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General Hospital

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

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RecordFirmDate
MEDTRONIC MINIMED PARADIGM MODEL 512 INSULIN PUMP AND THE BD PARADIGM LINK GLUCOSE METER (K030531)Minimed, Inc.2003-06-17
CORD STICK MULTIPLE DRAW SYSTEM (K031058)Cord Stick Corp.2003-06-13
CHLORINATED, POLYMER COATED, POWDER-FREE LATEX EXAMINATION GLOVE (K031021)Perusahaan Getah Asas Sdn. Bhd.2003-06-13
NON-STERILE POWDERED GREEN COLORED POWDERED LATEX PATIENT EXAMINATION GLOVES WITH & WITHOUT SOUR/APPLE/PEPPERMINT SCENTS (K030993)Sgmp Co., Ltd.2003-06-12
NON-STERILE ORANGE COLORED POWDERED LATEX PATINET EXAMINATION GLOVES WITH & WITHOUT ORANGE/VANILLA SCENTS (K030994)Sgmp Co., Ltd.2003-06-12
POWDERED VINYL EXAM GLOVES, WHITE (K031104)Glormed Intl., Inc.2003-06-10
DISPOSABLE POWDER FREE VINYL EXAM GLOVES (K031113)Elite International, Inc.2003-06-10
BAK'SNAP DUOPRO SAFETY SYRING (DUOPROSS) SAFETY'TRAY ALLERGY SAFETY SYRINGE TRAY (K031594)M.K. Meditech Co. , Ltd.2003-06-06
EZMANAGER PLUS (K022394)Animas Corp.2003-06-05
C-PORT (K030636)Clinisurg Vascular Products, LLC2003-06-05
SHANCHUAN SYRINGE (K021993)Shangdong Zibo Shanchuan Medical Instruments Co.2003-06-03
SPECTRUM SILICONE CATHETER (K021557)Cook, Inc.2003-05-30
CAREO RETRACTABLE SAFETY SYRINGE (K030976)Life-Shield Products, Inc.2003-05-30
STRYKER PAINPUMP2 (K030661)Stryker Instruments2003-05-30
SURSHIELD SAFETY WINGED BLOOD COLLECTION SET (K031279)Terumo Medical Products Hangzhou Co., Ltd.2003-05-30
SURSHIELD SAFETY WINGED INFUSION SET (K031266)Terumo Corp.2003-05-30
BANICIDE LIQUID CHEMICAL STERILANT/HIGH-LEVEL DISINFECTANT (K012889)Pascal Co., Inc.2003-05-27
DISPOSABLE POWDER FREE VINYL SYNTHETIC EXAM GLOVES (K031120)Synmertex Co, Ltd.2003-05-23
CADD HIGH-VOLUME ADMINISTRATION SETS WITH FLOWSTOP (K031361)Deltec, Inc.2003-05-23
DISPOSABLE POWDER FREE VINYL SYNTHETIC EXAM GLOVES WHITE COLOR (K031076)Synmertex Co, Ltd.2003-05-23
DISPOSABLE POWDERED VINYL SYNTHETIC EXAM GLOVES (K031171)Synmertex Co, Ltd.2003-05-23
ANSPACH IRRIGATION PUMP AND IRRIGATION PUMP II (K030576)The Anspach Effort, Inc.2003-05-21
FLEXISKIN LATEX EXAMINATION GLOVES, POWDERED, NON STERILE (K031020)Pt. Mandiri Inti Buana2003-05-21
ROSS EMBRACE ENTERAL PUMP (K031407)Ross Product Div. Abbott Laboratories2003-05-20
DISPOSABLE POWDERED VINYL EXAM GLOVES (K031134)Elite International, Inc.2003-05-20
