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General Hospital

15,616 FDA 510(k) clearances · Medical specialty

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RecordFirmDate
CYTOGUARD(TM) CLOSED LUER CONNECTOR (K112636)B.Braun Medical, Inc.2011-11-26
AMSCO V-PRO MAX LOW TEMPERATURE STERILIZATION SYSTEM (K112760)STERIS Corporation2011-11-22
POWER FREE VINYL PATIENT EXAMINATION GLOVES, YELLOW COLOR (K113191)Suqian Ruijang Medical Supplies Co., Ltd.2011-11-17
POWDERED VINYL PATIENT EXAMINATION GLOVES, CLEAR (NON-COLORED) (K113195)Suqian Ruijang Medical Supplies Co., Ltd.2011-11-16
XTRACT SYRINGE KEY SYSTEM (K112475)Xtract Solutions2011-11-10
T:SLIM (TM) INSULIN DELIVERY SYSTEM (K111210)Tandem Diabetes Care, Inc.2011-11-09
POWDER FREE LATEX PATIENT EXAM GLOVE WITH PROTEIN LABELING CLAIM (50 MICROGRAMS PER DM SQUARED OR LESS OF WATER SOLUBLE (K112988)Northstar Healthcare Holdings Limited2011-11-09
CATHETER CONNECTIONS' DUALCAP DUO (K112985)Catheter Connections, Inc.2011-11-09
INTERDRY SILVER (K110715)Milliken Healthcare Products, LLC2011-11-04
WOOJEON ACUPUNCTURE NEEDLE (=SERA ACUPUNCTURE NEEDLE) (K111392)Woojeon Company2011-11-04
SKIN GUARD, POWDER FREE LATEX EXAMINATION GLOVES, NON-STERILE (K111923)Pt. Intan Hevea Industry2011-11-04
ALCATRON AND / OR MULTIPLE BRAND (K112222)Alcatron Gloves Factory2011-10-27
NORFOLK MEDICAL-SPORTPORT-FAMILY OF PORTS (K112713)Norfolk Medical Products, Inc.2011-10-27
POWDER FREE NITRILE PATIENT EXAMINATION GLOVE, BLUE COLORED AND WHITE (NON-COLORED). NON-STERILE (K111772)Kossan Latex Industries(M)Sdn Bhd2011-10-20
SAPIENS TIP CONFIRMATION SYSTEM (K112744)C.R. Bard, Inc.2011-10-20
DERMAGRIP ULTRA POWDER FREE BLUE NITRILE PATIENT EXAMINATION GLOVES NON-STERILE,TESTED FOR USE W/ CHEMOTHERAPY DRUGS (K110979)Advanced Medical Products Sdn Bhd2011-10-20
DURA BLUE STERILIZATION WRAP (K112283)Cardinal Health200, LLC2011-10-20
VANISHPOINT BLOOD COLLECTION SET (K112512)Retractable Technologies, Inc.2011-10-20
DURA BLUE STERILIZATION WRAP (K112211)Cardinal Health200, LLC2011-10-20
THERMOFLASH(TM) INFRARED THERMOMETER (K112929)Visiomed Group SA2011-10-18
CLEARLINK LUER ACTIVATED VALVE, CLEARLINK SYSTEM NON-DEHP CATHETER EXTENSION SETS (K112893)Baxter Healthcare Corporation2011-10-18
WELLDOC DIABETES MANAGER SYSTEM AND DIABETES MANAGER RX SYSTEM (K112370)Welldoc, Inc.2011-10-14
MPXX POWDER FREE NATURAL RUBBER EXAMINATION GLOVES (K110250)Total Gloves Sdn Bhd2011-10-14
INVISIPORT (K110407)Stealth Therapeutics, Incorporated2011-10-13
