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General Hospital

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

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RecordFirmDate
VISCOUS FLUID INJECTOR SYSTEM MODULE (CX5700) (K993039)Bausch & Lomb, Inc.2000-01-07
OHMEDA MEDICAL OMNIBED (K993407)Ohmeda Medical2000-01-05
VACLOK SYRINGE (K994253)Merit Medical Systems, Inc.2000-01-05
INTRAVASCULAR ADMINISTRATION SET (K993463)Custom Assemblies, Inc.2000-01-04
CELSITE, MODELS ST401L, ST405L (K994111)B. Braun/Mcgaw2000-01-03
DISETRONIC D-TRON INSULIN INFUSION PUMP (K994186)Disetronic Medical Systems1999-12-30
HEALTH-PLUS, SANITEX, RELIANCE, BLUE PRE-POWDERED LATEX EXAMINATION GLOVES, WITH PROTEIN CONTENT LABELING CLAIM (100 MIC (K993621)Pamitex Industries Sdn Bhd1999-12-29
DISENTRONIC PENFINE INJECTION PEN NEEDLE (K994197)Disetronic Medical Systems1999-12-29
POWDER FREE LATEX EXAMINATION GLOVES, POLYMER COATED WITH PROTEIN CONTENT LABELING CLAIM (50 MICROGRAMS OR LESS) (K993529)Biografik (Malaysia) Sdn Bhd1999-12-29
ABBOTT GEMSTAR I.V. INFUSION PUMP-7 THERAPY CONFIGURATION, ABBOTT GEMSTAR I.V. INFUSION PUMP-6 THERAPY CONFIGURATION, AB (K994039)Abbott Laboratories1999-12-22
PEPPER GREEN MINT POWDERED LATEX EXAMINATION GLOVES (K993605)Top Glove Sdn. Bhd.1999-12-20
LATEX EXAMINATION POWDERED GLOVES (K993386)Great Glove Sdn Bhd1999-12-20
GREEN POWDERED LATEX EXAMINATION GLOVES (K993452)Top Glove Sdn. Bhd.1999-12-20
PRE-POWDERED VINYL EXAM GLOVE, NON STERILE (K994036)Shanghai Champion Plastic Products Co., Ltd.1999-12-20
SURE-WAY REUSABLE SHARPS CONTAINER (K992626)Sure-Way Systems, Inc.1999-12-16
PATIENT LATEX EXAMINATION POWDER-FREE POLYMER COATED GLOVES (K992676)Wear Safe Malaysia Sdn. Bhd.1999-12-16
MEDIPACK SEE-THROUGH SEAL STERILIZATION POUCH (K993764)Medipack Medical Packaging Mfg. Co.1999-12-16
PALL SUPOR AEF FILTER (K993379)Pall Corp.1999-12-16
PARAPOST SYSTEM STERILIZABLE ORGANIZER (K993835)Coltene/Whaledent, Inc.1999-12-16
PATIENT LATEX EXAMINATION GLOVE POWDERED & POWDER FREE, STERILE (K992681)Wear Safe Malaysia Sdn. Bhd.1999-12-16
SYNTHETIC VINYL MEDICAL EXAMINATION POWDER FREE GLOVE (K993680)Top Glove Sdn. Bhd.1999-12-13
HEPARIN IV FLUSH SYRINGE, 10 U/ML \ (K990390)Rocap Div. of Sabratek Corp.1999-12-10
ROCAP HEPARIN IV FLUSH SYRINGE, 100U/ML (K990308)Rocap Div. of Sabratek Corp.1999-12-10
AROMATIC AND FLAVORED TONGUE DEPRESSOR (K992995)Aga Plastic Ind. Com. Ltda.1999-12-09
BIOSONIC UC-70 STERILIZABLE INSTRUMENT CASSETTE (K993255)Coltene/Whaledent, Inc.1999-12-06
VIRIDIA INFORMATION CENTER SOFTWARE FOR M3154A OPT C22 (K993907)Agilent Technologies, Inc.1999-12-06
PRIMUS STEAM STERILIZERS (K991575)Primus Sterilizer Co., Inc.1999-12-03
