| AT HOME DRUG TEST, MODEL 9083 T (K010646) | Phamatech | 2001-03-30 |
| PARSET NEEDLELESS PRIMARY SET FOR BLUNT CANNULA, A10003E, PARSET NEEDLELESS SECONDARY SET WITH BLUNT CANNULA, A14003E (K010538) | Rd Medical Mfg., Inc. | 2001-03-30 |
| POWDER-FREE NITRILE EXAMINATION GLOVES WITH ALOE VERA, GREEN (TESTED FOR USE WITH CHEMOTHERAPY DRUGS) (K010097) | Shen Wei (Usa), Inc. | 2001-03-30 |
| RETROGRADE CARDIOPLEGIA CANNULA, SELF-INFLATING, WITH MALLEABLE OR GUIDEWIRE STYLET (K002019) | Sorin Group Italia S.R.L. | 2001-03-30 |
| AT HOME DRUG TEST, MODEL 9073 T (K010650) | Phamatech | 2001-03-30 |
| GE CT-PET SYSTEM (K010641) | Ge Medical Systems, Inc. | 2001-03-30 |
| AT HOME DRUG TEST, MODEL 9133 T (K010651) | Phamatech | 2001-03-30 |
| AT HOME DRUG TEST, MODEL 9063 T (K010645) | Phamatech | 2001-03-30 |
| SIGMA DIAGNOSTICS SIGMA-CAL, MODEL S2936 (K010652) | Sigma Diagnostics, Inc. | 2001-03-30 |
| REAADS IGM ANTI-PROTHROMBIN SEMI-QUANTITATIVE TEST KIT (K001398) | Corgenix, Inc. | 2001-03-30 |
| SARSTEDT NEEDLE PROTECTOR (K003382) | Sarstedt, Inc. | 2001-03-30 |
| ELISA TEST, SEROLOGY (K003794) | Micro Detect, Inc. | 2001-03-30 |
| SHEER THIN AROMAS RED LATEX CONDOM (K010028) | Eagle Twe, Inc. | 2001-03-30 |
| POWDERED SYNTHETIC VINYL PATIENT EXAM GLOVE (K010663) | Tong Ruhn Medical Products Co., Ltd. | 2001-03-30 |
| PROSPORE2 SELF-CONTAINED BIOLOGICAL INDICATOR (K994381) | Raven Biological Laboratories, Inc. | 2001-03-30 |
| AXIOM ARTIS MODULAR ANGIOGRAPHY SYSTEM (K010721) | Siemens Medical Corp. | 2001-03-30 |
| PRESSURE TRAK, MODEL 222-B (K010622) | Suntech Medical Instruments, Inc. | 2001-03-29 |
| REMSTAR PLUS CPAP SYSTEM (K010263) | Respironics, Inc. | 2001-03-29 |
| FINGER PULSE METER (K000814) | Bhs Intl., Inc. | 2001-03-29 |
| BAYER ADVIA IMS SYSTEM (K010201) | Bayer Corp. | 2001-03-29 |
| DIGITAL BLOOD PRESSURE MONITORS, MODELS TM-2655, TM-2655P, & TM-2655VP (K010828) | A&D Engineering, Inc. | 2001-03-29 |
| ATLANTIS SR PLUS CORONARY IMAGING CATHETER, MODEL 35975 (K010707) | Boston Scientific, Target | 2001-03-29 |
| SHEER THIN AROMAS YELLOW LATEX CONDOM (K004051) | Eagle Twe, Inc. | 2001-03-29 |
| REDTECH GIPC 2000 (K004040) | Red-Tech, Inc. | 2001-03-29 |
| MENTOR SELF-CATH CLOSED SYSTEM (K003873) | Mentor Corp. | 2001-03-29 |
| CYNOSURE PHOTOGENICA NEO-V (K004039) | Cynosure, Inc. | 2001-03-29 |
| DEFENDER ROOM AIR CLEANER, MODEL RAC-4000A (K010616) | Hmi Industries, Inc. | 2001-03-28 |
| OPTIFLOW CATHETER #5641190 CATHETER ONLY #5643150 CATHETER KIT #5631000 CATHETERLESS TRAY-GENERIC (COMBINED WITH CATHETR (K010567) | C.R. Bard, Inc. | 2001-03-28 |
| EXACTA-MIX 2400 COMPOUNDING SYSTEM, MODEL EXACTA-MIX 2400 (K002705) | Baxa Corp. | 2001-03-28 |
| ADC QS/IPD WORKSTATION (K010571) | Agfa Corp. | 2001-03-28 |
| KENDALL 14.5 FR MAXID CUFFED DUAL LUMEN CATHETER (K002901) | The Kendall Company | 2001-03-28 |
| ELECSYSCA 15-3 II ASSAY (K010588) | Roche Diagnostics Corp. | 2001-03-28 |
| NT SWIFT; TI\TEC; GATES GLIDDEN DRILLS; DENTAL POWER ENDODONTIC HAND FILES (K004031) | Dental Power, Inc. | 2001-03-28 |
