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General Hospital

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

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RecordFirmDate
NITRILE PATIENT EXAMINATION GLOVE POWDER FREE, NON STERILE (K000329)Siam Sempermed Corp., Ltd.2000-04-05
INSYTE CATHETER, INSYTE AUTOGUARD CATHETER (K000235)Becton Dickinson Infusion Therapy Systems, Inc.2000-04-05
NITRILE PATIENT EXAMINATION GLOVE (BLUE COLOR) POWDER FREE, NON STERILE (K000323)Siam Sempermed Corp., Ltd.2000-04-05
HYDROCISION DEBDRIDEMENT SYSTEM (K991383)Hydrocision, Inc.2000-03-31
VACUFLOW+ BLOOD COLLECTION SET, MODEL 52221/3/5; VACUFLOW+ WITH HOLDER BLOOD COLLECTION SET, MODEL 82021/3/5 WITH HOLDER (K000369)Medpro Technologies, Inc.2000-03-30
POWDERED LATEX EXAM GLOVES, PINK, WITH/WITHOUT STRAWBERRY SCENT, PROTEIN LABELING (K000671)Sgmp Co., Ltd.2000-03-29
SYNTHETIC POWDERED VINYL PATIENT EXAMINATION GLOVES (K992554)Shijiazhuang Great Vision Plastic Products Co., LT2000-03-29
ULTICARE DISPOSABLE SYRINGE (K994230)Ultimed, Inc.2000-03-24
ABBOTT GEMSTAR I.V. INFUSION PUMP - 7 THERAPY CONFIGURATION, 6 THERAPY CONFIGURATION, 1 THERAPY CONFIGURATION (K000821)Abbott Laboratories2000-03-24
VITAL SHIELD GOLD NON-STERILE POWDERED LATEX EXAM GLOVES BLUE, WITH AND/OR WITHOUT BUBBLEGUM SCENT, AND WITH PROTEIN LAB (K000488)Sgmp Co., Ltd.2000-03-20
MARHUKAR TRIPLE LUMEN CATHETER, MODEL 12 FR (K000087)The Kendal Co.2000-03-17
SOLOGUARD LOCKING PLUS SYRINGE (K993609)Safeguard Medical Products, Inc.2000-03-17
SUPERGLOVES STERILE POWDERED LATEX EXAMINATION GLOVES (K000644)Supermax Glove Manufacturing Sdn Bhd2000-03-17
PORTSETT (K000085)Portsett, Inc.2000-03-17
STERIS AMSCO MILLENNIUM STEAM STERILIZER (K000077)STERIS Corporation2000-03-17
STEAM/EO RECORD CARD, MODEL CI 121 (K000502)Steritec Products Mfg Co, Inc.2000-03-14
CELSITE IMPLANTABLE PORT WITH VALVED CATHETER (K993024)B. Braun of America, Inc.2000-03-13
SYNTHETIC POWDER-FREE VINYL PATIENT EXAMINATION GLOVES (K992821)Shijiazhuang Hongxiang Plastics Products Co., Ltd.2000-03-10
NEXT STEP POWDER FREE LATEX EXAMINATION GLOVES CONTAINS 50 MCGM OR LESS OF TOTAL WATER EXTRACTABLE PROTEIN PER GRAM (K000165)Ansell Perry2000-03-10
NITRI-CARE NITRILE POWDER-FREE STERILE MEDICAL EXAMINATION GLOVES (BLUE, CHERRY FLAVORED) (K993805)Best Manufacturing Company2000-03-10
BROTHERS POWDER-FREE VINYL EXAMINATION GLOVES (K000058)Kaohsiung Brothers Products Corp.2000-03-10
SUPERGUARD SAFETY SYRINGE (K990831)U.S. Safety Syringes Co., Inc.2000-03-08
KAWASUMI LABORATORIES PHILEBOTOMY SET (K994323)Kawasumi Laboratories Co., Ltd.2000-03-08
LUER ACCESS UNIVERSAL VIAL ADAPTER (K000657)Baxter Healthcare Corp2000-03-08
