| PREMIER III PHASED ARRAY CTL SPINE COIL (K013595) | Usa Instruments, Inc. | 2002-01-22 |
| V-GNATHOS SUPRA (K013769) | Metalor Technologies USA | 2002-01-22 |
| AIMSTEP PREGNANCY (K013857) | Germaine Laboratories, Inc. | 2002-01-22 |
| EMS TELEMEDICINE OPTION (FOR GEMS SERIES 4000) (K013533) | General Devices | 2002-01-18 |
| USA SERIES LAPAROSCOPES (K013165) | Circon Acmi | 2002-01-18 |
| DADE THROMBOPLASTIN C PLUS (K013155) | Dade Behring, Inc. | 2002-01-18 |
| BILIARY AND PANCREATIC ENDOPROSTHESES (STENTS) (K010549) | Medi-Globe Corp. | 2002-01-18 |
| BIO SPA INTELLIGENT (K992099) | Starbene | 2002-01-18 |
| ARTHROCARE CONTROLLER, PATIENT CABLE, FOOT CONTROL, POWER CORD (K014222) | Arthrocare Corp. | 2002-01-18 |
| CREATINE KINASE (CK-NAC) (K013912) | Jas Diagnostics, Inc. | 2002-01-18 |
| VASCULAR SOLUTIONS DUETT FLOWABLE HEMOSTAT (K012293) | Vascular Solutions, Inc. | 2002-01-18 |
| 3M COMPLY 1248 GAS PLASMA CHEMICAL INDICATOR (K013228) | Minnesota Mining and Mfg. Co. | 2002-01-18 |
| TANSMIT/RECEIVE QUADRATURE BODY COIL 3.0T (K013894) | Philips Medical Systems North America, Inc. | 2002-01-18 |
| MODIFICATION TO: WINNER ST-2 STIMULATOR (K013770) | Rich-Mar Corp. | 2002-01-18 |
| HEMO-LYTE HEMODIALYSIS GRADE SODIUM BICARBONATE POWDER (K012328) | Di-Chem, Inc. | 2002-01-18 |
| N LATEX LP(A) (K013128) | Dade Behring, Inc. | 2002-01-18 |
| EVTOOL MODEL # V. 1.0 (K013535) | 3D Line USA, Inc. | 2002-01-18 |
| AUTION MAX AX-4280 URINALYSIS SYSTEM (K013783) | International Remote Imaging Systems | 2002-01-18 |
| PLLA CANNULATED INTERFERENCE SCREW (K013685) | Future Medical Systems, Inc. | 2002-01-18 |
| PHILLIPS M1175A/76A/77A COMPONENT MONITORING SYSTEM; PHILLIPS V24/V26 PATIENT MONITOR (K014159) | Philips Medical Systems, Inc. | 2002-01-18 |
| REPROCESSED ELECTROSURGICAL ELECTRODE (K012684) | Sterilmed, Inc. | 2002-01-18 |
| PADPRO MODEL 2001, 2001-S, 2001-C, 2001-EPS (K014209) | Padpro, LLC | 2002-01-18 |
| WATERLASE MILLENNIUM (K012511) | Biolase Technology, Inc. | 2002-01-18 |
| HEMO-LYTE HEMODIALYSIS GRADE SODIUM BICARBONATE SOLUTION (K012547) | Di-Chem, Inc. | 2002-01-18 |
| MODIFICATION TO DYNALINK .035 BILIARY SELF-EXPANDING STENT SYSTEM (K014184) | Guidant Corp. | 2002-01-18 |
| POINT 4 MODIFIED (K013510) | Sybron Dental Specialties, Inc. | 2002-01-18 |
| ADVIA 1650 CHOLINESTERASE ASSAY (K013750) | Bayer Diagnostics Corp. | 2002-01-18 |
| EMBRYO FREEZE MEDIUM, EMBRYO THAW MEDIUM (K013518) | Irvine Scientific Sales Co., Inc. | 2002-01-18 |
| BIOTECH POWERED WHEELCHAIR, C650PW (K011846) | Roc Chinese-European Industrial Research Society | 2002-01-18 |
| THE QUANTECH FASTRAQ AUTOMATED ANALYZER, AND THE QUANTECH PREPAQ TOTAL HCG TEST CARTRIDGE (K012943) | Quantech , Ltd. | 2002-01-18 |
| 3.75MM AND 5.0MM SPLINE TWIST IMPLANT (K013494) | Sulzer Dental, Inc. | 2002-01-18 |
| MODIFICATION TO: WINNER CM-2 MUSCLE STIMULATOR, TENS, THERAPEUTIC ULTRASOUND AND COMBINATION DEVICE (K013771) | Rich-Mar Corp. | 2002-01-18 |
| DURQ/ QUALIDURA (K013116) | Ever-Safety Technical Service | 2002-01-18 |
| HEARTSTREAMFR2 AED WITH M3848A AND M3849A, MODELS M3860A, M3861, M3840A, M3841A (K014157) | Philips Medical Systems | 2002-01-17 |
