meddevicedb.com FDA Device Reference

Review Panel

General Hospital FDA 510(k) Clearances & Devices

Cleared Devices
15,723
Product Codes (page)
35
Latest Decision
1985-05-08

Clearances · page 137 of 158

K-Number Trade Name Applicant / Manufacturer Product Code Class Decision Date
K851360 IMED GRAVISET INTRAVASCULAR ADMIN. SET Imed Corp. FRN Class II 1985-05-08
K851384 MEDICAL/SURGICAL SUCTION SYSTEM Puritan Bennett Corp. GCX Class II 1985-05-08
K851551 MERIVAARA ELECTRIC HOSPITAL BED & ACCESSORIES Daun International, Inc. FNL Class II 1985-05-08
K851447 IVAC MODEL 580 GENER. USE VOLUMETRIC INFUSION PUMP Y FRN Class II 1985-05-08
K851552 MERIVAARA HOSPITAL BED Daun International, Inc. FNJ Class I 1985-05-08
K851299 CORRECT FLO Norton Performance Plastics Corp. FPA Class II 1985-05-07
K851017 QUEST 521 VARIABLE PRESSURE VOLUMETRIC INFUSION PU Quest Medical, Inc. FRN Class II 1985-05-07
K850888 PERCUTANEOUS CV CATHETER INSERTION KIT W OR W/O CV Creative Care Systems, Inc. LJT Class II 1985-05-07
K844664 THE I.V. BAG Kabivitrum, Inc. KPE Class II 1985-05-06
K851477 VYGON EXCHANGE TRANSFUSION TRAY 275.00 Vygon Corp. BRZ Class II 1985-05-03
K851315 ABCO INSTRUMENT PACKS & TRAYS Abco Dealers, Inc. FRG Class II 1985-05-01
K850887 DRESSING CHANGE KIT Creative Care Systems, Inc. FOZ Class II 1985-05-01
K845043 JMS NEEDLES & JMS SYRINGES Jms Co., Ltd. FMI Class II 1985-04-29
K851224 WEST BEND ELECTRIC THERMOMETER The West Bend Co. FLL Class II 1985-04-29
K851058 DOSI FLOW Leventon, S.A. LDR Class II 1985-04-29
K851121 PI-PHEUMO INTESTINAL INSTRUMENT SET Surgeons Choice, Inc. GAG Class II 1985-04-25
K850420 CHURCHILL HABER POINT NEEDLE ADMIN. SET Churchill Corp. FMI Class II 1985-04-24
K851340 BLUE SEAL II STERILIZATION POUCH American Sterilizer Co. FRG Class II 1985-04-24
K850067 MEDICAL, DISPOSABLE BEDDING East Texas Lighthouse For the Blind KME Class I 1985-04-19
K850947 V-MUELLER INVERTED LINEAR ANASTOMOSIS INSTRUMENTS American V. Mueller GAG Class II 1985-04-17
K844080 ARROW-GEISS PERCUTANEOUS TPN KIT Arrow Intl., Inc. LJS Class II 1985-04-17
K851101 BIONOMY'S MULTI-LUMEN CENTRAL VENOUS CATHETER-SET Bionomy, Inc. FOZ Class II 1985-04-12
K851379 HEALTHCHECK DIGITAL THERMOMETER MODEL 1 TH-2 Healthcheck Corp. FLL Class II 1985-04-12
K850277 VIGGO I.V. ACCESSORIES-VIGGO EXTENSION TUBES ETC. Viggo Products FPA Class II 1985-04-12
K851090 MONOJECT STERILE 1/2 CC & 1CC SYRINGES W & W/O NEE Sherwood Medical Co. FMF Class II 1985-04-12
K851089 MONOJECT STERILE 12CC SYRINGES, W/WO NEEDLES Sherwood Medical Co. FMF Class II 1985-04-12
K850276 VIGGO NEOFLON INFUSION CANNULA Viggo Products FOZ Class II 1985-04-12
K850280 VIGGO CONNECTA 3-WAY INFUSION STOPCOCK Viggo Products FMG Class II 1985-04-11
K850460 VIGGO SECALON T CATHETER Viggo Products FOZ Class II 1985-04-11
K850958 BLOOD GAS SAMPLER KIT Churchill Corp. FMF Class II 1985-04-10
K850826 POSIDYNE SOLUTION CONTAINER FILTER, RECORDER #96 Pall Biomedical Products Co. FPB Class II 1985-04-09
K850278 VASCULON I.V. CANNULAE Viggo Products FOZ Class II 1985-04-09
