meddevicedb.com FDA Device Reference

Review Panel

General Hospital FDA 510(k) Clearances & Devices

Cleared Devices
15,723
Product Codes (page)
34
Latest Decision
1997-11-07

Clearances · page 79 of 158

K-Number Trade Name Applicant / Manufacturer Product Code Class Decision Date
K973059 PATIENT NITRILE EXAMINATION GLOVE (LIGHTLY POWDERED) Sri Johani Sdn. Bhd. LZA Class I 1997-11-07
K971990 GESCO PER-Q-CATH PICC CATHETERS Bard Access Systems, Inc. FOZ Class II 1997-11-07
K971991 GESCO PER-Q-CATH MIDLINE CATHETERS Bard Access Systems, Inc. FOZ Class II 1997-11-07
K973058 PATIENT NITRILE EXAMINATION GLOVE (POWDERFREE) Sri Johani Sdn. Bhd. LZA Class I 1997-11-07
K973301 ANTI-STICK SYRINGE WITH INTEGRAL HYPODERMIC NEEDLE/VANISHPOINT SYRINGE Retractable Technologies, Inc. MEG Class II 1997-11-07
K970081 SUPER AIR 9000 ALTERNATING AIR FLOATATION MATTRESS SYSTEM Cathay Consolidated, Inc. FNM Class II 1997-11-07
K972624 POLY (VINYL) EXAM GLOVE, POWDER-FREE Copioumed Intl., Inc. LYZ Class I 1997-11-06
K973134 OMNI F.T. LATEX EXAMINATION GLOVE, POWDERED Omnigrace , Ltd. LYY Class I 1997-11-06
K973551 MEDI-PLUS, HEALTH-PLUS, SANITEX, RELIANCE Pwa Industries Sdn. Bhd. LZA Class I 1997-11-06
K973012 MDC SAFE STEP SAFETY BLOOD COLLECTION NEEDLE SYSTEM MDC Research , Ltd. FMI Class II 1997-11-05
K972090 POWDER-FREE HYPOALLERGENIC NITRILE EXAMINATION GLOVES Shen Wei (Usa), Inc. LZA Class I 1997-11-05
K972464 VITALMIX PLUS EMPTY I.V. CONTAINER Pacific Device, Inc. KPE Class II 1997-11-05
K972878 ULTRASAFE INJECTION SYSTEM NEEDLE GUARD, MODELS B50,B100L,B150,B225, AND B300 Safety Syringes, Inc. FMF Class II 1997-10-30
K972885 SERVO-CONTROL WALL-MOUNT COSYCOT INFANT WARMER MODEL IW960, MANUAL CONTROL WALL-MOUNT COSYCOT INFANT WARMER MODEL IW970 Fisher & Paykel Electronics , Ltd. FMT Class II 1997-10-30
K971514 REGENT BIOGEL DIAGNOSTIC PROCEDURE GLOVE London International Group, Inc. LYY Class I 1997-10-29
K973843 MSI PRESSURE INFUSOR Smith Assoc. KZD Class I 1997-10-29
K973911 2 GALLON ALTERNATE CARE SHARPS CONTAINER Sage Products, Inc. FMI Class II 1997-10-29
K972551 ARTISAN PULSE LAVAGE SYSTEM Howmedica Corp. FQH Class II 1997-10-29
K973550 TUTTNAUER TABLE-TOP AUTOCLAVE Tuttnauer U.S.A Co, Ltd. FLE Class II 1997-10-29
K972757 ROYAL SHIELD NON-STERILE POWDERFREE, COLORED NITRILE EXAMINATION GLOVE Shield Gloves Manufacturer (M) Sdn Bhd LZA Class I 1997-10-29
K970230 SPOROX Reckitt Benckiser, Inc. MED Class II 1997-10-29
K973654 VIAL-MATE RECONSTITUTION DEVICE (2B8071) Baxter Healthcare Corp LHI Class II 1997-10-24
K955243 BARIAIR Kinetic Concepts, Inc. FNM Class II 1997-10-23
K973283 ALGINATE/ZINC WOUND DRESSING Innovative Technologies , Ltd. KMF Class I 1997-10-21
K972801 ALLIANCE RUBBER, EC-GRIP Alliance Rubber Products Sdn. Bhd. LYY Class I 1997-10-21
K973811 POWDER-FREE LATEX EXAMINATION GLOVE, TEAL OR WHITE (NON-COLORED) Absolute Quality Leadership, Inc. LYY Class I 1997-10-21
K973440 REXAM FRACTURE RESISTANT POUCH Rexam Medical Packaging, Inc. KCT Class II 1997-10-20
K972780 ALEXANDER MANUFACTURING CO. RECHARGEABLE BATTERY PART NUMBER GL625 Alexander Mfg. Co. MRZ Class II 1997-10-20
K972779 ALEXANDER MANUFACTURING CO. RECHARGEABLE BATTERY PART NUMBER MS3030-P Alexander Mfg. Co. MRZ Class II 1997-10-20
