Atlas FDA

2006

3,217 FDA 510(k) clearances · Clearance year

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RecordFirmDate
ZODIAC ADJUSTABLE BRIDGES, MODELS 11-20XX,11-25XX,11-30XX,11-35XX (K061321)Alphatec Spine, Inc.2006-07-07
WATER PURIFICATION COMPONENTS FOR HEMODIALYSIS (K060942)Bob J. Johnson & Associates2006-07-07
LIV MEDICA CPR FACE MASK (K052458)Liv Medica Products Pvt. , Ltd.2006-07-07
HEMCON DENTAL DRESSING, 1 DRESSING, 4 DRESSING, 1 DRESSING, BOX OF 12, 4 DRESSING, BOX OF 12 (K060363)Hemcon, Inc.2006-07-07
APEX PINS (K061493)Stryker Howmedica Osteonics2006-07-07
POWDER FREE VINYL SYNTHETIC EXAMINATION GLOVES W/ALOE VERA, GREEN COLOR (K060785)Ever Light Plastic Products Co., Ltd.2006-07-07
TRIDENT CONSTRAINED ACETABULAR INSERT (K061654)Howmedica Osteonics Corp.2006-07-07
EPISTAT, V-STAT, MODELS EPISTAT-001-01, V-STAT-001-01 (K060289)Frontline Medical2006-07-07
INFINITY MASIMO SET SP02 POD (K061329)Draeger Medical Systems, Inc.2006-07-07
BALANCED KNEE SYSTEM MODULAR REVISION KNEE SYSTEM (K060569)Ortho Development Corp.2006-07-06
DIMENSION VISTA IGA FLEX REAGENT CARTRIDGE ASSAY (K061338)Dade Behring, Inc.2006-07-06
ACHTUNG BLOOD GLUCOSE MONITORING SYSTEM, MODEL TD-4207 (K061181)Taidoc Technology Corporation2006-07-06
SPIFE IFE-15 PENTAVALENT, MODEL 3456, SPIFE IFE-9 PENTAVALENT KIT, MODEL 3457, SPIFT IFE-6 PENTAVALENT KIT, MODEL 3458 (K061069)Helena Laboratories2006-07-06
ACTIVAPIN (K061164)Bioretec, Ltd.2006-07-06
ADVIA IMS CPSA CONTROL (K061137)Bayer Healthcare, LLC2006-07-06
ACCESS TPO ANTIBODY, AND ACCESS TPO ANTIBODY CALIBRATORS, MODELS A12985 AND A18227 (K061382)Beckman Coulter, Inc.2006-07-06
GRENGLOO (K061481)Ormco Corp.2006-07-06
PRODIGY (K053593)Diagnostic Devices, Inc.2006-07-06
SMITH & NEPHEW COMPETITOR DEUCE FEMORAL COMPONENTS (K061569)Smith & Nephew, Inc.2006-07-06
FORYOU POWERED WHEELCHAIR, MODEL FC-100 (K061693)Foryou Technology Co., Ltd.2006-07-06
SYSMEX AUTOMATED HEMATOLOGY ANALYZER, XT-SERIES (K061150)Sysmex America, Inc.2006-07-06
BI-OSTETIC FOAM, CEM-OSTETIC FOAM, TRI-OSTETIC FOAM, GENEROS FOAM (K053213)Berkeley Advanced Biomaterials, Inc.2006-07-06
BAYER ADVIA IMS PSA CALIBRATOR AND ADVIA IMS CPSA CALIBRATORS (K061139)Bayer Healthcare, LLC2006-07-06
ALLOFIX ANCHOR, 5.0 MM ANCHOR (K061498)Musculoskeletal Transplant Foundation2006-07-06
LUMENIS ONE FAMILY OF SYSTEMS; LUMENIS ONE. (K060448)Lumenis, Ltd.2006-07-06
DIMENSION VISTA SYSTEM ENZYME2 CALIBRATOR, MODEL KC320 (K061390)Dade Behring, Inc.2006-07-05
ANCHOR BAND SUTURING SYSTEM, MODEL SR-AB (K061386)Anulex Technologies, Inc.2006-07-05
LEKSELL GAMMAPLAN (K061540)Elekta Instrument AB2006-07-05
BARRIERPLUS GOLD POWDER-FREE SYNTHETIC POLYISOPRENE SURGICAL GLOVES (K053406)Barriermed Glove Co.2006-07-05
MEDCARE MECHANICAL WHEELCHAIR, MODELS MC-281S & MC-200S (K061694)Medcare Manufacturing, Inc.2006-07-05
LIGAFIX INTERFERENCE SCREW (K061262)Sciences For Bio Materials2006-07-05
