meddevicedb.com FDA Device Reference

Review Panel

General Hospital FDA 510(k) Clearances & Devices

Cleared Devices
15,723
Product Codes (page)
33
Latest Decision
2013-01-23

Clearances · page 33 of 158

K-Number Trade Name Applicant / Manufacturer Product Code Class Decision Date
K112728 HEPAIRX VENTILATING AIR PURIFIER Air Innovations, Inc. FRF Class II 2013-01-23
K121269 TBA Migada Plant FPA Class II 2013-01-22
K123967 CATHETER CONNECTIONS' DARK BLUE DUALCAP FOR MALE LUERS Catheter Connections, Inc. QBP Class II 2013-01-22
K123328 POWDER FREE NITRILE EXAMINATION GLOVES, BLUE AND BLACK Nitrilist Gloves Manufacturing Sdn Bhd LZA Class I 2013-01-18
K121592 POWDER FREE BLUE NITRILE EXAMINATION GLOVE TESTED WITH CHEMOTHERAPY DRUGS Tekmedic (M) Sdn Bhd LZA Class I 2013-01-18
K123300 BD PEN NEEDLE Becton, Dickinson & CO FMI Class II 2013-01-18
K122408 POWDER FREE NITRILE EXAMINATION GLOVES (BLACK, WHITE, GREEN) Hongye Plastic Products Co., Ltd. LZA Class I 2013-01-17
K122788 TEXTURED, NATURAL TO OFF-WHITE, LATEX, STERILE, POWDER FREE EXAMINATION GLOVES, WITH PROTEIN LABELING CLAIM (50 UG/DM2 O Northstar Healthcare Holdings LYY Class I 2013-01-17
K123734 BD NEXIVA DIFFUSICS CLOSED IV CATHETER SYSTEM Becton Dickinson Infusion Therapy Systems, Inc. FOZ Class II 2013-01-17
K121929 ZEPHYR 'X-SERIES PATIENT TRANSFER SLED Diacor, Inc. FRZ Class II 2013-01-17
K123874 INTERLINK SYSTEM BURETROL SOLUTION SETS, INTERLINK SYSTEM BURETROL SOLUTION SETS, CONTINUED, CLEARLINK SYSTEM BURETROL S Baxter Healthcare Corp FPA Class II 2013-01-10
K123213 BD PHASEAL CLOSED SYSTEM TRANSFER DEVICE Becton, Dickinson & CO ONB Class II 2013-01-09
K123868 INTERLINK SYSTEM LEVER LOCK CANNULA WITH CHECK VALVE, SECONDARY MEDICATION SETS, SOLUTION SETS, CONTINU-FLO SOLUTION SET Baxter Healthcare Corp FPA Class II 2013-01-08
K122818 OLYMPUS MAJ-172 INSTRUMENT TRAY FOR LTF VIDEOSCOPE Olympus Keymed (Medical & Industrial Equipment) LT KCT Class II 2013-01-04
K123759 CG+ ARROW PICC POWERED BY ARROW VPS STYLET Arrow International, Inc. (Subsidiary of Teleflex LJS Class II 2013-01-03
K122483 PEARL DIABETES MANAGEMENT SYSTEM Asante Solutions, Inc. LZG Class II 2013-01-03
K121007 NEO DELTA SELF SAFE T, NEO DELTA SELF SAFE T, NEO DELTA SELF SAFE 1, NEO DELTA SELF SAFE 1 Delta Med Srl FOZ Class II 2012-12-28
K121549 NON-STERILE, POWDER-FREE NITRILE EXAMINATION GLOVE, BLUE Siam Sempermed Corp., Ltd. LZA Class I 2012-12-27
K123017 STERRAD CYCLESURE 24 BIOLOGICAL INDICATOR MODEL 14324 Advanced Sterilization Products FRC Class II 2012-12-26
K123729 VERSARATE FLOW RATE CONTROLER Emed Technologies Corporation FPA Class II 2012-12-21
K123085 FUTURO (TM) TRAVEL KNEE-HIGHS; FUTURO (TM) TRAVEL SOCKS; FUTURO (TM) TRAVEL STOCKINGS; FUTURO (TM) TRAVEL PANTYHOSE 3M Company DWL Class II 2012-12-20
