| OCCU-FLO PUNCTUM PLUGS (K001768) | U.S. Iol, Inc. | 2000-09-19 |
| BIS ENGINE (K002837) | Aspect Medical Systems, Inc. | 2000-09-19 |
| KSEA PERCUTANEOUS FORAMINOSCOPY SET (K001918) | KARL STORZ Endoscopy-America, Inc. | 2000-09-19 |
| PAIN CARE 3000 (K002073) | Breg, Inc. | 2000-09-19 |
| ASCENT XXL OPEN BOX FEMORAL COMPONENT (K002735) | Biomet, Inc. | 2000-09-19 |
| BUFFLIGHT CLT SURGICAL LASER SYSTEM (K000727) | Y-Beam Technologies, Inc. | 2000-09-19 |
| ASCENT KNEE SYSTEM (K002678) | Biomet, Inc. | 2000-09-19 |
| POLY PER-Q-CATH PICC CATHETER,MODEL 3236100 AND POLY PER-Q-CATH MIDLINE CATHETER, MODEL 3134135 (K001901) | C.R. Bard, Inc. | 2000-09-19 |
| PROSTEC 125I BRANCHYTHERAPY SNAPSEED (K001366) | Prostec, LLC | 2000-09-19 |
| HL168T (K002750) | Health & Life Co., Ltd. | 2000-09-18 |
| MODIFICATION TO PANAVIA F (K002322) | Kuraray America, Inc. | 2000-09-18 |
| BIONOSTICS GLUCOSE QUALITY CONTROL SOLUTION FOR USE WITH MEDISENSE BLOOD GLUCOSE TEST STRIP SYSTEMS (K002540) | Bionostics, Inc. | 2000-09-18 |
| SERAGARD VASCULAR ACCESS PATCH (K001175) | Platinum Services, Inc. | 2000-09-18 |
| ACTI-FLEX IV ADMINISTRATION SET (K001599) | R-Group Intl. | 2000-09-18 |
| QUEST MPS BACK-UP SYSYEM (K002366) | Quest Medical, Inc. | 2000-09-18 |
| IPI HUMIDIFIER CHAMBER (K993282) | I.P.I. Medical Products | 2000-09-18 |
| RAEBBITT/EVOLUTION POWERED WHEELCHAIR (K000678) | Otto Bock Orthopedic Industry, Inc. | 2000-09-18 |
| DIAGNOSTIC ELECTROMYOGRAPHY NEEDLE ELECTRODE, DISPOSABLE HYPODERMIC NEEDLE (K001869) | Medicotest A/S | 2000-09-18 |
| 6060 MULTI-THERAPY PUMP, MODEL 2M9832; 6060 EPIDURAL PUMP, MODEL 2L9351 (K002679) | Baxter Healthcare Corp | 2000-09-18 |
| LARYNGO-TRACHEAL MUCOSAL ATOMIZATION DEVICE (MADGIC) (K002255) | Wolfe Tory Medical, Inc. | 2000-09-18 |
| COOK IVF FOLLICLE FLUSHING BUFFER, COOK IVF OOCYTE WASH BUFFER, COOK IVF FERTILIZATION MEDIUM, COOK IVF CLEAVAGE MEDIUM, (K002385) | Cook Ob/Gyn | 2000-09-18 |
| PELVX GELLHORN VAGINAL PESSARY 603-608 (K002329) | Deschutes Medical Products, Inc. | 2000-09-18 |
| POWDER FREE LATEX EXAMINATION PATIENT GLOVES (K994420) | Purna Bina Sdn Bhd | 2000-09-18 |
| K-CENTRUM ANTERIOR SPINAL FIXATION SYSTEM (K002371) | Spineology, Inc. | 2000-09-15 |
| DS DS I-SERIES (K002553) | Smv America | 2000-09-15 |
| PRO OSTEON 200R RESORBABLE BONE GRAFT SUBSTITUTE, MODELS 2RG051, 2RG101, 2RG151, 2RG201, 2RG301, 2RG050, 2RG100, 2RG150, (K000515) | Interpore Cross Intl. | 2000-09-15 |
| ADULT/PEDIATRIC CEREBRAL OXIMETER, MODEL INVOS 5100 (K001842) | Somanetics Corp. | 2000-09-15 |
