Atlas FDA

2007

2,987 FDA 510(k) clearances · Clearance year

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RecordFirmDate
EZ-FILL XPRESS EPOXY ROOT CANAL CEMENT SYSTEM (K063856)Essential Dental Systems, Inc.2007-02-06
GLUCO TRACK BLOOD GLUCOSE MONITORING SYSTEM (K062799)Apex BioTechnology Corp.2007-02-06
XPER INFORMATION MANAGEMENT/PHYSIOMONITORING 5 SYSTEM AND/OR VASCULAR 5, PATIENT CARE CONSOLE AND CENTRAL STATION (K063840)Witt Biomedical Corp2007-02-06
DBX STRIP (K062205)Musculoskeletal Transplant Foundation2007-02-05
NIPRO BIOHOLE NEEDLE (K063368)Nipro Medical Corp.2007-02-05
ZIPPREP ELECTRODE (K070069)Aspect Medical Systems, Inc.2007-02-05
RUIKE, MODEL 3411 (K062646)Shanghai Ruike Sports Goods Co., Ltd.2007-02-05
JUNIPER COOLING DEVICE XTRA (K063715)Juniper Medical, Inc.2007-02-05
VERSATILE 1 EZCARE WOUND VACUUM SYSTEM (K061919)Blue Sky Medical Group Incorporated2007-02-05
CLEARVIEW DENTAL HANDPIECE LUBRICATOR AND LUBRICANT (K070297)Dental Air Solutions of Nc, Inc.2007-02-05
SPECTRUM MONITOR, MODEL 0998-00-1000-XXXXX (K062098)Datascope Corp.2007-02-05
NISSIN PEDIATRIC SERIES WHEELCHAIR (K063521)Nissin Medical, Inc.2007-02-05
KODEA, MODELS XJ-2001AC; XJ-2002AS; XJ-2003A (K062893)Shanghai Kodea Economic and Trade Development , Ltd.2007-02-05
SONIC-STIM (K063135)Naimco, Inc.2007-02-05
SCIENT'X SPINAL SYSTEM (K062912)Scient'X2007-02-05
DERMOTHERAP GUN (K062339)Dermoequipos S.R.L.2007-02-05
CANDELA FLUORESCENT PULSED LIGHT SYSTEM (K063800)Candela Corp.2007-02-05
CERAMILL ZI (K063511)Amann Girrbach America, Inc.2007-02-02
STRYKER AUTO IRRIGATION SYSTEM (K061108)Stryker2007-02-02
DELTA XTEND REVERSE SHOULDER SYSTEM (K062250)DePuy Orthopaedics, Inc.2007-02-02
TITANIUM REPICCI II UNICONDYLAR FEMORAL KNEE COMPONENTS COCR REPICCI II UNICONDYLAR KNEE (K063515)Biomet Manufacturing, Inc.2007-02-02
MIRAGE QUATTRO FULL FACE MASK (K063122)Resmed, Ltd.2007-02-02
MASTER CLASSIC 5K LOW SPEED HANDPIECE, 20K LOW SPEED HANDPIECE, TM5 LOW SPEED HANDPIECE AND TM20 LOW SPEED HANDPIECE (K070001)Mti Precision Products2007-02-02
TUTTNAUER PREVACUUM STEAM HEATED AUTOCLAVE, MODELS 6990 SP-1A, 66120 SP-1A, 69150 SP-2A, 69120 L USA SP-2A, 69180 SP-2HA (K063711)Tuttnauer Co. , Ltd.2007-02-02
CLEARFIL MAJESTY FLOW (K063593)Kuraray America, Inc.2007-02-02
ACON DIGITAL THERMOMETER PROBE COVERS (K063418)ACON Laboratories, Inc.2007-02-02
STRYKER T4 HYTREL TOGA (K070078)Stryker Instruments, Instruments Div.2007-02-02
FIBULA PLATE PROLOCK WITH ANGULAR STABILITY (K063672)I.T.S. Implantat-Technologie-Systeme GmbH2007-02-02
PCA ALUMINA FEMORAL HEADS (K063816)Stryker Orthopaedics2007-02-02
DANA DIABECARE IIS (K063126)Sooil Development Co., Ltd.2007-02-02
MIRAGE LIBERTY FULL FACE MASK (K063011)Resmed, Ltd.2007-02-02
VORTEX CT PORT ACCESS SYSTEM AND LIFEGUARD SAFETY INFUSION SET (K062414)Rita Medical Systems, Inc.2007-02-01
