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General Hospital

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

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RecordFirmDate
TG MEDICAL POWDERED NITRILE EXAMINATION GLOVES (K992360)Tg Medical Sdn. Bhd.1999-10-12
CIDEX OPA SOLUTION (K991487)Advanced Sterilization Products1999-10-08
BROWNE CIDEX OPA INDICATOR (K991709)Albert Browne , Ltd.1999-10-08
SEALOUETTE FIBRIN SEALANT APPLICATOR (K992351)Biosurgical Corp.1999-10-08
0.9% SODIUM CHLORIDE FLUSH SYRINGE (K984590)Baxter Healthcare Corp1999-10-07
HEALTH-PLUS, SANITEX, RELIANCE, PRE-POWDERED MULTI-PLY EXAMINATION GLOVE, (NATURAL LATEX LAMINATED WITH NITRILE, EXTERNA (K991474)Pamitex Industries Sdn Bhd1999-10-06
SUPER SOOTHER (K991914)Mart Tiller Corp.1999-10-06
SENSI-PRO, DISPOSABLE POWDERED VINYL SYNTHETIC EXAMINATION GLOVES, WHITE COLOR (K992922)Shijiazhuang Hongray Plastic Products Co., Ltd.1999-10-06
SYNTHETIC POWDER FREE (YELLOW) VINYL PATIENT EXAMINATION GLOVES (K992861)Shijiazhuang Great Eagle Plastic Products Co., Ltd.1999-10-06
PRE-POWDERED VINYL PATIENT EXAMINATION GLOVES (K992271)Shanghai Cosmos Corp.1999-10-01
BECTON DICKINSON SYRINGE (K992734)Bd Becton Dickinson Vacutainer Systems Preanalytic1999-10-01
POWDER-FREE VINYL PATIENT EXAMINATION GLOVES (K992272)Shanghai Cosmos Corp.1999-10-01
PRE-POWDERED LATEX EXAMINATION GLOVE WITH OAT-STARCH POWDER (K992117)Pamitex Industries Sdn Bhd1999-09-27
HWA (AND) SILKTEX POWDER-FREE LATEX EXAMINATION GLOVE (K992810)Hwa Teh Industrial Sdn. Bhd.1999-09-27
NITRILE PATIENT EXAMINATION GLOVES, POWDERED, NON-STERILE (K992558)Riverstone Resources Sdn Bhd1999-09-27
EXTRA-CARE LATEX PATIENT EXAMINATION GLOVE, POWDER-FREE, POLYMER COATED (K992175)Ultrawin Sdn Bhd1999-09-24
DISPOSABLE POWDER FREE NITRILE EXAM GLOVE, BLUE COLOR (K992686)Sheen More Ent. Co., Ltd.1999-09-24
DISPOSABLE POWDER FREE VINYL SYNTHETIC EXAMINATION GLOVES, WHITE COLOR (K992860)Shijiazhuang Hongray Plastic Products Co., Ltd.1999-09-24
QTEXX PRE-POWDERED NITRILE EXAMINATION GLOVES (K992671)Latexx Partners Bhd.1999-09-24
HEALTH-PLUS, SANITEX, RELIANCE POWER-FREE LATEX EXAMINATION GLOVE WITH PROTEIN CONTENT LABELING CLAIM 73.13 MICROGRAMS O (K992364)Pamitex Industries Sdn Bhd1999-09-22
NAC PRN NEEDLELESS ACCESS CONNECTOR (K992268)The Kipp Group1999-09-15
BOLUS ACCESSORY SET (K992072)I-Flow Corp.1999-09-15
DASH SILICONIZED POLYMER COATED POWDER FREE LATEX EXAMINATION GLOVES WITH PROTEIN CONTENT LABELING CLAIM (50 MICROGRAMS (K992128)Dash Medical Gloves Sdn Bhd1999-09-14
