| SILICONE TISSUE/INFLATABLE TISSUE EXPANDER (K974209) | Specialty Surgical Products, Inc. | 1998-02-06 |
| THROMBOLYTIC BRUSH CATHETER, OVER THE WIRE (OTW) (K973669) | Micro Therapeutics, Inc. | 1998-02-06 |
| AMPLAID MK22 (K972959) | Amplifon S.P.A. | 1998-02-06 |
| EXTERNAL FUNCTIONAL NEUROMUSCULAR STIMULATOR (K974514) | Neuromotion, Inc. | 1998-02-06 |
| DUFFUSION-WEIGHTED MR IMAGING PACKAGE (K974530) | Philips Medical Systems (Cleveland), Inc. | 1998-02-06 |
| DATEX-ENGSTROM NETWORK (K974101) | Datex-Engstrom, Inc. | 1998-02-06 |
| A-2000 EEG MONITOR WITH BIS (K974496) | Aspect Medical Systems, Inc. | 1998-02-06 |
| MAGNETIC RESONANCE DIAGNOSTIC SYSTEM (K972990) | GE Medical Systems | 1998-02-05 |
| CARESIDE BUN (K980057) | Exigent Diagnostics, Inc. | 1998-02-05 |
| ACCURUN(TM) 132 BORRELIA BURDORFERI IGM POSITIVE CONTROL (K974810) | Boston Biomedica, Inc. | 1998-02-05 |
| AIR OXYGE MIXER (K974372) | Sk Med | 1998-02-05 |
| HEMORRELIEF DEVICE (K973590) | A.Stein - Regulatory Affairs Consulting | 1998-02-05 |
| VACUTAINER BRAND PRONTO NEEDLES HOLDER (K980098) | Becton Dickinson Vacutainer Systems | 1998-02-05 |
| SINGER ACUPUNCTURE NEEDLES (K974616) | Lorac, Inc. | 1998-02-05 |
| VACUETTE (MULTI-USE HOLDER) (K974873) | Greiner Meditech, Inc. | 1998-02-05 |
| EASYBLOOD GAS ANALYZER (K974526) | Medica Corp. | 1998-02-05 |
| ACCURUN(TM) 130 BORRELIA BURGDORFERI IGG POSITIVE CONTROL (K974809) | Boston Biomedica, Inc. | 1998-02-05 |
| STERILE WATER FOR DEVICE IRRIGATION/ STERILE SALINE FOR DEVICE IRRIGATION (K973734) | Welcon, Inc. | 1998-02-05 |
| DYRACT AP RESTORATIVE (K973235) | Dentsply Intl. | 1998-02-05 |
| IMEX STETHODOP (K973336) | Imex Medical Systems, Inc. | 1998-02-05 |
| PERRY-KOLBERG (PK) TITANIUM MOTILITY/SUPPORT SYSTEM (K974203) | Integrated Orbital Implants, Inc. | 1998-02-04 |
| ALPHA DX ANALYZER 01-0100, ALPHA DX MYO/CK/CK-MB/TNI CARDIAC PANEL TEST KIT 03-0001, ALPHA DX CK/CK-MB PANEL TEST KIT (K974839) | First Medical, Inc. | 1998-02-04 |
| GLUMA ONE BOND (K974390) | Heraeus Kulzer, Inc. | 1998-02-04 |
| FLEXIBLE TIP DIGITAL THERMOMETER (K974195) | K-Jump Health Co., Ltd. | 1998-02-04 |
| AMYLASE (K980013) | Ac Biochemicals, Inc. | 1998-02-04 |
| PARAGON LENS CARE (K974635) | Paragon Vision Sciences | 1998-02-04 |
| T-UPTAKE MICROPLATE EIA (K980088) | Monobind | 1998-02-04 |
| CARESIDE TOTAL PROTEIN (K980042) | Exigent Diagnostics, Inc. | 1998-02-04 |
| ALPHA 4 LS AUTOMATED MICROTITERPLATE PROCESSOR AND READER (K973938) | Sfri, Inc. | 1998-02-04 |
| CLEARLINE PLUS, DENTAL WATERLINE FILTER (K973996) | Scitech Solutions, Inc. | 1998-02-04 |
| CARESIDE ALBUMIN (K980041) | Exigent Diagnostics, Inc. | 1998-02-04 |
| AURORA TITANIUM SPINAL ROD SYSTEM (K974213) | United States Surgical, A Division of Tyco Healthc | 1998-02-04 |
| QUICKSCREEN ONE STEP PCP SCREENING TEST (K974582) | Phamatech | 1998-02-04 |
| DENTAL TRAY, STERILE, DISPOSABLE (K974238) | Trinity Laboratories, Inc. | 1998-02-04 |