GLOBAL AP POROUS COATED HUMERAL STEM (K063652)DePuy Orthopaedics, Inc.2007-02-01
THERMOMED 1.8 (K063748)Thermosurgery Technologies, Inc.2007-02-01
C.T.M. MOBILITY SCOOTER, MODEL HS-310 (K070025)C.T.M. Homecare Product, Inc.2007-02-01
HERPESELECT 1 AND 2 PLEXUS IGG, MODEL MP0900G (K062543)Focus Diagnostics, Inc.2007-02-01
SURGIMESH WN (K061445)Aspide Medical2007-02-01
OMNIGUIDE BEAM PATH CO2 MARK III WAVEGUIDE FIBER (K070157)Omniguide, Inc.2007-02-01
INHIBIN A CALIBRATORS & CONTROLS ON THE ACCESS IMMUNOASSAY SYSTEMS (K070144)Beckman Coulter, Inc.2007-02-01
LIBERTY NORMAL GLUCOSE CONTROL SOLUTION, MODEL 2120045/ HIGH GLUCOSE CONTROL SOLUTION, MODEL 2120047 (K063855)Liberty Healthcare Group, Inc.2007-02-01
FINOMETER MODEL-2 WITH ACCESSORIES (K063111)Finapres Medical Systems B.V.2007-02-01
GSO BONE FIXATION FASTENERS (K063589)Gold Standard Orthopaedics, LLC2007-01-31
CONMED LINVATEC 24K IRRIGATION SYSTEM (K063326)Conmed Linvatec2007-01-31
SOLARIS COMPATIBLE REUSABLE ADULT SPO2 FINGER SENSORS, MODELS S100A-090103 AND 300103, S200A-090101 AND 300101 (K061931)Solaris Medical Technology, Inc.2007-01-31
REPROCESSED TROCARS (K062497)Ascent Healthcare Solutions2007-01-31
SONOTIP II ULTRASOUND NEEDLE SYSTEM (K070129)Medi-Globe Corporation2007-01-31
SYNTHES ORACLE SPACER (K062933)Synthes Spine Co.Lp2007-01-31
ULTRASONIC BIOMETER/ PACHYMETER FOR OPHTHALMOLOGY, MODEL ODM 2100, 2200 (K063472)Meda , Ltd.2007-01-31
ENDOGUIDE (K063654)Kms Medical, LLC2007-01-31
COBAS INTEGRA CERULOPLASMIN (K062379)Roche Diagnostics Corp.2007-01-31
VOLUMETRIC TOMOGRAPHY (K063773)Instrumentarium Dental, Inc.2007-01-31
KARL STORZ VIDEO LOWER G.I. ENDOSCOPE SYSTEM (K063585)KARL STORZ Endoscopy-America, Inc.2007-01-31
X3C DIGITAL RADIOGRAPHIC DETECTOR (K070079)Imaging Dynamics Company , Ltd.2007-01-31
PTS PANELS METABOLIC CHEMISTRY PANEL TEST STRIPS (K070017)Polymer Technology Systems, Inc.2007-01-31
DEXTROSCOPE, MODEL MK10; DEXTROBEAM, MODEL MK3, MK4; RADIODEXTER, MODEL 1.0 (K063730)Volume Interactions Pte, Ltd.2007-01-31
NEUTRON THERAPY SYSTEM (K063691)Northern Illinois Univ. Outreach2007-01-31
AXCEL FLOW (K063714)Tri Dental Innovators2007-01-31
ASTRA 300 (K061571)Sdi Diagnostics, Inc.2007-01-31
CERULOPLASMIN, MODEL 2055953 (K062114)Roche Diagnostics Corp.2007-01-31
36MM COCR FEMORAL HEAD AND 36MM ACETABULAR INSERT (K070061)Hayes Medical, Inc.2007-01-31
AERO TRACHEOBRONCHIAL STENT SYSTEM, MODEL 90129-2XX (K062511)Alveolus, Inc.2007-01-31
COSMELIGHT (K061720)Penntack Enterprises, Inc.2007-01-31
FRAXEL II SR LASER SYSTEM (K062303)Reliant Technologies, Inc.2007-01-31
WAKO LBA DCP TEST SYSTEM, MODEL 993-05301; DCP CONTROL SET, MODEL 995-0551; DCP CALIBRATOR SET, LIBASYS, MODEL 999-05401 (K062368)Wako Chemicals USA, Inc.2007-01-31
RAPIDTEG TEG-ACT TEST (K062604)Haemoscope Corp.2007-01-31
YAG MIR II LASER (K070063)Cynosure, Inc.2007-01-30
GAMBRO QUICKSET BLOODLINES (K063290)Gambro Renal Products2007-01-30
