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

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RecordFirmDate
CULTURE-PAK COLLECTION AND TRANSPORT SYSTEM WITH CLINICAL TRANSPORT MEDIA (CARY-BLAIR OPTION) (K970597)Medical Packaging Corp.1997-03-24
IMMAGE IMMUNOCHEMISTRY SYSTEM ALPHA-1-ACID GLYCOPROTEIN (AAG) REAGENT (K964257)Beckman Instruments, Inc.1997-03-24
ELECSYS PROGESTERONE ASSAY (K964841)Boehringer Mannheim Corp.1997-03-24
THERMAPREP PLUS OVEN (K970134)Tulsa Dental Products, Ltd.1997-03-21
ALLCLENZ WOUND CLEANSER (K965120)Dpt Laboratories, Ltd.1997-03-21
FUJI COMPUTED RADIOGRAPHY FCR/DICOM GATEWAY UNIT CR-DM666 (K970293)Fujifilm Medical System U.S.A., Inc.1997-03-21
LATEX EXAM GLOVE WITH HYPOALLERGENIC LABELING (POWDERED) (K960842)Crocker Industrial Resources Sdn. Bhd.1997-03-19
DAKOTA SMITH, NICOLE MILLER SUNGLASSES (K965125)California Design Studio, Inc.1997-03-19
T1 CONTROL HIGH SPEED DENTAL HANDPIECE (K965238)Siemens AG1997-03-19
VITROS IMMUNODIAGNOSTICS PRODUCTS ESTRADIOL REAGENT PACK(GEM. 1050)/ESTRADIOL CALIBRATORS (GEM.C050) (K970643)Johnson & Johnson Clinical Diagnostics, Inc.1997-03-18
PATIENT EXAMINATION GLOVES (POWDER FREE-NON STERILE) (K970613)Sti Medical Sdn Bhd1997-03-18
ELECSYS TESTOSTERONE ASSAY (K964889)Boehringer Mannheim Corp.1997-03-18
GENESIS RMP (K963268)Tecan U.S., Inc.1997-03-18
EZ SURE ONE STEP OVULATION PREDICTOR HOME TEST KIT (K970467)Excel Scientific, Inc.1997-03-18
RSV ANTIGEN CONTROL SLIDES (K964870)Viral Antigens, Inc.1997-03-18
AMICAS WEB/INTRANET IMAGE SERVER (K970064)Autocyt Group, Inc.1997-03-17
ABC IN-LINE BLOOD SAMPLING KIT (K955663)Utah Medical Products, Inc.1997-03-17
ELEVATING AND REMOVABLE LEG AND REMOVABLE ARM WHEELCHAIR (K964932)L & M Resource Information Service, Inc.1997-03-17
BLUE CHIP GERMICIDAL CLEANER & DEODORANT (K970825)S.C. Johnson Professional1997-03-14
MOBILE OPERATING TABLE 1132.01 (K970807)Stierlen-Maquet AG1997-03-14
OOLI-U(TONGUE SCRAPER) (K970042)Telefax Intl.1997-03-14
TRACE HDL CHOLESTEROL - AUTOMATED (HOMOGEN (K962723)Trace America, Inc.1997-03-13
SMIIC (SECTRA MEDICAL IMAGE INPUT CONTROLLER) (K965161)Sectra-Imtec AB1997-03-12
WIDEX MODEL SENSO DIGITAL (C9) (K965254)Widex Hearing Aid Co., Inc.1997-03-12
DIFFUSER PANEL (K970240)Focused Viewer, Inc.1997-03-11
ADAPTIVE COMPRESSION - CLASS D/ CLASS D AGCI (K970430)Midwest City Hearing Aid Center1997-03-11
URIC ACID (LIQUID) REAGENT SET (K970560)Pointe Scientific, Inc.,1997-03-11
TRACH-EZE CLOSED VENTILATION SUCTION SYSTEM (K961707)Sorenson Critical Care1997-03-11
PREPOWDERED LATEX EXAMINATION GLOVE (K970313)Besglove Healthcare Sdn. Bhd.1997-03-11
ROCCOBAROCCO & PRO-DYNAMIX (K965170)Michelangelo, Inc.1997-03-11
ULTRAFREE STERILE LATEX POWDER-FREE SURGICAL GLOVES (K964474)Allegiance Healthcare Corp.1997-03-11
NASP HYDROCOLLOID DRESSING (REGULAR OR THIN) (K964231)North American Sterilization & Packaging Co.1997-03-10
