| CAMLOG ROOTFORM IMPLANT SYSTEM (K000100) | Altatec Biotechnologies | 2000-01-28 |
| CAMLOG SCREW IMPLANT SYSTEM (K000099) | Altatec Biotechnologies | 2000-01-28 |
| AROMA FINE (NORMAL AND FAST SET) (K994077) | GC America, Inc. | 2000-01-27 |
| GAMBRO DQM 200 (K990039) | Gambro Healthcare | 2000-01-27 |
| ONTRAK TESTSTIK FOR PCP, CAT. 07 6654 2 (K994020) | Roche Diagnostics Corp. | 2000-01-27 |
| EXCIMER LASER PHOTOTHERAPY SYSTEM, AL7000 (K992914) | Acculase, Inc. | 2000-01-27 |
| SYVA EMIT II PLUS BARBITURATE ASSAY, MODEL 9D029UL/9D129UL (K993987) | Syva Co. | 2000-01-27 |
| ELECTROSURGICAL ELECTRODE FAMILY (K992045) | Genesis Medical, Inc. | 2000-01-27 |
| ATRIUM MEDICAL CORPORATION ADVANTA PTFE FACIAL IMPLANT (K992991) | Atrium Medical Corp. | 2000-01-27 |
| ONTRAK TESTCUP 5, CAT. 07 6481 7 (K994030) | Roche Diagnostics Corp. | 2000-01-27 |
| ONTRAK TESTCUP 5 M2K, CAT. 11 1850 1 (K994017) | Roche Diagnostics Corp. | 2000-01-27 |
| METERED DOSE INHALER ADAPTER-DISPOSABLE, ADAPTER REUSABLE (K991355) | Instrumentation Industries, Inc. | 2000-01-27 |
| SYVA EMIT II PLUS PHENCYCLIDINE ASSAY, MODEL 9J029UL (K993983) | Syva Co. | 2000-01-27 |
| PLASTIC PORT IMPLANTABLE VENOUS ACCESS SYSTEM (K994216) | Sims Deltec, Inc. | 2000-01-27 |
| ABBOTT AEROSET CARBAMAZEPINE ASSAY AND CALIBRATORS; MODELS 1E12 AND 6E90 (K993028) | Syva Co. | 2000-01-27 |
| UNIGRAFT (K993784) | Unicare Biomedical | 2000-01-27 |
| SYVA EMIT II PLUS AMPHETAMINE/METHAMPHETAMINE ASSAY 9C029UL/9C129UL (K993982) | Syva Co. | 2000-01-27 |
| STERITITE PERFORATED BOTTOM RIGID REUSABLE STERILIZATION CONTAINER SYSTEM WITH SCF02 - POLYPROPYLENE NON-WOVEN DISPOSABL (K991023) | Case Medical, Inc. | 2000-01-27 |
| ABBOT AEROSET PHENYTOIN ASSAY & ABBOT AEROSET PHENYTOIN CALIBRATORS (K993026) | Syva Co. | 2000-01-27 |
| ABBOTT AEROSET PHENOBARBITAL ASSEY AND CALIBRATORS;MODELS 1E08 AND 5F54 (K993031) | Syva Co. | 2000-01-27 |
| EMS KERMIT (K992504) | (Ems Sa) Electro Medical Systems | 2000-01-27 |
| IMMULITE AMPHETAMINE, MODELS LKAM1, LKAM5 (K992632) | Diagnostic Products Corp. | 2000-01-27 |
| ABBOTT AEROSET THEOPHYLLINE ASSAY AND CALIBRATORS; MODELS 1E09 AND 6E89 (K993029) | Syva Co. | 2000-01-27 |
| NEUROCOMP (K993654) | Neurocybernetics | 2000-01-27 |
| IMPREGUM GARANT L DUOSOFT (K994190) | Espe Dental AG | 2000-01-27 |
| RX VIATRAC 18 PERIPHERAL DILATATION CATHETER, OTW VIATRAC 18 PERIPHERAL DILATATION CATHETER (K993639) | Guidant Corp. | 2000-01-27 |
