| REAADS IGM ANTI-B2GP1 TEST KIT (K982433) | Corgenix, Inc. | 1998-12-07 |
| ABBOTT ARCHITECT FERRITIN (K983759) | Abbott Laboratories | 1998-12-07 |
| IMMULITE AFP, MODEL LKAPI, LKAP5, IMMULITE 2000 AFP, MODEL L2KAP2 (K983263) | Diagnostic Products Corp. | 1998-12-07 |
| KSEA C-MOUNT ARTHROSCOPES (K983142) | Karl Storz Endoscopy | 1998-12-07 |
| CELL ROBOTICS' LASETTE (K981746) | Cell Robotics, Inc. | 1998-12-07 |
| IMMULITE TROPONIN I, MODEL LKTI1 AND LKT15 (K983972) | Diagnostic Products Corp. | 1998-12-07 |
| ANTI-TG IGG ELISA TEST SYSTEM (K983553) | Columbia Bioscience, Inc. | 1998-12-07 |
| OSTEO COMPRESSION CONDYLE SCREW SYSTEM (K983508) | Osteonics Corp. | 1998-12-07 |
| POLYMER-COATED, POWDER-FREE, LATEX PATIENT EXAMINATION GLOVE (K983721) | Kossan Latex Industries(M)Sdn Bhd | 1998-12-07 |
| GREEN-OR DENTIN DESENSITIZER (K981972) | Centrix, Inc. | 1998-12-07 |
| NEOFLOW OPTION MODEL NUMBERS 8413563, 8411900 (K983219) | Drager, Inc. | 1998-12-07 |
| MICRO X RESIDUAL TEST STRIPS (K974064) | Reprocessing Products Corp | 1998-12-07 |
| BAYER IMMUNO 1 SYSTEM, UPGRADED FOR A LABORATORY (K983345) | Bayer Corp. | 1998-12-07 |
| POWDER FREE (CHLORINATED) LATEX EXAMINATION GLOVES WITH PROTEIN CONTENT LABELING CLAIM (50 MICROGRAMS OR LESS) (K981917) | Oon Corp. Resources | 1998-12-07 |
| NELLCOR PURITAN BENNETT UNIPROBE ADAPTER CABLE, UP12A, UP12B, UP12C (K982728) | Nellcor Puritan Bennett, Inc. | 1998-12-07 |
| OMNI TOUCH NITRILE EXAMINATION GLOVE, POWDERED, BLUE (K983725) | Omnigrace , Ltd. | 1998-12-07 |
| NITRILE LATEX POWDER FREE EXAMINATION GLOVE (K983825) | Top Glove Sdn. Bhd. | 1998-12-04 |
| MULTIPULSE CO2 LASER (K983215) | Aesculap-Meditec GmbH | 1998-12-04 |
| QUADRANT TOTAL ETCH (K984043) | Cavex Holland BV | 1998-12-04 |
| QUADRANT CORE LC (K984042) | Cavex Holland BV | 1998-12-04 |
| PRE-POWDERED NON-STERILE SYNTHETIC EXAMINATION GLOVE (K982885) | Shanghai Poseidon Plastic Products Co., Ltd. | 1998-12-04 |
| SYNTEC-TAICHUNG NON-STERILE KNOWLES PIN, MODELS: FOR HEXAGONAL COLLAR: 2991-01/15,2992-01/15, FOR SQUARE COLLAR:29992-01 (K983757) | Syntec Scientific Corp. | 1998-12-04 |
| RUSCH POLYFLEX STENT KIT (K982614) | Rusch Intl. | 1998-12-04 |
| BIPOLAR HF CABLE (K983236) | Richard Wolf Medical Instruments Corp. | 1998-12-04 |
| HUMAN IGA SUBCLASS BNII COMBI KIT (K981912) | The Binding Site, Ltd. | 1998-12-04 |
| HOLLAND FEMORAL NAIL SYSTEM (K983641) | Biomet, Inc. | 1998-12-04 |
