Atlas FDA

2002

3,685 FDA 510(k) clearances · Clearance year

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RecordFirmDate
CATHETER REPAIR KIT WITH REPLACEMENT CONNECTOR, MODEL 5587000 (K022561)C.R. Bard, Inc.2002-08-23
IMMUNODIP URINARY ALBUMIN SCREEN ASSAY, CATALOGUE NUMBER 790-25 (K022538)Diagnostic Chemicals, Ltd. (Usa)2002-08-23
ENDIUS FLEXTIP BLADE (K022578)Endius, Inc.2002-08-23
SURGETICS ENTACT ENDONASAL NAVIGATION SYSTEM (K022239)Praxim2002-08-23
LITE MINERAL OIL (K022332)<Genx> Intl., Inc.2002-08-23
BRAINET (K021986)Nicolet Biomedical, Inc.2002-08-23
PRECISION SYSTEMS ANALETTE CHEMISTRY ANALYZER & MEDICAL ANALYSIS SYSTEMS REAGENTS (K022072)Precision Systems, Inc.2002-08-23
MONITORR ICP EXTERNAL CSF DRAINAGE AND MONITORING SYSTEM (K022554)Integra Neurosciences2002-08-23
BCLEAR (K021762)Lumenis, Inc.2002-08-23
BARD CRURASOFT PATCH, MODELS 0116003 & 0116001 (K022350)C.R. Bard, Inc.2002-08-23
CHITO-SEAL (K021062)Abbott Vascular, Inc.2002-08-23
ULTRASONIC STRAIGHT/ULTRASONIC KNIFE/ULTRASONIC RING CURRETTE (K020220)Synergetics, Inc.2002-08-23
MODIFICATION TO MEDAMICUS AXIA RSN (K022689)Medamicus, Inc.2002-08-23
MODEL EXS-63-INT SMALL EXTREMITY ARRAY COIL (K022487)Mri Devices Corp.2002-08-23
BOLTON PTA CATHETER (K021996)Bolton Medical, Inc.2002-08-23
UNI KNEE (K022437)Encore Medical L.P.2002-08-23
MODEL OBC-63 BREAST ARRAY COIL (K022488)Mri Devices Corp.2002-08-23
3T VESSEL CANNULAS (K020768)3t Medical Systems, LLC2002-08-23
ULTRASTIM KIT (K013532)Axelgaard Mfg. Co., Ltd.2002-08-22
SIGNA 3.0T MAGNETIC RESONANCE SYSTEM (K022397)GE Medical Systems2002-08-22
ARTERIA BLOOD FILTER (K021293)Arteria Medical Science, Inc.2002-08-22
BOSTON EQUALENS II (OPRIFOCON A) RIGID GAS PERMEABLE CONTACT LENS (K022128)Bausch & Lomb, Incorporated2002-08-22
CLEANTEXX POWDERFREE BARRIER-PRO SYNTHETIC BUTADIENE COPOLYMER EXAMINATION GLOVES, BLUE COLOUR (K022102)Latexx Manufacturing Sdn.Bhd.2002-08-22
NANMA ADJUSTABLE CONSTRICTION RING (K013051)Nanma Mfg Co., Ltd.2002-08-22
ACMI DISPOSABLE BIPOLAR CORD, MODEL DBC (K022480)Acmi Corporation2002-08-22
S2 FEMORAL NAIL (K022461)Howmedica Osteonics2002-08-22
LIQUICHEK URINE TOXICOLOGY CONTROL LEVEL S1E, MODEL 438; LEVEL S2E, MODEL 439 (K022707)Bio-Rad2002-08-22
CONTOUR SE MICROSPHERES (K022427)Boston Scientific Corp2002-08-22
XENOSTRIP-TV TRICHOMONAS DIAGNOSTIC TEST KIT; CATALOG NUMBERS S1383.01, S1383.02 & S1383.03 (K020226)Hellen Professional Services2002-08-22
DISPOSABLE PRESSURE MANOMETER (K022402)Vital Signs, Inc.2002-08-22
DORNIER MEDILAS H LASER FIBER CABLES (K022544)Dornier Medtech America, Inc.2002-08-21
SURE-LOK (K021315)Vital Signs, Inc.2002-08-21
COSMOS SYSTEM (K013046)Spacelabs Medical, Inc.2002-08-21
BLACKSTONE SPINAL FIXATION SYSTEM STAPLE & WASHER (K022605)Blackstone Medical, Inc.2002-08-21
FASTPACK TOTAL TESTOSTERONE IMMUNOASSAY (K021972)Qualigen, Inc.2002-08-21
