| C.T.M. MOBILITY SCOOTER, MODEL H2-686, HS-740, HS-580 (K000356) | Warepalmy Enterprise, LLC (Usa) | 2000-08-25 |
| FRESENIUS OPTIFLUX 200NR (K002277) | Fresenius Medical Care North America | 2000-08-25 |
| DATASCOPE REINFORCED PERCUTANEOUS CATHETER INTRODUCER SET (K002365) | Datascope Corp. | 2000-08-25 |
| WIZAIR COMPRESSION SYSTEM (K002287) | Medical Compression Systems (Dbn) , Ltd. | 2000-08-25 |
| RANGER II M6, MODEL IN-888WNL (K002157) | Invacare Corp. | 2000-08-25 |
| C-REACTIVE PROTEIN ANTISERUM KIT (K001636) | The Binding Site, Ltd. | 2000-08-24 |
| ODONTOSURGE 3 (K001560) | Odonto-Wave | 2000-08-24 |
| MODIFIED TO MODULAR FR SEVERE BONE LOSS TRAUMA (K002324) | Sulzermedica | 2000-08-24 |
| SYNTHES SACRAL BAR SYSTEM (K001720) | Synthes (Usa) | 2000-08-24 |
| MODIFICATION TO INTUITIVE SURGICAL STEREO VIEW ENDOSCOPIC SYSTEM (K001666) | Intuitive Surgical, Inc. | 2000-08-24 |
| ANTERIOR CERVICAL PLATE SYSTEM (K001847) | Encore Orthopedics, Inc. | 2000-08-24 |
| SUPER 1 (K002298) | Dental Alloy Products, Inc. | 2000-08-24 |
| VEINLASE, MODEL E50-K8-B5, SPECTRUM K8, MODEL E50-K8-B9 (K000158) | Fisma, Inc. | 2000-08-24 |
| HEMOSTATIX THERMAL SCALPEL SYSTEM - #12 BLADE (K002021) | Gyrus Ent LLC | 2000-08-24 |
| VAPOTHERM, MODEL 2000I (K000401) | Vapotherm, Inc. | 2000-08-24 |
| MODIFICATION TO AXYA MEDICAL, INC. BONE ANCHOR SYSTEM AND KIT (BAK) (K002435) | Axya Medical, Inc. | 2000-08-24 |
| HEDROCEL REVISION CUP, MODEL 02-2YY-ZZZZ (K001759) | Implex Corp. | 2000-08-24 |
| LIFESITE HEMODIALYSIS ACCESS SYSTEM/CANNULA EXCHANGE, MODEL LHAS14120 & LHCEK0000 (K001633) | Vasca, Inc. | 2000-08-24 |
| HI-TORQUE WHISPER LS GUIDE WIRE WITH HYDROCOAT HYDROPHILIC COATING, HI-TORQUE WHISPER MS GUIDE WIRE WITH HYDROCOAT HYDRO (K002206) | Guidant Corp. | 2000-08-24 |
| CHROMOSTREAK (K000718) | Novamed , Ltd. | 2000-08-24 |
| DATEX-OHMEDA COMPACT AIRWAY MODULE M-CAIOVX AND M-COVX (VERSION 01) AND ACCESSORIES (K001814) | Datex-Ohmeda | 2000-08-23 |
| RENDER-PLAN 3-D 4.00 & PRECISE-PLAN 1.0 (K002240) | Precision Therapy Intl., Inc. | 2000-08-23 |
| CECILIA PENGUIN MULTI-USE THERMOMETER, MODEL HP-ETO9999 (K993950) | Nien Made Electrnics Corp. | 2000-08-23 |
| CHRONALCO I.D.CDT (CARBOHYDRATE DEFICIENT TRANSFERRIN) ASSAY (K001943) | Sangui Biotech, Inc. | 2000-08-23 |
| PALM PUMP (K002434) | Sorenson Medical, Inc. | 2000-08-23 |
