Atlas FDA

2002

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

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RecordFirmDate
MK-DENT PUSH BUTTON HIGHSPEED HANDPIECE, 4 HOLES, MODELS HS 2012 (STANDARD HEAD) & HS 2014 (SMALL HEAD) (K021250)Handpiece Unlimited2002-10-24
AEU-425 TRANSPORT II PORTABLE DENTAL SYSTEM (K022217)Aseptico, Inc.2002-10-24
MICROSCAN SYNERGIES PLUS (K023202)Dade Microscan, Inc.2002-10-23
CMA CEREBRAL TISSUE MONITORING SYSTEM (K020285)Cma Microdialysis AB2002-10-23
LIGHTSPEED ULTRA COMPUTED TOMOGRAPHY SYSTEM WITH WIDE-VIEW (K023332)GE Medical Systems2002-10-23
DRYSTAR 5500 (K023287)Agfa Corp.2002-10-22
INTEGRATED UNIT: SYNTHESIS: ADULT MEMBRANE OXYGENATOR WITH INTEGRATED ARTERIAL FILTER AND HARDHSHELL VENOUS/CARDIOTOMY (K022450)Dideco S.P.A.2002-10-22
EXCALIBUR 9000 TOTALSENSE QUAD HEAD ARRAY COIL (K022582)Usa Instruments, Inc.2002-10-22
MICRUS STRETCH-RESISTANT MICROCOIL SYSTEM, MSR01 (K022420)Micrus Corp.2002-10-22
HCMI X-RAY HIGH REQUENCY CHIROPRACTIC RADIOGRAPHIC (K022737)Health Care Mfg., Inc.2002-10-22
BPTRU PORTABLE AUTOMATED NON-INVASIVE BLOOD PRESSURE MONITOR, MODEL BPM-200 (K023055)Vsm Medtech , Ltd.2002-10-22
SMITHWICK CAROTID SHUNT (K021608)Implantable Devices2002-10-22
MICROTECH PUSH BUTTON HANDPIECE, MODEL MHS-A100 (K022535)Microtech2002-10-22
CEDARA I-SOFTVIEW (K022881)Cedara Software Corp.2002-10-22
HCMI X-RAY (K022667)Health Care Mfg., Inc.2002-10-22
USG 2000SA (K023227)Ultraguide , Ltd.2002-10-22
56 SERIES JET NEBULIZER (K021443)Project Marketing2002-10-21
CRANIOCUT (K022942)Aesculap, Inc.2002-10-21
IQ 200 SYSTEM (K022774)Intl. Remote Imaging Systems2002-10-21
ANSPACH POWERED KERRISON SYSTEM (PKS) (K022907)The Anspach Effort, Inc.2002-10-21
DIASOL-ADDITIVES (K020231)Diasol, Inc.2002-10-21
LAXTEX EXAMINATION GLOVES, POWDERED CONTAINS 180 MCGM OR LESS OF TOTAL WATER EXTRACTABLE PROTEIN PER GRAM (K022987)Arista Latindo Industrial Ltd. P.T2002-10-21
NXSTAGE PREMIXED DIALYSATE (K022913)Nxstage Medical, Inc.2002-10-21
MODIFICATION TO KPS-1, KIDNEY PERFUSION SOLUTIION (K022391)Organ Recovery Systems, Inc.2002-10-21
BLOOD FLOW ANALYZER (BFA), MODEL 408-100-01 (K023245)Paradigm Medical Industries, Inc.2002-10-21
FRAMELOCK; FRAMELOCK ACCESSORIES (K022370)Medtronic Xomed, Inc.2002-10-18
CLEANTEXX MINT FLAVOUR BLUE COLOUR POWDER-FREE BARRIER PRO COPOLYMER EXAMINATION GLOVES (K022346)Latexx Manufacturing Sdn.Bhd.2002-10-18
NICALERT (K021688)Nymox Pharmaceutical Corporation2002-10-18
ALCON LADARWAVE CUSTOMCORNEA WAVEFRONT SYSTEM (K023249)Alcon Laboratories, Inc.2002-10-18
DURACON CS TIBIAL INSERT (K021451)Howmedica Osteonics Corp.2002-10-18
BD K-4000 MICROKERATOME SYSTEM (K023092)Becton, Dickinson & CO2002-10-18
XENON FIBEROPTIC LIGHT SOURCE, MODEL 1300 XSBP (K022384)Isolux America2002-10-18
1.2MM OSTEOMED AUTO-DRIVE SCREW SYSTEM (K023260)Osteomed Corp.2002-10-18
MODIFICATION TO EBI XFIX DFS SYSTEM (K023324)Ebi, L.P.2002-10-18
