meddevicedb.com FDA Device Reference

Review Panel

General Hospital FDA 510(k) Clearances & Devices

Cleared Devices
15,723
Product Codes (page)
29
Latest Decision
2012-09-10

Clearances · page 34 of 158

K-Number Trade Name Applicant / Manufacturer Product Code Class Decision Date
K121947 ETS BLUE POWDER-FREE PATIENT NITRILE EXAMINATION GLOVES Northstar Healthcare Holdings LZA Class I 2012-09-10
K122363 NON-STERILE, POWDER FREE NITRILE EXAMINATION GLOVES, BLUE Siam Sempermed Corp., Ltd. LZA Class I 2012-09-10
K120685 ZYNO MEDICAL ADMINISTRATION SET Zyno Medical, LLC FPA Class II 2012-09-07
K121941 ARROW PICC POWERED BY ARROW VPS STYLET Arrow International (Subsidiary of Teleflex Inc.) LJS Class II 2012-09-07
K113761 INFRARED THERMOMETER Famidoc Technology Co., Ltd. FLL Class II 2012-09-07
K122544 TERUMO SURFLASH SAFETY I.V. CATHETER Terumo Corporation FOZ Class II 2012-09-05
K121476 INFILL GRAFT DELIVERY SYSTEM Pinnacle Spine Group, LLC FMF Class II 2012-08-29
K122249 TERUMO SURGUARD3 SAFETY NEEDLE & HYPODERMIC SYRINGE WITH SAFETY NEEDLE Terumo (Philippines) Corporation FMI Class II 2012-08-28
K110954 ARJORAD STERILE WRAP Arjo Wiggins Medical, Inc. FRG Class II 2012-08-24
K120004 (MULTIPLE) DIGITAL THERMOMETER China Shenyang Med-Land Imp/Exp Corp., Ltd. FLL Class II 2012-08-23
K121089 NMI PICC III Navilyst Medical, Inc. LJS Class II 2012-08-23
K113312 HY-CHLO(TM)WOUND SCRUB Patrin Pharma FQH Class II 2012-08-21
K120890 POWDER-FREE NITRIE EXAMINATION GLOVES, ORANGE Shen Wei (Usa), Inc. LZA Class I 2012-08-17
K122265 VIALOK SINGLE VIAL ACCESS DEVICE VENTED Yukon Medical, LLC LHI Class II 2012-08-14
K121632 COMFORT EZ Simple Diagnostics, Inc. FMI Class II 2012-08-10
K113685 POWDER FREE LATEX EXAMINATION GLOVES Khai Hoan Joint Stock Company LYY Class I 2012-08-10
K121368 NITRILE EXAMINATION GLOVE, POWDER FREE (BLUE, BLACK OR WHITE) Matang Mfg. Sdn. Bhd. LZA Class I 2012-08-10
K121390 LUBE JELLY SURINGE Nurse Assist, Inc. KMJ Class I 2012-08-10
K113776 FLASHPAK Symmetry Medical FRG Class II 2012-08-08
K113673 MYSAFETY SYRINGE Medicalchain Internartional Corporation FMF Class II 2012-08-03
K121526 POWER-FREE NITRILE PATIENT EXAMINATION GLOVES Shandong Junchi Medical Products Co., Ltd. LZA Class I 2012-08-03
K121192 NITRILE EXAMINATION GLOVES (WHITE, BLUE AND BLACK) Tekmedic (M) Sdn Bhd LZA Class I 2012-08-03
K121990 PICC CONVENIENCE KIT Navilyst Medical, Inc. LJS Class II 2012-08-03
K121157 POWDER-FREE VIVYL PATIENT EXAMINATION GLOVES, CLEAR (NON-COLORED) Shijazhuang Jiuyuan Plastic Co., Ltd. LYZ Class I 2012-08-02
K121231 IND DRUG HOME MULTI-PANEL TEST (2-5) IND MORPHINE HOME TEST Ind Ndiagnostic, Inc. NGT Class II 2012-07-30
K120797 POWDER-FREE VINYL PATIENT EXAMINATION GLOVES, CLEAR (NON-COLORED) Shandong Shouguang Kingliyuan Medical Apparatus & LYZ Class I 2012-07-27
K120230 POWDER-FREE VINYL PATIENT EXAMINATION GLOVES, NON-STERILE Shandong Taixiang Medical Products Co., Ltd. LYZ Class I 2012-07-27
K110898 S.C.O.R.E.S. UNIT Ammed Surgical Equipment, LLC KCT Class II 2012-07-26
K121908 SAFETY INFUSION SET Greiner Bio-One North America, Inc. FMI Class II 2012-07-25
K120839 NOVACATH SECURE IV CATHETER SYSTEM-18G Tangent Medical Technologies, Inc. FOZ Class II 2012-07-20
K120970 NITRILE POWDER FREE PATIENT EXAMINATION GLOVES, COLORED (BLUE) Tangshan Zhonghong Pulin Plastic Co.,Ltd LZA Class I 2012-07-19