SYNTHETIC POWDERED VINYL PATIENT EXAMINATION GLOVES (K992464)Shijiazhuang Dilly Plastics Products Co., Ltd.1999-09-14
CONTROL III ELITE (K992661)Maril Products, Inc.1999-09-14
QUALATEX POWDERED LATEX EXAMINATION GLOVES (K992557)Tan Sin Lian Industries Sdn. Bhd.1999-09-14
HWA (AND) SILKTEX PRE-POWDERED LATEX EXAMINATION GLOVE (K992730)Hwa Teh Industrial Sdn. Bhd.1999-09-14
ROYAL SHIELD NON-STERILE POWDERED LATEX EXAMINATION GLOVES (PROTEIN LABELING CLAIM) 200 MCGM OR LESS OF TOTAL WATER EXTR (K992417)Shield Gloves Manufacturer (M) Sdn Bhd1999-09-13
ENDO-SPOR PLUS / HYPROCIDE (K972708)Cottrell, Ltd.1999-09-13
ROYAL SHIELD NON-STERILE BLUE COLORED POWDERED LATEX EXAMINATION GLOVE WITH PROTEIN CONTENT LABELING CLAIM (200 MCGM OR (K992419)Shield Gloves Manufacturer (M) Sdn Bhd1999-09-13
ROYAL SHIELD NON-STERILE PINK COLORED POWDERED LATEX EXAMINATION GLOVE WITH AND WITHOUT STRAWBERRY SCENT AND WITH PROTEI (K992418)Shield Gloves Manufacturer (M) Sdn Bhd1999-09-13
FREEDOM INFUSION SYSTEM (K992015)Novacon Corp.1999-09-10
BLUE NITRILE PATIENT EXAMINATION GLOVES, POWDER-FREE (K992588)Formosa Glove Industrial Co., Ltd.1999-09-10
SHIELDMASTER POWDERED PURPLE NITRILE EXAMINATION GLOVES (K992210)Safeskin Corp.1999-09-10
CORRECT TOUCH POWDER FREE 911 LATEX EXAMINATION GLOVES, (BLUE) (K992358)Biopro (M) Sdn Bhd1999-09-10
TERUMO U-100 INSULIN SYRINGE (K992802)Terumo Medical Corp.1999-09-09
PUNCTUR-GUARD REVOLUTION HOLDER, MODEL 4750 (K992091)Bio-Plexus, Inc.1999-09-09
HEALTH-PLUS, SANITEX, RELIANCE, PRE-POWDERED LATEX EXAMINATION GLOVES WITH PROTEIN LABELING CLAIM (137 MCG OR LESS) (K991969)Pamitex Industries Sdn Bhd1999-09-09
INFUSION DYNAMICS POWER INFUSER MODEL M100B (K992044)Infusion Dynamics, Inc.1999-09-08
N-DEX BLUE POWDER-FREE NITRILE MEDICAL EXAMINATION GLOVE (K992170)Best Manufacturing Company1999-09-07
SOF-SET MICRO QR INFUSION SET, MODELS 320 AND 321 (K991979)Medtronic Minimed1999-09-03
SAGE CONTRAST MANAGEMENT SYSTEM (K991112)Sage Laboratories, Inc.1999-09-02
MODIFICATION OF JMS NEEDLES AND JMS SYRINGES (K991904)Jms Co., Ltd.1999-08-31
LATEX EXAMINATION GLOVES POWDER-FREE WITH PROTEIN LABELING CLAIM (50 MICROGRAMS OR LESS TOTAL EXTRACTABLE PROTEIN) (K991777)Seltom Pacific Sdn. Bhd.1999-08-31
LATEX EXAMINATION GLOVES POLYMER COATED (POWDER-FREE) (K991778)Seltom Pacific Sdn. Bhd.1999-08-31
SAFESKIN PURPLE POWDER-FREE NITRILE EXAMINATION GLOVES FOR USE WITH CHEMOTHERAPEUTIC DRUGS LABELING CLAIM (K992162)Safeskin Corp.1999-08-30
