meddevicedb.com FDA Device Reference

Review Panel

General Hospital FDA 510(k) Clearances & Devices

Cleared Devices
15,723
Product Codes (page)
31
Latest Decision
2012-01-06

Clearances · page 36 of 158

K-Number Trade Name Applicant / Manufacturer Product Code Class Decision Date
K110559 AVITA INFRARED THEROMETER WITH BLUETOOTH Avita Corporation FLL Class II 2012-01-06
K113159 U-RIGHT TD-1240 THERMOMETER Taidoc Technology Corporation FLL Class II 2012-01-06
K112789 EASY TOUCH Mhc Medical Products, LLC FMI Class II 2011-12-23
K112799 MED-RX EXTENSION SET WITH T-CONNECTOR Benlan, Inc. FPA Class II 2011-12-23
K110794 AMECATH CVC AND AMECATH PRESSURE CVC SHORT TERM SINGLE AND MULTI-LUMEN CATHERIZATION KITS Ameco Medical Industries FOZ Class II 2011-12-21
DEN100013 VIOGUARD SELF-SANITIZING KEYBOARD, MODEL UVKB50 Vioguard OSZ Class II 2011-12-20
K113598 POWER-LOAD COT FASTENER SYSTEM Stryker Medical FPO Class II 2011-12-20
K113043 DIRECT ANTIBIOTIC INFUSION KIT Summit Medical Products, Inc. LJS Class II 2011-12-20
K112289 DISPOSABLE THERMOMETER COVERS AND SHEATHS Kang ZE Industrial Co. Limited FLL Class II 2011-12-16
K112055 AMSCO CHIMERON MEDIUM STEAM STERILIZER STERIS Corporation FLE Class II 2011-12-16
K112743 SAME/VARIOUS DISTRIBUTORS/WE MAY PRIVATE LABEL Clean Medical Manfacturing Co;Ltd LYZ Class I 2011-12-16
K113193 PATIENT EXAMINATION GLOVE Suqian Ruijang Medical Supplies Co., Ltd. LYZ Class I 2011-12-16
K111669 FREESTYLE GLUCOSE METER INCORPORATED INTO THE OMNIPOD INSULIN MANAGEMENT SYSTEMS Insulet Corporation LZG Class II 2011-12-15
K111313 EXSEPT SKIN AND WOUND CLEANSER WITH ANTIMICROBIAL PRESERVATIVE Alcavis Hdc, LLC FQH Class II 2011-12-14
K112057 KDL SYRINGES AND NEEDLE Shanghai Kindly Enterprise Dev. Group Co., FMF Class II 2011-12-14
K111736 TUTTNAUER EZ PLUS SERIES ELECTRONIC TABLETOP AUTOCLAVES Tuttnauer Co. , Ltd. FLE Class II 2011-12-08
K113227 NON-DEHP MICRO-VOLUME EXTENSION SET WITH 0.22 MICRON FILTER Baxter Healthcare Corp FPB Class II 2011-12-08
K111637 INFRARED EAR THERMOMETER Radiant Innovation, Inc. FLL Class II 2011-12-06
K112610 SYNTHETIC VINYL EXAMINATION GLOVES, POWDER FREE (AND MULTIPLE LABELS) Inpro Technology Device Factory LYZ Class I 2011-12-05
K112813 AMSCO V-PRO Steris Corp MLR Class II 2011-12-01
K111248 NON-STERILE, POWDER-FREE NITRILE EXAMINATION GLOVES (ORIGINAL BLUE, COBALT BLUE) Yty Industry (Manjung) Sdn Bhd LZA Class I 2011-12-01
K110424 DIGNITY MINI PORT- ATTACHABLE; DIGNITY MINI PORT- PRE ATTACHED; DIGNITY LOW PROFILE PORT- ATTACHABLE; DIGNITY LOW PROFIL Medcomp ( Medical Components) LJT Class II 2011-11-30
K113241 BD EMERALD SINGLE USE, HYPODERMIC SYRINGE Becton Dickinson FMF Class II 2011-11-28
K112636 CYTOGUARD(TM) CLOSED LUER CONNECTOR B.Braun Medical, Inc. FPA Class II 2011-11-26
K112760 AMSCO V-PRO MAX LOW TEMPERATURE STERILIZATION SYSTEM STERIS Corporation MLR Class II 2011-11-22