K123184 FINN CHAMBERS AQUA Smartpractice KXF Class I 2012-12-19
K121803 INTRAVASCULAR ADMINISTRATION SET Acta Medical, LLC FPA Class II 2012-12-19
K123398 DR. SCHOLL'S COMPRESSION SOCKS Renfro Corporation DWL Class II 2012-12-18
K123561 ELVAREX/ELVAREX SOFT/ELVAREX SOFT SEAMLESS Bsn Medical, Inc. DWL Class II 2012-12-18
K123065 CATHETER CONNECTIONS DUALCAP SOLO Catheter Connections, Inc. QBP Class II 2012-12-14
K122423 VASU-PICC Medical Components, Inc. LJS Class II 2012-12-12
K122555 STERITEC LEAD FREE STERILIZATION PROCESS INDICATOR TAPE Steritec Products Mfg Co, Inc. JOJ Class II 2012-12-12
K122828 POWDER-FREE VINYL PATIENT EXAMINATION GLOVES, CLEAR(NON-COLORED) Shandong Hongxin Chemicals Co., Ltd. LYZ Class I 2012-12-10
K122835 POWDER-FREE VINYL PATIENT EXAMINATION GLOVES, CLEAR(NON-COLORED) Yuanhang Plastic Co., Ltd. LYZ Class I 2012-12-10
K122874 POWDERED NITRILE EXAMINATION GLOVES, BLUE AND WHITE Nitrilist Gloves Manufacturing Sdn Bhd LZA Class I 2012-12-10
K122953 OMNIPOD INSULIN MANAGMENT SYSTEM Insulet Corporation LZG Class II 2012-12-07
K122787 COMFORT EZ Simple Diagnostics, Inc. FMF Class II 2012-12-06
K122920 POWDER FREE VINYL PATIENT EXAMINATION GLOVES, COLORED (YELLOW) Hebei Leader Plastic Co., Ltd. LYZ Class I 2012-11-30
K122893 POWDER-FREE VINYL PATIENT EXAMINATION GLOVES, CLEAR(NON-COLORED) Geenli Plastic Co, Ltd. LYZ Class I 2012-11-30
K122999 POWDER FREE NITRILE EXAMINATION GLOVES, TESTED FOR USE WITH CHEMOTHERAPY DRUGS Top Glove Sdn. Bhd. LZA Class I 2012-11-30
K121501 ARROW JUGULAR AXILLO-SUBCLAVIAN CENTRAL CATHETER (JACC) Arrow International (Subsidiary of Teleflex Inc.) LJS Class II 2012-11-29
K121775 ENFLOW IV FLUID WARMER, ENFLOW DISPOSABLE CARTRIDGE, ENFLOW CONTROLLER Vital Signs, Inc., A GE Healthcare Company LGZ Class II 2012-11-28
K121171 CUROS TIP Ivera Medical, Inc. QBP Class II 2012-11-26
K121811 POWDER FREE STERILE LATEX EXAM RADIATION ATTENUATION GLOVES Shen Wei (Usa), Inc. LZC Class I 2012-11-21
K120711 NON-CONTACT THERMOMETER K-Jump Health Co., Ltd. FLL Class II 2012-11-19
K123026 TEXTURED, BLUE, LATEX, POWDER FREE EXAMINATION GLVOES, WITH PROTEIN LABELING CLAIM (50UG/DM OR LESS OF WATER SOLUBLE PRO Northstar Healthcare Holdings LYY Class I 2012-11-16
K122686 ACCU-CHEK ULTRAFLEX INFUSION SET Roche Diabetes Care AG FPA Class II 2012-11-16
K120066 POWDER FREE NITRILE PATIENT EXAMINATION GLOVE, BLUE, WHITE AND GREEN COLORED. NON-STERILE, LOW DERMATITIS POTENTIAL Kossan Latex Industries(M)Sdn Bhd LZA Class I 2012-11-16
K122899 POWERPORT CLEARVUE SLIM IMPLANTABLE PORT C.R. Bard, Inc. LJT Class II 2012-11-15
K122122 REGEN SPRAY APPLICATOR, Regen Lab SA FMF Class II 2012-11-09
K121607 TERUMO(R) NEEDLE Terumo (Philippines) Corporation FMI Class II 2012-11-08
