meddevicedb.com FDA Device Reference

Review Panel

General Hospital FDA 510(k) Clearances & Devices

Cleared Devices
15,723
Product Codes (page)
33
Latest Decision
1985-02-06

Clearances · page 138 of 158

K-Number Trade Name Applicant / Manufacturer Product Code Class Decision Date
K844475 SPECIMEN COLLECTION & TRANSPORT SYSTEM Portable Medical Laboratories, Inc. FMF Class II 1985-02-06
K850088 ARTERIAL EXTENSION SET Medical Matrix, Inc. FPA Class II 1985-02-02
K844499 MEDSENTRY SOFTOUCH SYSTEM Medsentry Corp. FNM Class II 1985-01-30
K844627 STRATOFUSE SYRINGE PIGGYBACK PUMP Strato Medical Corp. FRN Class II 1985-01-28
K844730 BARD HARVARD MINI-INFUSER 400 MULTI DOSE SYRINGE C.R. Bard, Inc. FRN Class II 1985-01-28
K844718 MODEL 1001 A0kfusion Systems, Inc. FRN Class II 1985-01-28
K844719 360 INFUSER Bd Becton Dickinson Vacutainer Systems Preanalytic FRN Class II 1985-01-28
K843781 KINAIR, LOW AIR LOSS BED Kinetic Concepts, Inc. FNL Class II 1985-01-28
K844820 FLOW MED SK 140 BURET D.R.O. Medical, Inc. FPA Class II 1985-01-28
K844091 ABBOTT LIFECARE 900 VOLUMETRIC PUMP Abbott Laboratories FRN Class II 1985-01-25
K844879 HUNTLEIGH ALPHACARE, HM95 ALTERNATING PRESS-PUMP Huntleigh Technology, Inc. FNM Class II 1985-01-25
K844880 HUNTLEIGH AIR-O-PAD AOP1 ALTERNATING PRESS-MATTRES Huntleigh Technology, Inc. FNM Class II 1985-01-25
K844768 ABBOTT LIFECARE 500 INFUSER Abbott Laboratories FRN Class II 1985-01-25
K843609 ELEX ELECTRONIC DIGITAL THERMOMETER Ewing Intl. , Ltd. FLL Class II 1985-01-25
K844937 IVAC 52-99-0 UNVENTED & 52-99-1 VENTED VOL. INFUSI Y FPA Class II 1985-01-25
K844176 PREMIE COMFORT PAD PATIENT & INFANT SUPPORT PADS Premie Comfort Products FRP Class I 1985-01-23
K844048 DR. HESSEL'S INSECT POISON REMOVER Medie Group KYP Class I 1985-01-23
K844313 INFUSET W/HUBER NEEDLE Med Fusion Systems, Inc. FMI Class II 1985-01-22
K844851 MINIMED EXTERNAL INFUSION PUMP FOR DIAGETICS 504 Pacesetter Systems FRN Class II 1985-01-22
K844792 MINIMED EXTERNAL INFUSION PUMP FOR DIABETICS 502A Pacesetter Systems FRN Class II 1985-01-22
K844227 INFUSART Sartorius, Inc. FLN Class II 1985-01-22
K844309 IV RATEMETER Aci Medical, Inc. FLN Class II 1985-01-22
K844556 KHM 2000 DRIP WATCHER The Timeter Group FLN Class II 1985-01-14
K844106 SYRINGE W/NEEDLE COMBIN & SYRINGE ONLY Abco Dealers, Inc. FMF Class II 1985-01-14
K843639 ADD-A-VIAL SOLUTION TRANSFER DEVICE American Mcgaw LHI Class II 1985-01-14
K841880 ERYTHROCATH UMBILICAL CATHETER Cardio Search, Inc. FOZ Class II 1985-01-14
K844089 CASTLE 7515 UTENSIL/GLASSWARE WASHER Castle Co. LDS Class II 1985-01-14
K844056 THERMOCOUPLE SENSORS, ACCESS. FOR ELECTRONIC THERM Sensortek, Inc. FLL Class II 1985-01-09
K844340 TRAVENOL RECONSTITUTION DEVICE W/ADMIX CAP Travenol Laboratories, S.A. LHI Class II 1985-01-09
K844463 DERMIDRESS Kells Medical, Inc. KGX Class I 1985-01-08
K843748 ANTI-ASPIRATION VALVE Travenol Laboratories, S.A. FPA Class II 1985-01-03
