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

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RecordFirmDate
POLYMEDCO SPOTCHEM EZ CHEMISTRY ANALYZER (K040332)Arkray, Inc.2004-06-16
DENTSPLY CAVITRON JET WAVE AIR POLISHING PROPHYLAXIS SYSTEM, MODEL G125 (K041141)Dentsply Intl.2004-06-16
OLINDA/EXM (K033960)Vanderbilt University2004-06-15
RE-USEABLE MICROSTAAR INJECTOR, MSI-S (K032412)Staar Surgical Co.2004-06-10
RADENT PROPHY PASTE (K040661)Pascal Co., Inc.2004-06-09
NON STERILE SYNTHETIC POWDER FREE (YELLOW) VINYL PATIENT EXAMINATION GLOVES (K041041)Shanghai Foremost Plastic Industrial Co., Ltd.2004-06-08
IRRIGATION TUBING SET 2.2M AND 3.8M (K041124)W&H Dentalwerk Burmoos2004-06-07
SYNCHRON SYSTEMS HDL CHOLESTEROL (HDLD) REAGENT (K040767)Beckman Coulter, Inc.2004-06-07
SYNTHETIC (WHITE) VINYL PATIENT EXAMINATION GLOVES-POWDER FREE (K040681)Grand Work Plastic Products Co., Ltd.2004-06-03
ENNOBLE DISPOSABLE POWDER FREE VINYL SYNTHETIC EXAM GLOVES WITH VITAMIN COMPLEX, NOPAL AND LANOLIN (K040071)Elite International, Inc.2004-06-03
POLYMER COAT, POWDER FREE NITRILE EXAMINATION GLOVE (BLUE) (K040791)Pt. Smartglove Indonesia2004-06-03
GRAND WORK PLASTICS PRODUCTS CO., LTD., SYNTHETIC VINYL PATIENT EXAMINATION GLOVES - POWDERED (K041188)Grand Work Plastic Products Co., Ltd.2004-06-01
MGC DAU CONTROL SETS: PRIMARY, CLINICAL AND SELECT (K040758)Microgenics Corp.2004-05-28
PRO WALKER ML-300 FOLDABLE WHEELCHAIR (K041337)Pro Walker, Inc.2004-05-28
MODIFICATION TO:ROCHE DIAGNOSTICS PRECINORM UNIVERSAL AND PRECIPATH UNIVERSAL CONTROL SERA (K041227)Roche Diagnostics Corp.2004-05-27
DRI OXYCODONE ASSAY (K040411)Microgenics Corp.2004-05-27
C. DIFFICILE TOXIN A + B FECAL ANTIGEN DETECTION MICROWELL ELISA KIT MODEL; CDIFF-96 (K032897)Ivd Research, Inc.2004-05-27
M2 COMPATIBLE MICROKERATOME BLADE (K033457)Micro Specialties, Inc.2004-05-25
VITALAB IRON REAGENT (K033983)Clinical Data, Inc.2004-05-21
I-TEC PORTABLE DENTAL OPERATORY (K040153)Indigenous Peoples Technology and Education Center2004-05-21
DOCUMENT SALICYLATE CAL VER (K041073)Microgenics Corp.2004-05-21
LIFESTREAM PLUS CHOLESTEROL MONITOR, MODIFICATION TO RESOLUTION CHOLESTEROL MONITOR (K033899)Lifestream Technologies, Inc.2004-05-20
COMBI SELF PROPELLED SHOWER COMMODE (K040677)Kjaerulff Rehabilitation A/S2004-05-20
PHARMATECH MENOPAUSE CHECK, MODELS 9111 AND 9112 (K040575)Phamatech, Inc.2004-05-20
LIQUICHEK TORCH PLUS IGM CONTROL (K040822)Bio-Rad Laboratories, Inc.2004-05-19