SYREX PRE-FILLED SYRINGE (K023740)Excelsior Medical Corp.2003-05-13
MODEL 833HC VACUUM/GRAVITY STEAM STERILIZER (K031259)Getinge USA, Inc.2003-05-12
HYDROCISION GENERAL SURGERY FLUIDJET SYSTEM (K021813)Hydrocision, Inc.2003-05-09
SPSMEDICAL GAS PLASMA CHEMICAL INDICATOR (K030680)Spsmedical Supply Corp.2003-05-09
STERITITE CONTAINER WITH FLASHTITE VALVE PLATE(S) & MEDITRAY PRODUCTS (K022978)Case Medical, Inc.2003-05-09
SYNTHETIC (WHITE) VINYL PATIENT EXAMINATION GLOVES-POWDER FREE (K031293)Shijiazhuang Eversharp Plastic Products Co., Ltd.2003-05-09
SURETEMP PLUS (K030580)Welch Allyn, Inc.2003-05-06
PEDIATRIC CENTRAL VENOUS CATHETER KIT (K023253)B.Braun Medical, Inc.2003-05-06
DISPOSABLE POWDER FREE VINYL EXAM GLOVES WITH VITAMIN E (K031072)Shanghai Palomar Mountain Industries, Inc.2003-05-06
POLY PER-Q-CATH PICC CATHETERS; POLY RADPICC (K031129)C.R. Bard, Inc.2003-05-05
NITRILE POWDER-FREE EXAMINATION GLOVES, PROBLUE, #7235 7 #7735 (K030207)Shanghai Motex Healthcare Co., Ltd.2003-05-02
TMD 1ML SAFETY SYRINGE (FA11 SERIES 1ML/FA51 SERIES U-100 INSULIN/FA71 SERIES TUBERCULIN) (K031062)Taiject Medical Device Co., Ltd.2003-05-02
STERRAD CYCLESURE BIOLOGICAL INDICATOR (K031226)Advanced Sterilization Products2003-05-02
POWDERED VINYL EXAM GLOVES, WHITE (K030997)Heyuan Hongli Industries, Inc.2003-05-02
ABBOTT PLUM A+ INFUSION PUMP WITH A HPL/RS PLUG-AND-PLAY MODULE (K031185)Abbott Laboratories2003-04-30
ANGIODYNAMICS, INC. MORPHEUS PICC AND PROCEDURE KIT (K030415)AngioDynamics, Inc.2003-04-30
GO MEDICAL PATIENT CONTROLLED ANALGESIA DEVICES (K020418)P.T. Greenleaf2003-04-29
GO MEDICAL PATIENT CONTROLLED ANALGESIA DEVICES (K020421)Hennig Enterprises Europe Srl2003-04-29
BABY POD (K030283)Prism Enterprises, Inc.2003-04-22
MODIFICATION TO STRYKER PAINPUMP2 (K030885)Stryker Instruments2003-04-18
POWDERED VINYL EXAM GLOVES, WHITE (K030927)Copioumed Intl., Inc.2003-04-17
IMBIBE II SYRINGE (K030208)Orthovita, Inc.2003-04-16
IV ADD-ON FILTER ADMINISTRATION SET WITH AND WITHOUT Y CONNECT OR NEEDLELESS ACCESS CONNECTOR (K030385)Kawasumi Laboratories America, Inc.2003-04-15
VINCO BRAND ACUPUNCTURE NEEDLE (K024207)Helio Medical Supplies, Inc.2003-04-14
PROTEC-TOP, STERIDENT, BENTO (K031022)Ronpak, Inc.2003-04-14
3F X 60 CM SINGLE LUMEN SILISONE VASCU-PICC, 4F X 60CM SINGLE LUMEN SILICONE VASCU-PICC, 5F X 60 CM SINGLE LUMEN SILICON (K030270)Medcomp2003-04-11
THERMO BUDDY, MODELS TB-100, TB-110, TB-120 (K023412)Hubdic Co., Ltd.2003-04-09