AXYALOOP NONABSORBABLE BONE ANCHOR (K060970)Axya Medical, Inc.2006-07-05
COLLAWOUND DRESSING (K061474)Collamatrix Co., Inc.2006-07-05
OCULASE MD (K052354)Biolase Technology, Inc.2006-07-05
SMOOTHSHAPES (K061603)Biocellulase, Inc.2006-07-03
E.P.T. CERTAINTY 1-STEP PREGNANCY TEST (K061769)Unipath , Ltd.2006-07-03
OSTEO-LINK BONE VOID FILLER PELLETS (K060809)Promed Advance Technology Co., Ltd.2006-07-03
TT101, MODELS TT 101-1,-2,-3,-4,-5,-6,-7,-8 (K061060)Tissue Technologies Holdings, LLC2006-07-03
MODIFICATION TO QUANTUM VERTEBRAL BODY REPLACEMENT SYSTEM (K061576)Quantum Orthopedics, Inc.2006-07-03
POLYURETHANE INFUSION CATHETER, ALPHA CATH, MODEL PAC20, AND POLYURETHANE INFUSION CATHETER, MULTI DRIP, MODEL PMD20-6 (K061356)Advanced Infusion, Inc.2006-07-03
MYKRES SPINAL SYSTEM (K051704)Showa Ika Kohgyo Co., Ltd.2006-07-03
GE VIVID - I (K061525)General Electric Co.2006-07-03
STAXX FX SYSTEM (K053336)Spine Wave, Inc.2006-07-03
EASYTAC ANCHOR. EASYTAC DELIVERY SYSTEM (K060494)Medchannel, LLC2006-07-03
ENDOPATH ENDOCUTTER 60 ENDOSCOPIC LINEAR CUTTER, MODELS EC60, SC60 AND LONG60 AND ENDOPATH & PROXIMATE LINEAR CUTTERS (K061156)Ethicon Endo-Surgery, Inc.2006-07-03
I-CAT SCANNER (K061284)Imaging Sciences Intl., Inc.2006-07-03
CHOLINESTERASE GEN.2 TEST SYSTEM (K061093)Roche Diagnostics Corp.2006-07-03
DYNASTY ACETABULAR SHELL; DYNASTY A-CLASS POLY ACETABULAR LINER (K061547)Wrightmedicaltechnologyinc2006-07-03
STATARIUS, MODEL 001 003 (K061292)Kinetic Surgical, LLC2006-07-03
URGENT PC NEUROMODULATION SYSTEM, MODELS UPC200-A AND UPC250-12 (K061333)Uroplasty, Inc.2006-07-03
MOBILLIFE - MODEL (MOBIL RAIZER 22) - POWER WHEELCHAIR (K061116)Mobilife, LLC2006-07-03
INJECTRA INJECTION NEEDLE (K061222)Medi-Globe Corp.2006-07-03
I-STYLE BONE MARROW ASPIRATION NEEDLE (K061570)Busse Hospital Disposables, Inc.2006-07-03
MODIFICATION TO CD HORIZON SYSTEM (K061592)Medtronic Sofamor Danek, Inc.2006-07-03
BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM-AMOXICILLIN-CLAVULANATE (GN) 0.5/0.25-32/16 UG/ML, AMPICILLIN-SULBACTAM (GN) 0. (K061327)Becton, Dickinson & CO2006-07-03
LARGE UNI-CLIP STAPLE (K061594)New Deal, S.A.2006-07-03
VITROS IMMUNODIAGNOSTIC PRODUCTS CORTISOL REAGENT PACK AND CALIBRATORS AND METABOLISM CONTROLS (K060480)Ortho-Clinical Diagnostics2006-07-03
DIMENSION VISTA SYSTEM CHEMISTRY CALIBRATOR 4, MODEL KC140 (K061218)Dade Behring, Inc.2006-06-30
SCENIUM 1.1 (K061545)Siemens Molecular Imaging, Ltd.2006-06-30
LBI CATHETER SYSTEM (K053372)Lumen Biomedical, Inc.2006-06-30
MICROGEL ALKALINE HEMOGLOBIN ELECTROPHORESIS TEST SYSTEM, MICROGEL ACID HEMOGLOBIN ELECTROPHORESIS TEST SYSTEM (K053571)Interlab S.R.L.2006-06-30
ERCH ARCH BAR, MODEL 38-690-00 (K061271)KLS-Martin L.P.2006-06-30
ATLANTIS ABUTMENT FOR ZIMMER INTERFACE (K053373)Atlantis Components, Inc.2006-06-30
SFB & CFB IMPLANTS (K061003)Nobel Biocare AB2006-06-30
TRANQUIL TRI-BTE (K061459)General Hearing Instruments, Inc.2006-06-30