K113191 POWER FREE VINYL PATIENT EXAMINATION GLOVES, YELLOW COLOR Suqian Ruijang Medical Supplies Co., Ltd. LYZ Class I 2011-11-17
K113195 POWDERED VINYL PATIENT EXAMINATION GLOVES, CLEAR (NON-COLORED) Suqian Ruijang Medical Supplies Co., Ltd. LYZ Class I 2011-11-16
K112475 XTRACT SYRINGE KEY SYSTEM Xtract Solutions FMF Class II 2011-11-10
K112985 CATHETER CONNECTIONS' DUALCAP DUO Catheter Connections, Inc. QBP Class II 2011-11-09
K112988 POWDER FREE LATEX PATIENT EXAM GLOVE WITH PROTEIN LABELING CLAIM (50 MICROGRAMS PER DM SQUARED OR LESS OF WATER SOLUBLE Northstar Healthcare Holdings Limited LYY Class I 2011-11-09
K111210 T:SLIM (TM) INSULIN DELIVERY SYSTEM Tandem Diabetes Care, Inc. LZG Class II 2011-11-09
K111392 WOOJEON ACUPUNCTURE NEEDLE (=SERA ACUPUNCTURE NEEDLE) Woojeon Company MQX Class II 2011-11-04
K110715 INTERDRY SILVER Milliken Healthcare Products, LLC FRL Class I 2011-11-04
K111923 SKIN GUARD, POWDER FREE LATEX EXAMINATION GLOVES, NON-STERILE Pt. Intan Hevea Industry LYY Class I 2011-11-04
K112713 NORFOLK MEDICAL-SPORTPORT-FAMILY OF PORTS Norfolk Medical Products, Inc. LJT Class II 2011-10-27
K112222 ALCATRON AND / OR MULTIPLE BRAND Alcatron Gloves Factory LYZ Class I 2011-10-27
K110979 DERMAGRIP ULTRA POWDER FREE BLUE NITRILE PATIENT EXAMINATION GLOVES NON-STERILE,TESTED FOR USE W/ CHEMOTHERAPY DRUGS Advanced Medical Products Sdn Bhd LZA Class I 2011-10-20
K111772 POWDER FREE NITRILE PATIENT EXAMINATION GLOVE, BLUE COLORED AND WHITE (NON-COLORED). NON-STERILE Kossan Latex Industries(M)Sdn Bhd LZA Class I 2011-10-20
K112744 SAPIENS TIP CONFIRMATION SYSTEM C.R. Bard, Inc. LJS Class II 2011-10-20
K112283 DURA BLUE STERILIZATION WRAP Cardinal Health200, LLC FRG Class II 2011-10-20
K112512 VANISHPOINT BLOOD COLLECTION SET Retractable Technologies, Inc. FPA Class II 2011-10-20
K112211 DURA BLUE STERILIZATION WRAP Cardinal Health200, LLC FRG Class II 2011-10-20
K112893 CLEARLINK LUER ACTIVATED VALVE, CLEARLINK SYSTEM NON-DEHP CATHETER EXTENSION SETS Baxter Healthcare Corporation FPA Class II 2011-10-18
K112929 THERMOFLASH(TM) INFRARED THERMOMETER Visiomed Group SA FLL Class II 2011-10-18
K110250 MPXX POWDER FREE NATURAL RUBBER EXAMINATION GLOVES Total Gloves Sdn Bhd LYY Class I 2011-10-14
K112370 WELLDOC DIABETES MANAGER SYSTEM AND DIABETES MANAGER RX SYSTEM Welldoc, Inc. MRZ Class II 2011-10-14
K110407 INVISIPORT Stealth Therapeutics, Incorporated LJT Class II 2011-10-13
K112703 SHAKER DIGITAL THERMOMETER Measure Technology Co. , Ltd. FLL Class II 2011-10-04
K112116 DIGITAL CLINICAL THERMOMETER MODEL V901US Amperor-Electronic(Sz) Co., Ltd. FLL Class II 2011-10-04
K111662 VENOTRAIN CURAFLOW Bauerfeind AG DWL Class II 2011-10-04
K103675 CHIENMAX VIETNAM CO. LTD POWDER FREE BLUE NITRILE EXAMINATION GLOVE Chienmax Vietnam Co., Ltd. LZA Class I 2011-10-03
