| BRAHMS DIAGNOSTICA DYNOTEST ANTI-TG (K992790) | Brahms Diagnostica, LLC | 1999-11-12 |
| QUALITROL IMMUNOLOGY CONTROL, LEVEL 1, 2 AND 3 (K992770) | Seracare Technology | 1999-11-12 |
| LEGEND CRF FLUORO AND RAD SYSTEM (K993665) | Ge Medical Systems, Inc. | 1999-11-12 |
| THE APTUS (AUTOMATED) APPLICATION OF THE GLIADIN IGG ELISA TEST SYSTEM. (K993250) | Zeus Scientific, Inc. | 1999-11-12 |
| VARELISA RECOMBI ANA SCREEN EIA, MODELS 128 48/ 128 96 (K993108) | Pharmacia & Upjohn Co. | 1999-11-12 |
| IMPRESARIO (K993620) | Del Mar Medical Systems, LLC | 1999-11-12 |
| AUTOSTAT II ANTI-GLIADIN IGG ELISA (K993087) | Cogent Diagnotics , Ltd. | 1999-11-12 |
| SIGMA 3400 MONOPLACE HYPERBARIC CHAMBER (K990927) | Perry Baromedical Corp. | 1999-11-12 |
| CONSTELLATION CATHETERS, MODEL 8039 (K992777) | Boston Scientific Corp | 1999-11-12 |
| IMMULITE 2000 FOLIC ACID, MODEL L2KF02, L2KF06 (K993254) | Diagnostic Products Corp. | 1999-11-12 |
| AUTOSTAT II ANTI-GLIADIN IGA ELISA (K993086) | Cogent Diagnotics , Ltd. | 1999-11-12 |
| EZFLOW MAX, MODEL 1007 (K993558) | Piper Medical Products | 1999-11-12 |
| LEAD STYLET,MODELS 6505,6506,6507,6508 (K992863) | Guidant Corp. | 1999-11-12 |
| PRIMUS LIQUID CONTROL FOR GHB/ALC LEVEL I AND LEVEL II (K992921) | Primus Corp. | 1999-11-12 |
| FASTTAKE COMPACT BLOOD GLUCOSE MONITORING SYSTEM (K993632) | Selfcare, Inc. | 1999-11-12 |
| WAKO TRANSFERRIN, TRANSFERRIN CALIBRATOR (K993162) | Wako Chemicals USA, Inc. | 1999-11-12 |
| R&D HGB/GLC WHOLE BLOOD CONTROL (K993321) | R&D Systems, Inc. | 1999-11-12 |
| MICROALBUSTIX REAGENT STRIPS (OTC) (K991315) | Bayer Corp. | 1999-11-12 |
| VARELISA RECOMBI ANA PROFILE (K993109) | Pharmacia & Upjohn Co. | 1999-11-12 |
| PIKOS 01, PIKOS E01, PIKOS 01-B, PIKOS E01-B, PIKOS 01-A, PIKOS E01-A (K993434) | Biotronik, Inc. | 1999-11-10 |
| ROADRUNNER, PEP THERAPY DEVICE (K991561) | Dhd Healthcare Corp. | 1999-11-10 |
| MEDCOMP DUO-FLOW II CATHETER WITH LUBRICIOUS HEPARIN (K991320) | Medical Components, Inc. | 1999-11-10 |
| E.CAM COMPUTER (K992731) | Siemens Medical Solutions USA, Inc. | 1999-11-10 |
| AUTOJET 2 (NON-FIXED NEEDLE TYPE) (K993385) | Owen Mumford USA, Inc. | 1999-11-10 |
| COMPONENTS FOR CARDIOVASCULAR PROCEDURE KIT (K992906) | Olson Medical Sales, Inc. | 1999-11-10 |
| TERATECH, MODEL 2000 IMAGING IMAGING (K992505) | Teratech Corp. | 1999-11-10 |
| FS 1000 KNEE SYSTEM (K991052) | Renaissance Instruments, LLC | 1999-11-10 |
| ZURICH TITANIUM OSSICULAR REPLACEMENT SYSTEM (K993583) | Stryker Corp. | 1999-11-10 |
| RESPIRONICS TOTAL FACE MASK (K992969) | Respironics, Inc. | 1999-11-10 |
| PRIMEAIRE (K992722) | Thayer Medical Corp. | 1999-11-10 |
| POLYGRAF ID, POLYGRAM '98 ESOPHAGEAL MANOMETRY TESTING APPLICATION, MODELS 9043G0121-9043G0151, 9043S0101 (K992713) | Medtronic Functional Diagnostics A/S | 1999-11-10 |
| VACUUM ASSIST STABILIZER (K992833) | Cardio Thoracic Systems | 1999-11-10 |
| THE TAPER-FIT TOTAL HIP SYSTEM (K992234) | Corin USA | 1999-11-10 |
| LEVELSENS - FLEXIBLE, MODEL 201110, LEVELSENS - RIGID, MODEL 201070 (K992857) | Rocky Mountain Research, Inc. | 1999-11-10 |