| UREA-L3K ASSAY, CATALOGUE NUMBER 283-17/30 (K002694) | Diagnostic Chemicals , Ltd. | 2000-09-15 |
| GENX CODA AIR PURIFICATION SYSTEM (K001486) | <Genx> Intl., Inc. | 2000-09-15 |
| CORDLESS COMPACT MOBILE X-RAY SYSTEM (K002685) | Medison Radiology Systems, Inc. | 2000-09-15 |
| NICORE MODEL ESP -1 (K980937) | Nicore Equipment & Leasing, Inc. | 2000-09-15 |
| BIO-LOGIC CEEGRAPH NETLINK (K002570) | Bio-Logic Systems Corp. | 2000-09-14 |
| ACCOLADE C FEMORAL COMPONENT (K002320) | Howmedica Osteonics Corp. | 2000-09-14 |
| 14 FR TWO-LUMEN HEMODIALYSIS CATHERIZATION KIT WITH BLUE FLEXTIP ARROWG+ARD BLUE CATHETER FOR HIGH VOLUME INFUSIONS, PRO (K993933) | Arrow Intl., Inc. | 2000-09-14 |
| ASPECT MEDICAL SYTEMS EEG ENHANCED BIS SENSOR 186-0106 (K002734) | Aspect Medical Systems, Inc. | 2000-09-14 |
| THROMBELASTOGRAPH COAGULATION ANALYZER TEG-5000 SERIES (K002177) | Haemoscope Corp. | 2000-09-14 |
| ATRISORB-D FREEFLOW BIOABSORBABLE GUIDED TISSUE REGENERATION (GTR) BARRIER WITH 4% DOXYCYCLINE (K994137) | Atrix Laboratories, Inc. | 2000-09-13 |
| MIDAS TOUCH BLUE NITRILE EXAMINATION GLOVES-POWDERED (K000139) | Industrial Clothings, Ltd. | 2000-09-13 |
| HUMID-HEAT (K993773) | Hudson Rcj AB | 2000-09-13 |
| BESTEX POWDER-FREE LATEX EXAM GLOVES WITH LABELING CLAIM. (50 MICROGRAMS OR LESS) (K002087) | Qingdao Bestex Rubber & Plastic Products Co., Ltd. | 2000-09-13 |
| ABL-700 SERIES, MODEL ABL 7XX (VARIOUS MODELS) (K002290) | Radiometer Medical A/S | 2000-09-13 |
| MOTOR-DRIVE MANIPULATOR MM-89 (K002291) | Narishige Co., Ltd. | 2000-09-13 |
| METHAFILCON A (K002625) | CooperVision, Inc. | 2000-09-13 |
| COBE SMARXT VVR 4000 FILTERED HARDSHELL VENOUS RESERVOIR (K002591) | Cobe Cardiovascular, Inc. | 2000-09-13 |
| MARIETTA CONTACT LENS SERVICE, COLOR ENHANCED TINTED SOFT CONTACT LENS (K002647) | Marietta Contact Lens Service | 2000-09-13 |
| MEDILOG EXCEL 2 - HOLTER MANAGEMENT SYSTEM (K002544) | Oxford Instruments | 2000-09-13 |
| COOK IVF SPERM BUFFER, COOK IVF SPERM MEDIUM, AND COOK IVF SPERM GRADIENT KIT (K002383) | Cook Ob/Gyn | 2000-09-13 |
| MIDAS TOUCH NITRILE EXAMINATION GLOVES-POWDERFREE (K000138) | Industrial Clothings, Ltd. | 2000-09-13 |
| 3D MOTOR-DRIVEN COARSE MANIPULATOR MM-188NE (K002293) | Narishige Co., Ltd. | 2000-09-13 |
| POWDER FREE LATEX EXAMINATION GLOVES WITH WATER EXTRACTABLE PROTEIN LABELING CLAIM. (50 MICROGRAMS OR LESS) (K002701) | Alliance Rubber Products Sdn. Bhd. | 2000-09-13 |
| MIDAS TOUCH LATEX EXAMINATION GLOVES-POWDERED (K000141) | Industrial Clothings, Ltd. | 2000-09-13 |
