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General Hospital

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

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RecordFirmDate
POWDER FREE LATEX EXAMINATION GLOVES (K990901)Apl Products Sdn. Bhd.1999-05-04
TA CHIA POWDERED NON-STERILE NITRILE PATIENT EXAMINATION GLOVES (K990575)Ta Chia Rubber Ind. Corp.1999-05-04
POWDER-FREE LATEX EXAMINATION GLOVE WITH PROTEIN LABELING CLAIM (CONTAINS 50 MICROGRAMS OR LESS OF TOTAL WATER EXTRACTA (K990812)Ampri Rubberware Industries Sdn Bhd1999-05-04
OMNI GRACE LATEX EXAMINATION GLOVE, POWDER-FREE, POLYMER COATED WITH PROTEIN CLAIM (K990702)Omnigrace (Thailand) , Ltd.1999-05-04
SKINSENSE NITRILE POWDER-FREE SYNTHETIC MEDICAL EXAMINATION GLOVE (K984249)London International Group, Inc.1999-05-04
FERRIS POLYMEM POLYWIC STERILE CAVITY WOUND FILLER (K990906)Ferris Mfg. Corp.1999-04-29
LATEX EXAMINATION GLOVE W/ LOW PROTEIN LABELING (K990468)Top Glove Sdn. Bhd.1999-04-27
MODIFICATION TO MEDI-JECT CORPORATION MEDI-JECTOR CHOICE NEEDLE-FREE INSULIN DELIVERY SYSTEM (K991294)Medi-Ject Corp.1999-04-23
KLEENHANDS POWDERED LATEX EXAMINATION GLOVES (K990527)Ssn Gloves (M) Sdn Bhd1999-04-23
NITRILE EXAMINATION GLOVES, NON-STERILE, POWDERED, BLUE COLOR. (K990486)Alliance Rubber Products Sdn. Bhd.1999-04-23
SIDEKICK INFUSION KIT (K990425)I-Flow Corp.1999-04-23
NITRILE EXAMINATION GLOVES, NON-STERILE, POWDERED, GREEN COLOR (K990485)Alliance Rubber Products Sdn. Bhd.1999-04-23
KLEENHANDS POWDERFREE LATEX EXAMINATION GLOVES WITH PROTEIN LABELING CLAIM (K990526)Ssn Gloves (M) Sdn Bhd1999-04-23
DERMAGRIP POWDER FREE LATEX EXAMINATION GLOVE, NON STERILE (PROTEIN CONTENT LABELING) (K991044)Wrp Specialty Products Sdn. Bhd.1999-04-23
CHALLENGE TEST PACK (K983451)North American Science Assoc., Inc.1999-04-23
ARSOFT NITRILE EXAMINATION GLOVES, NON-STERILE POWDER FREE (K990427)Alliance Rubber Products Sdn. Bhd.1999-04-23
AVIA PAIN MEDICATION DELIVERY SYSTEM (K990312)Amtec Medical1999-04-22
DIABETIC NEEDLE DISPOSAL, MODEL # PMSM - 950 (K990371)Post Medical, Inc.1999-04-21
PHOTOTHERAPY LAMP (K984589)Medela, Inc.1999-04-20
MODIFICATION OF: MIDMARK M-11 ULTRACLAVE STEAM STERILIZER (K990189)Midmark Corp.1999-04-19
KINGLI ACUPUNCTURE NEEDLE (K990406)United Pacific Co., Ltd.1999-04-16
CODAN CHEMOSPIKE (K990711)Codan US Corp.1999-04-13
BRIGHTWAY BRAND LATEX EXAMINATION GLOVES (POWDER FREE) (K990539)Brightway Holdings Sdn. Bhd.1999-04-09
ANGIOCATH AUTOGUARD CATHETER, INSYTE AUTOGUARD CATHETER (K984059)Bd Becton Dickinson Vacutainer Systems Preanalytic1999-04-09
BRIGHTWAY BRAND NITRILE EXAMINATION GLOVE (LIGHTLY POWDERED) (K990542)Brightway Holdings Sdn. Bhd.1999-04-09
BRIGHTWAY BRAND NITRILE EXAMINATION GLOVE (POWDER FREE) (K990541)Brightway Holdings Sdn. Bhd.1999-04-09
BRIGHTWAY BRAND LATEX EXAMINATION GLOVE (LOW PROTEIN) (K990540)Brightway Holdings Sdn. Bhd.1999-04-09
BRIGHTWAY BRAND POLYMER COATED LATEX EXAMINATION GLOVE (POWDER FREE) (K990543)Brightway Holdings Sdn. Bhd.1999-04-09
SHARPS COLLECTION CONTAINER - SAF-T-SHELL (K982029)American Medical Mfg., Inc.1999-04-06
MEDEX 3000 SERIES SYRINGE INFUSION PUMP (K982640)Medex, Inc.1999-04-06
GLOBAL HEALTHCARE SELF-SEALING STERILIZATION POUCH (K990567)Global Healthcare, Inc.1999-04-05
