Atlas FDA

2013

3,052 FDA 510(k) clearances · Clearance year

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RecordFirmDate
KOSTEC MEDICAL GRADE LDC MONITORS (K123944)Kostec Co., Ltd.2013-09-05
LIAISON 25 TOTAL-D (K132492)DiaSorin, Inc.2013-09-05
5MP GRAYSCALE LCD DISPLAY (K132610)Shenzhen Beacon Display Technology Co., Ltd.2013-09-04
THE CVC WAND SAFETY INTRODUCER WITH VALVED PEELABLE SHEATH (K131148)Access Scientific, LLC2013-09-04
SEQUOIA PEDICLE SCREW SYSTEM INCLUDING SPEEDLINK II TRANSVERSE CONNECTOR SYSTEM (K131980)Zimmer Spine, Inc.2013-09-04
POLARIS SPINAL SYSTEM (K131615)Biomet Spine (Aka Ebi, LLC)2013-09-04
BIOSPACE (K131064)Biospace Corporation Limited2013-09-04
SENSICARDIAC MOBI DIAGNOSTIC HEART MURMUR APPLICATION (K131044)Diacoustic Medical Devices (Pty) , Ltd.2013-09-04
ADVANTAGESIM MD WITH CT ATLAS-BASED CONTOURING AND RE-PLANNING OPTIONS (K132045)Ge Hungary Kft2013-09-04
INTEGRA INTERSPINOUS PROCESS SYSTEM (K121924)Seaspine, Inc.2013-09-04
RESURFX 1565NM LASER MODULE (K130028)Lumenis, Ltd.2013-09-03
U-MOTION II PS+ CUP (K132455)United Orthopedic Corp.2013-09-03
ARDIS INTERBODY SYSTEM (K131242)Zimmer Spine, Inc.2013-09-03
PRELUDE PF FEMORAL COMPONENTS (MIM COCRMO), PRELUDE PF FEMORAL COMPONENTS (CAST COCRMO), PRELUDE PF PATELLA COMPONENTS, (K123907)Biomet Manufacturing Corp2013-09-03
INTERFUSE L INTERVERTEBRAL BODY FUSION DEVICE (K131540)Vertebral Technologies, Inc.2013-09-03
SPINAL INTERVERTEBRAL BODY FIXATION ORTHOSIS (K132366)Accel Spine2013-09-03
VARILIFT-L INTERBODY FUSION DEVICE (K131296)Wenzel Spine, Inc.2013-09-03
OPTIMA CT660 (K131576)Ge Medical Systems, LLC2013-08-30
CLEARFIL DC ACTIVATOR; CLEARFIL DC ACTIVATOR TRIAL (K131430)Kuraray Noritake Dental, Inc.2013-08-30
VITAL SIGNS MONITOR (K131818)Edan Instruments, Inc.2013-08-30
ReVive PV (Peripheral Vasculature) Thrombectomy Device (K132281)Codman & Shurtleff, Inc.2013-08-30
SUS (STENFILCON A) CONTACT LENS (K131378)CooperVision, Inc.2013-08-30
MRI PATIENT MONITORING SYSTEM (K132359)Invivo Corporation2013-08-30
SIRIUS FEMORAL STEM (K130610)Biomet, Inc.2013-08-30
SWIP (K131241)Philips Medical Systems Nederland B.V.2013-08-30
EASY DAY (METHAFILCON A) 1-DAY SOFT (HYDROPHILIC) CONTACT LENS (K130931)Jiangsu Horien Contact Lens Co., Ltd.2013-08-30
LIFESTENT BILIARY STENT SYSTEM, LIFESTENT XL BILIARY STENT SYSTEM (K130792)C.R. Bard, Inc.2013-08-30
RANGE SPINAL SYSTEM (K131784)K2m, Inc.2013-08-30
SAVIEW-AQUA 58 UV (ETAFILCON A) VISIBILITY TINTED SOFT (HYDROPHILIC) CONTACT LENS, SAVIEW-AQUA 58 UV TORIC (ETAFILCON A) (K132146)St. shine Optical Co., Ltd.2013-08-30
BAYLIS MEDICAL RF PERFORATION PROBE V2.0 (K132374)Baylis Medical Company, Inc.2013-08-30
UTF STEM-REDUCED, ADDITIONAL SIZES (K132207)United Orthopedic Corporation2013-08-30
