meddevicedb.com FDA Device Reference

Review Panel

General Hospital FDA 510(k) Clearances & Devices

Cleared Devices
15,723
Product Codes (page)
35
Latest Decision
2014-02-03

Clearances · page 31 of 158

K-Number Trade Name Applicant / Manufacturer Product Code Class Decision Date
K132767 MEDLINE SHARPS CONTAINER Medline Industries, Inc. MMK Class II 2014-02-03
K131249 ON-Q PAINBUSTER, ON-Q C-BLOC, HOMEPUMP ECLIPSE, HOMEPUMP C-SERIES I-Flow, LLC MEB Class II 2014-02-03
K132792 ECOSHIP DISPOSABLE SHARPS CONTAINER, ECOSHIP DISPOSABLE SHARPS CONTAINER Daniels Sharpsmart, Inc. MMK Class II 2014-01-31
K132221 POWDER-FREE VINYL PATIENT EXAMINATION GLOVES Shandong Haoyu Medical Products Co., Ltd. LYZ Class I 2014-01-31
K131555 MEDSOURCE IV SAFETY CATHETER Medsource International, LLC FOZ Class II 2014-01-31
K131344 POWDER FREE YELLOW SYNTHETIC VINYL PATIENT EXAMINATION GLOVES Shijiazhuang Wally Plastics Co., Ltd. LYZ Class I 2014-01-30
K133602 ADD-VANTAGE ADDAPTOR Hospira, Inc. LHI Class II 2014-01-24
K132841 ZYNO MEDICAL ADMINISTRATION SET Zyno Medical, LLC FPA Class II 2014-01-23
K133100 CAREFINE PEN NEEDLE Facet Technologies FMI Class II 2014-01-23
K130732 POWDER FREE VINYL PATIENT EXAMINATION GLOVES, CLEAR (NON-COLORED) Aide Plastic Co., Ltd. LYZ Class I 2014-01-16
K133856 POWERGLIDE MIDLINE CATHETER C.R. Bard, Inc. FOZ Class II 2014-01-16
K133021 MIXING SYRINGE SYSTEM Zimmer Knee Creations, Inc. FMF Class II 2014-01-13
K132880 MEDCOMP POWER INJECTABLE SAFETY HUBER NEEDLE Medical Components, Inc. FPA Class II 2014-01-08
K131832 POWDER-FREE VINYL PATIENT EXAMINATION GLOVES Shandong Binxiang Medical Products Co., Ltd. LYZ Class I 2014-01-07
K132439 SAKURA STEAM STERILIZER ASSR; -AO12, -A012W, -AO12P,-AO12PW / SKYTRON INTEGRITY 270;STEAM STERILIZER,VP STEAM STERILIZER Sakura Seiki Co., Ltd. FLE Class II 2014-01-06
K132520 NASAL EASE ALLERGY BLOCKER Hi-Tech Pharmacal, Inc. NUP Class II 2013-12-31
K132007 STERICYCLE SHARPS MANAGEMENT SERVICE REUSABLE SHARPS CONTAINER, 2 GALLON, RED, STERICYCLE SHARPS MANAGEMENT SERVICES REU Stericycle, Inc. MMK Class II 2013-12-27
K133111 KINGTECH DIGITAL THERMOMETER Kingtech Enterprise, Ltd. FLL Class II 2013-12-26
K133113 KINGTECH FOREHEAD THERMOMETER Kingtech Enterprise, Ltd. FLL Class II 2013-12-26
K130975 SWABCAP AND SWABFLUSH Excelsior Medical Corp. QBP Class II 2013-12-24
K133634 SPECTRUM TURBO-JECT PERIPHERALLY INSERTED CENTRAL VENOUS CATHETER SET Cook, Inc. LJS Class II 2013-12-23
K132618 ONETOUCH REVEAL Lifescan, Inc. MRZ Class II 2013-12-16
K132060 DURABLUE STERILIZATION WRAP Cardinal Health-Medical Products and Services FRG Class II 2013-12-13