| OFFICE BASED ANESTHESIA MACHINE, MODEL OBA-1 (K000859) | Charles A. Smith | 2000-08-23 |
| 3M COMPLY 1249 LIQUID PERACETIC ACID CHEMICAL INDICATOR (K000355) | Minnesota Mining and Mfg. Co. | 2000-08-23 |
| MICROLIFE DIGITAL INFRARED EAR THERMOMETER, MODEL IR1DA1 (K000969) | Microlife Corp. | 2000-08-22 |
| EPIC SPO2 FINGER SENSOR, MODEL E412-20 (K002223) | Epic Medical Equipment Services, Inc. | 2000-08-22 |
| KSEA MONOPOLAR VAPORIZATION ELECTRODES (K001740) | KARL STORZ Endoscopy-America, Inc. | 2000-08-22 |
| CAPIOX SX HARDSHELL RESERVOIR WITH X-COATING (K002238) | Terumo Cardiovascular Systems Corp. | 2000-08-22 |
| VINYL EXAMINATION GLOVE, POWDER-FREE, YELLOW (K002340) | Glormed Intl., Inc. | 2000-08-22 |
| ACCESS TESTOSTERONE REAGENTS FOR USE ON THE ACCESS IMMUNOASSAY ANALYZER, MODELS 33560, 33565 (K001935) | Beckman Coulter, Inc. | 2000-08-22 |
| ELECSYS HCG TEST SYSTEM (K002148) | Roche Diagnostics Corp. | 2000-08-22 |
| BRACHYSEED (K000475) | Draximage, Inc. | 2000-08-22 |
| BIOBAR, IMPLANTABLE BIODEGRADABLE COLLAGEN MEMBRANE FOR GUIDED BONE REGENERATION (K001598) | Col-Bar , Ltd. | 2000-08-22 |
| PATIENT LATEX POLYMER COATED POWDER-FREE GLOVES, CONTAINS 50 MICROGRAM OR LESS OF TOTAL WATER EXTRACTABLE PROTEIN PER GR (K002065) | Comfort Rubber Gloves Industries Sdn. Bhd. | 2000-08-22 |
| DOCUMENT ASSAYED CHEMISTRY CONTROL, LEVELS 1, 2 AND3 (K002174) | Casco-Nerl Diagnostics Corporation (Maine) | 2000-08-22 |
| IMPROVED ENLIGHT LV (K001881) | Sybron Dental Specialties, Inc. | 2000-08-22 |
| CARESIDE HEMOGLOBIN (K001462) | Careside, Inc. | 2000-08-21 |
| DIASTAT ANTI-CARDIOLIPIN IGA, MODEL FCAR 500 (K001981) | Axis-Shield , Ltd. | 2000-08-21 |
| LIQUICHEK BLOOD GAS CONTROL, MODEL 571, 572, 573 (K002120) | Bio-Rad | 2000-08-21 |
| WHOLE PTH (1-84) SPECIFIC IMMUNORADIOMETRIC IRMA DIAGNOSTIC ASSAY KIT, MODEL 3KG056 (K001411) | Scantibodies Laboratory, Inc. | 2000-08-21 |
| GLYCOSAL HBA1C TEST (K001392) | Provalis Diagnostics , Ltd. | 2000-08-21 |
| DIAMEDIX IS-RUBELLA IGM CAPTURE TEST SYSTEM (K001875) | Diamedix Corp. | 2000-08-21 |
| HEP-2 ANA TEST SYSTEM WITH IF-AIM TECHNOLOGY (K001556) | The Binding Site, Ltd. | 2000-08-21 |
| SYSMEX R-500 (K001683) | Sysmex Corporation of America | 2000-08-21 |
| POWERDRIVE 350 OPTION (K002415) | Philips Medical Systems (Cleveland), Inc. | 2000-08-18 |
| PARADIGM 1.5ML RESERVOIR, MODEL 326 (K001828) | Minimed, Inc. | 2000-08-18 |
