Atlas FDA

2013

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

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RecordFirmDate
INTERVENTIONAL HEMOSTATIC BANDAGE (K120782)Z-Medica Corporation2013-03-20
OIC DISTAL RADIUS PLATING SYSTEM, OIC PROXIMAL HUMERUS PLATING SYSTEM, OIC CLAVICLE PLATING SYSTEM, THE OIC SMALL FRAGME (K123832)The Orthopaedic Implant Company (Oic)2013-03-20
LIDCORAPID V2 MONITOR (K122247)Lidco, Ltd.2013-03-20
CPS AIM UNIVERSAL SLITTABLE INNER CATHETER (K130252)St Jude Medical2013-03-20
TX1 TISSUE REMOVAL SYSTEM (K123640)Tenex Health2013-03-20
CEREC BLOCS C IN (K123952)Sirona Dental Systems GmbH2013-03-20
OPTETRAK LOGIC POROUS FEMORAL COMPONENT (K123687)Exactech, Inc.2013-03-20
E-Z CHEK BLOOD LEAK TEST STRIPS (K123805)Reprocessing Products Corp2013-03-20
PENTAX EG-3870UTK ULTRASOUND VIDEO GASTROSCOPE + HI VISION PREIRUS (K130247)Pentax of America, Inc.2013-03-20
SUITEHEART (K130228)Neosoft, LLC2013-03-20
DEMI ULTRA (K123468)Kerr Corporation2013-03-20
PALM BLADDER SCANNER (K130229)Mianyang Meike Electronic Equipment Co., Ltd.2013-03-20
CADWELL DISPOSABLE PROBE HANDLE (K123589)Cadwell2013-03-19
DIGITAL RETINAL CAMERA (K123208)Canon Inc. -Medical Equipment Group2013-03-19
VIA MICROCATHETER, VIA PLUS MICROCATHETER (K123477)Sequent Medical, Inc.2013-03-19
AFFINITY AF100 ARTERIAL FILTER WITH CARMEDA BIOACTIVE SURFACE (K123351)Medtronic Perfusion Systems2013-03-19
BIODENTA DENTAL IMPLANT SYSTEM- BONE LEVEL TAPERED (K123415)Biodenta Swiss AG2013-03-19
DENTOETCH QUICKBOND BOND ACTIVATOR (K122522)Itena Clinical2013-03-19
AUDIT MICROCV BETA-HYDROXYBUTYRIC ACID LINEARITY SET (K130157)Aalto Scientific, Ltd.2013-03-19
IOGYN ENDOSCOPE (K123330)Iogyn, Inc.2013-03-19
GUIDEZILLA GUIDE EXTENSION CATHETER (K123765)Boston Scientific2013-03-19
ADVANCE MICRO 14 ULTRA LOW PROFILE BALLOON DILATATION CATHETER MODEL PTA3 (K122940)Cook, Inc.2013-03-19
ORBIT INFUSION SET (K130468)Ypsomed AG2013-03-19
ENI-EYE SH SOFT K SEMI SCLERAL (EFROFILCON A) SOFT (HYDROPHILIC) KERATOCONUS AND IRREGULAR COR ENI-EYE SH SOFT K TORIC S (K122220)Soflex Limited2013-03-19
URGOCLEAN ABSORBENT WOUND DRESSING (K123219)Laboratoires Urgo2013-03-18
3M ATTEST(TM) AUTO-READER (K123546)3M Company2013-03-18
BIOFRIEND BIOMASK N95 SURGICAL RESPIRATOR (K122702)Filligent Limited2013-03-18
STERILE LATEX SURGICAL GLOVE (K123628)Lucenxia Prescience AG2013-03-18
LANX FUSION SYSTEM- SA (K123767)Lanx, Inc.2013-03-18
ALL-SUTURE ANCHOR TWIST DRILL FOR ALL-SUTURE ANCHORS INLINE DRILL GUIDE FOR ALL-SUTURE ANCHORS (K122059)Smith & Nephew, Inc.2013-03-18
ACUMED CANNULATED SCREW SYSTEM (K123890)Acumed, LLC2013-03-18
JUGGERKNOTLESS SOFT ANCHORS, JUGGERKNOTLESS M SOFT ANCHORS, JUGGERKNOTLESS SOFT ANCHORS WITH NEEDLES, JUGGERKNOTLESS SOF (K123485)Biomet Sports Medicine2013-03-18
RAYSCAN A-EXPERT (K122918)Ray Co., Ltd.2013-03-15