ONETOUCH VERIO BLOOD GLUCOSE MONITORING SYSTEM (K131363)Cilag GmbH International2013-08-30
PICTZAR DIGITAL PLANIMETRY SOFTWARE APPLICATION 7.0 (K130165)Advanced Planimetric Services, LLC2013-08-30
INTEGRA LICOX PTO2 MONITOR (K131184)Integra Lifesciences Corp.2013-08-30
RESTORE MODULAR STERILIZATION TRAY SYSTEM (K131455)Restore Medical Solutions, Inc.2013-08-30
ALOE CADABRA LUBRICANT, ALOE CADABRA FLAVORED/SCENTED LUBRICANTS (K124044)Seven Oaks Ranch, Inc.2013-08-30
HORIZON XVU (FFR) (K123792)Mennen Medical , Ltd.2013-08-30
PG-800B SERIES, INCLUDING PG-800BD, PG-800B-1, PG-800BD-1, PG-800B3, PG-800B4, PG-800B4D, PG-800B5, PG-800B5-1, PG-800B6 (K131558)Shenzhen Pango Electronic Co., Ltd.2013-08-30
ROTATION MEDICAL BONE STAPLE (RMB STAPLE) (K131635)Rotation Medical, Inc.2013-08-29
QUIDEL MOLECULAR INFLUENZA A + B ASSAY (K131728)Quidel Corp.2013-08-29
OMNIPOD INSULIN MANAGEMENT SYSTEM (K131294)Insulet Corporation2013-08-29
REPROCESSED CLOSUREFAST RADIOFREQUENCY CATHETER 60CM, REPROCESSED CLOSUREFAST RADIOFREQUENCY CATHETER 100CM (K131614)Covidien2013-08-29
ARCHITECT IVANCOMYCIN (K123947)Biokit, S.A.2013-08-29
FRESENIUS DRY ACID DISSOLUTION UNITS (K131611)Fresenius Medical Care North America2013-08-29
MD242C2 24 DIAGNOSTIC IMAGING LCD MONITOR (K132587)Ned Display Solutions , Ltd.2013-08-29
MEDISIZE GOLD HEATER AND BOOSTER T-PIECE (K122885)Medisize BV2013-08-29
NUVASIVE DECADE LATERAL PLATE SYSTEM (K130868)Nuvasive, Inc.2013-08-29
ENSITE VELOCITY SYSTEM (K130727)St Jude Medical2013-08-29
MZ1000 (K132413)Care Fusion2013-08-29
EZDENTI-I; E2; PRORA VIEW (K131594)Ewoosoft Co., Ltd.2013-08-29
CONCIERGE GUIDING CATHETER (K132409)Merit Medical Systems, Inc.2013-08-29
CR 12-X DIGITIZER (K131408)Agfa Healthcare N.V.2013-08-29
TRINICA(R) ANTERIOR CERVICAL PLATE SYSTEM, TRINICA(R) SELECT ANTERIOR CERVICAL PLATE SYSTEM (K132012)Zimmer Spine, Inc.2013-08-29
ENDOWRIST ONE VESSEL SEALER (K130266)Intuitive Surgical, Inc.2013-08-29
SYNGO CT PULMO 3D (K123540)Siemens Medical Systems, Inc.2013-08-29
EZ3D-I, E3 (K131616)Ewoosoft Co., Ltd.2013-08-29
ASPIRON ACP SYSTEM (K131200)U&I Corporation2013-08-29
MAVEN PRO (K130242)Nsequence2013-08-29
EVIS EXERA III VIDEO SYSTEM (K131780)Olympus Medical Systems Corp.2013-08-29
OMNI-VUE 2 SYSTEM (K130374)Genesis Digital Imaging, Inc.2013-08-29
COLIGN (K131124)Jilin Coronado Medical , Ltd.2013-08-28
LARVAL DEBRIDEMENT THERAPY PRODUCTS - BIOBAG 50/100/200/300/400 (K131221)Biomonde2013-08-28
LIAISON(R) TOXO IGG II, LIAISON(R) CONTROL TOXO IGG II (K132234)DiaSorin, Inc.2013-08-28
RESTORE BUNION CORRECTION SYSTEM (K131061)Nextremity Solutions2013-08-28
ILLUMASK ACNE LIGHT THERAPY MASK (K123999)La Lumiere, LLC2013-08-28
