| POWDERED VINAL EXAM GLOVES (K011414) | Heyuan Hongli Industries, Inc. | 2001-06-05 |
| POWDER FREE LATEX EXAMINATION GLOVES WITH WATER EXTRACTABLE PROTEIN LABELING CLAIM (K011563) | U.O.P. Rubber Products Sdn Bhd | 2001-06-05 |
| ACCUTNI AND ACCUTNI CALIBRATORS ON THE ACCESS IMMUNOASSAY SYSTEM # 33340, 33345 (K010429) | Beckman Coulter, Inc. | 2001-06-05 |
| PERSONAL INFUSOR LOCAL PAIN MANAGEMENT PROCEDURAL KIT (K010824) | Science Incorporated | 2001-06-05 |
| POWDER-FREE VINYL EXAM GLOVE, YELLOW (K011413) | Heyuan Hongli Industries, Inc. | 2001-06-05 |
| SIMPLICITY SOFT QD SILVER INFUSION SET (K011580) | Sterling Medivations, Inc. | 2001-06-05 |
| STRYKER PAINPUMP PCA (K003543) | Stryker Instruments | 2001-06-05 |
| MEDTRONIC SOFAMOR DANEK BIPHASIC CALCIUM PHOSPHATE (BCP) BONE VOID FILLER (K010701) | Medtronic Sofamor Danek USA, Inc. | 2001-06-05 |
| MODIFICATION TO TSRH SPINAL SYSTEM (K011029) | Medtronic Sofamor Danek, Inc. | 2001-06-05 |
| HELAX-TMS V 5.1 RADIATION THERAPY TREATMENT PLANNING SYSTEM (K010682) | Mds Nordion | 2001-06-05 |
| NEUROGRAPH EVOKED POTENTIAL SYSTEMS (EPS), MODEL EPS-1 (K010669) | Thuris Corp. | 2001-06-04 |
| GAMBRO POLYFLUX 24S, GAMBRO POLYFLUX 24R (K010667) | Gambro Renal Products | 2001-06-04 |
| TDP CQ-27 HEAT LAMP (K003538) | Lhasa Medical, Inc. | 2001-06-04 |
| MODIFIED USS FRACTURE SYSTEM (K010658) | Synthes (Usa) | 2001-06-04 |
| CONTINUOUS FLOW Y-TUBING (K010122) | G.U.-Tek | 2001-06-04 |
| INTEGRA OXYGEN CONCENTRATORS MODEL 6400-OM (K003472) | Sequal Technologies, Inc. | 2001-06-04 |
| ISCREEN VISION SCREENER (K010315) | Iscreen, LLC | 2001-06-01 |
| JET SYRINGE MODEL-100500 (K003741) | Equidyne Systems, Inc. | 2001-06-01 |
| SENTINEL ENTERAL FEEDING PUMP, LH2001 ENTERAL FEEDING PUMP (K011587) | Entracon Corp. | 2001-06-01 |
| SPINAL EPIDURAL NEEDLES (K002405) | Te ME NA S.A.R.L. | 2001-06-01 |
| CUSTOM TCI-COMBI (TINNITUS CONTROL INSTRUMENT COMBINATION) (K011366) | Siemens Hearing Instruments, Inc. | 2001-06-01 |
| RESPIRATORY HUMIDIFIER, MODEL HC150 (K003973) | Fisher & Paykel Healthcare, Ltd. | 2001-06-01 |
| KOKO PEAK KP; KOKO PEAK KP+ (K010009) | Pds Healthcare Products, Inc. | 2001-06-01 |
| VERDICT -II METHAMPHETAMINE (K010226) | Medtox Diagnostics, Inc. | 2001-06-01 |
| DENVER PLEURAL EFFUSION SHUNT WITH EXTERNAL PUMP CHAMBER (K011020) | Denver Biomedicals, Inc. | 2001-06-01 |
| PERCUSURGE GUARDWIRE TEMPORARY OCCLUSION AND ASPIRATION SYSTEM (K003992) | Percu Surge, Inc. | 2001-06-01 |
| POWDERED SYNTHETIC (YELLOW) VINYL PATIENT EXAMINATION GLOVES (K011474) | Shijiazhuang Junfei Plastic Products Co., Ltd. | 2001-05-31 |
| INTRODUCER WITH DISTAL RADIOPAQUE MARKER BAND, MODEL OR-4926XX (K002847) | Maxxim Medical | 2001-05-31 |
| NAT - NUCLEIC ACID TRANSPORT (K003761) | Medical Packaging Corp. | 2001-05-31 |
| BUTTERFLY PLATE FUNCTION SYSTEM (K010632) | Medtronic Sofamor Danek USA, Inc. | 2001-05-31 |
| CADHEALTH SYSTEM, MODEL CHP-001 (K002514) | Caduceus Health Care , Ltd. | 2001-05-31 |
| X-TENDA CUFF POWDER FREE NON-STERILE LATEX EXAMINATION GLOVE WITH PROTEIN CONTENT LABELING CLAIM (50 MICROGRAMS OR LESS) (K010961) | Ansell Healthcare Products, Inc. | 2001-05-31 |
