meddevicedb.com FDA Device Reference

Review Panel

General Hospital FDA 510(k) Clearances & Devices

Cleared Devices
15,723
Product Codes (page)
38
Latest Decision
1991-02-07

Clearances · page 109 of 158

K-Number Trade Name Applicant / Manufacturer Product Code Class Decision Date
K905025 DIGITAL THERMOMETER KITS Abco Dealers, Inc. FLL Class II 1991-02-07
K895859 CONTAIN(TM) Arbor Technologies, Inc. GCX Class II 1991-02-07
K905251 MTP TRANSPORT INFUSION PUMP MODEL NO. 1001A Medical Technical Products FRN Class II 1991-02-07
K905365 INSTRUMENT MAKAR GRAVITY ASSIST SYSTEM Instrument Makar, Inc. KYZ Class I 1991-02-06
K910171 MAXI-FLOW SUCTION SET W/Y CONNECTOR Adler Instrument Co. GAZ Class II 1991-02-01
K910170 MAXI-FLOW SUCTION SET 12 FT. Adler Instrument Co. GAZ Class II 1991-02-01
K903571 MICREL LTD PORTABLE INFUSION MICROPUMP Technology Transfer Intl., Inc. FRN Class II 1991-02-01
K903847 VINYL GLOVE-POWEDERFREE (OBERON GLOVES INTL. LTD) Zest Mark Industrial Co., Ltd. LYZ Class I 1991-01-31
K905127 LATEX GLOVE APPLICATION AND REMOVAL SYSTEM Success Builders Intl., Inc. FMC Class I 1991-01-30
K905177 STAT(TM) GLOVE Success Builders Intl., Inc. LZC Class I 1991-01-30
K905172 PATIENT EXAMINATION GLOVES Tessile, Inc. LYY Class I 1991-01-28
K905503 TRU-TOUCH POWDER FREE Bd Becton Dickinson Vacutainer Systems Preanalytic LYZ Class I 1991-01-28
K910009 HYPOALLERGENIC LATEX EXAMINATION GLOVES Straitscom LYY Class I 1991-01-24
K905463 GENERAL MEDICAL PROCEDURE KIT/SKIN PREPARATION Angiosystems, Inc. FOZ Class II 1991-01-22
K905735 GENNY DENNY IV SHIELD Tadco, Inc. KMK Class I 1991-01-18
K905031 PATIENT EXAMINATION GLOVES Phoenix Medical Technology, Inc. LYZ Class I 1991-01-18
K905055 PM GLOVE Pm Gloves, Inc. LYZ Class I 1991-01-18
K905678 ALADERM Aladan Corp. LYY Class I 1991-01-18
K903823 SPEEDWRAP, DYNAWRAP, DYNAPLAST TAPE Smith and Nephew Donjoy, Inc. KGX Class I 1991-01-16
K904979 AVI MODEL 600 SYRINGE PUMP, MODIFICATION 3M Avi, Inc. FRN Class II 1991-01-15
K910045 PATIENT EXAMINATION GLOVES-POWDER FREED Pan-Century Rubber Products Sdn. Bhd. LYY Class I 1991-01-15
K905665 PATIENT EXAMINATION GLOVES Medical Products Search, Inc. LYY Class I 1991-01-15
K910046 PATIENT EXAMINATION GLOVES-ANATOMICAL GLOVES Pan-Century Rubber Products Sdn. Bhd. LYY Class I 1991-01-15
K910047 PATIENT EXAMINATION GLOVES-TEXTURED GLOVES Pan-Century Rubber Products Sdn. Bhd. LYY Class I 1991-01-15
K905551 PATIENT EXAMINATION GLOVES Johnson & Johnson Medical, Inc. LYY Class I 1991-01-15
K903439 DEFEND LATEX EXAM. GLOVES(AMBIDEXT/NON-STER/HYPOAL Glovco Malaysia Sdn Bhd LYY Class I 1991-01-14
K904886 VASCULAR ACCESS PORT CONTINUOUS INFUSION SETS Florida Infusion Services, Inc. FPA Class II 1991-01-11
K905783 MODIFIED WALKMED 400 Medfusion, Inc. FRN Class II 1991-01-11
K905667 LANEX EXAM GLOVES Mokiem & Julian Industrial Corp. LYY Class I 1991-01-02
K905201 TPN FLUID TRANSFER SET Mcgaw, Inc. LHI Class II 1991-01-02
K905003 BIO-GUARD SHAVE PREP TRAY Network Medical Systems, Inc. KME Class I 1990-12-28
