meddevicedb.com FDA Device Reference

Review Panel

General Hospital FDA 510(k) Clearances & Devices

Cleared Devices
15,723
Product Codes (page)
27
Latest Decision
1990-03-08

Clearances · page 113 of 158

K-Number Trade Name Applicant / Manufacturer Product Code Class Decision Date
K895704 ATI DISP. BIOLOGICAL TEST PACK FOR ETHYLENE OXIDE Pymah Corp., Ati Div. FRC Class II 1990-03-08
K896673 LATEX PATIENT EXAMINATION GLOVES Alliance Rubber Products Sdn. Bhd. LYY Class I 1990-03-08
K900648 NIL STERILE LATEX EXAMINATION GLOVES United Lion Rubber Industries Sdn. Bhd. LYY Class I 1990-03-08
K900092 MODIFIED SAFE VINYL EXAMINATION GLOVES Universal Gloves Corp. LYZ Class I 1990-03-08
K896672 LATEX PATIENT EXAMINATION GLOVES U.O.P. Rubber Products Sdn Bhd LYY Class I 1990-03-08
K897013 AVI MICRO 210CM INFUSION PUMP 3M Company FRN Class II 1990-03-08
K900368 P2/CHEMO PLUS GLOVES Biosafety Systems, Inc. LYY Class I 1990-03-08
K900650 LATEX EXAMINATION GLOVES Shenzhen Guang JI Emulsion Products Co., Ltd. LYY Class I 1990-03-08
K900152 POLY PATIENT EXAMINATION GLOVES Shanghai Strong Plastic Products Co., Ltd. LYZ Class I 1990-03-08
K900499 LATEX PATIENT EXAMINATION GLOVES Premium Fit LYY Class I 1990-03-08
K896952 THERMOSCAN-INSTANT THERMOMETER MODEL IR-2000 Thermoscan, Inc. FLL Class II 1990-03-07
K896959 RADIO-TEMP THERMOMETER Babymed Intl., Inc. FLL Class II 1990-03-06
K896914 IVAC MODEL 2090 INFRA RED THERMOMETER Y FLL Class II 1990-03-02
K897128 UMI BRAIDED CATHETER CONNECTOR Universal Medical Instrument Corp. LYY Class I 1990-03-01
K895776 AIV SYSTEMS' IV POLES Automated IV Systems, Inc. FOX Class I 1990-02-28
K900282 NEEDLE-SHIELD Macbrud Corp. Medical Div. FMI Class II 1990-02-28
K900427 IV TRIFURCATED EXTENSION SET Marquette Medical, Inc. FPA Class II 1990-02-28
K900426 IV BIFURCATED EXTENSION SET Marquette Medical, Inc. FPA Class II 1990-02-28
K890019 LATEX SURGICAL GLOVES Argos S.A. LYZ Class I 1990-02-27
K896907 3M IV FLOW REGULATOR 3M Company LDR Class II 1990-02-26
K900498 MODIFIED BETATRON IV INSULIN INFUSION SYSTEM Cardiac Pacemakers, Inc. LZG Class II 1990-02-23
K895740 SHOWER CHAIRS;BED/STRETCHER;LINEN & UTILITY CART Lumex, Inc. FPO Class II 1990-02-22
K895638 STEAM STERILIZER (AUTOCLAVE), DENTAL Porter Instrument Co., Inc. FLE Class II 1990-02-22
K900131 BIO FLOTE(R) Bio Clinic Co. FNM Class II 1990-02-16
K895769 EXEL HUBER NEEDLE Exel Intl. FMI Class II 1990-02-16
K895768 EXEL SAFELET CATHETER Exel Intl. FOZ Class II 1990-02-16
K895890 AUTOPEN Ulster Scientific, Inc. FMF Class II 1990-02-16
K895771 EXEL SPINAL NEEDLES Exel Intl. FMI Class II 1990-02-16
K897065 PORT INFUSION SET (PIS) INFUSION SET (IS) Prn Services, Inc. FPA Class II 1990-02-16
K896455 VITACHOICE WOUND DRESSING Vitaphore Corp. KGX Class I 1990-02-15
K897045 BOWIE-DICK TEST CARD CATALOG NUMBER 008018 Edward Weck, Inc. JOJ Class II 1990-02-15
K895902 LATEX PATIENT EXAMINATION GLOVE Rfb Latex Pvt. , Ltd. LYY Class I 1990-02-13
K893093 FLOUROSHIELD RADIATION REDUCTION GLOVE Acufex Microsurgical, Inc. LZC Class I 1990-02-13
