Atlas FDA

2004

3,373 FDA 510(k) clearances · Clearance year

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RecordFirmDate
DUOPATH VEROTOXINS GLISA TEST (K031367)Emd Chemicals, Inc.2004-01-23
NEWPORT E500 WAVE VENTILATOR (K030780)Newport Medical Instruments, Inc.2004-01-23
PERIO PROTECT TRAY (K031809)Perio Protect, LLC2004-01-23
MEDISISS REPROCESSED ULTRASONIC SURGICAL INSTRUMENTS (K030598)Medisiss2004-01-23
FOCUS MEDICAL 532 HAND PIECE ADAPTER AND DYE PACK ACCESSORIES (RED OR YELLOW) (K032667)Focus Medical, LLC2004-01-23
SONOSENS (K033193)Friendly Sensors AG2004-01-23
ONE COAT SE BOND (K033760)Coltene/Whaledent, Inc.2004-01-23
CA-1500 (K040028)R2 Technology, Inc.2004-01-22
N HIGH SENSITIVITY CRP (K033908)Dade Behring, Inc.2004-01-22
MODIFICATION TO VYSIS UROVYSION BLADDER CANCER RECURRENCE TEST (K033982)Vysis2004-01-22
MEDTRONIC SELECTSITE DEFLECTABLE CATHETER SYSTEM, MODELS C304-S59 AND C304-L69 (K033989)Medtronic Inc. Cardiac Rhythm Management2004-01-22
DAKOCYTOMATION BETA-2-MICROGLOBULIN KIT, CODE NO. OA 368 (K032692)Dako A/S2004-01-22
CYNOSURE TRIACTIVE THERAPEUTIC MASSAGE SYSTEM (K030876)Cynosure, Inc.2004-01-22
POSTERIOR CABLE SCREW (K022908)Pioneer Surgical Technology2004-01-22
POWERSTAND STAND-UP WHEELCHAIR (K032101)The Standing Co., Inc.2004-01-22
MATCH MASTER LOW FUSION PORCELAIN (K024252)Davis Schottlander & Davis, Ltd.2004-01-22
DISPOSABLE POWDER FREE VINYL SYNTHETIC EXAMINATION GLOVE, WHITE COLOR (K033835)Mdm Enterprise Corp.2004-01-22
T.S. MEDICAL CIRCUMCISION CLAMP (K033403)T.S. Medical2004-01-22
HUBERPRO SAFETY HUBER INFUSION SET (K033515)Command Medical Products2004-01-22
SPACER G TEMPORARY HIP PROSTHESIS (K031841)Exactech, Inc.2004-01-22
HERO 1, MODEL LY-ESB220 (K031621)Comfort Orthopedic Co., Ltd.2004-01-22
MODIFICATION TO LAPAROSHIELD CONDITIONED INSUFFLATION SET (K033991)Pall Medical2004-01-22
SUNPEX TECHNOLOGIES MODEL SE03 (K033019)Sunpex Technology Co., Ltd.2004-01-22
VARIFLEX (K033632)Great Lakes Orthodontics, Ltd.2004-01-21
IDEIA PCE CHLAMYDIA (K033865)Dakocytomation, Ltd.2004-01-21
LIQUISHIELD LIQUID BANDAGE, MODEL LSB 0001 (K031321)Medlogic Global Limited2004-01-21
CELLSEARCH EPITHELIAL CELL ENRICHMENT KIT; CELLSPOTTER SYSTEM (DEN040001)Advanced Diagnostic Systems2004-01-21
ESPRIT VENTILATOR, MODEL V1000 (K034040)Respironics, Inc.2004-01-21
10 ML BAK'SNAP DUOPROSS RETRACTABLE SAFETY SYRINGE (K034031)M.K. Meditech Co. , Ltd.2004-01-21
IMMULITE 2500 CK-MB, 2500 MYOGLOBIN, 2500 STAT TROPONIN I (K034055)Diagnostic Products Corp.2004-01-21
AMERSHAM HEALTH NEEDLE-GUARD (K033409)Gettig Pharmaceutical Instrument Co.2004-01-21
TRISTAR AESTHETIC WORKSTATION LASER (K033176)Cynosure, Inc.2004-01-21
