meddevicedb.com FDA Device Reference

Review Panel

General Hospital FDA 510(k) Clearances & Devices

Cleared Devices
15,723
Product Codes (page)
33
Latest Decision
1992-12-24

Clearances · page 103 of 158

K-Number Trade Name Applicant / Manufacturer Product Code Class Decision Date
K921595 Y-TYPE BLOOD ADMINISTRATION SET MODEL #HT-TR2 Haemotronic, Inc. BRZ Class II 1992-12-24
K923882 IV-TUBE SECURE Ximedix, Inc. FPA Class II 1992-12-24
K921594 HAEMOTROL MODEL #HT-SB/6 BURETTE SET Haemotronic, Inc. FPA Class II 1992-12-24
K923601 PANCRETEC PROVIDER INFUSION PUMP -- MODIFICAITON Abbott Laboratories FRN Class II 1992-12-23
K920713 FIRSTTEMP GENIUS Intelligent Medical Systems FLL Class II 1992-12-17
K921429 SOLUTION ADMINISTRATION SET Sierra Medical Devices FPA Class II 1992-12-17
K924072 BECTON DICKINSON SAFETY-LOK SYRINGE Bd Becton Dickinson Vacutainer Systems Preanalytic FMF Class II 1992-12-17
K923967 PATIENT EXAM GLOVES (POWDER FREE) American Health Products, Inc. LYY Class I 1992-12-15
K920737 LIFESHIELD VIAL ADAPTER Abbott Laboratories FMI Class II 1992-12-15
K922228 2ND SKIN STERILE ADHESIVE STRIP Spenco Medical Corp. KGX Class I 1992-12-11
K922147 DUAL PLASTIC VASCULAR ACCESS SYSTEM Gerard Medical Enterprises, Inc. LJT Class II 1992-12-04
K914276 SIME HEALTH SIME POWDERFREE EXAMINATION GLOVES Sime Health, Ltd. LYY Class I 1992-12-04
K923901 LATEX EXAMINATION GLOVES Medi Tex, Inc. LYY Class I 1992-12-04
K911238 TAHOE SUCTION IRRIGATOR Tahoe Pro Instruments GCX Class II 1992-11-27
K922522 MONOJECT SAFETY SYRINGE, 1 CC, 3CC AND 12 CC SIZES Sherwood Medical Co. FMF Class II 1992-11-25
K920036 SURECATH PORT ACCESS CATHETER Ivion Corp. LJT Class II 1992-11-25
K924568 TUBE, LEAD, AND CORD HOLDER NO. 102 Ansley Medical Products, Inc. KMK Class I 1992-11-23
K924566 RESTRAINT, PROTECTIVE N0. 103 Ansley Medical Products, Inc. KMK Class I 1992-11-23
K920015 QUICKTEST SYSTEM Q.I. Medical, Inc. LHI Class II 1992-11-23
K924567 FOLEY CATHETER TUBE HOLDER NO. 101 Ansley Medical Products, Inc. KMK Class I 1992-11-23
K904663 AUTO SASH (TM) Block Medical, Inc. FPA Class II 1992-11-23
K923512 OPERATING ROOM NEEDLE COUNTER Sharp-Trap, Inc. MMK Class II 1992-11-23
K922419 IPI IMPORT Pudenz-Schulte Medical Research Corp. LJT Class II 1992-11-20
K923707 BALDUR LATEX EXAMINATION GLOVES Hti Trading Group LYY Class I 1992-11-17
K923772 LATEX EXAMINATION GLOVES Trico Intl., Inc. LYY Class I 1992-11-17
K921797 PRECI-JET 50 Hmi Industries, Inc. KZE Class II 1992-11-17
K921928 SOFT-COVER Adroit Medical Systems, Inc. FMW Class I 1992-11-06
K922434 A PORT IMPLANTABLE VASCULAR ACCESS SYSTEM LINE EXT Therex Corp. LJT Class II 1992-11-06
K923173 OBALON COVER Turnsoft, Inc. FMW Class I 1992-11-06
K922041 PRIMARY SURGICAL DRESSING TRAY Transidyne General Corp. FMF Class II 1992-11-06
K921379 A-PORT IMPLANTABLE VASCULAR ACCESS SYSTEM LINE EXT Therex Corp. LJT Class II 1992-11-06
K913982 LIFESHIELD ANESTHESIA SET Abbott Laboratories FPA Class II 1992-11-05
