meddevicedb.com FDA Device Reference

Review Panel

General Hospital FDA 510(k) Clearances & Devices

Cleared Devices
15,723
Product Codes (page)
31
Latest Decision
2007-03-20

Clearances · page 48 of 158

K-Number Trade Name Applicant / Manufacturer Product Code Class Decision Date
K070532 SPIROS Icu Medical, Inc. FPA Class II 2007-03-20
K062308 LMT-KATH-S; LMT-KATH-I Licher Medizintechnologie GmbH FPA Class II 2007-03-20
K062873 SUNPOLAR HEALTHLINE, MODEL 100; COMPFRESH, MODEL 200; NATUREX , MODEL 300; AND IHEALTH, MODEL 400 STOCKINGS E.C.I. USA Corporation DWL Class II 2007-03-20
K061504 POWDER FREE NITRILE BLUE EXAMINATION GLOVE Liwe Trading LZA Class I 2007-03-19
K070188 POWDER FREE VINYL PATIENT EXAMINATION GLOVE, YELLOW Hong DI Plastic Products Co., Ltd. LYZ Class I 2007-03-19
K070342 CLINICAL ELECTRONIC THERMOMETER, MODELS TP11403 THROUGH TP11413 American I.V. Products, Inc. FLL Class II 2007-03-19
K984207 SILVERLON DIRECT PRESSURE WOUND DRESSING Argentum International, LLC KMF Class I 2007-03-19
K070440 BD HYPOINT NEEDLE Becton, Dickinson & CO FMI Class II 2007-03-16
K062651 PROCHEM EXT CHEMICAL INTEGRATOR Raven Biological Laboratories, Inc. JOJ Class II 2007-03-15
K063581 SENSTOUCH HIGH RISK BLUE LATEX EXAMINATION GLOVES, POWDERED, NON STERILE Pt Mahakarya Inti Buana LYY Class I 2007-03-15
K070072 NON-CHLORINATED POLYMER COATED POWDER-FREE NATURAL LATEX EXAMINATION GLOVES Medtexx Manufacturing Sdn. Bhd. LYY Class I 2007-03-15
K070096 POWDER FREE NITRILE EXAMINATION GLOVES, BLUE, WHITE, PINK, BLACK AND GRAY COLOR Gx Corporation Sdn Bhd LZA Class I 2007-03-14
K062909 REPEATER PUMP II TUBE SETS Baxa Corp. FPA Class II 2007-03-09
K070026 POWDERED (YELLOW) VINYL PATIENT EXAMINATION GLOVES Shijiazhuang Lianhe Shunda Plastic Products Co., L LYZ Class I 2007-03-07
K063340 SAF-T-SYRINGE- 0.5 AND 1ML/CC Safety Medical International, Incorporated MEG Class II 2007-03-06
K063722 SEKURIT SHARPS COLLECTION CONTAINER Techen Safety, Inc. MMK Class II 2007-03-05
K063776 ABLE GLOVE LATEX POWDERED EXAMINATION GLOVES Bright Element Sdn Bhd LYY Class I 2007-03-02
K063466 TOP FINE Daejin Tech Medical Manufacturing Co., Ltd. FMI Class II 2007-03-02
K063348 TOP FINE INSULIN SYRINGE Daejin Tech Medical Manufacturing Co., Ltd. FMF Class II 2007-03-01
K070145 POWDERED VINYL PATIENT EXAMINATION GLOVES Wuxi Shenzhou Plastic Products Co., Ltd. LYZ Class I 2007-02-28
K063471 SHIJIAZHUANG JUNFEI PLASTICS PRODUCTS CO., LTD. POWDER FREE (WHITE) VINYL PATIENT EXAMINATION GLOVES Shijiazhuang Junfei Plastic Products Co., Ltd. LYZ Class I 2007-02-28
K062764 POWDER-FREE NITRILE PATIENT EXAMINATION GLOVE, WHITE (NON-COLORED) AND BLUE COLORED Kossan Latex Industries(M)Sdn Bhd LZC Class I 2007-02-27
K063755 PORTEX HYPODERMIC NEEDLE-PRO FIXED NEEDLE SYRINGE Smiths Medical Asd, Inc. MEG Class II 2007-02-27
