meddevicedb.com FDA Device Reference

Review Panel

General Hospital FDA 510(k) Clearances & Devices

Cleared Devices
15,723
Product Codes (page)
33
Latest Decision
2014-12-04

Clearances · page 29 of 158

K-Number Trade Name Applicant / Manufacturer Product Code Class Decision Date
K140285 B TRAVELSAVVY SHARPS CONTAINER Bellegrove Medical Supply, Inc. MMK Class II 2014-12-04
K141412 STERILUCENT SELF-SEAL STERILIZATION POUCH Gs Medical Packaging, Inc. FRG Class II 2014-12-03
K140589 STERRAD CYCLESURE 24 PLUS BIOLOGICAL INDICATOR Mesa Laboratories, Inc. FRC Class II 2014-12-03
K141287 HUIKANG NITRILE POWDER FREE PATIENT EXAM GLOVES, BLUE COLOR Huikang Glove Co., Ltd. LZA Class I 2014-12-03
K141279 WANGHUI NITRILE POWDER FREE PATIENT EXAMINATION GLOVES, BLUE COLOR Wanghui Glove Co., Ltd. LZA Class I 2014-12-03
K142270 LATEX POWDERED EXAMINATION GLOVES WITH PROTEIN LABELING CLAIM OF 200 MICROGRAM OR LESS PER GRAM OF GLOVE Hartalega Sdb. Bhd. LYY Class I 2014-11-25
K142367 Hospira Primary Sets Hospira, Inc. FPA Class II 2014-11-25
K140566 SPSMEDICAL VH2O2 INDICATOR STRIPS, INDICATOR LABELS, INDICATOR TAPE Crosstex International JOJ Class II 2014-11-24
K143234 MaxZero Administration Sets Care Fusion FPA Class II 2014-11-20
K141640 AUTOMATICALLY RETRACTABLE SAFETY SYRINGES WITH FIXED NEEDLE Shantou Wealy Medical Instrument Co.,Ltd MEG Class II 2014-11-19
K142399 DualCap IV Pole Strips(Disinfectant Caps for Male Luers) Catheter Connections, Inc. QBP Class II 2014-11-19
K142600 VIAL-MATE Adaptor Baxter Healthcare Corporation LHI Class II 2014-11-19
K133446 HEPARIN LOCK / FLUSH SYRINGES Excelsior Medical Corporation NZW Class II 2014-11-14
K140439 OMNIPOD INSULIN MANAGEMENT SYSTEM Insulet Corporation LZG Class II 2014-11-13
K140963 KIMGUARD SMART-FOLD STERILIZATION WRAP Kimberly-Clark Corp. FRG Class II 2014-11-10
K141877 LEAF PATIENT MONITORING SYSTEM Leaf Healthcare, Inc. KMI Class I 2014-11-10
K140244 YONGHE Yonghe Plastic Products Co., Ltd. LYZ Class I 2014-11-06
K140246 YONGFA Yongfa Glove Co., Ltd. LYZ Class I 2014-11-06
K141238 STERILUCENT SELF-CONTAINED BIOLOGICAL INDICATOR Sterilucent, Inc. FRC Class II 2014-11-03
K141758 T:SLIM INSULIN DELIVERY SYSTEM Tandem Diabetes Care, Inc. LZG Class II 2014-10-31
K140464 STERILUCENT PSD-85 HYDROGEN PEROXIDE STERILIZER Sterilucent, Inc. MLR Class II 2014-10-31
K141312 STERILUCENT PROCESS CHALLENGE DEVICE Sterilucent, Inc. FRC Class II 2014-10-31
K140940 PROCESS INDICATOR TAPE FOR STEAM STERILIZATION Canadian Technical Tape, Ltd. JOJ Class II 2014-10-27
K141759 OAK RIDGE PRODUCTS MULTI-PURPOSE SHARPS CONTAINERS Oak Ridge Products, LLC MMK Class II 2014-10-24
