS (K013658) | Smith & Nephew, Inc. | 2001-12-05 |
| GENETRA (K013660) | Radiomed Corporation | 2001-12-05 |
| HOMECHOICE PERSONAL CYCLER PERITONEAL DIALYSIS SYSTEM, MODELS 5C8310, 5C8302, 5C4471, 5C4469 (K012988) | Baxter Healthcare Corp | 2001-12-05 |
| RANDOX PHENYTOIN (K011393) | Randox Laboratories, Ltd. | 2001-12-04 |
| CRP-LATEX (II) SEIKEN HIGH SENSITIVITY ASSAY KIT (K011958) | Denka Seiken'S | 2001-12-04 |
| MILLCOMP (K011845) | Math Resolutions, LLC | 2001-12-04 |
| CTXA HIP; CTXA; QCT PRO CTXA HIP (K002113) | Mindways Software, Inc. | 2001-12-04 |
| MODIFICATION TO VIKING OPTIMA GUIDING CATHETER (K013638) | Guidant Corp. | 2001-12-04 |
| MEDTRONIC DLP ARTERIAL CANNULA WITH 3D TIP - 22 FR. (K013013) | Medtronic Cardiac Surgical Products | 2001-12-04 |
| SELECTIVA GUIDEWIRE (K013024) | Neometrics, Inc. | 2001-12-04 |
| APPLIED ACCESS SEAL (K012968) | Applied Medical Resources Corp. | 2001-12-03 |
| NON-STERILE POWDER FREE GREEN LATEX EXAMINATION GLOVES WITH ALOE VERA AND VITAMIN E (K013288) | Sgmp Co., Ltd. | 2001-12-03 |
| MICROMARK II TISSUE MARKER,MODEL C1535 (K013413) | Ethicon Endo-Surgery, Inc. | 2001-12-03 |
| MODIFICATION TO: STRYKER NAVIGATION SYSTEM, STRYKER FLUOROSCOPY SYSTEM,VIRTUAL FLUOROSCOPY (K012380) | Stryker Leibinger | 2001-12-03 |
| MODIFICATION TO: BIOMET HUMERAL CABLE PLATES (K013657) | Biomet Orthopedics, Inc. | 2001-12-03 |
| MODIFICATION TO HOFFMANN II MICRO EXTERNAL FIXATION SYSTEM (K013772) | Howmedica Osteonics | 2001-12-03 |
| PAIN CARE 3200 (K013928) | Breg, Inc. | 2001-12-03 |
| RESORBABLE NO PROFILE SCREW AND WASHER (K012469) | Biomet Manufacturing, Inc. | 2001-12-03 |
| MACROPORE SURGIWRAP (TS) (K012025) | Macropore Biosurgery, Inc. | 2001-12-03 |
| MENTOR CONTOUR PROFILE TISSUE EXPANDER (K011500) | Mentor Corp. | 2001-12-03 |
| LIFEPAK 600 AUTOMATED EXTERNAL DEFIBRILLATOR (K011144) | Medtronic Physio-Control Corp. | 2001-12-03 |
| XPLAN 2.2 WITH THE BODY SYSTEM (K013661) | Radionics, A Division of Tyco Healthcare Group LP | 2001-12-03 |
| SYNTHES 3.9 MM PELVIC SCREWS (K013044) | Synthes (Usa) | 2001-12-03 |
| MODIFICATION TO AGILENT COMPONENT MONITORING SYSTEM (CMS), V24/V26 PATIENT MONITORS, BLOOD ANALYSIS PORTAL SYSTEM PLUG-I (K013624) | Philips Medizin Systeme Boblingen GmbH | 2001-12-03 |
| COMPANION MODEL 221, 321, 421 (K012258) | Golden Technologies, Inc. | 2001-12-03 |
| ENT LASERVISION (K012071) | Union Medical USA | 2001-12-03 |
| SYNTHES 2.4 MM CANNULATED SCREW (K012945) | Synthes (Usa) | 2001-12-03 |
| TRIMAX (K012268) | Standard Textile Co., Inc. | 2001-12-03 |
| AVID-NIT PLASTIC HUB LUTZ EPIDURAL NEEDLE,MODEL RP2035L, AVID-NIT METAL HUB LUTZ EPIDURAL NEEDLE, MODEL RM2035L (K013231) | Avid N.I.T., Inc. | 2001-12-03 |
| SIMPLICITY CLASSIC WING QD INFUSION SET (K013502) | Sterling Medivations, Inc. | 2001-12-03 |
| IMAGYN ISOSLEEVE / ISOSTAR NEEDLE SYSTEM (K010166) | Imagyn Medical Technologies, Inc. | 2001-12-03 |
| SOFT TISSUE SCREW AND WASHER (K012572) | Biomet, Inc. | 2001-12-03 |
| REMINGTON PARAFFIN SPA, MODELS HS-200. PFS-600 (K013328) | Remington Products Company, LLC | 2001-12-03 |
| NIPRO SAFELET CATH (K013287) | Nipro Medical Corp. | 2001-12-03 |
| TETRAD MODEL TC-EC7-ACP, -L5-, -L7-, -V4-ACP TRANSDUCERS (K013849) | Tetrad Corp. | 2001-12-03 |
| GIOTTO IMAGE (K012953) | Medx, Inc. | 2001-11-30 |
| EMTRAC; DELPHIN; SEMTRAC 2000 SET (K013536) | Gynetics Medical Products NV | 2001-11-30 |
| AMEDITECH IMMUTEST DRUG SCREEN AMPHETAMINE (K012484) | Ameditech, Inc. | 2001-11-30 |
| OSMETECH MICROBIAL ANALYSER-URINARY TRACT INFECTION DETECTOR (OMA-UTI) (K011043) | Osmetech | 2001-11-30 |
| AMEDITECH IMMUTEST DRUG SCREEN OPIATES (K012483) | Ameditech, Inc. | 2001-11-30 |
| SERIM BLOOD LEAK TEST STRIP-2 (K012115) | Serim Research Corp. | 2001-11-30 |
| AMEDITECH IMMUTEST DRUG SCREEN PCP (K012582) | Ameditech, Inc. | 2001-11-30 |
| BINAX NOW STREPTOCOCCUS PNEUMONIAE TEST (K012521) | Binax, Inc. | 2001-11-30 |
| LYMPHA PRESS PLUS DEVICE (K013331) | Mego Afek | 2001-11-30 |
| ONE TOUCH FASTTAKE COMPACT BLOOD GLUCOSE MONITORING SYSTEM, ONE TOUCH ULTRA BLOOD GLUCOSE MONITORING SYSTEM (K011479) | Inverness Medical Innovations, Inc. | 2001-11-30 |
| INFLUENZA A/B RAPID TEST, CAT NO 2158 663 (K011684) | Roche Diagnostics Corp. | 2001-11-30 |