| SITE-RITE 3 ULTRASOUND SYSTEM (K993624) | Dymax Corp | 1999-11-10 |
| MICROMEDICS S&T PARTIAL OSSICULAR REPLACEMENT PROSTHESIS (K993234) | Micromedics, Inc. | 1999-11-10 |
| POWDERED LATEX EXAMINATION GLOVES (PROTEIN LABEL CLAIM) (K993458) | Sri Johani Sdn. Bhd. | 1999-11-10 |
| METRX SYSTEM (K993021) | Surgical Navigation Technologies, Inc. | 1999-11-10 |
| AKRON ATP9 TRACTION MACHINE (K992733) | Huntleigh Technology, Inc. | 1999-11-10 |
| MILLENNIUM INFANT VENTILATOR (K993167) | Sechrist Industries, Inc. | 1999-11-10 |
| LIGHT-CORE (K993488) | Bisco, Inc. | 1999-11-10 |
| STINGRAY DR, MODEL 1 (K992794) | Infimed, Inc. | 1999-11-09 |
| COPAN EASY-SWAB COLLECTION AND TRANSPORT SYSTEM (K993161) | Copan Diagnostics, Inc. | 1999-11-09 |
| ADDITIONAL IMS ASSAYS FOR THE BAYER ADVIA IMS SYSTEM (K991907) | Bayer Corp. | 1999-11-09 |
| BAYER ADVIA INTEGRATED MODULAR SYSTEM (IMS) (K992136) | Bayer Corp. | 1999-11-09 |
| SL990, SL980, SL950 (K992836) | Cso | 1999-11-09 |
| SYSMEX XE-2100, AUTOMATATED HEMATOLOGY ANALYZER (K992875) | Sysmex Corp. | 1999-11-09 |
| SYSMEX AUTOMATED COAGULATION ANALYZER, MODEL CA-6000 (K993174) | Dade Behring, Inc. | 1999-11-09 |
| BILIBLANKET PLUS HIGH OUTPUT PHOTOTHERAPY SYSTEM (K993712) | Ohmeda Medical | 1999-11-09 |
| POWERVIEW ULTRASOUND WORKSTATION, UIDM-400A (K992886) | Toshiba America Medical Systems, In.C | 1999-11-09 |
| K-ASSAY IGG (K993281) | Kamiya Biomedical Co. | 1999-11-09 |
| LYPHOCHEK ANEMIA CONTROL, MODEL 500 (K992741) | Bio-Rad | 1999-11-09 |
| ECUSIT COMPOSITE REPAIR (K992879) | Dmg Hamburg | 1999-11-09 |
| TED 60T OXYGEN ANALYZER (K990457) | Teledyne Electronic Technologies | 1999-11-09 |
| WAKO BILIRUBIN CALIBRATOR (K993219) | Wako Chemicals USA, Inc. | 1999-11-09 |
| EBT ULTRAFAST CT SCANNER SYSTEM; ULTRAFAST CT SCANNER SYSTEM; C-100, C-150, C-150LXP OR C-150XP SCANNER SYSTEMS (K992740) | Imatron, Inc. | 1999-11-09 |
| WAKO L-TYPE TRIGLYCERIDE TEST (K993466) | Wako Chemicals USA, Inc. | 1999-11-09 |
| CARBOCEM ZINC POLYCARBOXYLATE CEMENT (K993324) | Scientific Pharmaceuticals, Inc. | 1999-11-09 |
| OSTEOMARK NTX POC (K992997) | Metrika, Inc. | 1999-11-09 |
| LIGHT DIAGNOSTICS SIMULFLUOR HSV 1/2 IMMUNOFLUORECENCE ASSAY (K991880) | Light Diagnostics | 1999-11-09 |
| WAKO L-TYPE UA F TEST (K993469) | Wako Chemicals USA, Inc. | 1999-11-09 |
| MENISCUS ARROW, MODELS 531110, 531113, 531116 (K993453) | Bionx Implants, Ltd. | 1999-11-09 |
| SIGNA HFO/I MAGNETIC RESONANCE SYSTEM (K992746) | Ge Medical Systems, Inc. | 1999-11-09 |
| 1818 TENS UNIT (K992709) | 138 Medical Supplies, Inc. | 1999-11-09 |
| SYNCHRON SYSTEMS OP 300 LOW AND HIGH URINE CALIBRATORS (K993022) | Beckman Coulter, Inc. | 1999-11-09 |
| OMNI GRACE NITRILE, GREEN, EXAMINATION GLOVE, POWDER-FREE, POLYMER COATED (K993050) | Omnigrace , Ltd. | 1999-11-09 |
| HP VIRIDIA CMS PATIENT MONITOR WITH EEG PARAMETER, MODEL M1027A (K992674) | Hewlett-Packard GmbH | 1999-11-08 |
| EVENT ALLERGEN BARRIERS, EVENT MATTRESS ENCASING, EVENT DUVET ENCASING, EVENT PILLOW ENCASING, EVENT BEDDING SYSTEM (K992702) | Allergy Direct | 1999-11-08 |
