Atlas FDA

2015

3,020 FDA 510(k) clearances · Clearance year

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RecordFirmDate
Sensis (K150493)Siemens Medi Cal Solutions, Inc.2015-06-30
Modular Power Positioning System (K150574)Motion Concepts2015-06-30
Aneroid Sphygmomanometer (K151246)Jiaxing Zhongfa Medical Products Co., Ltd.2015-06-30
Artemis Hand Held Imaging System (K143474)Quest Medical Imaging2015-06-30
Disposable Blood Pressure Cuff, Reusable Blood Pressure Cuff (K151290)Xuzhou Maicuff Technology Co., Ltd.2015-06-30
AGE Automatic Wrist Blood Pressure Monitor (K151281)Dongguan Ageless Health Industrial Co., Ltd.2015-06-30
The UltraPulse system (UltraPulse and UltraPulse DUO models,members of the modified Lumenis Family of UltraPulse SurgiTouch (K151331)Lumenis, Ltd.2015-06-30
ASAHI Peripheral Guide Wire Series (ASAHI Gladius, ASAHI Halberd, ASAHI Gaia PV) (K150445)Asahi Intecc Co., Ltd.2015-06-30
GENESIS (K151485)Dornier Medtech America, Inc.2015-06-30
AUXEIN BRAND OF Bone Plates and Bone Screws & AUXEIN Brand of DCS Plate System AUXEIN brand of Locking Plates and Locking Screws (K141680)Auxein Medical2015-06-30
Lineum OCT Spine System (K151224)Biomet Spine2015-06-30
Besmed Reusable Jet Nebulizer (K150591)Besmed Health Business Corp2015-06-30
Vitalograph Model 6600 Compact (K142642)Vitalograph (Ireland) , Ltd.2015-06-30
Immunalysis Benzoylecgonine Urine Enzyme Immunoassay, Immunalysis Benzoylecgonine Urine Calibrators, Immunalysis Benzoylecgonine Urine Control Set (K150925)Immunalysis Corporation2015-06-29
NOVA Dental Implants System (K150363)Nova Implants , Ltd.2015-06-29
AeroDR SYSTEM 2 (K151465)Konica Minolta, Inc.2015-06-29
Airway with Bite Block and Tongue Depressor 80 mm, Airway with Bite Block and Tongue Depressor 90 mm (K150518)Dupaco, Inc.2015-06-29
First Sign Drug of Abuse Dip Card Test, First Sign Drug of Abuse Cup Test (K151441)W.H.P.M., Inc.2015-06-29
Stryker ICONIX with Needles (K151201)Stryker2015-06-29
Vitalograph Model 6800 Pneumotrac (K142812)Vitalograph (Ireland) , Ltd.2015-06-29
TRAUS ENDO (K143411)Saeshin Precision Co., Ltd.2015-06-29
BioZorb Marker (K143484)Focal Therapeutics2015-06-29
Dunamis Force DFX Suture, Size 5, Dunamis Force DFX Suture Size 2 (K150327)Dunamis, LLC2015-06-29
FILAO NC RX PTCA DILATATION CATHETER (K141933)Natec Medical , Ltd.2015-06-28
Proteus Digital Health Feedback Device (K150494)Proteus Digital Health, Inc.2015-06-27
Freedom Cementless Femoral Component (K150680)Maxx Orthopedics, Inc.2015-06-26
Arrow Epidural Catheter Kit (K143581)Teleflexmedical, Inc.2015-06-26
CapLOX II/TowerLOX Pedicle Screw System (K151116)Captiva Spine2015-06-26
CORA (Coagulation Resonance Analysis) System (K150041)Coramed Technologies, LLC2015-06-26
XENOMEM WOUND MATRIX (K140820)Viscus Biologics, LLC2015-06-26
Plato MICROCATH 27B Microcatheter (K143398)Scientia Vascular, LLC2015-06-26
ADH 200 Analyzer Software (K143449)Adams Meditech, LLC2015-06-26
Nacera Pearl (K143071)Doceram Medical Ceramics GmbH2015-06-26
JiveX (K142750)Visus Technology Transfer GmbH2015-06-26
Biomet Orthopaedic Salvage System (OSSTM) - Proximal Femoral & Hybrid Tibial (K142814)Biomet Manufacturing, LLC2015-06-25
Philips IntelliVue MP2/MP5/MPSC Patient Monitors, Philips IntelliVue X1 and X2 multi-msrmt-modules for use with IntelliVue patient monitors (K150975)Philips Medizin Systeme Boeblingen GmbH2015-06-25
aeris Balloon Dialation Catheter (K150951)Bryan Medical, Inc.2015-06-25
Droplet Pen Needles (K143437)Htl-Strefa S.A2015-06-25
Alvision Interventional Cardiology Diagnostic Catheter, Alvicath Endovascular Diagnostic Catheters (K143604)Alvimedica Tibbi Urunler Sanayi VE Dis Ticaret A.S2015-06-25
MEDIHONEY WOUND DRESSINGS (K133279)Derma Sciences, Inc.2015-06-25
Ophthalmed Bending Laser Probes (K142830)Ophthalmed, LLC2015-06-25
K-Pack II Needle - 29G x 5/16 Thin Wall (K151398)Terumo Europe N.V.2015-06-25
CRYOCARE CS SURGICAL SYSTEM (K141110)Healthtronics2015-06-25
DuraSheath Introducer Sheath System (K142357)Contract Medical International, GmbH2015-06-25
Zimmer Patient-Specific Abutment, Internal Hex, Titanium (K143505)Zimmer Dental, Inc.2015-06-25
ALIF Interfixated System (K151214)Nu Vasive, Incorporated2015-06-25