K850669 PROMINJECT PROGRAMMABLE INFUSION PUMP Pharmacia, Inc. FRN Class II 1985-04-09
K850653 IMED 440 INFUSION PUMP & ADMINISTRATION SET Imed Corp. FRN Class II 1985-04-09
K850729 ACUFLO VOLUMETRIC CONTROLLED DELIVERY SYS 2000 Surgidev Corp. FRN Class II 1985-04-09
K850674 CORMED II AMBULATORY INFUSION PUMP Cormed, Inc., Sub. C.R.Bard, Inc. FRN Class II 1985-04-09
K850349 VIGGO ARTERIAL CANNULA Viggo Products FOZ Class II 1985-04-09
K844843 IVAC DRUG ADMINISTRATION DEVICE Y FPA Class II 1985-04-09
K850825 AEF POSIDYNE I.V. FILTER/AIR ELIMINATOR Pall Biomedical Products Co. FPB Class II 1985-04-09
K850181 AEQUITRON MED-7100 PHOTOTHERAPY LIGHT Aequitron Medical, Inc. LBI Class II 1985-04-05
K850797 TEMPALERT LIQUID CRYSTAL THERMOMETER Medical Frontiers, Inc. KPD Class II 1985-04-05
K850757 TANDEM SETS I.V. Acacia, Inc. LHI Class II 1985-04-04
K851010 NORELCO DIGITAL MODEL 987 THERMOMETER Philips Park FLL Class II 1985-04-04
K850710 TRAVENOL FLO-GARD 500 IV MONITOR Travenol Laboratories, S.A. FLN Class II 1985-04-04
K850244 CLINICAL ELECTRONIC THERMOMETERS Sheridan Catheter Corp. FLL Class II 1985-04-04
K851075 NORELCO DIGITAL MODEL 970 THERMOMETER Philips Park FLL Class II 1985-04-04
K850503 SECU-TAPE UNIVERSAL FLEXIBLE MEDICAL CLAMPS Turn Needle Intl., Inc. KMK Class I 1985-04-01
K850470 BED PRODUCTS Abco Dealers, Inc. FMQ Class I 1985-04-01
K844920 CSR WRAP - CENTRAL SUPPLY ROOM WRAP FOR STERIL- Papeteries Depont-Audemer FRG Class II 1985-04-01
K844976 MEDI-MAN WATER POWERED BATH LIFT & HYDRAULIC LIFT Medi-Man Rehabilitation Products, Inc. FSA Class I 1985-04-01
K850506 CORRECT FLO INTRAVASCULAR ADMINISTRATION SET Biomedical Dynamics, Inc. FPA Class II 1985-04-01
K850398 NU-CATH EMERGENCY KIT Intl. Medical Devices , Ltd. FOZ Class II 1985-03-27
K850061 MICRO VOLUME DOUBLE LINE EXTENSION SET Travenol Laboratories, S.A. FPA Class II 1985-03-27
K851014 ACME LOW-PROFILE CHAIR SCAL 7300 Acme Medical Scale Co. FRW Class I 1985-03-27
K850083 TISSUE TEMP PROBE Pat O. Daily FLL Class II 1985-03-27
K850811 PAD, PRE-OPERATIVE PREPARATION East Texas Lighthouse For the Blind KME Class I 1985-03-21
K844624 BASIS DIGITAL THERMOMETER MODEL BTM-1 Terayco Intl., Ltd. FLL Class II 1985-03-21
K850488 STRATOFUSE SYRINGE PIGGYBACK PUMP 1030 Strato Medical Corp. FRN Class II 1985-03-21
K850533 ATLANTIC OPTICAL SYSTEMS OPTIFILTER SYSTEM Atlantic Optical Systems, Inc. FPA Class II 1985-03-21
K844512 DART DAILY AIR REMOVAL TEST American Sterilizer Co. JOJ Class II 1985-03-21
K842577 CATH-TECH POLYURETHANE UMBILICAL VESS Catheter Technology Corp. FOZ Class II 1985-03-13
K850183 CADD-VT, 5300 AMBULATORY INFUSION PUMP W/3050, 50M Deltec Systems, Inc. FRN Class II 1985-03-13
K843311 IV ADMIN. SET FOR MVP 1 INFUSION PUMP Ziehm International, Inc. FRN Class II 1985-03-13
K844401 REPRO-MED SYSTEMS INFUSION DEVICE Repro-Med Systems, Inc. FRN Class II 1985-03-12
K850544 SHAVE PREP TRAY Packaging Technologies, Inc. KME Class I 1985-03-12