AQUILLA MODULAR WHEELCHAIR (K023005)Haywood Vocational Opportunities2002-10-18
MODIFICATION TO EBI VUELOCK ANTERIOR CERVICAL PLATE SYSTEM (K023133)Ebi, L.P.2002-10-18
MULTIPLE PRIVATE LABELS VINYL EXAMINATION GLOVES, POWDER-FREE (K023235)Shandong Jiazhan Plastic Products Co., Ltd.2002-10-18
AROX 45-JBP; AROX 53-JBP; MEROX 45-JBP; MEROX 53-JBP (K023099)Biotronik, Inc.2002-10-18
COMPAS (K021200)Morgan Scientific, Inc.2002-10-18
MODIFICATION TO EBI OMEGA21 SPINAL FIXATION SYSTEM (K023204)Ebi, L.P.2002-10-18
VKS KNEE SYSTEM (K022204)Plus Orthopedics2002-10-18
PLASMALITE PULSED LIGHT SYSTEM (K022378)Medical Bio Care Sweden AB2002-10-18
NIPRO BIO-FLEX CATHETER (K022756)Nipro Medical Corp.2002-10-18
UNIVERSAL CERAMIC SOLDER (K022969)Ivoclar Vivadent, Inc.2002-10-18
ELCAM STOPCOCKS AND MANIFOLDS (K022895)Medical Device Consultants, Inc.2002-10-18
PROFILE 1320 LASER SYSTEM (K022381)Sciton, Inc2002-10-18
CORDIS OPTEASE PERMANENT VENA CAVA FILTER, MODELS 466-F200A, 466-F200B (K023116)Cordis Corp.2002-10-18
I-FLOW ELASTOMERIC PUMP WITH BOLUS (K023318)I-Flow Corp.2002-10-18
ISO FUNCTIONAL (K022430)GC America, Inc.2002-10-18
MICROFIX (K023314)Fixano SA2002-10-18
SMART PLUG, MODEL 500; SMARTPLUG FORCEPS, MODEL 502; PUSH ROD, MODEL 503 (K022043)Medennium, Inc.2002-10-18
TIMEX DIGITAL ORAL THERMOMETERS; TIMEX ACCUCURVE ORAL THERMOMETER (K023069)Medport, Inc.2002-10-18
TRANSCURE, MODEL 2910 (K022862)Kinetic Instruments, Inc.2002-10-18
SMITH & NEPHEW IMAGE SURGICAL INSTRUMENTS FOR TRAUMA APPLICATIONS (K021815)Smith & Nephew, Inc.2002-10-17
OSSTAPLE (K023203)Biomedical Ent., Inc.2002-10-17
PORGES SILICONE DOUBLE LOOP URETERAL STENT, MODEL # AJ4X / BJ1X / BJ2X (K013921)Porges S.A.2002-10-17
WILSON-COOK CYSTOTOME (K022595)Wilson-Cook Medical, Inc.2002-10-17
BRENNEN MEDICAL SURGICAL MESH, GLUCAMESH/GLUCATEX (K021835)Brennen Medical, Inc.2002-10-17
HOFFMANN 30 DEGREE PELVIC DOUBLE BALL JOINT (K022651)Howmedica Osteonics Corp.2002-10-17
GMRS PRESS FIT STEMS WITH PUREFIX HA (K022403)Howmedica Osteonics Corp.2002-10-17
SAS STREPALERT (K023270)Sa Scientific, Inc.2002-10-17
CARRAKLENZ AND ULTRAKLENZ (K022670)Carrington Laboratories, Inc.2002-10-17
SHERPA MOBILITY SYSTEM (MANUAL WHEELCHAIR) (K022924)Otto Back Healthcare, LP2002-10-17
DYNAREX IODOFORM PACKING STRIPS, MODELS 3411, 3412, 3413, 3414 (K012816)Dynarex Corp.2002-10-17
RX 90 FEMORAL STEM AND RX 90 LATERALIZED FEMORAL STEM (K023085)Biomet Orthopedics, Inc.2002-10-17
ECHO-VIEW 5.X, EASY-VIEW 2.X, OMNI VIEW 2.X, CARDIO-VIEW 1.X, LV ANALYSIS 1.X & SURGICAL VIEW 1.X (K022824)Tomtec Imaging Systems GmbH2002-10-17
PORGES URETERAL CATHETERS, MODELS ACN6XX, ACN5XX, AC5B, AC5C07, ACP5XX, ACP2XX, ACP3XX, ACP4XX, ACP6XX (K021856)Porges S.A.2002-10-17
BIOSTEON CROSS PIN (K021351)Biocomposites, Ltd.2002-10-17
LINICAL PROTEIN 2 CALIBRATION VERIFIERS LEVELS A-E FOR THE BECKMAN-COULTER IMMAGE (K023250)Cliniqa Corporation2002-10-17