| MODIFICATION TO MASIMO SET RADICAL PULSE OXIMETER WITH SATSHARE AND LNOP SERIES OF SENSORS AND CABLES (K002682) | Masimo Corp. | 2000-09-13 |
| PILLING WECK SURGICAL HEART STABILIZER REMOVABLE PADS (K992476) | Pilling Weck Surgical | 2000-09-13 |
| MIDAS TOUCH NITRILE EXAMINATION GLOVES-POWDERED (K000143) | Industrial Clothings, Ltd. | 2000-09-13 |
| MIDAS TOUCH LATEX EXAMINATION GLOVES-POWDER FREE (K000142) | Industrial Clothings, Ltd. | 2000-09-13 |
| MIDAS TOUCH BLUE NITRILE EXAMINATION GLOVES-POWDER FREE (K000145) | Industrial Clothings, Ltd. | 2000-09-13 |
| MEDTRONIC PS MEDICAL POLYURETHANE SHUNT, MODELS 27521, 27116, 20022 (K991502) | Medtronic PS Medical | 2000-09-12 |
| MAGNA FORTIS OPHTHALMOSCOPE DIAGNOSTIC KIT (K002044) | Magna Fortis Corporation | 2000-09-12 |
| REFRACTIVE SURGERY BLADES (K001806) | Millennium Biomedical, Inc. | 2000-09-12 |
| ACCUWARM EMG HEAT LAMP (K001800) | Rjl Associates, LLC | 2000-09-12 |
| USS VAS (K002517) | Synthes (Usa) | 2000-09-12 |
| MOSS MIAMI 6.35MM ROD SYSTEM MONOAXIAL SCREWS, POLYAXIAL REDUCTION SCREWS AND SACRAL EXTENDERS (K002607) | Depuyacromed | 2000-09-12 |
| EL-ANA PROFILES-2K1 (K002559) | Theratest Laboratories, Inc. | 2000-09-12 |
| INSIGHT IMAGE GUIDED SURGICAL SYSTEM (K001642) | Surgical Insights, Inc. | 2000-09-12 |
| TPN NUTRITION BAG (EVA), EMPTYING TUBE, BAG SYRINGE FILL SET (K001461) | Biometrix , Ltd. | 2000-09-11 |
| FMS SOLO (K002040) | Future Medical Systems, Inc. | 2000-09-11 |
| GOLDEN-RULE SCALING CATHETER (K002416) | Medical Device Technologies, Inc. | 2000-09-11 |
| VIRIDIS LASER (K001784) | Cosmos Medical Technology | 2000-09-11 |
| FETALTROL (K002511) | Trillium Diagnostics, LLC | 2000-09-11 |
| INFUSOR PATIENT CONTROL MODULE, 2ML, MODEL 2C1067K (K002739) | Baxter Healthcare Corp | 2000-09-11 |
| ENZYME IMMUNOASSAY ANTI-SSDNA ANTIBODY TEST (K001900) | Helix Diagnostics, Inc. | 2000-09-11 |
| LATEX EXAMINATION GLOVES, POWDERED, (CONTAINS 100 MICROGRAMS OR LESS OF TOTAL WATER EXTRACTABLE PROTEIN PER GRAM). (K002448) | Oon Corp. Resources | 2000-09-11 |
| C02 LASER MULTIPULSE (K002032) | Asclepion-Meditec AG | 2000-09-11 |
| DIGITAL BLOOD PRESSURE MONITOR, MODELS HD-503 AND HD-505 (K002722) | Jawon Medical Co., Ltd. | 2000-09-11 |
| PROLITE VL PULSED LIGHT SYSTEM (K002072) | Medical Bio Care Sweden AB | 2000-09-11 |
| PRIMED PLEATED TIE-BACK, PROCEDURE MASK PM4-305, PRIMED PLEATED EAR-LOOP, PROCEDURE MASK PM4-306 (K001951) | Primeline Medical Products, Inc. | 2000-09-08 |
| OLYMPUS XGIF-N200H GASTROINTESTINAL VIDEOSCOPE (K001766) | Olympus Optical Co., Ltd. | 2000-09-08 |
