meddevicedb.com FDA Device Reference

Review Panel

General Hospital FDA 510(k) Clearances & Devices

Cleared Devices
15,723
Product Codes (page)
32
Latest Decision
1998-08-03

Clearances · page 76 of 158

K-Number Trade Name Applicant / Manufacturer Product Code Class Decision Date
K982015 VINYL PATIENT EXAMINATION POWDER FREE GLOVES, NON-STERILE Taian Plastics Products (Jingxing) Co., Ltd. LYZ Class I 1998-08-03
K982368 MANIFOLD WITH EXTENSION SET Interpore Cross Intl. FMG Class II 1998-07-31
K981673 POWDERFREE GREEN NITRILE EXAMINATION GLOVES Besglove Medicare Sdn. Bhd. LZA Class I 1998-07-28
K981674 POWDERED GREEN NITRILE EXAMINATION GLOVES Besglove Medicare Sdn. Bhd. LZA Class I 1998-07-28
K981683 HUBER NEEDLE INFUSION SET MODEL #20G01 & Y-SITE MODEL #20G01Y Venusa , Ltd. FPA Class II 1998-07-28
K981675 POWDERFREE GREEN NITRILE EXAMINATION GLOVES (POLYMER COATED) Besglove Medicare Sdn. Bhd. LZA Class I 1998-07-28
K982048 MPS RESERVOIR BAG Medical Product Specialists KPE Class II 1998-07-27
K981774 MEDI-PLUS, HEALTH-PLUS, SANITEX, RELIANCE Pwa Industries Sdn. Bhd. LYY Class I 1998-07-24
K981963 SENSITEX EXAMINATION GLOVE Oak Carolina, Inc. LYZ Class I 1998-07-24
K981708 DENTAL PORCELAIN-VARIOUS Excel Porcelain Products FLL Class II 1998-07-23
K980966 SUPERGLOVES POWDERED NITRILE Supermax Sdn Bhd LZA Class I 1998-07-22
K982123 CONTRAST CONTROL DEVICE Medex, Inc. FPA Class II 1998-07-21
K982047 MPS HUBER NEEDLE EXTENSION SET Medical Product Specialists FPA Class II 1998-07-21
K981619 VACUETTE MULTIPLE SAMPLE LUER ADAPTER Greiner Meditech, Inc. FMI Class II 1998-07-15
K972538 FLOW-EZE BLUNT CANNULA (1999BC) Acacia, Inc. FMI Class II 1998-07-15
K972728 STERILE WATER FOR INJECTION PREFILLED SYRING (SWFIPS) Bd Becton Dickinson Vacutainer Systems Preanalytic FMF Class II 1998-07-15
K981266 AUTO-INJECTOR, SURE-INJECT 2000 Mighty Mo, Corp. KZH Class II 1998-07-14
K974415 KIMBERLY-CLARK GAS PLASMA STERILIZATION INDICATOR STRIP Kimberly-Clark Corp. JOJ Class II 1998-07-10
K981509 TEMPO III Medical Products, Inc. LGZ Class II 1998-07-10
K971971 BROWNE TST SINGLE USE BOWIE-DICK TYPE TEST PACK Board of Directors, Albert Browne , Ltd. JOJ Class II 1998-07-10
K981488 GLOVE, OAKTEX EXAMINATION, GLOVE, PATIENT EXAMINATION Oak Carolina, Inc. LYZ Class I 1998-07-07
K981456 BABY PACIFIER DIGITAL THERMOMETER K-Jump Health Co., Ltd. FLL Class II 1998-07-02
K981386 MANAN BLUNT NEEDLE Manan Medical Products, Inc. FPA Class II 1998-06-29
K980779 THALAFIX NATURAL SEA SALT DRESSING Dumex Medical Surgical Products, Ltd. KMF Class I 1998-06-26