K141579 EMG BLACK NITRILE MEDICAL EXAMINATION GLOVE POWDER FREE Eco Medi Glove Sdn. Bhd. LZA Class I 2014-10-17
K142636 Merit 10mL Syringe Merit Medical Systems, Inc. FMF Class II 2014-10-17
K140783 HALO AMBULATORY INFUSION SYSTEM Zyno Medical, LLC FRN Class II 2014-10-17
K142267 Sherlock 3CG Tip Positioning System Stylet C.R. Bard, Inc. LJS Class II 2014-10-17
K142616 PICC Maximal Barrier Nursing Kit Navilyst Medical, Inc. LJS Class II 2014-10-14
K141623 EMG BLUE NITRILE MEDICAL EXAMINATION GLOVE WITH CHEMOTHERAPY DRUG LABELING CLAIM Eco Medi Glove Sdn. Bhd. LZA Class I 2014-10-07
K141510 EMG WHITE NITRILE MEDICAL EXAMINATION GLOVES (POWDER FREE) Eco Medi Glove Sdn. Bhd. LZA Class I 2014-10-07
K141664 SAFE'N'SOUND STAKED PASSIVE DELIVERY SYSTEM - CONE VERSION Rexam Healthcare MEG Class II 2014-10-02
K141200 PADI-LOCK Padi-Lock, LLC FPA Class II 2014-10-02
K141633 PRO-PICC WITH VALVE TECHNOLOGY Medical Components, Inc. LJS Class II 2014-09-29
K141616 STERILIZATION CASSETTE Oticon Medical AB KCT Class II 2014-09-23
K142527 Extension Set with BD Q-Syte Luer Access Split Septum Acacia, Inc. FPA Class II 2014-09-19
K141108 YUSHENG Zibo Yusheng Plastic Products Co., Ltd. LYZ Class I 2014-09-16
K141384 WHISPERJECT AUTOINJECTOR Scandinavian Health Limited KZH Class II 2014-09-12
K140050 NITRILE POWDER FREE EXAMINATION GLOVE WITH COLLOIDAL OATMEAL USP SKIN PROTECTANT DRUG - DKBU /DARK BLUE Hartalega Sdn Bhd LZA Class I 2014-09-12
K141464 NOVAGUARD S A SAFETY SYSTEM West Pharmaceutical Services MEG Class II 2014-09-10
K130742 POWDER FREE VINYL PATIENT EXAMINATION GLOVES, CLEAR (NON-COLORED) Dahoon Plastic Co., Ltd. LYZ Class I 2014-09-10
K141565 GLOBE-TROTTER GT5400 Draeger Medical Systems, Inc. FPL Class II 2014-09-10
K141244 NAMSA BIOLOGICAL INDICATOR SPORE STRIPS (DUAL SPECIES) NAMSA BIOLOGICAL INDICATOR SPORE STRIPS (SINGLE SPECIES) North American Science Assoc., Inc. FRC Class II 2014-09-09
K131340 POWDER FREE YELLOW SYNTHETIC VINYL PATIENT EXAMINATION GLOVES Made Plastic Co., Ltd. LYZ Class I 2014-09-09
K140710 BIOMET GRAFT DELIVERY SYRINGES Biomet Spine (Aka Ebi, LLC) FMF Class II 2014-09-04
K134003 RHINIX NASAL FILTER Rhinix Aps NUP Class II 2014-09-04
K140418 POWDER FREE BLUE NITRILE PATIENT EXAMINATION GLOVES, NON-STERILE Wrp Rubber Products Sdn Bhd LZA Class I 2014-09-03
K141590 EMG BLUE NITRILE MEDICAL EXAMINATION GLOVE POWDER FREE Eco Medi Glove Sdn. Bhd. LZA Class I 2014-09-03
K142097 SELEC-3 I.V.ADMINISTRATION SET Biomedix, Inc. FPA Class II 2014-08-29
K142086 NIO -INTRAOSSEOUS DEVICE Waismed, Ltd. FMI Class II 2014-08-28
