meddevicedb.com FDA Device Reference

Review Panel

General Hospital FDA 510(k) Clearances & Devices

Cleared Devices
15,723
Product Codes (page)
35
Latest Decision
1994-05-26

Clearances · page 96 of 158

K-Number Trade Name Applicant / Manufacturer Product Code Class Decision Date
K940022 LATEX PATIENT EXAMINATION GLOVE Siam Sempermed Corp., Ltd. LYY Class I 1994-05-26
K931342 LPH Calgon Vestal Div. LRJ Class I 1994-05-26
K941657 BD MICRO FINE, ULTRA FINE, AND ALLERGY SYRINGE Bd Becton Dickinson Vacutainer Systems Preanalytic FMF Class II 1994-05-26
K941562 1ML LUER-LOK SYRINGE Bd Becton Dickinson Vacutainer Systems Preanalytic FMF Class II 1994-05-26
K940576 PATIENT EXAMINATION GLOVES Vijay Latex Products Private , Ltd. LYY Class I 1994-05-26
K931816 VESTA-SYDE(R) INTERIM INSTR DECONTAMINATION SYSTEM Calgon Vestal Div. LRJ Class I 1994-05-26
K941545 ADVANTAGE SYRINGE Bd Becton Dickinson Vacutainer Systems Preanalytic FMF Class II 1994-05-23
K941665 SHARPS DISPOSAL CONTAINER/PHLEBOTOMY Bemis Mfg. Co. MMK Class II 1994-05-23
K931664 SHARPS DISPOSABLE CONTAINERS Bemis Mfg. Co. MMK Class II 1994-05-23
K934179 DISPOSABLE BAG DECANTER Byron Medical KPE Class II 1994-05-23
K941664 SHARP DISPOSAL CONTAINERS WALL SAFE Bemis Mfg. Co. MMK Class II 1994-05-23
K941542 ORION CENTRAL LINE DRESSING CHANGE TRAY Regulatory & Marketing Services, Inc. FRG Class II 1994-05-23
K942000 BURN DRESSING TRAY Medcare Custom Packaging, Inc. FRG Class II 1994-05-20
K941216 HYDRODERM EXTRA THIN INTELLIGENT HYDROCOLLIOID DRESSING Wilshire Medical Products KMF Class I 1994-05-20
K941163 MON-KLENZ Calgon Vestal Div. FLG Class I 1994-05-18
K940263 NPH-KLENZ Calgon Corp. FLG Class I 1994-05-18
K932405 NITRILE RUBBER EXAMINATION GLOVES (POWERED) Safeskin Corp. FMC Class I 1994-05-18
K932404 NITRILE RUBBER POWDER-FREE EXAMINATION GLOVE Safeskin Corp. FMC Class I 1994-05-18
K935866 COMFIT POWERED EXAMINATION GLOVES(BEADED, HYPOALLERG) Wembley Rubber Products (M) Sdn Bhd LYY Class I 1994-05-18
K933652 FREEDOM 60 SYRINGE INFUSION PUMP SYSTEM WITH SYRINGE SET & TUBING Repro-Med Systems, Inc. FRN Class II 1994-05-18
K925055 POLLENEX HEPA AIR CLEANERS Pollenex Corp. FRF Class II 1994-05-18
K942061 DISPOSABLE SUCTION PROBE United States Surgical, A Division of Tyco Healthc JOL Class II 1994-05-16
K933674 ONGARD 2 GALLON CHEMO SHARPS CONTAINER Ongard Systems, Inc. FMI Class II 1994-05-16
K931573 VESPHENE II Calgon Vestal Div. LRJ Class I 1994-05-16
K933274 ONGARD 3 QUART SHARPS CONTAINER Ongard Systems, Inc. FMI Class II 1994-05-16
K932277 LONZA FORMULATION R-82 Calgon Vestal Div. LRJ Class I 1994-05-12
K941468 DEBRIDEMENT TRAY, INCISION AND DRAINAGE TRAY Clinical Resources, Inc. FRG Class II 1994-05-12
K941471 CENTRAL LINE DRESSING CHANGE TRAY Clinical Resources, Inc. FRG Class II 1994-05-12
K932803 CLESTRACLEAN(R) ROOM AIR PURIFIER Clestra Cleanroom Technology, Inc. FRA Class II 1994-05-12
K941469 IV START KIT Clinical Resources, Inc. LRS Class II 1994-05-12