K904403 BARD AMBULATORY PCA DRUG DELIVERY SYSTEM C.R. Bard, Inc. FRN Class II 1990-12-28
K905029 MODEL 2001, MODIFICATION Medfusion, Inc. FRN Class II 1990-12-24
K902178 YUEFA DISPOSABLE SYRINGE Blue & Red Corp. FMF Class II 1990-12-21
K903559 HIGH RISK Medical Resources, Ltd. LYY Class I 1990-12-21
K905585 PATIENT EXAM GLOVES(MFG: LIAONING MACHINERY) Pioneer Trading Co. LYY Class I 1990-12-21
K904198 SAFETY NEEDLE SHEATH Concord/Portex FMI Class II 1990-12-19
K905550 PATIENT EXAMINATION GLOVES Medical Device Inspection Co., Inc. LYY Class I 1990-12-19
K905515 ZOETIC GLOVES Janco Polymers Pvt., Ltd. LYY Class I 1990-12-19
K905009 DIGITCARE I.V. START KIT Digitcare Corp. FOZ Class II 1990-12-18
K902858 AVI MODEL 4206 MANIFOLD CHECKVALVE IV ADMIN. SET 3M Avi, Inc. FPA Class II 1990-12-14
K904107 CAP-AID Nda Systems FMI Class II 1990-12-14
K903614 HARVARD/LTE LABORATORY STEAM STERILIZER AUTOCLAVE Harvard Apparatus, Inc. FLE Class II 1990-12-14
K904648 SAFE SYTE I.V. CATHETER PLACEMENT UNIT Deseret Medical, Inc. FOZ Class II 1990-12-14
K903347 SODIUM CHLORIDE SOLUTION Superior Healthcare Group, Inc. FOZ Class II 1990-12-13
K902724 ADVANCE DISPOSABLE STOPCOCK Advance Medical Designs, Inc. FMG Class II 1990-12-05
K904921 STERI-VAC(TM) AERATOR MODEL XL 3M Health Care, Ltd. FLI Class II 1990-12-05
K904417 CHEMOSITE IMPLANTABLE DRUG DELIVERY SYSTEM Device Labs, Inc. LJT Class II 1990-12-05
K902796 LATEX EXAMINATION GLOVES Ek Hong Rubber Industry (Thailand) Co., Ltd. LYY Class I 1990-12-04
K901147 JOSLYN STEAM STERILIZER / STEAM MODERNIZATION KIT Joslyn Valve Corp. FLE Class II 1990-11-30
K902157 JOHNSON & JOHNSON DUAL SYRINGE APPLICATOR Johnson & Johnson Medical, Inc. FMF Class II 1990-11-29
K903490 NORPLANT(R) TROCAR Wyeth-Ayerst Laboratories, Inc. FMI Class II 1990-11-28
K904411 INTRASITE GEL (LABELING REVISION) Smith & Nephew United, Inc. KMF Class I 1990-11-26
K895275 MAC LAVE STEAM STERILIZER Merchants Export Development Corp. FLE Class II 1990-11-23
K904526 HYPOALLERGENIC CRANBERRY/MALAYTEX LATEX EXAM GLOVE Malaytex USA, Inc. LYY Class I 1990-11-23
K905109 PATIENT EXAMINATION GLOVE/HYPOALLERGENIC Tactyl Technologies, Inc. FMC Class I 1990-11-21
K904500 ELASTOPLAST Beiersdorf, Inc. KGX Class I 1990-11-21
K904685 EXEL HUBER INFUSION SET WITHOUT INJECTION SITE (Y) Exel Intl. FPA Class II 1990-11-21
K904148 PREVEN-A-STIK Preven-A-Stik, Inc. MMK Class II 1990-11-21
K903343 SYRINGE INFUSION PUMP Baxter Healthcare Corp FRN Class II 1990-11-21
K902891 VERIFUSE AMBULATORY PUMP Block Medical, Inc. FRN Class II 1990-11-21
K901803 SYRINGE NEEDLE INTRODUCER Glaxo, Inc. KZH Class II 1990-11-20
K902410 MEDICAL PROCEDURE TRAY Sorex Medical LDQ 1990-11-20
K904138 SMART SCALE X-RAY PLATFORM Olympic Medical Corp. FRW Class I 1990-11-19
K905033 SLIMFLEX, PATIENT EXAMINATION GLOVES Slim River Latex Sdn. Bhd. LYY Class I 1990-11-19
K904150 CATH-FINDER(TM) CATHETER TRACKING SYSTEM Pharmacia Deltec, Inc. FOZ Class II 1990-11-19
K904855 ADD-A-VIAL Kendall Mcgaw Laboratories, Inc. LHI Class II 1990-11-19
