meddevicedb.com FDA Device Reference

Review Panel

General Hospital FDA 510(k) Clearances & Devices

Cleared Devices
15,723
Product Codes (page)
36
Latest Decision
1984-10-19

Clearances · page 139 of 158

K-Number Trade Name Applicant / Manufacturer Product Code Class Decision Date
K843631 MINISET VEIN INFUSION SETS Travenol Laboratories, S.A. FPA Class II 1984-10-19
K842568 RADIONUCLIDE INFUSION SYSTEM Squibb Diagnostics FRN Class II 1984-10-19
K842984 EXTENSION SET W/INJECTION SITE Med Fusion Systems, Inc. FPA Class II 1984-10-16
K843523 EMPTY SOLUTION TRANSFER CONTAINER 1000 Polymer Technology Corp. KPE Class II 1984-10-16
K842351 STERILE DESIGN-CUSTOM STERILE IV KIT Sterile Design, Inc. FPA Class II 1984-10-15
K843463 PROVIDER BAG SPIKE W/12 MICROBORE EXTEN Pancretec, Inc. FPA Class II 1984-10-11
K843254 DK*300 VOLUMETRIC INFUSION CONTROLLER Deka Research & Development Corp. LDR Class II 1984-10-11
K843381 URI TX-100 MULTICHANNEL THERMOCOUPLE Uri Therm-X, Inc. FLL Class II 1984-10-11
K842678 I.V. TRANSFER SPIKE Lyphomed, Inc. FPA Class II 1984-10-09
K843182 MASTER-CHEK BOWIE-DICK TYPE TEST Arvey Corp. JOJ Class II 1984-10-09
K842708 MED. SUPPORT STOCKING-VENOFIT LASTOFLEX Kundt + Co. AG DWL Class II 1984-10-09
K842399 48 HOUR SET CHANGES Tri-Med, Inc. FPB Class II 1984-10-09
K843720 COTTON TIPPED APPLICATORS, SINGLE Abco Dealers, Inc. KXF Class I 1984-10-04
K841709 48 HOUR BIOLOGICAL INDICATORS SPORSTRIP Skyland Scientific Services, Inc. FRC Class II 1984-10-02
K843476 PHARMA-PLAST SMOOTH BORE CONNECTORS Zimmar Consulting , Ltd. GAZ Class II 1984-09-24
K842999 VENI-SHIELD U.S. Mfg. & Management, Inc. KMK Class I 1984-09-24
K842517 UNILET LANCET Ulster Scientific, Inc. FML Class I 1984-09-20
K843185 IVAC C80014 Y SOLUTION ADMIN. SET Y FPA Class II 1984-09-20
K843188 WELLS JOHNSON CO. CHAJ-CHIR-SUCTION TIP Wells Johnson Co. JOL Class II 1984-09-20
K843157 DISPOSABLE TISSUE EFFECT BIOSENSOR-T Pan Dynamics Medical Corp. FLL Class II 1984-09-19
K840481 INFUSE-A-PORT HEPARIN LOCK MAINT KIT Infusaid Corp. LJT Class II 1984-09-18
K843054 DEKA SOLUTION ADMIN. SET DK 302-A Deka Research & Development Corp. FPA Class II 1984-09-13
K843439 CENTURIAN HYDRAULIC STRETCHER American Sterilizer Co. FPO Class II 1984-09-13
K842858 FLUID ADMINISTRATION LINE W/SPIKE 14-923 Norton Performance Plastics Corp. FPA Class II 1984-09-11
K843249 T-TYPE IV EXTENSION SET Strato Medical Corp. FPA Class II 1984-09-07
K843402 MOLINEA UNDERPADS Paul Hartmann Corp. KME Class I 1984-09-07
K843414 TOP HYPODERMIC SYRINGE PISTON Top Surgical Manufacturers Co. FMF Class II 1984-09-07
K842629 HOME NUTRIBAG MIXING CONTAINER 3000ML Medical & Pharmaceutical Supplies, Inc. KPE Class II 1984-09-07
K842628 HOME NUTRIBAG MIXING CONTAINER 1000ML Medical & Pharmaceutical Supplies, Inc. KPE Class II 1984-09-07
K841949 DOSE RELEASE OF STERILIZATION LOTS Medcare Disp Products, Inc. FMF Class II 1984-09-05