FLIXENE IFG VASCULAR GRAFT (K130142)Atrium Medical Corporation2013-03-15
ULTRASONIC NEBULIZER (MESH TYPE) (K121520)K-Jump Health Co., Ltd.2013-03-15
3M ATTEST (TM) SUPER RADID READOUT STEAM CHALLENGE PACK 3M ATTEST(TM) SUPER RAPID 5 STEAM-PLUS CHALLENGE PACK (K121593)3M Company2013-03-15
BONOS R 1X20, BONOS R 2X20, BONOS R 1X40, BONOS R 2X40, BONOS R 1X60 (K123225)Aap Biomaterials GmbH & Co. KG2013-03-15
RANGE + QUALICHECK LEVEL 1, RANGE + QUALICHECK LEVEL 2, RANGE + QUALICHECK LEVEL 3 (K130236)Radiometer Medical Aps2013-03-15
TVC IMAGING SYSTEM MODEL NIRS-MC7-70 (K123108)Infraredx, Inc.2013-03-15
FEM-FELX, FEX-FLEX II FEMORAL ACCESS CANNULA WITH DURAFLO COATING (K123298)Edwards Lifesciences, LLC2013-03-15
MEDELA THOPAZ (K130210)Medela AG2013-03-15
SUPER SANI-CLOTH/ ACCU-CHEK INFORM II SYSTEM (K130138)Roche Diagnostics Corp.2013-03-15
GALILEOS FAMILY (K123070)Sirona Dental Systems GmbH2013-03-15
X-FIX DYNAMIC EXTERNAL DISTRACTOR (K122415)Arex USA, LLC2013-03-15
EASYCARE ONLINE (K123557)Resmed, Ltd.2013-03-14
CATALYST II AND III (K130124)Cardiva Medical, Inc.2013-03-14
FASTEP AT-HOME PREGNANCY, HCG, OVER THE COUNTER (K122907)Polymed Therapeutics, Inc.2013-03-14
SMARTGUARD NIGHT GUARD, SMARTGUARD ORIGINAL, SMARTGUARD NIGHT GUARD ORIGINAL, SMARTGUARD ELITE (K123161)Smartguard, Inc.2013-03-14
FACEFIT AND FACEFIT PORTED NON-INVASIVE VENTILATION MASKS (K121747)Intersurgical Incorporated2013-03-14
RESOLUTIONMD MOBILE 3.1 MODEL RMD-MOB-31 (K123186)Calgary Scientific, Inc.2013-03-14
VERSAPORT V2 BLADELESS OPTICAL TROCAR (K130435)Covidien, Formerly US Surgical A Divison of Tyco H2013-03-14
IMMULITE 1000 THIRD GENERATION PSA CALIBRATION VERIFICATION MATERIAL (K122534)Siemens Healthcare Diagnostics, Inc.2013-03-14
NIDEK RS-3000 (K121622)Nidek Co., Ltd.2013-03-14
STA- COAG CONTROL (N+ABN) PLUS (K120014)Diagnostica Stago, Inc.2013-03-14
NANOTACK SUTURE ANCHOR 1.4MM WITH FLEX INSERTER (K130351)Pivot Medical, Inc.2013-03-14
CHINA NAILS AND ACCESSORIES (K123948)Smith & Nephew, Inc.2013-03-14
NEXSITE HD HEMODIALYSIS CATHETER FOR LONG TERM USE (28CM) NEXSITE HD HEMODIALYSIS CATHETER FOR LONG TERM USE (24CM) (K121933)Marvao Medical Devices, Ltd.2013-03-14
ELLIPSE OCCIPITO-CERICO-THORACIC SPINAL SYSTEM AND CAPITOL IMPLANTS (K123783)Globus Medical, Inc.2013-03-14
PARAGON HIP SYSTEM (K123782)Global Manufacturing Technology2013-03-14
BEGOPAL+ (K123929)Bego Bremer Goldschlaegerei Wilh. Herbst GmbH & CO2013-03-14
MICROSCAN DRIED GRAM-POSITIVE MIC/COMBO PANELS - CEFTAROLINE (K123933)Siemens Healthcare Diagnostics, Inc.2013-03-14
EZ GLIDE AORTIC CANNULA, AORTIC PERFUSION CANNULA WITH DURAFLO COATING, DISPERSION AORTIC PERFUSION CANNULA (K123370)Edwards Lifesciences, LLC2013-03-13
ORALID (K123169)Forward Science, LLC2013-03-13
CAPIX RX HOLLOW FIBER OXYGENATOR WITH/WITHOUT HARDSHELL RESERVOIR (K130333)Terumo Cardiovascular Systems Corp.2013-03-13