ARROWG +ARD BLUE PLUS ANTIMICROBIAL MULTI-LUMEN CENTRAL VENOUS CATHETER (K993691)Arrow Intl., Inc.2000-03-08
HORIZON LIGHT (K994375)B.Braun Medical, Inc.2000-03-08
BD PREEFILE NORMAL SALINE FLUSH SYRINGE FLUSH SYRINGE (K982558)Bd/Preefil2000-03-08
MODIFICATION TO AUTOJECT MINI (K000482)Owen Mumford, Ltd.2000-03-06
SOAKER CATHETER (K994374)I-Flow Corp.2000-03-03
VENUSA, LTD. EXTENSION SET WITH FILTER (K994429)Venusa , Ltd.2000-03-03
TERUMO NEEDLE WITH LOCKING SHEATH (K000387)Terumo Medical Corp.2000-03-02
MULTISAFE POWDERED LATEX EXAMINATION GLOVES, NONSTERILE (K993811)Multisafe Sdn. Bhd.2000-03-02
SAFESKIN PFE-XTRA POWDER-FREE LATEX EXAMINATION GLOVES, PROTEIN CONTENT 50 MCG OR LESS, FOR USE WITH CHEMOTHERAPEUTIC AG (K993117)Safeskin Corp.2000-03-02
DISPOSABLE POWDER FREE NITRILE EXAM GLOVES, WHITE COLOR (K000226)Sheen More Ent. Co., Ltd.2000-03-02
NAC Y-ADP (K000343)The Kipp Group2000-03-01
SECURMIX (K000367)Eurospital2000-02-29
KIPPMED I.V. MANIFOLD (K000152)The Kipp Group2000-02-29
SYNTHETIC POWDER FREE (WHITE) VINYL PATIENT EXAMINATION GLOVES (K000071)Shijiazhuang Great Eagle Plastic Products Co., Ltd.2000-02-29
PROFI DISPOSABLE SYRINGE, PROFI DISPOSABLE NEEDLE, DM JECT INSULIN SYRINGE (K993017)Shinchang Medical Co., Ltd.2000-02-25
MEDEFIL'S NORMAL SALINE FLUSH SYRINGE, IN VARIOUS FILL SIZES - 1 ML FILL IN 3 ML SYRINGE LL; 1 ML FILL IN 6 ML SYRINGE L (K993515)Medefil, Inc.2000-02-25
E.N.S.I. SYRINGE (K000572)Tri-Ject Intl. Corp.2000-02-24
EXEL INJECTION PLUG WITH CAP (K992290)Exel Intl.2000-02-23
SIMS PORTEX ANESTHESIA CATHETER (K994275)Sims Portex, Inc.2000-02-22
SYNTHETIC (WHITE) VINAL POWDERED PATIENT EXAMINATION GLOVES (K000166)Shijiazhuang Great Eagle Plastic Products Co., Ltd.2000-02-22
SMART SHIELD NON-STERILE POWDER-FREE PEPPERMINT SCENTED GREEN LATEX EXAMINATION GLOVES (K000156)Shield Gloves Manufacturer (M) Sdn Bhd2000-02-18
ROYAL SHIELD NON-STERILE PURPLE (PINK/BLUE) COLORED POWDERED LATEX EXAM WITH PROTEIN LABELING CLAIM [<200 MCG OR LESS] W (K000217)Shield Gloves Manufacturer (M) Sdn Bhd2000-02-18
PERCUGUARD (K992539)Digit-Pro2000-02-18
CASTLE SERIES 100HC STEAM STERILIZERS (K994314)Getinge/Castle, Inc.2000-02-16
HWA & SILKTEX POWDERED LATEX EXAMINATION GLOVES, WITH PROTEIN CONTENT LABELING CLAIM (140 MICROGRAMS OR LESS) (K994432)Hwa Teh Industrial Sdn. Bhd.2000-02-16
NIPRO BLOOD COLLECTION NEEDLE (K992699)Nipro Medical Corp.2000-02-14
VEIN ENTRY INDICATOR DEVICE (VEID) (K993995)Vascular Technologies , Ltd.2000-02-14
NIPRO INSULIN SYRINGE (K000144)Nipro Medical Corp.2000-02-11
PARSET SECONDARY ADMINISTRATION SET, LUERLOCK, MODEL A14001E, PARSET SECONDARY SECONDARY ADMINISTRATION SET, MODEL A1400 (K000017)Rd Medical Mfg., Inc.2000-02-10