SHAKER DIGITAL THERMOMETER (K112703)Measure Technology Co. , Ltd.2011-10-04
DIGITAL CLINICAL THERMOMETER MODEL V901US (K112116)Amperor-Electronic(Sz) Co., Ltd.2011-10-04
VENOTRAIN CURAFLOW (K111662)Bauerfeind AG2011-10-04
CHIENMAX VIETNAM CO. LTD POWDER FREE BLUE NITRILE EXAMINATION GLOVE (K103675)Chienmax Vietnam Co., Ltd.2011-10-03
BD NEXIVA DIFFUSICS CLOSED IV CATHETER SYSTEM (K111366)Becton, Dickinson and Company (BD)2011-09-30
TRUECARE BIOMEDIX INTRAVASCULAR ADMINISTRATION SET, TRUECARE BIOMEDIX EXTENSION SET (K111351)Us Infusion Dba Truecare Biomedix2011-09-29
MV INTRADERMIC NEEDLES; MAGIC NEEDLE; MAGIC NEEDLE (K110606)M.V.S.R.L.2011-09-29
RAPID INTRAVASCULAR CATHETER START SYSTEM 22 GAUGE / 20 GAUGE / 18 GAUGE (K112347)Vascular Pathways, Inc.2011-09-22
27 G X 1/2 K-PACK SURSHIELD NEEDLE (K111797)Terumo Europe N.V.2011-09-22
SYNTHETIC VINYL EXAMINATION GLOVE POWDER FREE (K111857)Inmed Gloves Factory2011-09-21
TRIPLE LUMEN PFM PICC (K110914)Pfm Medical, Inc.2011-09-21
AMSCO CHIMERON SMALL STEAM STERILIZER (K111223)STERIS Corporation2011-09-20
NAVIGATOR DELIVERY SYSTEM (NAVIGATOR DS) (K112067)Carticept Medical, Inc.2011-09-16
POWDER-FREE YELLOW SYNTHETIC VINYL PATIENT EXAMINATION GLOVES (K110945)Zhaoyang Plastic Co., Ltd.2011-09-13
MEDLINE VIAL DECANTER (K111577)Medline Industries, Inc.2011-09-08
MYSAFETY SYRINGE (K111734)Medicalchain Intl. Corp.2011-09-06
AMSCO V-PRO 1 AND V-PRO 1 PLUS LOW TEMPERATURE STERILIZATION UNITS (K111810)STERIS Corporation2011-09-02
POWDER-FREE VINYL PATIENT EXAMINATION GLOVES (K110944)Wangda Plastic Co., Ltd.2011-09-01
VERIFY BIOLOGICAL INDICATOR CHALLENGE PACK FOR VAPORIZED VH202 STERILIZATION PROCESSES (K103331)STERIS Corporation2011-09-01
S-CATH ESOPHAGEAL TEMPERATURE PROBE AND TEMPERATURE MONITORING SYSTEM (K112376)Circa Scientific, LLC2011-08-31
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 (K111236)B.Braun Melsungen AG2011-08-30
MEDFUSION MODEL 4000 SYRINGE INFUSION PUMP, PHARMGUARD TOOLBOX 2 MEDICATION SAFETY SOFTWARE AND SUPPORTED SYRINGES (PSS) (K111386)Smiths Medical MD, Inc.2011-08-29
NORPORT CT-PC, LUCENT NON-CORING NEEDEL INFUSION SET (K111101)Norfolk Medical2011-08-25
DIGITAL THERMOMETER MT SERIES (K110776)Sejoy Electronics & Instruments Co., Ltd.2011-08-24
SHENGKUN CHEMICAL (K110621)Zibo Shengkun Chemical Industrial Co., Ltd.2011-08-24
POWDER FREE NITRILE PATIENT EXAMINATION GLOVE WITH COLLOIDAL OATMEAL USP A SKIN PROTECTANT DRUG (K111589)Derma Care Plus Products, LLC2011-08-23