K132484 DERMAGRIP POWDER FREE BLACK NITRILE PATIENT EXAMINATION GLOVES, NON-STERILE Wrp Asia Pacific Sdn. Bhd. LZA Class I 2013-12-13
K132120 WTF SECURA SYRINGE AND NEEDLE Beijing Wantefu Medical Apparatus Co., Ltd. FMF Class II 2013-12-12
K132177 MEDCOMP GEN III POWER INJECTABLE PORT Medcomp ( Medical Components) LJT Class II 2013-12-12
K122834 POLYSITE IMPLANTABLE INFUSION PORTS Perouse Medical LJT Class II 2013-12-11
K130394 CADD -SOLIS AMBULATORY INFUSION PUMP, VERSION 3.0 Smiths Medical Asd, Inc. MEA Class II 2013-12-09
K132202 DC SERIES FLUID WARMING CABINET, DC SERIES FLUID WARMING CABINET Enthermics Medical Systems, Inc. LGZ Class II 2013-12-06
K132153 SAFETOUCH PSV WINGED INFUSION SET WITH/WITHOUT FILTER Nipro Medical Corporation FOZ Class II 2013-12-05
K132896 CJ-TYPE: METAL HANDLE WITH GUIDE TUBE, PJ-TYPE: PLASTIC HANDLE WITH GUIDE TUBE, CB-TYPE: METAL HANDLE WITHOUT GUIDE TUBE Asia-Med GmbH and CO KG MQX Class II 2013-12-02
K132514 KINSA SMART THERMOMETER Kinsa, Inc. FLL Class II 2013-12-02
K132201 SYNMAX SYNTHETIC EXAMINATION VINYL GLOVES, POWDER FREE, BLUE COLOR Zibo Intco Medical Products Co., Ltd. LYZ Class I 2013-11-27
K122024 SPSMEDICAL SPORVIEW 10 STEAM SELF CONTAINED BIOLOGICAL INDICATOR Spsmedical Supply Corp. FRC Class II 2013-11-26
K131646 DISPOSABLE INFUSION SET Shanghai Jinta Medical Co., Ltd. LHI Class II 2013-11-26
K131828 POWDER FREE VINYL PATIENT EXAMINATION GLVOES, LIGHT YELLOW COLOR Jiangsu Handsafe Glove Co., Ltd. LYZ Class I 2013-11-26
K132372 STERITEC GREEN CARD PACK BOWIE-DICK TEST Steritec Products Mfg Co, Inc. JOJ Class II 2013-11-26
K130135 DANA REUSABLE BI TEST PACK Dana Products, Inc. JOJ Class II 2013-11-25
K131826 TOPTOUCH /OTHER CLIENTS PRIVATE LABELING Jiangsu Toptouch Glove Co., Ltd. LYZ Class I 2013-11-22
K133264 NMI PICC III Navilyst Medical, Inc. LJS Class II 2013-11-20
K130212 SAFETY HYPODERMIC NEEDLES WITH/WITHOUT SYRINGE Wuxi Yushou Medical Applicances Co., Ltd. FMI Class II 2013-11-20
K130230 STERILE PISTON HYPODERMIC SYRINGES (WITH/WITHOUT NEEDLE), HYPODERMIC NEEDLES Wuxi Yushou Medical Applicances Co., Ltd. FMF Class II 2013-11-20
K133031 SHARPSOLOGY 2 Industrial Water Solutions, Inc. MMK Class II 2013-11-15
K132552 U&U STERILE HYPODERMIC NEEDLE U&U Medical Technology Co, Ltd. FMI Class II 2013-11-13
K131243 NON-CONTACT INFRARED THERMOMETER Shenzhen Jumper Medical Equipment Co., Ltd. FLL Class II 2013-11-12
K132276 STERILE EMPTY GLASS CONTAINER, 250ML, STERILE EMPTY GLASS CONTAINER, 500 ML, STERILE EMPTY GLASS CONTAINER, 1000 ML Hospira, Inc. KPE Class II 2013-11-12
K130101 BYTECH Bytech Dongtai Co., Ltd. LYZ Class I 2013-11-08
