| BIPAP VISION VENTILATORY SUPPORT (K982454) | Respironics, Inc. | 1998-11-03 |
| BARDEX I.C 4-WAY FOLEY CATHETER MODEL 1865SIXX XX = 18,20,22,24 (K983101) | C.R. Bard, Inc. | 1998-11-03 |
| QUICKSET LIQUID AND POWDER (K982773) | Specialites Septodont | 1998-11-03 |
| MODIFICATION TO TIELLE HYDROPOLMER DRESSING (K983394) | Johnson & Johnson Medical, Div. of Ethicon, Inc. | 1998-11-03 |
| HALOLITE AAD SYSTEM (K981772) | Medic-Aid , Ltd. | 1998-11-03 |
| SMALL VAGINAL/RECTAL ELECTRODE (K983206) | Empi | 1998-11-03 |
| SILICONE SOFT RELINE (K981691) | Harry J. Bosworth Co. | 1998-11-03 |
| PIPER IPPB MODEL 2055 (K982016) | Vortran Medical Technology 1, Inc. | 1998-11-03 |
| HAWK ANAESTHESIA INDUCTION UNIT (K981845) | Medical Industrial Equipment | 1998-11-03 |
| BI-POLAR CORD SET 1.88 TR, BI-POLAR CORD SET 1.83 TR, MODEL #'S SB223, SB 224 (K982748) | New Deantronics Taiwan , Ltd. | 1998-11-03 |
| ALL-IN-ONE CONTAINER CAT#'S 2B8114,2B8124, 2B8134, 2B8144, 2B8102, 2B8152, 2B8112, 2B8117M 2B8122, 2B8132, 2B8142, 2B712 (K983294) | Baxter Healthcare Corp | 1998-11-03 |
| EARSCAN 3 (K982878) | Micro Audiometrics Corp. | 1998-11-03 |
| COAMATIC HEPARIN (K983178) | Instrumentation Laboratory CO | 1998-11-03 |
| 2.5 MM LACTOSORB SCREWS (K981666) | Biomet, Inc. | 1998-11-03 |
| VITROS IMMUNODIAGNOSTIC PRODUCTS RANGE VERIFIERS (K983513) | Ortho-Clinical Diagnostics, Inc. | 1998-11-03 |
| SYSMEX R-3500, AUTOMATED RETICCULOCYTE ANALYZER, MODEL R-3500 (K981950) | Sysmex Corp. | 1998-11-03 |
| VRAC HIGH DOSE RATE (HDR) REMOTE AFTERLOADING CATHETER (K981886) | Cook, Inc. | 1998-11-03 |
| NEEDLE GUIDE (K983621) | Remington Medical, Inc. | 1998-11-03 |
| VARIAN ENDOMETRIAL APPLICATOR FOR VARISOURCE REMOTE HIGH DOSE RATE AFTERLOADER (K980576) | Varian Medical Systems, Inc. | 1998-11-02 |
| MEDRAD QUAD T/L COIL (1.5T, 1.0T & 0.5T) MODELS M64TLC, M42TLC, M21TLC (K982919) | Medrad, Inc. | 1998-11-02 |
| BARCHENS COMPANY DIGITAL PACIFIER THERMOMETER (K983619) | Barchens Co. | 1998-11-02 |
| POS-T-VAC (AVP-1000) (K983245) | Pos-T-Vac, Inc. | 1998-11-02 |
| SOMNOPLASTY SYSTEM, MODELS S2, 1010/2010,2000/1000,1100,3000/30XX/6000, 1200 (K982717) | Somnus Medical Technologies, Inc. | 1998-11-02 |
| CITREX HOSPITAL SPRAY DISINFECTANT (K982985) | Caltech Industries, Inc. | 1998-11-02 |
| MEDRAD ANTERIOR NECK COIL, 1.5T & 1.0T MODEL NUMBERS M64ANC AND M42ANC (K982932) | Medrad, Inc. | 1998-11-02 |
| LATEX EXAMINATION GLOVES BUBBLE GUM FLAVOURED PRE-POWDERED (K981600) | Young Innovations, LLC Dba Plak Smacker | 1998-11-02 |
| POS-T-VAC (IVP-600) (K983246) | Pos-T-Vac, Inc. | 1998-11-02 |
| 9303 NEONATAL/ADULT VITAL SIGNS MONITOR (K982776) | Cas Medical Systems, Inc. | 1998-11-02 |
| CADD-LEGACY PCA AMBULATORY INFUSION SYSTEM, MODEL 6300 (K982839) | Sims Deltec, Inc. | 1998-11-02 |
| UNIJECT LATEX EXAMINATION GLOVES (POWDER FREE) (K982611) | Uniject Gloves Pcl | 1998-11-02 |
| CADD-LEGACY PLUS AMBULATORY INFUSION SYSTEM (K982836) | Sims Deltec, Inc. | 1998-11-02 |
| PHILIPS DUO DIAGNOST (K983069) | Philips Medical Systems North America, Inc. | 1998-11-02 |
