meddevicedb.com FDA Device Reference

Review Panel

General Hospital FDA 510(k) Clearances & Devices

Cleared Devices
15,723
Product Codes (page)
34
Latest Decision
1984-06-28

Clearances · page 140 of 158

K-Number Trade Name Applicant / Manufacturer Product Code Class Decision Date
K841487 INTRAVASCULAR CATHETER SECUREMENT DEV Tapemark Co. KMK Class I 1984-06-28
K842075 CRITIKON I.V. FILTER Critikon Company, LLC FPB Class II 1984-06-28
K841704 THINWALL PUNCTURE NEEDLE Meadox Surgimed, Inc. FMI Class II 1984-06-28
K841679 VASCULAR-ACCESS-PORT WITHDRAWL-BLOOD Norfolk Medical Products, Inc. LJT Class II 1984-06-28
K840877 ARGYLE ENTERNAL FEEDING BAG W/ADMIN Sherwood Medical Co. HFS Class I 1984-06-28
K841252 GLATTELAST COMPRESSION PANTY HOSE Baurs Krey Assoc., Inc. DWL Class II 1984-06-27
K841187 BLOOD COLLECTION SET, STERILE, DISPOS. Marbex, Inc. BRZ Class II 1984-06-22
K840787 CRAFTMATIC ELECTRIC ADJUSTABLE BED Contour, Inc. LLI Class II 1984-06-13
K840669 SUCTION DEVICE-PHARYNEAL DEVICE Lipsky-Dale Medical Products JOL Class II 1984-06-11
K841784 FLEXIFLO-III PORTABLE ENTERAL NUTRI Abbott Laboratories FRN Class II 1984-06-07
K841215 GLATTELAST COMPRESSION STOCKINGS Baurs Krey Assoc., Inc. DWL Class II 1984-06-07
K841630 ENTERAL NUTRITION PUMP Superior Plastic Products Corp. FRN Class II 1984-06-07
K840648 TEMPROBE MONITOR Vital Signs, Inc. FLL Class II 1984-06-05
K841728 LCI MEDICAL INC AIR/PAL Lehigh Consolidated Industries FRZ Class II 1984-06-05
K841882 THREE WAY INFUSION SET Med Fusion Systems, Inc. FPA Class II 1984-06-05
K841166 HEPARIN LOCK FLUSH PROCEDURE PACK Solo Pak Laboratories FMI Class II 1984-06-04
K841305 HEPARIN LOCK FLUSH SOLUTION USP KIT Solo Pak Laboratories FMI Class II 1984-06-04
K841306 HEPARIN LOCK FLUSH SOLUTION USP KIT,100 Solo Pak Laboratories FMI Class II 1984-06-04
K841729 ACCUPRO ENTERAL FEEDING PUMP American Mcgaw FRN Class II 1984-06-01
K833688 SUTURE REMOVAL KITS STERILE Carwild Corp. KGX Class I 1984-05-31
K841534 ACME DIGITAL INFANT SCALE-30 Acme Medical Scale Co. FRW Class I 1984-05-31
K834106 INTRAVENOUS INFUSION CONTROLLER Cutter Laboratories, Inc. LDR Class II 1984-05-30
K840620 TPN/CVP DRESSING CHANGE KIT Marwood Medical, Inc. FMC Class I 1984-05-30
K841583 SPORSTRIP Skyland Scientific Services, Inc. FRC Class II 1984-05-25
K840792 INFANT RADIANT WARMER Hatch Bio Medical FMT Class II 1984-05-25
K840335 SHEER ENERGY PANTY HOSE Leggs Products, Inc. DWL Class II 1984-05-25
K841589 C-LITE Suncoast Medical Manufacturers, Inc. KYT Class I 1984-05-22
K841588 SUN-LITE WHITE SPOT Suncoast Medical Manufacturers, Inc. KYT Class I 1984-05-22
K841676 DISPOSABLE POLY GLOVES Abco Dealers, Inc. LZA Class I 1984-05-22
K841260 ALBINAR ELECTRONIC DIGITAL THERMOMETER Dimension Specialty Co., Inc. FLL Class II 1984-05-21
K841512 ETHOX RELIA-FLO 2001 ENTERAL FEED Ethox Corp. FRN Class II 1984-05-21