LIQUICHECK URINE TOXICOLOGY NEGATIVE CONTROL (K970666)Bio-Rad1997-03-10
MITEK SUTURE RETROGRADER (K970360)Mitek Products1997-03-10
TECH SIMPLE SYPHILIS POSITIVE SERUM CONTROL MONITOR ONTRAK SYPHILIS POSITIVE SERUM CONTROL (K970100)Simplicity Diagnostics, Inc.1997-03-10
FLAT CLOSED WOUND DRAIN WITH TROCAR (K965146)Axiom Medical, Inc.1997-03-10
SYNCHRON LX 20 CLINICAL CHEMISTRY SYSTEM, SYNCHRON LX ALBUMIN REAGENT, SYNCHRON LX CREATININE PICRIC REAGENT, SYNCHRON L (K965240)Beckman Instruments, Inc.1997-03-10
ELECSYS CALCHECK CEA (K970459)Boehringer Mannheim Corp.1997-03-06
LIPASE REAGENT SET (COLIPASE METHOD) (K970124)Teco Diagnostics1997-03-06
SENTURA SURGICAL GLOVES (K964962)Maxxim Medical1997-03-06
SEKURE SEAT ADULT PASSIVE RESTRAINING DEVICE (K962327)Sekure Seat Corp.1997-03-06
ELECSYS CALCHECK CEA (K970452)Boehringer Mannheim Corp.1997-03-06
ELECSYS CALCHECK PSA (K970458)Boehringer Mannheim Corp.1997-03-06
ULTREX POWDER-FREE SURGICAL GLOVES/ULTREX POWDER-FREE SURGICAL GLOVES WITH LOW PROTEIN CLAIM (K964980)Maxxim Medical1997-03-06
STERILE WATER PUMP (K970002)Micro Motors, Inc.1997-03-05
LATEX EXAM GLOVES (K965155)P.T. Irama Dinamika Latex1997-03-05
JAMES ALEX SUNGLASSES (K970101)D&K Stores, Inc.1997-03-04
MARK 20 AND MARK 25 HAND ENGINE CONTROLLER (K964860)Bell Intl., Inc.1997-03-03
ABBOTT HCG SERUM CONTROLS (K970527)Abbott Laboratories1997-03-03
KENLOR H. PYLORI CONTROL SERUM (K964014)Kenlor Industries, Inc.1997-03-03
MODEL 45E HANDENGINE & CONTROLLER, MODEL 45EH HANDENGINE & CONTROLLER, MODEL RX-100 HANDENGINE & CONTROLLER, MODEL ETELN (K964863)Bell Intl., Inc.1997-02-28
SPINE-TECH BONE HARVESTER (K970040)Spine-Tech, Inc.1997-02-28
MEDNEXT SURGICAL BUR (K970023)Mednext, Inc.1997-02-28
NINGBO YUJIANG LATEX EXAMINATION GLOVES, POWDER-FREE, WITH PROTEIN LABELING (K964847)Ningbo Yujiang Plastic & Rubber Co. , Ltd.1997-02-27
JINHUA LATEX EXAM GLOVE, POWDER FREE WITH PROTEIN LABELING (K964845)Jinhua Latex Products Factory1997-02-27
AHS OMEGA SP (K970057)Authorized Hearing Systems, Inc.1997-02-26
SPONGETRAC (K964181)Surgitrac Corp.1997-02-26
OMNI GRIP LATEX EXAMINATION GLOVE, POWDER-FREE (K970297)Omni Sales Corp.1997-02-25
NON-PRESCRIPTION SUNGLASSES (K965021)Victory Eyewear Co., Ltd.1997-02-25
HOLLISTER RETRACTED PENIS POUCH (K970443)Hollister, Inc.1997-02-25
SUTURE LOCK (K964935)Smith & Nephew Endoscopy, Inc.1997-02-25
ACCESS ESTRADIOL REAGENTS ON THE ACCESS IMMUNOASSAY ANALYZER (33550,33540,33545) (K970126)Bio-Rad Laboratories, Inc.1997-02-25
SUNGLASSES (NON-PRESCRIPTION) (K964943)Micron Eyewear Manufactory Co., Ltd.1997-02-25
DISPOSABLE APRON (K964364)Instrument Makar, Inc.1997-02-25
VITROS IMMUNODIAGNOSTIC PRODUCTS PROLACTIN REAGENT PACK/CALIBRATORS (K970281)Johnson & Johnson Clinical Diagnostics, Inc.1997-02-25
MEDRAD CONTRAST HOLDER (K964782)Medrad, Inc.1997-02-25