K932502 LONZA FORMULATION R-82 Lonza, Inc. LRJ Class I 1994-05-12
K941467 WOUND DRESSING KIT Clinical Resources, Inc. FRG Class II 1994-05-12
K930048 SAFE-PICC CATHETER Menlo Care, Inc. FOZ Class II 1994-05-12
K941232 THORA-CATH Gesco Intl., Inc. JOL Class II 1994-05-11
K941263 COMFEEL PLUS WOUND DRESSING Richard Hamer Assoc., Inc. KMF Class I 1994-05-10
K941754 POWDER FREE LATEX EXMINATION GLOVES Sj Medical Products (M) Sdn Bhd LYY Class I 1994-05-09
K925731 ISOFLUX IXP FLOW REGULATOR Ferguson Medical FPA Class II 1994-05-09
K935864 POWDERED EXAMINATION GLOVES (HYPOALLERGENIC) Wembley Rubber Products (M) Sdn Bhd LYY Class I 1994-05-09
K925086 AUTOMATIC NEEDLE DISCONECT (A.N.D.) Post Medical, Inc. FMI Class II 1994-05-09
K925732 ISOFLUX IXZ FLOW REGULATOR Ferguson Medical FPA Class II 1994-05-09
K935063 INSTRU KLENZ Calgon Corp. FLG Class I 1994-05-09
K925733 ISOFLUX IXL FLOW REGULATOR Ferguson Medical FPA Class II 1994-05-09
K926185 PRIMUS PSS SERIES STERILIZERS Primus Sterilizer Co., Inc. FLE Class II 1994-05-09
K940738 KTI HY-Q(TM) WOUND DRESSING Kingston Technologies, Inc. KMF Class I 1994-05-06
K940867 CONTROL-A-FLO(TM) REGULATOR Baxter Healthcare Corp FPA Class II 1994-05-05
K931073 CATH-FINDER Pharmacia Deltec, Inc. FOZ Class II 1994-05-05
K940394 AMG MED BRAND CLINICAL GLASS THERMOMETER Technolab Industries (Canada) , Ltd. FLK Class II 1994-05-04
K940404 ALGINATE FIBER TOPICAL WOUND DRESSING Adri KMF Class I 1994-05-04
K940380 AMG MED BRAND CLINICAL GLASS THERMOMETER Amg Medical, Inc. FLK Class II 1994-05-04
K940624 3M TEGASORB HYDROCOLLOID DRESSING 3M Company KMF Class I 1994-05-04
K932464 PERIPHERALLYINSRTED VENOUS CATH. ALTERNATE CATH. Pharmacia Deltec, Inc. LJS Class II 1994-05-02
K932198 PHARMACIA DELTEC PERIPHERALLY INSERTED VENOUS CATH Pharmacia Deltec, Inc. LJS Class II 1994-05-02
K932430 DUAL LUMEN PERIPHERALLY INSERTED VENOUS CATHETER Pharmacia Deltec, Inc. LJS Class II 1994-05-02
K932211 PROCEDURAL TRAY FOR PERIPHERALLY INSERTED VENOUS Pharmacia Deltec, Inc. LJS Class II 1994-05-02
K934482 VITAL SIGNS DUAL DISPLAY TEMPERATURE MONITOR, MODEL 1600 Vital Signs, Inc. FLL Class II 1994-05-02
K935980 CIR LATEX GLOVES (CIR GOLD SEAL) Crocker Industrial Resources Sdn. Bhd. LYY Class I 1994-05-02
K926448 I.V. ADMINISTRATION SET Gainor Medical Europe, Ltd. FPA Class II 1994-05-02
K932433 PHERIPHERALLY INSERTED VENOUS CATHETER-Y SITE Pharmacia Deltec, Inc. LJS Class II 1994-05-02
K932283 PATIENT EXAMINATION GLOVES Eac Rubber Industries (M) Sdn. Bhd. LYY Class I 1994-05-02
K940871 UMBILI-CATH-P Gesco Intl., Inc. FOS Class II 1994-04-29
K925816 SHARPS CONTAINMENT SYSTEM Post Medical, Inc. FMI Class II 1994-04-29
K933171 INMAN IRRIGATION TAPERED PROBE Inman Medical Corp. KYZ Class I 1994-04-29
K941357 VINYL EXAMINATION GLOVE, POWDER FREE Canopus Medical Supply Co., Ltd. LYZ Class I 1994-04-29
K941056 LATEX EXAMINATION GLOVES, POWDER FREE Pt. Eka Wira Asia LYY Class I 1994-04-29
K934344 HOME AMB-ALERT Medway KMI Class I 1994-04-29