K841186 INFUSION SET SCALP VEIN Marbex, Inc. FPA Class II 1984-05-21
K841280 SOLOPAK BRAND FILTER NEEDLE W/5 MICRO Smith & Nephew, Mpl Division FPB Class II 1984-05-21
K841361 SYRINGE ADDITIVE IV ADMIN. SETS Quest Medical, Inc. FPA Class II 1984-05-21
K841481 WINDSOR MEDICAL MODEL 50-00002 Windsor Medical, Inc. FRN Class II 1984-05-21
K841185 PLASTIC, STERILE TUBING CLOSED SET Marbex, Inc. FPA Class II 1984-05-21
K841373 PROVIDER IV MODEL 2000 INFUSIN SYS Pancretec, Inc. FRN Class II 1984-05-14
K841106 DELTA MULTIPLE NON RETURN CONNECTOR Tefra Med, Inc. FPA Class II 1984-05-14
K834376 FILTRARE TM ALLVENT TM Alltek, Inc. FPB Class II 1984-05-11
K841168 STERILIZATION PROCESS INDICATOR Parke-Davis Co. JOJ Class II 1984-05-09
K833705 BETAJECT BD U100 Orange Medical Instruments, Inc. FMI Class II 1984-05-09
K841578 DISPOSABLE SYRINGE Ava Medical Products of Canada, Inc. FMF Class II 1984-05-07
K841577 HYPODERMIC NEEDLES Ava Medical Products of Canada, Inc. FMI Class II 1984-05-07
K840295 AMBULARM Rigi Systems, Inc. KMI Class I 1984-05-07
K841398 VARIABLE HEIGHT TRANSFER CHAIR Setma, Inc. FSA Class I 1984-05-07
K841395 SHOWER TROLLEY Setma, Inc. FSA Class I 1984-05-07
K834585 CELLTRAK-B R&D Systems, Inc. FRZ Class II 1984-05-02
K834299 LONG TERM CENTRAL VENOUS ACCESS CATH Burron Medical Products, Inc. LJS Class II 1984-05-01
K834383 DUAL-LUMEN LONG TERM CENTRAL VENOUS CAT Burron Medical Products, Inc. LJS Class II 1984-05-01
K841017 PROVIDER INFUSION SET Pancretec, Inc. FRN Class II 1984-04-30
K834473 MULTI-LUMEN CENTRAL VENOUS CATH. KIT Burron Medical Products, Inc. LJS Class II 1984-04-30
K840526 AMETHERM Egnell, Inc. FMZ Class II 1984-04-30
K834430 OMNI INFANT PHOTOTHERAPY UNIT Rocky Mountain Medical Corp. LBI Class II 1984-04-30
K841217 PICKER MYELOGRAM TRAY-PMS MYELOGRAM Professional Medical Systems FMI Class II 1984-04-27
K840107 TUBE-BANDAGE FOR HUMAN DIGITS 200 Zens Health Care Products FQM Class I 1984-04-25
K841150 VASCULAR-ACCESS PORT CHANGE CATHETER Norfolk Medical Products, Inc. LJT Class II 1984-04-24
K840788 VASCULAR ACCESS PORT CHANGES IN MATER Norfolk Medical Products, Inc. LJT Class II 1984-04-24
K841149 VASCULAR-ACCESS PORT - ENLARGEMENT Norfolk Medical Products, Inc. LJT Class II 1984-04-24
K834381 POSIDYNE I.V. FILTER/AIR ELIMINATOR Pall Biomedical Products Co. FPB Class II 1984-04-24
K832826 AAP DOSIMETRY RELEASE OR BASIN SETS American Hospital Supply Corp. FNY Class I 1984-04-23
K840796 TENDER LIFTING CARE Lancer Assoc. FRZ Class II 1984-04-20
K840248 IV-FILTER Tri-Med, Inc. FPB Class II 1984-04-20
K840696 LCD DIGITAL THERMOMETER Ltd Commodities, Inc. FLL Class II 1984-04-20
K834335 AMEDA PHOTOTHERAPY LAMP FOR NEWBORN Egnell, Inc. LBI Class II 1984-04-20
K841409 BUSH NECK W/PLUG Warne Surgical Products, Ltd. BYZ Class II 1984-04-18