K843040 COPAL DIGITAL THERMOMETER UF-10 Takeda Medical, Inc. FLL Class II 1985-01-03
K844273 AUTORANGING DIGITAL THERMOMETER Micro Idea Instrument Co., Ltd. FLL Class II 1984-12-20
K844611 SINGLE BASIN SET Packaging Technologies, Inc. FRG Class II 1984-12-19
K844614 IV START KIT Packaging Technologies, Inc. LRS Class II 1984-12-19
K844255 GENT-L-KARE STERILE I.V. START KIT Geneva Laboratories, Inc. FPA Class II 1984-12-19
K844078 PROVIDER PA 3000 INFUSION SYSTEM Pancretec, Inc. FRN Class II 1984-12-18
K844796 MICRO-BETA U100 SYRINGE Orange Medical Instruments, Inc. FMF Class II 1984-12-18
K844417 APPOSE ULTRA DISPOS. SKIN STAPLER W/AUTO RELEASE Davis & Geck, Inc. GAG Class II 1984-12-17
K843264 MONOJECT MENGHINI SOFT TISSUE BIOPSY Sherwood Medical Co. FMI Class II 1984-12-17
K844628 V. MUELLER PHEUMO-INTESTINAL INSTRUMENT SET American V. Mueller GAG Class II 1984-12-14
K844654 SHARP COLLECTION SYSTEM-SHARP-A-GATOR Devon Industries, Inc. MMK Class II 1984-12-12
K842946 ACU-PATCH Acutek KGX Class I 1984-12-07
K843415 TOP HYPODERMIC SYRINGE LUER LOCK Top Surgical Manufacturers Co. FMF Class II 1984-12-07
K843887 IV JET Nuclear Concepts, Inc. FMF Class II 1984-12-07
K844124 TOSHIBA DIGITAL CLINICAL THERMOMETER Toshiba Medical Systems FLL Class II 1984-12-07
K843772 CADD-1 5100 AMBULATORY INFUSION PUMP Deltec Systems, Inc. FRN Class II 1984-12-06
K843878 HEPARIN INFUSIN PUMP Armament Systems, Inc. FRN Class II 1984-12-06
K843773 CADD-PAC 5200 AMBULATORY INFUSION PUMP Deltec Systems, Inc. FRN Class II 1984-12-06
K842989 SHAVE PREP KITS Biological & Environmental Control Laboratories KME Class I 1984-12-04
K842209 ARM-A-FLOW INTRAVENOUS FLOW REGULATOR Armour Pharmaceutical Co. LDR Class II 1984-12-04
K843090 UNIVERSITY OF CHICAGO VASCULAR ANGIOGRAM Geneva Laboratories, Inc. FPA Class II 1984-12-04
K844196 WET SKIN SCRUB TRAY STERILE WET SKIN SCRUB KIT Biological & Environmental Control Laboratories KME Class I 1984-12-04
K843033 DESERET INTRAVASCULAR CATHETER Parke-Davis Co. FOZ Class II 1984-12-03
K842461 TONGUE DEPRESSOR The Torrent Corp. FMA Class I 1984-11-30
K844306 GAINOR MEDICAL SYRINGE Gainor Medical FMF Class II 1984-11-30
K844305 GAINOR MEDICAL FLOWMAX NEEDLES Gainor Medical FMI Class II 1984-11-30
K843949 I.V. PUMP ADMINISTRATION SET Travenol Laboratories, S.A. FRN Class II 1984-11-30
K843954 MIXING CONTAINER American Mcgaw KPE Class II 1984-11-28
K844113 DESERET SUBCLAVIAN JUGULAR CATHETER SET Parke-Davis Co. FOZ Class II 1984-11-28
K844111 DERATA MEDI-JECTOR III Derata Corp. KZE Class II 1984-11-28
K844410 NUTRIBAG MIXING CONTAINER -2000 ML Medical & Pharmaceutical Supplies, Inc. KPE Class II 1984-11-28
K844219 DESERET DENTRAL LINE CATHETER Parke-Davis Co. FOZ Class II 1984-11-28
K842754 CUSTOM ULTRASONICS-SYS 80, 81-24, 83-2 Custom Ultrasonics FLG Class I 1984-11-28
K843587 PETIT BANDS Micori Gifts, Inc. KGX Class I 1984-11-27
