| SHARPLAN EPITOUCH ALEXANDRITE LASER SYSTEM (5000) (K973354) | Sharplan Lasers, Inc. | 1997-12-04 |
| AQUASIL XLV SMART WETTING IMPRESSION MATERIAL (K973782) | Dentsply Intl. | 1997-12-04 |
| STERLING DIAGNOSTIC IMAGING DIRECT RADIOGRAPHY (K973206) | Sterling Diagnostic Imaging, Inc. | 1997-12-04 |
| VAPOPHENE (K961289) | Germiphene Corp. | 1997-12-04 |
| MECHANICAL FOLDING WHEEL CHAIR (K973491) | Heartway Medical Products Co., Ltd. | 1997-12-04 |
| KENDALL CURASORB ZN + MG ALGINATE WOUND DRESSING (K973509) | Kendall Healthcare Products Co. Div.Of Tyco Health | 1997-12-04 |
| AUTIMO 2.5-D AND AUTIMO 3-D (K972016) | C.L. Mcintosh & Assoc., Inc. | 1997-12-04 |
| REACH FEMORAL HIP COMPONENT (K971824) | Biomet, Inc. | 1997-12-04 |
| EPIC-FLO (K973976) | Parkell, Inc. | 1997-12-04 |
| DIGMI-2000 (GSI INTERNAL REFERENCE)/LD2800 (MARKETING NAME) (K973411) | General Scanning, Inc. | 1997-12-04 |
| UNIFINE PENTIPS (K973899) | Owen Mumford USA, Inc. | 1997-12-04 |
| GOWN POLY REINFORCED LARGE(PRODUCT NO.900-522)/(REORDER NO. 0522) (K971920) | Customed, Inc. | 1997-12-04 |
| CANDELA GENTLELASE GL DERMATOLOGICAL VASCULAR LESION LASER (K972767) | Candela Corp. | 1997-12-04 |
| CARDIOCALL CARDIAC EVENT RECORDER (K972649) | Reynolds Medical , Ltd. | 1997-12-04 |
| POWDER-FREE EXAM GLOVES (K970773) | Pt. Sarana Indoprotex | 1997-12-04 |
| RHYTHMSTAT XL (K971650) | Data Critical Corp. | 1997-12-04 |
| MENTOR SUPER ABSORBENT DRAPE (K973146) | Mentor Ophthalmics, Inc. | 1997-12-04 |
| SMC FEMORAL HIP COMPONENT (K971681) | Signal Medical Corp. | 1997-12-04 |
| DENTAL/SURGICAL DRILLS, BURS, TAPS (K973771) | Implant Innovations, Inc. | 1997-12-04 |
| JACKSON-PRATT HEMADUCT WOUND DRAIN, JACKSON-PRATT GOLD HEMADUCT WOUND DRAIN (K973703) | Allegiance Healthcare Corp. | 1997-12-04 |
| HEWLETT-PACKARD MODELS M1001B ECG M1002B ECG/RESPIRATION PLUG-IN MODULES (K973437) | Hewlett-Packard GmbH | 1997-12-03 |
| TRIAGE PANEL FOR DRUGS OF ABUSE, PLUS TRICYCLIC ANTIDEPRESSANTS AND OTHER TRIAGE DRUG TESTS (K973784) | Biosite Incorporated | 1997-12-03 |
| STARLIGHT PULSED DIODE ARRAY LASER SYSTEM (K973324) | Star Medical Technologies, Inc. | 1997-12-03 |
| TWEEZER-TYPE EPILATOR (K973340) | Mobit, Inc. | 1997-12-03 |
| SENDX 100 PH, BLOOD GAS AND ELECTROLYTE ANALYSIS SYSTEM (K973742) | Sendx Medical, Inc. | 1997-12-03 |
| S-357 VIDEO IMAGING SYSTEM (K973798) | Sopro | 1997-12-03 |
| ISO-GARD FILTER ANGLED(18212)/ISO-GARD FILTER STRAIGHT(19212) (K965016) | Gibeck, Inc. | 1997-12-02 |
| FUKUDA DENSHI MODEL FCP-2155 MULTI CHANNEL, INTERPRETIVE ELECTROCARDIOGRAPH (K971440) | Fukuda Denshi USA, Inc. | 1997-12-02 |
| SPECTRASCIENCE REUSABLE BIOPSY FORCEPS (K973611) | Spectrascience, Inc. | 1997-12-02 |
| AQUAPLAST PALATAL STENT (K973370) | Wfr/Aquaplast Corp. | 1997-12-02 |
| OHMEDA INFANT RESUSCITATION SYSTEM (K971243) | Ohmeda Medical | 1997-12-02 |
| ALCON MULTI-PURPOSE DISINFECTING SOLUTION ID 90746 (K973332) | Alcon Laboratories | 1997-12-02 |
| QUANTA LITE TOXOPLASMA IGG (K971441) | Inova Diagnostics, Inc. | 1997-12-02 |