K063696 COLLEAGUE VOLUMETRIC INFUSION PUMP MODEL# 2M8151,8153,8161,8163,9161,9163 Baxterhealthcare, Inc. FRN Class II 2007-02-27
K063535 CAPTION APPLICATOR Smith & Nephew, Inc. FMF Class II 2007-02-26
K061497 SYREX HEPARIN LOCK FLUSH SYRINGE, 1 UNIT/ML & 2 UNITS/ML Excelsior Medical Corp. NZW Class II 2007-02-23
K070149 POWDER-FREE VINYL PATIENT EXAMINATION GLOVES Wuxi Shenzhou Plastic Products Co., Ltd. LYZ Class I 2007-02-23
K063777 ABLE GLOVE NITRILE BLUE POWDER FREE EXAMINATION GLOVE Bright Element Sdn Bhd LZA Class I 2007-02-23
K070268 SIGNATURE EDITION INFUSION SYSTEM, MODELS 710X, 720X Cardinal Health 303,Inc. FRN Class II 2007-02-23
K070042 POWDERED VINYL PATIENT EXAMINATION GLOVES, YELLOW Super Safe Plastic Products Co., Ltd. LYZ Class I 2007-02-23
K070076 POWDER FREE VINYL PATINET EXAMINATION GLOVES, CLEAR (NON-COLORED) Jiangsu Cureguard Glove Co., Ltd. LYZ Class I 2007-02-22
K070189 ACCU-CHEK ULTRAFLEX INFUSION SET Disetronic Medical Systems AG FPA Class II 2007-02-21
K070037 POWDER FREE VINYL PATIENT EXAMINATION GLOVE Shijiazhuang Lianhe Shunda Plastic Products Co., L LYZ Class I 2007-02-20
K062527 BLUE POWDER FREE LATEX EXAMINATION GLOVES, NON-STERILE Multisafe Sdn. Bhd. LYY Class I 2007-02-20
K070030 POWDER FREE VINYL PATIENT EXAMINATION GLOVE Super Safe Plastic Products Co., Ltd. LYZ Class I 2007-02-16
K062445 MONITORING EAR THERMOMETER, MODEL BTM-D1A Rio Flexon Technology Co., Ltd. FLL Class II 2007-02-16
K070187 POWDER FREE VINYL PATIENT EXAMINATION GLOVE Hong DI Plastic Products Co., Ltd. LYZ Class I 2007-02-13
K070075 POWDERED VINYL PATIENT EXAMINATION GLOVES, CLEAR (NON-COLORED) Jiangsu Cureguard Glove Co., Ltd. LYZ Class I 2007-02-09
K063114 DISPOSABLE TRANSFER SETS WITH AND WITHOUT SWABBABLE VALVES AND/OR CHECK VALVES Coeur, Inc. FPK Class II 2007-02-09
K070028 CLASSIC/HYPOTHERMIA, FLEXIBLE, 10-SECOND, LEFT-RIGHT HANDED, BASAL, LIGHTWEIGHT-PROBE DIGITAL CLINICAL THERMOMETER Actherm, Inc. FLL Class II 2007-02-08
K070043 POWDER FREE VINYL PATIENT EXAMINATION GLOVES, WHITE Super Safe Plastic Products Co., Ltd. LYZ Class I 2007-02-08
K062753 FORSURE DISPOSABLE SYRINGE WITH NEEDLE, MODEL 1CC, 3C, 5CC, 10CC, 20CC, 50CC Surgimed, Inc. FMF Class II 2007-02-08
K063522 POWDER NITRILE EXAMINATION GLOVE (WHITE AND BLUE COLOR) Hl Rubber Industries Sdn Bhd LZA Class I 2007-02-08
K070008 POWDERED VINYL PATIENT EXAMINATION GLOVES Zibo Hengde Plastic & Rubber Products Co., Ltd. LYZ Class I 2007-02-08
K070046 POWDERED VINYL PATIENT GLOVE Shijiazhuang Lianhe Shunda Plastic Products Co., L LYZ Class I 2007-02-07
K062339 DERMOTHERAP GUN Dermoequipos S.R.L. KZH Class II 2007-02-05
K063418 ACON DIGITAL THERMOMETER PROBE COVERS ACON Laboratories, Inc. FLL Class II 2007-02-02
K063126 DANA DIABECARE IIS Sooil Development Co., Ltd. LZG Class II 2007-02-02
K061108 STRYKER AUTO IRRIGATION SYSTEM Stryker FRN Class II 2007-02-02