| AMSCO CENTURY MEDIUM STERILIZER, MODEL CENTURY (K010865) | STERIS Corporation | 2001-05-31 |
| VASOTRAC APM205A (K011152) | Medwave, Inc. | 2001-05-31 |
| ULTRACISION HARMONIC SCALPEL BLADES, MODEL DH105,DH145,SH105, SH145,HC145 (K010898) | Ethicon Endo-Surgery, Inc. | 2001-05-31 |
| VERSYO.COM (K010800) | Heraeus Kulzer, Inc. | 2001-05-31 |
| POWDER-FREE VINYL EXAM GLOVES (K011412) | Heyuan Hongli Industries, Inc. | 2001-05-31 |
| ACTIWARE-PLMS (K011430) | Mini-Mitter Co., Inc. | 2001-05-31 |
| OSTEOBELL (K011104) | Biopsybell S.A.S. | 2001-05-31 |
| LAPAROSCOPIC HAND PORT (K003871) | Applied Medical Resources Corp. | 2001-05-31 |
| ESU HANDSWITCHING PENCIL (K001442) | Surgex, Inc. | 2001-05-31 |
| ALPCO MILENIA ANTI-TG EIA (K011415) | American Laboratory Products Co., Ltd. | 2001-05-30 |
| EUB-6000 DIAGNOSTIC ULTRASOUND SCANNER SP-711 SONOPROBE SYSTEM (K011252) | Hitachi Medical Corp. | 2001-05-30 |
| MARK 9000 PHASED ARRAY SHOULDER COIL (K010946) | Usa Instruments, Inc. | 2001-05-30 |
| CONVERGENCE CERVICAL SPINAL SYSTEM (K010639) | Spinal Innovations, LLC | 2001-05-30 |
| ENSIL FABRIC (K010675) | Gottfried Medical, Inc. | 2001-05-30 |
| INTUITIVE SURGICAL DA VINCI SURGICAL SYSTEM, MODEL ISI 1000 (K011002) | Intuitive Surgical, Inc. | 2001-05-30 |
| BREAST BIOPSY DEVICE/MAGNETOM SYSTEMS (K010773) | Siemens Medical Solutions USA, Inc. | 2001-05-30 |
| SYNTHES RESORABLE MESHES AND SHEETS (K003788) | Synthes (Usa) | 2001-05-30 |
| PERC-D SPINEWAND (K010811) | Arthrocare Corp. | 2001-05-30 |
| REBSTOCK YASARGIL ANEURYSM CLIP (K003500) | Rebstock - Instrumente GmbH | 2001-05-30 |
| PROGNOST ES, MODEL 0302 0000 (K011290) | Xmar Corp. | 2001-05-30 |
| VAL LUX 600 SURGICAL LIGHT (PLUS AND RS), MODEL ML600/S: SINGLE LIGHT HEAD, ML600/SS: SINGLE LIGHT HEAD, ML600/1D): DOUB (K010716) | Valmed Corp. | 2001-05-30 |
| FORTAFLEX SURGICAL SLING (K011027) | Organogenesis, Inc. | 2001-05-30 |
| MXD100/MX 20, OR MX 30, OR MX 40 OR MX 50--(MXD 100 SERIES) (K011111) | Modular X-Ray Devices | 2001-05-30 |
| 2.0/2.4 CANNULATED SCREW SYSTEM (K010783) | Osteomed Corp. | 2001-05-30 |
| SUTURTEK FASTCLOSE FASCIA CLOSURE DEVICE (K011105) | Qrc Consulting | 2001-05-30 |
| SCAPHIX, STAPLE, FIXATION, BONE (K003033) | Avanta Orthopaedics, Inc. | 2001-05-30 |
| INSTANT-VIEW METHADONE URINE DIP STRIP TEST (K010014) | Alfa Scientific Designs, Inc. | 2001-05-29 |
| GOLD CORE 73 LS (K011362) | Jeneric/Pentron, Inc. | 2001-05-29 |
| SYNCHRON LX SYSTEMS HIGH SENSITIVITY C-REACTIVE PROTIEN (CRPH) REAGENT (K010597) | Beckman Coulter, Inc. | 2001-05-29 |
| INSTANT-VIEW BENZODIAZEPINE (BZD) URINE CASSETTE TEST (K003881) | Alfa Scientific Designs, Inc. | 2001-05-29 |
| INSTANT-VIEW MORPHINE (2000) URINE DIP STRIP TEST (K010079) | Alfa Scientific Designs, Inc. | 2001-05-29 |
| CEDIA DAU AMPHETAMINES/ECSTASY ASSAY (K010496) | Microgenics Corp. | 2001-05-29 |
| MEDISYSTEMS LUER ACCESS INJECTION SITE (K010279) | Medisystems Corp. | 2001-05-29 |
| INSTANT-VIEW PHENCYCLIDINE (PCP) URINE DIP STRIP TEST (K010045) | Alfa Scientific Designs, Inc. | 2001-05-29 |
| TINA-QUANT D-DIMER TEST SYSTEM (K011143) | Roche Diagnostics Corp. | 2001-05-29 |