COBRA COOLED CARDIAC SURGICAL PROBE, MODEL 1596X (K023291)Boston Scientific Corp2002-10-17
NEXGEN COMPLETE KNEE SOLUTION CRUCIATE RETAINING (CR)-FLEX FEMORAL COMPONENTS (K023211)Zimmer, Inc.2002-10-17
OPTETRAK TOTAL KNEE SYSTEM OFFSET TIBIAL TRAY (K023186)Exactech, Inc.2002-10-17
EB-1830T3, VIDEO BRONCHOSCOPE (K023376)Pentax Precision Instrument Corp.2002-10-16
OPTICAL INTEGRITY GENERAL SHAPED FIBER (K022338)Optical Integrity, Inc.2002-10-16
MOIST PUNCTAL PLUG SYSTEM (K021936)Moist Medical, Inc.2002-10-16
BD-3000 MICROKERATOME SYSTEM, MODEL K-3000 MICROKERATOME (K022637)Becton, Dickinson & CO2002-10-16
CYCLOSPORINE (CSA) FLEX REAGENT CARTRIDGE (K023065)Dade Behring, Inc.2002-10-16
NOVUS SPECTRA (K022327)Lumenis, Inc.2002-10-16
OLEEVA FABRIC (K023136)Bio Med Sciences, Inc.2002-10-16
DIODENT DENTAL LASER SYSTEM (K022351)Continuum Electro-Optics, Inc.2002-10-16
SURGIFORM AUGMENTATION MATERIAL (S.F.A.M.) (K021889)Surgical Technology Laboratories, Inc.2002-10-16
SANARUS INDICA MARKER SYSTEM (K020054)Sanarus Medical, Inc.2002-10-16
TRANSEND 300 ES GUIDEWIRE, MODEL 46-814 & TRANSEND 300 FLOPPY GUIDEWIRE, MODEL 46-815 (K022357)Boston Scientific, Target2002-10-16
S&T SINGLE USE MICRO ANASTOMOSIS CLAMP (K022754)S & T AG2002-10-16
ADVIA 120 HEMATOLOGY SYSTEM COMPLETE BLOOD COUNT (CBC) METHOD (K022668)Bayer Diagnostics Corp.2002-10-15
POLYMER COATED POWDERFREE LATEX EXAMINATION GLOVE (K022016)Top Glove Medical (Thailand) Co., Ltd.2002-10-15
POWDER-FREE LATEX EXAMINATION GLOVE (GREEN) WITH NATURAL WATER SOLUBLE VITAMIN E AND PROTEIN CONTENT LABELING (50 MICRO (K022566)Qingdao Bestex Rubber & Plastic Products Co., Ltd.2002-10-15
SANARUS VISICA TREATMENT SYSTEM (K022314)Sanarus Medical, Inc.2002-10-15
OEMEDIC INTERNATIONAL INC. BESMED SILICONE ADULT, CHILD, INFANT MANUAL RESUSCITATOR WITH MASK AND RESERVOIR (K021446)Oemedic International, Inc.2002-10-11
COMFORT DREAMRIDER SCOOTER, LY-EW402 (K021910)Comfort Orthopedic Co., Ltd.2002-10-11
NEICH NM ADVANCE CATHETER SHEATH INTRODUCER (K020964)Neich Medical(Shenzhen)Company, Ltd.2002-10-11
E-SPEED EBT SCANNER SYSTEM (K022794)Ge Imatron2002-10-11
ENCIRCLE LOCALIZATION DEVICE (K022286)Vivant Medical, Inc.2002-10-11
IN-VISION VIEW WITH MEASUREMENTS MODULE, MODEL 1.0 (K022940)Intelligent Images Srl2002-10-11
VOXELPLUS PACS (K022692)Mevisys Co., Ltd.2002-10-11
KONICA DIRECT DIGITIZER REGIUS, MODEL 170 (K023061)Konica Minolta Medical & Graphic, Inc.2002-10-11
MAJESTIK (TM) SHIELDED ANGIOGRAPHY NEEDLE, MODEL STAN18T71W-25, MAJESTIK (TM) SHIELDED ANGIOGTAPHY NEEDLE, SRAN18T71WR-5 (K022117)Merit Medical Systems, Inc.2002-10-11
REPROCESSED IMAGING CATHETERS (K012537)Sterilmed, Inc.2002-10-11
GLUCOBALANCE DATA MANAGEMENT SOFTWARE, MODEL 555020 (K022545)Hypoguard USA, Inc.2002-10-11
BONE INJECTION GUN (B.I.G.) FOR PEDIATRICS, MODEL 1ST (K022415)Waismed, Ltd.2002-10-11
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Every clearance here is in the API, with alerts when new ones post.