K982097 WORLDWIDE MEDICAL TECHNOLOGIES INTRACERVICAL BLOCK NEEDLE, MODEL TBD Worldwide Medical Technologies, LLC FMI Class II 1998-06-25
K980580 BECTON DICKINSON SYRINGES Bd Becton Dickinson Vacutainer Systems Preanalytic FMF Class II 1998-06-25
K981140 MINRAD DRTS LIGHT SABER SYRINGE Minrad, Inc. FMF Class II 1998-06-25
K981333 NITRILON CORRECT-TOUCH Biopro (M) Sdn Bhd LZA Class I 1998-06-22
K981304 NITRILON CORRECT-TOUCH Ct Intl. LZA Class I 1998-06-22
K981893 HEALTH + AID PREMIUM PRE-POWDERED LATEX EXAMINATION GLOVES M.R.G. Industries Sdn. Bhd. LYY Class I 1998-06-22
K981184 SHARPTRACK REUSABLE SHARPS CONTAINER Bfi- Medical Waste Systems FMI Class II 1998-06-22
K981547 NFC NEEDLEFREE Y-SITE, MODEL 69970 Filtertek, Inc. FPA Class II 1998-06-18
K981548 NFC NEEDLEFREE CONNECTOR MODEL 69900 Filtertek, Inc. FPA Class II 1998-06-18
K981157 STABLE FLOW Cmed FPA Class II 1998-06-16
K980738 PSI-TEC SYRINGE INFUSION PUMP AND ACCESSORIES FOR GENERAL FLUID IRRIGAION/INFILTRATION Byron Medical FRN Class II 1998-06-16
K981797 B-D PEN ULTRA Bd Becton Dickinson Vacutainer Systems Preanalytic FMF Class II 1998-06-12
K981767 QTEXX POWDERFREE LATEX EXAMINATION GLOVES Latexx Partners Bhd. LYY Class I 1998-06-11
K980987 BECTON DICKINSON SYRINGE Bd Becton Dickinson Vacutainer Systems Preanalytic FMF Class II 1998-06-11
K980899 JIN ACUPUNCTURE NEEDLES, MODELS ST, GL, SI, PT, AND ID Kenshin Trading Corp. MQX Class II 1998-06-11
K980785 STERILE, POWDERFREE LATEX EXAMINATION GLOVE London Intl., LLC LYY Class I 1998-06-10
K981147 CLEAR (TM) LICE EGG REMOVER SYSTEM Care Technologies, Inc. LJL Class I 1998-06-09
K980494 SUPERGLOVES Supermax Sdn Bhd LYY Class I 1998-06-09
K962959 PERACIDIN DIALYZER REPROCESSING CONCENTRATE Hdc Medical, Inc. MED Class II 1998-06-05
K981133 POWDERED NITRILE EXAMINATION GLOVES Servicom Services Sdn Bhd LZA Class I 1998-06-05
K973888 SMARTLOCK SAFETY SYRINGE Medical Innovation , Ltd. MEG Class II 1998-06-03
K974363 BECTON DICKINSON BLUNT PLASTIC CANNULA Bd Becton Dickinson Vacutainer Systems Preanalytic FMI Class II 1998-06-03
K981159 PROFLEX POWDER FREE NITRILE EXAMINATION GLOVES Latexx Partners Bhd. LZA Class I 1998-06-01
K981062 POLYMER COATED, POWDER-FREE LATEX EXAMINATION GLOVES Ideal Quality Sdn., Bhd. LYY Class I 1998-06-01
K964332 EAGLE CENTURY STEAM STERILIZER Amsco Intl., Inc. FLE Class II 1998-06-01
K974678 B-D AUTO-INJECTOR Bd Becton Dickinson Vacutainer Systems Preanalytic KZH Class II 1998-05-29
K980886 BABYTHERM 8000 LDR Draeger Medical, Inc. FMZ Class II 1998-05-29