POWDER FREE VINYL PATIENT EXAMINATION GLOVES, COLORED (YELLOW) (K110016)Rongyao Plastic Produce Co., Ltd.2011-08-23
POWDER FREE NITRILE EXAMINATION GLOVES WHITE COLORED NON-STERILE (K103734)Central Medicare Sdn Bhd2011-08-19
IMC BLOOD COLLECTION NEEDLE (K110656)International Medsurg Connection2011-08-18
AMSCO V-PRO 1 LOW TEMPERATURE STERILIZATION SYSTEM; AMSCO V-PRO 1 PLUS LOW TEMPERATURE STERILIZATION SYSTEM (K102394)STERIS Corporation2011-08-18
IMC INSULIN SYRINGE (K110882)International Medsurg Connection2011-08-18
MEDILED MINI (K103735)Medix I.C.S.A.2011-08-15
ION HEALTH USB INSTA-SCAN THERMOMETER (K111974)Taidoc Technology Corporation2011-08-15
NITRILE POWDER FREE EXAMINATION GLOVES (K110758)Hartalega Sdn Bhd2011-08-12
SENSTOUCH NITRILE EXAMINATION GLOVES, POWDER FREE, NON STERILE (GREEN, ORANGE, VIOLET AND WHITE) (K111300)Pt Mahakarya Inti Buana2011-08-12
AMSCO V-PRO MAX LOW TEMPERATURE STERILIZATION SYSTEM (K102330)STERIS Corporation2011-08-12
NEXSITE 9FR DUAL LUMEN CRITICAL CARE CENTRAL VENOUS CATHETER (K110627)Marvao Medical Devices, Ltd.2011-08-12
DISPOSABLE TEMPERATURE PROBES / SENSORS AND INTERCONNECT INSTRUMENT CABLES (K111282)Starboard Medical, LLC2011-08-11
INFILL GRAFT DELIVERY SYSTEM (K111632)Pinnacle Spine Group, LLC2011-08-11
LATEX EXAMINATION GLOVES POWDER-FREE (BLACK COLOR) WITH PROTEIN LABELING CLAIM (50 MICROGRAMS OR LESS) (K111158)Innovative Gloves Co;, Ltd.2011-08-10
SYNTHETIC EXAM GLOVE POWDER FREE COATED WITH ALLOGEL (GREEN/ BLUE / WHITE / MAGENTA / CLEAR - NON COLORED) (K103619)Shandong Blue Sail Innovation Co., Ltd.2011-08-10
SIGMA STERILIZATION POUCH & ROLL (K102158)Sigma Medical Supplies Corp.2011-08-02
VERSAJET II HYDROSURGERY SYSTEM CONSOLE / EXACT HANDPIECES / PLUS HANDPIECES, VERSAJET FOOTSWITCH (K110958)Smith & Nephew, Inc.2011-08-01
JIANGSU SHENLI MEDICAL PRODUCTION CO. LTD. PISTON SYRINGE (5CC LUER LOCK) (K103830)Jiangsu Shenli Medical Production Factory2011-07-29
VACUETTE PREMIUM SAFETY NEEDLE SYSTEM TUBE-TOUCH (K111424)Medpro Safety Products, Inc.2011-07-29
AMSCO WARMING CABINET (K111870)STERIS Corporation2011-07-29
SODIUM CHLORIDE INJECTION, 0.9%, USP 5 ML, 10 ML AMPULE (K103740)Spectra Medical Devices, Inc.2011-07-29
XCELA HYBRID PICC WITH PASV VALVE TECHNOLOGY (K111906)Navilyst Medical, Inc.2011-07-29
BD AUTOSHIELD DUO PEN NEEDLE (K110703)Becton, Dickinson and Company2011-07-27
POWDER FREE VINYL PATIENT EXAMINATION GLOVES, CLEAR (NON-COLORED) (K111752)Shandong Jianhong New Material Company2011-07-27