K895021 MEDICARE GLOVES Shangrila Latex Industries Pvt. , Ltd. LYY Class I 1990-02-13
K900561 GLOVEX LATEX EXAMINATION GLOVES Medical Latex Corp. LYY Class I 1990-02-13
K896363 NON-STERILE LATEX EXAMINATION GLOVES Contemporary Medical Technology, Inc. LYY Class I 1990-02-13
K892085 PATIENT EXAMINATION GLOVES (LATEX) Howard Associates, Inc. LYY Class I 1990-02-13
K891663 LEEDAR (PATIENT EXAMINATION GLOVES - LATEX) Darchet (Usa), Inc. LYY Class I 1990-02-13
K894450 LATEX PATIENT EXAMINATION GLOVES Kannex Gloves, Div. of Kanoi Plantations Private LYY Class I 1990-02-13
K900454 MODIFIED LOW POWDER SINGLE USE LATEX EXAM GLOVES Phoenix Medical Technology, Inc. LYY Class I 1990-02-13
K897187 PROBE PATIENT EXAMINATION GLOVES Glove India Pvt. , Ltd. LYY Class I 1990-02-13
K900453 MODIFIED SINGLE USE LATEX EXAMINATION GLOVES Phoenix Medical Technology, Inc. LYY Class I 1990-02-13
K896018 BIOTEMP Medadvances, Inc. LGZ Class II 1990-02-09
K891784 BI-O.K.(TM)-BIOLOGICAL/CHEMICAL INDICATOR Propper Mfg. Co., Inc. FRC Class II 1990-02-09
K896891 LEUKOSILK(TM) SURGICAL TAPE Beiersdorf, Inc. KGX Class I 1990-02-09
K896804 MANIFOLD Westmark, Sterile Packing Systems, Inc. (Sps) GCX Class II 1990-02-08
K896697 PLEUR-EVAC(R) A-6020--INFANT SINGLE USE CHEST DRAI Deknatel, Inc. KDQ Class II 1990-02-08
K896556 UNIVERSAL POOLE SUCTION TUBE Westmark, Sterile Packing Systems, Inc. (Sps) GCX Class II 1990-02-06
K896562 STOPCOCK Westmark, Sterile Packing Systems, Inc. (Sps) GCX Class II 1990-02-06
K896558 YANKAUER SUCTION TUBE-RIGID TYPE Westmark, Sterile Packing Systems, Inc. (Sps) GCX Class II 1990-02-06
K896546 HOMEPUMP (DISP. ELASTOMERIC INFUSION DEVICE) Block Medical, Inc. FRN Class II 1990-02-06
K896557 YANKAUER SUCTION TUBE-FLEXIBLE TYPE Westmark, Sterile Packing Systems, Inc. (Sps) GCX Class II 1990-02-06
K896611 OLYMPIC LIGHT-WARM Olympic Medical Corp. KZF Class I 1990-02-06
K896563 TUBING CONNECTORS Westmark, Sterile Packing Systems, Inc. (Sps) GCX Class II 1990-02-06
K891289 FLO-GARD 6300 DUAL CHANNEL VOLUME INFUSION PUMP Baxter Healthcare Corp FRN Class II 1990-02-02
K896203 SOLCOSEPT(TM) BLOOD TRANSFUSION FILTER Solco Basle, Inc. CAK Class II 1990-02-01
K896733 VACCON Unoplast A/S KGX Class I 1990-02-01
K896358 VARI/MOIST WOUND DRESSING Catalina Biomedical Corp. KGX Class I 1990-02-01
K896561 EXTENSION SET Westmark, Sterile Packing Systems, Inc. (Sps) FPA Class II 1990-02-01
K896421 TRANSPARENT FILM I.V. SITE/WOUND DRESSING Catalina Biomedical Corp. KMK Class I 1990-01-31
K894802 AWC BUTTERFLY WOUND CLOSURES American White Cross, Inc. FPX Class I 1990-01-31
K891662 PATIENT EXAMINATION GLOVES (LATEX) Darchet (Usa), Inc. LYY Class I 1990-01-26
K896957 POWDER-FREE VINYL PATIENT EXAMINATION GLOVES Honyee Enterprise Co. LYY Class I 1990-01-26
K892619 LATECHNICS LATEX EXAMINATION GLOVES Ssangyong Corp. (M) Sdn. Bhd. LYY Class I 1990-01-26
K894686 POWDER-FREE VINYL EXAMINATION GLOVES Dynarex Corp. LYY Class I 1990-01-26
K895970 POWDER-FREE LATEX EXAMINATION GLOVES Usamal Latex Products Sdn Bhd LYY Class I 1990-01-26