K140850 GENESIS REUSABLE RIGID CONTAINER SYSTEM Carefusion 2200, Inc. KCT Class II 2014-08-27
K141307 AOK POWDER-FREE VINYL PATIENT EXAMINATION GLOVES, CLEAR (NON-COLORED) Shijiazhuang Aok Plastic Co., Ltd. LYZ Class I 2014-08-27
K141762 PERFUSE PERCUTANEOUS DECOMPRESSION SYSTEM Biomet, Inc. FMF Class II 2014-08-27
K141305 RICHFUL POWDER-FREE VINYL PATIENT EXAMINATION GLOVES, CLEAR (NON-COLORED) Shijiazhuang Richful Plastic Co., Ltd. LYZ Class I 2014-08-27
K133549 STERITEC BIOLOGICAL TEST PACK WITH INSTANT READOUT INTEGRATOR Steritec Products Mfg Co, Inc. FRC Class II 2014-08-27
K141239 LITONG POWDER-FREE YELLOW VINYL PATIENT EXAMINATION GLOVES Zibo Litong Plastic Products Co., Ltd. LYZ Class I 2014-08-27
K141505 BASAL DIGITAL THERMOMETER K-Jump Health Co., Ltd. FLL Class II 2014-08-26
K141021 POWDER-FREE NITRILE EXAMINATION GLOVES, ORANGE, COLOR Hl Rubber Industries Sdn Bhd LZA Class I 2014-08-26
K142036 INFUSOMAT SPACE VOLUMETRIC INFUSION PUMP ADMINISTRATION SETS B.Braun Medical, Inc. FPA Class II 2014-08-25
K133322 STERITEC SMART-READ BIOLOGICAL TEST PACK WITH INSTANT READOUT INTEGRATOR Steritec Products Mfg Co, Inc. FRC Class II 2014-08-25
K140681 BELTER INFRA-RED EAR THERMOMETER Shenzhen Belter Health Measurement and Analysis TE FLL Class II 2014-08-21
K141127 MEDLINE ANTI-EMBOLISM STOCKING Medline Industries, Inc. DWL Class II 2014-08-21
K133532 ALARIS SYSTEM WITH GUARDRAILS SUITE MX Carefusion 303, Inc. FRN Class II 2014-08-21
K140270 NEXUS MIDLINE CT CATHETER Health Line International Corporation FOZ Class II 2014-08-20
K140703 OPA 30 SOLUTION Ciden Technologies, LLC MED Class II 2014-08-19
K142011 SOLUTION SET/EXTENSION SET Baxter Healthcare Corporation FPA Class II 2014-08-18
K130720 SYNTHES REUSABLE STERILIZATION CONTAINER SYSTEM Synthes (USA) Products, LLC KCT Class II 2014-08-14
K133685 0.9% SODIUM CHLORIDE FLUSH SYRINGE Am USA NGT Class II 2014-08-13
K140392 3M ATTEST RAPID READOUT BIOLOGICAL INDICATOR / 3M ATTEST AUTO-READER 3M Company FRC Class II 2014-08-13
K131407 BAHADIR STERILIZATION TRAYS Bahadir USA Corp. KCT Class II 2014-08-12
K133325 BLUE NITRILE POWDER FREE EXAM GLOVES Shandong Xinshi Medical Products Co., Ltd. LZA Class I 2014-08-08
K133168 DERMAGRIP POWDER FREE BLUE NITRILE PATIENT EXAMINATION GLOVES, NON-STERILE Wrp Asia Pacific Sdn. Bhd. LZA Class I 2014-08-07
K140620 SPORVIEW PLUS BI TEST PACK Crosstex International FRC Class II 2014-08-07
K131384 KERICURE ADVANCED LIQUID BANDAGE, NATURAL SEAL LIQUID BANDAGE, LIQUID BANDAGE Kericure, Inc. KMF Class I 2014-08-07
K141612 KIMGUARD ONE-STEP STERILIZATION WRAP Kimberly-Clark Health Care FRG Class II 2014-08-07
