| VIRAZYME INFLUENZA ID TEST FOR INFLUENZA TYPES A AND B VIRUSES (K971494) | Zymetx, Inc. | 1997-09-10 |
| SHOE COVER (K972227) | American Seal Co. | 1997-09-09 |
| DIGITIZER DIRECTOR (HSC025-01) (K972191) | Howtek, Inc. | 1997-09-08 |
| DRY & STORE (K972776) | Ear Technology Corp. | 1997-09-08 |
| STAPHYTECT PLUS/DRYSPOT STAPHYTECT PLUS (K972030) | Oxoid , Ltd. | 1997-09-08 |
| PRISMA (K972998) | Siemens Hearing Instruments, Inc. | 1997-09-05 |
| POWDER FREE SYNTHETIC EXAMINATION GLOVES (K971356) | Arista Latindo Industrial Ltd. P.T | 1997-09-05 |
| STRYKER SYSTEM 4000 HEAVY DUTY BATTERY POWERED EQUIPMENT (K972367) | Stryker Instruments | 1997-09-04 |
| AP-4000, AIR PULSE SENSORY STIMULATOR (K964815) | Pentax Precision Instrument Corp. | 1997-09-04 |
| VITROS IMMUNODIAGNOSTICS PRODUCTS/CK-MB REAGENT PACK(GEM.1300)/CK-MB CALIBRATORS (GEM.C300) (K973030) | Johnson & Johnson Clinical Diagnostics, Inc. | 1997-09-04 |
| FOLLICLE STIMULATING HORMONE (FSH) MICROPLATE ELISA (425-300) (K972720) | Monobind | 1997-09-02 |
| ARRIPRO 35 ST/TV (K973115) | Arnold & Richter Cine Technik | 1997-09-02 |
| ENZIP IMMUNOTURBIDIMETRIC MICROALBUMIN ASSAY KIT (K971458) | Diagnostic Specialties | 1997-09-02 |
| AMBIDERM (K971102) | Supertex Industrial, S.A. DE C.V. | 1997-08-29 |
| FRESHCELLS (K972414) | Diagnostic Hybrids, Inc. | 1997-08-29 |
| W.A. (K971200) | W.A. Rubbermate Co., Ltd. | 1997-08-29 |
| CARDIAC MARKERS CONTROL - LEVEL 1, LEVEL 2, LEVEL 3, TRI-LEVEL (K972976) | More Diagnostics | 1997-08-29 |
| AG CHEMISTRY ANALYZER SYSTEM (K972409) | Landmark Scientific, Inc. | 1997-08-28 |
| TRADEMARK BLOOD GAS/ELECTROLYTE/GLUCOSE, LACTATE, BUN AND CREATININE CONTROL (K972868) | Bionostics, Inc. | 1997-08-28 |
| FEMALE EXTERNAL URINARY COLLECTION POUCH (K971499) | Mediquest, Inc. | 1997-08-28 |
| RAICHEM PREALBUMIN SPIA (K972812) | Hemagen Diagnostics, Inc. | 1997-08-28 |
| POLY (VINYL) EXAM GLOVE, POWDERED (K971316) | Copioumed Intl., Inc. | 1997-08-27 |
| NURSES BOUFFANT CAP (K965237) | Copioumed Intl., Inc. | 1997-08-27 |
| SURGICAL BURS AND SURGICAL DRILL BITS (K972508) | Synvasive Technology, Inc. | 1997-08-26 |
| OPT80 THE TRANSPORTABLE (OPT80) (K972810) | O.P.T. USA, Inc. | 1997-08-26 |
| DASH, SULLIVAN, VITAL GARD (K971044) | Dash Medical Gloves, Inc. | 1997-08-25 |
| THE YELLOW IRIS URINALYSIS WORKSTATION (K972141) | Intl. Remote Imaging Systems | 1997-08-25 |
| NEW SOUND HIDDEN AID COMPLETELY IN CANAL (CIC) (K972039) | Nu-Sound | 1997-08-25 |
| RUFF WORK EYEGEAR (K972717) | Ruff House, Inc. | 1997-08-25 |
| NITRILE GLOVES (K970135) | Sage Products, Inc. | 1997-08-25 |
| CRT2000 THERMOGRAPHIC SYSTEM (K971956) | Werner Eidam Medizin-Technologie GmbH | 1997-08-22 |
| WARMETTE (K971117) | Olympic Medical Corp. | 1997-08-22 |
| AD-HEAL HYDROGEL DRESSING, VARIOUS SIZES (K972646) | Ludlow Technical Products | 1997-08-21 |
