meddevicedb.com FDA Device Reference

Review Panel

General Hospital FDA 510(k) Clearances & Devices

Cleared Devices
15,723
Product Codes (page)
35
Latest Decision
1987-04-16

Clearances · page 131 of 158

K-Number Trade Name Applicant / Manufacturer Product Code Class Decision Date
K870191 DISPOSABLE SYRINGE WITH NEEDLE Can-Am Surgical Corp. FMF Class II 1987-04-16
K870519 SUBCUTANEOUSLY IMPLANTED DRUG DELIVERY DEPOT Norfolk Medical Products, Inc. LJT Class II 1987-04-15
K870260 HICKMAN TITANIUM SUBCUTANEOUS PORT C.R. Bard, Inc. LJT Class II 1987-04-15
K870416 LP EXTENSION SETS North Coast Medi-Tek FPK Class II 1987-04-06
K864086 VAPOR-SEAL(TM) PERCUTANEOUS CATHETERS Pharmacia, Inc. LJS Class II 1987-04-03
K870317 IVAC (R) SITE-SAVER (TM) VOLUMETRIC CONTROLLER 280 Y LDR Class II 1987-04-03
K864900 VIGGO EXACTA PRESSURE MONITORING KIT Ohmeda Medical FMG Class II 1987-04-01
K870261 VIGGO EXACTA PRESSURE MONITORING SYSTEM Ohmeda Medical FMG Class II 1987-04-01
K862921 MODEL 10200 PREMATURE INFANT INCUBATOR Rotem Industries C/O Medsys, Inc. FMT Class II 1987-04-01
K871169 LUBRICATING JELLY H & P Industries, Inc. KMJ Class I 1987-04-01
K864446 PORT-A-CATH VASCULAR ACCESS SYSTEMS Pharmacia, Inc. LJT Class II 1987-03-31
K870900 THE GRIPPER SEAL(TM) Pharmacia Deltec, Inc. KGX Class I 1987-03-31
K864552 PORT-A-CATH IMPLANTABLE CATHETER SYSTEM Pharmacia, Inc. LLD Class II 1987-03-31
K864937 'EXMOOR' ZOELLNER SUCKER ENDS Exmoor Plastics , Ltd. JOL Class II 1987-03-30
K870279 VP2000 INFUSION PUMP Vickers , Ltd. FRN Class II 1987-03-25
K870913 INJECTION SITE #014456-120 Clinical Connections, Inc. FPA Class II 1987-03-17
K870912 T-CONNECTORS 014500/014501/014502/014503-120 Clinical Connections, Inc. FPK Class II 1987-03-17
K864276 PERSONAL INFUSION PUMP Bionica, Inc. FRN Class II 1987-03-17
K870940 SOLUTION ADMINI. SETS- ALTER. DRIP CHAMBER/CONNEC. Travenol Laboratories, S.A. FPA Class II 1987-03-17
K870078 ACCUPEN(R) Ulster Scientific, Inc. FMF Class II 1987-03-17
K870888 WARM WEIGH MODEL N-10 INFANT SCALE Air-Shields, Inc. FRW Class I 1987-03-17
K870925 PAD, BED LINEN PROTECTIVE Quality Disposables, Inc. KME Class I 1987-03-17
K870768 AC ADAPTER ACCESSORY, PRODUCT CODE 600123A Deltec Systems, Inc. FRN Class II 1987-03-13
K870522 DEPEND UNDERPAD Kimberly-Clark Corp. KME Class I 1987-03-13
K870166 PLATFORM MATTRESS W/DISPOSABLE BEDPAN BAG George C. Kuhn FNJ Class I 1987-03-13
K870324 #014460-120 3-WAY & #014461-120 4-WAY STOPCOCK Clinical Connections, Inc. FMG Class II 1987-03-13
K870242 INTERMATE(TM) Infusion Systems Corp. FRN Class II 1987-03-13
K870474 INSTAJECT Pavel Jordan & Associates, Inc. KZH Class II 1987-03-13
K870762 EAR APPLICATOR, CATALOG NO. 2229 Treace Medical, Inc. KXF Class I 1987-03-06
K865012 YSI MODEL 801 Yellow Springs Instrument Co., Inc. FMT Class II 1987-03-04
K870681 HUNTLEIGH BETA II HM85 Huntleigh Technology, Inc. FNM Class II 1987-03-04
K864296 S.C.T. MULTI PORT, INJECTION SITE Salt Creek Medical Technologies FPA Class II 1987-03-02