PERFUSOR COMPACT WITH FM SYSTEM (K022575)B.Braun Medical, Inc.2002-08-21
REPROCESSED VENODYNE SEQUENTIAL COMPRESSION SLEEVES / WRAP (K021528)Adven Medical2002-08-21
MODIFICATION TO ACUITY CENTRAL MONITORING SYSTEM (K022453)Welch Allyn Protocol, Inc.2002-08-21
IMMULITE 1000 AUTOMATED IMMUNOASSAY ANALYZER (K022603)Diagnostic Products Corp.2002-08-21
TRIONOMER (K022150)Pentron Clinical Technologies2002-08-21
PTS PANELS MULTI-CHEMISTRY CONTROLS (K022401)Polymer Technology Systems, Inc.2002-08-21
SAPH-LOOP LIGATING LOOP (K022410)Genzyme Biosurgery2002-08-20
FLASH-LITE LED DENTAL CURING LIGHT (K022184)Discus Dental, Inc.2002-08-20
ENDOSCOPIC LIGHT SOURCE, MODEL XL300/L5 (K021717)World of Medicine Lemke GmbH2002-08-20
LASER FIBER GF500 (K021686)W.O.M. World of Medicine AG2002-08-20
GENESIS STERRAD COMPATIBLE REUSABLE STERILIZATION CONTAINER SYSTEM (K012931)Allegiance Healthcare Corp.2002-08-20
VASCLIP (K021745)Vmbc, LLC2002-08-20
CAMINO INTRACRANIAL PRESSURE MONITORING CATHETER WITH LICOX IMC BOLT FITTING, MODEL 110-4L (K022553)Integra Neurosciences2002-08-20
MSS-28CS-301/701 NEEDLESCOPE (K013759)Olympus Optical Co., Ltd.2002-08-20
RETROX (DEN020003)Auric Hearing Systems, Inc.2002-08-20
20G SMA LASER FIBER, MODEL LF20; 25G SMA LASER FIBER, MODEL LF25 (K021696)Ophthalmed, LLC2002-08-20
PHILIPS BABY THERMOMETER SET (SBC SC530) (K022542)Philips Consumer Electronics2002-08-20
INDUS TEXTILES TOWEL-STERILE AND NON-STERILE (K013958)Indus Textiles, Inc.2002-08-19
SEAL & PROTECT PROTECTIVE SEALANT (K021805)Dentsply Intl.2002-08-19
TOTAL KNEE FEMORAL COMPONENT (K022010)Smith & Nephew, Inc.2002-08-19
FLAT PANEL DISPLAYS, ME SERIES & CCL SERIES (K021738)Totoku Electric Co., Ltd.2002-08-19
DORNIER DIODE LASER FAMILY, INCLUDING MEDILAS D FIBERTOM, MEDILAS D SKINPULSE & MEDILAS D SKINPULSE S LASER SYSTEMS (K021724)Dornier Medtech America, Inc.2002-08-19
SMITH & NEPHEW IMAGE GUIDED SURGICAL SYSTEM FOR KNEE APPLICATIONS (K022460)Smith & Nephew, Inc.2002-08-19
PALMO THERMOREGULATION INTERFACE ACCESSORY (K014210)Avacore Technologies, Inc.2002-08-16
PRECISION POINT OF CARE BLOOD GLUCOSE TEST STRIP WITH TRUE MEASURE TECHNOLOGY (K021960)Abbott Laboratories2002-08-16
CLEARLIGHT PHOTOTHERAPHY SYSTEM, MODEL CL 420 (K013623)Curelight, Ltd.2002-08-16
ATHOSCAN FOR THE ATHOS LASER CONSTANS COOLING HAND PIECE FOR THE ATHOS LASER (K021650)Quantel Medical2002-08-16
MODULITH SLK LITHOTRIPTER (K011700)Karl Storz Endoscopy2002-08-16
CEMENT RESTRICTOR, SMALL AND LARGE (K021765)Exactech, Inc.2002-08-16
HA MODULAR REACH PROXIMAL POROUS AND HA MODULAR REACH COLLARED PROXIMAL POROUS FEMORAL STEMS (K022463)Biomet Orthopedics, Inc.2002-08-16
MULTI FUCTIONAL REHABILITATION CHAIR (K022407)Raye'S, Inc.2002-08-16
DB1 EMBRYO FREEZE (K011327)Zander Medical Supplies, Inc.2002-08-15