K063711 TUTTNAUER PREVACUUM STEAM HEATED AUTOCLAVE, MODELS 6990 SP-1A, 66120 SP-1A, 69150 SP-2A, 69120 L USA SP-2A, 69180 SP-2HA Tuttnauer Co. , Ltd. FLE Class II 2007-02-02
K062414 VORTEX CT PORT ACCESS SYSTEM AND LIFEGUARD SAFETY INFUSION SET Rita Medical Systems, Inc. LJT Class II 2007-02-01
K070044 POWDER FREE (YELLOW) VINYL PATIENT EXAMINATION Shijiazhuang Lianhe Shunda Plastic Products Co., L LYZ Class I 2007-01-29
K070040 POWDERED VINYL PATIENT EXAMINATION GLOVES, WHITE Super Safe Plastic Products Co., Ltd. LYZ Class I 2007-01-26
K063530 ON-Q, PAINBUSTER, C-BLOC, SELECT-A-FLOW, ONDEMAND, HOMEPUMP, ECLIPSE, C-SERIES, ONE-STEP KVO, EASYPUMP I-Flow Corp. MEB Class II 2007-01-26
K063851 AUTO-FILL SYRINGE KIT, MODEL 7600 Vascular Solutions, Inc. FMF Class II 2007-01-26
K063567 EZ-MIO STERNAL Vidacare Corporation FMI Class II 2007-01-26
K061242 DERMATHERAPY, MODEL 22216 Precision Fabrics Group, Inc. FMW Class I 2007-01-25
K052973 IPUMP PAIN MANAGEMENT SYSTEM, MODEL 2L3107, 2L3107K Baxter Healthcare Corp FRN Class II 2007-01-25
K063666 SHARPS CONTAINER, MODEL 039-413 Biodex Medical Systems, Inc. MMK Class II 2007-01-25
K063377 POWERPORT POLYMETRIC PORT WITH 8 FR S/L CHRONOFLEX CATHETER C.R. Bard, Inc. LJT Class II 2007-01-25
K063450 PORTEX HYPODERMIC NEEDLE- PRO EDGE SAFETY DEVICE, 18GX1, 401810, 19GX1, 401910, 20GX1,402010, 21GX1402110 Smiths Medical Asd, Inc. FMI Class II 2007-01-25
K063524 POWDER FREE NITRILE EXAMINATION GLOVES (WHITE AND BLUE COLOR) Hl Rubber Industries Sdn Bhd LZA Class I 2007-01-23
K070035 POWDERED VINYL PATIENT EXAMINATION GLOVE Super Safe Plastic Products Co., Ltd. LYZ Class I 2007-01-23
K070006 POWDER-FREE VINYL PATIENT EXAMINATION GLOVES Zibo Hengde Plastic & Rubber Products Co., Ltd. LYZ Class I 2007-01-19
K063285 RELIANCE CI PROCESS INDICATOR Albert Browne , Ltd. JOJ Class II 2007-01-12
K063151 HUMAPEN LUXURA HD Eli Lilly and Co. NSC Class II 2007-01-09
K063799 STEAMPLUS STEAM INTEGRATOR Spsmedical Supply Corp. JOJ Class II 2007-01-05
K062780 CLICKZIP, MODEL U-100 INSULIN SAFETY SYRINGE Medical Device Manufacturer (Thailand) , Ltd. MEG Class II 2007-01-05
K062318 BIOTOP HOOKSAFE U-100 INSULIN SYRINGE, MODELS 0.5CC/ML AND 1CC/ML Biotop Technology Co., Ltd. MEG Class II 2007-01-03
K063613 MODIFICATION TO TERUMO SYRINGE WITH/WITHOUT NEEDLE Terumo Medical Corp. FMF Class II 2006-12-26
K062940 BONE INJECTION GUN (B.I.G.) Waismed, Ltd. FMI Class II 2006-12-22
K061615 INTERDRY TEXTILE WITH SILVER Milliken Chemical FRL Class I 2006-12-22
K063160 ALLERGEAZE PATCH TEST CHAMBERS Smartpractice KXF Class I 2006-12-22
K062965 CHLORINATED, POLYMER-COATED POWDER-FREE LATEX EXAMINATION GLOVE WITH PROTEIN LABELING CLAIM Kossan Latex Industries(M)Sdn Bhd LYY Class I 2006-12-22
K060851 SOFT SACK IV FLUID WARMER, THE FLOORMOUNT IV FLUID WARMER, THE PAK 2 IV WARMER AND THE THERMAL SAC PRESSURE INFUSER The Smithworks Company LGZ Class II 2006-12-22