| EPILIGHT HAIR REMOVAL SYSTEM, PHOTODERM HR SYSTEM (K991935) | Esc Medical Systems , Ltd. | 2000-01-27 |
| SYVA EMIT II PLUS METHAQUALONE ASSAY, MODEL 9Q029UL/9Q129UL (K993986) | Syva Co. | 2000-01-27 |
| SYVA EMIT II PLUS BENZODIAZEPINE ASSAY, MODELS 9F029UL/9F129UL (K993985) | Syva Co. | 2000-01-27 |
| MILLENNIUM HUBER PLUS SAFETY INFUSION SET (K993848) | Millennium Medical Distribution, Inc. | 2000-01-27 |
| QUANTA LITE LYME B. BURGDORFERI IGG/IGM ELISA KIT (K994004) | Inova Diagnostics, Inc. | 2000-01-27 |
| SYVA EMIT II PLUS COCAINE METABOLITE ASSAY, MODEL 9H029UL (K993988) | Syva Co. | 2000-01-27 |
| NEUROTREK PHYSIOLOGICAL NAVIGATION SYSTEM FOR NEUROSURGERY (K993622) | Alpha Omega , Ltd. | 2000-01-24 |
| MD 420/440/460/470/480/490 (K993200) | Isopure, Corp. | 2000-01-24 |
| PURE WATER, INC.'S WATER PURIFICATION SYSTEMS (K992786) | Pure Water, Inc. | 2000-01-24 |
| PURE WATER INC'S ACIDIFIED STORAGE AND DISTRIBUTION SYSTEM WITH OPTIONAL REMOTE FILL (K993058) | Pure Water, Inc. | 2000-01-24 |
| CANDELA SCLERO LONG PULSE DYE LASER (K993671) | Candela Corp. | 2000-01-24 |
| RAPID DRUG SCREEN 3-PANEL TEST FOR COCAINE, MARIJUANA (THC) (CANNABINOIDS) AND OPIATES (3 PANEL TEST FOR CTO) (K993961) | American Bio Medica Corp. | 2000-01-24 |
| POWERHEART AECD (K993533) | Cardiac Science, Inc. | 2000-01-24 |
| SECURLINE UMBILICAL CORD CLAMP CLIPPER #3540 (K994263) | Precision Dynamics Corp. | 2000-01-24 |
| VERSAPOINT ELECTROSURGERY SYSTEM (SCUBA) (K994418) | ETHICON, Inc. | 2000-01-24 |
| BABY DOPPLEX 4000, MODEL BD 4000 (K990569) | Huntleigh Healthcare, Inc. | 2000-01-24 |
| FIBERED GDC-18 VORTX SHAPE GUGLIELMI DETACHABLE COIL (K993418) | Boston Scientific, Target | 2000-01-21 |
| MRP-TITAN (K992403) | Rotec Medizintechnik GmbH | 2000-01-21 |
| DERMAFREEZE (K992286) | Rhealm Pharmaceuticals, Inc. | 2000-01-21 |
| GDC-10 GUGLIELMI DETACHABLE COIL (GDC) (3D SHAPE GDC), GDC-18 GUGLIELMI DETACHABLE COIL (GDC) (3D SHAPE GDC) (K993417) | Boston Scientific, Target | 2000-01-21 |
| REVEAL PLUS INSERTABLE LOOP RECORDER SYSTEM, MODEL 9526 IMPLANTED RECORDER AND MODEL 6191 PATIENT ACTIVATOR (K994331) | Medtronic Vascular | 2000-01-21 |
| XPS STRAIGHTSHOT OR MODEL 2000 MICRODEBRIDER SYSTEM OR XPS POWERSCULPT (K992855) | Xomed, Inc. | 2000-01-21 |
| CITATION TMZF HA STEM (K993768) | Howmedica Osteonics Corp. | 2000-01-21 |
| ABI VEST AIRWAY CLEARANCE SYSTEM (K993629) | American Biosystems, Inc. | 2000-01-21 |
