meddevicedb.com FDA Device Reference

Review Panel

General Hospital FDA 510(k) Clearances & Devices

Cleared Devices
15,723
Product Codes (page)
33
Latest Decision
1983-12-29

Clearances · page 142 of 158

K-Number Trade Name Applicant / Manufacturer Product Code Class Decision Date
K832284 SOLUTION ADMIN. SET 2C9096 W/10 PVC Travenol Laboratories, S.A. FPA Class II 1983-12-29
K833120 ONE TIME COMPOUND BENZOIN TINCTURE- Acme United Corp. KGX Class I 1983-12-29
K833655 GILLETTE SABRE SYRINGE Intermedics, Inc. FRN Class II 1983-12-29
K833958 FLO-GARD 8100 INFUSION PUMP Travenol Laboratories, S.A. FRN Class II 1983-12-29
K833953 ELECTRONIC GRAVITY 300VC Ivent Corp. LDR Class II 1983-12-29
K832917 PORT-A-CATH Pharmacia, Inc. LJT Class II 1983-12-28
K833904 TEMPTREND II Biosynergy, Inc. KPD Class II 1983-12-27
K833294 ALPHA Y-RECIPIENT SET Alpha Therapeutic Corp. BRZ Class II 1983-12-27
K833740 VENOSET MULTI-MED PIGGYBACK W/IVEX-2 Abbott Laboratories FPA Class II 1983-12-27
K833657 ANGIO-SET INTRAVENOUS CATH. SET Deseret Medical, Inc. FOZ Class II 1983-12-27
K832285 VOLUMETRIC PUMP SET 2C9100 FOR NITROGLY Travenol Laboratories, S.A. FRN Class II 1983-12-27
K833684 IVEX-INT Abbott Laboratories FPB Class II 1983-12-27
K833741 VENOSET MULTI MED DUAL RATE PIGGYBACK Abbott Laboratories FPA Class II 1983-12-22
K834063 STERILE RUBBER BANDS Devon Industries, Inc. LDQ 1983-12-22
K832739 STEDIFLO INFUSION SET Dravon Medical, Inc. LDR Class II 1983-12-22
K832637 AMEDA NEONATAL RESUSCITATION UNIT- Egnell, Inc. FMT Class II 1983-12-22
K833520 RATEMINDER II SPECIALTY CARE Anatros Corp. LDR Class II 1983-12-22
K834165 SYRINGE Elfa Trading Co. FMF Class II 1983-12-13
K834164 SPINAL NEEDLES & ACCESSORY Elfa Trading Co. FPK Class II 1983-12-13
K833435 MULTI PURPOSE SYRINGE I M, Inc. FMF Class II 1983-12-12
K833178 SOLUTION ADMINISTRATION LINE W/SPIKE Intramed, Inc. FPA Class II 1983-11-30
K833659 IV EXTENSION SET Dna Medical, Inc. FPK Class II 1983-11-29
K832606 WINDSOR MEDICAL VARIOUS MODELS Windsor Medical, Inc. FRN Class II 1983-11-29
K832544 SYSTENET American Intl. Medical Supply Co. KGX Class I 1983-11-29
K833493 DISPOSABLE SYRINGES & NEEDLES Aldrich Chemical Co., Inc. FMF Class II 1983-11-29
K832349 PROGRAMED Intrabionic Co. FRN Class II 1983-11-28
K832845 EGERTON TURNING & TILTING NET SUSPEN BED Kinetic Concepts, Inc. FNJ Class I 1983-11-28
K833306 BETATRON I AMBULATORY INSULIN PUMP Cardiac Pacemakers, Inc. FRN Class II 1983-11-28
K832272 TOURNIQUET CUFF PRESSURE MONITOR #TCPM Electromedics, Inc. LDQ 1983-11-28
K833460 SYRINGE,PISTON NEEDLE, HOLLOW LUMEN Aldrich Chemical Co., Inc. FMF Class II 1983-11-28
K833682 PRIMARY PIGGYBACK INFUSION SET W/PERM Cosmetic Sciences, Inc. LDR Class II 1983-11-28
K832350 INTRABIONIC CO. - MICRO SYRINGE Intrabionic Co. FRN Class II 1983-11-28