K980994 IV ADMINISTRATION SETS WITH NEEDLE ACCESS DEVICES Venetec Intl., Inc. FPA Class II 1998-05-29
K981296 GEEN MEDISOX Geen Healthcare, Inc. DWL Class II 1998-05-29
K980558 PAINBUSTER INFUSION SYSTEM I-Flow Corp. MEB Class II 1998-05-28
K980992 IV ADMINISTRATION SETS WITH NEEDLELESS ACCESS DEVICES Venetec Intl., Inc. FPA Class II 1998-05-28
K981250 LICEMEISTER COMB National Pediculosis Assoc. LJL Class I 1998-05-28
K980989 3M TEGAGEN HI ALGINATE DRESSING & 3M TEGAGEN HG ALGINATE DRESSING Innovative Technologies , Ltd. KMF Class I 1998-05-27
K981037 CLEAR (TM) SPECIAL NIT COMB Care Technologies, Inc. LJL Class I 1998-05-22
K974571 SOLUTION ADMINISTRATION SET WITH CAPPED LUER ACTIVATED VALVE Baxter Healthcare Corp FPA Class II 1998-05-21
K980673 SPYROSORB FOAM ISLAND WOUND DRESSING Innovative Technologies (Us), Inc. KMF Class I 1998-05-21
K973615 SKINGARD TPF/AOSSTEX TPF/SENSIFREE/ESSENTIAL TPF/AMERIGLO TPF LATEX EXAMINATION GLOVES Macro Rubber Industrial, Inc. LYY Class I 1998-05-20
K974830 ULTRA BILI LIGHT Physician Engineered Products, Inc. LBI Class II 1998-05-20
K974015 ARGYLE QUICK- PICC PERIPHERALLY INSERTED CENTRAL CATHETER- PICC TRAYS, ARGYLE QUICK- PICC PERIPHERALLY INSERTED CENTRAL Davis & Geck, Inc. FOZ Class II 1998-05-18
K970726 VAPOCIDE Cottrell, Ltd. MED Class II 1998-05-18
K981348 SMARTTEX PREPOWDERED LATEX EXAMINATION GLOVES Smart Glove Corp. Sdn Bhd LYY Class I 1998-05-18
K980754 CIR LATEX EXAMINATION GLOVES, NON-STERILE, POWDERED, WITH PROTEIN LABELING CLAIM OF <=200 UG/G Crocker Industrial Resources Sdn. Bhd. LYY Class I 1998-05-18
K981349 SMART-FEEL POWDER FREE NITRILE EXAMINATION GLOVES Smart Glove Corp. Sdn Bhd LZA Class I 1998-05-18
K981347 SMARTTEX POWDER FREE LATEX EXAMINATION GLOVES, WITH PROTEIN LABELING CLAIM Smart Glove Corp. Sdn Bhd LYY Class I 1998-05-18
K971077 COVERTIP SAFETY SYRINGE Medisys Technologies, Inc. MEG Class II 1998-05-15
K980014 THE SYSTEM 2S STEAM STERILIZER STERIS Corporation FLE Class II 1998-05-15
K981179 LOVYTEX POWDER-FREE NITRILE EXAMINATION GLOVES Lovytex Sdn Bhd LZA Class I 1998-05-15
K980065 C/T MED-SYSTEMS CASSETTE SYSTEM C/T Med System, Ltd. KCT Class II 1998-05-11
K973561 MEDCOMP TRI-FLOW SOFT TIP TRIPLE LUMEN CATHETER 11.5F X 12CM, MEDCOMP TRI-FLOW SOFT TIP TRIPLE LUMEN CATHETER 11.5F X 1M Medical Components, Inc. FOZ Class II 1998-05-11
K980863 DUMEX PAK-ITS NON-WOVEN DRESSING IMPREGNATED SITH SODIUM CHLORIDE (HYPERTONIC) Dumex Medical Surgical Products, Ltd. KMF Class I 1998-05-11
K973747 CONTROLLED TEMPERATURE CABINET SYSTEM Smith LDQ 1998-05-07