K111366 BD NEXIVA DIFFUSICS CLOSED IV CATHETER SYSTEM Becton, Dickinson and Company (BD) FOZ Class II 2011-09-30
K110606 MV INTRADERMIC NEEDLES; MAGIC NEEDLE; MAGIC NEEDLE M.V.S.R.L. FMI Class II 2011-09-29
K111351 TRUECARE BIOMEDIX INTRAVASCULAR ADMINISTRATION SET, TRUECARE BIOMEDIX EXTENSION SET Us Infusion Dba Truecare Biomedix FPA Class II 2011-09-29
K112347 RAPID INTRAVASCULAR CATHETER START SYSTEM 22 GAUGE / 20 GAUGE / 18 GAUGE Vascular Pathways, Inc. FOZ Class II 2011-09-22
K111797 27 G X 1/2 K-PACK SURSHIELD NEEDLE Terumo Europe N.V. FMI Class II 2011-09-22
K111857 SYNTHETIC VINYL EXAMINATION GLOVE POWDER FREE Inmed Gloves Factory LYZ Class I 2011-09-21
K110914 TRIPLE LUMEN PFM PICC Pfm Medical, Inc. LJS Class II 2011-09-21
K111223 AMSCO CHIMERON SMALL STEAM STERILIZER STERIS Corporation FLE Class II 2011-09-20
K112067 NAVIGATOR DELIVERY SYSTEM (NAVIGATOR DS) Carticept Medical, Inc. FRN Class II 2011-09-16
K110945 POWDER-FREE YELLOW SYNTHETIC VINYL PATIENT EXAMINATION GLOVES Zhaoyang Plastic Co., Ltd. LYZ Class I 2011-09-13
K111577 MEDLINE VIAL DECANTER Medline Industries, Inc. LHI Class II 2011-09-08
K111734 MYSAFETY SYRINGE Medicalchain Intl. Corp. MEG Class II 2011-09-06
K111810 AMSCO V-PRO 1 AND V-PRO 1 PLUS LOW TEMPERATURE STERILIZATION UNITS STERIS Corporation MLR Class II 2011-09-02
K110944 POWDER-FREE VINYL PATIENT EXAMINATION GLOVES Wangda Plastic Co., Ltd. LYZ Class I 2011-09-01
K103331 VERIFY BIOLOGICAL INDICATOR CHALLENGE PACK FOR VAPORIZED VH202 STERILIZATION PROCESSES STERIS Corporation JOJ Class II 2011-09-01
K112376 S-CATH ESOPHAGEAL TEMPERATURE PROBE AND TEMPERATURE MONITORING SYSTEM Circa Scientific, LLC FLL Class II 2011-08-31
K111236 INTROCAN SAFETY (R) 3 CLOSED IV CATHETER 18GA X 1-3/4 (45MM) AND 18GA X 1-1/4 (32MM) / 20GA X 1-1/4 (32MM) / 20GA X 1 B.Braun Melsungen AG FOZ Class II 2011-08-30
K111386 MEDFUSION MODEL 4000 SYRINGE INFUSION PUMP, PHARMGUARD TOOLBOX 2 MEDICATION SAFETY SOFTWARE AND SUPPORTED SYRINGES (PSS) Smiths Medical MD, Inc. FRN Class II 2011-08-29
K111101 NORPORT CT-PC, LUCENT NON-CORING NEEDEL INFUSION SET Norfolk Medical LJT Class II 2011-08-25
K110776 DIGITAL THERMOMETER MT SERIES Sejoy Electronics & Instruments Co., Ltd. FLL Class II 2011-08-24
K110621 SHENGKUN CHEMICAL Zibo Shengkun Chemical Industrial Co., Ltd. LYZ Class I 2011-08-24
K111589 POWDER FREE NITRILE PATIENT EXAMINATION GLOVE WITH COLLOIDAL OATMEAL USP A SKIN PROTECTANT DRUG Derma Care Plus Products, LLC LZA Class I 2011-08-23
K110016 POWDER FREE VINYL PATIENT EXAMINATION GLOVES, COLORED (YELLOW) Rongyao Plastic Produce Co., Ltd. LYZ Class I 2011-08-23
K103734 POWDER FREE NITRILE EXAMINATION GLOVES WHITE COLORED NON-STERILE Central Medicare Sdn Bhd LZA Class I 2011-08-19
K110882 IMC INSULIN SYRINGE International Medsurg Connection FMF Class II 2011-08-18
K110656 IMC BLOOD COLLECTION NEEDLE International Medsurg Connection FMI Class II 2011-08-18