K923972 OPHTHALMIC FLUID DISTRIBUTION SETS Visitec Co. FPK Class II 1992-11-04
K921493 LS100 HALOGEN EXAMINATION LIGHT, MODEL NO: 44100 Welch Allyn, Inc. KZF Class I 1992-11-03
K912921 VSI 1000 Vitaltrends Technology, Inc. FMT Class II 1992-10-30
K922760 ATRAUM WOUND DRESSING--MODIFICATION Axiom Medical, Inc. KMF Class I 1992-10-30
K923592 PATIENT EXAMINATION GLOVES Hindustan Latex , Ltd. LYY Class I 1992-10-28
K921243 CONVERTORS STERILIZATION WRAP Baxter Healthcare Corp FRG Class II 1992-10-28
K921374 VYGON XRO VENOUS/ARTERIAL UMBILICAL CATHETER Vygon Corp. FOS Class II 1992-10-26
K921352 VYGON POLYURETHANE VENOUS/ARTERIAL XRO UMBIL. CATH Vygon Corp. FOS Class II 1992-10-26
K922190 LAPAROSCOPIC CHOLANGIOGRAPHY CATHETER Advanced Surgical, Inc. FMF Class II 1992-10-23
K914867 QWIK-1(TM) IN-LINE IV FLUID WARMER Microwave Medical Systems, Inc. LGZ Class II 1992-10-23
K921755 8 FR SINGLE LUMEN HIGH PERF. GROSHONG CENT. VENOUS Davol, Inc. LJS Class II 1992-10-23
K920480 DRESSING CHANG & WOUND MANAGEMENT Cypress Medical Products, Ltd. FRG Class II 1992-10-19
K922558 INTERLINK(TM) INJECTION SITE Baxter Healthcare Corp FPA Class II 1992-10-19
K921031 EDGE MEDICAL DISPENSING PIN Edgewater Medical Center LHI Class II 1992-10-19
K921475 A-PORT IMPLANT VASCULAR ACCESS SYST CATH - 75CM Therex Corp. LJT Class II 1992-10-16
K923385 BOSTON BRAND HYPOALLERGENIC LATEX GLOVES Boston Medical Corp. LYY Class I 1992-10-15
K922352 THE ADVANCE SERIES FROM HILL-ROM Hill-Rom, Inc. FNL Class II 1992-10-13
K920537 SUBCUTANEOUS INFUSION SET Marquette Medical, Inc. FPA Class II 1992-10-13
K914528 SAFEDWEL(R) CENTRAL VENOUS CATHETER Becton Dickinson Vascular Access, Inc. FOZ Class II 1992-10-13
K923400 DERMCO A-I Dermaco, Inc. KGX Class I 1992-10-06
K914148 PRIME CADI-120 Prime Medical Products, Inc. MEB Class II 1992-10-05
K921490 DRESSING CHANGE TRAY DECUBITUS ULCER/STERILE-DISP Trinity Laboratories, Inc. FRG Class II 1992-10-05
K922255 LATEX EXAMINATION GLOVES Balak Rubber (Malaysia) Sdn. Bhd. LYY Class I 1992-10-01
K923326 OPHTHALMIC VISCOINJECTOR DRIVE Synergetics, Inc. KZE Class II 1992-09-30
K923645 VISITEC ASPIRATING SYRINGE Visitec Co. FMF Class II 1992-09-30
K921502 HYSORB WOUND DRESSING Kingston Technologies, Inc. KMF Class I 1992-09-29
K921270 SAFE-DWELL PLUS CENTRAL VENOUS CATHETER Bd Becton Dickinson Vacutainer Systems Preanalytic FOZ Class II 1992-09-28
K922909 MEDICAL BATTERY PACKS Access / God Loves You FRN Class II 1992-09-23
K921674 LIFEPORT INFUSION SET AND INFUSION SET W/ Y SITE Strato Medical Corp. FPA Class II 1992-09-23
K922379 STERILE LATEX EXAMINATION GLOVES Smith & Nephew Perry LYY Class I 1992-09-22
K921576 STRATO LIFEPORT LARGE BORE INFUSION SET Starto Medical Corp. FPA Class II 1992-09-21
K921833 ENDOPATH ENDO-SURGERY PERCUTANEOUS CATHETER INTROD ETHICON, Inc. FMF Class II 1992-09-21
K912000 TYPE INTERFACE 9271/1 INCUBATOR/WARMER S & W Medico Teknik FMZ Class II 1992-09-21