K940414 IODOFLEX PASTE Oclassen Pharmaceuticals, Inc. KMF Class I 1994-04-28
K930495 PANOJECT MINIFUSOR MODEL 200 AMBU. INFUSION PUMP Elan Medical Technologies, Ltd. FRN Class II 1994-04-26
K936088 WAVE FLUORESCENT MAGNIFIER Burton Medical Products Corp. KZF Class I 1994-04-26
K933869 EXTENSION SET WITH 0.22 MICRON 96 HOUR FILTER Baxter Healthcare Corp FPB Class II 1994-04-26
K930494 PANOJECT MINIFUSOR MODEL 100 AMBULATORY INFUSION Elan Medical Technologies, Ltd. FRN Class II 1994-04-26
K941466 SURGICAL INSTRUMENTS KIT Clinical Resources, Inc. FRG Class II 1994-04-22
K940873 SAFETEX HYPOALLERGENIC POWDERFREE LATEX EXAMINATION GLOVE Aladan Corp. LYY Class I 1994-04-22
K925822 CUSTOM SYRIGENE KITS Syrigene Medical Technologies, Inc. FMF Class II 1994-04-22
K940074 Y-TYPE BLOOD ADMINISTRATION SET Puritas Health Care, Inc. BRZ Class II 1994-04-21
K926385 BARD APII PUMP C.R. Bard, Inc. FRN Class II 1994-04-18
K940055 MULTISET Puritas Health Care, Inc. BRZ Class II 1994-04-15
K934666 PDS ULTRACLEAN Medical Polymers, Inc. FLG Class I 1994-04-15
K931173 PRIMARY ADMIN SET W/UNIV SP-MAN BELOW/ABV PUMP CH Imed Corp. FPA Class II 1994-04-15
K940054 MEASURED VOLUME SOLUTION ADMINISTRATION SET Puritas Health Care, Inc. FPA Class II 1994-04-15
K924596 SES-2012 AUTOMATIC STEAM STERILIZER Porter Instrument Co., Inc. FLE Class II 1994-04-15
K940147 AUTO SYRINGE AS40A INFUSION PUMP Baxter Corp. FRN Class II 1994-04-15
K940405 TELETOM Berchtold Holding GmbH KMI Class I 1994-04-14
K932165 INTRAVASCULAR ADMINISTRATION SET Mcgaw, Inc. FPA Class II 1994-04-13
K934914 ICS 9400 ULTRAVIOLET AIR PURIFIER Medair, Inc. FRA Class II 1994-04-13
K931270 SURGICLEAN ENZYMATIC INSTRUMENT CLEANER Surgicot, Inc. FLG Class I 1994-04-13
K933560 BARRIER PLASTIC PACKAGING (MODIFICATION) Maxxim Medical KCT Class II 1994-04-11
K925792 EXAC-TEMP & CLINI-TEMP TYMPANIC & MYOCARDIAL PROBE Deroyal Industries, Inc. FLL Class II 1994-04-08
K936193 COMB-18 WOUND DRESSING Vsc Health Care Products KMF Class I 1994-04-07
K940407 KALTOGEL WOUND DRESSING Calgon Corp. KMF Class I 1994-04-07
K930473 ONECATH L-CATH CATHETER SYSTEM Luther Medical Products, Inc. LJS Class II 1994-04-07
K933742 TOP GUN Bio-Medical Devices, Inc. FQH Class II 1994-04-07
K940371 SURGICAL SEALANT APPLICATOR TIP ENDOSCOPIC TIP Micromedics, Inc. KYZ Class I 1994-04-06
K920406 DECOMAT 228 Getinge International, Inc. MDZ Class II 1994-04-05
K920413 DECOMAT A 8666 Getinge International, Inc. MDZ Class II 1994-04-05
K935088 POWDER FREE GLOVES Avt Rubber Products , Ltd. LYY Class I 1994-04-05
K935532 TRANSFER SET Puritas Health Care, Inc. LHI Class II 1994-04-04
K940056 WINGED INFUSION SET A-PORT VASCULAR ACCESS SYSTEM Puritas Health Care, Inc. FPA Class II 1994-04-04
K925154 JOBST-CUSTOM Jobst Institute, Inc. DWL Class II 1994-04-04
K940070 STOPCOCK INTRAVENOUS THERAPY Puritas Health Care, Inc. FMG Class II 1994-04-04
K930682 EZTEST-STEAM Sgm Biotech, Inc. FRC Class II 1994-04-04

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