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32,815 FDA 510(k) clearances · Device class

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RecordFirmDate
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
CARONY (K002205)Bruno Independent Living Aids, Inc.2000-08-10
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
LA JOIE (K000736)Goomi Ehwa, Inc.2000-08-08
LYPHOCHEK FERTILITY CONTROL, MODELS 480, 481, 482, 483 (K002196)Bio-Rad2000-08-07
MODEL 9000 PEDIATRIC WHEELCHAIR (K002170)Invacare Corp.2000-08-04
HDL CHOLESTEROL PLUS (K000568)Roche Diagnostics Corp.2000-08-04
WATER PURIFIER (K001878)Waterclave, LLC2000-08-03
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
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
DERMAGUARD PF BROWN POWDER FREE LATEX SURGICAL GLOVES; MODEL STYLE 38 (K002192)Ansell Perry2000-07-27
MULTISAFE-POWDERED NITRILE GLOVES, NON-STERILE (BLUE) (K001497)Multisafe Sdn. Bhd.2000-07-26
SMILIE PC (K001445)Julie Alliance2000-07-26
MULTISAFE POWDER FREE NITRILE GLOVES, NON STERILE (BLUE) (K001619)Multisafe Sdn. Bhd.2000-07-26
POWDERED STERILE LATEX SURGICAL GLOVE, WITH PROTEIN CONTENT LABELING CLAIM (200 MICROGRAMS OR LESS) (K001959)Hartalega Sdn Bhd2000-07-26
NITRILE EXAMINATION GLOVES, PRE-POWDERED, COLOR WHITE (K001836)Shanghai Poseidon Plastic Products Co., Ltd.2000-07-26
ULTIMATE N-DEX POWER FREE NITRILE EXMINATION GLOVE (TESTED FOR USE WITH CHEMOTHERAPY DRUGS) (K001375)Best Manufacturing Company2000-07-25
BLAINE SCARCARE PATCH (K001608)Blaine Labs, Inc.2000-07-25
RLP-CHOLESTEROL IMMUNOSEPARATION ASSAY (K001032)Otsuka Pharmaceutical Co., Ltd.2000-07-24
BONUS MECHANICAL WHEELCHAIR (K001391)Bonus Ent. Corp.2000-07-24
SHERPA/KODIAK CUB MOBILITY SYSTEM (MANUAL WHEELCHAIR) (K001890)Otto Bock Orthopaedische Industrie, Kg.2000-07-24
ELECSYS SERUM B-CROSSLAPS/SERUM IMMUNOASSAY (K993706)Roche Diagnostics Corp.2000-07-24
RESOLUTION CHOLESTEROL MONITOR (K000610)Lifestream Technologies, Inc.2000-07-21
MINICAM (K001541)Video Dental Concepts, Inc.2000-07-21
J.A.G. LIGHTWEIGHT MANUAL WHEELCHAIR (K001298)Roll-Ability (Pty) , Ltd.2000-07-18
COATED STERILE LATEX POWDEER-FREE SURGICAL GLOVES WITH PROTEIN CONTENT LABELING CLAIM (50 MICROGRAM OR LESS0 (K001924)Allegiance Healthcare Corp.2000-07-14
NITRILE EXAMINATION GLOVES, PRE-POWDERED, COLOR BLUE (K001837)Shanghai Poseidon Plastic Products Co., Ltd.2000-07-11
PUMA DENTAL CHAIR AND UNIT (K000837)Castellini S.P.A.2000-07-11
SYNTHETIC POWDERED (YELLOW) VINYL PATIENT EXAMINATION GLOVES (K001861)Shijiazhuang Hongxiang Plastics Products Co; , Ltd.2000-07-11
SYNTHETIC POWDERED (WHITE) VINYL PATIENT EXAMINATION GLOVES (K001863)Shijiazhuang Hongxiang Plastics Products Co; , Ltd.2000-07-11
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
DADE TRU-LIQUID MONI-TROL CHEMISTRY CONTROL LEVELS 1, MID, 2, AND S (ASSAYED) (K001758)Medical Analysis Systems, Inc.2000-07-05