| COBRA EXTERNAL FIXATOR (K983881) | Orthopaedic Innovations, Inc. | 1998-12-04 |
| ULNAR HEAD IMPLANT (K982268) | Avanta Orthopaedics, Inc. | 1998-12-04 |
| RAPPORT V.T.D. (K982275) | Owen Mumford USA, Inc. | 1998-12-04 |
| NATURAL-KNEE II POSTERIOR STABILIZED (P.S.) CONDYLAR KNEE TIBIAL INSERTS (K983153) | Sulzer Orthopedics, Inc. | 1998-12-04 |
| STEALTHSTATION TREATMENT GUIDANCE PLAFFORM (K983397) | Surgical Navigation Technologies, Inc. | 1998-12-04 |
| QUADRANT UNIVERSAL LC (K984041) | Cavex Holland BV | 1998-12-04 |
| SYNTHETIC POWDERED VINYL PATIENT EXAMINATION GLOVES (K983645) | Shijiazhuang Great Eagle Plastic Products Co., Ltd. | 1998-12-04 |
| ELECTROSURGICAL UNIT (K981781) | Hill-Med, Inc. | 1998-12-04 |
| OSTEONICS X CEMENTED HIP STEM SERIES (K983226) | Osteonics Corp. | 1998-12-04 |
| G2 TOTAL HIP SYSTEM FEMORAL STEM (11/13 TAPER) (K982812) | Johnson & Johnson Professionals, Inc. | 1998-12-04 |
| AMERSE 2 (K983947) | STERIS Corporation | 1998-12-04 |
| DISPOSABLE MICROSTAAR INJECTOR (MODEL MSI-P1) (K983129) | Staar Surgical Co. | 1998-12-04 |
| ACCUTRAX, MODEL EPF840 (K982995) | Korr Medical Technologies, Inc. | 1998-12-04 |
| INTRAMEDULLARY NAIL SYSTEM, LOCKING SCREW, NAIL CAP (K983942) | Smith & Nephew, Inc. | 1998-12-04 |
| BONE BAND (K983685) | Chapel and Assoc. | 1998-12-04 |
| THERATRON ELITE (K983917) | Theratronics, Inc. | 1998-12-04 |
| NITRILE LATEX POWDERED EXAMINATION GLOVE (K983816) | Top Glove Sdn. Bhd. | 1998-12-04 |
| CUE AMBULATORY VOLUMETRIC INFUSION PUMP (K981816) | Becton Dickinson Curlin, LLC | 1998-12-04 |
| LIQUICHEK HOMOCYSTEINE CONTROL, CAT #644 (K984071) | Bio-Rad | 1998-12-03 |
| MONITOR ONE NDX (K972991) | Qmed, Inc. | 1998-12-03 |
| ELECTROSURGICAL INFLATABLE BASKET ELECTRODES (K983116) | Conway Stuart Medical, Inc. | 1998-12-03 |
| PREMIER CRYPTOSPORIDIUM (K982764) | Meridian Diagnostics, Inc. | 1998-12-03 |
| NELSON RESURFACING HEAD (K983452) | Biomet, Inc. | 1998-12-03 |
| DEPUY ACROMED MOSS AND MOSS MIAMI SPINAL SYSTEMS (K983583) | Depuy, Inc. | 1998-12-03 |
| IMPLEX HEDROCEL REPLACEMENT CUP INSERT MODEL NUMBERS 02-246-XXYYY, 02-247-XXYYY, 02-248-XXYYY (K983128) | Implex Corp. | 1998-12-03 |
| OSTEO 4.0MM CANNULATED SCREW SYSTEM (K983165) | Osteonics Corp. | 1998-12-03 |
| ENDOCAM CAMERA SYSTEMS 5502 WITH ELECTRONIC CCD ENDOSCOPE (K983279) | Richard Wolf Medical Instruments Corp. | 1998-12-02 |
