meddevicedb.com FDA Device Reference

Review Panel

General Hospital FDA 510(k) Clearances & Devices

Cleared Devices
15,723
Product Codes (page)
34
Latest Decision
1986-07-08

Clearances · page 133 of 158

K-Number Trade Name Applicant / Manufacturer Product Code Class Decision Date
K860610 ADCOMP Healthtek, Inc. LHI Class II 1986-07-08
K862348 SINGLE-USE PATIENT UNDERPAD Procter & Gamble Mfg. Co. KME Class I 1986-07-02
K861479 CAVAFIX, CENTRAL VENOUS CATHETER KIT Burron Medical Products, Inc. FOZ Class II 1986-07-01
K861771 META - HEALTH MODEL MTG III Meta Health, Inc. FLL Class II 1986-06-30
K861207 INTELLIJECT INFUSION PUMP Intelligent Medicine, Inc. FRN Class II 1986-06-30
K861208 INTELLIJECT MEDICATION SYRINGE Intelligent Medicine, Inc. FRN Class II 1986-06-30
K861040 ENTERNAL INFUSER MULTIPUMP 203 Medix Medical Electronics (U.S.A.), Inc. FRN Class II 1986-06-23
K861147 UCS-2, ULTRASONIC CLEANING SOLUTION Keymed, Inc. FLG Class I 1986-06-23
K861209 STREAM-SWITCH MANIFOLD Intelligent Medicine, Inc. FRN Class II 1986-06-23
K861117 ANTHRON CATHETERS & SETS Toray Industries (America), Inc. FOZ Class II 1986-06-18
K860826 VENOTRAIN COLOR COMPRESSION STOCKINGS & PANTYHOSE Bauerfeind GmbH & Co. DWL Class II 1986-06-18
K855120 ATI DISPOSABLE BIOLOGICAL TEST PACK Parke-Davis Co. FRC Class II 1986-06-18
K861592 WEC-WASH, CATALOG NO. 850-115 Palmetto Chemical & Supply Co., Inc. FLG Class I 1986-06-17
K861588 WECK INSTRUMENT CLEANER, CAT. NO. 850-103 Palmetto Chemical & Supply Co., Inc. FLG Class I 1986-06-17
K861590 WEC-KLEEN, CATALOG N. 850-102 Palmetto Chemical & Supply Co., Inc. FLG Class I 1986-06-17
K861001 PARENTERAL INFUSER MEDIPUMP 204 Medix Medical Electronics (U.S.A.), Inc. FRN Class II 1986-06-12
K861498 MEDTRONIC MODEL 8501 ACCESS PORT Medtronic Vascular LJT Class II 1986-06-12
K861510 MULTILUMEN VIAPIC CENTRAL LINE CATHETER Warner-Lambert Co. FOZ Class II 1986-06-09
K861838 POLYPOLE Poly Medical Technologies, Inc. FOX Class I 1986-06-09
K861324 PATIENTCARE 1000 Criticare Technologies Corp. FRN Class II 1986-06-09
K860222 70 ML RESERVOIR BAG AND ADMINISTRATION SETS Prn Services, Inc. FRN Class II 1986-06-09
K861436 SOF SET, MODELS 111 AND 112 Pacesetter Systems FRN Class II 1986-06-09
K861757 5 IN 1 CONNECTOR Jackson Plastics, Inc. GAZ Class II 1986-06-06
K860609 TIMELINE VENIPUNCTURE SYSTEM Ipax, Inc. FPA Class II 1986-06-04
K861182 TIMELINE VENIPUNCTURE SYSTEM Ipax, Inc. FPA Class II 1986-06-04
K861558 APLICARE SKIN PROTECTANT SWABSTICK Aplicare, Inc. NEC Class I 1986-06-04
K860616 VOLUME CONTROL SET WITH EXTENSION Med Fusion Systems, Inc. FPA Class II 1986-06-02
K861275 HIGH FLOW I.V. SET Migada, Ltd. FPA Class II 1986-06-02
K861626 CHURCHILL EXTENSION TUBE Churchill Corp. FPK Class II 1986-06-02
K860372 FAST FLOW XX (AQUEOUS SOLUTION FILTER) Healthtek, Inc. FPB Class II 1986-05-30
K861261 OHMEDA POSI-PULSE SUCTION UNIT Ohmeda Medical GCX Class II 1986-05-30
K854631 ASSERT EO BIOLOGICAL TEST PACK Surgicot, Inc. FRC Class II 1986-05-27
