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General Hospital

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

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RecordFirmDate
VINYL EXAMINATION GLOVES, POWDER FREE, BLUE COLOR (K002745)Arista Latindo Industrial Ltd. P.T2000-10-12
VINYL EXAMINATION GLOVES, POWDER FREE, VANILLA COLOR (K002746)Arista Latindo Industrial Ltd. P.T2000-10-11
ATOM INFA WARMER V-505 (K002355)Atom Medical Corp2000-10-10
POLYMER COAT, POWDER FREE, LATEX EXAMINATION GLOVES WITH PROTEIN CONTENT LABELING CLAIM (50 MICROGRAMS OR LESS) (K002568)Smart Glove Corp. Sdn Bhd2000-10-03
BULL'S-EYE DISPOSABLE NEEDLE RECAPPING AID (K002213)Hunter Research Laboratories, Inc.2000-10-03
IBIS CHEMO-PORT IMPLANTABLE VASCULAR ACCESS SYSTEM, MODEL 700-08-10,700-08-11,700-08-12,700-08-15,700-08-16,735-08-10 (K002770)Hdc Corp.2000-09-26
PERIPHERALLY INSERTED CENTRAL CATHETER (K001874)Utah Medical Products, Inc.2000-09-25
PHOTOTHERAPY LAMP 900IW501JE PHOTOTHERAPY POWER MODULE 900IW502JE (K002414)Fisher & Paykel Healthcare, Ltd.2000-09-25
PAIN CARE 3000 (K002073)Breg, Inc.2000-09-19
POLY PER-Q-CATH PICC CATHETER,MODEL 3236100 AND POLY PER-Q-CATH MIDLINE CATHETER, MODEL 3134135 (K001901)C.R. Bard, Inc.2000-09-19
SERAGARD VASCULAR ACCESS PATCH (K001175)Platinum Services, Inc.2000-09-18
ACTI-FLEX IV ADMINISTRATION SET (K001599)R-Group Intl.2000-09-18
6060 MULTI-THERAPY PUMP, MODEL 2M9832; 6060 EPIDURAL PUMP, MODEL 2L9351 (K002679)Baxter Healthcare Corp2000-09-18
POWDER FREE LATEX EXAMINATION PATIENT GLOVES (K994420)Purna Bina Sdn Bhd2000-09-18
MIDAS TOUCH BLUE NITRILE EXAMINATION GLOVES-POWDERED (K000139)Industrial Clothings, Ltd.2000-09-13
BESTEX POWDER-FREE LATEX EXAM GLOVES WITH LABELING CLAIM. (50 MICROGRAMS OR LESS) (K002087)Qingdao Bestex Rubber & Plastic Products Co., Ltd.2000-09-13
MIDAS TOUCH NITRILE EXAMINATION GLOVES-POWDERFREE (K000138)Industrial Clothings, Ltd.2000-09-13
POWDER FREE LATEX EXAMINATION GLOVES WITH WATER EXTRACTABLE PROTEIN LABELING CLAIM. (50 MICROGRAMS OR LESS) (K002701)Alliance Rubber Products Sdn. Bhd.2000-09-13
MIDAS TOUCH LATEX EXAMINATION GLOVES-POWDERED (K000141)Industrial Clothings, Ltd.2000-09-13
MIDAS TOUCH NITRILE EXAMINATION GLOVES-POWDERED (K000143)Industrial Clothings, Ltd.2000-09-13
MIDAS TOUCH LATEX EXAMINATION GLOVES-POWDER FREE (K000142)Industrial Clothings, Ltd.2000-09-13
MIDAS TOUCH BLUE NITRILE EXAMINATION GLOVES-POWDER FREE (K000145)Industrial Clothings, Ltd.2000-09-13
TPN NUTRITION BAG (EVA), EMPTYING TUBE, BAG SYRINGE FILL SET (K001461)Biometrix , Ltd.2000-09-11
INFUSOR PATIENT CONTROL MODULE, 2ML, MODEL 2C1067K (K002739)Baxter Healthcare Corp2000-09-11