POWDERED PATIENT EXAMINATION GLOVES, LATEX (K001715)Fitco Dipped Products Pvt., Ltd.2000-07-05
BIOSCANNER TRIGLYCERIDES TEST STRIPS (K000586)Polymer Technology Systems, Inc.2000-07-03
EZ LDL CHOLESTEROL TEST SYSTEM (K993741)Sigma Diagnostics, Inc.2000-07-03
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
SUGAR CHEX ONE (K001443)Streck Laboratories, Inc.2000-06-29
ELECSYS INSULIN CALCHECK (K001846)Roche Diagnostics Corp.2000-06-28
MONARCH II IOL DELIVERY SYSTEM (K001157)Alcon Research, Ltd.2000-06-27
ADVIA IMS (K001344)Bayer Corp.2000-06-26
POWDER-FREE POLYMER-COATED LATEX EXAMINATION GLOVES (K001672)Pamitex Industries Sdn Bhd2000-06-23
LATEX SURGEON SURGEON'S GLOVES POWDER-FREE WITH PROTEIN CONTENT LABELING CLAIM (50 MICROGRAMS OR LESS) (K001274)Pt. Maja Agung Latexindo2000-06-23
HANWELLA LATEX PATIENT EXAM. GLOVES POWDER-FREE (K000351)Hanwella Rubber Products , Ltd.2000-06-23
DISPOSABLE POWDER FREE NITRILE EXAM GLOVE, GREEN COLOR (K001637)Sheen More Ent. Co., Ltd.2000-06-23
DISPOSABLE PVC POWDERED SYNTHETIC EXAM GLOVES (K001601)Shanghai PT Plastics Enterprise Company, Ltd.2000-06-23
SERAGARD INJECTION PATCH (K001240)Platinum Services, Inc.2000-06-21
OPTI-CHECK PLUS MULTI-ANALYTE CONTROL, MODEL HC7009 (K001632)Avl Scientific Corp.2000-06-19
TRUBYTE DENTURE CLEANSER/POLISHING COMPOUND (K000996)Dentsply Intl.2000-06-16
MICROPERFORATION INSTRUMENT (K001507)Smith & Nephew, Inc.2000-06-14
HEALTH-PLUS, SANITEX, RELIANCE, POWDER-FREE LATEX EXAMINATION GLOVES (K001485)Pwa Industries Sdn. Bhd.2000-06-13
HEALTH-PLUS, SANITEX, RELIANCE, POWDERED LATEX EXAM GLOVES CONTAINS 100 MICROGRAMS OR LESS OF TOTAL WATER EXTRACTABLE PR (K001475)Pwa Industries Sdn. Bhd.2000-06-13
NATURAL-IRIS PRE-PIGMENTED CORNEAL BUTTON (K001326)Ocular Concepts, LLC2000-06-13
SYNTHES REAMER/IRRIGATOR/ASPIRATOR (RIA) SYSTEM (K993335)Synthes (Usa)2000-06-12
EUDERMIC PF POWDER-FREE SURGICAL GLOVES (K001343)Maxxim Medical, Inc.2000-06-12
MULTIPLE PRIVATE LABELS, NITRILE EXAM GLOVES, POWDER-FREE (WHITE) (K001549)Shanghai Poseidon Plastic Products Co., Ltd.2000-06-12
MAXHEALTH WHEELCHAIR, MODEL HE-8631, HE-8621, HE-8651 (K001252)Maxhealth Corp.2000-06-12
POLYMER COATED, POWDER-FREE LATEX EXAMINATION GLOVE WITH PROTEIN LABELLING CLAIM, CONTAINS 50 MICROGRAMS OR LESS OF TOTA (K001529)Perusahaan Getah Asas Sdn. Bhd.2000-06-12
LAXTEX POWDERED EXAMINATION GLOVE WITH PROTEIN LABELING CLAIM (100 MICROGRAMS OR LESS) (K001557)Kossan Latex Industries(M)Sdn Bhd2000-06-09
MASIF POWDER-FREE PATIENT EXAMINATION GLOVES (K000377)Masif Healthcare Products Sdn. Bhd.2000-06-09
FLEXAM NITRILE T AMBI EXAMINATION GLOVES WITH CHEMO CLAIM (K000813)Allegiance Healthcare Coporation2000-06-08
SYNCHRON CONTROL (K001458)Beckman Coulter, Inc.2000-06-02
AMMONIA-L3K ASSAY, MODEL 263-17, AMMONIA-L3K ASSAY, MODEL 263-30 (K001285)Diagnostic Chemicals , Ltd.2000-06-02