HARMONIC FOCUS CURVED SHEARS AND TORQUE WRENCH, HARMONIC BLUE HAND PIECE AND TEST TIP (K063192)Ethicon Endo-Surgery, LLC2007-01-30
COMPUTERIZED LABOR MONITORING SYSTEM (DEN060006)Barnev, Ltd.2007-01-30
ULTRACLIP II WING AND ULTRACLIP II COIL (K063238)Inrad2007-01-30
POLYSORB* SYNTHETIC ABSORBABLE SUTURE WITH MODIFIED PACKAGING (K063536)Tyco Healthcare Group2007-01-29
URGOCELL AG ANTIMICROBIAL WOUND DRESSING WITH SILVER (K062559)Laboratoires Urgo2007-01-29
BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM - CEFPODOXIME (GN) 0.125-8UG/ML (K063300)Becton, Dickinson & CO2007-01-29
15.5 FR DECATHLON GOLD, FUNNEL TIPS, COATED HEMODIALYSIS CATHETER, DFC19SH24, DFC23SH28, DFC27SH32, DFC31SH36, DFC35SH40 (K063431)Spire Biomedical, Inc.2007-01-29
COAGUCHEK XS PT CONTROLS (K063823)Roche Diagnostics Corp.2007-01-29
POWDER FREE (YELLOW) VINYL PATIENT EXAMINATION (K070044)Shijiazhuang Lianhe Shunda Plastic Products Co., L2007-01-29
COAGUCHEK XS SYSTEM (K062925)Roche Diagnostics Corp.2007-01-29
LUMINEX LL LASER SYSTEM (K063574)Medical Laser Systems, Inc.2007-01-29
VISION BIOSYSTEMS PROGESTERONE RECEPTOR PGR CLONE 16 (K062615)Vision Biosystems, Inc.2007-01-29
ULTRASONIC BIOMETER/PACHYMETER FOR OPTHALMOLOGY ODM 2100 AND ODM 2200 (K063433)Meda , Ltd.2007-01-29
TRIAGE PROTEIN C TEST (K062530)Biosite Incorporated2007-01-29
ENSEAL PTC TRIO (K070165)Surgrx, Inc.2007-01-29
ASTRAGUARD PULMONARY FUNCTION FILTER (K062913)Sdi Diagnostics, Inc.2007-01-26
CARRARA VOLUMIA (K070019)Dentsply Intl.2007-01-26
ATRICURE ABLATION SYSTEM (K063630)AtriCure, Inc.2007-01-26
POWDERED VINYL PATIENT EXAMINATION GLOVES, WHITE (K070040)Super Safe Plastic Products Co., Ltd.2007-01-26
DIMENSION VISTA B2MIC FLEX REAGENT CARTRIDGE, PROTEIN 1 CALIBRATOR, CONTROL MEDIUM, CONTROL HIGH (K063272)Dade Behring, Inc.2007-01-26
ON-Q, PAINBUSTER, C-BLOC, SELECT-A-FLOW, ONDEMAND, HOMEPUMP, ECLIPSE, C-SERIES, ONE-STEP KVO, EASYPUMP (K063530)I-Flow Corp.2007-01-26
ASAHI PTCA GUIDE WIRE, FIELDER FC (K063819)Asahi Intecc Co., Ltd.2007-01-26
CIRRUS HD-OCT, MODEL 4000 (K063378)Carl Zeiss Meditec, Inc.2007-01-26
AUTO-FILL SYRINGE KIT, MODEL 7600 (K063851)Vascular Solutions, Inc.2007-01-26
ANSPACH IMRI SAFE SURGICAL DRILL SYSTEM (K061297)The Anspach Effort, Inc.2007-01-26
K-Y BRAND TOUCH MASSAGE 2-IN-1 TINGLING (K062535)Mcneil-Ppc, Inc.2007-01-26
VECTRA GENISYS VMS FR (K062354)Encore Medical L.P.2007-01-26
LIFEPAK 12 DEFIBRILLATOR/MONITOR (K063510)Medtronic Emergency Response Systems, Inc.2007-01-26
EZLASE (K061898)Biolase Technology, Inc.2007-01-26
ERBE MONOPOLAR ATTACHMENT FOR HELIX HYDRO-JET, MODEL P/N 20139-094 (K062712)Erbe USA, Inc.2007-01-26
EIGEN DSA 2000 (K063846)Eigen2007-01-26
FLIGHT DENTAL SYSTEMS A-SERIES DENTAL OPERATIVE UNIT (K070196)Hr Dental Products, Inc.2007-01-26
OSFERION (K061499)Olympus America, Inc.2007-01-26
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