CANNABINOID ENZYME IMMUNOASSAY, CATALOG 0070, 0071 (K021887)Lin-Zhi International, Inc.2002-08-15
MEDTEXX GREEN COLOUR POWDERED NITRILE RUBBER EXAMINATION GLOVES (K022347)Latexx Manufacturing Sdn.Bhd.2002-08-15
LIQUICHEK BLOOD GAS PLUS CO-OXIMETER CONTROL (IL SYNTHESIS SERIES) LEVELS 1,2, AND 3, MODELS 667,668,669 (K022529)Bio-Rad2002-08-15
ALTAIRE MAGNETIC RESONANCE IMAGING SYSTEM (K021751)Hitachi Medical Systems America, Inc.2002-08-15
SPIFE LIPPOROTEIN-12, MODEL 3344 (K022333)Helena Laboratories2002-08-15
VITEK GRAM POSITIVE SUSCEPTIBILITY (GPS) CARD FOR LINEZOLID (K022045)bioMerieux, Inc.2002-08-15
FORTITUDE CEMENT RESTRICTOR (K021719)Spinal Concepts, Inc.2002-08-15
LIQUICHEK BLOOD GAS PLUS CO-OXIMETER CONTROL (RADIOMETER 700 SERIES) LEVELS, 1,2 AND 3, MODEL 507, 508, 509 (K022525)Bio-Rad2002-08-15
MODIFICATION TO POTASSIUM NITRATE-POLYCARBOXYLATE DENTAL CEMENT (K022025)Milton Hodosh, M.D.2002-08-15
MININEPH HUMAN B2-MICROGLOBULIN KIT (K014270)The Binding Site, Ltd.2002-08-15
DEGALL LAPAROSCOPIC GALLBLADDER EXTRACTOR (K021747)Surgicon, Inc.2002-08-15
TL10 TENSYMETER BLOOD PRESSURE MONITORING SYSTEM (K020537)Tensys Medical, Inc.2002-08-15
KSEA QUADRO SWITCH (K021776)Karl Storz Endoscopy2002-08-15
INTRAORAL IMAGING SYSTEM, MODEL SUNI-RAY (K021718)Suni Imaging Microsystems, Inc.2002-08-15
AUTOPULSE RESUSCITATION SYSTEM (K022345)Revivant Corp.2002-08-15
ANTERIOR STABILIZED TIBIAL BEARINGS (K022586)Biomet Orthopedics, Inc.2002-08-15
BLADDERSCAN BVI 6100 (K022153)Diagnostic Ultrasound Corp.2002-08-15
ACCESS CONCENTRATION SYSTEM, MODEL ACC-100, ACCESS DISPOSABLE SET, MODEL ADS-2000 (K022348)Interpore Cross Intl.2002-08-15
MEDTEXX BLUE COLOUR POWDER-FREE NITRILE RUBBER EXAMINATION GLOVES (K022548)Latexx Manufacturing Sdn.Bhd.2002-08-15
ECAT VISION PET SCANNER, MODELS 3000 & 5000 (K021633)Cti Pet Systems, Inc.2002-08-14
BIOTEST HEMOGLOBIN MEASURING SYSTEM (K020710)Biotest Medizintechnik GmbH2002-08-14
507EL VITAL SIGNS MONITOR (K022435)Criticare Systems, Inc.2002-08-14
K-ASSAY HS-CRP CONTROLS (K022486)Kamiya Biomedical Co.2002-08-14
MAEDA SILVER ACUPUNCTURE NEEDLE (K021904)Maeda Toyokichi Shoten2002-08-14
RHIGENE MESACUP-2 TEST RNP, MODEL M7741 (K022017)Rhigene, Inc.2002-08-14
7.0 FR. ENDOBRONCHIAL BLOCKER (K021920)Cook, Inc.2002-08-14
BILAYER MATRIX WOUND DRESSING (K021792)Integra Lifesciences Corp.2002-08-14
REGISTRADO X-TRA (K022066)Voco GmbH2002-08-14
STEALTHSTATION SYSTEM THREE DIMENSIONAL C-ARM INTERFACE (K022414)Medtronic Surgical Navigation Technologies2002-08-14
SCREWLINE (K022425)Altatec Biotechnologies N.A., Inc.2002-08-14
INTERVASCULAR INTERGARD KNITTED VASCULAR GRAFT SIZER (K022242)Intervascular2002-08-14
SAFE MAXI HOLLOW FIBER OXYGENATOR, MODEL 016010 (K013038)Polystan A/S2002-08-14
REPROCESSED SEALED ELECTROPHYSIOLOGY DIAGNOSTIC CATHETERS (K012678)Sterilmed, Inc.2002-08-14
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