K833999 COMBION SKIN TEST - FOUR PRONG Nicholas H. Maganias SCL Class II 1984-09-05
K842173 DISPOSABLE STOPCOCKS Procedure Products, Inc. FMG Class II 1984-09-05
K834558 CK10000 SERIES POUCH & BAGS ETC. Currie Medical Specialties, Inc. KCT Class II 1984-09-05
K843075 UTILITY SCISSORS DISPOSABLE ITEMS Greene International Corp. JOK Class I 1984-09-05
K842107 COMBO SKIN TEST READY TO USE TAPE Combion Systems, Inc. SCL Class II 1984-09-05
K841561 HESUNG'S BLOOD DONOR SETS Amkor Trading Co. BRZ Class II 1984-08-30
K842542 AMER. PHARMASEAL CHEMONUCLEOLYSIS TRAY American Pharmaseal Div. Ahsc FMI Class II 1984-08-20
K842657 ACCESS. TO INTERAVACULAR ADMIN. SET Tanner Corp. FPA Class II 1984-08-17
K842421 ARGYLE ENTERITE ENTERAL FEEDING PUMP Sherwood Medical Co. FRN Class II 1984-08-17
K840447 MICROPOROUS MED. ADHESIVE TAPE Lectec Corp. KGX Class I 1984-08-17
K842490 SKIN SCRUB TRAY STERILE SKIN SCRUB KIT Biological & Environmental Control Laboratories FRG Class II 1984-08-17
K840947 CLOTH-HYPOALLERGENIC Gainor Medical KGX Class I 1984-08-17
K842898 CURITY I.V. START KIT The Kendal Co. LRS Class II 1984-08-17
K842345 MAXIFILL TRANSFER SET Lyphomed, Inc. LHI Class II 1984-08-17
K842088 FLU MET 2 Venusa , Ltd. FPA Class II 1984-08-17
K840949 CLEAR PLASTIC-HYPOALLERGENIC Gainor Medical KGX Class I 1984-08-17
K842405 DR. GOULD HAND PACK SUSTOM STERIL Pro-Lab, Inc. FRG Class II 1984-08-15
K842064 ACU-DERM TRANSPARENT IV DRESSING Acme United Corp. KMK Class I 1984-08-15
K841898 FIRST RESPONSE EMERG. MEDICSL - BURNS Reed Products, Inc. FPY Class I 1984-08-14
K842419 IVAC 280 VOLUMETRIC INFUSION CONTROLLER Y LDR Class II 1984-08-07
K842985 T- EXTENSION SET T-04-C Tico Medical Instruments, Inc. FPA Class II 1984-08-07
K842355 INFUSAID INFUSE-A-PORT Infusaid Corp. LJT Class II 1984-08-06
K842335 PILLOW W/STAPHCHEK TICKING Monterey Mills, Inc. KME Class I 1984-08-01
K841443 REDO CENTRAL VENOUS CATHETER-NEONATE Intl. Hospital Products, Inc. LJS Class II 1984-07-27
K841827 ENTEROPORT NUTRITION PUMP Diatek, Inc. FRN Class II 1984-07-27
K842631 STERELIS SEALING EQUIPMENT Sterelis Corp. FLE Class II 1984-07-26
K842263 MTP E.V. INFUSION PUMP Ziehm International, Inc. FRN Class II 1984-07-25
K842210 IVENT 302VC DUAL CONTROLLER Ivent Corp. LDR Class II 1984-07-25
K840339 UMBILICAL VESSEL CATHETER Catheter Technology Corp. FOS Class II 1984-07-25
K842289 SR- MODEL 230 Hirata Sangyo Co. USA, Inc. FRN Class II 1984-07-25
K842227 AIMED DISPOSABLE SYRINGE, VARIOUS SIZES Tech-Cons Ltd., Intl. FMF Class II 1984-07-23
K841897 FIRST RESPONSE EMERG. MEDICAL SYSTEM Reed Products, Inc. KGX Class I 1984-07-23
K841899 FIRST RESPONSE EMERG. MEDICAL SYS BONES Reed Products, Inc. KGX Class I 1984-07-23
K842756 BUTTERFLY II PN INFUSION NEEDLE Cosmetic Sciences, Inc. FMI Class II 1984-07-23