| BACT/ALERT FAN CULTURE BOTTLES (K973325) | Organon Teknika Corp. | 1997-12-02 |
| BONDING BASE (K973353) | Straumann USA | 1997-12-02 |
| CHIN DISTRACTOR (K973484) | Howmedica, Inc. | 1997-12-02 |
| CRITERION, CRITERION I.V., MODIFIED (K952267) | Nova-Ventrx | 1997-12-02 |
| CURVILINEAR SUTURE PLACEMENT SYSTEM (K973415) | Laurus Medical Corp. | 1997-12-02 |
| OLICON IMAGING SYSTEMS, INC. ARCHIVE SYSTEMS, NT ARCHIVE, 02ARCHIVE, ARCHIVE (K973463) | O Tech, Inc. | 1997-12-02 |
| FOUNDATION POROUS HIP STEM (K973302) | Encore Orthopedics, Inc. | 1997-12-02 |
| THERAPAX DXT 300 MODEL HF-300 (K973315) | Pantak, Inc. | 1997-12-02 |
| ACCUDEXA BONE DENSITOMETER (K971735) | Schick Technologies, Inc. | 1997-12-02 |
| QUICKIE P90 SERIES (K972230) | Quickie Designs, Inc. | 1997-12-02 |
| MVM 3.3 MM MICROENDOSCOPE (K973304) | KARL STORZ Endoscopy-America, Inc. | 1997-12-02 |
| MONOCOL/LEX-IM TEST (K972457) | Immunostics Inc., | 1997-12-01 |
| ACL CLIP-IN (K973323) | Innovasive Devices, Inc. | 1997-12-01 |
| INTRADUCER PORT SC CATALOG#31275,31035,30915, AND 31450 (K972112) | Taut, Inc. | 1997-12-01 |
| IT HYDROCOLLOID WITH ZINC (K973855) | Innovative Technologies , Ltd. | 1997-12-01 |
| BECKMAN URINE PROTEIN CALIBRATOR (UCAL) (K973928) | Beckman Instruments, Inc. | 1997-12-01 |
| TRI TEST REAGENT CD4 FIT C/CD8 PE/CD3 PERCP WITH TRUCOUNT ABSOLUTE COUNT TUBES (K971205) | Becton Dickinson Immunocytometry Systems | 1997-12-01 |
| MICROCON 800MUV, MICROCON 400MUV, MICROCON EXC-BUV (K972064) | Biological Controls, Inc. | 1997-12-01 |
| INNOVASIVE DEVICES Y-KNOT SUTURE CLIP (K973313) | Innovasive Devices, Inc. | 1997-12-01 |
| BIODERM FOAM WOUND DRESSING (K973429) | Bioderm, Inc. | 1997-12-01 |
| QUANTA LITE CMV IGG ELISA (K971335) | Inova Diagnostics, Inc. | 1997-12-01 |
| CEFMETAZOLE ANTIMICROBIAL SUSCEPTIBILITY TEST DISC (K973479) | Oxoid , Ltd. | 1997-12-01 |
| GLENROE GLOW IN DARK ELASTOMERIC LIGATURES (K973495) | Glenroe | 1997-12-01 |
| ARGLAES-AB ANTIMICROBIAL BARRIER ISLAND DRESSING (K973657) | Maersk Medical, Ltd. | 1997-12-01 |
| NON-PRESCRIPTION SUNGLASSES (K974179) | Taipan Optical Company , Ltd. | 1997-12-01 |
| QUICKVUE ONE-STEP HCG-COMBO (K973841) | Quidel Corp. | 1997-12-01 |
| THE CA 15-3 ASSAY FOR THE TECHNICON IMMUNO 1 SYSTEM (IN VITRO DIAGNOSTIC SYSTEM) (K964703) | Bayer Corp. | 1997-12-01 |
| THE AUTO SUTURE* MIBB** SYSTEM (K973496) | United States Surgical, A Division of Tyco Healthc | 1997-12-01 |
| MEDI-DX 7000 (K964622) | Neuro-Diagnostic Assoc. | 1997-12-01 |
| AURENORM 68 (K972945) | Aurex Precious Metal Industries (Pty)Ltd | 1997-11-26 |
| PORTABLE SERIES REVERSE OSMOSIS SYSTEMS 700, 701, 702, 703, 704, 750, MRE-NF, F800-F802, RO SECURA, REVERSE OSMOSIS SYST (K964539) | Zyzatech Water Systems, Inc. | 1997-11-26 |
| PIN CARE KIT (K973299) | Brown Medical Industries | 1997-11-26 |
| STERI-OSS 3.25 MM REPLACE DENTAL IMPLANT SYSTEM (K973402) | Steri-Oss, Inc. | 1997-11-26 |
| INTELLIFLOW RESPIRATORY ANALYZER (K970840) | Simtec, Inc. | 1997-11-26 |