K845031 KARECO INT'L - DOUGLE-HOOK I.V. STAND Kareco Intl., Inc. FOX Class I 1985-03-12
K850339 SPECIAL PROCEDURES PACK Marwood Medical, Inc. FPA Class II 1985-03-12
K844942 PLURA-GARD CHEST DRAINAGE SYSTEM Consolidated Medical Equipment, Inc. KDQ Class II 1985-03-12
K850671 IMPACT 901 SERIES PORT-A-WALL Impact Instrumentation, Inc. FOX Class I 1985-03-11
K850507 CRITIKON I.V. ADMINISTRAION SET Critikon Company, LLC FPA Class II 1985-03-07
K850051 VERSA-FILL 120 & FILL SET 42-50 Intl. Medical Industries LHI Class II 1985-03-06
K844915 IMED 980 VOLUMETRIC INFUSION PUMP Imed Corp. FRN Class II 1985-03-06
K850240 KM PRODUCTS SUCTION TIPS Km Products JOL Class II 1985-03-06
K844201 HI-LO TEMP THERMOCOUPLE TO THERMISTER ADAPTOR Mallinckrodt Critical Care FLL Class II 1985-03-04
K850200 SUCTION REGULATOR 7700 SERIES Boehringer Laboratories KDP Class II 1985-03-04
K844882 RICO RS-6X EMERGENCY MEDICAL ASPIRATOR Rico Suction Laboratories, Inc. GCX Class II 1985-03-01
K844881 RICO RS4-XP EMERGENCY MEDICAL ASPIRATOR Rico Suction Laboratories, Inc. GCX Class II 1985-03-01
K850133 VENI-GARD AP & TPN, DERMA-SHIELD, DERMA-SHIELD JR. Consolidated Medical Equipment, Inc. KGX Class I 1985-02-28
K850098 SILVER SPOON ENTERAL FEEDING PUMP Sterling Medical Devices, Inc. FRN Class II 1985-02-22
K844672 INSTRUTAINER Intrumed, Inc. FRG Class II 1985-02-22
K844904 CYTOSAFE NEEDLE Baxa Corp., Sub. of Cook Group, Inc. LHI Class II 1985-02-22
K850112 OMNIMED IV SOLUTION ADMINISTRATION SET Omni Intl., Inc. FPA Class II 1985-02-22
K843875 LEUKOSILK Beiersdorf, Inc. KGX Class I 1985-02-21
K843873 LEUKOFIX R Beiersdorf, Inc. KGX Class I 1985-02-21
K843874 LEUKOPOR SURGICAL TAPE Beiersdorf, Inc. KGX Class I 1985-02-21
K843876 LEUKOFLEX SURGICAL TAPE Beiersdorf, Inc. KGX Class I 1985-02-21
K850564 CLINIC ELECTRONIC THERMOMETER Gemini Electronics Co. , Ltd. FLL Class II 1985-02-19
K842133 EYRTHROCATH DOUBLE-LUMEN CENTRAL VENOUS Cardio Search, Inc. FOZ Class II 1985-02-19
K850369 QUINTON WHITE SEALING CAP Quinton, Inc. FOZ Class II 1985-02-15
K850362 POLLENEX DIGITAL THERMOMETER T-125 Associated Mills, Inc. FLL Class II 1985-02-15
K850363 POLLENEX DIGITAL THERMOMETER T-225 Associated Mills, Inc. FLL Class II 1985-02-15
K844077 NUTRIMIX EMPTY CONTAINER Abbott Laboratories KPE Class II 1985-02-15
K841374 HOME PRO VOLUMETRIC INFUSION PUMP American Edwards Laboratories FRN Class II 1985-02-15
K844871 CENTURY SAF-LIFT SCALE Century Manufacturing Co. FNG Class II 1985-02-08
K844872 CENTURY SCALE Century Manufacturing Co. FNG Class II 1985-02-08
K844221 HMB ALLERGOGEN SKIN PRICK TEST NEEDLE Aller/Guard, Inc. SCL Class II 1985-02-08
K850195 COPAL DIGITAL THERMOMETER UF-12 Takeda Medical, Inc. FLL Class II 1985-02-07
K844917 TURN NEEDLE INTRAVENOUS CANNUL, NUB, W/TUBING INTE Turn Needle Intl., Inc. FPA Class II 1985-02-07
K850196 COPAL DIGITAL THERMOMETER UF-22B Takeda Medical, Inc. FLL Class II 1985-02-07
K850245 BREWER HEAVE-DUTY I.V. STAND W/FOOT OPERATED PNUEM E.F. Brewer Co. FOX Class I 1985-02-07

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