| ALEXANDER MANUFACTURING CO. RECHARGEABLE BATTERY PART NUMBER GL625 (K972780) | Alexander Mfg. Co. | 1997-10-20 |
| DONG BANG ACUPUNCTURE NEEDLES (K972659) | Dong Bang, U.S.A. | 1997-10-17 |
| MAGI ACUPUNCTURE NEEDLES (K972658) | Dong Bang, U.S.A. | 1997-10-17 |
| ARROW-HOWES LARGE BORE MULTI-LUMEN CENTRAL VENOUS CATHETERS (K970864) | Arrow Intl., Inc. | 1997-10-17 |
| STORZ MILLENNIUM VISCOUS FLUID SYSTEM (K972664) | Storz Instrument Co. | 1997-10-10 |
| LUBRIGLIDE (K973557) | Qualis, Inc. | 1997-10-10 |
| AUTOMIX 3+3/AS COMPOUNDER SYSTEM (K961008) | Baxter Healthcare Corp | 1997-10-10 |
| PACER MODEL 100 INFUSION CONTROLLER (K963136) | Health Watch, Inc. | 1997-10-10 |
| MILLENNIUM CRT INFUSION PUMP AND MILLENNIUM CRT INFUSION PUMP ADMINISTRATION SETS (K972678) | Mcgaw, Inc. | 1997-10-07 |
| MEDI-PLUS, HEALTH-PLUS, SANITEX, RELIANCE (K972169) | Pwa Industries Sdn. Bhd. | 1997-10-03 |
| BABYTHERM 8004 BABYTHERM 8010 (K971198) | Drager, Inc. | 1997-10-03 |
| MEDCORP FLOW I.V. REGULATOR EXTENSION SET (K971004) | Medcorp Intl. | 1997-10-02 |
| AMSINO I.V. ADMINISTRATION SET (K973107) | Amsino Intl., Inc. | 1997-10-02 |
| PERACT 20 LIQUID STERILANT (K960513) | Minntech Corp. | 1997-10-01 |
| CORE RESISTANT HUBER INFUSION SETS (K972712) | Icu Medical, Inc. | 1997-10-01 |
| CONVATEC ODOR CONTROL WOUND DRESSING (K972530) | Convatec, A Division of E.R. Squibb & Sons | 1997-10-01 |
| SA-EF MULTI-LUMEN EXTENSION SET (K972957) | Vlv Associates, Inc. | 1997-09-29 |
| NITRILE EXAMINATION GLOVES-PRE POWDERED (K970216) | Influx Pacific Sdn. Bhd. | 1997-09-26 |
| SPORTROL RAPID STERILITY INDICATOR (K962649) | North American Science Assoc., Inc. | 1997-09-26 |
| DUO-LITE PHOTOTHERAPY SYSTEM (K971256) | Air-Shields, Inc. | 1997-09-24 |
| OLYMPIC BILI-BASSINET (K971601) | Olympic Medical Corp. | 1997-09-24 |
| DISETRONIC PENFINE INJECTION PEN NEEDLE (K973339) | Disetronic Medical Systems | 1997-09-24 |
| DIGI-INJECTOR (K971067) | Medical Instrument Development Laboratories, Inc. | 1997-09-19 |
| TST CONTROL INTEGRATOR FOR STEAM AUTOCLAVE (K965154) | Albert Browne , Ltd. | 1997-09-19 |
| CONFORM NO POWDER (PROTEIN LABELING CLAIM) EXAMINATION GLOVES (K972785) | Ansell Perry | 1997-09-19 |
| PHASEAL, SYSTEM FOR SEALED HANDLING OF CHEMOTHERAPEUTIC AGENTS (K972527) | Quality System Consulting | 1997-09-18 |
| NIPRO DISPOSABLE SOLUTION INFUSION SET (K972493) | Nipro Medical Corp. | 1997-09-18 |
| OPPURTUNITY TRACHEOSTOMY CARE KIT (K971091) | Opportunity, Inc. | 1997-09-16 |
| OPPORTUNITY DRESSING CHANGE TRAY (K971090) | Opportunity, Inc. | 1997-09-16 |
| DISETRONIC H-TRON PLUS V 100 INSULIN INFUSION PUMP (K973044) | Disetronic Medical Systems | 1997-09-15 |
| FIRST PICC CATHETER WITH DUAL LUMENS (K972263) | Becton Dickinson Infusion Therapy Systems, Inc. | 1997-09-15 |