| MODIFICATION TO INSTANT-VIEW METHAMPHETYAMINE (METH1000) URINE TEST (CASSETTE) (K003847) | Alfa Scientific Designs, Inc. | 2001-05-29 |
| INSTANT-VIEW BARBITUATE URINE DIP STRIP TEST (K010125) | Alfa Scientific Designs, Inc. | 2001-05-29 |
| SCS CLOSED SCREW (K003733) | Ortho Tec, LLC | 2001-05-29 |
| INSTANT-VIEW PHENCYCLIDINE (PCP) URINE CASSETTE TEST (K010047) | Alfa Scientific Designs, Inc. | 2001-05-29 |
| DANMAR PRODUCTS MICHIGAN CRANIAL HELMET (K003630) | Danmar Products, Inc. | 2001-05-29 |
| OB-1 FETAL MONITOR (K011304) | Analogic Corp. | 2001-05-29 |
| ALANTE, BATTERY OPERATED POWER WHEELCHAIR (K011153) | Golden Technologies, Inc. | 2001-05-29 |
| INSTANT-VIEW MORPHINE (2000) URINE CASSETTE TEST (K010080) | Alfa Scientific Designs, Inc. | 2001-05-29 |
| VECTORSURGE 5, MODEL VS-500 (K002058) | Metron Medical Australia, Pty, Ltd. | 2001-05-29 |
| MODIFICATION TO INSTANT-VIEW METHAMPHETAMINE (METH 1000) URINE TEST (DIP STRIP) (K003845) | Alfa Scientific Designs, Inc. | 2001-05-29 |
| INSTANT-VIEW BARBITURATE URINE CASSETTE TEST (K003647) | Alfa Scientific Designs, Inc. | 2001-05-29 |
| DJ ORTHOPEDICS POST SCREW (K010594) | Dj Orthopedics, LLC | 2001-05-29 |
| INSTANT-VIEW METHADONE URINE CASSETTE TEST (K010015) | Alfa Scientific Designs, Inc. | 2001-05-29 |
| SYNTHES SYNEX SPACER SYSTEM (K003836) | Synthes | 2001-05-29 |
| INSTANT-VIEW BENZODIAZEPINE (BZD) URINE TEST (DIP STRIP) (K003879) | Alfa Scientific Designs, Inc. | 2001-05-29 |
| JEWEL MPS (K011374) | Vestil Manufacturing Corp. | 2001-05-29 |
| ULTRASAFE PASSIVE X-SERIES, NEEDLE GUARD SYRINGE, PISTON (ACCESSORY) (K011369) | Safety Syringes, Inc. | 2001-05-29 |
| SNOW LOTUS POWDER FREE LATEX EXAMINATION GLOVES WITH A PROTEIN CONTENT LABELING CLAIM (50 MICROGRAMS OR LESS) (K010947) | Beijing Reagent Latex Products Co., Ltd. | 2001-05-25 |
| MENISCUS ARROW SHEATH #CN1000A; SMARTSCREW ACL SHEATH #SSA2000A (K010554) | Bionx Implants, Inc. | 2001-05-25 |
| KFA-127 KNEE, FOOT AND ANKLE ARRAY (K003505) | Mri Devices Corp. | 2001-05-25 |
| JAX GRANULES BONE VOID FILLER (K010557) | Smith & Nephew, Inc. | 2001-05-25 |
| END-TO-END AND SIDE-BY-SIDE CONNECTORS (K010563) | Spinal Concepts, Inc. | 2001-05-25 |
| EVERGREEN AND MULTIPLE PRIVATE LABELS NON-STERILE POWDERED LATEX PATIENT EXAMINATION GLOVES, WITH PROTEIN LABELING (200 (K011376) | Yty Industry (Manjung) Sdn Bhd | 2001-05-25 |
| HUMMER IV MICRODEBRIDER SYSTEM (K011381) | Stryker Instruments | 2001-05-25 |
| POWDER-FREE STERILE SYNTHETIC VINYL EXAMINATION GLOVES (K011186) | Allegiance Healthcare Corp. | 2001-05-25 |
| RADIUS COUGAR WIRE (K011287) | Radius Medical Technologies, Inc. | 2001-05-25 |
| AMBU GEL, HYDROGEL BURN DRESSING (K010583) | Ambu, Inc. | 2001-05-25 |
| GOODNET (K010763) | Goodman Co., Ltd. | 2001-05-25 |
| SPO2 WRAP SENSOR (K002848) | Epic Medical Equipment Services, Inc. | 2001-05-24 |
| INFANT LIMB HOLDER, MODELS 306080 & 306081 (K010818) | Skil-Care Corp. | 2001-05-24 |
| VELOGENE GENOMIC IDENTIFICATION ASSAY FOR MRSA WITH ONE-STEP DETECTION (K010858) | Id Biomedical Corp. | 2001-05-24 |
| HEMODIALYSIS TUBING SETS (K001971) | Ofi Biomedica S.P.A. | 2001-05-24 |
| ULTRAGUIDE MR-GUIDE 3000 (K011418) | Ultraguide , Ltd. | 2001-05-24 |