CHLAMYDIA IGG ELISA TEST SYSTEM (K962558)Armkel, LLC1997-02-24
SEALITE SCIENCES, INC. AQUALITE PROLACTIN (K970188)Sealite Sciences, Inc.1997-02-20
VITROS IMMUNODIAGNOSTICS PRODUCTS LH REAGENT PACK (GEM.1055) AND LH CALIBRATORS (GEM.CO55) (K964982)Johnson & Johnson Clinical Diagnostics, Inc.1997-02-20
IRON REAGENT (K964913)Derma Media Lab., Inc.1997-02-20
TUMOR MARKER CONTROL (K965114)Diagnostic Products Corp.1997-02-20
ACCUMETER H. PYLORI TEST (K965099)Chemtrak, Inc.1997-02-20
THE ADVANCED OSMOMETER (3900) (K965036)Advanced Instruments, Inc.1997-02-20
RMI DUAL FLUID IRRIGATING SYRINGE (K964833)Research Medical, Inc.1997-02-19
STRATEC LIA II ANALYZER (K961142)Nichols Institute Diagnostics1997-02-18
ELECSYS ESTRADIOL ASSAY (K965109)Boehringer Mannheim Corp.1997-02-18
ALT/SGPT (K965134)Derma Media Lab., Inc.1997-02-18
JIAWANG PRE-POWDERED VINYL EXAMINATION GLOVES (K964800)Shanghai Jiawang Industrial Co. , Ltd.1997-02-14
BENTLEY MANUALLY OPERATED WHEELCHAIR (K970311)Pdg Product Design Group, Inc.1997-02-14
BALDUR VINYL POWDERED GLOVES (K963441)Hti Trading Group1997-02-14
PROD. NO. 01-132 - SUTURE REMOVAL KIT (K964827)Continental Medical Laboratories, Inc.1997-02-14
SEALITE SCIENCES AQUALITE FSH (K970085)Sealite Sciences, Inc.1997-02-14
PEDIATRIC LIMB HOLDER (K963466)Deroyal Industries, Inc.1997-02-13
IN-TAC BONE ANCHOR SYSTEM (K964953)Influence, Inc.1997-02-13
IMPLATECH RP MEDICAL GRADE SILICONE GEL SHEETING (K964846)Implantech Associates, Inc.1997-02-12
BREATHE FIT (K963326)Cambridge Assoc.1997-02-12
ENDOLUMINA II TRANSILLUMINATION SYSTEM 56FR E-5630, 50FR E-5030 AND 40FR E-4020, ENDOLUMINA II DETACHABLE TIPS, 56FR, TA (K964561)Bioenterics Corp.1997-02-11
SUPER K-AMP, EZ-COMPRESSION, TRIM-PRO, HF-PRO, ENVIRO-PRO, COMPRESSION-PRO, COMPRESSION 3000, HF 3000, OCTIVA, REFLEX HF (K964657)Micro-Ear Technology, Inc.1997-02-11
UNIVISION ECHOCARDIOLOGY SYSTEM (K964803)Network Concepts, Inc.1997-02-11
CANTROL SERUM IRON AND TOTAL IRON BINDING CAPACITY TEST SYSTEM (K970248)Canyon Diagnostics, Inc.1997-02-11
EPI 2 (K935706)Universal H.R. System, Inc.1997-02-11
TRACH CARE SET WITH MICROBAN (K964369)Ballard Medical Products1997-02-11
ELECSYS CALCHECK PROLACTIN (K970147)Boehringer Mannheim Corp.1997-02-10
PFINGST PRESSURE PASTE (K965026)Pfingst & Co., Inc.1997-02-10
DERMADAM (K964810)Ultradent Products, Inc.1997-02-10
NITRILE POWDER-FREE EXAMINATION GLOVES (K964628)Shen Wei (Usa), Inc.1997-02-10
IMMAGE IMMUNOCHEMISTRY SYSTEM APOLIPOPROTEIN A-1 REAGENT (APA)/ IMMAGE IMMUNOCHEMISTRY SYSTEM APOLIPOPROTEIN B REAGENT (K964010)Beckman Instruments, Inc.1997-02-10
EVERT-IT (K962828)Genesis Industries, Inc.1997-02-10
GAMMA GUIDANCE SYSTEM (K961321)Radiation Monitoring Devices, Inc.1997-02-10
VINYL PATIENT EXAMINATION GLOVES (K964629)Arista Medi Prima1997-02-10
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