SYNTHETIC POWDER-FREE VINYL PATIENT EXAMINATION GLOVES (K992463)Shijiazhuang Dilly Plastics Products Co., Ltd.1999-08-30
WELLS JOHNSON INFUSION SYSTEM, MODEL 20-6000-00 (K991437)Wells Johnson Co.1999-08-30
HEALTH-PLUS, SANITEX, RELIANCE POWDER-FREE NITRILE EXAMINATION GLOVE (K992223)Pamitex Industries Sdn Bhd1999-08-30
CHARTER MEDICAL, LTD MP 450 (40 MICRON FILTER) (K990310)Charter Medical, Ltd.1999-08-30
SEDATELEC ASP ACUPUNCTURE NEEDLES (K983798)Sedatelec1999-08-27
FERRIS POLYOSTOMY STERILE WOUND DRESSING (K991729)Ferris Mfg. Corp.1999-08-27
ACUMASTER BRAND ACUPUNCTURE NEEDLE (K991508)Helio Medical Supplies, Inc.1999-08-27
KANGNIAN BRAND ACUPUNCTURE NEEDLE (K991507)Helio Medical Supplies, Inc.1999-08-27
URETHANE PICC LINE MODEL UPICS- (K992198)Cook, Inc.1999-08-27
DN ACUPUNTURE NEEDLES (K983800)Sedatelec1999-08-27
POWDER-FREE NITRILE EXAMINATION GLOVE, BLUE OR WHITE (NON-COLORED) (K992496)Kossan Latex Industries(M)Sdn Bhd1999-08-25
POWDERED NITRILE EXAMINATION GLOVE, BLUE OR WHITE (NON-COLORED) (K992497)Kossan Latex Industries(M)Sdn Bhd1999-08-25
SAFESKIN STERILE PURPLE NITRILE EXAMINATION GLOVES (K992062)Safeskin Corp.1999-08-25
MED-RX EXTENSION SETS (K990777)Benlan, Inc.1999-08-25
HEALTH-PLUS, SANITEX, RELIANCE POWDER-FREE LATEX EXAMINATION GLOVE (K992165)Pamitex Industries Sdn Bhd1999-08-25
BIOSHIELD EXPRESS STERILIZATION WRAP (K983719)Allegiance Healthcare Corp.1999-08-25
BELMONT FLUID MANAGEMENT SYSTEM (FMS2000) (K992672)Belmont Instrument Corp.1999-08-24
QS DELIVERY SYSTEM (K991254)Sub-Q, Inc.1999-08-23
HEALTH-PLUS, SANITEX, RELIANCE PRE-POWDERED NITRILE EXAMINATION GLOVE (K992299)Pamitex Industries Sdn Bhd1999-08-23
PARSET, MODEL A10001E (K992104)Rd Medical Mfg., Inc.1999-08-23
BALDUR BRAND VINYL POWDERED EXAMINATION GLOVES (K992107)General Gloves Corp.1999-08-23
INTRAVASCULAR ADMINISTRATION SET (K991932)The Kipp Group1999-08-20
COOK HIGH VOLUME INFUSION ADAPTER INTRAVASCULAR ADMINISTRATION SET (K991985)Cook, Inc.1999-08-20
MODIFICATION OF JELCO*,JELCO*-W AND JELCO* PLUS I.V. CATHETERS, CATHLON* I.V. CATHETERS, OPTIVA* I.V. CATHETERS, PROTECT (K990236)Johnson & Johnson Medical, Div. of Ethicon, Inc.1999-08-20
JOBST READY-TO-WEAR ARM SLEEVES (K991570)Beiersdorf-Jobt, Inc.1999-08-20
ACRY ISLAND BORDER DRESSING, MODELS 2031, 2032, 2033 (K992032)Acrymed, Inc.1999-08-19
DUTECK DIGITAL CLINICAL THERMOMETER (K992327)Duteck Industrial Co., Ltd.1999-08-18
TEXTURED POWDER-FREE LATEX EXAMINATION GLOVES WITH ALOE VERA GREEN, CONTAINS 50 MCGM OR LESS OF TOTAL WATER EXTRACTABLE (K992200)Shen Wei (Usa), Inc.1999-08-17