GLOVCO, POWDER-FREE CHLORINATED LATEX EXAMINATION GLOVES WITH PROTEIN LABELING CLAIM (50 MICROGRAMS OR LESS) (K993752)Glovco (M) Sdn. Bhd.1999-12-03
CATHETER INNOVATIONS IMPLANTABLE PORT (K993860)Catheter Innovations, Inc.1999-12-03
POWDERFREE LATEX EXAMINATION GLOVES (POLYMER COATED) (PROTEIN LABEL CLAIM - 50 MICROGRAMS OR LESS) (K993454)Sri Johani Sdn. Bhd.1999-12-03
POWDER FREE LATEX EXAMINATION GLOVES, NON-STERILE WITH PROTEIN LABELING CLAIM 50 MICROGRAM OR LESS (K993820)Felda Rubber Corp.1999-12-02
QUALITY LATEX POWDERED LATEX MEDICAL GLOVES WITH PROTEIN CONTENT LABELING CLAIM OF 170 MICROGRAM OR LESS (K993271)Quality Latex Corp. Sdn Bhd1999-12-02
POWDERFREE LATEX EXAMINATION GLOVES (POLYMER COATED) (PROTEIN LABEL OF 50 MCROGRAM OR LESS) (K993500)Besglove Medicare Sdn. Bhd.1999-12-02
MULTI-COMFORT NITRILE EXAMINATION GLOVES, (POWDER FREE) (K993127)Glovesworld Industries Sdn. Bhd.1999-12-02
POWDERFREE LATEX EXAMINATION GLOVES (PROTEIN LABEL CLAIM) [50 MICROGRAMS OR LESS] (K993457)Sri Johani Sdn. Bhd.1999-12-02
SYNTHETIC POWDERED (YELLOW) VINYL PATIENT EXAMINATION GLOVES (K992862)Shijiazhuang Great Vision Plastic Products Co., LT1999-11-29
POWDERED LATEX EXAMINATION GLOVES(PROTEIN LABEL CLAIM 150 MICROGRAMS OR LESS) (K993495)Besglove Medicare Sdn. Bhd.1999-11-24
POWDERFREE LATEX EXAMINATION GLOVES (PROTEIN LABEL CLAIM 50 MICROGRAMS OR LESS) (K993502)Besglove Medicare Sdn. Bhd.1999-11-24
CIDEX OPA SOLUTION TEST STRIP (K992341)Serim Research Corp.1999-11-23
BLUE CHLORINATED POWDER FREE LATEX EXAMINATION GLOVES WITH PROTEIN CONTENT LABELING CLAIM OF 50 MICROGRAMS OR LESS. (K993722)Hartalega Sdn Bhd1999-11-23
GREEN CHLORINATED POWDER-FREE LATEX EXAMINATION GLOVES WITH PROTEIN CONTENT LABELING CLAIM OF 50 MICROGRAMS OR LESS (K993725)Hartalega Sdn Bhd1999-11-23
COMFIT POWDER FREE BLUE NITRILE EXAMINATION GLOVE, STERILE (K993313)Wrp Asia Pacific Sdn. Bhd.1999-11-23
DISETRONIC PEN P100 (K993666)Disetronic Medical Systems1999-11-22
COMFIT POWDER FREE NITRILE EXAMINATION GLOVE, STERILE (K993311)Wrp Asia Pacific Sdn. Bhd.1999-11-19
POWDER FREE GLOVES (POLYMER COATED) (K993183)Pan-Century Rubber Products Sdn. Bhd.1999-11-19
OMNI GRACE LATEX EXAMINATION GLOVE, POWDERED, WITH PROTEIN CLAIM (100 MICROGRAMS OR LESS) (K993479)Omnigrace (Thailand) , Ltd.1999-11-19
DISPOSABLE PVC POWDERED SYNTHETIC EXAMINATION GLOVES (K993049)Shanghai Antares Industries, Inc.1999-11-19
NIL, NITRILE EXAMINATION GLOVE - POWDER FREE (K993348)Sri Anusham Rubber Industries Pvt., Ltd.1999-11-19
NIL, NITRILE EXAMINATION GLOVE - POWDERED (K993347)Sri Anusham Rubber Industries Pvt., Ltd.1999-11-19
OMNIGRACE LATEX EXAMINATION GLOVE, POWDER-FREE; POLYMER COATED WITH PROTEIN CLAIM (50 MICROGRAMS OR LESS) (K993419)Omnigrace , Ltd.1999-11-19