K131841 KIMBERLY-CLARK LAVENDER NITRILE POWDER-FREE EXAM GLOVE Kimberly-Clark Corp. LZA Class I 2013-11-07
K132006 STERILE NITRILE POWDER FREE EXAMINATION GLOVE(VBLU), STERLE NITRILE POWDER FREE EXAMINATION GLOVE(ABLU) Hartalega Sdn Bhd LZA Class I 2013-11-07
K131519 BELMONT HYPERTHERMIA PUMP Belmont Instrument Corp. LGZ Class II 2013-11-06
K131661 INFUSION SYRINGE SET Innovative Medical Manufacturing Co. FMF Class II 2013-11-05
K132567 ARGYLE PERIPHERALLY INSERTED CENTRAL CATHETER SINGLE LUMEN, ARGYLE PERIPHERALLY INSERTED CENTRAL CATHETER DUAL LUMEN Covidien LJS Class II 2013-11-05
K132494 VISCOELASTIC INJECTOR Sight Sciences, Inc. MRH Class II 2013-10-22
K130897 MEDCOMP VASCU-PICC WITH VALVE Medcomp ( Medical Components) LJS Class II 2013-10-22
K131963 TAUTONA INJECTOR DEVICE Tautona Group, LLC FMF Class II 2013-10-22
K123049 SAPPHIRE INFUSION PUMP Q Core Medical , Ltd. FRN Class II 2013-10-17
K130231 NON-CONTACT INFRARED THERMOMETER Jinxinbao Electronic Co.,Ltd FLL Class II 2013-10-15
K132885 TURBO-JECT PERIPHERALLY INSERTED CENTRAL VENOUS CATHETER (PICC) SET Cook Incorporated LJS Class II 2013-10-11
K131585 INTEL-GE CARE INNOVATIONS QUIETCARE Intel-Ge Care Innovations, LLC KMI Class I 2013-10-08
K132142 NERIA SOFT 90 INFUSION SET Unomedical A/S FPA Class II 2013-10-08
K132734 NEUTRAL LUER ACTIVATED DEVICE (ONE-LINK NEEDLE-FREE IV CONNECTOR) AND EXTENSION SETS Baxter Healthcare Corp FPA Class II 2013-10-08
K131771 CAREGIVER PROFESSIONAL CLINICAL THERMOMETER, PRO-TF SERIES Thermomedics, Inc. FLL Class II 2013-10-07
K132863 SMARTSITE VIALSHIELD Yukon Medical, LLC LHI Class II 2013-10-04
K132905 200 MICRON BLOOD COMPONENT FILTER AND SYRINGE ADAPTER Arteriocyte Medical Systems, Inc. BRZ Class II 2013-10-04
K131617 COLONGLIDE(R) LUBRICANT Pediatric Pharmaceuticals, Inc. KMJ Class I 2013-10-03
K132110 NATUS WARMETTE BLANKET AND DUAL CABINETS Natus Nicolet Ireland, Ltd. LGZ Class II 2013-10-03
K123822 KLEIN TOUCH PUMP AND DISPOSABLE TUBING SET Hk Surgical, Inc. FRN Class II 2013-09-27
K131440 POWDER FREE NITRILE PATIENT EXAMINATION GLOVES, BLUE Hebei Hongsen Plastics Technology Co, Ltd. LZA Class I 2013-09-25
K130172 BELIMED STEAM STERILIZER MST-V Belimed, Inc. FLE Class II 2013-09-23
K124026 LOBSTER AUTO-INJECTOR Scandinavian Health Limited KZH Class II 2013-09-13
K124037 JUNG RIM SINGLE USE HYPODERMIC SYRINGE WITH NEEDLE Jung Rim Medical Industrial Co., Ltd. FMF Class II 2013-09-12
K122102 POWER FREE VINYL EXAMINATION GLOVES Wang Tong Xinghua Co., Ltd. LYZ Class I 2013-09-09
K132233 K-PACK II NEEDLE - 27G X 3/4 THIN WALL Terumo Europe N.V. FMI Class II 2013-09-06