| GDC-10 STRETCH RESISTANT GUGLIELMI DETACHABLE COIL, GDC-10 2-DIAMETER STRETCH RESISTANT GUGLIELMI DETACHABLE COIL, GDC-1 (K993415) | Boston Scientific, Target | 2000-01-21 |
| IMMULITE METHAMPHETAMINE, MODEL LKMA1, LKMA5 (K992634) | Diagnostic Products Corp. | 2000-01-20 |
| SMITH & NEPHEW XENON LIGHT SOURCES AND ACCESSORIES (K994084) | Smith & Nephew, Inc. | 2000-01-20 |
| HP M2376A DEVICE LINK SYSTEM (K993587) | Hewlett-Packard Co. | 2000-01-20 |
| COLORED AND FLAVORED POWDER FREE LATEX EXAMINATION GLOVES (K993864) | Supermax Sdn Bhd | 2000-01-20 |
| MSAS PROFESSIONAL (K993824) | Biomeridian, Int. | 2000-01-20 |
| MODEL 1000 HOLMIUM LASER SYSTEM (K994273) | New Star Lasers, Inc. | 2000-01-20 |
| MRI EQUIPMENT COVER (K993682) | Image-Guided Neurologics, Inc. | 2000-01-20 |
| STELLARTECH RADIOFREQUENCY GENERATOR,MODEL 1025A-115, STELLARTECH RADIOFREQUENCY GENERATOR, MODEL 1025A-230 (K994173) | Stellartech Research Corp. | 2000-01-20 |
| UFI GEL HARD (K993827) | Voco GmbH | 2000-01-20 |
| PATIENT NITRILE EXAMINATION GLOVES (POWDERED) (K992675) | Wear Safe Malaysia Sdn. Bhd. | 2000-01-20 |
| MAMMOGRAPHY PRO, MODEL 13017, DIAGNOSTIC PRO W/ MAMMOGRAPHY OPTION, MODEL 13205 (K993598) | Vidar Systems Corp. | 2000-01-20 |
| GOWN BACK, MODEL 13-403N; 13-404N; 13-405N (K992436) | Techstyles | 2000-01-20 |
| ALKALINE PHOSPHATASE LIQUID REAGENT-KINETIC, MODELS A504-150 AND A504-500H (K000067) | Teco Diagnostics | 2000-01-20 |
| CAUTERY GRASPER/DISSECTOR (K994019) | Starion Instruments | 2000-01-20 |
| MTP DISPOSABLE TROCARS (K994066) | Mtp Medical Technical Promotion GmbH | 2000-01-20 |
| ACON ONE STEP HOME PREGNANCY TEST STRIP (K993483) | ACON Laboratories, Inc. | 2000-01-20 |
| SYVA EMIT II PLUS METHADONE ASSAY, MODELS 9E029UL/9E129UL (K994005) | Syva Co. | 2000-01-20 |
| GREEN PEPPERMINT FLAVORED POWDERED LATEX EXAMINATION GLOVES (K993865) | Supermax Sdn Bhd | 2000-01-20 |
| DIMENSION TOTAL IRON BINDING CAPACITY (IBCT) CALIBRATOR (K994114) | Dade Behring, Inc. | 2000-01-20 |
| REVELATION POROUS HIP STEM (K994070) | Encore Orthopedics, Inc. | 2000-01-20 |
| EXACTECH ACUMATCH INTEGRATED HIP SYSTEM M-SERIES FEMORAL STEM COMPONENT (K993736) | Exactech, Inc. | 2000-01-20 |
| MODIFICATION TO LASER-SHIELD II (K993582) | Xomed, Inc. | 2000-01-20 |
| POWDERED LATEX EXAMINATION GLOVES WITH PROTEIN CONTENT LABELING CLAIM (100 MICROGRAMS OR LESS) (K994013) | Glovco (M) Sdn. Bhd. | 2000-01-20 |
| EC-7701 FLUID WARMING CABINET (K993797) | Enthermics Medical Systems, Inc. | 2000-01-20 |