POLY PER-Q-CATH PICC CATHETERS (K034019)C.R. Bard, Inc.2004-01-21
AEROMIST LT, MODEL HCS15004 (K031686)Medline Industries, Inc.2004-01-21
SK MED ME202 MONITORING MIXER (K031860)Sk Med2004-01-21
INTUITION IMAGE (K032511)Brainlab AG2004-01-21
MODIFICATION TO PRISMALIX SURGICAL LIGHT (K040015)Alm S.A.2004-01-21
GROSHONG NXT PICC CATHETERS (K034020)C.R. Bard, Inc.2004-01-21
NON-CONTACT TONOMETERS, OCULAR RESPONSE ANALYZER (K032799)Reichert, Inc.2004-01-20
ONTRAK TESTCUP II AND ONSITE CUPKIT (K033902)Varian, Inc.2004-01-20
SPHINX LASER SYSTEMS (K033437)Allmed Systems, Inc.2004-01-20
MODIFICATION TO: THE MARGRON HIP REPLACEMENT SYSTEM (K032641)Portland Orthopaedics Pty. , Ltd.2004-01-20
AUTOSTAT II ANTI-TISUE TRANSGLUTAMINASE IGA ELISA (K033744)Hycor Biomedical , Ltd.2004-01-20
MOBILE SINGLE CIRCULAR CAMERA (MSC) & MOBILE DIGITAL CARDIAC CAMERA (MDCC) (K033956)Is2 Research, Inc.2004-01-20
GII SPINAL FIXATION SYSTEM (K032604)Co-Ligne AG2004-01-20
MRJ (K033507)Paramed S.R.L.2004-01-20
EXCELON TRANSBRONCHIAL ASPIRATION NEEDLE, MODELS 6410, 6411, 6412 (K040018)Boston Scientific Corp2004-01-20
MODIFICATION TO HOFFMANN II MICRO EXTERNAL FIXATION SYSTEM (K033476)Howmedica Osteonics Corp.2004-01-20
STRYKER CONSOLIDATED OPERATING ROOM EQUIPMENT (CORE) SYSTEM (K032303)Stryker Instruments2004-01-16
POWDER-FREE VINYL EXAMINATION GLOVES (K033693)Shen Wei (Usa), Inc.2004-01-16
NOVOSCI TUBING AND CONNECTORS WITH NOVOCOAT TREATMENT (K033328)Novosci Corp.2004-01-16
LIGAND PLUS CONTROL LEVEL 1-3 (K033344)Consolidated Technology2004-01-16
DISPOSABLE POWDER FREE VINYL SYNTHETIC EXAMINATION GLOVE, WHITE COLOR (K033877)One Touch Products Co., Ltd.2004-01-16
PVS PIVOT STEERABLE DELIVERY SYSTEM MICROCATHETER (K033726)Precision Vascular2004-01-16
ARTIC (K033628)Heraeus Kulzer, Inc.2004-01-16
MODIFICATION TO SERAQUEST EB VCA IGG (K033915)Quest Intl., Inc.2004-01-16
ZIMMER UNICOMPARTMENTAL KNEE SYSTEM (K033363)Zimmer, Inc.2004-01-16
PRE-IMPLANTATION GENETIC DIAGNOSIS PIPETTES (BIOPSY PIPETTES) (K033904)Cook Urological, Inc.2004-01-16
POWDERED VINYL EXAMINATION GLOVES (K033692)Shen Wei (Usa), Inc.2004-01-16
BISBLOCK (K033521)Bisco, Inc.2004-01-16
CANDELA VBEAM PULSE DYE LASER SYSTEM (K033461)Candela Corp.2004-01-16
E.P.T. PREGNANCY TEST (K033658)Unipath , Ltd.2004-01-16
MODIFICATION TO INTRACYTOPLASMIC SPERM INJECTION (ISCI), MICRO-INJECTION PIPETTES, HOLDING PIPETTES, DENUDING PIPETTES, (K033903)Cook Urological, Inc.2004-01-16
DIAPEX (K033585)Bisco, Inc.2004-01-16
DUREX PLAY LUBRICANT (K032124)Ssl Americas, Inc.2004-01-16
MODIFICATION TO INSPIRATION VENTILATOR SYSTEM (K030341)eVent Medical, Ltd.2004-01-16
