Atlas FDA

2013

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

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RecordFirmDate
AUTOMATED ENDOSCOPE LEAK TESTER (K123704)Olympus Medical Systems Corp.2013-02-04
CIANNA MEDICAL TISSUE MARKER AND DELIVERY SYSTEM (K120804)Cianna Medical2013-02-04
WRIST PULSE OXIMETER (K122046)Beijing Choice Electronic Technololgy Co., Ltd.2013-02-04
VARI-PASS VARIABLE LENGTH ACCESS SHEATH (K123170)Olympus Surgical Technologies America2013-02-04
CADD SOLIS VIP AMBULATORY INFUSION PUMP AND CADD SOLIS MEDICATION SAFETY SOFTWARE (K111275)Smiths Medical Asd, Inc.2013-02-01
VIVIX-S WIRELESS (K122865)Vieworks Co., Ltd.2013-02-01
INVIVO DENTAL (K123519)Anatomage, Inc.2013-02-01
E-CUBE 15 (K123610)Alpinion Medical Systems Co., Ltd.2013-02-01
NUVASIVE LONG LATERAL SPINAL SYSTEM (K122081)Nuvasive, Inc.2013-02-01
ICS IMPULSE (K122550)Gn Otometrics2013-02-01
ANTERIOR CERVICAL PLATE SYSTEM (K123578)Weigao Orthopaedic Device Co., Ltd.2013-02-01
ARCHITECT TOTAL BILIRUBIN (K121985)Abbott Laboratories2013-02-01
DORNIER MEDILAS H30 SOLVO (K122159)Dornier Medtech America, Inc.2013-02-01
NOVEL FIT AND FILL STEM (K122853)Howmedica Osteonics Corp.2013-02-01
EASYSPINE SYSTEM (K123134)Ldr Spine USA, Inc.2013-02-01
POWDER FREE LATEX PATIENT EXAMINATION GLOVES, WITH PROTEIN CONTENT LABELING CLAIM, NATURAL COLOR (K123757)Assurguard Sdn. Bhd.2013-02-01
EPIEN ROOT CANAL CLEANSER (K123538)Epien Medical, Inc.2013-02-01
AUTION HYBRID AU-4050 FULLY AUTOMATED INTEGRATED URINE ANALYZER SYSTEM; URIFLET S 9HA URINE TEST STRIPS; AUTION CONTROL (K121456)Arkray, Inc.2013-02-01
INCORIS TZI (K123545)Sirona Dental Systems GmbH2013-02-01
SYNGO, BREAST CARE (K123420)Siemens Medical Solutions USA, Inc.2013-02-01
PLANMED VERITY (K121418)Planmed OY2013-02-01
MICRODOSE SI (K123995)Philips Digital Mammography Sweden AB2013-02-01
MILAGRO ADVANCE INTERFERENCE SCREW (K123362)Depuy Mitek, A Johnson & Johnson Company2013-02-01
DEKA SMARTXIDE AND DELIVERY ACCESSORIES (K113504)El.En Electronic Engineering Spa2013-02-01
DIOLASE 10S (K121327)Biolase Technology, Inc.2013-02-01
ROCKET IPC INSERTION PACK, ROCKET IPC MINI INSERTION SET, ROCKET IPC DRESSING PACK AND BOTTLE SET, ROCKET IPC DRAINAGE B (K123033)Rocket Medical Plc2013-02-01
V8 TRANSLUMINAL BAV CATHETER (K123111)Intervalve, Inc.2013-01-31
ULTRASONIC SCALER (K113530)Nakanishi, Inc.2013-01-31
THE ADVANCE CATHETER FOR HSG AND SIS (K123258)Catheter Research, Inc.2013-01-31
POWDER-FREE NITRILE EXAMINATION GLOVES (COOL BLUE) (K122696)Cardinal Health, Inc.2013-01-31
POWERED VINYL PATIENT EXAMINATION GLOVES, CLEAR (NON-COLORED) (K122396)Wealth on (Jiangsu) Co., Ltd.2013-01-31
LIQUICHEK SPINAL FLUID CONTROL LEVEL 1, LIQUICHEK SPINAL FLUID CONTROL LEVEL 2, LIQUICHEK SPINAL FLUID CONTROL MINIPAK (K123775)Bio-Rad Laboratories2013-01-31