| LATEX EXAMINATION GLOVES-POWDER FREE (K010356) | Enzymic Technologies Sdn Bhd | 2001-03-27 |
| ARTHROCARE UROLOGY ELECTROSURGERY SYSTEM (K010568) | Arthrocare Corp. | 2001-03-27 |
| F1 DIODE LASER SYSTEM (K004021) | Opus Medical, Inc. | 2001-03-27 |
| SHEER THIN AROMAS GREEN LATEX CONDOM (K004036) | Eagle Twe, Inc. | 2001-03-27 |
| KSEA SCB-RUI SCO (K003113) | KARL STORZ Endoscopy-America, Inc. | 2001-03-27 |
| LOCALISA CARDIAC NAVIGATION SYSTEM (K002869) | Medtronic Surgical Navigation Technologies | 2001-03-27 |
| 3M LITTMANN (K003723) | 3M Company | 2001-03-27 |
| RAPID EXCHANGE BIOPSY CAP AND LOCKING DEVICE #4526 & 4527 (K010610) | Boston Scientific Corp | 2001-03-27 |
| POLYCARBOXYLATE (PCA) CEMENT (K010240) | Rite-Dent Manufacturing Corp. | 2001-03-27 |
| CALEX CONDITIONER (K010176) | Stephen M Koral, Dmd | 2001-03-27 |
| LATEX EXAMINATION GLOVES-POWDERED, NONSTERILE (K010347) | Enzymic Technologies Sdn Bhd | 2001-03-27 |
| R & D DESIGNATION AP-035 (K010414) | Jensen Industries, Inc. | 2001-03-27 |
| IMPRA CARBOFLO VASCULAR GRAFT, IMPRA CARBOFLO VASCULAR GRAFTS FOR A-V ACCESS (K004011) | Impra, Inc. | 2001-03-27 |
| ARGLAES-AB ANTIMICROBIAL BARRIER POWDER DRESSING (K004028) | Maersk Medical, Ltd. | 2001-03-27 |
| SHEER THIN AROMAS BLUE LATEX CONDOM (K004016) | Eagle Twe, Inc. | 2001-03-27 |
| WILLI GELLER CREAPEARL (K010160) | Jensen Industries, Inc. | 2001-03-27 |
| R & D DESIGNATION AP-047 (K010611) | Jensen Industries, Inc. | 2001-03-27 |
| REAL PATIENT AMBULATORY EEG, MODEL EX-AMB-RP (PROPOSED) (K010088) | Excel Tech. , Ltd. | 2001-03-26 |
| DJ ORTHOPEDICS FEMORAL ANCHOR (K002829) | Dj Orthopedics, LLC | 2001-03-26 |
| AMS FASCIAL-ANCHORING SYSTEM (K010277) | American Medical Systems, Inc. | 2001-03-26 |
| FOGARTY VALVULOTOME, MODEL 700091 (K001734) | Edwards Lifesciences, LLC | 2001-03-26 |
| ULTRAVUE/P 2000T, ULTRAVUE/C 2000T (HIOXIFILCON B) SOFT (MULTIFOCAL TORIC) DAILY WEAR CONTACT LENS (CLEAR & BLUE VISIBIL (K010256) | Opti-Centre Laboratories | 2001-03-26 |
| PPCID- PNEUMATIC PERIPHERAL CIRCULATION IMPROVEMENT (FOOTREST) DEVICE (K000655) | Ahava Stein | 2001-03-26 |
| DORNIER MEDILAS D SKINPULSE LASER SYSTEM (SKINPULSE) (K003993) | Dornier Surgical Products, Inc. | 2001-03-26 |
| AOSEPT PLUS CLEANING AND DISINFECTING SOLUTION (K003345) | Ciba Vision Corporation | 2001-03-26 |
| REAL PATIENT WIRELESS AMBULATORY EEG, MODEL EX-AMB-WIRELESS-RP (PROPOSED) (K010089) | Excel Tech. , Ltd. | 2001-03-26 |
| SELECTA 7000 FREQUENCY DOUBLED, Q-SWITCHED ND:YAG OPHTHALMIC LASER (K004006) | Lumenis, Inc. | 2001-03-26 |
| LIGASURE LAPAROSCOPIC SEALER DIVIDER MODEL LS1100 (K010013) | Valleylab, Inc. | 2001-03-26 |
| PRESTIGE IQ BLOOD GLUCOSE TEST SYSTEM, MODEL 507400, 537600, 550600, 561700, 563700 (K010403) | Home Diagnostics, Inc. | 2001-03-26 |
| XLTEK EVOKED POTENTIAL HEADBOX, MODEL EP-4-RP (PROPOSED) (K010090) | Excel Tech. , Ltd. | 2001-03-26 |
| CHAD THERAPEUTICS OXYMATIC MODEL 401 AND OXYMATIC MODEL 411 (K010389) | Chad Therapeutics, Inc. | 2001-03-23 |
| COMPONENTS FOR CARDIOVASCULAR PROCEDURE KIT - HEAT EXCHANGER COILS (K000977) | Olson Medical Sales, Inc. | 2001-03-23 |