K864158 THERMAPAD Avail-Southwest Division KME Class I 1987-03-02
K862325 THE INJECTOR American Medical Innovations, Inc. KZH Class II 1987-02-27
K870052 INFUMIX MIXING CONTAINER Biodynamics Corp. KPE Class II 1987-02-27
K864997 MEDTRAC VP VOLUMETRIC INFUSION PUMP American Edwards Laboratories FRN Class II 1987-02-27
K870193 A+MED DISPOSABLE NEEDLE Can-Am Surgical Corp. FMI Class II 1987-02-27
K864949 INSTRUCTION CHANGE FOR RIGHT ATRIAL/RAAF CATHETER Quinton, Inc. FOZ Class II 1987-02-25
K870113 THERMAL JACKET FOR I.V. FLUID BAGS Thermal Medical Systems, Inc. KPE Class II 1987-02-25
K864561 DERATA MEDI-JECTOR IV Derata Corp. KZE Class II 1987-02-19
K870473 STAT-STAND(TM) AND STAT-STAND II(TM) I.V. League Medical FOX Class I 1987-02-13
K870285 THERMOMETER SHEATHES, STERILE (GLASS) The Medical Group, Inc. FLK Class II 1987-02-12
K865051 GRASEBY PCAS MODEL NO. 0124-0701, PVS DYTINHR PUMP Panamedix, Inc. FRN Class II 1987-02-10
K870327 BACK REST, LITTER, NONADJUSTABLE Military Engineering, Inc. FPP Class I 1987-02-10
K870326 VARIOUS LUER AND TUBING FITTINGS Clinical Connections, Inc. FPK Class II 1987-02-10
K870310 VSID MEDICAL THREE-FOLDING BED China National Medicines & Health Prod. I/E Corp. FNJ Class I 1987-02-10
K864809 IVAC(R) STAR-FLOW(TM) VOLUMETRIC PUMP - MODEL 580 Y FRN Class II 1987-02-10
K864349 MEDIPORT II SINGLE LUM/PORT IMPLANT VASC ACS PORT C.R. Bard, Inc. LJT Class II 1987-02-10
K870188 NORFOLK MEDICAL BUTTERFLY INFUSION SET Norfolk Medical Products, Inc. FPA Class II 1987-02-10
K870274 DI-MIX PARENTERAL NUTRITION & MEDICINE CONTAINER Gil-Med Industries C/O Kegan & Kegan, Ltd. KPE Class II 1987-02-10
K865058 ABBOTT LIFECARE (R) 5000, PUMP SYSTEM Abbott Laboratories FRN Class II 1987-02-06
K865060 I.V. SET WITH DUAL-CHANNEL CASSETTE Abbott Laboratories FRN Class II 1987-02-06
K864327 MODEL 304-S EXTERNAL MICRO-VOLUME INFUSION PUMP Medtronic Minimed FRW Class I 1987-02-06
K865059 I.V. SET W/SINGLE-CHANNEL CASSETTE Abbott Laboratories FRN Class II 1987-02-06
K870132 IVAC FLOW CONTROL ADMINISTRATION SET Y LDR Class II 1987-02-05
K870093 MEDICAL ADHESIVE TAPE & BANDAGE USING PCCE FILM Avery Intl. KGX Class I 1987-02-05
K870021 MEDICAL ADHESIVE TAPE AND ADHESIVE BANDAGE Avery Intl. KGX Class I 1987-02-05
K870092 MEDICAL ADHESIVE TAPE & BANDAGE USING HYTREL FILM Avery Intl. KGX Class I 1987-02-05
K862610 ULTRA-VUE SPINAL TYPE BIOPSY NEEDLE Bd Becton Dickinson Vacutainer Systems Preanalytic FMI Class II 1987-02-04
K870091 IV SECUREMENT DEVICE USING PCCE THERMO. FILM Avery Intl. KGX Class I 1987-02-04
K864113 CLYDE (TM) FILTRATION SYSTEM Arbor Technologies, Inc. FPB Class II 1987-02-04
K863699 SHEER ENERGY, ACTIVE & SILKY SUPPORT PANTY HOSE Hanes Group DWL Class II 1987-02-04
K870020 IV SECUREMENT DEVICE Avery Intl. KGX Class I 1987-02-04
K863864 AMBULATORY INFUSION PUMP, MODEL AS30C Travenol Laboratories, S.A. FRN Class II 1987-02-04
K870018 E-Z JECT INSULIN SYRINGE Can-Am Surgical Corp. FMF Class II 1987-02-04
K870090 IV SECUREMENT DEVICE USING HYTREL THERMO. FILM Avery Intl. KGX Class I 1987-02-04