| NLITE SYSTEM,MODEL A00-1025 (K013461) | Icn Photonics , Ltd. | 2002-01-17 |
| EXEL HUBER INFUSION SET WITH NEEDLELESS INJECTION SITE (K012879) | Exelint Intl. Co. | 2002-01-17 |
| GLOBAL HEALTHCARE VAGINAL SPECULUM (K013835) | Dynascend Consulting Int'L, LLC | 2002-01-17 |
| HEALTHLIFE OXYGEN CONCENTRATOR MODEL AS009 (K012037) | Airsep Corp. | 2002-01-17 |
| SIMPLICITY STARPLUS SOFT INFUSION SET (K014061) | Sterling Medivations, Inc. | 2002-01-17 |
| CHLORINATED POWDER FREE LATEX MEDICAL EXAMINATION GLOVES WITH PROTEIN LABELING CLAIM (50 MICROGRAMS OR LESS) (K013498) | Maxter Glove Manufacturing Sdn Bhd | 2002-01-17 |
| INSPECTRA TISSUE SPECTROMETER SYSTEM (INSPECTRA), MODEL 325 (K012759) | Hutchinson Technology, Inc. | 2002-01-17 |
| MAGICFIL (K013571) | Dmg USA, Inc. | 2002-01-17 |
| SMITH & NEPHEW OPERATIVE HYSTEROSCOPE, MODEL 7209208; SMITH & NEPHEW CONTINUOUS FLOW SHEATH, MODEL 8105224 (K013870) | Smith & Nephew, Inc. | 2002-01-17 |
| ERCHONIA PL2000 (K012580) | Tuco Innovations, Inc. | 2002-01-17 |
| SELF-DRILLING RADIOGRAPHIC MARKER (K014148) | Walter Lorenz Surgical, Inc. | 2002-01-17 |
| MEDLITE IV Q-SWITCHEDND: YAGLASER REPLACED BY THE MEDLITE C6 Q-SWICTHED ND: YAG LASER (K014234) | Continuum Electro-Optics, Inc. | 2002-01-17 |
| PERMACOL (K013625) | Tissue Science Laboratories, Plc | 2002-01-17 |
| DOXADENT DENTAL COMPOSITE, MODELS A, B, C, 12A, 12B, 12C, 6A, 6B, AND 6C (K011839) | Doxa Certex AB | 2002-01-17 |
| ROSSMAX MEDIPRO, MODELS 100F, 200F, AND 300F BLOOD PRESSURE MONITORS (K013539) | Rossmax International , Ltd. | 2002-01-17 |
| SIMPLE (K013519) | Bisco, Inc. | 2002-01-17 |
| RANDOX THEOPHYLLINE (K011771) | Randox Laboratories, Ltd. | 2002-01-17 |
| MODIFICATION TO EBI XFIX VISION FIXATION SYSTEM (K014194) | Ebi, L.P. | 2002-01-17 |
| ECG HOME (K012012) | H&C Medical Devices Spa | 2002-01-17 |
| SIMPLICITY EASY ACCESS INFUSION SET (K014062) | Sterling Medivations, Inc. | 2002-01-17 |
| TOCO LITE, MODEL TD-01 (K013477) | Ventrex, Inc. | 2002-01-17 |
| SIEMENS INFINITY GATEWAY SUITE (K014213) | Siemens Medical Solutions USA, Inc. | 2002-01-17 |
| CEMENTED CALCAR HIP SYSTEM (K013490) | Encore Orthopedics, Inc. | 2002-01-17 |
| PLAGIOCEPHALIC APPLIED PRESSURE ORTHOSIS P.A.P. ORTHOSIS (K012804) | Scott E Allen CP | 2002-01-17 |
| BREATHTEK - UBIT UBT FOR H. PYLORI (K014225) | Meretek Diagnostics, Inc. | 2002-01-17 |
| MICROLIFE UPPER ARM AUTOMATIC BLOOD PRESSURE MONITOR, MODEL BP-3BTO-1, WITH OPTIONAL THERMAL PRINTER, MODEL PR 1KA1 (K013485) | Microlife Corp. | 2002-01-17 |
| MODIFICATION TO PROTEGE SELF-EXPANDING NITINOL STENT WITH STARPORT DELIVERY TECHNOLOGY (K014136) | Sulzer Intratherapeutics, Inc. | 2002-01-17 |
| POLYMER COATED POWDER FREE LATEX MEDICAL EXAMINATION GLOVES WITH PROTEIN LABELING CLAIM (50 MICROGRAMS OR LESS) (K013554) | Maxter Glove Manufacturing Sdn Bhd | 2002-01-17 |
| DEKOMPRESSOR PERCUTANEOUS LUMBAR DISCECTOMY PROBE (K013513) | Pain Concepts, Inc. | 2002-01-17 |
| BIOLIGHT PCD (K011355) | Biolight International AB | 2002-01-17 |
| MODIFICATION OF NC-STAT (K013459) | Neurometrix, Inc. | 2002-01-17 |