PORT-A-CATH II TRANS-ARTERIAL PERCUTANEOUS SYSTEM (K992697)Sims Deltec, Inc.1999-11-18
PATIENT NITRILE EXAMINATION GLOVES POWDER FREE CHLORINATED (K992678)Wear Safe Malaysia Sdn. Bhd.1999-11-17
NON-STERILE POLYMER COATED POWDER FREE LATEX EXAMINATION GLOVES WITH A PROTEIN LABELING CLAIM (70 MICROGRAMS OR LESS PER (K993326)Seal Polymer Industries Bhd.1999-11-17
CASHMERE NON-STERILE POWDERED NITRILE EXAMINATION GLOVES BLUE AND GREEN (K993133)Seal Polymer Industries Bhd.1999-11-17
CASHMERE NON-STERILE BLUE POWDERED NITRILE EXAMINATION GLOVESBLUE AND GREEN) (K993134)Seal Polymer Industries Bhd.1999-11-17
MODIFIED BLOOD RECIPIENT SET (K993120)Baxter Healthcare Corp1999-11-17
MINIMED COM-STATION, HARDWARE-7301; SOFTWARE-7311 (K993012)Medtronic Minimed1999-11-15
AUTOJET 2 (NON-FIXED NEEDLE TYPE) (K993385)Owen Mumford USA, Inc.1999-11-10
POWDERED LATEX EXAMINATION GLOVES (PROTEIN LABEL CLAIM) (K993458)Sri Johani Sdn. Bhd.1999-11-10
BILIBLANKET PLUS HIGH OUTPUT PHOTOTHERAPY SYSTEM (K993712)Ohmeda Medical1999-11-09
OMNI GRACE NITRILE, GREEN, EXAMINATION GLOVE, POWDER-FREE, POLYMER COATED (K993050)Omnigrace , Ltd.1999-11-09
EVENT ALLERGEN BARRIERS, EVENT MATTRESS ENCASING, EVENT DUVET ENCASING, EVENT PILLOW ENCASING, EVENT BEDDING SYSTEM (K992702)Allergy Direct1999-11-08
INNOVATIVE GLOVES, LATEX EXAMINATION GLOVES, PREPOWDERED (K993221)Innovative Gloves Co;, Ltd.1999-11-05
SHELLY PROTECTED AV FISTULA NEEDLE (K993187)Diasol, Inc.1999-11-05
SYNTHETIC POWDERED VINYL PATIENT EXAMINATION GLOVES (K992797)Shijiazhuang Hongxiang Plastics Products Co., Ltd.1999-11-05
INNOVATIVE GLOVES, LATEX EXAMINATION GLOVES POWDERFREE (K993222)Innovative Gloves Co;, Ltd.1999-11-05
INNOVATIVE GLOVES, NITRILE BUTADIENE RUBBER POWDER-FREE (K993325)Innovative Gloves Co;, Ltd.1999-11-05
NITRILE POWDER FREE PATIENT EXAMINATION GLOVES (K993247)Jda Intl., Inc.1999-11-05
DAISY PROTECTED SCALP VEIN SET (K992999)Diasol, Inc.1999-11-05
QTEXX, NON-CHLORINATED, POWDER FREE NITRILE EXAMINATION GLOVES, POLYMER-COATED (K992924)Latexx Partners Bhd.1999-11-05
DECAP (K993147)The Kipp Group1999-11-02
IPUMP PAIN MANAGEMENT SYSTEM, MODEL 2L3107K (K993387)Baxter Healthcare Corp1999-11-01
ABSOGEL CHEMOTHERAPHY GLOVES (K990677)Ampri Rubberware Industries Sdn Bhd1999-11-01
TG MEDICAL POWDERED NITRILE BLUE EXAMINATION GLOVES (K992841)Tg Medical Sdn. Bhd.1999-10-29
HEALTH-PLUS, SANITEX, RELIANCE (50 MICROGRAMS) (K993093)Pamitex Industries Sdn Bhd1999-10-29
POWDER FREE (SILICON COATED) LATEX EXAMINATION GLOVES WITH PROTEIN LABELING CLAIM (K993287)Pan-Century Rubber Products Sdn. Bhd.1999-10-29
ALPHA INFUSION PUMP (K992551)Advanced Infusion, Inc.1999-10-27