K972658 MAGI ACUPUNCTURE NEEDLES Dong Bang, U.S.A. MQX Class II 1997-10-17
K970864 ARROW-HOWES LARGE BORE MULTI-LUMEN CENTRAL VENOUS CATHETERS Arrow Intl., Inc. FOZ Class II 1997-10-17
K972659 DONG BANG ACUPUNCTURE NEEDLES Dong Bang, U.S.A. MQX Class II 1997-10-17
K963136 PACER MODEL 100 INFUSION CONTROLLER Health Watch, Inc. LDR Class II 1997-10-10
K961008 AUTOMIX 3+3/AS COMPOUNDER SYSTEM Baxter Healthcare Corp LHI Class II 1997-10-10
K972664 STORZ MILLENNIUM VISCOUS FLUID SYSTEM Storz Instrument Co. MRH Class II 1997-10-10
K973557 LUBRIGLIDE Qualis, Inc. KMJ Class I 1997-10-10
K972678 MILLENNIUM CRT INFUSION PUMP AND MILLENNIUM CRT INFUSION PUMP ADMINISTRATION SETS Mcgaw, Inc. FRN Class II 1997-10-07
K972169 MEDI-PLUS, HEALTH-PLUS, SANITEX, RELIANCE Pwa Industries Sdn. Bhd. LZA Class I 1997-10-03
K971198 BABYTHERM 8004 BABYTHERM 8010 Drager, Inc. FMT Class II 1997-10-03
K971004 MEDCORP FLOW I.V. REGULATOR EXTENSION SET Medcorp Intl. FPA Class II 1997-10-02
K973107 AMSINO I.V. ADMINISTRATION SET Amsino Intl., Inc. FPA Class II 1997-10-02
K972530 CONVATEC ODOR CONTROL WOUND DRESSING Convatec, A Division of E.R. Squibb & Sons KMF Class I 1997-10-01
K972712 CORE RESISTANT HUBER INFUSION SETS Icu Medical, Inc. FPA Class II 1997-10-01
K960513 PERACT 20 LIQUID STERILANT Minntech Corp. MED Class II 1997-10-01
K972957 SA-EF MULTI-LUMEN EXTENSION SET Vlv Associates, Inc. FPA Class II 1997-09-29
K970216 NITRILE EXAMINATION GLOVES-PRE POWDERED Influx Pacific Sdn. Bhd. LZA Class I 1997-09-26
K962649 SPORTROL RAPID STERILITY INDICATOR North American Science Assoc., Inc. MTC Class II 1997-09-26
K973339 DISETRONIC PENFINE INJECTION PEN NEEDLE Disetronic Medical Systems FMI Class II 1997-09-24
K971601 OLYMPIC BILI-BASSINET Olympic Medical Corp. LBI Class II 1997-09-24
K971256 DUO-LITE PHOTOTHERAPY SYSTEM Air-Shields, Inc. LBI Class II 1997-09-24
K971067 DIGI-INJECTOR Medical Instrument Development Laboratories, Inc. MRH Class II 1997-09-19
K965154 TST CONTROL INTEGRATOR FOR STEAM AUTOCLAVE Albert Browne , Ltd. LRT Class II 1997-09-19
K972785 CONFORM NO POWDER (PROTEIN LABELING CLAIM) EXAMINATION GLOVES Ansell Perry LYY Class I 1997-09-19
K972493 NIPRO DISPOSABLE SOLUTION INFUSION SET Nipro Medical Corp. FPA Class II 1997-09-18
K972527 PHASEAL, SYSTEM FOR SEALED HANDLING OF CHEMOTHERAPEUTIC AGENTS Quality System Consulting FPA Class II 1997-09-18
K971091 OPPURTUNITY TRACHEOSTOMY CARE KIT Opportunity, Inc. KMF Class I 1997-09-16
K971090 OPPORTUNITY DRESSING CHANGE TRAY Opportunity, Inc. KMF Class I 1997-09-16
K972262 FIRST PICC CATHETER Becton Dickinson Infusion Therapy Systems, Inc. FOZ Class II 1997-09-15
K973044 DISETRONIC H-TRON PLUS V 100 INSULIN INFUSION PUMP Disetronic Medical Systems LZG Class II 1997-09-15
K972264 FIRST MIDCATH CATHETER Becton Dickinson Infusion Therapy Systems, Inc. FOZ Class II 1997-09-15
K972263 FIRST PICC CATHETER WITH DUAL LUMENS Becton Dickinson Infusion Therapy Systems, Inc. FOZ Class II 1997-09-15
K972254 FIRST MIDCATH CATHETER Becton Dickinson Infusion Therapy Systems, Inc. FOZ Class II 1997-09-12
K972306 POWDERFREE COLORED AND FLAVORED NITRILE COPOLYMER PATIENT EXAMINATION GLOVES-MEDICAL DEVICE P.T. Irama Dinamika Latex LZA Class I 1997-09-12
K973133 BIG BAG 3000 PRESSURE INFUSOR Byron Medical FRN Class II 1997-09-12