K904216 STERILE WATER SOLUTION CATALOG # 10000 Superior Healthcare Group, Inc. JOL Class II 1990-11-16
K895137 DIOTHERM Science Regulatory Services Intl. FLL Class II 1990-11-16
K903545 CAREKITS(TM), IV/CATH/CENT LINE DRESS/TPN/CVP KITS J.J. Skinner, Inc. FOZ Class II 1990-11-13
K902810 STERILE I.V. START KIT Orion Life Systems, Inc. FPA Class II 1990-11-13
K904936 PATIENT EXAMINATION GLOVES Slim River Latex Sdn. Bhd. LYY Class I 1990-11-08
K904121 VIALON OBTURATOR Deseret Medical, Inc. FOZ Class II 1990-11-08
K903159 VALVE CONTROLLER FOR MICROMACRO COMPOUNDER Baxa Corp., Sub. of Cook Group, Inc. LHI Class II 1990-11-07
K903613 HARVARD/LTE BENCHTOP STEAM STERILIZER (AUTOCLAVE) Harvard Apparatus, Inc. FLE Class II 1990-11-07
K904334 PERCUTANEOUS INTRAVENOUS CATHETER REPAIR KIT Pharmacia Deltec, Inc. LJS Class II 1990-11-05
K904225 KWIKMIX Baxa Corp., Sub. of Cook Group, Inc. LHI Class II 1990-11-05
K902700 HEVEASHIELD EXAMINATION GLOVES Pacificlink Export LYY Class I 1990-11-02
K902956 LATEX EXAMINATION GLOVES Pacificlink Export Industries Private , Ltd. LYY Class I 1990-11-02
K903532 UNNA-SLEEVE(TM) Aci Medical, Inc. LLK Class II 1990-11-02
K903382 ALLERGY CONTROL COVERS Allergy Control Products, Inc. FMW Class I 1990-11-02
K902958 TST CONTROL INTEGRATOR FOR STEAM AUTOCLAVE Board of Directors, Albert Browne , Ltd. JOJ Class II 1990-11-01
K900217 BARD MICROBORE ANTI-SIPHON NITRO SET C.R. Bard, Inc. FRN Class II 1990-10-31
K903364 GERARD MEDICAL, INC. TRIM-PORT Gerard Medical Enterprises, Inc. LJT Class II 1990-10-31
K904598 ACCU PATH STERILE LABEL Accu-Path LDQ 1990-10-30
K903947 QUALTEX NEEDLE COUNTERS Deroyal Industries, Inc. MMK Class II 1990-10-30
K903857 NON-STERILE LATEX DENTAL PROCEDURE GLOVES Formtex Medical Sdn. Bhd. LYY Class I 1990-10-29
K903445 OLYMPIC BILI-METER(TM) WITH TYPE-F SENSOR Olympic Medical Corp. LBI Class II 1990-10-29
K902079 ADMIXTURE CONTAINER FOR TOTAL PARENTERAL NUTRITION Chartermed, Inc. KPE Class II 1990-10-29
K904221 SEPACELL(R) PL-5A/10A LEUKOCYTE REMOVAL FILTERS Baxter Healthcare Corp CAK Class II 1990-10-26
K895677 THE MURRAY MOBILIFT(TM) Medical/Surgical Specialties, Ltd. FNG Class II 1990-10-26
K903111 LATEX EXAMINATION GLOVES Kaen Yang Industry Co., Ltd. LYY Class I 1990-10-26
K904484 BAXTER SINGLE PATIENT USE PRESSURE INFUSOR Tecnadyne Scientific, Inc. KZD Class I 1990-10-26
K902625 CLINICAL THERMOMETER; RECTAL/ORAL, INNER ARMPIT Liaoning-Usa Corp. FLK Class II 1990-10-26
K903759 IRRICLEAR EAR IRRIGATION SYRINGE Nortech Laboratories, Inc. KYZ Class I 1990-10-26
K903142 AUKUFLEX(TM) RADIATION RESISTANT GLOVES Aukland Mfg., Inc. LZC Class I 1990-10-26
K904740 AMPRO LATEX EXAM GLOVE American Pro Latex, Inc. LYY Class I 1990-10-26
K904223 SEPACELL(R) R-200/500 LEUKOCYTE REMOVAL RECIP SETS Baxter Healthcare Corp CAK Class II 1990-10-26
K903910 LUBRICATING JELLY Lake Pharmaceutical, Inc. KMJ Class I 1990-10-26
K904274 RECEIVING BLANKET Anago, Inc. KME Class I 1990-10-26

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