| SENSI-PRO DISPOSABLE POWDER FREE SYNTHETIC VINYL PATIENT EXAMINATION GLOVES WITH BEIGE PIGMENT ADDITIVES (K994258) | Shinemound Enterprise, Inc. | 2000-01-20 |
| OLYMPUS CREATINE KINASE REAGENT OSR6179/6279 (K994189) | Olympus Diagnostica GmbH | 2000-01-20 |
| WATCH STYLE WRIST DIGITAL BLOOD PRESSURE MONITOR, MODEL: KLOCK (K991545) | Industrielle Entwicklung Medizintechnik Und Vertri | 2000-01-19 |
| SONOACE 600 DIAGNOSTIC ULTRASOUND SYSTEM (K000030) | Medison America, Inc. | 2000-01-19 |
| INTER-OS BONE GENERATOR (K993869) | Inter-Os Technologies, LLC | 2000-01-19 |
| AF-180 HEMODIALYZER (K992564) | Althin Medical AB | 2000-01-18 |
| DIAGNOSTIC PRO, MODEL 12772, VXR-16, MODEL 13020, VXR-16 DOSIMETRY PRO, MODEL 13019 (K993599) | Vidar Systems Corp. | 2000-01-18 |
| SYVA EMIT II PLUS CANNABINOID ASSAY, MODELS 9N029UL/9N129UL (K993984) | Syva Co. | 2000-01-18 |
| LATEX CONDOM (K994095) | Thai Nippon Rubber Industry Co., Ltd. | 2000-01-18 |
| TEH LOONG VINYL, POWDER-FREE, PATIENT EXAMINATION GLOVE (K993849) | Longbest (Xiamen) Balls Co., Ltd. | 2000-01-18 |
| ORA-50 ELECTROTHERMAL SYSTEM AND ACCESSORIES (K994333) | Oratec Interventions, Inc. | 2000-01-18 |
| FAS ENDOLUMINAL BRUSH (K993614) | Fas Medical , Ltd. | 2000-01-18 |
| 1ST RESPONSE INFANT MANUAL RESUSCITATOR, BAG RESEVOIR, 1ST RESPONSE PEDIATRIC MANUAL RESUSCITATOR, BAG RESERVOIR, 1ST RE (K991861) | Sims Portex, Inc. | 2000-01-18 |
| 3.0 ML RESERVOIR, MODEL 103/193 (K991936) | Medtronic Minimed | 2000-01-18 |
| RENAMEL SCULPT (K993658) | Cosmedent, Inc. | 2000-01-18 |
| 1.5 M PROPANEDIOL FREEZING MEDIUM, 1.5 PROPANEDIOL 0.1 SUCROSE FREEZING MEDIUM, 9% GLYCEROL, 0.2 M SUCROSE FREEZING MEDI (K991390) | Sage Biopharma | 2000-01-18 |
| GYNECARE VERSAPOINT G-VAP ELECTRODE (K992901) | Gynecare, Inc. | 2000-01-18 |
| AF-150 HEMODIALYZER (K992566) | Althin Medical AB | 2000-01-18 |
| ACCESS HYBRITECH PSA QC, MODEL 37209 (K994200) | Beckman Coulter, Inc. | 2000-01-18 |
| UNSCENTED INTERLABIAL MENSTRUAL PAD (K993870) | Procter & Gamble Co. | 2000-01-18 |
| CYNOSURE M2 DERMATOLOGY LASER FOR HAIR REMOVAL (K994427) | Cynosure, Inc. | 2000-01-18 |
| AF-220 HEMODIALYZER (K992573) | Althin Medical AB | 2000-01-18 |
| LUMAGEM SCINTILLATION CAMERA (K993813) | Gamma Medica | 2000-01-18 |
| TRANSDUCERS FOR ULTRASOUND AND TOCODYNAMOMETER FETAL MONITORING (K992811) | Epic Medical Equipment Services, Inc. | 2000-01-18 |
| WAKO-IGG II-HA, IMMUNOGLOBULIN CALIBRATOR SET, IMMUNOLOBULIN STANDARD (K993928) | Wako Chemicals USA, Inc. | 2000-01-18 |