| COPAN VENTURI TRANSYSTEM AMIES MEDIUM WITH CHARCOAL (K972449) | Copan Italia Spa | 1997-08-20 |
| IMMUNOCARD STAT! ROTAVIRUS (K971585) | Meridian Diagnostics, Inc. | 1997-08-20 |
| MEDNEXT 1000 DRILL (K972308) | Mednext, Inc. | 1997-08-20 |
| COPAN VENTURI TRANSYSTEM AMIES MEDIUM WITHOUT CHARCOAL (K972448) | Copan Italia Spa | 1997-08-20 |
| MYCOPLASMA IGM ELISA TEST SYSTEM (K971503) | Zeus Scientific, Inc. | 1997-08-20 |
| IL TEST CONTRIL SPECTRUM (LEVELS 1, 2 AND 3) (K972861) | Instrumentation Laboratory CO | 1997-08-19 |
| TDK MEDICAL GRADE CD-R (K971848) | Tdk Electronics Corporation of America | 1997-08-15 |
| LIGHTLY POWDERED VINYL SYNTHETIC EXAMINATION GLOVES (K972104) | Shinemound Enterprise, Inc. | 1997-08-15 |
| FULL BODY RESTRAINT SYSTEM (K972046) | Gillen Industries | 1997-08-15 |
| QUANTIFY(901) (K972710) | Hematronix, Inc. | 1997-08-15 |
| HEARTLAND TECHNOLOGIES, ITE, ITC, CIC (K971845) | Sound Hearing Instruments, Inc. | 1997-08-15 |
| AIR CONDUCTION HAEARING AIDS (K971852) | Beltone Electronics Corp. | 1997-08-15 |
| IL TEST IRON (K972363) | Instrumentation Laboratory CO | 1997-08-15 |
| POWDER FREE LATEX EXAMINATION GLOVES (K970115) | Pt Mbf Buana Multicorpora | 1997-08-15 |
| POWDER-FREE NITRILE, POLY-COATED EXAMINATION GLOVE, PURPLE OR WHITE (NON-COLORED) (K972838) | Absolute Synthetic Technologies Malaysia Sdn. Bhd. | 1997-08-15 |
| LORIPRO, LORIPRO II (K972058) | Lori Medical Laboratories, Inc. | 1997-08-15 |
| PHONAK NOVO FORTE E3 (K972106) | Phonak, Inc. | 1997-08-15 |
| AQUA SPRAY (K971941) | Boyd Industries, Inc. | 1997-08-14 |
| CONVATEC NON-ADHESIVE DRESSING (K972062) | Convatec, A Division of E.R. Squibb & Sons | 1997-08-14 |
| ABBOTT STREP A CONTROLS (K972182) | Abbott Diagnostics | 1997-08-13 |
| VIGIL TDM CONTROLS (K972819) | Beckman Instruments, Inc. | 1997-08-13 |
| DERMAGRAN WOUND MANAGEMENT SYSTEM (K970660) | Derma Sciences, Inc. | 1997-08-12 |
| ACCURUN 117 HBEAG POSITIVE CONTROL (K972048) | Boston Biomedica, Inc. | 1997-08-12 |
| CHLAMYDIATROL AG (K972129) | Blackhawk Biosystems, Inc. | 1997-08-12 |
| TOOL-LESS WHEEL CHAIR (K972797) | Sunrise Medical, Inc. | 1997-08-12 |
| ACCURUN 121 HAV IGM POSITIVE CONTROL (K971657) | Boston Biomedica, Inc. | 1997-08-12 |
| PRECICONTROL TUMOR MARKER 1 AND 2 (K972235) | Boehringer Mannheim Corp. | 1997-08-12 |
| ZIP CONDOM CATHETER (K964219) | Goulter Medical, Inc. | 1997-08-11 |
| DCLARE IMMUNODIP STICKFOR MICROALBUMINURIA (K972337) | Diagnostic Chemicals , Ltd. | 1997-08-08 |
| GOLD FINGERS (K971183) | Alliance Rubber Products Sdn. Bhd. | 1997-08-08 |
| BACTEC MYCO/F-SPUTA CULTURE VIALS (K972758) | Becton Dickinson Microbiology Systems | 1997-08-08 |
| ROTAVIRUS EIA (K964424) | Trinity Biotech, Inc. | 1997-08-08 |
| ACCURUN 120 HAV IGG POSITIVE CONTROL (K971406) | Boston Biomedica, Inc. | 1997-08-07 |
| ACCURUN 119 ANTI-HEPATITIS B E ANTIGEN (ANTI-HBE) POSITIVE CONTROL (K972307) | Boston Biomedica, Inc. | 1997-08-07 |