| FIRST MIDCATH CATHETER (K972264) | Becton Dickinson Infusion Therapy Systems, Inc. | 1997-09-15 |
| FIRST PICC CATHETER (K972262) | Becton Dickinson Infusion Therapy Systems, Inc. | 1997-09-15 |
| FIRST MIDCATH CATHETER (K972254) | Becton Dickinson Infusion Therapy Systems, Inc. | 1997-09-12 |
| BIG BAG 3000 PRESSURE INFUSOR (K973133) | Byron Medical | 1997-09-12 |
| POWDERFREE COLORED AND FLAVORED NITRILE COPOLYMER PATIENT EXAMINATION GLOVES-MEDICAL DEVICE (K972306) | P.T. Irama Dinamika Latex | 1997-09-12 |
| VYGON UMBILICAL CATHETHER INSERTION TRAY (K963196) | Vygon Corp. | 1997-09-09 |
| DYE STOP AND SAVE - QUICKFILL (K971624) | Shepherd Laboratories, Inc. | 1997-09-08 |
| BIOSURGICAL, CORP. MULTI CHAMBER SUCTION SYRINGE (K964597) | Biosurgical Corp. | 1997-09-08 |
| OLYMPIX MINI-PASTEURMATIC (58210) (K972193) | Olympic Medical Corp. | 1997-09-05 |
| KT AIR BED (K970468) | Kinetic Concepts, Inc. | 1997-09-05 |
| POWDER FREE SYNTHETIC EXAMINATION GLOVES (K971356) | Arista Latindo Industrial Ltd. P.T | 1997-09-05 |
| BKMI DISPOSABLE SYRINGE (K971487) | Sumi Salud C.A. | 1997-09-04 |
| SMART SET (K972663) | Top Spins, Inc. | 1997-09-02 |
| AMBIDERM (K971102) | Supertex Industrial, S.A. DE C.V. | 1997-08-29 |
| VOLKER HOSPITAL BED, MODEL K960 (K972115) | Volker Healthcare, Inc. | 1997-08-29 |
| W.A. (K971200) | W.A. Rubbermate Co., Ltd. | 1997-08-29 |
| SHARPS SHUTTLE (K972279) | Sage Products, Inc. | 1997-08-29 |
| SPOROX TEST STRIPS (K972035) | Serim Research Corp. | 1997-08-29 |
| POLY (VINYL) EXAM GLOVE, POWDERED (K971316) | Copioumed Intl., Inc. | 1997-08-27 |
| SELFSHIELD HN SELF SHEATHING HYPODERMIC NEEDLE (K972469) | Beech Medical Products, Inc. | 1997-08-27 |
| BLOOD COLLECTION TUBE HOLDER VANISHPOINT TUBE HOLDER/SMALL TUBE ADAPTER (K971763) | Retractable Technologies, Inc. | 1997-08-26 |
| MAERSK MEDICAL PURELINE COMFORT SUBCUTANEOUS INFUSION SET (K972135) | P/L Biomedical | 1997-08-26 |
| BAG DECANTER (K972134) | Remington Medical, Inc. | 1997-08-26 |
| MSI BOTTLEFLOW, TRANSFLOW, VIALFLOW (K972117) | Medical Specialty Innovations, Inc. (Msi) | 1997-08-26 |
| ACCUTEMP-PROBE (K970686) | Kentec Medical, Inc. | 1997-08-25 |
| DASH, SULLIVAN, VITAL GARD (K971044) | Dash Medical Gloves, Inc. | 1997-08-25 |
| NITRILE GLOVES (K970135) | Sage Products, Inc. | 1997-08-25 |
| ARROWGARD BLUE QUAD-LUMEN CENTRAL VENOUS CATHETER (K962577) | Arrow Intl., Inc. | 1997-08-21 |
| RID-DECUBE II (K965207) | Skin Care Management, Inc. | 1997-08-21 |
| ACCESS SYSTEMS NEEDLELESS VIAL ADAPTER (K971500) | Biological & Environmental Control Laboratories | 1997-08-18 |
| MINIMED INFUSION PUMP, MODEL 507C (K972107) | Medtronic Minimed | 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 |
| SYRINGE NEEDLE REMOVER (S.N.R.) (K972536) | Post Medical, Inc. | 1997-08-15 |
| MEDI-SIS SYRINGE INFUSION SYSTEM (K972173) | I-Flow Corp. | 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 |