| RT DESKTOP (K982713) | Elekta Oncology Systems, Ltd. | 1998-11-02 |
| AS/3 ANAESTHESIA DELIVERY UNIT (AS/3 ADU) (K973985) | Datex-Engstrom, Inc. | 1998-10-30 |
| FINE-JECT (K983067) | Henke Sass Wolf of America, Inc. | 1998-10-30 |
| MILL-ROSE LABORATORIES TRANSBRONCHIAL NEEDLE ASPIRATION (TBNA) CYTOLOGY PROCEDURAL KIT (K983124) | Mill-Rose Laboratory | 1998-10-30 |
| SYNTHETIC POWDER-FREE VINYL PATIENT EXAMINATION GLOVES (K983207) | Shijiazhuang Great Eagle Plastic Products Co., Ltd. | 1998-10-30 |
| MILL-ROSE LABORATORIES TRANSBRONCHIAL NEEDLE ASPIRATION (TBNA) COMBINATION CYTOLOGY/HISTOLOGY PROCEDURAL KIT (K983122) | Mill-Rose Laboratory | 1998-10-30 |
| STATIC AND DYNAMIC COMPLIANCE, A RESPIRATORY MECHANICS OPTION FOR THE VMAX SERIES (K981366) | Sensor Medics Corp. | 1998-10-30 |
| LTV 1000 VENTILATOR (K981371) | Pulmonetic Systems, Inc. | 1998-10-30 |
| PASTE OPAQUE EX-3 (K982766) | Noritake Co., Inc. | 1998-10-30 |
| SILENT NIGHT II (K981034) | Sleep Solutions, Inc. | 1998-10-30 |
| AUTOVENT 1000 (K983785) | O-Two Systems Intl., Inc. | 1998-10-29 |
| ELECTRODE SWITCHBOX, MODEL 11-081002 (K982835) | Cardima, Inc. | 1998-10-29 |
| NITRA-TOUCH POWDER-FREE NITRILE MEDICAL EXAMINATION GLOVE (K982131) | Ansell Edmont Industrial, Inc. | 1998-10-29 |
| MEDICAL AIR COMPRESSOR, MODEL # 8413419 (K982789) | Drager, Inc. | 1998-10-29 |
| SEMPERMED SURGEONS' GLOVES - SUPREME (K981096) | Semperit Technische Produkte Gesellshaft | 1998-10-29 |
| XCT 2000 L PQCT BONE DENSITOMETER (K983273) | Medical Systems, Inc. | 1998-10-29 |
| STERITEC DISPOSABLE BIOLOGICAL TEST PACK-EO GAS (K981497) | Steritec Products Mfg Co, Inc. | 1998-10-29 |
| AIRWATCH II ZONE (K982676) | Enact Health Management Systems | 1998-10-29 |
| GENESIS BLS (K983643) | O-Two Systems Intl., Inc. | 1998-10-29 |
| JUST BETWEEN US, PERSONAL LUBRICANT & CONDOM (K982673) | Key West Fragrance & Cosmetic | 1998-10-29 |
| GAMMAMED PLUS HIGH DOSE RATE REMOTE AFTERLOADING SYSTEM (K983436) | Gammamed USA | 1998-10-29 |
| RESTGRID PACKAGE/GYROSCAN NT (K982834) | Philips Medical Systems North America, Inc. | 1998-10-29 |
| WISE (II) IMAGE MANAGEMENT SYSTEM (K983447) | Sectra-Imtec AB | 1998-10-29 |
| AIRWATCH II ZONELESS (K982675) | Enact Health Management Systems | 1998-10-29 |
| X-RAY TIMER MODEL I.E.D. 7888 I.D. 7881 AND B764ID (K982824) | I.E.D., Inc. | 1998-10-29 |
| VECTORVISION SPINE MODULE (K981508) | Brainlab AG | 1998-10-29 |
| MEDRAD 1.5T, 1.0T & 0.5T SHOULDER COIL, MODELS M64SHC, M42SHC, M21SHC (K982916) | Medrad, Inc. | 1998-10-29 |
| EMT RESUSCITATOR (K983705) | O-Two Systems Intl., Inc. | 1998-10-29 |
| VACUTAINER BRAND ECLIPSE BLOOD COLLECTION NEEDLE, MODELS# 368607 & 368608 (K982541) | Becton Dickinson Vacutainer Systems | 1998-10-28 |
| SPIRACLE TECHNOLOGY-BI-FLOW DEMAND/RESUSCITATOR VALVE, MODEL 504 (K982225) | Spiracle Technology | 1998-10-28 |
| HANDISOL WOUND HEALING (K982082) | National Biological Corp. | 1998-10-28 |
| BEGOPAL 300 (K983081) | Bego Bremer Goldschlaegerei Wilh. Herbst GmbH & CO | 1998-10-28 |