K121270 BIOJECT NEEDLE-FREE INJECTION MANAGEMENT SYSTEM Bioject Medical Technologies, Inc. KZE Class II 2012-07-19
K111353 ACCU-CHECK COMBO SYSTEM Roche Diagnostics LZG Class II 2012-07-17
K121428 NON-CONTACT CLINICAL THERMOMETER Radiant Innovation, Inc. FLL Class II 2012-07-17
K121161 EMPTY EVA SOLUTION CONTAINER EMPTY EVA DUAL CHAMBER SOLUTION CONTAINER Acta Medical, LLC KPE Class II 2012-07-13
K121198 BW685, BW685S Biegler GmbH LGZ Class II 2012-07-12
K120836 0.9% SODIUM CHLORIDE FLISH SYRINGE Am USA NGT Class II 2012-07-12
K121529 BLACK NITRILE POWDER-FREE EXAMINATION GLOVES Northstar Healthcare Holdings LZA Class I 2012-07-12
K120424 MEDSOURCE IV ADMINSTRATION SET Medsource International, LLC LHI Class II 2012-07-11
K111939 M/29TM - PRESSURE INJECTABLE Flexicath , Ltd. FOZ Class II 2012-07-11
K120474 GYRUS ACMI TELESCOPE STORAGE-STERILIZATION TRAY Gyrus Acmi, Inc. KCT Class II 2012-07-10
K112872 STATIM 2000 G4 CASSETTE Scican , Ltd. FLE Class II 2012-07-10
K120584 POWER FREE STRETCH VINYL PATIENT EXAMINATION GLOVES Wealth on (Jiangsu) Co., Ltd. LYZ Class I 2012-07-10
DEN120011 PROTEUS INGESTION CONFINMATION SYSTEMS Proteus Biomedical, Inc. OZW Class II 2012-07-10
K120195 SAFETY SUBCUTANEOUS TISSUE INFUSION SET Multi Med FPA Class II 2012-07-06
K120937 SUNFLOWER WARNER Atom Medical Corporation FMT Class II 2012-07-06
K121464 BLUE POWER FREE NITRILE EXAMINATION GLOVE Northstar Healthcare Holdings LZA Class I 2012-07-05
K121506 UTB BLUE POWDER FREE NITRILE Northstar Healthcare Holdings LZA Class I 2012-07-03
K120963 POWDER FREE NATURAL RUBBER LATEX EXAMINATION GLOVES Medtexx Manufacturing Sdn. Bhd. LYY Class I 2012-06-29
K121634 INTERLINK SYSTEM EXTENSION SET WITH CONTROL-A-FLO-REGULATORY CLEARLINK SYSTEM EXTENSION SET WITH CONTROL-A-FLO-REGULATOR Baxter Healthcare Corporation FPA Class II 2012-06-29
K121092 FLOWEASE [SUBCUTANEOUS] INFUSION SET Baxter Healthcare Corp FPA Class II 2012-06-29
K120375 MED-RX PATIENT DELIVERY SET Benlan, Inc. FPA Class II 2012-06-28
K121274 PIXEL APP Gauss Surgical, Inc., LWH Class I 2012-06-27
K120632 AMSCO V-PRO 1 LOW/PLUS/MAX TEMPERATURE STERILIZATION SYSTEM STERIS Corporation MLR Class II 2012-06-26
K120336 NITRILE POWDER FREE EXAMINATION GLOVES (VIO) TESTED FOR USE WITH CHENITRILE POWDER FREE EXAMINATION (ABLU) TESTED FOR U Hartalega Sdn Bhd LZC Class I 2012-06-25
K120690 INSULIN PEN NEEDLE Tiger Medical Products, Ltd. FMI Class II 2012-06-22
K112805 KIMGUARD ONE-STEP STERILIZATION WRAP Kimberly-Clark Corp. FRG Class II 2012-06-22
K113277 ARROWADVANTAGES PRESSURE INJECTABLE PERIPHERALLY INSCRTED CENTRAL CATHETER KITS Arrow International, Inc. LJS Class II 2012-06-21
K121032 PRIMARY SYMBIQ SET, DITAL MICROBORE TUBING, 0.2 MICRON FILTER, NON-DEHP Hospira, Inc. FPA Class II 2012-06-21
K121118 FORA COMFORTSCAN EAR THERMOMETER Foracare, Inc. FLL Class II 2012-06-15
K120658 DURABLUE STERILIZATION WRAP Cardinal Health200, LLC FRG Class II 2012-06-13
K111718 LANO-E Ug Global Resources Sdn. Bhd. LZA Class I 2012-06-08
K120820 GIRAFFE BLUE SPOT PT LITE Lumitex, Inc. LBI Class II 2012-06-08
K121554 Q-FLO CLOSED MALE LUER CONNECTOR Us Fusion, LLC. Dba Truecare Biomedix-USA FPA Class II 2012-06-08
K111604 LANO-E Ug Global Resources Sdn. Bhd. LYY Class I 2012-06-08
K112090 BAHADIR STERILIZATION TRAYS Bahadir USA Corp. KCT Class II 2012-06-07