K841123 DRESSING CHANGE TRAY Medcare Products FRG Class II 1984-04-17
K840675 COR-TEMP-TEMP. MONITOR Product Research Organizations,Inc. FLL Class II 1984-04-17
K840915 DIMIX CONTAINER FOR PARNETERAL NUTRIT Gil-Med Industries C/O Kegan & Kegan, Ltd. KPE Class II 1984-04-17
K840997 BATTERY POWERED PATIENT LIFT Invacare Corp. FSA Class I 1984-04-17
K840958 DESERET LONG TERM INDWELLING CATHETER Parke-Davis Co. LJS Class II 1984-04-17
K840490 FLUID REMOVAL ASSEMBLY Ackrad Laboratories FMF Class II 1984-04-17
K840443 RETROGRADE INFUSION SET 3ML & 6ML- Tico Medical Instruments, Inc. FPA Class II 1984-04-17
K841027 PROVIDER SITE PREP & CHECK STRIP KIT Pancretec, Inc. FPA Class II 1984-04-16
K840681 DAYPAK SYSTEM III CATHETER CARE KIT Creative Care Systems, Inc. LJS Class II 1984-04-16
K833983 PROVIDER U-100 INSULIN INFUSION SYS Pancretec, Inc. FRN Class II 1984-04-13
K840334 CHEMONUCLEOLYSIS/DISCOGRAPHY TRAY Applied Medical Devices, Inc. FMI Class II 1984-04-13
K833711 THERMO SENTRY 1200 THERMO-SYS-TS1200 Clini-Therm Corp. FLL Class II 1984-04-13
K841156 VANTAGE E American Sterilizer Co. FRG Class II 1984-04-13
K840944 INFUSION NEEDLE IIPN Medi Tex, Inc. FMI Class II 1984-04-13
K840760 HARVARD ANTI-REFLUX Y-SET C.R. Bard, Inc. FPA Class II 1984-04-05
K841018 PANCRETEC PUMP CHECK Pancretec, Inc. FRN Class II 1984-04-05
K841028 PROVIDER CAP SET Pancretec, Inc. FPA Class II 1984-04-05
K840253 ONE-WAY AIR VALVE Delta Medical Industries BYZ Class II 1984-04-05
K833802 INFANT WARMER Kinetic Concepts, Inc. FMT Class II 1984-04-05
K833706 CLICK-COUNT U100 INSULIN SYRINGE Orange Medical Instruments, Inc. FMF Class II 1984-04-05
K840033 HYPODERMIC NEEDLES & STYLETS Microvasive FMI Class II 1984-04-05
K840616 MINI-PUMP U-100 Advanced Bio Systems, Inc. FRN Class II 1984-03-30
K832904 INTRAVENOUS NEEDLE Yolan R. Guttman FMI Class II 1984-03-30
K840878 QUIK LOK Abbott Laboratories FPA Class II 1984-03-30
K841025 TOP DISPOSABLE INFUSION SET Top Surgical Manufacturers Co. FPA Class II 1984-03-30
K840838 MMG CONNECTIVE TUBING Medical Marketing Group GAZ Class II 1984-03-30
K833158 BSD-200 Bsd Medical Corp. FLL Class II 1984-03-30
K833915 VASCULAR ACCESS CATH. REPAIR KIT Cormed, Inc., Sub. C.R.Bard, Inc. LJS Class II 1984-03-30
K840942 IVY COMMANDEER Ivy Medical, Inc. LDR Class II 1984-03-30
K840619 I.V. START KIT Marwood Medical, Inc. FPA Class II 1984-03-27
K833981 SHILEY DISPOS. TEMP. PROBES Shiley, Inc. FLL Class II 1984-03-27
K840342 PDI PREPMASTER WET PACK PATIENT PREP KIT Nice-Pak Products, Inc. FRG Class II 1984-03-27
K840344 PDI PREPMASTER WET PACK MINOR PROCEDURE Nice-Pak Products, Inc. FRG Class II 1984-03-26
K840823 TREONIC C30 Vickers America Medical Corp. LDR Class II 1984-03-23
K834256 PBC SYRINGE IRRIGATING Philadelphia Biologics Center FMF Class II 1984-03-23

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