| OLYMPUS MH-246R BALLOON SHEATH, FOR BRONCHIAL USE (K982733) | The Olympus Optical Co. | 1998-10-28 |
| MILLENNIA 3500 SERIES MONITOR WITH ANTHESTHETIC AGENT (K974581) | Invivo Research, Inc. | 1998-10-28 |
| PIEZO TRONIC (K982793) | Advanced Medical Devices, Inc. | 1998-10-28 |
| MEDINE DISPOSABLE STERILE ZONED IMPERVIOUS SURGICAL GOWNS (K982693) | Medline Industries, Inc. | 1998-10-28 |
| ELAN-2 (K983091) | Kerr Dental Materials Center | 1998-10-28 |
| MRI'S ALL SILICONE IRRIGATION 3-WAY FOLEY CATHETER (K982970) | Mri Manufacturing and Research, Inc. | 1998-10-28 |
| MAICO MA42 (K982723) | Bernafon-Maico, Inc. | 1998-10-28 |
| SHELHIGH NO-REACT VASCUPATCH (K982810) | Shelhigh, Inc. | 1998-10-28 |
| CLEARPLAN EASY FERTILITY MONITOR (K981207) | Unipath , Ltd. | 1998-10-28 |
| SYNCHRON SYSTEMS DAT LOW AND HIGH URINE CONTROLS 1 (K983709) | Beckman Coulter, Inc. | 1998-10-28 |
| HIGH VISCOSITY COMPOSITE TEMPORARY (PROVISIONAL) MATERIAL (K980799) | Cosmedent, Inc. | 1998-10-28 |
| BEGOCER G (K983082) | Bego U.S.A. | 1998-10-28 |
| DEPUY PROFILE ROUND HEAD INTERFERENCE SCREW, DEPUY PHANTOM RESORBABLE INTERFERENCE SCREW (K982662) | DePuy Orthopaedics, Inc. | 1998-10-28 |
| SPIROCARD (K973138) | Qrs Diagnostic, LLC | 1998-10-28 |
| MEPILEX (K983184) | Molnlycke Health Care, Inc. | 1998-10-28 |
| AUROLLOYD KF (K983080) | Bego U.S.A. | 1998-10-28 |
| SONOLINE ELEGRA DIAGNOSTIC ULTRASOUND SYSTEM (K981528) | Siemens Medical Solutions USA, Inc. | 1998-10-28 |
| PIOLAX HYDROPHILIC GUIDEWIRE (K980977) | Piolax Medical Devices, Inc. | 1998-10-27 |
| SUMMIT ACETABULAR SYSTEM (K983014) | Johnson & Johnson Professionals, Inc. | 1998-10-27 |
| CHEMSTRIP 101 URINE ANALYZER (K983510) | Boehringer Mannheim Corp. | 1998-10-27 |
| ELECSYS PSA, MODEL 2010 (K982949) | Boehringer Mannheim Corp. | 1998-10-27 |
| FERRITIN CALIBRATOR (K983548) | Dade Behring, Inc. | 1998-10-27 |
| ELECSYS PSA, MODEL # ELECSYS 1010 (K982948) | Boehringer Mannheim Corp. | 1998-10-27 |
| OSTEO DYNATROC PROXIMAL FEMORAL NAIL (K983339) | Osteonics Corp. | 1998-10-27 |
| DEPUY ACE COMPOSITE LOCKING NUT (K983265) | Depuy Ace Medical Co. | 1998-10-26 |
| 3M TEGASORB HYDROCOLLOID DRESSING (K982893) | 3M Company | 1998-10-26 |
| SURGICAL DYNAMICS RODDING SYSTEM (PREVIOUSLY KNOWN AS THE AURORA TITANIUM SPINAL ROD SYSTEM) (K983197) | United States Surgical, A Division of Tyco Healthc | 1998-10-26 |
| COBE SMARXT TUBING AND CONNECTORS (K981613) | Cobe Cardiovascular, Inc. | 1998-10-26 |
| 3M TEGASORB THIN HYDROCOLLOID DRESSING (K982892) | 3M Company | 1998-10-26 |
| PATIENT WARMER- MODEL PW810 (K982636) | Fisher & Paykel Healthcare, Ltd. | 1998-10-26 |
| MOLDCARE HEAD & NECK CUSHION, MODEL # MT-ACL-14242 (K982624) | Med-Tec,Inc. | 1998-10-26 |
| ADVANCED UROSCIENCE INJECTION NEEDLE (K982890) | Advanced Uroscience, Inc. | 1998-10-26 |
| ZIPPIE GS, MODEL # EIZGS (K983639) | Sunrise Medical, Inc. | 1998-10-25 |
| OLYMPUS MH-246R BALLOON SHEATH, FOR FEMALE REPRODUCTIVE TRACT USE (K982725) | Olympus America, Inc. | 1998-10-23 |
| MG (K981791) | Abbott Laboratories | 1998-10-23 |
| BEGOPAL (K983078) | Bego U.S.A. | 1998-10-23 |