K895858 CLP ELEVATED LIPID CONTROL Creative Laboratory Products, Inc. LYY Class I 1990-01-26
K897048 CLEAN HAND-VCL GLOVE DISPENSER Safety Today, Inc. LYY Class I 1990-01-25
K896872 LATEX NON-POWDERED EXAMINATION GLOVES Thaisan Industries Co., Ltd. LYY Class I 1990-01-25
K896976 MODIFIED SEPACELL R-500 AND R-500A BLOOD FILTERS Asahi Medical Co., Ltd. CAK Class II 1990-01-24
K896906 LATEXINDO LATEX EXAMINATION GLOVES P.T. Latexindo Sejahtera LYY Class I 1990-01-24
K896086 PROGUARD II(TM) Safety-Ject, Inc. FMF Class II 1990-01-24
K892300 PATIENT EXAMINATION GLOVES (LATEX) Ryoden Intl., Ltd. LYY Class I 1990-01-24
K896127 THORA-KLEX CHEST DRAINAGE UNIT Davol, Inc. KDQ Class II 1990-01-24
K896664 MODIFIED SEPACELL PL-SERIES LEUKOCYTE REMOVAL FILT Asahi Medical Co., Ltd. CAK Class II 1990-01-24
K896722 PISTON SYRINGE Safe Tech Medical Products, Inc. FMF Class II 1990-01-24
K893027 PATIENT EXAM GLOVES (MFG JET FAR INDU. INC.) Wen Hao, Inc. LYY Class I 1990-01-24
K891490 SEAMLESS LATEX PATIENT EXAMINATION GLOVES Med-Care Sdn. Bhd. LYY Class I 1990-01-23
K892307 PATIENT EXAMINATION GLOVES (LATEX) Guangming Latex Factory LYY Class I 1990-01-23
K897139 LATEX PATIENT EXAMINATION GLOVES Kanam Latex Industries Pvt. , Ltd. LYY Class I 1990-01-23
K900212 SURETEX LATEX EXAMINATION GLOVES Gulf Medical Technologies, Inc. LYY Class I 1990-01-23
K893025 EXAM GLOVES (MFG. GUEY HER ENT. CO. LTD) Wen Hao, Inc. LYY Class I 1990-01-23
K891624 J.M. PATIENT EXAMINATION GLOVES Jann Maw (U.S.A.), Inc. LYY Class I 1990-01-22
K893074 PATIENT EXAMINATION GLOVES Taba Gloves Pvt. , Ltd. LYY Class I 1990-01-22
K894695 VACUSAFE DISP. VACUUM - EXTRACTION SYSTEM Medistad Corp. GCX Class II 1990-01-22
K895617 PATIENT EXAMINATION GLOVES Lit Seng Development Sdn. Bhd. LYY Class I 1990-01-22
K896721 MODEL 7-AT TREATMENT CHAMBER J. H. Emerson Co. LGM Class II 1990-01-22
K897066 PATIENT EXAMINATION GLOVES Golden Gloves Intl. LYY Class I 1990-01-22
K896293 VIRAFREE CORP. EJECTABLE NEEDLE HOLDER Virafree Corp. FMI Class II 1990-01-18
K896346 GRIPPER PORT-A-CATH NEEDLE WITH STOPCOCK Pharmacia Deltec, Inc. FPA Class II 1990-01-18
K897047 LATEX PATIENT EXAMINATION GLOVES P.T. Gotong Rojong Djaja LYY Class I 1990-01-17
K897095 DISPOSINEEDLE SHARPS DISPOSAL UNIT Specialites Septodont MMK Class II 1990-01-17
K897038 LATEX PATIENT EXAMINATION GLOVES Multi Trading Corp. of America, Inc. LYY Class I 1990-01-17
K893273 LATEX EXAMINATION GLOVES Tien Yee Screen Works Co., Ltd. LYY Class I 1990-01-17
K893190 LATEX EXAMINATION GLOVES Chia Huang Cotton Mfg. Co. LYY Class I 1990-01-17
K896094 LATEX EXAMINATION GLOVES Matang Mfg. Sdn. Bhd. LYY Class I 1990-01-17
K895576 PATIENT EXAMINATION GLOVE Yong XU Co, Ltd. LYY Class I 1990-01-17
K892947 VINYL EXAMINATION GLOVES Chung Kuo Industrial Co., Ltd. LYY Class I 1990-01-17
K895490 YUETONG LATEX EXAMINATION GLOVES The New York Whitney Group LYY Class I 1990-01-17
K896016 LATEX EXAMINATION GLOVES Sudinar Sdn Bhd LYY Class I 1990-01-17

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