K121094 MEDCOMP VASCU-PICC & MIDLINE CATHETERS Medical Components, Inc. LJS Class II 2012-06-06
K120712 FORA COMFORTSCAN EAR THERMOMETER Taidoc Technology Corporation FLL Class II 2012-06-06
K120435 BROWNE ALDAHOL GLUTARALDEHYDE INDICATOR STERIS Corporation JOJ Class II 2012-06-04
K120661 THE T.A.L.O.N. INTRAOSSOUS INFUSION SYSTEM BY VIDACRE Vidacare Corporation FMI Class II 2012-06-03
K121073 POWERGLIDE MIDLINE CATHETER C.R. Bard, Inc. FOZ Class II 2012-06-01
K120542 CARDINAL HEALTH DURABLUE STERILIZATION WRAP Cardinal Health-Medical Products and Services FRG Class II 2012-06-01
K120441 GETINGE 700HC-E SERIES STEAM STERILIZER Getinge Sourcing, LLC FLE Class II 2012-05-31
K121283 BD EMERALD SAF-T SINGLE USE, HYPODERMIC Becton, Dickinson and Company FMF Class II 2012-05-30
K120412 3M SPOTON TEMPERATURE MONITORING SYSTEM Arizant Healthcare, Inc. FLL Class II 2012-05-30
K120395 NERIA MULTI SUBCUTANEOUS INFUSION SET Unomedical Devices S.A DE C.V. FPA Class II 2012-05-30
K121427 UNIMED TEMPERATURE PROBE Unimed Medical Supplies, Inc. FLL Class II 2012-05-29
K120150 DUAL SPIKE TRANSFER DEVICE B.Braun Medical, Inc. LHI Class II 2012-05-24
K120191 PUSH-ON NEEDLE 30GX8MM Scandinavian Health Limited FMI Class II 2012-05-23
K113440 HIGH FIVE Central Medicare Sdn Bhd LZA Class I 2012-05-23
K120443 NEUTRAL LUER ACTIVATED DEVICE AND EXTENSION SETS WITH NEUTRAL LUER ACTIVATED DEVICE Baxter Healthcare Corporation - Renal Division FPA Class II 2012-05-22
K113565 MULTI-MED CENTRAL VENOUS CATHETERS (CVCS), WITH AND WITHOUT HEPARIN VANTEX CENTRAL VENOUS CATHETERS (CVCS), WITH HEPARIN Edwards Lifesciences, LLC FOZ Class II 2012-05-18
K113622 ORION II CT CVC Health Line International Corporation (Hlic) FOZ Class II 2012-05-18
K120894 HAYMAX Haymax Limited NUP Class II 2012-05-17
K120059 LIQUID BANDAGE Chesson Laboratory Associates, Inc. KMF Class I 2012-05-17
K121124 ARTHREX MIXING AND DELIVERY SYSTEM Arthrex, Inc. FMF Class II 2012-05-16
K113194 POWDER FREE VINYL PATIENT EXAMINATION GLOVES, WHITE COLOR Suqian Ruijang Medical Supplies Co., Ltd. LYZ Class I 2012-05-14
K120798 DISPOSABLE POWER FREE VINYL EXAM GLOVE, PINK COLOR Canopus Medical Supply Co., Ltd. LYZ Class I 2012-05-14
K120692 LATEX EXAMINATION GLOVES (POWDER FREE) Top Calibre Sdn Bhd LYY Class I 2012-05-14
K112896 ARRW EVOLUTION Arrow International (Subsidiary of Teleflex Inc.) LJS Class II 2012-05-10
K113639 C2 MEDICAL GLOVES Amercare, Inc. LZA Class I 2012-05-08
K112403 AMSCO CHIMERON MEDIUM STEAM STERLILZER STERIS Corporation FLE Class II 2012-05-08
K120860 INFU BOX TYPE 0412A Medical Rescue Equipment Holding AS LGZ Class II 2012-05-08
K112266 POWDER-FREE VINYL PATIENT EXAMINATION GLOVES, YELLOW COLOR Shandong Zhiyuan Medical Products Co., Ltd. LYZ Class I 2012-05-08
K120149 SKYRON INTEGRITY 215 STEAM STERILIZER SKYTRON INTEGRITY 215 SG STEAM STERILIZER SAKURA STEAM STERILIZER ASSV-AB09 SAKURA Sakura Seiki Co., Ltd. FLE Class II 2012-05-08
K120026 PERFORMER HT/ HANG&GO HT BASIC Rand S.R.L. LGZ Class II 2012-05-08
K120693 LATEX EXAMINATION GLOVES (POWDERED) Top Calibre Sdn Bhd LYY Class I 2012-05-08
K113689 DUKAL LUBRICATING JELLY Dukal Corporation KMJ Class I 2012-05-04
K120548 HLIC NEEDLE-LESS VALVE Health Line International Corporation FPA Class II 2012-05-04
K112671 STERILCONTAINER SYSTEM Aesculap, Ltd. KCT Class II 2012-05-04

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