| HP M2600A VIRIDIA TELEMETRY SYSTEM (K993516) | Hewlett-Packard Co. | 1999-11-08 |
| AT HOME QUICKCUP PREGNANCY TEST, MODEL 9015 (K993141) | Phamatech | 1999-11-08 |
| LORENZ SMALL FRAGMENT SYSTEM (K992961) | Walter Lorenz Surgical, Inc. | 1999-11-08 |
| DIGIT WIDGET (K992970) | Hand Biomechanics Lab, Inc. | 1999-11-08 |
| ADI 9000/9001 ARTHROSCOPE AND ACCESSORIES (K992621) | Advanced Diagnostics & Interventions | 1999-11-08 |
| CASTLE SURGICAL LIGHT, MODEL 3000 (K993242) | Getinge/Castle, Inc. | 1999-11-08 |
| DORNIER SCANNER HANDPIECE (K993146) | Dornier Surgical Products, Inc. | 1999-11-08 |
| ISOBAR SPINAL SYSTEM (K992738) | Encore Orthopedics, Inc. | 1999-11-08 |
| ISOBAR SEMI-RIGID SPINAL SYSTEM (K991326) | Scien'Tx USA, Inc. | 1999-11-08 |
| TITANIUM HARTSHILL SYSTEM (K991662) | Surgicraft , Ltd. | 1999-11-08 |
| ULTRA-CBX (K991486) | Medcanica, Inc. | 1999-11-05 |
| INNOVATIVE GLOVES, LATEX EXAMINATION GLOVES, PREPOWDERED (K993221) | Innovative Gloves Co;, Ltd. | 1999-11-05 |
| SHELLY PROTECTED AV FISTULA NEEDLE (K993187) | Diasol, Inc. | 1999-11-05 |
| ANTIBACTERIAL ADHESIVE BANDAGE (K992817) | William Feinstein & Associates, Inc. | 1999-11-05 |
| WORLDWIDE MEDICAL TECHNOLOGIES SEEDING SPACERS (K991344) | Worldwide Medical Technologies, LLC | 1999-11-05 |
| SYNTHETIC POWDERED VINYL PATIENT EXAMINATION GLOVES (K992797) | Shijiazhuang Hongxiang Plastics Products Co., Ltd. | 1999-11-05 |
| MONOLYTH C 600 AND 1200 HOLLOW FIBER MEMBRANE LUNG WITH INTEGRATED SOFTSHELL VENOUS RESERVOIR , CVR 600 AND 1200 SOFTSHE (K990103) | Sorin Biomedical, Inc. | 1999-11-05 |
| ORBITER ST DIAGNOSTIC ELECTRODE CATHETER & ORBITER ST EXTENSION CABLE (K992373) | C.R. Bard, Inc. | 1999-11-05 |
| URF DIGITAL - OT (K992660) | Siemens Medical Solutions USA, Inc. | 1999-11-05 |
| SURGEON'S GLOVES PRE-POWDERED, MODELS 6.5, 7, 7.5, 8, 8.5 (K992752) | Pt. Maja Agung Latexindo | 1999-11-05 |
| DEPUY TOTAL ELBOW SYSTEM (K992656) | DePuy Orthopaedics, Inc. | 1999-11-05 |
| COLDLIGHTSOURCE PL3000 (K993300) | Fiber Imaging Technologies, Inc. | 1999-11-05 |
| PLUG 'N VIEW 3D, VERSION 1.0 (K992654) | Voxar Limited | 1999-11-05 |
| ECHO VIEW, EASY VIEW, OMNI VIEW (K993398) | Tomtec Imaging Systems GmbH | 1999-11-05 |
| INNOVATIVE GLOVES, LATEX EXAMINATION GLOVES POWDERFREE (K993222) | Innovative Gloves Co;, Ltd. | 1999-11-05 |
| MODIFICATION TO MP-3 POWER BASE CHAIR (K993032) | Merits Health Products., Inc. | 1999-11-05 |
| MODIFICATION TO BRENNEN BIOSYNTHETIC SURGICAL MESH MATRIX (K993459) | Advanced Uroscience, Inc. | 1999-11-05 |
| GE LOGIQ 700 WITH CODED EXCITATION MODIFICATION (K993364) | Ge Medical Systems, Inc. | 1999-11-05 |
| INNOVATIVE GLOVES, NITRILE BUTADIENE RUBBER POWDER-FREE (K993325) | Innovative Gloves Co;, Ltd. | 1999-11-05 |
| NITRILE POWDER FREE PATIENT EXAMINATION GLOVES (K993247) | Jda Intl., Inc. | 1999-11-05 |
| GE LOGIQ 700 WITH HARMONIC IMAGING MODIFICATION (K993365) | Ge Medical Systems, Inc. | 1999-11-05 |
| DAISY PROTECTED SCALP VEIN SET (K992999) | Diasol, Inc. | 1999-11-05 |