K861523 STANDARD BLOOD TRANSFUSION FILTER SET (CODE 1025) Jufrey Multimed Corp. BRZ Class II 1986-05-27
K861518 UNIVERSAL DISPOSABLE INFUSION SET (CODE 0205F) Jufrey Multimed Corp. FPA Class II 1986-05-27
K860857 SOF SET, MODELS 113 AND 114 Pacesetter Systems FRN Class II 1986-05-27
K861521 UNIVERSAL DISPOSABLE INFUSION SET (CODE 0330) Jufrey Multimed Corp. FPA Class II 1986-05-27
K861519 UNIVERSAL DISPOSABLE INFUSION SET (CODE 0330F) Jufrey Multimed Corp. FPA Class II 1986-05-27
K861520 UNIVERSAL DISPOSABLE INFUSION SET (CODE 0205) Jufrey Multimed Corp. FPA Class II 1986-05-27
K861250 MESULIN, INSULIN INFUSION SET Molnlycke A/S Hospital Products FPA Class II 1986-05-23
K861007 BECTON DICKINSON PCAINFUSER Bd Becton Dickinson Vacutainer Systems Preanalytic FRN Class II 1986-05-20
K854902 SURGICOT STEAM TEST PACK Surgicot, Inc. FRC Class II 1986-05-20
K854737 SURGICAL IRRIGATION DEVICE (SID)/ARTHROSCOPIC SURG Orthopaedic Devices , Ltd. FQH Class II 1986-05-19
K861587 WECK CONCENTRATED LIQUID CLEANER Palmetto Chemical & Supply Co., Inc. FLG Class I 1986-05-19
K861560 MEDIPOINT MULTI-SAMPLE BLOOD COLLECTING NEEDLE Medi Point, Inc. FMI Class II 1986-05-12
K861430 CHURCHILL INJECTION SITE Churchill Corp. FPA Class II 1986-05-12
K861100 ISO-THERMEX Columbus Instruments Intl. Corp. FLL Class II 1986-05-12
K861678 COT, FOLDING HOSPITAL ALUMINUM - MANUAL BED Sierra Corp. FNJ Class I 1986-05-08
K860781 ICU MEDICAL NEEDLE, LOPEZ NEEDLE Icu Medical, Inc. FMI Class II 1986-05-06
K861152 EXEL VACUUM BLOOD COLLECTING SYSTEM Exel Intl. FMI Class II 1986-05-06
K860474 STREAM LINE* I.V. CATHETER PLACEMENT UNIT Menlo Care, Inc. FOZ Class II 1986-05-06
K860703 U - STAR (MICRO-STAR) Corning Costar Corp. LHI Class II 1986-05-06
K861439 CHURCHILL FEMALE LUER LOCK CAP Churchill Corp. FPA Class II 1986-05-06
K861473 MODEL 63-654 THERMOMETER, ELECTRONICS, CLINICAL Radio Shack Div. Tandy Corp. FLL Class II 1986-05-06
K860969 FLUID MANAGEMENT SYSTEM (MODIFIED) Haemonetics Corp. FRN Class II 1986-05-06
K861406 NON-KOR WINGED INFUSION SETS Creative Care Systems, Inc. FMI Class II 1986-05-06
K861276 TAMPER PROOF CAP Intl. Medical Industries FMF Class II 1986-05-05
K861317 DISPOSABLE NEEDLE COUNTER (20-530) Anago, Inc. MMK Class II 1986-05-02
K861319 DISPOSABLE NEEDLE COUNTER (20-560) Anago, Inc. MMK Class II 1986-05-02
K861318 DISPOSABLE NEEDLE COUNTER (20-720) Anago, Inc. FMI Class II 1986-05-02
K861316 DISPOSABLE NEEDLE COUNTER (20-240) Anago, Inc. MMK Class II 1986-05-02
K861307 DISPOSABLE NEEDLE COUNTER Anago, Inc. MMK Class II 1986-05-02
K853988 FORAN CORP-SURESERT INTRAVENOUS CATHETER PLACE UNI Foran Industries, Inc. FOZ Class II 1986-05-01
K861434 MODIFIED HC-417 BAG TO BAG & HC-418 BOTTLE TO BAG Churchill Corp. LHI Class II 1986-05-01
K861025 T-VAC PLEURAL DRAINAGE UNIT, 7800 SERIES Boehringer Laboratories KDQ Class II 1986-04-28
K845003 CUDDLE CARRIER - INFANT BED International Purchasing Services FMS Class II 1986-04-23