PHARMAJET STRATIS 0.5 ML NEEDLE-FREE INJECTION SYSTEM MODEL 501-01, STRATIS INJECTOR CATALOG 501-10, STRATIS RESET STATI (K111517)Pharmajet, Inc.2011-07-27
POWDERED VINYL PATIENT EXAMINATION GLOVES, CLEAR (NON-COLORED) (K110970)Ppp Medical and Safety Products Company Limited2011-07-21
INFUSION SET FOR POWERPICC SOLO 2 CATHETER (K102405)C.R. Bard, Inc.2011-07-21
POWDERED VINYL PATIENT EXAMINATION GLOVES, LIGHT YELLOW COLOR (NON-COLORED) (K110966)Ppp Medical and Safety Products Company Limited2011-07-21
POWDER-FREE NON-STERILE VINYL EXAMINATION GLOVE (K111598)Lpl (Hui Zhou) Glove Co., Ltd.2011-07-20
STERI-DENT, STERI-SURE (K110867)Cpac, Inc.2011-07-20
BD INSYTE AUTOGUARD BC (K110443)Becton, Dickinson & CO2011-07-19
MEDIVANCE NASOGASTRIC TUBE TEMPERATURE SENSOR (K110956)Medivance, Inc.2011-07-18
POWDER FREE NITRILE EXAMINATION GLOVES (K111328)Gx Corporation Sdn Bhd2011-07-15
POWDER-FREE VINYL PATIENT EXAMINATION GLOVES, YELLOW COLOR (K110857)Shandong Zhanpeng Medical Products Co., Ltd.2011-07-15
DISPOSABLE POWDER FREE VINYL SYNTHETIC EXAMINATION GLOVE, BLUE COLOR (K111240)Xuzhou Full Sun Medical Products , Ltd.2011-07-14
AM USA 0.9% SODIUM CHLORIDE FLUSH SYRINGE (K111034)Am USA2011-07-14
ROYAL IMPERIAL NITRILE EXAMINATION GLOVES TEXTURED POWDER-FREE (K110960)Koon Seng Sdn Bhd2011-07-14
TIGER SYRINGES AND NEEDLES (K110697)Tiger Medical Products, Ltd.2011-07-14
POWDER FREE NITRILE EXAMINATION GLOVES (K110418)W.A. Rubbermate Co., Ltd.2011-07-13
STERI-DENT, STERI-SURE (K094026)Cpac, Inc.2011-07-12
NAVIGATOR DELIVERY SYSTEM (OR NAVIGATOR DS) MODEL: NAV-010 (K101194)Carticept Medical, Inc.2011-07-11
STERITEC SMART-READ BIOLOGICAL TEST PACK WITH INSTANT READOUT INTEGRATOR (K111150)Steritec Products Mfg Co, Inc.2011-07-08
SYNTHETIC VINYL EXAMINATION GLOVES, POWDER FREE (BLUE/GREEN) (AND MULTIPLE LABELS) (K111012)True Glove Factory2011-07-06
STERITITE CONTAINER SYSTEM & MEDITRAY PRODUCTS (K110682)Case Medical, Inc.2011-07-01
NON-STERILE, POWDER FREE LATEX EXAMINATION GLOVES WITH PROTEIN CLAIM (50 MG OR LESS) (K111133)Ssc Surat Thani2011-06-24
MERIT MEDICAL 20 ML SYRINGE (K111091)Merit Medical Systems, Inc.2011-06-24
CUROS PORT PROTECTOR (K110826)Ivera Medical2011-06-23
CENTURION PRESSURE INJECTABLE EXTENSION SET (K103562)Centurion Medical Products Corporation2011-06-23
STAT-MAT MINOR (K110500)Macpherson Medical, Inc.2011-06-23
BIOMATE STERILE ACUPUNCTURE NEEDLE (K103061)Biomate Medical Devices Technology Co., Ltd.2011-06-20
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