| JAS MAGNESIUM REAGENT (K003835) | Jas Diagnostics, Inc. | 2001-03-23 |
| SYNOVIALSCOPICS, SYNOVIAL FLUID CONTROL (K010598) | Quantimetrix Corp. | 2001-03-23 |
| BIOSAFE CAPILLARY BLOOD TRANSPORT SYSTEM FOR TESTING THYROID STIMULATING HORMONE (TSH) (K003752) | Biosafe Laboratories, Inc. | 2001-03-23 |
| FLEXI-SITE SP02 EAR SENSOR (K010718) | Epic Medical Equipment Services, Inc. | 2001-03-23 |
| FOCUS DAILIES (NELFILCON A) ONE-DAY SOFT CONTACT LENSES, FOCUS DAILIES PROGRESSIVES (NELFILCON A) ONE-DAY SOFT CONTACT (K010636) | Ciba Vision Corporation | 2001-03-23 |
| MCC-MIV ONE 2 ONE SOFTWARE (K010364) | Invacare Corp. | 2001-03-22 |
| THROMBOMAX-HS WITH CALCIUM, MODEL T6540 (K010158) | Sigma Diagnostics, Inc. | 2001-03-22 |
| BLASTASSIST SYSTEM (K003156) | Medicult A/S | 2001-03-22 |
| LDOB OCCLUSION BALLOON CATHETER (K002286) | Cook, Inc. | 2001-03-22 |
| SILVERSPEED HYDROPHILIC GUIDEWIRE, MODELS 103-0601-300 AND 103-0602-300 (K010497) | Micro Therapeutics, Inc. | 2001-03-22 |
| SYNVITRO FLUSH (K003163) | Medicult A/S | 2001-03-22 |
| MEDICA HP 300 HEMOFILTRATION PUMP, MODEL 300 (K000724) | Medica S.R.L. | 2001-03-22 |
| DAUM DOUBLE-SHOOT BISOPSY GUN (K010037) | Daum GmbH | 2001-03-22 |
| K.E.A.T. (K002154) | Emd Electronic Medical Devices, Corp. | 2001-03-22 |
| MODIFICATION TO SYNERGY SPINAL SYSTEM (K010515) | Interpore Cross Intl. | 2001-03-22 |
| ENDIUS BIPOLAR SHEATH (K003897) | Endius, Inc. | 2001-03-22 |
| SUPRASPERM SYSTEM (K003404) | Medicult A/S | 2001-03-22 |
| NIROYAL BILIARY PREMOUNTED STENT SYSTEM (K003929) | Boston Scientific Corp | 2001-03-22 |
| MEDEVIEW SYSTEM (K002789) | Medeview.Com | 2001-03-21 |
| TWO-LUMEN CENTRAL VENOUS ACCESS KIT WITH HEMOSTASIS VALVE/SIDE PORT (K002507) | Arrow Intl., Inc. | 2001-03-21 |
| VENTURE HOME FILL II, MODEL IOH 200 (K003939) | Invacare Corp. | 2001-03-21 |
| IMAGE IV DICOM IMAGE ARCHIVAL PACS NETWORK (K010058) | Witt Biomedical Corporation | 2001-03-21 |
| KTJ-20C BLOOD PRESSURE CUFF, MODEL KTJ-20C (K010686) | Golden Horse Medical Equipment (Wuxi) Co. , Ltd. | 2001-03-21 |
| DJ ORTHOPEDICS TIBIAL ANCHOR (K003960) | Dj Orthopedics, LLC | 2001-03-21 |
| 0.9% SODIUM CHLORIDE INJECTION, USP BD PRE-FILLED FLUSH SYRINGE (K003553) | Bd Becton Dickinson Vacutainer Systems Preanalytic | 2001-03-21 |
| PECTOFIX STERNAL REPAIR WIRE (K003951) | Pectofix, Inc. | 2001-03-21 |
| OHMEDA MEDICAL GIRAFFE INCUBATOR (K010222) | Ohmeda Medical | 2001-03-21 |
| AXYA MEDICAL, INC. MODEL 1000 AXYALOOP BONE ANCHOR (K003971) | Axya Medical, Inc. | 2001-03-21 |
| WHITTLESTONE BREASTPUMP (K002696) | Whittlestone, Inc. | 2001-03-21 |
| APEX MODULAR ZIRCONIA FEMORAL HEAD (K003923) | Apex Surgical, LLC | 2001-03-20 |
| FS ACTIVATOR III (K003185) | Activator Methods International, Ltd. | 2001-03-20 |
| PLEURX PLEURAL CATHETER AND DRAINAGE KITS (K010642) | Denver Biomedicals, Inc. | 2001-03-20 |
| EXHALE DOPPLER SYSTEM (K010649) | Broncus Technologies, Inc. | 2001-03-20 |
| ESCREEN SYSTEM (K003352) | Escreen, Inc. | 2001-03-20 |
| ECHOFLOW PORTABLE DOPPLER BLOOD FLOW MEASUREMENT SYSTEM; MODEL PEF-1 (K010482) | Echocath, Inc. | 2001-03-20 |