| MEDTRONIC MODEL 3998 LEAD (K971756) | Medtronic Vascular | 1998-02-03 |
| NON-REBREATHING 'T' (BE 117) (K973066) | Instrumentation Industries, Inc. | 1998-02-03 |
| LYSONIX IRRIGATION SYSTEM (K974233) | Lysonix, Inc. | 1998-02-03 |
| TYTRON C-3000 (K974208) | Titronics Research & Development Co. | 1998-02-03 |
| MD TECH BIOPSY SET FOR BONE AND BONE MARROW (K980196) | Medical Device Technologies, Inc. | 1998-02-03 |
| CRYOGEN CARDIAC CRYOSURGICAL SYSTEM (K974320) | Cryogen, Inc. | 1998-02-03 |
| 3M UNIVERSAL ELECTROSURGICAL PAD, SPLIT (9160) 3M UNIVERSAL ELECTROSURGICAL PAD (9130) (K974553) | 3M Healthcare | 1998-02-03 |
| RESPOSABLE BARE FIBERS (K973172) | Trimedyne, Inc. | 1998-02-03 |
| SPACELABS MEDICAL 90482 BISPECTRAL INDEX ANALYSIS (BIS) MODULE (K973596) | Spacelabs Medical, Inc. | 1998-02-03 |
| MALONEY BOUGE (1210-XX)/HURST BOUGIE (1212-XX) (K972119) | Medovations, Inc. | 1998-02-02 |
| UTERINE MANIPULATOR/INJECTOR (K974357) | Catheter Research, Inc. | 1998-02-02 |
| RUMORS DYNAMIC AIR THERAPY UNIT (K972111) | Hill-Rom, Inc. | 1998-02-02 |
| PERMAFLO (K974413) | Ultradent Products, Inc. | 1998-02-02 |
| DBEST ONE-STEP OVULATION TEST (K974508) | Ameritek, Inc. | 1998-02-02 |
| RANDOX CALCIUM (K974607) | Randox Laboratories, Ltd. | 1998-02-02 |
| COOPERSURGICAL DIGITAL COLPOSCOPY SYSTEM (K972630) | CooperSurgical, Inc. | 1998-02-02 |
| ULTRAMIST 2000 (K972657) | Texas Medical Industries, Inc. | 1998-02-02 |
| ALT (GPT) LIQUID STABLE 2 VIAL - INCORPORATING DYNAMIC STABILIZATION TECHNOLOGY - (DST) (K980028) | Trace America, Inc. | 1998-02-02 |
| AURAFLEX FT3 150 TEST PACK, AURAFLEX FT3 CALIBRATOR PACK (K974027) | Alfa Biotech (Uk) , Ltd. | 1998-02-02 |
| COMPOLUTE APLICAP (K974458) | Espe Dental-Medizin GmbH & Co.Kg. | 1998-02-02 |
| MINIMED SOF-SET ULTIMATE QR INFUSION SET MODELS 315 AND 316 (K974163) | Medtronic Minimed | 1998-02-02 |
| TRUMP-IT II AND MAGNUM 250 (K973814) | Valley West, Inc. | 1998-01-30 |
| AST )GOT) LIQUID STABLE 2 VIAL - INCORPORATING DYNAMIC STABILIZATION TECHNOLOGY - (DST) (K980030) | Trace America, Inc. | 1998-01-30 |
| SOMNUS TISSUE COAGULATING ELECTRODE (K973701) | Somnus Medical Technologies, Inc. | 1998-01-30 |
| UROSURGE UROSTENT (K973504) | Princeton Regulatory Assoc. | 1998-01-30 |
| VITALMAX 4000 CONFIGURED/VITALMAX 4000 MODULAR/VITALMAX 4100/MINIPACK 3100/3000/VITALMAX 800+/MINIPACK 300 (K970445) | Pace Tech Medical Monitors, Inc. | 1998-01-30 |
| LEADFIX BIORESORBABLE MEMBRANCE PIN SYSTEM (K974392) | Biovision GmbH | 1998-01-30 |
| PHOSPHORUS-SL ASSAY, CATALOGUE NUMBER 117-10, 117-30 (K974858) | Diagnostic Chemicals , Ltd. | 1998-01-30 |
| MANAN SOFT TISSUE BIOPSY NEEDLES (K980122) | Medical Device Technologies, Inc. | 1998-01-30 |
| NON-PRESCRIPTION SUNGLASSES (K974860) | Wenzhou Ming Ming Optical Co. , Ltd. | 1998-01-30 |
| MITEK ABSORBABLE POLYDIOXANONE (PDS) H FIX (K970119) | Mitek Products | 1998-01-30 |