K845004 CRIB CUDDLE - INFANT BED International Purchasing Services FMS Class II 1986-04-23
K845002 CUDDLE HEART -AUDITORY/VIBRATION DEVICE International Purchasing Services FMS Class II 1986-04-23
K861153 DISPOSABLE SYRINGES AND HYPODERMIC NEEDLES Exel Intl. FMF Class II 1986-04-23
K860694 IV7200 AND IV7400 INFUSION PUMP Valleylab, Inc. FRN Class II 1986-04-22
K861015 ONE TIME HYPERAL & CATHETER DRESSING CHANGE TRAYS Acme United Corp. FOZ Class II 1986-04-22
K861410 LIC MOBILE TRANSPORT STRETCHERS Lada Intl., Inc. FPO Class II 1986-04-22
K861289 BASIC LIGHT Burton Medical Products Corp. KZF Class I 1986-04-18
K860162 FLO-GARD 6200 VOLUMETRIC INFUSION PUMP Travenol Laboratories, S.A. FRN Class II 1986-04-18
K860537 THE CELL CARE SYSTEM The Clell Corp. KMI Class I 1986-04-17
K854807 LIFE PAC Lifemed Technologies, Inc. KZD Class I 1986-04-15
K854349 TIGER'S DIGITAL THERMOMETER Tiger Electronics, Inc. FLL Class II 1986-04-14
K860229 MODEL 900 INFUSION PUMP C.R. Bard, Inc. FRN Class II 1986-04-09
K861081 DISPOSABLE HYPODERMIC NEEDLE SAFETY SHEATH Perkins & Perkins, Inc. FMI Class II 1986-04-09
K860157 NITROGLYCERIN INTRAVASCULAR ADMINISTRATION SET Quest Medical, Inc. FPA Class II 1986-04-09
K860042 NUTRIMIX EMPTY CONTAINER Abbott Laboratories KPE Class II 1986-04-09
K860803 IV FILTER EXTENSION SET Med Fusion Systems, Inc. FPB Class II 1986-04-09
K860284 DIAMATIC, AUTOMATIC INSULIN INJECTOR Ulster Scientific, Inc. KZH Class II 1986-04-07
K860322 CLINISET INFUSION SET Zimmar Consulting , Ltd. FPA Class II 1986-04-07
K860218 SYRINGE PUMP: VM 07 Vial Medical , Ltd. FRN Class II 1986-04-07
K860746 AUTO SYRINGE MICRO VOL EXT SET W/AIR VENT FILTER Travenol Laboratories, S.A. FPB Class II 1986-04-07
K860889 SAMPLE MANIFOLD HOLDER R. Bell FMG Class II 1986-04-07
K852616 MIRAGE INTRAVENOUS INFUSION SET OLOVSON-STERILE Medical Hospital Equipment FPA Class II 1986-04-07
K860595 TRANSFER SET Migada, Ltd. LHI Class II 1986-04-07
K854598 VICKERS MEDICAL MODEL 272 TEMPERATURE MONITOR Vickers , Ltd. FLL Class II 1986-04-07
K854308 POLYCATH-H CATHETER Abbott Laboratories FOZ Class II 1986-04-07
K860256 BRAWN AND GROSHONG CATHETERS Catheter Technology Corp. FOZ Class II 1986-03-28
K860837 HOYER ONE-TOUCH POWER LIFTER Ted Hoyer & Co., Inc. FSA Class I 1986-03-27
K860927 HD CRYSTALINE SUCTION TIP Hospital Disposables, Inc. JOL Class II 1986-03-27
K860541 SOLUTION ADMINISTRATION SET Travenol Laboratories, S.A. FPA Class II 1986-03-25
K854950 BED PATIENT MONITOR Clearview Electronics Corp. KMI Class I 1986-03-25
K860086 ENTERAL NUTRITION PUMPS PN 1000 AND VM 05 Vial Medical , Ltd. FRN Class II 1986-03-24
K854365 IV SETS WITH NO PHTHALATE PLASTICIZER COMPONENTS Migada, Ltd. FPA Class II 1986-03-24
K860804 MEDICAL ADHESIVE TAPE W.R. Grace & Co.-Conn. KGX Class I 1986-03-24
K860605 FILTER SET 1) 1.2 MIC FILTER 2) 3.0 MIC FILTER Migada, Ltd. FPA Class II 1986-03-24
K852615 R.R. AGHI HYPODERMIC SINGLE LUMEN NEEDLE Medical Hospital Equipment FMI Class II 1986-03-21

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