MULTILINK AUTOMIX (K123397)Ivoclar Vivadent, AG2013-01-31
CLEARPATH DS-120(R) LENS FLUORESCENCE BIOMICROSCOPE (K112880)Freedom Meditech, Inc.2013-01-31
PALINDROME PRECISION H CHRONIC CATHETER, PALINDROME PRECISION SI CHRONIC CATHETER, PALINDROME PRECISION HSI CHRONIC CATH (K123196)Covidien2013-01-31
GEMINI STERILZATION WRAP (K113353)Medline Industries, Inc.2013-01-31
X4 SYSTEM (K130013)Advanced Brain Monitoring, Inc.2013-01-31
MAGNIFUSE BONE GRAFT (CLEARED AS GRAFTON II EDBM) (K123691)Medtronic Sofamor Danek, Inc.2013-01-31
DURETTE OCULAR IMPLANT (K123764)Oculo-Plastik, Inc.2013-01-31
GC AADVA ABUTMENT- ZIRCONIUM-BO AC BH SV (K113816)GC America, Inc.2013-01-30
MINI TREK RX CORONARY DILATATION CATHETER (INCLUDING 1.20 MM SIZE), MINI TREK OTW CORONARY DILATATION CATHETER (INCLUDIN (K123279)Abbott Vascular2013-01-30
LIGASURE IMPACT CURVED, LARGE JAW, OPEN SEALER / DIVIDER (K123444)Covidien, Formerly Valleylab, A Division of Tyco H2013-01-30
T3 DENTAL IMPLANT (K122300)Biomet 3i2013-01-30
DIGITAL FLAT PANEL X-RAY DETECTOR/1417PGA (K122928)Rayence Co., Ltd.2013-01-30
ILUMIEN OPTIS (K123369)Lightlab Imaging, Inc.2013-01-30
FASTECT II PPX DRUG SCREEN DIPSTICK, FASTECT II DRUG SCREEN DIPSTICK, QUICKTOX DRUG SCREEN DIPCARD (K122752)Branan Medical Corp.2013-01-30
TRACTUS TISSUEMAPPER REVIEWER APPLICATION (K123901)Tractus Corporation2013-01-29
BIOGRAPH MCT FAMILY (K123737)Siemens Medical Solutions USA, Inc.2013-01-29
PACIFIC PLUS (K123358)Medtronic Vascular2013-01-29
IMMUNOCAP ALLERGEN K82 (K121463)Thermo Fisher Scientific2013-01-29
PROGRESS GUIDE WIRE FAMILY, PILOT GUIDE WIRE FAMILY (K123067)Abbott Vascular, Inc.2013-01-29
IMAGEQUBE (K124048)Intuitive Imaging Informatics, LLC2013-01-29
GE ECHOPAC (K123894)Ge Vingmed Ultrasound AS2013-01-29
VARILIFT -C (K120603)Wenzel Spine2013-01-29
PROCEDURE REHEARSAL STUDIO (K123269)Simbionix , Ltd.2013-01-29
HEARTSPAN STEERABLE INTRODUCER KIT (K122431)Thomas Medical Products, Inc.2013-01-29
A-SCAN PLUS CONNECT (K123349)Accutome, Inc.2013-01-29
CONTRAST ENHANCED DIGITAL MAMMOGRAPHY (K123873)Hologic, Inc.2013-01-29
INION CPS ORBITAL PLATES (K122890)Inion OY2013-01-29
MULTIPLE NAME (K123760)Assurguard Sdn. Bhd.2013-01-28
AXERA 2 ACCESS SYSTEM MODEL AXE200 (K123135)Arstasis, Inc.2013-01-28
ORTHOCON ABSORBABLE HEMOSTATIC BONE PUTTY (K122156)Orthocon, Inc.2013-01-28
MEDYSSEY CANNULATED PEDICLE SCREW (K121670)Medyssey Co, Ltd.2013-01-25
ASA LASER SH1 (K122125)El.En Electronic Engineering Spa2013-01-25
REPROCESSED VESSEL SEALER (K123096)Sterilmed, Inc.2013-01-25
BACT/ALERT FN PLUS CULTURE BOTTLE (K121455)bioMerieux, Inc.2013-01-25
DECLIPSESPECT VIEWER (K123917)Surgiceye GmbH2013-01-25
RIGHTEST BLOOD GLUCOSE MONITORING SYSTEM GM700 GE GE200 BLOOD GLUCOSE MONITORING SYSTEM RIGHTEST BLOOD GLUCOSE MONITORIN (K123008)Bionime Corporation2013-01-25