| DEPUY DURALOC ACETABULAR CUP SYSTEM-ENDURON LINER (K983491) | DePuy Orthopaedics, Inc. | 1998-12-02 |
| VERITAS BIPOLAR, INSULATED, 0.5MM TIP, MODEL N301-005 VERITAS BIPOLAR, INSULATED 1.0MM TIP MODEL N301-010 (K982212) | Synergetics, Inc. | 1998-12-02 |
| ERADIC-ALL (K981171) | Theratechnologies, Inc. | 1998-12-02 |
| BARRON MICROKERATOME SYSTEM, MODEL B2000 (K983317) | Barron Precision Instruments, LLC | 1998-12-02 |
| 150MM COCR BIMETRIC HEAD/NECK REPLACEMENT HIP STEM- COLOR BUFF FINISH (K983710) | Biomet, Inc. | 1998-12-02 |
| DRG SHERLOCK MF BONE SCREW, COCRMO SELF-TAPPING, TI ALLOY SELF-TAPPING/SELF DRILLING, COCRMO SELF-TAPPING/ SELF DRILLING (K981881) | Doctor'S Research Group, Inc. | 1998-12-02 |
| PACEMAKER DATA PMD TRANSMITTER, MODEL CG-4000 (K983026) | Card Guard Scientific Survival , Ltd. | 1998-12-02 |
| OSTEONICS RESTORATION HA HIP STEMS (K983870) | Osteonics Corp. | 1998-12-02 |
| CAIRD TECHNOLOGY SPIROMETER (K971336) | Caird Technology | 1998-12-01 |
| PERIPHERAL VASCULAR DILATOR (K974617) | Endovascular Instruments, Inc. | 1998-12-01 |
| MENTOR ULTRASOUND-ASSISTED TISSUE REMOVAL SYSTEM (K983065) | Mentor Corp. | 1998-12-01 |
| ROCHE DIAGNOSTICS, BOEHRINGER MANNHEIM CORPORATION INORGANIC PHOSPHORUS REAGENT CATALOG NUMBER 1730347 (K983503) | Boehringer Mannheim Corp. | 1998-12-01 |
| COAGULATION CONTROL LEVEL 2 (ABNORMAL) (K984130) | Pacific Hemostasis | 1998-12-01 |
| VENOUS FLEX II PERIPHERAL AND INTRA-OPERATIVE ACCESS VENOUS RETURN CANNULAE (K974259) | Edwards Lifesciences Research Medical | 1998-12-01 |
| DELIVERY SHEATH (K983415) | Conway Stuart Medical, Inc. | 1998-12-01 |
| AMBULATORY EEG/SLEEP RECORDER AND ACCESSORIES, MODEL # SSR3201 (K983072) | Nihon Kohden America, Inc. | 1998-12-01 |
| COAGULATION CONTROL LEVEL 3 (ABNORMAL) (K984131) | Pacific Hemostasis | 1998-12-01 |
| RITA MODEL 70 ELECTROSURGICAL PROBE (K983871) | Rita Medical Systems | 1998-12-01 |
| MODIFICATION OF: ODYSSEY I DENTAL WATER UNIT (K983847) | Germiphene Corp. | 1998-12-01 |
| ABBOTT ARCHEITECT TOTAL B-HCG (K983424) | Abbott Laboratories | 1998-12-01 |
| COAGULATION CONTROL LEVEL 1 (NORMAL) (K984129) | Pacific Hemostasis | 1998-12-01 |
| BELMONT FLUID MANAGEMENT SYSTEM (FMS2000) (K983975) | Belmont Instrument Corp. | 1998-11-30 |
| FLUIDSENSE FLUID DELIVERY SYSTEM (K982170) | Fluidsense Corp. | 1998-11-30 |
| UNISEAL GLOVES LOW PROTEIN POWDERED (K981979) | American Healthcare Products (M) Sdn Bhd | 1998-11-30 |