| BOEHRINGER MANNHEIM C.F.A.S. - HDL/LDL-C-PLUS (K974825) | Boehringer Mannheim Corp. | 1998-01-30 |
| WORLDWIDE MEDICAL TECHNOLOGIES BONE MARROW BIOPSY PROCEDURE TRAY (K980137) | Worldwide Medical Technologies, LLC | 1998-01-30 |
| CRANIOFACIAL ANCHORS (K974136) | Biomet, Inc. | 1998-01-30 |
| CAPIOX HEMOCONCENTRATOR (K973516) | Terumo Medical Corp. | 1998-01-30 |
| 3M UNIVERSAL ELECTROSURGICAL PAD, WITH CORD (CATALOG NUMBER 9135), 3M UNIVERSAL ELECTROSURGICAL PAD, SPLIT WITH CORD (C) (K974279) | 3M Healthcare | 1998-01-30 |
| ETB TELESCOPE W/WORKING CHANNEL FOR SEPS (K972298) | The Altomec Corp. | 1998-01-30 |
| IBI (K974440) | Gallini U.S., LLC | 1998-01-30 |
| INFANT FLOW SYSTEM (K974303) | Sensor Medics Corp. | 1998-01-30 |
| NON-PRESCRIPTION SUNGLASSES (K974852) | Chia Hui Spectacles Mfg. Corp. | 1998-01-30 |
| LACTOSORB PANELS (K974309) | Biomet, Inc. | 1998-01-30 |
| IMCOR 3.75 AND 5.00MM EXTERNALLY HEXED, SELF TAPPING HA COATED SCREW IMPLANTS WITH COVER SCREW (K974126) | Imcor | 1998-01-30 |
| ROCKET ELECTRODE (K974138) | A & A Medical, Inc. | 1998-01-30 |
| ADVANCE TOTAL KNEE SYSTEM (K974328) | Wrightmedicaltechnologyinc | 1998-01-30 |
| UROMED NEEDLE GRASPER (K974137) | Uromed Corp. | 1998-01-30 |
| PHILIPS EASYVISION (K971965) | Philips Medical Systems, Inc. | 1998-01-30 |
| EXCEL AV STIM 1000 (K972157) | Excel Tech. , Ltd. | 1998-01-30 |
| XPS STRAIGHTSHOT MICROBRIDER SYSTEM OR TREBAY SHAVER SYSTEM (K973499) | Xomed, Inc. | 1998-01-30 |
| COMPOGLASS FLOW (K974577) | Ivoclar North America, Inc. | 1998-01-30 |
| VINYL EXAMINATION GLOVES POWDER FREE (K974777) | Sun Flower Gloves Co., Ltd. | 1998-01-30 |
| POWDERED GREEN NITRILE EXAMINATION GLOVES (K974886) | Sri Johani Sdn. Bhd. | 1998-01-30 |
| KARL STORZ ENDOVISION XL ENDOSCOPIC CAMERA SYSTEM (K974391) | Karl Storz Imaging, Inc. | 1998-01-30 |
| MANAN D BAG (K980005) | Medical Device Technologies, Inc. | 1998-01-30 |
| TTM5000 TELEPHONIC EKG MONITOR (K973267) | Hds Medical, Inc. | 1998-01-29 |
| PQ 1 (K974283) | Ultradent Products, Inc. | 1998-01-29 |
| 3 CHANNEL DIGITAL AMBULATORY ECG RECORDER (K971670) | Galix Biomedical Instrumentation, Inc. | 1998-01-29 |
| NORLAND MODEL PDEXA BONE DENSITOMETER (K973104) | Norland Corp. | 1998-01-29 |
| LUBRICATED BAGGY TACTYLON CONDOM (K974121) | Sensicon Corp. | 1998-01-29 |
| BROWNE MVI STEAM INDICATOR (K971369) | Albert Browne , Ltd. | 1998-01-29 |
| GOLEMB DISPOSABLE BAG MASK RESUSCITATOR (K973106) | Allied Healthcare Products, Inc. | 1998-01-29 |
| SAFEPASS STERILIZATION POUCH (K973981) | Adroit Medical Systems, Inc. | 1998-01-29 |
| VITALESCENCE (K974282) | Ultradent Products, Inc. | 1998-01-29 |
| CLEARFIL LINER BOND 2V (K974486) | Kuraray America, Inc. | 1998-01-29 |
| SUPER-DENT INTERMEDIATE RESTORATIVE MATERIAL (K972935) | S.S. White Mfg., Ltd. | 1998-01-29 |
| POSITION PENTA, POSITION PENTA QUICK (K974231) | Espe GmbH & Co. Kg. | 1998-01-29 |
| VACUDAP, MODEL 2000, 2001 (K974112) | Victoreen, Inc. | 1998-01-29 |