K864789 BETAFLO 2000 PIGGYBACK SYSTEM Betaflo, Inc. LDR Class II 1987-02-04
K864853 OMNI THERM TEMPERATURE MONITOR Omni Therm, Inc. KPD Class II 1987-02-04
K861582 INJET-100, FLUID INJECTOR Injet Medical Products, Inc. KZE Class II 1987-02-03
K864953 WEIGHMOBILE, IN BED PATIENT WEIGHING SCALE Dittmar and Penn Corp. FRW Class I 1987-01-21
K864541 BT HYPODERMIC SYRINGE Baron Technologies, Inc. FMF Class II 1987-01-21
K861686 NOVOPEN SYSTEM (INSULIN SYRINGE) Squibb-Novo, Inc. FMF Class II 1987-01-21
K864667 PENOX HOSPITAL BED Penox Technologies, Inc. FNJ Class I 1987-01-21
K864808 STRATO(R) PCA INFUSER Strato Medical Corp. FRN Class II 1987-01-21
K864827 RSVP SYSTEMS, SERIES I, BED-PATIENT MONITOR Tactilitics, Inc. KMI Class I 1987-01-21
K863686 BACK REST, LITTER, NON-ADJUSTABLE Brenner Metal Prod Corp. FPP Class I 1987-01-20
K864310 RYMCO STERILE SINGLE-USE NEEDLE/SINGLE USE SYRINGE Rymco Ltda FMI Class II 1987-01-20
K864453 EMERGENCY & MILITARY INFUSION SYSTEM Migada, Ltd. FPA Class II 1987-01-20
K863694 BED/ADJUST/HOSPITAL/FOLDING FIELD WITHOUT MATTRESS Brenner Metal Prod Corp. FNJ Class I 1987-01-20
K864440 CHURCHILL 3-WAY STOPCOCK Churchill Corp. FMG Class II 1987-01-20
K863688 ROD, IRRIGATOR, SUPPORTING TELESCOPING, TYPE Brenner Metal Prod Corp. FNJ Class I 1987-01-20
K864441 CHURCHILL BLOOD ADMINISTRATION SET Churchill Corp. BRZ Class II 1987-01-20
K864964 5 - IN - 1 CONNECTOR Medovations, Inc. GAZ Class II 1987-01-20
K863691 COT, FOLDING, HOSPITAL, ALUMINUM Brenner Metal Prod Corp. FNJ Class I 1987-01-20
K864753 FREE SPIRIT(TM) I.V. STAND Demstar Corp. FOX Class I 1987-01-20
K864407 REFILLABLE SYRINGE Med Fusion Systems, Inc. FMF Class II 1987-01-20
K864227 PERCUPUMP (TM) E-Z-Em, Inc. FRN Class II 1987-01-16
K863685 CART, ORTHOPEDIC BED, STRYKER Brenner Metal Prod Corp. FNJ Class I 1987-01-15
K864636 ERYPUR B Organon Teknika Corp. CAK Class II 1987-01-14
K863532 MODIFIED LABELING TO MODEL 2000 AMBULATORY INFUSER Parker Hannifin Corp. FRN Class II 1987-01-14
K864190 E-Z HOLD - #4060 John F. Greer Co., Inc. KMK Class I 1987-01-14
K860132 AIR CARE AIR SANITIZER Cooper-Hewitt Electric Co. FRA Class II 1987-01-13
K864233 BARD HARVARD MINI-INFUSER 950 PUMP C.R. Bard, Inc. FRN Class II 1987-01-12
K864878 ICU/CPU TRANSPORT TRAY Orthopedic Systems, Inc. FNJ Class I 1987-01-06
K863470 DALTEX IV INFUSION PUMP Daltex Medical Sciences, Inc. FRN Class II 1987-01-05
K864747 VARIOUS SYRINGES W/NEEDLES, W/OUT NEEDLES, NEEDLES Jms Co., Ltd. FMF Class II 1986-12-29
K864777 MACLEE/BOIN MEDICA STERILE NEEDLE & SYRINGE 3ML/CC Mac Lee Medical Products FMF Class II 1986-12-29
K864779 MACLEE/BOIN MEDICA STERILE NEEDLE/SYRINGE 50ML/CC Mac Lee Medical Products FMF Class II 1986-12-29
K864781 MACLEE/BOIN MEDICA STERILE NEEDLE/SYRINGE 20ML/CC Mac Lee Medical Products FMF Class II 1986-12-29
K864138 MINIMED MODEL 404-S EXTERNAL INFUSION PUMP Medtronic Minimed FRN Class II 1986-12-29

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