| TAMPAX SATIN TAMPONS, CLOSED END FLUSHABLE APPLICATOR; TAMPAX TAMPONS, OPEN END FLUSHABLE APPLICATOR (K002096) | Procter & Gamble Co. | 2000-09-08 |
| RESPIRONICS SILHOUETTE NASAL MASK, MODELS 1003224 AND 1003223 (K000705) | Respironics, Inc. | 2000-09-08 |
| VITALOGRAPH BASE STATION (K000599) | Vitalograph, Inc. | 2000-09-08 |
| SUPER 3 (K002299) | Dental Alloy Products, Inc. | 2000-09-08 |
| MASIMO SET RADICAL PULSE OXIMETER WITH SATSHARE AND LNOP SERIES OF SENSORS AND CABLES (K002477) | Masimo Corp. | 2000-09-08 |
| M2424A SONOS 5500/4500 DIAGNOSTIC ULTRASOUND SYSTEM, VERSION B.2. 21330A TRANSDUCER (K002470) | Agilent Technologies, Inc. | 2000-09-08 |
| RUBBERCARE POLYMER-COATED POWDERED LATEX EXAMINATION GLOVES/GUARDIAN POLYMER-COATED POWDERED EXAMINATION GLOVES. CONTAI (K002111) | Perusahaan Pelindung Getah (M) Sdn Bhd | 2000-09-08 |
| SPECTRUM 2 REUSABLE FULL FACE MASK, MODEL 1004884 AND 1004876 (K002465) | Respironics, Inc. | 2000-09-08 |
| HEARTSTREAM XL DEFIBRILLATOR/MONITOR, MODEL M4735A (K001725) | Agilent Technologies, Inc. | 2000-09-08 |
| DERMAGRIP POWDERFREE POLYMER COATED LATEX EXAMINATION GLOVE WITH PROTEIN CONTENT LABELING CLAIM (50 MICROGRAM OR LESS) (K002579) | Wrp Specialty Products Sdn. Bhd. | 2000-09-08 |
| SPIROXCARD DIAGNOSTIC SPIROMETER AND PULSE OXIMETER (K001995) | Qrs Diagnostic, LLC | 2000-09-08 |
| SUPER 12 (K002301) | Dental Alloy Products, Inc. | 2000-09-08 |
| NATURAL ORDINARY RIBBED,DOTTED,AND CONTOURED (MALE RUBBER LATEX CONDOM, LUBRICATED W/SILICONE OIL (K002060) | Dongkuk Techco Rubber Industries | 2000-09-07 |
| CANNULATION TOURNIQUET SET, 2 TUBE OR 5 TUBE (K000830) | California Medical Laboratories, Inc. | 2000-09-07 |
| I.V. SET-LUER LOCK WITH LATEX FREE INJECTION SITE, MODEL B411 (K001872) | Codan US Corp. | 2000-09-07 |
| INPLANT ORTHODONTIC ANCHOR SYSTEM (K000643) | Nobel Biocare Uas, Inc. | 2000-09-07 |
| P.O.P. PAIN KIT (K001342) | Post Operative Pain Management | 2000-09-07 |
| LOOK COLLAGEN SPACERS, MODEL 1514B (K001765) | Surgical Specialties Corp | 2000-09-07 |
| ZORTRAN DETECTOR (K000997) | Lucent Medical Systems | 2000-09-07 |
| MASIMO SET RADICAL PULSE OXIMETER WITH SATSHARE AND LNOP SERIES OF SENSORS AND CABLES, MODEL RADICAL, LNOP-ADT, LNOP-PDT (K002574) | Masimo Corp. | 2000-09-06 |
| CAPIOX ARTERIAL FILTER (K002026) | Terumo Medical Corp. | 2000-09-06 |
| AUGUSTINE MEDICAL BAIR HUUGER, MODEL 750 TOTAL TEMPERATURE MANAGEMENT SYSTEM-(MODEL 750 WARMING UNIT, BAIR HUGGER BLANK (K001149) | Augustine Medical, Inc. | 2000-09-06 |
| S/5 COMPACT CRITICAL CARE MONITOR WITH S-00C03 OR S-00C04 SOFTWARE (K002158) | Datex-Ohmeda, Inc. | 2000-09-06 |