LATEX EXAMINATION GLOVES, POWDERED, (CONTAINS 100 MICROGRAMS OR LESS OF TOTAL WATER EXTRACTABLE PROTEIN PER GRAM). (K002448)Oon Corp. Resources2000-09-11
RUBBERCARE POLYMER-COATED POWDERED LATEX EXAMINATION GLOVES/GUARDIAN POLYMER-COATED POWDERED EXAMINATION GLOVES. CONTAI (K002111)Perusahaan Pelindung Getah (M) Sdn Bhd2000-09-08
DERMAGRIP POWDERFREE POLYMER COATED LATEX EXAMINATION GLOVE WITH PROTEIN CONTENT LABELING CLAIM (50 MICROGRAM OR LESS) (K002579)Wrp Specialty Products Sdn. Bhd.2000-09-08
I.V. SET-LUER LOCK WITH LATEX FREE INJECTION SITE, MODEL B411 (K001872)Codan US Corp.2000-09-07
P.O.P. PAIN KIT (K001342)Post Operative Pain Management2000-09-07
ZORTRAN DETECTOR (K000997)Lucent Medical Systems2000-09-07
INFUSOR SV, INFUSOR LV, BAXTER PAIN MANAGEMENT SYSTEM (K002380)Baxter Healthcare Corp2000-09-05
D. R. MEDICAL CONTROLLED PRESSURE GARMENTS (K001300)Confection Medicale D.R., Inc.2000-08-30
AVID-NIT LOSS OF RESISTANCE SYRINGE (K001731)Avid Medical, Inc.2000-08-29
CIDEX OPA SOLUTION (0.55% ORTHRO-PHTHALALDEHYDE SOLUTION) (K002401)Advanced Sterilization Products2000-08-29
PARADIGM SILHOUETTE, MODELS MMT-377, 378, 379, 380 (K002138)Maersk Medical A/S2000-08-29
CECILIA PENGUIN MULTI-USE THERMOMETER, MODEL HP-ETO9999 (K993950)Nien Made Electrnics Corp.2000-08-23
PALM PUMP (K002434)Sorenson Medical, Inc.2000-08-23
3M COMPLY 1249 LIQUID PERACETIC ACID CHEMICAL INDICATOR (K000355)Minnesota Mining and Mfg. Co.2000-08-23
MICROLIFE DIGITAL INFRARED EAR THERMOMETER, MODEL IR1DA1 (K000969)Microlife Corp.2000-08-22
VINYL EXAMINATION GLOVE, POWDER-FREE, YELLOW (K002340)Glormed Intl., Inc.2000-08-22
PATIENT LATEX POLYMER COATED POWDER-FREE GLOVES, CONTAINS 50 MICROGRAM OR LESS OF TOTAL WATER EXTRACTABLE PROTEIN PER GR (K002065)Comfort Rubber Gloves Industries Sdn. Bhd.2000-08-22
PARADIGM 1.5ML RESERVOIR, MODEL 326 (K001828)Minimed, Inc.2000-08-18
PARADIGM SOF-SET ULTIMATE QR, MODELS 317 AND 318 (K001832)Minimed, Inc.2000-08-18
PARADIGM SOF-SET MICRO QR, MODELS 324 AND 325 (K001827)Minimed, Inc.2000-08-18
MINIMED PARADIGM INSULIN PUMP, MODEL 511 (K001829)Minimed, Inc.2000-08-18
LATEX PATIENT EXAMINATION GLOVES POWDERED WITH PROTEIN CONTENT LABELING CLAIM; 100 MICROGRAM OR LESS OF TOTAL WATER EXTR (K002314)Perusahaan Getah Asas Sdn. Bhd.2000-08-17
MEDIVATORS 5 MINUTE HIGH-LEVEL DISINFECTANT (K993042)Medivators, Inc.2000-08-17
MASTERSITE NEEDLELESS LUER ACTIVATED IV CONNECTOR, MODEL MS 1000 (K001106)Creative Plastic Technology2000-08-16
NITRILE EXAM GLOVE, POWDER-FREE, COLOR BLUE (K002218)Shanghai Champion Plastic Products Co., Ltd.2000-08-15
NITRILE EXAM GLOVE, PRE-POWDERED, COLOR BLUE (K002220)Shanghai Champion Plastic Products Co., Ltd.2000-08-15
CHARTER MEDICAL NEONATAL SYRINGE SET (K000685)Charter Medical, Ltd.2000-08-15