K122912 DIGITAL THERMOMETER (WITH DISPOSABLE THERMOMETER COVER) Hangzhou Hua'An Medical & Health Instruments Co., FLL Class II 2012-11-07
K113225 NYLUS PICC Semprus Biosciences LJS Class II 2012-11-06
K122998 BLUE POWDERED NITRILE EXAMINATION GLOVE Northstar Healthcare Holdings LZA Class I 2012-11-06
K120642 RESUSCITAIRE WITH AUTOBREATH Draeger Medical Systems, Inc. FMT Class II 2012-11-02
K123267 SURFFLASH(R) PLUS SAFETY I.V. CATHETER Kofu Factory of Terumo Corp. FOZ Class II 2012-11-02
K122215 NAVIGATOR DELIVERY SYSTEM (NAVIGATOR DS) Carticept Medical, Inc. FRN Class II 2012-10-26
K122971 CLICKFINE PEN NEEDLE P/L Biomedical FMI Class II 2012-10-25
K122969 CLICKFINE PEN NEEDLE P/L Biomedical FMI Class II 2012-10-25
K121594 COLORED POWDER FREE LATEX EXAMINATION GLOVE (WHITE AND BLUE) Tekmedic (M) Sdn Bhd LYY Class I 2012-10-25
K121637 AUTO-DISABLE STERILE SAFTY SYRING FOR SINGLE USE Sunwell Biotech Co., Ltd. MEG Class II 2012-10-25
K121484 3M ATTEST(TM) SUPER RAPID READOUT BIOLOGICAL INDICATOR, 3M ATTEST(TM) AUTO-READER 3M Company FRC Class II 2012-10-19
K113471 NIPRO HUBER INFUSION SET, EXCEL HUBER INFUSION SET Nipro Medical Corporation FPA Class II 2012-10-18
K113469 NIPRO HUBER INFUSION, EXCEL HUBER NEEDLE Nipro Medical Corporation FMI Class II 2012-10-18
K120420 STERILE BLUNT FOR SINGLE USE Shanghai Double Dove Industrial Co., Ltd. FMI Class II 2012-10-18
K122882 NMI HPICC III Navilyst Medical, Inc. LJS Class II 2012-10-18
K120947 THS INSTRUMENT TRAY Hologic, Inc. KCT Class II 2012-10-17
K113470 NIPRO SAFE TOUCH HUBER INFUSION SET Nipro Medical Corporation FPA Class II 2012-10-17
K120641 GLOBAL MEDI PRODUCTS RETRACTABLE SAFETY SYRINGE Global Medi Products MEG Class II 2012-10-17
K122131 POWDER FREE NITRILE EXAMINATION GLOVE-BLUE (CHEMOTHERAPY) Matang Mfg. Sdn. Bhd. LZA Class I 2012-10-17
K121992 POWDER-FREE NITRILE PATIENT EXAMINATION GLOVES, BLUE COLOR Xinwei (Shandong) Plastic and Rubber Products Co., LZA Class I 2012-10-16
K122465 MIDAS TOUCH, NITRILE EXAMINATION GLOVES, POWDER-FREE, PINK Industrial Clothings, Ltd. LZA Class I 2012-10-16
K112087 TYVEK SELF-SEAL POUCHES ,TYVEK HEAT-SEAL ROLLS Advanced Sterilization Products KCT Class II 2012-10-15
K122837 AUTOJECT 2 FOR GLASSY SYRINGE Owen Mumford, Ltd. KZH Class II 2012-10-15
K120652 RAPICIDE OPA-28 TEST STRIP Serim Research Corp. JOJ Class II 2012-10-12
K121696 WIRELESS THERMOMETER Raling Medical Company FLL Class II 2012-10-11
K121591 FLAVORED POWDER FREE AND POLYMER COATED EXAMINATION GLOVE (VANLLA, GRAPE AND STRAWBERRY) Tekmedic (M) Sdn Bhd LYY Class I 2012-10-11
K122023 MIXJECT WITH SPRAY HEAD Medimop Medical Projects, Ltd. FMF Class II 2012-10-04
K122044 STERRAD(R) CYCLESURE(R) 24 BIOLOGICAL INDICATOR Advanced Sterilization Products FRC Class II 2012-10-04