CAPIOX FX HOLLOW FIBER OXYGENATOR W/ RESERVOIR (K130280)Terumo Corporation2013-03-13
BIOGENESIS IMPLANT SYSTEM (K120089)Biogenesis Co., Ltd.2013-03-13
K SERIES CPAP SYSTEMS (K123897)Curative Medical, Inc.2013-03-13
INSIGNIA WITH ITERO (K123416)Ormco Corp.2013-03-13
CAPIOX RX05 HOLLOW FIBER OXYGENATOR/RESERVOIR (K130493)Terumo Corporation2013-03-13
VISIOFOCUS (K122412)Tecnimed S.R.L.2013-03-13
CAPIOX SX18 HOLLOW FIBER OXYGENATOR WITH DETACHABLE HARDSHELL RESERVOIR, CAPIOX SX25 HOLLOW FIBER OXGENATOR WITH DETACHA (K130359)Terumo Cardiovascular Systems Corp.2013-03-13
PULMOSAL (K130091)Pharmacaribe2013-03-13
CAPIOX FX15 AND FX25 HOLLOW FIBER OXYGENATOR/RESERVOIR (K130520)Ashitaka Factory of Terumo Corp.2013-03-13
NOBELPROCERA TI ABUTMENT CAMLOG PLATFORMS (K122602)Nobel Biocare AB2013-03-13
NUVON VITALS CHARTING SYSTEM (K130234)Nuvon, Inc.2013-03-13
AUTOMATED IN VITRO QUANTITATIVE ASSAY FOR THE MEASUREMENT OF ALLERGEN SPECIFIC IGE ANTIBODIES (K121156)Phadia AB2013-03-13
NAVIGATOR DELIVERY SYSTEM (NAVIGATOR DS) (K124053)Carticept Medical, Inc.2013-03-13
ESOPHAGUS BOUGIE SET (K130251)Varian Medical Systems, Inc.2013-03-13
OPTIMA MR450W (K123522)Ge Healthcare (Ge Medical Systems, LLC)2013-03-13
GETINGE 400HC-E / SERIES STEAM STERILIZER (K122071)Getinge Sourcing, LLC2013-03-12
S4 SPINAL SYSTEM (K123939)Aesculap Implant Systems, Inc.2013-03-12
DIGITAL FLAT PANEL X-RAY DETECTOR / 1012WCA (K123345)Rayence Co., Ltd.2013-03-12
SOPROCARE (K121685)Sopro2013-03-12
ZIMMER NEXEL TOTAL ELBOW (K123862)Zimmer, Inc.2013-03-12
RAYSCAN A-EXPERT 3D (K122981)Ray Co., Ltd.2013-03-12
SYNGO, CT BONE READING (K123584)Siemens Medical Solutions USA, Inc.2013-03-12
HEARSTART MRX WITH AIRWAY CONFIMRATION ASSIST (K130153)Philips Medical Systems2013-03-12
IODOFOAM IODOPHOR FOAM DRESSING (K122634)Progressive Wound Care Technologies, LLC2013-03-12
PERKINELMER 226 SAMPLE COLLECTION DEVICES (K121864)Perkinelmer, Inc.2013-03-12
MEMORY METAL STAPLES, EASYCLIP (K122113)Stryker Corp.2013-03-12
DIGITAL AUTOMATIC BLOOD PRESSURE MONITOR BPM03 SERIES MODEL MD03X0 (K123073)Grandway Technology (Shenzhen) Limited2013-03-11
STEREOS WORKSTATION (K130395)Eos Imaging, Inc.2013-03-11
SURFACE APPLICATOR SET WITH LEIPZIG-STYLE CONE (K123815)Varian Medical Systems, Inc.2013-03-11
DX-D IMAGING PACKAGE (K122736)Agfa Healthcare N.V.2013-03-11
AAP RADIUS SET 2.5 (K123875)Aap Implantate AG2013-03-11
PICCOLO LACTATE TEST SYSTEM (K130113)Abaxis, Inc.2013-03-11
SILEX SACROILIAC JOINT FUSION SYSTEM (K123702)X-Spine Systems, Inc.2013-03-11
DISCOVERY TMAX MANUAL WHEELCHAIR (K113164)Otto Bock Healthcare LP2013-03-11
SOLARYS VENTILATOR AEROSOL DELIVERY SYSTEM (AS) (K123614)Trudell Medical Intl.2013-03-11
CS-MAG II (K121825)Biomagnetik-Park GmbH2013-03-11
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