K974533 TRIMPORT Gerard Medical, Inc. LJT Class II 1998-05-07
K971831 QUICK CHECK INSTANT THERMOMETER Ejb Medical, Inc. FLL Class II 1998-05-07
K963658 EXEL AVF SINGLE NEEDLE Exel Intl. FMI Class II 1998-05-05
K980827 LATEX FINGER COT, POWDER-FREE, WITH PROTEIN LABELING Tucker & Associates LZB Class I 1998-05-04
K981382 PASV DUAL LUMEN PERIPHERALLY INSERTED MIDLINE CATHETER MODEL NUMBER MIDLINE-NUMEROUS Catheter Innovations, Inc. FOZ Class II 1998-05-01
K963364 GLASS VAN GLASS SYRINGES Myco Medical Supplies, Inc. FMF Class II 1998-05-01
K971994 B-D ASSURE EAR THERMOMETER Becton Dickinson Consumer Products FLL Class II 1998-05-01
K981368 PASV DUAL LUMEN PERIPHERALLY INSERTED CENTRAL CATHETER (PICC) MODEL NUMBER PIC-NUMEROUS Catheter Innovations, Inc. FOZ Class II 1998-05-01
K980640 HEELBO WAIST AND CHEST VEST Heelbo, Inc. FMQ Class I 1998-05-01
K981023 KLEENASEPTIC Metrex Research Corp. LRJ Class I 1998-04-30
K972705 RESHEATHER DEVICE-METAL OR PLASTIC, RESHEATER/ NEEDLE HOLDER DEVICE-PLASTIC Sage Products, Inc. FMI Class II 1998-04-30
K980493 I.V. CATHETER SYSTEM Johnson & Johnson Medical, Inc. FOZ Class II 1998-04-28
K980848 HYPOALLERGENIC LATEX PATIENT EXAM GLOVES-PREPOWDERED P.T. Irama Dinamika Latex LYY Class I 1998-04-28
K980583 EXTENSION SET WITH 0.2U FILTER AND ANTI-SIPHON VALVE CADD ADMINISTRATION SET WITH 0.2U FILTER AND ANTI-SIPHON VALVE Sims Deltec, Inc. FPA Class II 1998-04-27
K965212 STERITEC DISPOSABLE INTEGRATOR LOAD CHALLENGE-STEAM Steritec Products Mfg Co, Inc. JOJ Class II 1998-04-23
K974424 COMFORT RUBBER GLOVES INDUSTRIES SDN BHD Comfort Rubber Gloves Industries Sdn. Bhd. LYY Class I 1998-04-23
K981164 POWDER FREE CHLORINATED GLOVES-(TEXTURED) Pan-Century Rubber Products Sdn. Bhd. LYY Class I 1998-04-23
K980227 MANAN GALACTOGRAPHY KIT Medical Device Technologies, Inc. FMI Class II 1998-04-23
K981318 DUAL LUER LOCK CAP Baxter Healthcare Corp FPA Class II 1998-04-22
K974371 CLK INT'L POWDER FREE LATEX EXAMINATION GLOVE Clk Intl., Inc. LYY Class I 1998-04-21
K981039 POWDERFREE GREEN NITRILE EXAMINATION GLOVES (POLYMER COATED) Sri Johani Sdn. Bhd. LZA Class I 1998-04-21
K980165 INFUTEST 2000 INFUSION DEVICE ANALYZER Datrend Systems, Inc. MRZ Class II 1998-04-20
K980587 IV DECANTER-FLEXIBLE Inrad LHI Class II 1998-04-17
K961486 IVAC MEDSYSTEM III, INFUSION PUMP W/DRUG EDITING SOFTWARE KIT Ivac Medical Systems MRZ Class II 1998-04-17
K980720 NONWOVEN PAD Convatec, A Division of E.R. Squibb & Sons KMF Class I 1998-04-15

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