K832558 RELEASE OF ETHYLENE OXIDE-STERILIZ. DEV Deseret Medical, Inc. FOZ Class II 1983-11-28
K831438 ELASTOPLAST Beiersdorf, Inc. FPX Class I 1983-11-25
K833450 NUK BREAST SHIELD Reliance Products Corp. HFS Class I 1983-11-21
K832922 TRAVASPORE BIOLOGICAL INDICATOR Travenol Laboratories, S.A. FRC Class II 1983-11-21
K833092 DESERET ANGIO-GUIDE LARGE VEIN CATH. Warner-Lambert Co. FOZ Class II 1983-11-21
K833091 DESERET SUBCLAVIAN JUGULAR CATH-SET Warner-Lambert Co. FOZ Class II 1983-11-21
K832624 TOP VENULA I.V. CATHETER SET Top Surgical Manufacturers Co. FOZ Class II 1983-11-21
K833076 C-FLEX MEDICAL GRADE TUBING Concept, Inc. FPK Class II 1983-11-21
K833135 INTRACATH INTRAVENOUS CATHETER UNIT Parke-Davis Co. FOZ Class II 1983-11-21
K832702 POCKET AID M.C. Johnson Co., Inc. LDR Class II 1983-11-17
K832605 TRANCOJECT DISPOSABLE SYRINGES Huborga, Inc. FMF Class II 1983-11-14
K831988 INTRAVASCULAR CATHETER C.R. Bard, Inc. FOS Class II 1983-11-08
K833033 INFUSION SET-52-05-1 20 DROPS-MI VOL Y FPA Class II 1983-11-07
K833074 CASTLE TEC-TEST S.M.A.R.T. PACK Castle Co. JOJ Class II 1983-11-07
K833034 UNIVERSAL VENTED & NON/VOLUME INFUS- Y FPA Class II 1983-11-07
K832923 AMBULATORY INSULIN INFUSION PUMP Caridac Pacemakers, Inc. FRN Class II 1983-11-03
K833343 STERILIZATION CONTAINER Medin Corp. FRG Class II 1983-11-03
K832755 INFUSION PUMP & IV SETS #4000 Omni-Glow, Inc. FRN Class II 1983-11-03
K833030 INTRAVASCULAR ADMINISTRATION SET Gish Biomedical, Inc. FPA Class II 1983-11-03
K833264 ADLER STEAM INDICATOR-GAS INDICATOR Adler Instrument Co. JOJ Class II 1983-11-03
K832542 I.V. ADMINISTRATION SET Research Industries Corp. FPA Class II 1983-10-31
K832090 SCD SKIN TEMP. SENSORS #3400 ETC Science Development Corp. FLL Class II 1983-10-31
K830429 WEIL PERFUSOMETER #100 Wescor, Inc. FLL Class II 1983-10-31
K832880 TRACHEOSTOMY CARE TRAYS Packaging Technologies, Inc. JOL Class II 1983-10-31
K830568 GUTTMAN INFUSION NEEDLE Cosmetic Sciences, Inc. FMI Class II 1983-10-27
K832549 SOLUTION ADMIN. LINE W/SPIKE Vascular Specialties, Inc. FPA Class II 1983-10-27
K832519 ASPIRATING TUBING Wells Johnson Co. GAZ Class II 1983-10-20
K832273 SURGICAL STOCKINGS Wells Johnson Co. DWL Class II 1983-10-19
K832298 BABY LIGHT DOSIMETER Rocky Mountain Medical Corp. LBI Class II 1983-10-19
K831587 TEMP. REPAIR KIT-DUAL LUMEN CATHETER Norton Performance Plastics Corp. LJS Class II 1983-10-19
K832945 EAGLE 2000 STERILIZER SERIES GAS/AERA Amsco Co. FLF Class II 1983-10-19
K832761 AIR FLUID EXCHANGE PUMP Intek Int'L, Inc. FMF Class II 1983-10-19
K832517 CUSTOM KWIK SET AND/OR PAK Norton Texas Medical Products JOL Class II 1983-10-14
K831386 GROSHONG CATHETER, LONG TERM TYPE Catheter Technology Corp. LJS Class II 1983-10-14
K832622 WINGED INFUSION SET Top Surgical Manufacturers Co. FPA Class II 1983-10-14