| TRANSDUCER POSITIONER (K973622) | Protek Medical Products, Inc. | 1997-11-26 |
| BELZER-MPS (K972066) | Trans-Med Corp. | 1997-11-26 |
| AUROFILM 2000 (K973372) | Metalor Dental USA Corp. | 1997-11-26 |
| ENDOASSIST (K973249) | Armstrong Healthcare , Ltd. | 1997-11-26 |
| SERUM HCG CONTROL SET (NEGATIVE, LOW POSITIVE AND HIGH POSITIVE) (K974108) | Quidel Corp. | 1997-11-26 |
| CARDS Q.S. HCG SERUM/URINE;CONCISE PERFORMANCE PLUS HCG-COMBO (K973858) | Quidel Corp. | 1997-11-26 |
| ENDOCERVICAL BLOCK NEEDLE (K973671) | A & A Medical, Inc. | 1997-11-26 |
| PERSONAL LUBRICATING LIQUID (K973780) | Qualis, Inc. | 1997-11-26 |
| NIPRO BLOOD TUBING SET WITH TRANSDUCER AND SOLUTION SET FOR HEMODIALYSIS (K972206) | Nipro Medical Corp. | 1997-11-26 |
| DICOM 3.0 SOFTWARE VERSION 2.0 (K973239) | Adac Laboratories | 1997-11-26 |
| MICROAIRE POWER ASPIRATION DEVICE PAD SYSTEM (K973268) | Microaire Surgical Instruments, Inc. | 1997-11-26 |
| COBRA HAND PIECE (K973366) | Vidamed, Inc. | 1997-11-26 |
| YASARGIL TITANIUM ANEURYSM CLIPS (FTXXXT) (K970050) | Aesculap, Inc. | 1997-11-26 |
| BODYSTAT (K971554) | Bodystat , Ltd. | 1997-11-26 |
| BIOPOLAR BUTTON ELECTRODE, WL 150MM, W/SUCTION APPLICATOR/WL 280MM, W/SUCTION APPLICATOR(8801.451 (K973295) | Richard Wolf Medical Instruments Corp. | 1997-11-26 |
| ARTICULATE FITTING SYSTEM (K973320) | Decibel Instruments, Inc. | 1997-11-25 |
| LEG'MAP OPTION (K973270) | Ge Medical Systems, Inc. | 1997-11-25 |
| RHEUMACOL RHEUMATOID FACTOR TEST (K972456) | Immunostics Inc., | 1997-11-25 |
| IMAGE FUSION AND REVIEW SYSTEM (K973233) | Adac Laboratories | 1997-11-25 |
| IMATION MODEL 9410 NETWORK INTERFACE (K973303) | Imation Corp. | 1997-11-25 |
| TRITEST REAGENT CD3 FITC/CD16+CD56 PE/CD45 PERCP;WITH TRUCOUNT ABSOLUTE COUNT TUBES (K971110) | Becton Dickinson Immunocytometry Systems | 1997-11-25 |
| MONARCH (IN 2125)/INTELLISYSTEM (IN 1125) (K973230) | Merit Medical Systems, Inc. | 1997-11-25 |
| FAVC-HH: FEMORAL ARTERY VASCULAR CLAMP-HAND HELD: 1/2 & 3 POUNDS (RMDS810T/815T/820T) (K973216) | Rmds, Inc. | 1997-11-25 |
| MEDENTAL CHEMICAL CURING SEALANT PIT & FISSURE TINTED (K973541) | Medental Intl. | 1997-11-25 |
| WHITTINGHAM ULTRACLEAN PHACO HANDPIECE (K972063) | William F. Whittingham | 1997-11-25 |
| D.O.R.C. HEXON ILLUMINATION SYSTEM (K973229) | Dutch Ophthalmic USA, Inc. | 1997-11-25 |
| ENDOSCOPIC HYSTERECTOMY AND UTERUS MANIPULATOR (K964276) | Richard Wolf Medical Instruments Corp. | 1997-11-25 |
| STING SKIN PREP WIPE(59420600)/STING SKIN PREP SWAB (59420700) (K973228) | Smith & Nephew, Inc. | 1997-11-25 |
| ID. STORE (RELEASE 2.0) (K973413) | I.S.G. Technologies, Inc. | 1997-11-25 |
| ABBOTT AXSYM TROPONIN-I (K974103) | Abbott Laboratories | 1997-11-25 |
| CERTODYN RAECG UNIVERSAL ADAPTER (K973371) | B.Braun Medical, Inc. | 1997-11-24 |
| PANOVIEW PLUS TELESCOPE, 3.5MM, O,WL 300MM/25,WL 300MM/0,WL 180MM (K973359) | Richard Wolf Medical Instruments Corp. | 1997-11-24 |
| PSN-120 HOLLOW FIBER DIALYZER AND PSN-140 HOLLOW FIBER DIALYZER (K963933) | Baxter Healthcare Corp | 1997-11-24 |