2.5MM TURBO ELITE 035, 2.3MM TURBO ELITE 035 (K123632)Spectranetics Corp.2013-01-25
LIAISON TESTOSTERONE; LIAISON TESTOSTERONE CONTROL SET (K122793)DiaSorin, Inc.2013-01-25
GLUCOSE METER-CHECK SOLUTION FOR BAYER (K123966)Bionostics, Inc.2013-01-25
VASCULAR OCCLUSION SYSTEM (TRUFILL PUSHABLE COILS), AND TRUFILL DCS ORBIT DETACHABLE COIL SYSEM (K123560)Codman & Shurtleff, Inc.2013-01-25
ESA615 (K121860)Fluke Biomedical2013-01-25
ESWALLOW USA ELECTRODE,ESWALLOW USA LEADWIRE (K113375)Eswallow USA2013-01-25
SYSTEM 83 PLUS (K122172)Custom Ultrasonics2013-01-25
SMITH & NEPHEW, INC SCREW AND PLATE SYSTEM INSTRUMENTATION (K123055)Smith & Nephew, Inc.2013-01-25
POWER LED 175 (K123956)KARL STORZ Endoscopy-America, Inc.2013-01-25
ENSEAL G2 ARTICULATING TISSUE SEALERS, STRAIGHT JAW, ENSEAL G2 ARTICULATING TISSUE SEALERS, CURVED JAW (K122797)Ethicon Endo-Surgery, LLC2013-01-25
ZERONA 2.0 LASER (K123237)Erchonia Corporation2013-01-25
LANTOS 3D EAR SCANNER (K121326)Lantos Technologies2013-01-25
BACT/ALERT PF PLUS CULTURE BOTTLE (K121446)bioMerieux, Inc.2013-01-25
SR NEXCO PASTE LAYERING MATERIALS, SR NEXCO OPAQUER, SR NEXCO LINER-SR NEXCO CONNECT, SR NEXCO STAINS, SR NEXCO RETENTIO (K123304)Ivoclar Vivadent, AG2013-01-24
POINT 500 HD POINT500C HD (K121800)Pointnix Co., Ltd.2013-01-24
REPROCESSED STEERABLE INTRODUCER (K123334)Stryker Sustainability Solutions, Inc.2013-01-24
DIAZYME D-DIMER ASSAY KIT,CALIBRATOR SETAND CONTROL SET (K112120)Diazyme Laboratories2013-01-24
Medafor Direct Gas-Assisted Application System (K123325)Medafor, Inc.2013-01-24
VITRA MULTISPOT (K122251)Quantel Medical2013-01-24
SUREFLEX STEERABLE GUIDING SHEATH KIT (K122926)Baylis Medical Co., Inc.2013-01-24
VASHE SKIN AND WOUND HYDROGEL (K123071)Puricore, Inc.2013-01-24
GAMMA3 AND T2 RECON TARGETING DEVICES (K123401)Stryker Trauma AG2013-01-23
MARKIT TISSUE MARKER-1ML MARKIT TISSUE MARKER-3ML MARKIT TISSUE MARKER-10ML (K121964)Augmenix, Inc.2013-01-23
FERRISCAN R2-MRI ANALYSIS SYSTEM (DEN130012)Resonance Health Analysis Services Pty, Ltd.2013-01-23
HEPAIRX VENTILATING AIR PURIFIER (K112728)Air Innovations, Inc.2013-01-23
FINESSE 3RD GENERATION (MODELS FINESSE+ AND FINESSEII+) (K123310)Utah Medical Products, Inc.2013-01-23
FOOTPRINT ULTRA PK4.5MM AND 5.5MM SUTURE ANCHOR, SL (K123579)Smith & Nephew, Inc.2013-01-23
ENVITEC MYSIGN O OXYGEN MEASURING DEVICE (K122290)Envitec-Wismar GmbH2013-01-23
DURABLUE STERILIZATION WRAP (K123857)Cardinal Health200, LLC2013-01-23
OSSEOSPEED ANGLED ABUTMENT EV (K121810)Astra Tech AB2013-01-23
TURON GLENOID PEGGED, E+, TURON KEELED GLENOID, E+ (K123982)Encore Medical L.P.2013-01-23
ACCULIF TL-PEEK CAGE (K123281)Coalign Innovations, Inc.2013-01-23
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Every clearance here is in the API, with alerts when new ones post.