S.P.A.R STERILE AMBULATORY RESERVOIR (K990091)Faulding Pharmaceutical Co.1999-04-04
PREPOWDERED NITRILE EXAMINATION GLOVES (K990499)Flexitech Sdn. Bhd.1999-04-02
POWDER FREE LATEX EXAMINATION GLOVES, W/ PROTEIN LABELING CLAIM (K990501)Flexitech Sdn. Bhd.1999-04-02
POWDER FREE NITRILE EXAMINATION GLOVES (K990495)Flexitech Sdn. Bhd.1999-04-02
PREPOWDERED LATEX EXAMINATION GLOVES WITH PROTEIN CONTENT LABELING CLAIM (100 MICROGRAMS OR LESS) (K990502)Flexitech Sdn. Bhd.1999-04-02
ULTRA CARE NON-STERILE POWDER FREE (GREEN) NATURAL RUBBER LATEX PATIENT EXAMINATION GLOVE (K982505)Tillotson Healthcare Corp.1999-04-02
SECOND WIND AIR PURIFIER (K980745)Monagan Ent., Inc.1999-04-02
SPOROX II STERILIZING & DISINFECTING SOLUTION (K990703)Reckitt Benckiser, Inc.1999-03-30
LAGLOVE BRAND NITRILE EXAMINATION GLOVE (POWDER FREE) (K990420)La Glove (M) Sdn. Bhd.1999-03-29
POWDER FREE BLUE COPOLYMER NITRILE MEDICAL EXAMINATION GLOVES (K990299)Shanghai Palomar Mountain Industries, Inc.1999-03-29
CRANBERRY POWDER FREE LATEX EXAMINATION GLOVES WITH PROTEIN CONTENT LABELING CLAIM (50 MICROGRAMS OR LESSS) (K984039)Cranberry (M) Sdn. Bhd.1999-03-29
TUTOPLUS IV ADMINISTRATION SET (K990388)Myco Medical Supplies, Inc.1999-03-29
POWDERED BLUE NITRILE MEDICAL EXAMINATION GLOVES (K990267)Shanghai Palomar Mountain Industries, Inc.1999-03-29
LAGLOVE BRAND NITRILE EXAMINATION GLOVES (LIGHTLY POWDERED) (K990415)La Glove (M) Sdn. Bhd.1999-03-29
POWDERED LATEX EXAMINATION GLOVES WITH PROTEIN CONTENT LABELING CLAIM (100 MICROGRAMS OR LESS OF TOTAL WATER EXTRACTABP (K990210)Mexpo Intl., Inc.1999-03-29
PEREGRINE WET SET, MODEL PD400.00 (K990518)Peregrine Surgical , Ltd.1999-03-25
PERSONAL INFUSOR WITH DRUG DISPOSAL SEPTAL PORT (K990208)Science Incorporated1999-03-25
SOUTHLAND POWDERFREE (POLYMER-COATED) LATEX EXAMINATION GLOVES (K990751)Southland Products Co., Ltd.1999-03-23
SOUTHLAND POWDERFREE LATEX EXAMINATION GLOVES WITH PROTEIN LABEL CLAIM (K990746)Southland Products Co., Ltd.1999-03-23
EVERGREEN NON-STERILE POWDER-FREE, COLORED NITRILE EXAMINATION GLOVES (K990013)Yty Industry (Manjung) Sdn Bhd1999-03-23
DR180-R/OXY (K983576)North East Monitoring, Inc.1999-03-23
CHEMO MINI SPIKE PLUS (K983794)B. Braun of America, Inc.1999-03-23
PAIN CONTROL INFUSION PUMP (K990101)Sgarlato Laboratories, Inc.1999-03-19
NATURAL RUBBER PRE-POWDERED COLORED & FLAVORED PATIENT EXAMINATION GLOVES WITH PROTEIN LABELLING CLAIM (K984449)P.T. Irama Dinamika Latex1999-03-19
BRAUN THERMOSCAN IRT3020/3500 ONE SECONS EAR THERMOMETER, MODEL IRT3020/3520 (K983295)Braun AG1999-03-15
SABRATEK APM-2000 AMBULATORY PATIENT MONTOR, TRANSCUTANEOUS TEMPERATURE MONITOR (K983355)Sabratek Corp.1999-03-12
NITRILE EXAMINATION GLOVES, POWDER FREE, GREEN COLOR (K990453)Alliance Rubber Products Sdn. Bhd.1999-03-09
BLUE POWDER-FREE NITRILE EXAMINATION GLOVES (K990283)Hartalega Sdn Bhd1999-03-09
SPORICIDIN STERILIZING AND DISINFECTING SOLUTION (SSDS) (K983194)Sporicidin Intl.1999-03-05
ALLISON MEDICAL INSULIN SYRINGE (AMIS) (K984017)Allison Medical, Inc.1999-03-04
NERVE BLOCK INFUSION KIT (K984502)I-Flow Corp.1999-03-04
NATURAL BRAND ACUPUNCTURE NEEDLES (K983671)Tcm Supply Corp.1999-03-04