K121844 POWDER FREE NATURAL RUBBER LATEX EXAMINATION GLOVES Worldmed Manufacturing Sdn. Bhd. LYY Class I 2013-09-06
K131455 RESTORE MODULAR STERILIZATION TRAY SYSTEM Restore Medical Solutions, Inc. KCT Class II 2013-08-30
K131294 OMNIPOD INSULIN MANAGEMENT SYSTEM Insulet Corporation LZG Class II 2013-08-29
K132413 MZ1000 Care Fusion FPA Class II 2013-08-29
K131155 UGFT3; FHT7 Medisim, Ltd. FLL Class II 2013-08-28
K131641 MONOJECT 60ML SYRINGE (LUER LOCK TIP, LUER SLIP TIP, CATHETER TIP) Nipro Medical Corporation FMF Class II 2013-08-28
K131170 SONICISION STERILIZATION TRAY Covidien, Formerly Valleylab, A Division of Tyco H KCT Class II 2013-08-28
K122100 POWDERED VINYL EXAMINATION GLOVES Wang Tong Xinghua Co., Ltd. LYZ Class I 2013-08-22
K113806 KIMGUARD ONE STEP STERILIZATION WRAP Kimberly-Clark Health Care FRG Class II 2013-08-20
K131842 STERICAN CANNULA B.Braun Medical, Inc. FMI Class II 2013-08-20
K131687 6F X 60CM TRIPLE PRO-LINE CT BASIC IR SET Medical Components, Inc. LJS Class II 2013-08-16
K130160 VERIFY PROCESS INDICATOR FOR RELIANCE EPS STERIS Corporation JOJ Class II 2013-08-16
K132334 TURBO-JECT PERIPHERALLY INSERTED CENTRAL VENOUS CATHETER (PICC) SET Cook, Inc. LJS Class II 2013-08-16
K130752 DYNASENSE SYSTEM Centauri Medical, Inc. KMI Class I 2013-08-15
K123766 NOVOPEN ECHO, A DIAL A DOSE INSULIN DELIVERY PEN Novo Nordisk, Inc. FMF Class II 2013-08-15
K131247 MULTIBOLUS II DISPOSABLE PAIN MANAGEMENT SYSTEM Mfs - Medical Flow Systems, Ltd. MEB Class II 2013-08-14
K130900 EVICEL APPLICATION DEVICE Ethicon Inc (On Behalf of Omrix Biopharaceuticals FMF Class II 2013-08-13
K130179 MP VIAL ADAPTER 13MM Medimop Medical Projects, Ltd. LHI Class II 2013-08-08
K130846 MIDAS TOUCH, NITRILE EXAMINATION GLOVES, POWDER FREE, GREEN Industrial Clothings, Ltd. LZA Class I 2013-08-08
K131694 NMI PORT II CATHETER Navilyst Medical, Inc. LJT Class II 2013-08-08
K131517 MEDRAD TWIST & GO HIGH PRESSURE CONNECTOR TUBING Medrad, Inc. / Bayer Medical Care, Inc. FPK Class II 2013-08-02
K130923 5F DIGNITY CT TITANIUM PORT Medical Components, Inc. LJT Class II 2013-07-31
K131942 NMI PICC III CATHETER, NMI HPICC III CATHETER Navilyst Medical, Inc. LJS Class II 2013-07-31
K132040 VIAL CONNECTOR 13MM CLOSED COLLAR Medimop Medical Projects, Ltd. LHI Class II 2013-07-31
K131549 CHEMOLOCK, CHEMOLOCK PORT Icu Medical, Inc. ONB Class II 2013-07-26
K130667 POWDERFREE LATEX EXAMINATION GLOVES COATED WITH ALLOGEL Preventive Care, Inc. LYY Class I 2013-07-24
K130702 AIRSONETT AIR-4 Airsonett AB FRF Class II 2013-07-23

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