| BARD CONQUEST PTA BALLOON DILATATION CATHETER (K014212) | C.R. Bard, Inc. | 2002-01-17 |
| DILATING TIP OBTURATOR (K012884) | Applied Medical Resources Corp. | 2002-01-17 |
| 3DFIS, MODEL IES-FL-101 (K013841) | 3Dsharp, Inc. | 2002-01-17 |
| SWIFT LOW PROFILE CUP (PRO CUP) (K013460) | Swift Delivery Products | 2002-01-17 |
| ROSSMAX MEDIPRO MODEL 10 AND 60, MEDICARE MODEL 10 AND 60 BLOOD PRESSURE MONITORS (K013583) | Rossmax International , Ltd. | 2002-01-17 |
| MODIFICATION TO TELESCOPIC PLATE SPACER THORACOLUMBAR (TPS-TL) SPINAL SYSTEM, MODEL 8130, 8131 (K014145) | Interpore Cross Intl. | 2002-01-17 |
| VAMOS ANESTHETIC GAS MONITOR (K012139) | Draeger Medical, Inc. | 2002-01-17 |
| MODIFIED TO LDL/HDL CHOL DIRECT KIT-P.N. 4005, 4103,4123 (K012789) | Morax | 2002-01-17 |
| OSTEOMED BIORESORBABLE FIXATION SYSTEM (K012486) | Osteomed Corp. | 2002-01-16 |
| REVOLUTION FORMULA 2 (K013647) | Sybron Dental Specialties, Inc. | 2002-01-16 |
| KSEA CLEARVISION LENS IRRIGATION SYSTEM (K013838) | KARL STORZ Endoscopy-America, Inc. | 2002-01-16 |
| HL168E (K014122) | Health & Life Co., Ltd. | 2002-01-16 |
| KONICA LASER IMAGER, DRYPRO MODEL 751/752 (K013052) | Konica Minolta Medical & Graphic, Inc. | 2002-01-16 |
| SEMPERMED SUPREME, SIZES 5.5, 6, 6.5, 7, 7.5, 8, 8.5, AND 9 (K013560) | Semperit Technische Produkte Gesellshaft | 2002-01-16 |
| MODIFICATION TO EBI OMEGA 21 SYSTEM (K014137) | Ebi, L.P. | 2002-01-16 |
| NEXUS 2 CLEAR (K013609) | Sybron Dental Specialties, Inc. | 2002-01-16 |
| LOGIQBOOK (K014206) | General Electric Co. | 2002-01-16 |
| HI-TOQUE BALANCE MIDDLEWEIGHT UNIVERSAL GUIDE WIRE WITH HYDROCOAT HYDROPHILIC COATING, #1009659,1009659J, 1009660, 10096 (K013833) | Guidant Corp. | 2002-01-16 |
| LUMEND PERCUTANEOUS CATHETER (K011562) | Lumend, Inc. | 2002-01-16 |
| PLANMED SOPHIE & PLANMED SOPHIE CLASSIC (K013656) | Planmed OY | 2002-01-16 |
| NUMED COEFFICIENT PTV CATHETERS (K014124) | NuMED, Inc. | 2002-01-16 |
| SYNCHRON SYSTEMS PANCREATIC AMYLASE (PAM) REAGENT (K013978) | Beckman Coulter, Inc. | 2002-01-15 |
| PASS SPINAL SYSTEM (K013442) | Encore Orthopedics, Inc. | 2002-01-15 |
| SJM TAILOR ANNULOPLASTY RING MODEL TARP- (SIZE) (K014161) | St. Jude Medical, Inc. | 2002-01-15 |
| PRISMASATE (K013448) | Gambro Renal Products | 2002-01-15 |
| ISOBAR SPINAL SYSTEM (K013447) | Scien'Tx USA, Inc. | 2002-01-15 |
| RANDOX CARBAMAZEPINE (K011648) | Randox Laboratories, Ltd. | 2002-01-15 |
| STAT PROFILE PHOX BASIC ANALYZER (K013729) | Nova Biomedical Corp. | 2002-01-15 |
| M2376A DEVICELINK SYSTEM, MODEL M2376A (K014181) | Philips Medical Systems, Inc. | 2002-01-15 |
| ACCENT (K013574) | Confirma, Inc. | 2002-01-15 |
| MODIFICATION TO OPTIMUM CLEANING, DISINFECTING AND (K014162) | Lobob Laboratories, Inc. | 2002-01-15 |
| RANDOX VALPROIC ACID (K011649) | Randox Laboratories, Ltd. | 2002-01-15 |
| 80 CHANNEL EEG (K014147) | Xltek | 2002-01-14 |
| ANTERIOR CERVICAL PLATE SYSTEM (K013439) | Scien'Tx USA, Inc. | 2002-01-14 |
| MODIFICATION TO BRIDGE SELF-EXPANDING BILIARY STENT DELIVERY SYSTEM (BRIDGE SE) (K014205) | Medtronic Ave, Inc. | 2002-01-14 |