RUBBERCARE POLYMER-CHLORINATED POWDER-FREE GUARDIAN POLYMER-CHLORINATED POWDER-FREE (K002112)Perusahaan Pelindung Getah (M) Sdn Bhd2000-08-14
NEOLUS NEEDLE (K001572)Terumo Europe N.V.2000-08-14
DANA DIABECARE (K001604)Sooil Development Co., Ltd.2000-08-14
PAIN CARE 2000L (K002321)Breg, Inc.2000-08-14
NITRILE EXAM GLOVE, POWDER-FREE, COLOR WHITE (K002217)Shanghai Champion Plastic Products Co., Ltd.2000-08-11
NITRILE EXAMINATION GLOVE, PRE-POWDERED, COLOR WHITE (K002216)Shanghai Champion Plastic Products Co., Ltd.2000-08-11
NIPROTECT POWDER-FREE NITRILE EXAMINATION GLOVES (K994124)Mapa Professional2000-08-11
RUBBERCARE GUARDIAN POLYMER-COATED POWDER-FREE LATEX EXAMINATION GLOVES: CONTAINS 100 MICROGRAMS OR LESS OF TOTAL WATER (K002114)Perusahaan Pelindung Getah (M) Sdn Bhd2000-08-11
LIFESHIELD ADDITIVE PIERCING PIN (K002006)Abbott Laboratories2000-08-10
POWDER FREE LATEX PATIENT EXAMINATION GLOVES WITH PROTEIN LABELING CLAIM (50 MICROGRAMS OR LESS) (K000913)Handsafe Products Sdn. Bhd.2000-08-10
SYNTHETIC POWDERED (YELLOW) VINYL PATIENT EXAMINATION GLOVES (K002012)Shijiazhuang Great Vision Plastic Products Co., LT2000-08-09
SYNTHETIC POWDER FREE (YELLOW) VINYL PATIENT EXAMINATION GLOVES (K002015)Shijiazhuang Great Vision Plastic Products Co., LT2000-08-09
HOTLINE 2 FLUID WARMER (K001764)Sims Level 1, Inc.2000-08-09
ALLEGIANCE GENESIS CONTAINER SYSTEM (K983299)Allegiance Healthcare Corp.2000-08-04
VYGON LIFECATH-PICC (PUR) CATHETERS (SINGLE AND DOUBLE LUMEN 3FR, 4FR, 4.5FR, AND 5FR) (K993442)Vygon Corp.2000-08-03
VYGON 2 FR EPICUTANEO PUR-CATHETER (K993052)Vygon Corp.2000-08-03
ADVANTIS ASC INFUSION PUMP AND ADMINISTRATION SETS (K993524)Alaris Medical Systems, Inc.2000-08-01
PROTECTIV SAFETY BLOOD COLLECTION NEEDLE (K001690)Johnson & Johnson Medical, Inc.2000-07-31
NON-STERILE POWDER FREE BUBBLE-GUM SCENTED LATEX EXAMINATION GLOVE WITH PROTEIN CONTENT LABELING CLAIM (50 MICROGRAMS OR (K002175)Sgmp Co., Ltd.2000-07-31
NON-STERILE POWDER FREE PINEAPPLE SCENTED LATEX EXAMINATION GLOVES WITH PROTEIN CONTENT LABELING CLAIM (50 MICROGRAMS LE (K002176)Sgmp Co., Ltd.2000-07-31
COLLEAGUE CX VOLUMETRIC INFUSION PUMP 2M8161 AND VOLUMETERIC INFUSION PUMP 2M8151 (K002211)Baxter Healthcare Corp2000-07-28
POLYMER COATED POWDER-FREE LATEX EXAMINATION GLOVES, CONTAINS 50 MICROGRAMS OR LESS OF TOTAL WATER EXTRACTABLE PROTEIN P (K001739)Allegiance Healthcare Corp.2000-07-27
TOP QUALITY CHLORINATED-POWDERFREE EXAMINATION GLOVES (K000050)Top Quality Mfg., Inc.2000-07-27
MODIFICATION TO SYRINGE PREFILLED WITH 0.9% SODIUM CHLORIDE (K001616)Abbott Laboratories2000-07-27
MULTISAFE-POWDERED NITRILE GLOVES, NON-STERILE (BLUE) (K001497)Multisafe Sdn. Bhd.2000-07-26