SYNSATION STERILE POWDER FREE, POLYVINYL CHLORIDE MEDICAL EXAMINATION GLOVES (K992156)Ansell Perry1999-10-27
SAFESKIN POLYMER-COATED NITRILE EXAMINATION GLOVES, POWDER-FREE SHIELDMASTER NITRILE GLOVE (K992830)Safeskin Corp.1999-10-27
SUPERGLOVES, POWDER FREE NITRILE EXAMINATION GLOVES (K993258)Supermax Sdn Bhd1999-10-27
PRE-POWDERED NON-STERILE VINYL EXAMINATION GLOVES (K983613)Shanghai Jiatai Plastic Products Co., Ltd.1999-10-27
IV ADMINISTRATION SET (K992266)New Alliance of Independent Medical Distributors,1999-10-27
SENSI-PRO DISPOSABLE POWDER FREE VINYL SYNTHETIC EXAMINATION GLOVES WITH WHITE PIGMENT ADDITIVES (K993240)Shinemound Enterprise, Inc.1999-10-27
SENSI-PRO DISPOSABLE POWDERED VINYL SYNTHETIC EXAMINATION GLOVES WITH WHITE PIGMENT ADDITIVES (K993231)Shinemound Enterprise, Inc.1999-10-27
HEALTH-PLUS, SANITEX, RELIANCE PRE-POWDERED LATEX EXAMINATINO GLOVES, WITH PROTEIN CONTENT LABELING CLAIM (100 MICROGRAM (K993097)Pamitex Industries Sdn Bhd1999-10-27
TEMP TELLER - DIGITAL THERMOMETER, MODELS DT-101, DT-102, DT-103, DT-201, DT-202, DT-203 (K992601)Oriental System Technology, Inc.1999-10-27
INTRAOP CATHETER (K991543)I-Flow Corp.1999-10-25
CATHETER INNOVATIONS IMPLANTABLE PORT (K991897)Catheter Innovations, Inc.1999-10-21
BRAUN THERMOSCAN PRO3000 INFARED THERMOMETER (K992468)Braun GmbH1999-10-20
AMBIDERM LATEX EXAMINATION GLOVES (VIOLET, BLUE , GREEN, AND PINK) CONTAINING 50 MCGM OR LESS OF TOTAL WATER EXTRACTABLE (K993080)Medtexx Partners, Inc.1999-10-20
P.A.S. PORT ELITE IMPLANTABLE VENOUS ACCESS SYSTEM (K992880)Sims Deltec, Inc.1999-10-19
DERMAGRIP POWDER FREE NITRILE EXAMINATION GLOVE, NON STERILE (K990752)Wrp Specialty Products Sdn. Bhd.1999-10-18
HEALTH-PLUS SANITEX,RELIANCE PRE-POWDERED MULTI-PLY LATEX EXAMINATION GLOVE (NATURAL RUBBER LATEX-NITRILE-CONSTRUCTION W (K992523)Pamitex Industries Sdn Bhd1999-10-18
DERMAGRIP POWDER FREE BLUE NITRILE EXAMINATION GLOVE, NON STERILE (K990750)Wrp Specialty Products Sdn. Bhd.1999-10-15
POLYMER COATED POWDER FREE LATEX EXAMINATION GLOVES LABELING CONTENT: 100 MCGM OR LESS OF TOTAL WATER EXTRACTABLE PROTEI (K992870)Alliance Rubber Products Sdn. Bhd.1999-10-15
IRRIGATION OR INFUSION PUMP K PUMP (K991203)Kmi Kolster Methods, Inc.1999-10-15
ECOMED SCALP VEIN SET (K992145)Greiner Meditech, Inc.1999-10-14
SYNTHETIC POWDER-FREE VINYL PATIENT EXAMINATION GLOVES (K992555)Shijiazhuang Great Vision Plastic Products Co., LT1999-10-14
NITRA-TOUCH STERILE POWDER-FREE NITRILE MEDICAL EXAMINATION GLOVE (K992768)Ansell Perry1999-10-13
SENSICARE XP VINYL POWDER FREE MEDICAL EXAMINATION GLOVE (K992865)Maxxim Medical1999-10-13
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