K141818 TURBO-JECT PICC SETS Cook Corporated LJS Class II 2014-08-05
K140516 Terumo Pen Injector Needle 34 Kofu Factory of Terumo Corp. FMI Class II 2014-08-05
K141834 SAPPHIRE ADMINISTRATION SET Q Core Medical , Ltd. FPA Class II 2014-08-05
K140175 INTRAVASCULAR ADMINISTRATION SET Delta Med Spa FPA Class II 2014-08-05
K133942 ENDOSCOPE STERILIZATION TRAY Intuitive Surgical KCT Class II 2014-08-01
K141473 SMC ACUPUNCTURE NEEDLE Smc Intl., Inc. MQX Class II 2014-08-01
K141026 LEADERFLEX Vygon FOZ Class II 2014-07-30
K141254 ELCAM STOPCOCKS AND MANIFOLDS Elcam Medical Acal FMG Class II 2014-07-30
K141749 CAREFINE PEN NEEDLE FAMILY INCLUDING QUINTAPOINT AND SUPERPOINT Facet Technologies, LLC FMI Class II 2014-07-29
K141071 KIMGUARD ONE-STEP STERILIZATION WRAP Kimberly-Clark Health Care FRG Class II 2014-07-28
K141193 MEDFUSION 4000 PUMP DEVICE SPECIFIC REPORTS SOLFWARE FOR PHARMGUARD SERVER VERSION 2.0 Smiths Medical Asd, Inc. PHC Class II 2014-07-25
K141311 0.9% SODIUM CHLORIDE INJECTION, USP BD POSIFLUSH; SP SYRINGE, SF SYRINGE Becton, Dickinson and Company NGT Class II 2014-07-25
K140494 V-PRO STERILIZATION TRAY/ STERILIZATION MAT STERIS Corporation KCT Class II 2014-07-25
K140890 NITRILE POWDER FREE EXAMINATION GLOVES (WHITE/DAWN BLUE/DARK VIOLET BLUE (DVBU)/COBALT BLUE (CBLU) Hartalega NGC Sdn. Bhd. LZA Class I 2014-07-24
K141028 COLONGLIDE LUBRICANT Pediatric Pharmaceuticals, Inc. KMJ Class I 2014-07-24
K140498 V-PRO 60 LOW TEMPERATURE STERILIZATION SYSTEM STERIS Corporation MLR Class II 2014-07-24
K140487 VIS-U-ALL LOW TEMPERATURE STERILIZATION POUCH/TUBING STERIS Corporation FRG Class II 2014-07-22
K130097 MEDMATE TRANSFER ADAPTER AM5500 & AM5500-NS American Medical Manufacturing, Inc./ Advanced Med FMI Class II 2014-07-22
K133699 POWDER FREE GREEN, BLUE AND BROWN POLYCHLOROPRENE EXAMINATION GLOVES Pt. Smartglove Indonesia LZA Class I 2014-07-18
K141654 THE BELMONT RAPID INFUSER Belmont Instrument Corporation FRN Class II 2014-07-18
K140499 VERIFY V24 SELF-CONTAINED BIOLOGICAL INDICATOR FOR VAPORIZED VH202 STERILIZATION PROCESSES STERIS Corporation FRC Class II 2014-07-17
K140504 ACCUCATH BC INTRAVASCULAR CATHETER SYSTEM Vascular Pathways, Inc. FOZ Class II 2014-07-17
K140515 VERIFY HPU CHEMICAL INDICATOR/ VERIFY VAPORIZED VH202 PROCESS INDICATOR ADHESIVE LABEL STERIS Corporation JOJ Class II 2014-07-17
K140316 EXAMINATION GLOVES Hl Rubber Industries Sdn Bhd LZA Class I 2014-07-11
K133443 MARATHON NO STING LIQUID SKIN PROTECTANT Advanced Medical Solutions (Plymouth), Ltd. KMF Class I 2014-07-10

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