| IN THE EAR, IN THE CANAL, COMPLETELY IN THE CANAL (K971807) | Hear-Right, Inc. | 1997-08-07 |
| ROCHE HEMOGLOBIN A1C CONTROL N AND CONTROL P (K972721) | Roche Diagnostic Systems, Inc. | 1997-08-06 |
| PATIENT RESTRAINT (K971948) | E.M. Adams Co., Inc. | 1997-08-06 |
| PATIENT LATEX EXAMINATION GLOVE (PREPOWDERED) (K971629) | Besglove Medicare Sdn. Bhd. | 1997-08-06 |
| UNIGLOVES (K971731) | Uni-Glove (Usa), Inc. | 1997-08-05 |
| V-12 LONG LIFE 675 HEARING AID (K972755) | Vista Labs | 1997-08-05 |
| PLASMA CATECHOLAMINE KIT (K972167) | Bioanalytical Systems, Inc. | 1997-08-04 |
| RHINOCELL NASAL PACKINGS (K972459) | Boston Medical Products, Inc. | 1997-08-04 |
| RANDOX ASSAYED SPECIFIC PROTEIN CONTROL (K972608) | Randox Laboratories, Ltd. | 1997-08-04 |
| MODIFICATION OF EST CULTURE SYSTEM II - MYCO (K972756) | Accumed Intl., Inc. | 1997-08-01 |
| UROMED ALTERNATIVE BLADDER CONTROL CONTINENCE DEVICE(ABCPN-0026) (K971992) | Uromed Corp. | 1997-08-01 |
| PHONAK EPICA (K972105) | Phonak, Inc. | 1997-08-01 |
| VENTED EXTERNAL MALE URINARY CATHETER(VENTED CATH 5000) (K972100) | Advanced Care Medical Products | 1997-07-31 |
| AUDIFON H24 AGC/AUDIFON H25 AGC/AUDIFON H30 AGC (K972550) | Trutone | 1997-07-31 |
| NEVADA EYEWORKS, LUIGI LANATTA SUNGLASSES (K972590) | Lbi U.S.A. | 1997-07-31 |
| CODA AUTOMATED EIA ANALYZER (K972024) | Bio-Rad | 1997-07-30 |
| PHONAK MICROZOOM P 2 (K972097) | Phonak, Inc. | 1997-07-30 |
| AUDIFON H20 PC/AUDIFON H32 PP (K972552) | Trutone | 1997-07-30 |
| POWDER-FREE NITRILE EXAMINATION GLOVE, BLUE OR WHITE (NON-COLORED) (K972195) | Absolute Synthetic Technologies Malaysia Sdn. Bhd. | 1997-07-29 |
| OVATION HDP (K972373) | Orsonique, Inc. | 1997-07-29 |
| COMFEEL PURILON GEL,15G(3900)/COMFEEL PURILON GEL,25G(3903) (K971597) | Coloplast Corp. | 1997-07-29 |
| MEDICAL Z, S.A. MEDIGEL Z SCAR MANAGEMENT GEL (K971916) | Medical Z, S.A. | 1997-07-29 |
| DERMAMEND HYDROGEL GAUZE DRESSING (K972336) | Dermarx Corp. | 1997-07-29 |
| BONE AND MARROW COLLECTION SYSTEM KIT (K971782) | Biomedical Ent., Inc. | 1997-07-29 |
| SCAR CARE (K971009) | Target Health, Inc. | 1997-07-29 |
| POWDERED NITRILE EXAMINATION GLOVE, BLUE OR WHITE (NON-COLORED) (K972177) | Absolute Synthetic Technologies Malaysia Sdn. Bhd. | 1997-07-29 |
| CARDIAC STATUS CONTROLS/TROPONIN I (K972687) | Spectral Diagnostics, Inc. | 1997-07-28 |
| ALLEGIANCE NON STERILE POWDER FREE LOW PROTEIN LATEX EXAMIATION GLOVES (K972291) | Allegiance Healthcare Corp. | 1997-07-28 |
| POWDER-FREE PATIENT EXAMINATION GLOVES (K971949) | Tekmedic (M) Sdn Bhd | 1997-07-28 |
| PROTECTIVE RESTRAINT MODELS #302,440,750,850,AND905 (K972123) | Smith | 1997-07-25 |
| POCKET COUNT OR SAFETCOUNT (K972302) | Sage Products, Inc. | 1997-07-25 |
| CARDIAC STATUS CONTROLS (K972408) | Spectral Diagnostics, Inc. | 1997-07-25 |
| D'ARC EYE CARE SUNGLASSES (K972490) | M & R Dist. | 1997-07-25 |