AUTOMATED IN VITRO QUANTITATIVE ASSAY FOR THE MEASUREMENT OF ALLERGEN SPECIFIC IGE ANTIBODIES (K122197)Phadia US, Inc.2013-08-28
XARIO 200 DIAGNOSTIC ULTRASOUND SYSTEM (K131507)Toshibamedical Systems Corporation2013-08-28
BIORETEC ACTIVASCREW INTERFERENCE (K130716)Bioretec, Ltd.2013-08-28
LIDCO CNAP MODULE (K131048)Lidco, Ltd.2013-08-28
UGFT3; FHT7 (K131155)Medisim, Ltd.2013-08-28
SENSUS HELTHCARE IMAGE-DUIDED SUPERFICIAL RADIOTHERAPY SYSTEM (K131582)Sensus Healthcare2013-08-28
POWDERED LATEX SURGEON'S GLOVE (K121925)Suzhou Colour-Way Enterprise Development Co., Ltd.2013-08-28
MONOJECT 60ML SYRINGE (LUER LOCK TIP, LUER SLIP TIP, CATHETER TIP) (K131641)Nipro Medical Corporation2013-08-28
STALIF X (K130461)Centinel Spine, Inc.2013-08-28
DERMISEB CREAM (K123724)Igi Laboratories, Inc.2013-08-28
CARESCAPE MONITOR B850 (K131414)GE Healthcare Finland Oy2013-08-28
CARESCAPE MONITOR B650 (K131223)GE Healthcare Finland Oy2013-08-28
SELF-COMPRESSIVE SCREW (K131471)Neosteo2013-08-28
SONICISION STERILIZATION TRAY (K131170)Covidien, Formerly Valleylab, A Division of Tyco H2013-08-28
SEVIIN FRACTURE SHOULDER (K131277)Ingen Orthopedics, LLC2013-08-28
PALTOP NARROW IMPLANT, PALTOP SHORT IMPLANT (K130462)Paltop Advanced Dental Solutions, Ltd.2013-08-27
NT1D VITAL SIGNS MONITOR (K123797)New Tech, Inc.2013-08-27
ZRP (K131049)Apex Dental Materials, Inc.2013-08-27
SMARTCOAT 2.5% NAF VARNISH (K131376)Elevate Oral Care2013-08-27
KENDALL SCD 700 SEQUENTIAL COMPRESSION CONTROLLER (K132360)Covidien2013-08-27
TEETHMATE DESENSITIZER SET; TEETHMATE DESENSITIZER POWDER; TEETHMATE DESENSITIZER LIQUID (K131068)Kuraray Noritake Dental, Inc.2013-08-27
EDGEWISE CERAMIC BRACKETS, ROTH CERAMIC BRACKETS (K131197)Dental Morelli2013-08-27
TIPI OTC (K131198)Contipi , Ltd.2013-08-27
IMPROVE BLOOD COLLECTION SET AND IMPROSAFE BLOOD COLLECTION SET (K123987)Innovative Medical Technologies, Inc.2013-08-27
ATG/SM-OSA APPLIANCES (K130130)Selane Products, Inc.2013-08-26
INTERFORM INTERBODY CAGE SYSTEM (K131082)Next Orthosurgical2013-08-26
SEVIIN SURFACE REPLACEMENT SHOULDER (K130635)Ingen Orthopedics, LLC2013-08-26
AEM DISPOSABLE SUCTION IRRIGATION ELECTRODES (K131949)Encision, Inc.2013-08-26
PROPARAFLU+ ASSAY (K132238)Gen-Probe Prodesse, Inc.2013-08-26
FIRST RESPONSE EARLY RESULT PREGNANCY TEST (K123436)Church & Dwight Co., Inc.2013-08-26
ITERO SOFTWARE (K131101)Cadent, Ltd. an Align Technology Company2013-08-26
PREMIER CERAMIC PRIMER (K131212)Premier Dental Products Co.2013-08-26
PRODESSE PROFAST+ ASSAY (K132237)Gen-Probe Prodesse, Inc.2013-08-26
LOGIQ S8 (K131527)GE Healthcare2013-08-26
SUTTER BIPOLAR FORCEPS - SUPERGLISS (K131012)Sutter Medizintechnik GmbH2013-08-23
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Every clearance here is in the API, with alerts when new ones post.