MICRO H2 BREATH MONITORING DEVICE WITH HYDRA SOFTWARE UTILITY (K033688)Micro Direct, Inc.2004-05-19
LINICAL PROTEIN 1 CALIBRATION VERIFIERS LEVELS A - E FOR OLYMPUS AU ANALYZERS (K040927)Cliniqa Corporation2004-05-17
RESTORE WOUND CLEANSER (K040779)Hollister, Inc.2004-05-17
WAKO LIPID CONTROL, LEVEL 1 AND LEVEL 2 (K040918)Wako Chemicals USA, Inc.2004-05-17
BILIRUBIN ASSAY ON THE OMNI S ANALYZER (K040174)Roche Diagnostics Corp.2004-05-14
MINI GAMMA CAMERA, MODEL MGC-500 (K040587)Acrorad Co., Ltd.2004-05-14
POLYMER COATED, CHLORINATED, POWDER-FREE LATEX EXAMINATION GLOVES WITH PROTEIN LABELING (LESS THAN 50 UG/G PER GLOVE) (K040406)Shun Thai Rubber Gloves Industry Public Co., Ltd.2004-05-14
KUSCHALL CHAMPION, KUSCHALL COMPACT, KUSCHALL ULTRA-LIGHT (K041072)Invacare Corporation2004-05-12
DERMAGRIP-X POWDER FREE LATEX EXAMINATION GLOVES COATED WITH ALPHA LIPOIC ACID AND VITAMIN E, AND WITH PROTEIN CONTENT (K032016)Wrp Specialty Products Sdn. Bhd.2004-05-11
LATEX POWDER-FREE EXAMINATION GLOVES WITH COATING (K033789)Cardinalhealth2004-05-07
NOVA GLUCOSE LOW/HIGH LEVEL CONTROL SOLUTIONS (K041016)Nova Biomedical Corp.2004-05-07
E-Z LUBRICATING JELLY (K041060)Chester Labs, Inc.2004-05-07
KING LTS REUSABLE OROPHARYNGEAL AIRWAY WITH DRAIN/SUCTION CHANNEL, MODELS KLT 303, KLT 304 AND KLT 305 (K033189)King Systems Corp.2004-05-04
PETIT SILMA ELASTIC BANDAGE WITH GERMANIUM/TITANIUM OXIDE (K040936)Leda Co., Ltd.2004-05-03
RAPID AID INSTANT DISPOSABLE INFANT HEEL WARMER (K040856)Rapid Aid , Ltd.2004-05-03
QUICKVUE ADVANCE PH AND AMINES GLL TEST (K040008)Quidel Corp.2004-04-29
ELEMENTS OBTURATION UNIT (K031664)Sybron Endo/Analytic2004-04-28
NORMAL AND HYPERGAMMA CONTROL SERUM (K040925)Sebia2004-04-28
MAS CARDIOIMMUNE TL LIQUID ASSAYED CARDIAC MARKER CONTROL, LEVELS 1,2 AND 3 (K040880)Medical Analysis Systems, Inc.2004-04-28
DERMAGRIP-G, AND MULTIPLE CUSTOMERS TRADE NAME GREEN, ALOE VERA COATED, POWDER FREE LATEX EXAMINATION GLOVES WITH PROTEI (K040645)Wrp Asia Pacific Sdn. Bhd.2004-04-28
PROTEGRITY STEILE LATEX SURGICAL GLOVES WITH COATING (K033905)Cardinalhealth2004-04-27
BACK IN ACTION COMPRESSION & SUPPORT WITH MAGNETS FOR THE LOWER BACK, KNEE AND ANKLE (K040054)Theodore Barash2004-04-27
SYNTHETIC (YELLOW) VINYL PATIENT EXAMINATION GLOVES - POWDER FREE (K040702)Grand Work Plastic Products Co., Ltd.2004-04-27
KETOCHECKS (K033114)Neo Diagnostics, Inc.2004-04-26