K062714 SYNTHETIC VINYL PATIENT EXAM GLOVES, PRE-POWDERED, YELLOW Baoding Guanzhong Glove Co., Ltd. LYZ Class I 2006-12-15
K061033 MILTEX RIGID STERILIZATION CONTAINER SYSTEM, (47 COMPONENTS) Miltex, Inc. KCT Class II 2006-12-12
K063239 LIFESHIELD LATEX-FREE GRAVITECH FLOW CONTROLLER I.V. SETS, MODELS 17528, 17527, 17525 & 17526 Hospira, Inc. FPK Class II 2006-12-11
K062602 BAND-AID(R) BRAND LIQUID BANDAGE Johnson & Johnson Consumer Companies, Inc. KMF Class I 2006-12-11
K063215 EVER LIGHT PLASTIC PRODUCTS CO., LTD. POWDERED (YELLOW) VINYL PATIENT EXAMINATION GLOVES Ever Light Plastic Products Co., Ltd. LYZ Class I 2006-12-08
K062986 MEDTRONIC GRAFT DELIVERY SYRINGE Medtronic Sofamor Danek USA, Inc. FMF Class II 2006-12-08
K063142 MANUAL PD-IO; POWERED PD-IO Vidacare Corporation FMI Class II 2006-12-08
K063214 EVER LIGHT PLASTIC PRODUCTS CO., LTD. POWDERED (WHITE) VINYL PATIENT EXAMINATION GLOVES Ever Light Plastic Products Co., Ltd. LYZ Class I 2006-12-08
K062709 POWDER FREE LATEX EXAMINATION GLOVES, BLACK Pt. Maja Agung Latexindo LYY Class I 2006-12-06
K062867 MICROLIFE INSTANT DIGITAL ELECTRONIC THERMOMETER, MODEL QT1JC1 Microlife Intellectual Property GmbH FLL Class II 2006-12-06
K062100 ARJOWRAP 47/100 AND 47/88 Arjo Wiggins Medical, Inc. FRG Class II 2006-12-05
K062956 EZ-MIO, EZ-IO DISTAL TIBIA Vidacare Corporation FMI Class II 2006-12-05
K063213 EVER LIGHT PLASTIC PRODUCTS CO., LTD. POWDER FREE (WHITE) VINYL PATIENT EXAMINATION GLOVES Ever Light Plastic Products Co., Ltd. LYZ Class I 2006-12-05
K063469 MEDICAN ALPHA Eastern Medikit , Ltd. FOZ Class II 2006-12-01
K062688 POWDER-FREE BLACK LATEX EXAMINATION GLOVE WITH PROTEIN LABELING CLAIM Ug Healthcare (Usa), Inc. LYY Class I 2006-11-30
K062313 SENSTOUCH HIGH RISK LATEX EXAMINATION GLOVES, POWDER FREE, NON STERILE Pt Mahakarya Inti Buana LYY Class I 2006-11-30
K062702 ULTICARE DISPOSABLE SYRINGES AND NEEDLES Ultimed, Inc. FMF Class II 2006-11-29
K062592 CADD-SENTRY PRO MEDICATION SAFETY SOFTWARE Smiths Medical MD, Inc. FRN Class II 2006-11-29
K062579 OMNIPICC P.I. Rita Medical Systems, Inc. LJS Class II 2006-11-28
K063288 SIGNATURE EDITION GOLD INFUSION SYSTEM, MODEL 7X3X Cardinal Health 303,Inc. FRN Class II 2006-11-28
K063146 ACCU-CHEK LINKASSIST Disetronic Medical Systems AG KZH Class II 2006-11-27
K061517 PRECISION PRESS TACK / INTRADERM, SEVEN STAR AND ACUPUNCTURE NEEDLES; ALPHA AND FINE POINT ACUPUNCTURE NEEDLES Prime Herbs Corporation MQX Class II 2006-11-22
K050263 MILLENNIUM SERIES, INCLUDING MILLENNIUM B, B+, B2 AND BU M.O. Com S.R.L. FLE Class II 2006-11-21
K063240 SHERLOCK TLS STYLET, SHERLOCK TLS DETECTOR C.R. Bard, Inc. LJS Class II 2006-11-21
K063291 INFRARED EAR THERMOMETER, MODEL IRT-21 AND IRT-22 Choice Smart Health Care Co. , Ltd. FLL Class II 2006-11-21

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