IMMULITE H. PYLORI IGG AND IMMULITE 2000 H. PYLORI IGG (K000463)Diagnostic Products Corp.2000-06-01
ELECSYS ANTI-TPO CALCHECK (K001014)Roche Diagnostics Corp.2000-06-01
WHEELCHAIR, MODELS H001A, 4422 (K000738)Jackson Company, LLC2000-05-26
IIVS INTEGRATED IMAGE VIEWING STATION (K994329)Terarecon,Inc.2000-05-26
LIQUICHEK IMMUNOASSAY PLUS CONTROL, MODEL 360, 361, 362, 363 (K001373)Bio-Rad2000-05-25
BIOSCANNER TRIGLYCERIDES TEST STRIPS (K991894)Polymer Technology Systems, Inc.2000-05-24
GLOVETEX, LATEX EXAMINATION GLOVES, POWDERED NON-STERILE.(PROTEIN CONTENT LABELING) (K994426)Pt. Wrp Buana Multicorpora2000-05-23
RAPID RHINO-ANTERIOR 90MM, MODEL RR-A 90, RAPID RHINO-POSTERIOR 100MM, MODEL RR-P 100 (K000108)Bhk Holding2000-05-23
POWDERED LATEX EXAM GLOVES, PROTEIN LABELING (150 MICROGRAM OR LESS) (K001327)Premier Pathway Sdn. Bhd.2000-05-23
COMFORT LATEX POWDERED PATIENT EXAMINATION GLOVES WITH PROTEIN LABEL CLAIM CONTAINS 200 MICROGRAMS OR LESS OF TOTAL WATE (K001042)Comfort Rubber Gloves Industries Sdn. Bhd.2000-05-23
NUZONE NITRILE SURGICAL GLOVES, POWDERED, GREEN (K000178)Terang Nusa Sdn Bhd2000-05-23
POLYMER COATED, POWDER-FREE LATEX EXAMINATION GLOVE CONTAINS 50 MICROGRAMS OR LESS OF TOTAL WATER EXTRACTABLE PROTEIN PE (K001190)Kossan Latex Industries(M)Sdn Bhd2000-05-23
DISPOSABLE POWDERED NITRILE EXAM GLOVE, BLUE COLOR (K001065)Sheen More Ent. Co., Ltd.2000-05-23
NITRILE EXAM GLOVES, POWDER-FREE, COLOR BLUE (K001128)Shanghai Poseidon Plastic Products Co., Ltd.2000-05-23
DISPOSABLE POWDERED NITRILE EXAM GLOVE, WHITE COLOR (K001155)Sheen More Ent. Co., Ltd.2000-05-23
VINYL PATIENT EXAMINATION GLOVES-POWDER FREE (K994098)Evergreen Medical Produts (Jingxing) Co., Ltd.2000-05-23
GUTHRIE POWDER-FREE LATEX SURGICAL GLOVE WITH (50 MICROGRAMS OR LESS) (K001049)Guthrie Medicare Products (Melaka) Sdn Bhd2000-05-23
MULTISAFE POWDER-FREE PATIENT LATEX EXAMINATION GLOVES WITH PROTEIN CONTENT LABELING CLAIM (50 MICROGRAMS OR LESS) (K000999)Multisafe Sdn. Bhd.2000-05-22
DMC SAPHENOUS VEIN DISTENTION SYSTEM (SVDS) (K000704)Dmc Medical, Ltd.2000-05-19
CUSTOMCORNEA MEASUREMENT DEVICE (CCMD) (K000637)Alcon Laboratories, Inc.2000-05-19
FREE TESTOSTERONE ENZYME IMMUNOASSAY, MODEL DSL-10-4900 (K001086)Diagnostic Systems Laboratories, Inc.2000-05-18
ARACHNOPHLEBECTOMY NEEDLE (K000932)Advanced Medical Products, Inc.2000-05-17
MRI FASTSYSTEM RETRACTOR SYSTEM (K001339)Omni-Tract Surgical, Div. Minn. Scientific, Inc.2000-05-17
BELMONT UNIT, MODEL 2000 SERIES (K000799)Belmont Equipment Corp.2000-05-17
ENCORE POWDER FREE LATEX SURGICAL GLOVES WITH PROTEIN CONTENT LABELING CLAIM (50 MICROGRAMS OR LESS) (K001239)Ansell Perry2000-05-15
BVBLUE (K993732)Gryphus Diagnostics, LLC2000-05-15
NON-STERILE POWDER-FREE LATEX EXAMINATION GLOVES WITH PROTEIN LABELING CLAIM 50 MICROGRAMS OR LESS (K001232)Fitco Dipped Products Pvt., Ltd.2000-05-15
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