MODIFICATION TO POWDERFREE COLORED AND FLAVORED CHLOROPRENE PATIENT EXAMINATION GLOVES (K040607)Pt. Medisafe Technologies2004-04-22
UNIPORT SELF-CONTAINED PORTABLE DENTAL UNIT (K040117)Arrow Industries, LLC2004-04-21
HAWK INTRAORAL CAMERA AND ACCESSORIES (K040116)Dxm Co., Ltd.2004-04-20
DISPOSABLE POWDERED VINYL PATIENT EXAMINATION GLOVES (K040828)Zibo Borui Plastic & Rubber Products Co., Ltd.2004-04-19
FREEDOM HP (K040622)Freedom Designs, Inc.2004-04-16
FELCARE POWDER FREE, POLYMER COATED LATEX EXAMINATION GLOVES (K040793)Hl Rubber Products Sdn Bhd2004-04-14
KING LT-D DISPOSABLE OROPHARYNGEAL AIRWAY, MODELS KLT 203, KLT 204 AND KLT 205 (K033186)King Systems Corp.2004-04-14
BIOFREE (K033925)Dental Components, Inc.2004-04-07
EASY COMFORT DELUXE MANUAL BREAST PUMP, MODEL 1187 (K032845)The First Years, Inc.2004-04-05
NOVA-ONE LIPID CONTROL (SPECIAL LOW INTERFERENCE LIQUID LIPID CONTROL) (K040352)Bioresource Technology, Inc.2004-04-02
BRITESMILE MASKING CREAM (K040797)Britesmile, Inc.2004-04-02
GENZYME OSOM TRICHOMONAS RAPID TEST (K033864)Genzyme Corp.2004-04-02
MANUAL WHEELCHAIR SERIES (K040561)Shanghai Wheelchair Factory2004-03-31
ONEUSE- PLUS MICROKERATOME (K040297)Moria SA2004-03-31
LINICAL ENZYME CALIBRATION VERIFIERS LEVELS A-E FOR BECKMAN COULTER SYNCHRON SYSTEMS (K040535)Cliniqa Corporation2004-03-29
CHEETAH WHEELCHAIR (K033460)R82 A/S2004-03-26
PRIZM KERATOME BLADE, MODEL MK8512M2 (K033236)Surgin Surgical Instrumentation, Inc.2004-03-26
ACCESS DHEA-S REAGENT ASSAY (K040181)Beckman Coulter, Inc.2004-03-24
INTRA ORAL CAMERA SYSTEM & ACCESSORIES, MODEL WIN-100D (K040691)Win-Us Technology Co., Ltd.2004-03-23
GENTLE SKIN AND (MULTIPLE LABELS) LATEX EXAMINATION GLOVE, POWDER FREE, POLYMER COATED WITH PROTEIN CLAIM (K040448)Rosner-Mautby Meditrade(Thailand) , Ltd.2004-03-23
POWDER FREE VINYL SYNTHETIC EXAMINATION GLOVES, WHITE COLOR (SENSI-PRO) (K040532)Zi BO Hong Wang Plastic & Rubber Products Co. , Ltd.2004-03-23
ZYOPTIX XP MICROKERATOME (K040204)Bausch & Lomb, Inc.2004-03-22
POLYMER COATED, POWDER-FREE LATEX EXAMINATION GLOVES WITH PROTEIN LABELING (LESS THAN 50 UG/G PER GLOVE) (K040408)Shun Thai Rubber Gloves Industry Public Co., Ltd.2004-03-17
DISPOSABLE POWDERED VINYL SYNTHETIC EXAM GLOVES, WHITE COLOR (K031142)Shanghai Palomar Mountain Industries, Inc.2004-03-17
ALOETOUCH POWDER FREE, POLYMER COATED POLYISOPRENE SURGICAL GLOVES, STERILE, COATED WITH ALOE VERA, NATURAL COLOUR (K040503)Wrp Asia Pacific Sdn. Bhd.2004-03-16