GSI TympStar Pro Middle Ear Analyzer (K151509)Diagnostic Group, Dba Grason-Stadler2015-06-25
Reprocessed LigaSure ImpactTM Curved, Large Jaw, Open Sealer/Divider (K150538)Stryker Sustainability Solutions2015-06-25
0.018 Arrow GPSCath Balloon Dilatation Catheter (150 cm) (K143093)Hotspur Technologies, Inc.,2015-06-24
STALIF C; STALIF C-Ti (K150053)Centinel Spine, Inc.2015-06-24
Plus Surgical Gowns (EO Sterilized), PMGB-XXX (K133075)Foshan Nanhai Plus Medical Co, Ltd.2015-06-24
VariAx 2 Wrist Fusion System (K151178)Stryker Trauma AG2015-06-24
Virage OCT Spinal Fixation System (K151031)Zimmer Spine, Inc.2015-06-24
GALAXY MIS Screw System (K143110)Bm Korea2015-06-24
Carestream DRX-1 System (K150766)Carestream Health, Inc.2015-06-24
MEDIKRO SPIROSTAR, M929 Medikro Spirostar USB and M921 Medikro SpiroStar DX (K120577)Medikro OY2015-06-24
Plus Surgical Drapes (EO Sterilized), PMDB-XXX (K133080)Foshan Nanhai Plus Medical Co, Ltd.2015-06-24
Habib EUS RFA (K150029)Emcision , Ltd.2015-06-24
Stryker Universal Neuro III System: UN III AXS Screw, UN III AXS Screwdriver Blade (K151387)Stryker2015-06-24
VICTUS Femtosecond Laser Platform (K151161)Technolas Perfect Vision GmbH2015-06-24
Progressive Orthopaedic Total Knee System (K150783)The Progressive Orthopaedic Company, LLC2015-06-23
Merits Yoga Power Scooter, S542 (K142912)Merits Health Products Co., Ltd.2015-06-23
Henschke Titanium Applicator Set (K151272)Nucletron B.V.2015-06-23
GF50A (K151419)Samsung Electronics Co., Ltd.2015-06-23
Fill-Up! (K150218)Coltene/Whaledent AG2015-06-23
Jade 37% Phosphoric Acid Etchant Gel (K150696)Dharma Research, Inc.2015-06-23
ASAHI Corsair Microcatheter (K151103)Asahi Intecc Co., Ltd.2015-06-23
DiscoverEEG System, Model DE-401 (K142834)Neurowave Systems, Inc.2015-06-23
Kubtec DIGIVIEW 395 (K151221)Kub Technologies, Inc.2015-06-23
Ontex Unscented Tampons with Colored Plastic Applicators (K142786)Ontex Bvba2015-06-23
ESOPHAGEAL COOLING DEVICE (DEN140018)Advanced Cooling Therapy, LLC2015-06-23
Flowtron ACS900 (K143438)Getinge (Suzhou) Co., Ltd.2015-06-23
Solana GAS Assay, Solana instrument (K150868)Quidel Corporation2015-06-23
SMV Scientific Bone Screws (K150981)Smv Scientific2015-06-23
Digi-One (K143476)Rimed , Ltd.2015-06-23
Dental Bone Cutting Instruments (K150796)Synthes (USA) Products, LLC2015-06-23
syngo.via MI Workflows (K151192)Siemens Medical Solutions USA, Inc.2015-06-23
LiverMultiScan (K143020)Mirada Medical, Ltd.2015-06-23
iNSIGHT Color Doppler Ultrasound System (K150002)Saset (Chengdu), Inc.2015-06-23
MIDSLEEVE (K142548)Medical Innovation Development2015-06-23
VISCO SOFT CONTACT LENS (K141348)Visco Vision, Inc.2015-06-22
LIASON 1-84 PTH Assay, LIASON 1-84 PTH Control Set, LIASON 1-84 PTH Calibration Verifiers (K150879)DiaSorin, Inc.2015-06-22
Instru-Safe Instrument Protection System (K150540)Summit Medical, Inc.2015-06-22
SURGICAL FACE MASK (Ear Loops and Tie-on) (K133070)Bh Medical Products Co., Ltd.2015-06-22
uNion Cervical Plate System (K150666)Ulrich Medical USA2015-06-22
Life Fast Set, Life Regular Set (K150559)Sybron Dental Specialties2015-06-19
Propeller Model 2014-D Sensor (K143671)Reciprocal Labs2015-06-19
SPEC Model M16 (K150895)Source Production and Equipment Co., Inc.2015-06-19
Arthrex FiberTak Anchors (K151230)Arthrex, Inc.2015-06-19
Elevate Moisturizing Spray (K150074)Elevate Oral Care2015-06-19
NEURON-SPECTRUM-4/P WITH NEURON-SPECTRUM.NET SOFTWARE (K133995)Neurosoft , Ltd.2015-06-19
Px PEEK IBF System (K150500)Innovasis, Inc.2015-06-19
XLR8 PLUS (XLR8+) (K143726)Genadyne Biotechnologies, Inc.2015-06-19
miraDry System MD4000 (K150419)Miramar Labs, Inc.2015-06-19
PRECICE Intramedullary Limb Lengthening System (K151131)Ellipse Technologies, Incorporated2015-06-19
PreludeEASE Hydrophilic Sheath Introducer (K150257)Merit Medical Systems, Inc.2015-06-19
Tissue Removal Pouch (K150781)Boehringer Laboratories, LLC2015-06-19
ZIO SR ECG Monitoring Service (K143513)iRhythm Technologies, Inc.2015-06-19
BRAINPORT V100 DEVICE (DEN130039)Wicab, Inc.2015-06-18
iPulse Smooth Skin Gold Hair Removal System (K143003)Ipulse Limited2015-06-18
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Track 2015 automatically

Every clearance here is in the API, with alerts when new ones post.