K963196 VYGON UMBILICAL CATHETHER INSERTION TRAY Vygon Corp. FOZ Class II 1997-09-09
K964597 BIOSURGICAL, CORP. MULTI CHAMBER SUCTION SYRINGE Biosurgical Corp. FMF Class II 1997-09-08
K971624 DYE STOP AND SAVE - QUICKFILL Shepherd Laboratories, Inc. FPA Class II 1997-09-08
K971356 POWDER FREE SYNTHETIC EXAMINATION GLOVES Arista Latindo Industrial Ltd. P.T LZA Class I 1997-09-05
K972193 OLYMPIX MINI-PASTEURMATIC (58210) Olympic Medical Corp. LDS Class II 1997-09-05
K970468 KT AIR BED Kinetic Concepts, Inc. FNM Class II 1997-09-05
K971487 BKMI DISPOSABLE SYRINGE Sumi Salud C.A. FMI Class II 1997-09-04
K972663 SMART SET Top Spins, Inc. FPA Class II 1997-09-02
K972035 SPOROX TEST STRIPS Serim Research Corp. JOJ Class II 1997-08-29
K971200 W.A. W.A. Rubbermate Co., Ltd. LYY Class I 1997-08-29
K972115 VOLKER HOSPITAL BED, MODEL K960 Volker Healthcare, Inc. FNL Class II 1997-08-29
K972279 SHARPS SHUTTLE Sage Products, Inc. FMI Class II 1997-08-29
K971102 AMBIDERM Supertex Industrial, S.A. DE C.V. LYY Class I 1997-08-29
K971316 POLY (VINYL) EXAM GLOVE, POWDERED Copioumed Intl., Inc. LYZ Class I 1997-08-27
K972469 SELFSHIELD HN SELF SHEATHING HYPODERMIC NEEDLE Beech Medical Products, Inc. FMI Class II 1997-08-27
K972135 MAERSK MEDICAL PURELINE COMFORT SUBCUTANEOUS INFUSION SET P/L Biomedical FPA Class II 1997-08-26
K972134 BAG DECANTER Remington Medical, Inc. LHI Class II 1997-08-26
K971763 BLOOD COLLECTION TUBE HOLDER VANISHPOINT TUBE HOLDER/SMALL TUBE ADAPTER Retractable Technologies, Inc. FMI Class II 1997-08-26
K972117 MSI BOTTLEFLOW, TRANSFLOW, VIALFLOW Medical Specialty Innovations, Inc. (Msi) LHI Class II 1997-08-26
K970686 ACCUTEMP-PROBE Kentec Medical, Inc. FMT Class II 1997-08-25
K971044 DASH, SULLIVAN, VITAL GARD Dash Medical Gloves, Inc. LYY Class I 1997-08-25
K970135 NITRILE GLOVES Sage Products, Inc. LZC Class I 1997-08-25
K962577 ARROWGARD BLUE QUAD-LUMEN CENTRAL VENOUS CATHETER Arrow Intl., Inc. FOZ Class II 1997-08-21
K965207 RID-DECUBE II Skin Care Management, Inc. FNM Class II 1997-08-21
K971500 ACCESS SYSTEMS NEEDLELESS VIAL ADAPTER Biological & Environmental Control Laboratories FPA Class II 1997-08-18
K972173 MEDI-SIS SYRINGE INFUSION SYSTEM I-Flow Corp. MEB Class II 1997-08-15
K972536 SYRINGE NEEDLE REMOVER (S.N.R.) Post Medical, Inc. FMI Class II 1997-08-15
K972046 FULL BODY RESTRAINT SYSTEM Gillen Industries FMQ Class I 1997-08-15
K972838 POWDER-FREE NITRILE, POLY-COATED EXAMINATION GLOVE, PURPLE OR WHITE (NON-COLORED) Absolute Synthetic Technologies Malaysia Sdn. Bhd. LZA Class I 1997-08-15
K972107 MINIMED INFUSION PUMP, MODEL 507C Medtronic Minimed LZG Class II 1997-08-15
K970115 POWDER FREE LATEX EXAMINATION GLOVES Pt Mbf Buana Multicorpora LYY Class I 1997-08-15
K972104 LIGHTLY POWDERED VINYL SYNTHETIC EXAMINATION GLOVES Shinemound Enterprise, Inc. LYZ Class I 1997-08-15
K972062 CONVATEC NON-ADHESIVE DRESSING Convatec, A Division of E.R. Squibb & Sons KMF Class I 1997-08-14
K970660 DERMAGRAN WOUND MANAGEMENT SYSTEM Derma Sciences, Inc. KMF Class I 1997-08-12
K971183 GOLD FINGERS Alliance Rubber Products Sdn. Bhd. LYY Class I 1997-08-08
K971629 PATIENT LATEX EXAMINATION GLOVE (PREPOWDERED) Besglove Medicare Sdn. Bhd. LYY Class I 1997-08-06

15,723 clearances in the General Hospital panel. Data: openFDA.