K120110 ELEGANT NITRILE POWDER FREE EXAMINATION GLOVE BLUE VIOLET Profit Point Manufacturing Sdn Bhd LZA Class I 2012-10-04
K111519 STERRAD SEALSURE CHEMICAL INDICATOR TAPE MODEL 14202 Advanced Sterilization Products JOJ Class II 2012-10-03
K121287 HT-WEDGE D.T. Davis Enterprises Ltd. T/A Hovertech Int'L FNG Class II 2012-10-03
K111518 STERRAD CHEMIAL INDICATOR STRIP MODEL 14100 Advanced Sterilization Products JOJ Class II 2012-10-03
K122267 GIRAFFE AND PANDA WARMERS Ohmeda Medical, A Division of Datex-Ohmeda, Inc. FMT Class II 2012-10-02
K122263 14.5-16.0 FRENCH CUFFED CATHETER REMOVAL DEVICE, SYMMETRY SURGICAL SINGEL USE Symmetry Medical ODY Class II 2012-09-28
K120306 RAPICIDE OPA-28 Minntech Corp. MED Class II 2012-09-27
K122266 POWDER-FREE VINYL PATIENT EXAMINATION GLOVES, CLEAR (NON-COLORED) Shandong Junfeng Industries Co., Ltd. LYZ Class I 2012-09-27
K122507 DURABLUE STERILIZATION WRAP, MODEL NUMBERS CH100, CH200, CH300, CH400, CH500 AND CH600, STERRAD NX STERILIZATION Cardinal Health200, LLC FRG Class II 2012-09-26
K111391 STERRAD (R) 100NX DUO CYCLE TEST PACK Advanced Sterilization Products FRC Class II 2012-09-26
K122545 CG+ ARROW PICC POWERED BY ARROW VPS STYLET Arrow International (Subsidiary of Teleflex Inc.) LJS Class II 2012-09-20
K121262 MEDEFLUSH NORMAL SALINE I.V. FLUSH SYRINGE-STERILE FIELD READY Medefil, Inc. NGT Class II 2012-09-20
K122373 NEOMED ORAL/ENTERAL SYRINGE Neomed, Inc. FMF Class II 2012-09-20
K122558 ULTRASAFE PASSIVE NEEDLE GUARD Safety Syringes, Inc. MEG Class II 2012-09-20
K121926 BLUE, LATEX POWDER FREE EXAMINATION GLOVES, TESTED FOR USE WITH CHEMOTHERAPY DRUGS WITH PROTEIN LABLING CLAIM (50UG/DM Northstar Healthcare Holdings LZC Class I 2012-09-20
K120968 POWER-FREE VINYL PATIENT EXAMINATION GLOVES, CLEAR(NON-COLORED) Tangshan Zhonghong Pulin Plastic Co.,Ltd LYZ Class I 2012-09-19
K120281 DIGNITY POWER INJECTABLE TITANIUM PORT Medical Components, Inc. LJT Class II 2012-09-17
K111375 STERRAD (R) CYCLESURE (R) 24 BIOLOGICAL INDICATOR Advanced Sterilization Products FRC Class II 2012-09-14
K121625 LULLABY TM WARMER Wipro GE Healthcare Private, Ltd. FMT Class II 2012-09-14
K111377 STERRAD(R) 100NX STERILIZER DUO CYCLE Advanced Sterilization Products MLR Class II 2012-09-13
K112741 POWDER FREE VINYL PATIENT EXAMINATION GLOVE Lifestyle Safty Products (Hui Zhou) Co., Ltd. LYZ Class I 2012-09-13
K112693 NON-STERILE, POWER FREE YELLOW LATEX EXAMINATION GLOVES Sgmp Co., Ltd. LYY Class I 2012-09-12
K120384 PROTECTOR, INJECTOR, CONNECTOR Bd Medical-Medical Surgical Systems LHI Class II 2012-09-12
K121528 POWER-FREE NITRILE EXAMINATION GLOVES, PEPPERMINT SCENTED, BLUE COLOR Shen Wei (Usa), Inc. LZA Class I 2012-09-11
K113393 POWDER FREE BLACK NITRILE EXAMINATION GLOVES Tg Medical Sdn. Bhd. LZA Class I 2012-09-11

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