K915571 CLAVE CONNECTOR Icu Medical, Inc. FPA Class II 1992-09-21
K915752 FIRST TOUCH/VILEDON NON-WOVEN FILTER First Touch Disposables, Inc. FMZ Class II 1992-09-17
K922897 STRAPPAL Smith & Nephew United, Inc. KGX Class I 1992-09-15
K922262 SPORICIDIN BRAND DISINFECT TOWELETTES/SPRAY/SOLUT Sporicidin Intl. LRJ Class I 1992-09-15
K915676 SPLATTER SHIELD Chathamborough Research Group, Inc. FMF Class II 1992-09-11
K920469 MYOCARDINAL TEMPERATURE SENSOR WITH TYPE 400 SERIE Respiratory Support Products, Inc. FLL Class II 1992-09-11
K922959 ISOPORE TAPE Lectec Corp. KGX Class I 1992-09-11
K921976 FIRST AID KIT The Home Emergency Room LYY Class I 1992-09-10
K914364 ASTOTHERM IFT 250, IFT 260, ASTOTUBE VARIOUS NO. North American Technical Services Corp. LGZ Class II 1992-09-10
K923404 LUEKOFLEX SURGICAL TAPE Beiersdorf, Inc. KGX Class I 1992-09-09
K915329 PATIENT EXAMINATION GLOVES (MAYCARE) Malaysian Healthcare Sdn. Bhd LYY Class I 1992-09-09
K922495 SUPER GLOVES(R) HYPOALLERGENIC Taiping Super Holdings Sdn Bhd LYY Class I 1992-09-04
K914122 VITAL INFUSION PUMP Vital Resources Corp. FRN Class II 1992-09-03
K921395 HOT SACK C.F. Electronics, Inc. LGZ Class II 1992-09-02
K915407 PHARMETRIX MEDIPUMP MODEL 524 Pharmetrix, Inc. FRN Class II 1992-09-02
K921391 SOLUTION ADMINISTRATION SET Douglas Medical Products Corp. FPA Class II 1992-09-02
K923300 DEROYAL EYE DRESSING Deroyal Industries, Inc. KGX Class I 1992-09-01
K922681 CUTINOVA FOAM Jobst Institute, Inc. KMF Class I 1992-08-31
K922540 WOUND DRESSING Les Laboratorires Brothier, S.A. KMF Class I 1992-08-24
K915270 PATIENT CONTROLLED SYRINGE PUMP TYPE 3300 Graseby Medical , Ltd. MEA Class II 1992-08-24
K922513 COMFIT STERILE LATEX EXAMINATION GLOVE Wembley Rubber Products (M) Sdn Bhd LYY Class I 1992-08-20
K920675 DUODERM SUSTAINED COMPRESSION BANDAGE Convatec, A Division of E.R. Squibb & Sons KGX Class I 1992-08-18
K922461 COMFEEL WOUND DRESSING ORD Coloplast A/S KMF Class I 1992-08-17
K922466 COMFEEL WOUND DRESSING SD Coloplast A/S KMF Class I 1992-08-17
K920828 SAFE-PICC PERIPHERALLY INSERTED CENTRAL VENOUS CAT Menlo Care, Inc. FOZ Class II 1992-08-14
K922205 BIO THERAPY PLUS Sunrise Medical, Inc. FNM Class II 1992-08-11
K922143 AMERICAN BURN SHEET American Silk Sutures, Inc. KME Class I 1992-08-10
K921760 TRICOPLAST Beiersdorf, Inc. KGX Class I 1992-08-10
K922212 MDT CASTLE BIOSIGN TEST PACK Mdt Corp., Inc. FRC Class II 1992-08-10
K921759 ACRYLASTIC Beiersdorf, Inc. KGX Class I 1992-08-10
K920794 BRND SKIN PROTECTION PREP SERIES 33XX 3M Health Care, Ltd. KMF Class I 1992-08-10
K915566 DISETRONIC PANOMAT PUMP Disetronic Medical Systems FRN Class II 1992-08-07
K915054 STATIM CASSETT AUTOCLAVE, MODIFICATION Scican FLE Class II 1992-08-04
K921994 BARD PCA II PUMP WITH PROGRAM CARTRIDGES C.R. Bard, Inc. MEA Class II 1992-08-03
K921860 MODIFICATION TO IV SPIKE Mcgaw, Inc. FPA Class II 1992-07-30

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