CTS-5500/CTS-6600 ULTRASONIC PULSED ECHO IMAGING SYSTEM (K061488)Shantou Institute of Ultrasonic Instruments (Siui2006-06-30
ALARA CRYSTALVIEW COMPUTED RADIOGRAPHY SYSTEM, MODEL R200 (K061538)Alara, Inc.2006-06-30
OPTERYX ANTERIOR CERVICAL PLATE SYSTEM (K061147)Innovasis, Inc.2006-06-30
KAWASUMI LABORATORIES EMPTY SOLUTION CONTAINER (K061197)Kawasumi Laboratories, Inc.2006-06-30
SPEEDFLOW 0.2UM FILTER, MODEL 11214; SPEEDFLOW 1.2UM FILTER, MODEL 11215; EASYDROP CONTROLLER, MODEL 11216 (K061115)Gvs Spa2006-06-30
SYNAPSE MIP/MPR IMAGE VISUALIZATION SOFTWARE OBLIQUUS (K061672)Fujifilm Medical Systems U.S.A, Inc.2006-06-29
SONOHYSTEROGRAPHY BIOPSY DEVICE (K060908)Cook Urological, Inc.2006-06-29
MICROLIFE WRIST WATCH BLOOD PRESSURE MONITOR, MODEL BP3BU1-4U (K061558)Microlife Intellectual Property GmbH2006-06-29
VASHE WOUND CLEANSING SYSTEM (K060901)Sterilox Technologies, Inc.2006-06-29
GERATHERM SOS-VACUTHERM (THERMAMED SMARTCARE) (K051278)Rg Ent., Inc.2006-06-29
CAROTID ACCESS KIT (K060666)Terumo Medical Corp.2006-06-29
Y-CLICK CONNECTOR (K060759)Elcam Medical Acal2006-06-29
CALCANEAL TRAUMA SYSTEM (K061400)Orthohelix Surgical Designs, Inc.2006-06-29
GERATHERM SOS-RESCUE BAG (K051336)R.G. Enterprises, Inc.2006-06-29
AMSURE DISPOSABLE SYRINGE WITH/WITHOUT NEEDLE (K061039)Amsino International, Inc.2006-06-29
PRIMATRIX DERMAL REPAIR SCAFFOLD (K061407)Tei Biosciences, Inc.2006-06-29
SYNGO TRUED, MODEL VC10A (K061671)Siemens Medical Solutions2006-06-29
NPOSES (NOCTURNAL PULSE OXIMETRY STUDY EXPERT SYSTEM), MODEL NPOSES-100 (K060616)PHD Medical2006-06-29
MODIFICATION TO I VENT 201 (K061627)Versamed Medical Systems, Inc.2006-06-29
SURGI-MAX (K061174)Ellman Int'L, Inc.2006-06-28
L4 OXYGEN CONCENTRATOR (K061261)Respironics, Inc.2006-06-28
JSZ MULTIACTION GP CONTACT LENS SOLUTION (K060924)Szabocsik and Associates2006-06-28
DEPUY GLOBAL AP SHOULDER SYSTEM (K060874)DePuy Orthopaedics, Inc.2006-06-28
BABY SNOOPY WATER FILLED TEETHER, MODEL 95367 (K052513)Delta Enterprise Corporation2006-06-28
PARTIAL OSSICULAR REPLACEMENT PROSTHESES (K060518)Grace Medical, Inc.2006-06-28
VITREA, VERSION 3.9 (K061624)Vital Images, Inc.2006-06-27
NEOMARKERS RABBIT MONOCLONAL ANTI-HUMAN ESTROGEN RECE[PTOR ANTIBODY (CLONE SP1) (K061360)Lab Vision Corp.2006-06-27
GE DATEX-OHMEDA AISYS (K061609)Datex-Ohmeda, Inc.2006-06-27
CARD 43 CARDIOTOMY RESERVOIR WITH PHOSPHORYLCHOLINE COATING (K061527)Sorin Group Italia S.R.L.2006-06-27
CAPILLARY'S HEMOGLOBIN(E) (PN 2007) (K052291)Sebia2006-06-27
P.D (K061440).Decimal, Inc.2006-06-27
LASERSCOPE GUIDED DELIVERY DEVICE (GDD) CYSTOURETHROSCOPE & ACCESSORIES (K061646)Laserscope2006-06-27
V-2200 INFANT INCUBATOR (K061280)Neoforce Group, Inc.2006-06-27
BOD POD (K060848)Life Measurement, Inc.2006-06-27
FUNCTIONAL ANAESTHETIC DISCOGRAPHY (FAD) CATHETER SYSTEM, MODEL D01A ; INTRODUCER NEEDLE, MODEL D01B (K061210)Kyphon, Inc.2006-06-27
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