| PARADIGM SOF-SET ULTIMATE QR, MODELS 317 AND 318 (K001832) | Minimed, Inc. | 2000-08-18 |
| FLO ASSISTANT, MODEL 4-250-00 (K001325) | Northgate Technologies, Inc. | 2000-08-18 |
| XIA SPINE SYSTEM SACRAL BLOCK ASSEMBLY (K001653) | Howmedica Osteonics Corp. | 2000-08-18 |
| REMED MALE TUTTI FRUTTI CONDOM (COCONUT) PREVENTOR, LUCKY BOY, SUMMIT (K993409) | Remed Pharma | 2000-08-18 |
| GE MARQUETTE ECG ANALYSIS PROGRAM (K002209) | General Electric Medical Systems Information Techn | 2000-08-18 |
| CAMBRIDGE HEART MICRO-V ALTERNANS SENSOR, MODEL 20327-002 (K002230) | Cambridge Heart, Inc. | 2000-08-18 |
| HUNTER SCIENTIFIC INJECTION PIPETTES (K001615) | Hunter Scientific Limited | 2000-08-18 |
| ORTHONE (K001773) | Oni, Inc. | 2000-08-18 |
| PARADIGM SOF-SET MICRO QR, MODELS 324 AND 325 (K001827) | Minimed, Inc. | 2000-08-18 |
| REMED MALE TUTTI FRUTTI CONDOM (BANANA), PREVENTOR, LUCKY BOY, SUMMIT (K993389) | Remed Pharma | 2000-08-18 |
| CANDELA DYNAMIC COOLING DEVICE (K001589) | Candela Corp. | 2000-08-18 |
| DOSE 1 (K000209) | Scanditronix Wellhofer North America | 2000-08-18 |
| TREATVISION (K002194) | Varian Medical Systems, Inc. | 2000-08-18 |
| ML EYE SPEAR, MODEL ML 27 ES (K002279) | Med-Logics, Inc. | 2000-08-18 |
| REMED MALE TUTTI FRUTTI CONDOM (STRAWBERRY) PREVENTOR, LUCKY BOY, SUMMIT (K993403) | Remed Pharma | 2000-08-18 |
| MINIMED PARADIGM INSULIN PUMP, MODEL 511 (K001829) | Minimed, Inc. | 2000-08-18 |
| KONTUR 55 SOFT LENS (K001908) | Kontur Kontact Lens Co., Inc. | 2000-08-18 |
| GROSS FEMORAL COMPONENT (K001580) | Biomet, Inc. | 2000-08-17 |
| PRIMAFLOW (K002086) | Dmg USA, Inc. | 2000-08-17 |
| LATEX PATIENT EXAMINATION GLOVES POWDERED WITH PROTEIN CONTENT LABELING CLAIM; 100 MICROGRAM OR LESS OF TOTAL WATER EXTR (K002314) | Perusahaan Getah Asas Sdn. Bhd. | 2000-08-17 |
| COOLTOUCH II (K002347) | New Star Lasers, Inc. | 2000-08-17 |
| SUREFIT DISPERSIVE ELECTRODE (K002002) | Conmedcorp | 2000-08-17 |
| ARTHROCARE SYSTEM 2000 CONTROLLER, ARTHROCARE SYSTEM 2000 CABLE, ARTHROCARE SYSTEM 2000 FOOTSWITCH, ARTHROCARE SYSTEM 20 (K001588) | Arthrocare Corp. | 2000-08-17 |
| MEDIVATORS 5 MINUTE HIGH-LEVEL DISINFECTANT (K993042) | Medivators, Inc. | 2000-08-17 |
| SYNTHES SCALLOPED DISTAL TIBIA PLATE (K001793) | Synthes (Usa) | 2000-08-17 |
| STELKAST PROVEN KNEE SYSTEM (K002281) | Stelkast Company | 2000-08-17 |
| NDO SURGICAL SURGICAL OVERTUBE (K002018) | Surgical, Inc. | 2000-08-17 |