K843469 PHARMA-PLAST SUCTION TIP, TYPE ORTHOPAE- Zimmar Consulting , Ltd. JOL Class II 1984-11-19
K843470 PHARMA-PLAST CONNECTING TUBE TYPE SUCT- Zimmar Consulting , Ltd. BYY Class II 1984-11-16
K843331 INTERMEDICS/GRASEBY DYNAMICS MS 36 Intermedics, Inc. FRN Class II 1984-11-15
K843450 ARGYLE SILICONE CENTRAL VENOUS CATH- Sherwood Medical Co. LJS Class II 1984-11-15
K842644 TPN/HYPERALIMENTATION TRAY Deroyal Industries, Inc. FRG Class II 1984-11-08
K840815 LUER LOCKING ADAPTER(MATERIAL CHANGE) Quinton, Inc. FOZ Class II 1984-11-08
K843300 SKIN-LITE Guardian Chemical KMF Class I 1984-11-07
K842301 DISPOSABLE LATEX BANDAGE Inmed Corp. KGX Class I 1984-11-05
K842511 BAND-AID BRAND ADHESIVE BANDAGE-MEDICA Johnson & Johnson Professionals, Inc. KGX Class I 1984-11-05
K843882 TRENDS LANCET Orange Medical Instruments, Inc. KMK Class I 1984-11-05
K843784 VITAJET JET INSULIN INJECTION DEVICE Vitajet Industriae Comercioltda. KZE Class II 1984-11-02
K841913 TEMPTREND PEDS AXILLARY TEMP. INDICATOR Biosynergy, Inc. KPD Class II 1984-11-02
K842479 I.V. TEAMATE Medical Delivery Systems FRN Class II 1984-11-02
K840609 SKIN TECH. ISOTEX 86L Lectec Corp. KGX Class I 1984-10-31
K843692 FLU VEN I.V. SET 0153-C PERMA-SET Venusa , Ltd. FPA Class II 1984-10-31
K843472 PHARMA-PLAST SYRINGE WITH NEEDLE Zimmar Consulting , Ltd. FMF Class II 1984-10-31
K840951 FIRST AID BANDAGE Gainor Medical KGX Class I 1984-10-31
K843473 PHARMA-PLAST INSULIN SYRINGE Zimmar Consulting , Ltd. FMF Class II 1984-10-31
K843982 O.B. BASIN SET Pro-Lab, Inc. FRG Class II 1984-10-31
K843471 PHARMA-PLAST SYRINGE Zimmar Consulting , Ltd. FMF Class II 1984-10-31
K843616 AVI GUARDIAN 400 INFUSION PUMP Avi, Inc. FRN Class II 1984-10-31
K843615 AVI GUARDIAN MICRO 410 INFUSION PUMP Avi, Inc. FRN Class II 1984-10-31
K840448 MEDICAL ADHESIVE FOAM TAPE Lectec Corp. KGX Class I 1984-10-31
K843548 INTERMEDICS SYRINGE PUMP 710-02 Intermedics, Inc. FRN Class II 1984-10-31
K840446 MEDICAL TAPE Lectec Corp. KGX Class I 1984-10-31
K840945 SKIN CLOSURE Gainor Medical FPX Class I 1984-10-31
K840950 ZINC OXIDE TAPE Gainor Medical KGX Class I 1984-10-31
K841597 GIL-MED PARENTERAL NUTRITION OR MEDICINE Gil-Med Industries C/O Kegan & Kegan, Ltd. KPE Class II 1984-10-26
K842621 SUTURE STRIP Genetic Laboratories, Inc. FPX Class I 1984-10-25
K842973 HAYFEVER HELMET R.H. Hinchli Fle & Sons, Ltd. FRF Class II 1984-10-25
K843168 ENTERAL FEEDING PUMP 14-800 SERIES Biosearch Medical Products, Inc. FRN Class II 1984-10-24
K843038 DISPOSABLE PATIENT BLANKET Anago, Inc. KME Class I 1984-10-24
K843591 INTERCEPT Vital Signs, Inc. KDP Class II 1984-10-19
K843274 MODULAR VOLUMETRIC INFUSION PUMP SYS American Edwards Laboratories FRN Class II 1984-10-19
K842170 EMPTY SOLUTION TRANSFER CONTAINER The Healthcare Group Laboratories, Inc. KPE Class II 1984-10-19

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