K102394 AMSCO V-PRO 1 LOW TEMPERATURE STERILIZATION SYSTEM; AMSCO V-PRO 1 PLUS LOW TEMPERATURE STERILIZATION SYSTEM STERIS Corporation MLR Class II 2011-08-18
K103735 MEDILED MINI Medix I.C.S.A. LBI Class II 2011-08-15
K111974 ION HEALTH USB INSTA-SCAN THERMOMETER Taidoc Technology Corporation FLL Class II 2011-08-15
K111300 SENSTOUCH NITRILE EXAMINATION GLOVES, POWDER FREE, NON STERILE (GREEN, ORANGE, VIOLET AND WHITE) Pt Mahakarya Inti Buana LZA Class I 2011-08-12
K102330 AMSCO V-PRO MAX LOW TEMPERATURE STERILIZATION SYSTEM STERIS Corporation MLR Class II 2011-08-12
K110627 NEXSITE 9FR DUAL LUMEN CRITICAL CARE CENTRAL VENOUS CATHETER Marvao Medical Devices, Ltd. LJS Class II 2011-08-12
K110758 NITRILE POWDER FREE EXAMINATION GLOVES Hartalega Sdn Bhd LZA Class I 2011-08-12
K111632 INFILL GRAFT DELIVERY SYSTEM Pinnacle Spine Group, LLC FMF Class II 2011-08-11
K111282 DISPOSABLE TEMPERATURE PROBES / SENSORS AND INTERCONNECT INSTRUMENT CABLES Starboard Medical, LLC FLL Class II 2011-08-11
K103619 SYNTHETIC EXAM GLOVE POWDER FREE COATED WITH ALLOGEL (GREEN/ BLUE / WHITE / MAGENTA / CLEAR - NON COLORED) Shandong Blue Sail Innovation Co., Ltd. LYZ Class I 2011-08-10
K111158 LATEX EXAMINATION GLOVES POWDER-FREE (BLACK COLOR) WITH PROTEIN LABELING CLAIM (50 MICROGRAMS OR LESS) Innovative Gloves Co;, Ltd. LYY Class I 2011-08-10
K102158 SIGMA STERILIZATION POUCH & ROLL Sigma Medical Supplies Corp. FRG Class II 2011-08-02
K110958 VERSAJET II HYDROSURGERY SYSTEM CONSOLE / EXACT HANDPIECES / PLUS HANDPIECES, VERSAJET FOOTSWITCH Smith & Nephew, Inc. FQH Class II 2011-08-01
K111424 VACUETTE PREMIUM SAFETY NEEDLE SYSTEM TUBE-TOUCH Medpro Safety Products, Inc. FMI Class II 2011-07-29
K111906 XCELA HYBRID PICC WITH PASV VALVE TECHNOLOGY Navilyst Medical, Inc. LJS Class II 2011-07-29
K103830 JIANGSU SHENLI MEDICAL PRODUCTION CO. LTD. PISTON SYRINGE (5CC LUER LOCK) Jiangsu Shenli Medical Production Factory FMF Class II 2011-07-29
K111870 AMSCO WARMING CABINET STERIS Corporation LGZ Class II 2011-07-29
K103740 SODIUM CHLORIDE INJECTION, 0.9%, USP 5 ML, 10 ML AMPULE Spectra Medical Devices, Inc. NGT Class II 2011-07-29
K110703 BD AUTOSHIELD DUO PEN NEEDLE Becton, Dickinson and Company FMI Class II 2011-07-27
K111517 PHARMAJET STRATIS 0.5 ML NEEDLE-FREE INJECTION SYSTEM MODEL 501-01, STRATIS INJECTOR CATALOG 501-10, STRATIS RESET STATI Pharmajet, Inc. KZE Class II 2011-07-27
K111752 POWDER FREE VINYL PATIENT EXAMINATION GLOVES, CLEAR (NON-COLORED) Shandong Jianhong New Material Company LYZ Class I 2011-07-27
K102405 INFUSION SET FOR POWERPICC SOLO 2 CATHETER C.R. Bard, Inc. FPA Class II 2011-07-21
K110970 POWDERED VINYL PATIENT EXAMINATION GLOVES, CLEAR (NON-COLORED) Ppp Medical and Safety Products Company Limited LYZ Class I 2011-07-21

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