K841717 INTRAVENOUS INJECTION SET Philadelphia Biologics Center FPA Class II 1984-07-23
K841562 HESUNG BLOOD TRANSFUSION SETS Amkor Trading Co. FPA Class II 1984-07-23
K842143 BENT WINGED MINI-VOL INFUSION SET Med Fusion Systems, Inc. FPA Class II 1984-07-20
K842080 ABBOTT LIFECARE 1050 CONTROLLER Abbott Laboratories LDR Class II 1984-07-18
K842317 SIGNAL ELECTRONIC CLINICAL THERMOMETER Yukosha Co., Inc. FLL Class II 1984-07-18
K831356 STEAM STERILIZER Ars Enterprises, Inc. FLE Class II 1984-07-18
K842199 ELEC. DIGITAL THERMOMETER MT-20 & 30 Sharp Electronics Corp. FLL Class II 1984-07-18
K841318 A.S.A.P. Trimedyne, Inc. LDR Class II 1984-07-18
K841322 OPTIMIST SIZED PARTICLE AEROSOL NEBULIZ Airmed Corp. FLL Class II 1984-07-18
K842027 IVAC 3080 ENTERAL FEEDING PUMP Y FRN Class II 1984-07-18
K841740 TERUMO DIGITAL CLINICAL THERMOMETER Terumo Medical Corp. FLL Class II 1984-07-18
K842132 TYCOS SELF-CHECK/DIGITAL FEVER THERMO Sybron Corp. FLL Class II 1984-07-18
K841565 HESUNG'S HYPERDERMIC NEEDLES Amkor Trading Co. FMI Class II 1984-07-17
K841566 HESUNG DISPOSABLE SYRINGE Amkor Trading Co. FMF Class II 1984-07-17
K841564 HESUNG SCALP VEIN SET Amkor Trading Co. FPA Class II 1984-07-17
K841563 HESUNG'S SOLUTION INFUSION SETS Amkor Trading Co. FPA Class II 1984-07-17
K841922 ACCUPRO VOLUMETRIC INFUSION PUMP W/RS232 American Edwards Laboratories FRN Class II 1984-07-13
K842336 DISPOSABLE PILLOW Monterey Mills, Inc. KME Class I 1984-07-13
K841878 SHEATH REMOVER Datascope Corp. LJS Class II 1984-07-13
K840742 RIGHT ATRIAL CATHETER The Healthcare Group Laboratories, Inc. LJS Class II 1984-07-13
K841931 DISPO. AES DISPOS. SYRINGE W/NEEDLE Hirsch Chemie , Ltd. FMF Class II 1984-07-06
K841772 HEPARIN CAP, INJECTION CAP MALE LUER- Linton Biomed Corp. FPA Class II 1984-07-06
K841780 CLINICAL ELECTRONIC THERMOMETER Fidelity Medical, Inc. FLL Class II 1984-07-06
K842135 HI-LO FLOOR STANDING EXAM. LIGHT Good-Lite Co. KZF Class I 1984-07-06
K842136 STERILE PAN SET Medi-Plast Intl., Inc. FRG Class II 1984-07-06
K840846 STERILE HICHMAN/BROVIAC INJECTION CAP Evermed, Inc. LJS Class II 1984-07-06
K841742 NON-CORING NEEDLE Creative Care Systems, Inc. FMI Class II 1984-07-06
K842015 SAWYER FIRST AID KIT Saffeta, Inc. KYP Class I 1984-07-06
K841810 MARK5 ARTERIAL BLOOD GAS KIT Martell Medical Products, Inc. FMF Class II 1984-07-06
K842012 UMI CURVED CHEMONUCLEOLYSIS NEEDLE Universal Medical Instrument Corp. FMI Class II 1984-07-06
K841671 FALL-SAFE MONITOR Fsm Corp. KMI Class I 1984-07-03
K841105 MULTICHANNEL 2000 FLUOROPTIC THERMOMET Luxtron FLL Class II 1984-07-03
K842016 DISPOS. POLY APRONS Abco Dealers, Inc. LDQ 1984-07-03
K841672 FALL-SAFE VEST Fsm Corp. KMI Class I 1984-07-03
K841859 SECURA SET Diatek, Inc. FPA Class II 1984-07-03
K841484 STERILE O.R. BASIN KIT PRODUCT LINE Medline Industries, Inc. FRG Class II 1984-07-02

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