| M2430 DIAGNOSTIC ULTRASOUND SYSTEM WITH THE 21420 TRANSDUCER (K002397) | Agilent Technologies, Inc. | 2000-08-17 |
| STACKHOUSE LENS HOOD, MODEL SA-700/F (K000605) | Stackhouse, Inc. | 2000-08-17 |
| OPERATING ROOM TOWEL, STERILE, COLORS BLUE OR WHITE (K001858) | China Nantong Guangda Textile Co., Ltd. | 2000-08-17 |
| NEURO SCAN MEDICAL SYSTEMS A4000 (K001562) | Neuro Scan Labs | 2000-08-16 |
| APS SERIES DIALYZERS (WET MODELS), APS SERIES DIALYSIS (DRY MODELS) (K001250) | Asahi Medical Co., Ltd. | 2000-08-16 |
| MASTERSITE NEEDLELESS LUER ACTIVATED IV CONNECTOR, MODEL MS 1000 (K001106) | Creative Plastic Technology | 2000-08-16 |
| WMT MODULAR SHOULDER SYSTEM (K001706) | Wrightmedicaltechnologyinc | 2000-08-16 |
| WILLI GELLER CREATION & AV PORCELAIN (K002041) | Jensen Industries, Inc. | 2000-08-16 |
| SURGICAL DYNAMICS SPINAL RETRACTOR (K002008) | United States Surgical, A Division of Tyco Healthc | 2000-08-16 |
| SLIMCATH-DX MODELS, 3SUXXXX, 3SBXXXX, AND FCXXXX (K993698) | Mogul Enterprises | 2000-08-16 |
| ACUMATCH P-SERIES PRESS-FIT PLASMA, ACUMATCH P-SERIES PRESS-FIT, ACUMATCH L-SERIES PRESS-FIT (K002141) | Exactech, Inc. | 2000-08-16 |
| LINKMAX (K001823) | GC America, Inc. | 2000-08-16 |
| GT2 FUSION GUIDE WIRE, MODEL NTLHLJ180,NTLHLS180, NTLHLJ300, NTLHLS300 (K001969) | Medtronic Vascular | 2000-08-16 |
| QUANTA LITE ASCA (S. CEREVISIAE) IGG ELISA (DEN000007) | Inova Diagnostics, Inc. | 2000-08-16 |
| NITRILE EXAM GLOVE, POWDER-FREE, COLOR BLUE (K002218) | Shanghai Champion Plastic Products Co., Ltd. | 2000-08-15 |
| NITRILE EXAM GLOVE, PRE-POWDERED, COLOR BLUE (K002220) | Shanghai Champion Plastic Products Co., Ltd. | 2000-08-15 |
| CHARTER MEDICAL NEONATAL SYRINGE SET (K000685) | Charter Medical, Ltd. | 2000-08-15 |
| SURGICAL DRAPES (K002419) | Allegiance Healthcare Coporation | 2000-08-15 |
| V QUICK PATCH (K993934) | Vq Corp. | 2000-08-15 |
| SANSIBAR CPAP SYSTEM (K000888) | Prym Medical , Ltd. | 2000-08-15 |
| DIALGUARD ENDOTOXIN REMOVAL DEVICE (K993806) | Clarigen, Inc. | 2000-08-14 |
| INSTANT-VIEW COCAINE (BENZYLECGONINE) URINE DIP STRIP TEST (K994403) | Alfa Scientific Designs, Inc. | 2000-08-14 |
| PVP-POLYVINYLPYRROLIDONE REAGENT, MODEL CAT#2210 (K001967) | Invitrocare, Inc. | 2000-08-14 |
| BIOGEL NEOTECH II POWDER-FREE NEOPRENE SURGEON'S GLOVE (K000421) | Ssl Americas, Inc. (Regent Medical) | 2000-08-14 |