| SENSITITRE 18-24 HR SUSCEPTIBILITY PLATES(ADDITION OF MEROPENEM) (K983244) | Trek Diagnostic Systems, Inc. | 1998-11-30 |
| QUADRANT UNICHEM (K983751) | Cavex Holland BV | 1998-11-30 |
| ACCU-BASE HEMOGLOBIN A1C SAMPLE COLLECTION KIT (K983172) | Diabetes Technologies, Inc. (Dti) | 1998-11-30 |
| TERUMO VENOJECT,LUER ADAPTER (K983490) | Terumo Corp. | 1998-11-30 |
| OMNIGRACE LATEX EXAMINATION GLOVE, POWDER-FREE, WITH PROTEIN CLAIM (K982716) | Omnigrace (Thailand) , Ltd. | 1998-11-30 |
| BETATRANS INTRAOP I AND II MODEL NUMBERS DS100X AND DS10XX (K982241) | Duxbury Scientific, Inc. | 1998-11-30 |
| KLS INTRAORAL VERTICAL DISTRACTOR (K983515) | KLS-Martin L.P. | 1998-11-30 |
| MATANG POWDER-FREE LOW PROTEIN LATEX PATIENT EXAMINATION GLOVE (K982877) | Matang Mfg. Sdn. Bhd. | 1998-11-30 |
| BLUNT T-PEEL INTRODUCER MODEL NUMBER PE-16PICB, PE-18PICB, PE-20PICB, PE-24PICB (K982797) | Luther Medical Products, Inc. | 1998-11-30 |
| IMMUGLO ANTI-NEUTROPHIL CYTOPLASMIC ANTIBODY (ANCA) TEST SYTEM (K982898) | Immco Diagnostics, Inc. | 1998-11-30 |
| MODIFICATION OF PQ1 (K983668) | Ultradent Products, Inc. | 1998-11-30 |
| NEUTRALON PF POWDER FREE BROWN LATEX SURGICAL GLOVES (K983240) | Johnson & Johnson Medical, Div. of Ethicon, Inc. | 1998-11-30 |
| POWDER FREE COPOLYMER NITRILE MEDICAL EXAMINATION GLOVE, COLORED (K983532) | Shanghai Antares Industries, Inc. | 1998-11-30 |
| ROTECNO 2000 SURGICAL GOWN (K982059) | Encompass Group, LLC | 1998-11-30 |
| THE APTUS (AUTOMATED) APPLICATION OF THE ANCA SCREEN ELISA TEST SYSTEM. AN ENZYME LINKED IMMUNOSORBENT ASSAY (ELISA) FOR (K984034) | Zeus Scientific, Inc. | 1998-11-30 |
| DISPATCH HOSPITAL CLEANER DISINFECTANT TOWELS WITH BLEACH (K983869) | Caltech Industries, Inc. | 1998-11-30 |
| DEROYAL INDUSTRIES, INC TRACECART SHARPS COLLECTION CONTAINER (K983750) | Deroyal Industries, Inc. | 1998-11-30 |
| NON-STERILE E.P. LATEX EXAMINATION GLOVE (K982453) | Ansell Perry | 1998-11-30 |
| POWDERED NITRILE MEDICAL EXAMINATION GLOVE, COLORED (K983531) | Shanghai Antares Industries, Inc. | 1998-11-30 |
| NITRILE POWDER-FREE UNISEAL GLOVES (K982218) | American Healthcare Products (M) Sdn Bhd | 1998-11-30 |
| DOMINATOR (K983681) | Impact Wheelchair Manufacture, Inc. | 1998-11-27 |
| SUTURE WELDING SYSTEM AND KIT (SWK) (K983108) | Axya Medical, Inc. | 1998-11-27 |
| FIRSTCLASS POWER TILT SEAT SYSTEM, MODEL S300 (K983066) | Teftec Corp. | 1998-11-27 |