HORIZON MEDICAL PRODUCTS MICROPORT 2 PERIPHERAL ACCESS PORT SYSTEM (K994196)Horizon Medical Products, Inc.2000-02-10
R1000 SERIES INSULIN PUMP (K993184)Animas Corp.2000-02-10
HEALTH-PLUS, SANITEX, RELIANCE, POWDER-FREE MULTI-PLY LATEX EXAMINATION GLOVE (NATURAL RUBBER LATEX-NITRILE-CONSTRUCTION (K993918)Pamitex Industries Sdn Bhd2000-02-10
GUTHRIE PRIME POWDER-FREE CHLORINATED PATIENT EXAMINATION GLOVES (K000090)Guthrie Medicare Products (Melaka) Sdn Bhd2000-02-10
SHANGHAI POSEIDON POWDER-FREE SYNTHETIC VINYL EXAMINATION GLOVES, YELLOW (K992979)Shanghai Poseidon Plastic Products Co., Ltd.2000-02-09
POWERED DENTAL POWDERED EXAMINATION GLOVES, WITH PROTEIN CONTENT LABELING CLAIM (75 MICROGRAMS OR LESS) (K994162)Allegiance Healthcare Corp.2000-02-09
AMBIDERM POWDER FREE LATEX EXAMINATION GLOVES (VIOLET, BLUE, GREEN AND PINK), WITH PROTEIN CONTENT LABELING CLAIM (50 MI (K993912)Latexx Partners, Inc.2000-02-09
AUTODOSE INFUSION SYSTEM, MODEL AD4120, BE4210, S12050,100,200, FF0005, 10 (K993832)Tandem Medical, Inc.2000-02-09
TEKMEDIC POWDER-FREE LATEX EXAMINATION GLOVES WITH PROTEIN CONTENT LABELING CLAIM (50 MICROGRAMS OR LESS) (K994250)Tekmedic (M) Sdn Bhd2000-02-07
DISPOSABLE INFUSION PUMP KIT (K993972)Biomet, Inc.2000-02-07
AMBIDERM POWDERFREE LATEX EXAMINATION GLOVES WITH A PROTEIN CLAIM OF 50 MICROGRAMS OR LESS PER GRAM (BLACK COLORED) (K994131)Medtaxx Partners2000-02-07
SENSI-PRO DISPOSABLE POWDER FREE VINYL SYNTHETIC EXAMINATION GLOVES, BEIGE COLOR (K994222)Shijiazhuang Hongray Plastic Products Co., Ltd.2000-02-07
POWDER-FREE NITRILE EXAMINATION GLOVES WITH ALOE VERA (K993876)Shen Wei (Usa), Inc.2000-02-07
SENSI-PRO DISPOSABLE POWDERED VINYL SYNTHETIC EXAMINATION GLOVES, BEIGE COLOR (K994206)Shijiazhuang Hongray Plastic Products Co., Ltd.2000-02-07
LATEX EXAMINATION GLOVES-PRE-POWDERED-STERILE (K994255)Pt. Maja Agung Latexindo2000-02-07
RUBBERCARE POWDER-FREE, GUARDIAN POWDER-FREE LATEX EXAM GLOVES WITH PROTEIN LABELING CLAIM (50 MICROGRAMS OR LESS) (K994201)Perusahaan Pelindung Getah (M) Sdn Bhd2000-02-07
POWDER-FREE NON-STERILE VINYL EXAMINATION GLOVES (K994136)Shanghai Champion Plastic Products Co., Ltd.2000-02-03
VERSALET 7700 CARE CENTER, MODEL # 7700 (K993051)Hill-Rom Air-Shields2000-02-03
POLYMER COATED POWDER FREE NITRILE EXAMINATION GLOVES, BLUE (K994416)Flexitech Sdn. Bhd.2000-02-03
SEALOUETTE FIBRIN SEALANT EXTENDED DROPLET APPLICATOR, MODEL TE-1 (K000048)Biosurgical Corp.2000-01-31
OMNI GRACE NITRILE, BLUE, EXAMINATION GLOVE, POWDER-FREE, POLYMER COATED (K994246)Omnigrace , Ltd.2000-01-31
POLYMER COATED, POWDER FREE, LATEX EXAMINATION GLOVES WITH PROTEIN CONTENT LABELING CLAIM (50 MICROGRAMS OR LESS) (K994354)Flexitech Sdn. Bhd.2000-01-31