| CONVATEC NON-ADHESIVE DRESSING (K972062) | Convatec, A Division of E.R. Squibb & Sons | 1997-08-14 |
| DERMAGRAN WOUND MANAGEMENT SYSTEM (K970660) | Derma Sciences, Inc. | 1997-08-12 |
| GOLD FINGERS (K971183) | Alliance Rubber Products Sdn. Bhd. | 1997-08-08 |
| 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 |
| DOUBLE LUMEN PICC (K970926) | B.Braun Medical, Inc. | 1997-08-01 |
| AEROQUIP SAFESTART IV CATHETER (K970669) | Aeroquip Medical Products | 1997-08-01 |
| AEROQUIP SAFESTART (TM) IV CATH (TM) SYSTEM (K970644) | Aeroquip Medical Products | 1997-07-31 |
| ALTERNATING PRESSURE AIR FLOTATION MATTRESS (K972153) | Decubiti Concepts, Inc. | 1997-07-31 |
| POWDER-FREE NITRILE EXAMINATION GLOVE, BLUE OR WHITE (NON-COLORED) (K972195) | Absolute Synthetic Technologies Malaysia Sdn. Bhd. | 1997-07-29 |
| DERMAMEND HYDROGEL GAUZE DRESSING (K972336) | Dermarx Corp. | 1997-07-29 |
| STRYKER INTERPULSE HANDPIECE SET, SPLASH SHIELDS, IRRIGATION AND SUCTION TIPS, RECHARGEABLE BATTERY PACK (K972069) | Stryker Instruments | 1997-07-29 |
| POWDERED NITRILE EXAMINATION GLOVE, BLUE OR WHITE (NON-COLORED) (K972177) | Absolute Synthetic Technologies Malaysia Sdn. Bhd. | 1997-07-29 |
| ALLEGIANCE NON STERILE POWDER FREE LOW PROTEIN LATEX EXAMIATION GLOVES (K972291) | Allegiance Healthcare Corp. | 1997-07-28 |
| DYNA GLIDE 2600 ROLL-IN AMBULANCE COT (95759) (K972528) | Dyna Corp. | 1997-07-28 |
| POWDER-FREE PATIENT EXAMINATION GLOVES (K971949) | Tekmedic (M) Sdn Bhd | 1997-07-28 |
| SERVO-CONTROL COSYCOT INFANT WARMER, MANUAL-CONTROL COSYCOT INFANT WARMER (K971695) | Fisher & Paykel Electronics , Ltd. | 1997-07-28 |
| RAMY PISTON SYRINGE (K971664) | Alshifa Medical Syringes Mfg. Co., Ltd. | 1997-07-25 |
| SUCTION INSTRUMENTATION (K972074) | Walter Lorenz Surgical, Inc. | 1997-07-25 |
| PROTECTIVE RESTRAINT MODELS #302,440,750,850,AND905 (K972123) | Smith | 1997-07-25 |
| POCKET COUNT OR SAFETCOUNT (K972302) | Sage Products, Inc. | 1997-07-25 |
| DEPUY ORTHOTECH HEAVY DUTY VEST RESTRAINT (K971742) | Depuy, Inc. | 1997-07-24 |
| RAMY INTEGRATED NEEDLE SYRINGE (K972452) | Alshifa Medical Syringes Mfg. Co., Ltd. | 1997-07-24 |
| PROTECTIVE RESTRAINT(MODELS #302,440,750 AND A30 X 30 BELT. (K972338) | Geriatric Products, Inc. | 1997-07-24 |
| CORELIFE (K964230) | Core Healthcare , Ltd. | 1997-07-24 |
| FENWAL 40 MICRON TRANSFUSION FILTER (K972159) | Baxter Healthcare Corp | 1997-07-23 |
| REST MATTRESS (K971568) | Rest Mattress | 1997-07-18 |
| ISOLYSER SDS SHARPS CONTAINER (K970547) | Thantex Specialties, Inc. | 1997-07-18 |
| STERILE AMBULATORY RESERVOIR 60ML/100ML (K962159) | Faulding Medical Device Co. | 1997-07-18 |
| PULSE*SPRAY INJECTOR (K963574) | AngioDynamics, Inc. | 1997-07-18 |
| MODIFIED PEDIKAIR (K954320) | Kinetic Concepts, Inc. | 1997-07-18 |