BLACK COLOUR POWDER-FREE NITRILE RUBBER EXAMINATION GLOVES (K034052)Latexx Manufacturing Sdn.Bhd.2004-03-15
IMMUNICON CELLTRACKS AUTOPREP SYSTEM (K040077)Immunicon Corp.2004-03-12
RANDOX LIQUID CRP CONTROLS (K040351)Randox Laboratories, Ltd.2004-03-12
PRECINORM PROTEINS IN URINE/CSF PRECIPATH PROTEINS IN URINE/CSR CONTROLS (K040280)Roche Diagnostics Corp.2004-03-11
VITALAB TRIGLYCERIDES REAGENT AND VITALAB CALIBRATOR (K034000)Clinical Data, Inc.2004-03-10
R&D GLU-LINE HEMATOLOGY CONTROL (K034048)R&D Systems, Inc.2004-03-10
LIQUICHEK CARDIAC MARKER CONTROL LT (K040277)Bio-Rad Laboratories, Inc.2004-03-10
AMMONIA-L3K ASSAY, CATALOGUE NUMBER 233-10 (K033921)Diagnostic Chemicals , Ltd.2004-03-10
DIRECT HDL-CHOLESTEROL LIQUID COLOR; DIRECT HDL/LDL-CHOLESTEROL CALIBRATOR (K032932)Stanbio Laboratory2004-03-10
MIDAS TOUCH BLUE LATEX EXAMINATION GLOVES - POWDER FREE FOR CHEMOTHERAPY USE (K033496)Industrial Clothings, Ltd.2004-03-09
TELETHERMOGRAPHIC CAMERA, SERIES A, E, S AND P (K033967)Flir Systems2004-03-09
VITALAB URIC ACID REAGENT (K040467)Clinical Data, Inc.2004-03-08
VITALAB MAGNESIUM REAGENT (K040508)Clinical Data, Inc.2004-03-08
LINICAL URIC ACID CALIBRATION VERIFIERS LEVELS A - E FOR OLYMPUS AU SYSTEMS (K040455)Cliniqa Corporation2004-03-05
LYPHOCHEK ASSAYED CHEMISTRY CONTROL (K040273)Bio-Rad Laboratories, Inc.2004-03-04
POWDERED LATEX EXAMINATION GLOVES (K033531)Apl International Incorporated Limited2004-03-03
A1C-CELLULAR (K040025)Streck Laboratories, Inc.2004-03-02
NON-STERILE BLUE & WHITE COLOUR POWDER FREE BARRIER PRO POLYBUTADIENE COPOLYMER EXAMINATION GLOVES (K033887)Yty Industry (Manjung) Sdn Bhd2004-03-02
CT OIA (K032330)Thermo Biostar, Inc.2004-03-02
RANDOX URIC ACID (K033278)Randox Laboratories, Ltd.2004-02-27
NEOSOOTHE POLYMER COATED POWDER-FREE POLYCHLOROPRENE PATIENT EXAMINATION GLOVES WITH ALOE (K033086)Pt. Medisafe Technologies2004-02-26
PROSPECT CLOSTRIDIUM DIFFICILE TOXIN A/B MICROPLATE ASSAY (K033479)Remel, Inc.2004-02-26
OSSTELL MENTOR RFA (K033689)Integration Diagnostics, Ltd.2004-02-26
ELECSYS C-PEPTIDE CALCHECK (K040157)Roche Diagnostics Corp.2004-02-25
DISPOSABLE POWDERED VINYL PATIENT EXAMINATION GLOVES (K033723)Baoding Guanzhong Glove Co., Ltd.2004-02-24
POWDER FREE LATEX SURGEONS GLOVES POLYMER COATED STERILE WITH OPTIONAL LABELING CLAIM OF E.P. LESS THAN 50 UG/DM2 (K033564)Kanam Latex Industries Pvt. , Ltd.2004-02-24
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