BLUE NITRILE EXAMINATION GLOVES - POWDER FREE (K994064)Glove Source, Inc.2000-01-28
POWDERED LATEX EXAMINATION GLOVES (PROTEIN LABEL CLAIM) (50 MICROGRAM OR LESS) (K994082)Besglove Medicare Sdn. Bhd.2000-01-28
SENSI-PRO, DISPOSABLE PRE-POWDERED SYNTHETIC VINYL PATIENT EXAMINATION GLOVES WITH BEIGE PIGMENT ADDITIVES (K994248)Shinemound Enterprise, Inc.2000-01-28
PLASTIC PORT IMPLANTABLE VENOUS ACCESS SYSTEM (K994216)Sims Deltec, Inc.2000-01-27
STERITITE PERFORATED BOTTOM RIGID REUSABLE STERILIZATION CONTAINER SYSTEM WITH SCF02 - POLYPROPYLENE NON-WOVEN DISPOSABL (K991023)Case Medical, Inc.2000-01-27
MILLENNIUM HUBER PLUS SAFETY INFUSION SET (K993848)Millennium Medical Distribution, Inc.2000-01-27
COLORED AND FLAVORED POWDER FREE LATEX EXAMINATION GLOVES (K993864)Supermax Sdn Bhd2000-01-20
PATIENT NITRILE EXAMINATION GLOVES (POWDERED) (K992675)Wear Safe Malaysia Sdn. Bhd.2000-01-20
GREEN PEPPERMINT FLAVORED POWDERED LATEX EXAMINATION GLOVES (K993865)Supermax Sdn Bhd2000-01-20
POWDERED LATEX EXAMINATION GLOVES WITH PROTEIN CONTENT LABELING CLAIM (100 MICROGRAMS OR LESS) (K994013)Glovco (M) Sdn. Bhd.2000-01-20
SENSI-PRO DISPOSABLE POWDER FREE SYNTHETIC VINYL PATIENT EXAMINATION GLOVES WITH BEIGE PIGMENT ADDITIVES (K994258)Shinemound Enterprise, Inc.2000-01-20
TEH LOONG VINYL, POWDER-FREE, PATIENT EXAMINATION GLOVE (K993849)Longbest (Xiamen) Balls Co., Ltd.2000-01-18
FAS ENDOLUMINAL BRUSH (K993614)Fas Medical , Ltd.2000-01-18
3.0 ML RESERVOIR, MODEL 103/193 (K991936)Medtronic Minimed2000-01-18
TEH LOONG, VINYL, POWDERED, PATIENT EXAMINATION GLOVES (K993847)Longbest (Xiamen) Balls Co., Ltd.2000-01-18
INFRARED EAR THERMOMETER, MODEL KI-8120 (K984551)K-Jump Health Co., Ltd.2000-01-14
NIPRO LUER ADAPTOR (K992729)Nipro Medical Corp.2000-01-13
GUTHRIE PRIME PRE-POWDERED PATIENT LATEX EXAMINATION GLOVE (K993793)Guthrie Medicare Products (Melaka) Sdn Bhd2000-01-12
INNOVATIVE GLOVES LATEX EXAMINATION GLOVES POWDERFREE WITH PROTEIN LABELING CLAIM [50 MICROGRAMS OR LESS] (K993567)Innovative Gloves Co;, Ltd.2000-01-12
SHANGHAI GLOVMAX ENTERPRISE CO., LTD. PRE-POWDERED VINYL PATIENT EXAMINATION GLOVES (K993859)Shanghai Glovmax Enterprise Co.,Ltd2000-01-12
SHANGHAI GLOVMAX ENTERPRISE CO, LTD., POWDER-FREE VINYL PATIENT EXAMINATION GLOVES (K993880)Shanghai Glovmax Enterprise Co.,Ltd2000-01-12
CORRECT TOUCH LATEX POWDERED EXAMINATION GLOVES (K994043)Biopro (M) Sdn Bhd2000-01-11
SYNTHETIC VINYL MEDICAL EXAMINATION POWDERED GLOVES (K993664)Top Glove Sdn. Bhd.2000-01-11
BROWNE PACKAGING AND LABEL STEAM PROCESS INDICATOR (K992767)Albert Browne , Ltd.2000-01-10
MIDMARK M4*9 EASYCLAVE STEAM STERILIZER (K992744)Midmark Corp.2000-01-10
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