FERRIS POLYMEM CALCIUM ALGINATE STERILE WOUND DRESSING (K984539)Ferris Mfg. Corp.1999-03-01
TUTODROP 1 AND TUTODROP 2 (K982098)Myco Medical Supplies, Inc.1999-03-01
MICROLIFE IT2CA1 (K990168)Microlife Systems AG1999-02-25
FREE FLOW SAFETY DEVICE, MODEL MG 245052 (K990288)Teva Medical, Ltd.1999-02-24
SABRATEK 4040 INFUSION PUMP (K980751)Sabratek Corp.1999-02-24
PREPARE HOME INFUSION PUMP (K983634)Medical Infusion Technologies, Inc.1999-02-24
LAGLOVE BRAND POLYMER COATED LATEX EXAMINATION GLOVE (POWDER FREE) (K990268)La Glove (M) Sdn. Bhd.1999-02-24
KVO CHECK VALVE ACCESSORY, MODEL EV-0001 (K984441)I-Flow Corp.1999-02-22
DISPOSABLE VINYL SYNTHETIC EXAM GLOVES, POWDER FREE (K990117)Shanghai Palomar Mountain Industries, Inc.1999-02-19
NITRILE POWDER FREE EXAMINATION GLOVES (K983334)Cranberry (M) Sdn. Bhd.1999-02-19
GUTHRIE PRIME POWDER-FREE (K990228)Guthrie Medicare Products (Melaka) Sdn Bhd1999-02-19
BURETROL SOLUTION SETS (K984381)Baxter Healthcare Corp1999-02-19
DISPOSABLE VINYL SYNTHETIC EXAM GLOVES, POWDERED (K990081)Shanghai Palomar Mountain Industries, Inc.1999-02-19
LAGLOVE BRAND LATEX EXAMINATION GLOVES (LOW PROTEIN) (K990285)La Glove (M) Sdn. Bhd.1999-02-18
LAGLOVE BRAND LATEX EXAMINATION GLOVE (POWDER FREE) (K990270)La Glove (M) Sdn. Bhd.1999-02-18
CARE BAND ANTIBACTERIAL BANDAGES (K983368)Aso Corp.1999-02-17
POWDERED NITRILE EXAMINATION GLOVES (K984615)Shiva Medicare , Ltd.1999-02-17
NBR 4 MILS, NITRILE EXAMINATION GLOVE NON-STERILE POWDERED (K984309)Sumirubber Industries (Kedah) Sdn. Bhd.1999-02-12
UP-GRADE AND UP-GRADE PRO (K983887)Medisim, Ltd.1999-02-12
DISETRONIC MULTIFUSE INFUSION PUMP SYSTEM (K990259)Disetronic Medical Systems1999-02-12
CADD ADMINISTRATION SET, CADD 250ML FLEXIBLE MEDICATION RESERVOIR, MODIFIED SECURIT SHELL, SECURITY SHELL ADAPTER (K990083)Sims Deltec, Inc.1999-02-12
SUPRASHIELD EXPRESS STERILIZATION WRAP (K990300)Allegiance Healthcare Corp.1999-02-10
NBR4 MILS NITRILE POWDER FREE EXAMINATION GLOVES NON-STERILE (K984311)Sumirubber Industries (Kedah) Sdn. Bhd.1999-02-09
PARAGON BASAL/BOLUS ADMINISTRATION SET (K984063)I-Flow Corp.1999-02-09
LITE-TOUCH SYRINGE (K983430)Medicore, Inc.1999-02-09
POWDERED LATEX EXAMINATION GLOVES, NON-STERILE (K984125)Kilang Barangan Getah Dioh1999-02-09
PARAGON INFUSION (K984146)I-Flow Corp.1999-02-09
PARAGON BOLUS ACCESSORY SET (K984638)I-Flow Corp.1999-02-09
STERITITE PROCESS INDICATOR ACCESSORIES (K982151)Case Medical, Inc.1999-02-09
PRE-POWDER VINYL PATIENT EXAMINATION GLOVES (K984461)Shanghai Huamao Gloves Co., Ltd.1999-02-09
POWDER-FREE VINYL PATIENT EXAMINATION GLOVES (K984460)Shanghai Huamao Gloves Co., Ltd.1999-02-09
COLORVEES IV SET 20 DROPS/ML 105, 60 DROPS/ML 105, VENTED 20 DROPS 105, VENTED 60 DROPS 105 (K983411)Valnet Medical Corp.1999-02-09
POWDER FREE NITRILE EXAMINATION GLOVES (K984610)Shiva Medicare , Ltd.1999-02-09
SUBCUTANEOUS INFUSION SETS, MSR MODEL A & B (K984561)Msr, Inc.1999-02-04
CLARICEL STERILIZATION POUCHES AND STERILIZATION REELS (K972719)Medicel, S.A. DE C.V.1999-02-04
BROWNE SPORICIDIN PHENOL INDICATOR FOR SPORICIDIN STERILIZING AND DISINFECTING SOLUTION (K984613)Albert Browne , Ltd.1999-02-04
PERFUSOR COMPACT (K983005)B.Braun Medical, Inc.1999-02-04
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