STERITITE RIGID REUSABLE STERILIZATION CONTAINER SYSTEM (K023614)Case Medical, Inc.2003-04-07
DRIP ALERT (K030136)Drip Alert, Inc.2003-04-07
NITRILE EXAMINATION GLOVES, POWDER FREE, POLYMER COATED, PURPLE COLOR (K030245)Arista Latindo Industrial Ltd. P.T2003-04-04
FLEXIBLE TIP THERMOMETER, MODEL 011206 (K030673)Global Treasure Industries , Ltd.2003-04-04
MEDLEY SYSTEM WITH MEDICATION MANAGEMENT SYSTEM (MMS) (K030459)Alaris Medical Systems, Inc.2003-04-04
STERRAD 50 & STERRAD 100S STERILIZERS (K023290)Advanced Sterilization Products2003-04-03
EVA EMPTY SOLUTION CONTAINER (K030888)Metrix Co.2003-04-02
MRI-CADDY (K030323)Mammendorfer Institute For Physics & Medicine GmbH2003-04-02
RITA CLIPS FOR INFUSION PUMPS (K030936)Rita Medical Systems, Inc.2003-04-01
DISPOSABLE POWDER FREE VINYL SYNTHETIC EXAM GLOVES WITH ALOE VERA, GREEN COLOR (K030094)Shanghai Palomar Mountain Industries, Inc.2003-04-01
POWDER FREE SYNTHETIC NITRILE NEOPRENE EXAMINATION GLOVES, SIZES SMALL,MEDIUM, LARGE, AND X-LARGE (K030386)Shamrock Manufacturing Company2003-03-28
ACUVANCE PLUS SAFETY IV CATHETER, PROTECTIV PLUS SAFETY IV CATHETER, OPTIVA IV CATHETER (K030571)Ethicon Endo-Surgery, Inc.2003-03-28
POWDERFREE LATEX EXAMINATION GLOVES WITH BUBBLEGUM (K030325)Pt.Shamrock Manufacturing Corp.2003-03-28
EXEL BUTTERFLY SCALP VEIN SET (K020189)Exelint International, Co.2003-03-27
AMSCO CENTURY STEAM STERILIZER (K030789)STERIS Corporation2003-03-26
GLOVETEX LATEX EXAMINATION GLOVES, POWDERED, BLUE, NON STERILE (K030273)Pt. Wrp Buana Multicorpora2003-03-26
LATEX EXAMINATION GLOVES POWDER FREE WITH NEOPRENE LINED, SIZES XSMALL, SMALL, MEDIUM, LARGE, XLARGE (K030134)Pt.Shamrock Manufacturing Corp.2003-03-25
STERILIZATION CASES AND TRAYS (K023658)Carr Metal Products, Inc.2003-03-25
STANDARD THERMOMETER (K030658)Global Treasure Industries , Ltd.2003-03-25
POWDER FREE NITRILE EXAMINATION GLOVES (NATURAL, BLUE,PURPLE) (K030284)Pt. Smartglove Indonesia2003-03-25
VINYL EXAMINATION GLOVES, PRE-POWDERED WITH VITAMIN E (K023753)Arista Latindo Industrial Ltd. P.T2003-03-25
VINYL EXAMINATION GLOVES, POWDER-FREE WITH VITAMIN E (K023754)Arista Latindo Industrial Ltd. P.T2003-03-25
STERITITE PERFORATED BASE RIGID REUSABLE STERILIZATION CONTAINER SYSTEM WITH SCF02-POLYPROPYLENE NON-WOVEN DISPOSABLE FI (K030853)Case Medical, Inc.2003-03-21
POWDERFREE LATEX EXAMINATION GLOVES WITH GRAPE (K030560)Pt.Shamrock Manufacturing Corp.2003-03-21
LATEX EXAMINATION GLOVE,POWEDERED TYPE II, LOW MODULUS,WITH PROTEIN LABLING CLAIM (K030333)Perusahaan Getah Asas Sdn. Bhd.2003-03-21