BLOSSOM POWDER FREE LATEX EXAMINATION GLOVES WITH PROTEIN CONTENT LABELING CLAIM 50 MCGM OR LESS OF TOTAL WATER EXTRACTA (K992337)Mexpo Intl., Inc.1999-08-17
KLOUT SHAMPOO AND LICE COMBING PRETREATMENT KIT (K991958)Kiel Laboratories, Inc.1999-08-13
DERMAPHYLYX HYDROPHILIC FOAM WOUND DRESSING (K991920)Dermaphylyx, Inc.1999-08-12
AB2 MED-FLO SOLUTION SET (K984569)Ab2 Medical Products, Llp1999-08-12
NITRILE EXAMINATION GLOVES POWDER FREE (BLUE) (K991779)Seltom Pacific Sdn. Bhd.1999-08-11
NITRILE EXAMINATION GLOVES POWDER FREE (WHITE) (K991776)Seltom Pacific Sdn. Bhd.1999-08-11
LAGLOVE BRAND BLUE COLOLRED NITRILE EXAMINATION GLOVE (POWDERED) (K990883)La Glove (M) Sdn. Bhd.1999-08-10
ACCUTOUCH POWDER FREE NATURAL RUBBER LATEX PATIENT EXAMINATION GLOVE (K992428)Tillotson Healthcare Corp.1999-08-09
DISPOSABLE PVC SYNTHETIC EXAMINATION GLOVES, POWDER FREE (K992017)Shanghai Antares Industries, Inc.1999-08-05
PATIENT EXAMINATION GLOVES, NITRILE POWDER FREE, TURQUOISE,NON-STERILE. (K991845)Omnigrace , Ltd.1999-08-05
PATIENT EXAMINATION GLOVE, NITRILE, POWDERED, TURQUOISE, NON-STERILE (K991846)Omnigrace , Ltd.1999-08-05
NITRILE EXAMINATION GLOVES, NON-STERILE, POWDER FREE, DARK BLUE COLOR (K991981)Alliance Rubber Products Sdn. Bhd.1999-08-05
VINYL POWDERED EXAM GLOVE / CAT.# 15-020 (K992289)Vitalcare Group, Inc.1999-08-04
CIRCON SURGIFLEX WAVE TSUNAMI SUCTION-IRRIGATION SYSTEM (K992126)Circon Corp.1999-08-03
DERMAPHYLYX FOAM ISLAND DRESSING (K991933)Dermaphylyx, Inc.1999-07-30
POLYURETHANE POWDER FREE DENTAL EXAMINATION GLOVE, POLYURETHANE POWDER FREE MEDICAL EXAMINATION GLOVE (K991615)Maxxim Medical1999-07-30
QUICK-SERTER, MODEL 395 (K992300)Medtronic Minimed1999-07-29
BIOTHANE PATIENT RESTRAINT (K991591)Bioplastics1999-07-29
SD-100 SKYEAR THERMOMETER (K984506)Skylark Device Co., Ltd.1999-07-29
NITRILE EXAMINATION GLOVES- PRE-POWDERED, SMALL, MEDIUM, AND LARGE (K992177)Pt. Berlian Glovindo1999-07-29
PVC (POLYVINYL CHLORIDE) SYNTHETIC EXAMINATION GLOVES, POWDERED (K992100)Shanghai Palomar Mountain Industries, Inc.1999-07-29
POWDER-FREE VINYL PATIENT EXAMINATION GLOVES (K992206)Shanghai China Star Corp1999-07-29
SAFESKIN SYNTHETIC BINYO POWDER-FREE POLYMER COATED EXAMINATION GLOVES (GREEN, WHITE) (K991951)Safeskin Corp.1999-07-26
LUER ACCESS INJECTION SITE (K984060)Baxter Healthcare Corp1999-07-26
PRE-POWDERED VINYL PATIENT EXAMINATION GLOVES (K992205)Shanghai China Star Corp1999-07-23
DERMAPHYLYX SUPER ABSORBENT FIBER DRESSING (K991609)Dermaphylyx, Inc.1999-07-20
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