K832621 TOP DISPOSABLE PLASTIC SYRINGES Top Surgical Manufacturers Co. FMF Class II 1983-10-14
K832300 I.V. FILTER HOLDER Saxnor Corp. KMK Class I 1983-10-04
K832641 WINDSOR MEDICAL MODEL 52 Windsor Medical, Inc. FRN Class II 1983-10-04
K832635 HI-LO TEMP TYMPANIC TEMP. SENSOR Mallinckrodt Critical Care FLL Class II 1983-10-04
K832651 ATI FOREHEAD THERMOMETER American Thermal Instruments, Inc. KPD Class II 1983-10-04
K832658 DIRECTOR Pharmacia, Inc. FMF Class II 1983-10-04
K832952 MILLIPORE IVEX INT FILTER UNIT Millipore Corp. FPB Class II 1983-10-04
K832865 FLEX BUBBLE TUBING Sheridan Catheter Corp. BYY Class II 1983-09-29
K831439 ELASTOPLAST T.P.N. Beiersdorf, Inc. FPX Class I 1983-09-29
K831999 FEMORAL CANAL SUCTION TAMPON Richards Manufacturer Co. JOL Class II 1983-09-29
K832858 INTRADISCAL THERAPY TRAY Ulti-Med Intl., Inc. FMI Class II 1983-09-29
K831882 POSIDYNE SOLUTION CONTAINER FILTER Pall Biomedical Products Co. FPB Class II 1983-09-20
K832434 HBO-1 PASS-THROUGH/EXTENSION TUBE Nauset Labs FPA Class II 1983-09-20
K830657 AMBULATORY MARK XI DRUG INFUSION DEV- Windsor Medical, Inc. FRN Class II 1983-09-16
K832788 INFUSE-A-PORT Infusaid Corp. LJT Class II 1983-09-15
K832289 LIFECARE MICRO PUMP Abbott Laboratories FRN Class II 1983-09-12
K832392 SDC ORAL-RECTAL TEMP. PROBE Science Development Corp. FLL Class II 1983-09-12
K832105 ADMINISTRATIVE IV SET Lee Medical Intl., Inc. FPA Class II 1983-09-12
K832101 STERILE DISPOSABLE SYRINGE Lee Medical Intl., Inc. FMF Class II 1983-09-12
K832683 MONOJECT INJECTOMATIC Sherwood Medical Co. KZH Class II 1983-09-12
K832391 QT-100 ELECTRONIC TEMP. MONITOR Science Development Corp. FLL Class II 1983-09-12
K830389 ACCU-RYNGE PUMP SP-250 Delta Medical Industries FRN Class II 1983-09-12
K832418 OHIO TEMPERATURE SIMULATOR Airco/Ohio Medical Products FMZ Class II 1983-09-12
K832347 TWOFER NEEDLE Baxa Corp., Sub. of Cook Group, Inc. LHI Class II 1983-09-12
K831445 INFUSION SETS #'S 124 & 142 PERSONAL Pacesetter Systems FPA Class II 1983-09-12
K832410 GRASEBY DYNAMICS MS302 SYRINGE DRIVER Intermedics, Inc. FRN Class II 1983-09-12
K832758 RED COLOR-TINTED TUBING Custom Medical, Inc. FPK Class II 1983-09-12
K832104 STERILE DISP. BUTTERFLY INFUSION SET Lee Medical Intl., Inc. FPA Class II 1983-09-12
K832404 RECTAL TEMP. TELEMETRY MONITOR Xomed, Inc. FLL Class II 1983-09-12
K831444 SINGLE USE SYRINGE #103 PERSONAL MEDIC Pacesetter Systems FRN Class II 1983-09-12
K832332 VENTED I.V. TRANSFER NEEDLE Baxa Corp., Sub. of Cook Group, Inc. LHI Class II 1983-09-12
K832312 I.V. TRANSFER NEEDLE Baxa Corp., Sub. of Cook Group, Inc. LHI Class II 1983-09-12
K832609 A.V.R. KNEE LENGTH THERAPEUTIC STOCK- The Kendal Co. DWL Class II 1983-09-12

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