ON-LINE POWDER-FREE LATEX EXAMINATION GLOVE, TYPE II,LOW MODULUS, WITH PROTEIN LABELING CLAIM (K030331)Perusahaan Getah Asas Sdn. Bhd.2003-03-21
CROSSEAL APPLICATION DEVICE (K030032)Omrix Biopharmaceuticals, Inc.2003-03-21
MEDTRONIC MINIMED SOF-SITE INFUSION SET, MODELS MMT-359S6, MMT-359M6, MMT-359L6, MMT-359S9, MMT-359M9, AND MMT-359L9 (K030149)Avail Medical Products, Inc.2003-03-20
POWDERED SYNTHETIC VINYL PATIENT EXAMINATION GLOVES, WHITE (K030200)Kaohsiung Brothers Products Corp.2003-03-20
VISTA BASIC WITH FM SYSTEM (K023189)B.Braun Medical, Inc.2003-03-20
FENESTRATED INFUSION CATHETER (K024190)Promedic, Inc.2003-03-17
GRAVITECH TM FLOW CONTROLLER PRIMARY SET/GRAVITECH FLOW CONTROLLER EXTENSION SET (K030467)Iv Medical, Inc.2003-03-14
MOBILE PARTICULATE CONTAMINATION CONTROL SYSTEM, MODEL M-100 (K023693)Airex, Inc.2003-03-12
IMBIBE BONE MARROW ASPIRATION SYRINGE (K023074)Orthovita, Inc.2003-03-11
NON-STERILE, POWDER-FREE, POLYMER COATED, NATURAL AND/OR VIOLET AND BLACK COLOR, LATEX EXAMINATION GLOVES WITH PROTEIN (K030164)Yty Industry (Manjung) Sdn Bhd2003-03-07
SYNTHETICARE POWDER-FREE VINYL EXAMINATION GLOVES (K030483)Emerald Medical, Inc.2003-03-06
SYNTHETICARE POWDERED VINYL EXAMINATION GLOVES (K030484)Emerald Medical, Inc.2003-03-06
NITRILE POWDER-FREE MEDICAL EXAMINATION GLOVE (BLUE) (TEXTURED AND NON-TEXTURED) (K030075)Best Manufacturing Company-Distribution Center2003-03-05
SELF SEAL STERILIZATION POUCH (K023025)Granton Medical , Ltd.2003-03-04
POWDER FREE VINYL EXAM GLOVES WITH ALOE COATING INSIDE (K024338)General Gloves Corp.2003-03-03
ON-LINE POWDER-FREE NITRILE EXAMINATION GLOVE, VIOLET COLORED (K030335)Perusahaan Getah Asas Sdn. Bhd.2003-03-03
MIDMARK M9 ULTRACLAVE STEAM STERILIZER (K023348)Midmark Corp.2003-03-03
SILBERG T.P.S., TISSUE PREPARATION SYSTEM, MODEL ME 800 (K023083)Mettler Electronics Corp.2003-02-28
RADIANT INNOVATION INC. INFRARED EAR THERMOMETER, MODELS TH1 SERIES (K030324)Radiant Innovation, Inc.2003-02-27
ALIBI BIOLOGICAL INDICATOR, MODEL WS (K024079)Arden Laboratories, Incorporated2003-02-27
POWDER FREE LATEX EXAMINATION GLOVES WITH PROTEIN LABELING CLAIM LESS THAN 50 MICROGRAM OR LESS OF TOTAL WATER EXTRACTAB (K030112)Pt. Smartglove Indonesia2003-02-27
AUTOMED 3200 INFUSION PUMP (K023973)Help Technologies2003-02-27
NITRILE POWDER FREE EXAM GLOVE, WITH PEPPERMINT FLAVOR (K030406)Pt. Smartglove Indonesia2003-02-27
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