LUXAFORM PLUS (K033227)Dmg USA, Inc.2004-01-16
CANDELA CBEAM PULSE DYE LASER SYSTEM (K033331)Candela Corp.2004-01-16
MEDIPLUS SINGLE USE LOWER GI MANOMETRY CATHETER (K031617)Mediplus , Ltd.2004-01-16
ADVANCE DOUBLE HIGH INSERT (K033890)Wrightmedicaltechnologyinc2004-01-15
EEG MONITOR WITH BIS, MODEL A-2000 (K030267)Aspect Medical Systems, Inc.2004-01-15
BIO-OSS, BIO-OSS BLOCKS AND BIO-OSS COLLAGEN (K033815)Geistlich-Pharma2004-01-15
MODIFICATION TO SERAQUEST VCA IGM (K033780)Quest Intl., Inc.2004-01-15
ARTHOSCOPY PUMP A115 (K033927)W.O.M. World of Medicine AG2004-01-15
CONCEPT HP ADD-ON; CONCEPT HP ENAMEL (K033773)Ivoclar Vivadent, AG2004-01-15
LEXATITE QUICK ACRYLIC (K033432)Imtec Corp.2004-01-15
GOLD DENTAL CASTING ALLOYS (K033279)Bego U.S.A.2004-01-15
MICROLIFE DIGITAL INFRARED EAR THERMOMETER, MODEL IR1DE1-1 (K034023)Microlife Intellectual Property GmbH2004-01-15
EARLY CLEAVAGE MEDIUM (ECM) (K033462)Irvine Scientific Sales Co., Inc.2004-01-15
REVOLIX LASER SYSTEMS (K033423)Allmed Systems, Inc.2004-01-15
ELECTRO-NERVE STIMULATOR TENS, MODEL BMLS03-5 (K033455)Biomedical Life Systems, Inc.2004-01-15
SOLAR 9500 INFORMATION MONITOR (K033964)Ge Medical Systems Information Technologies2004-01-15
ACUMED LOWER EXTREMITY CONGRUENT PLATE SYSTEM (K033639)Acumed, LLC2004-01-15
UGYTEX MESH (K033376)Sofradim Production2004-01-15
TESCERA U-BAR AND BARRELS (K033472)Bisco, Inc.2004-01-15
GAMMA3 NAIL SYSTEM (K034002)Howmedica Osteonics Corp.2004-01-15
FORCE FIBER (K033654)Teleflex Medical2004-01-15
KLS-MARTIN ORTHO ANCHORAGE SYSTEM (K033483)KLS-Martin L.P.2004-01-15
TRANS1 TRANS-SACRAL SPINAL ACCESS AND PREPARATION KIT (K032891)Trans1, Inc.2004-01-15
SMALL BONE FIXATION SYSTEM (K033406)Hand Innovations, Inc.2004-01-15
REMEEX SYSTEM FOR URINARY INCONTINENCE (K033310)Specialities Remeex International, S.L.2004-01-15
B-SMART, MODEL B-01 (K031128)Macosta Medical USA, LLC2004-01-15
SEARCH EVOLUTION (LC) TOTAL KNEE SYSTEM (POROUS COATED) (K032108)Aesculap, Inc.2004-01-15
PROSMILE AIR POLISHER AND PROPHYLAXIS POWDER (K033675)Sirona Dental Systems GmbH2004-01-15
BIODHOC (K024185)Future Medical Systems, SA2004-01-15
EASI ECG ALGORITHM (K033513)Philips Medical Systems2004-01-15
SCORPIO KNEE SYSTEM - TIBIAL INSERTS (K033342)Howmedica Osteonics Corp.2004-01-15
MODIFICATION TO X-PORT DUO PORT (K034065)C.R. Bard, Inc.2004-01-15
AEROCHAMBER MAX VALVED HOLDING CHAMBER (K032972)Trudell Medical Intl.2004-01-14
ORACLE ORAL MASK, MODEL HC451A (K033087)Fisher & Paykel Healthcare, Ltd.2004-01-14
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Every clearance here is in the API, with alerts when new ones post.