MULTISAFE POWDER FREE NITRILE GLOVES, NON STERILE (BLUE) (K001619)Multisafe Sdn. Bhd.2000-07-26
NITRILE EXAMINATION GLOVES, PRE-POWDERED, COLOR WHITE (K001836)Shanghai Poseidon Plastic Products Co., Ltd.2000-07-26
BD INSYTE AUTOGUARD -P AND BD INSYTE AUTOGUARD -P WINGED IV CATHETERS (K002033)Becton Dickinson Infusion Therapy Systems, Inc.2000-07-26
ULTIMATE N-DEX POWER FREE NITRILE EXMINATION GLOVE (TESTED FOR USE WITH CHEMOTHERAPY DRUGS) (K001375)Best Manufacturing Company2000-07-25
KAWASUMI LABORATORIES IV ADMINISTRATION SET, STANDARD (K001424)Kawasumi Laboratories America, Inc.2000-07-21
KAWASUMI LABORATORIES IV ADMINISTRATION SET, PRIMARY (K001423)Kawasumi Laboratories America, Inc.2000-07-21
KAWASUMI LABORATORIES IV ADMINISTRATION SET WITH FILTER (K001426)Kawasumi Laboratories America, Inc.2000-07-21
ABBOTT ACCLAIM ENCORE STANDARD TUBING PUMP (K002126)Abbott Laboratories2000-07-20
UNIVEC AUTO-DISABLE HYPODERMIC SYRINGE (K993996)Univec, Inc.2000-07-17
ISOLETTE INFANT INCUBATOR, MODEL C2HS (K001242)Hill-Rom Air-Shields2000-07-13
NITRILE EXAMINATION GLOVES, PRE-POWDERED, COLOR BLUE (K001837)Shanghai Poseidon Plastic Products Co., Ltd.2000-07-11
SYNTHETIC POWDERED (YELLOW) VINYL PATIENT EXAMINATION GLOVES (K001861)Shijiazhuang Hongxiang Plastics Products Co; , Ltd.2000-07-11
NEEDLELESS TRANSFER DEVICE (K001831)Medimop Medical Projects, Ltd.2000-07-11
SYNTHETIC POWDERED (WHITE) VINYL PATIENT EXAMINATION GLOVES (K001863)Shijiazhuang Hongxiang Plastics Products Co; , Ltd.2000-07-11
TISSOMAT AND SPRAY SET (K981089)Baxter Healthcare Corp2000-07-05
DISPOSABLE PVC SYNTHETIC EXAM GLOVES, POWDER FREE (K001432)Shanghai PM Plastics Ent. Co., Ltd.2000-07-05
POLYMER COATED POWDER FREE, LATEX EXAMINATION GLOVES WITH PROTEIN CONTENT LABELING CLAIM (50 MICROGRAMS OR LESS) (K001165)Medipure Corporation (M) Sdn. Bhd.2000-07-05
POWDERED PATIENT EXAMINATION GLOVES, LATEX (K001715)Fitco Dipped Products Pvt., Ltd.2000-07-05
DANIELS SHARPSMART REUSABLE SHARPS CONTAINER (K001337)The Daniels Corp.2000-07-05
SYNTHETIC POWDER FREE (WHITE) VINYL PATIENT EXAMINATION GLOVES (K001862)Shijiazhuang Hongxiang Plastics Products Co; , Ltd.2000-06-30
DISPOSABLE PVC SYNTHETIC EXAMINATION GLOVES, POWDER FREE (K001611)Shanghai PT Plastics Enterprise Company, Ltd.2000-06-30
SYNTHETIC POWDER FREE (YELLOW) VINYL PATIENT EXAMINATION GLOVES (K001834)Shijiazhuang Hongxiang Plastics Products Co; , Ltd.2000-06-30
HEALTH-PLUS, SANITEX, RELIANCE PRE-POWDERED LATEX EXAMINATION GLOVES - BLUE COLOR (K000952)Pamitex Industries Sdn Bhd2000-06-30
POWDER-FREE LATEX EXAMINATION GLOVES-BLUE COLOR (K001674)Pamitex Industries Sdn Bhd2000-06-30
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