Atlas FDA

2017

3,200 FDA 510(k) clearances · Clearance year

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RecordFirmDate
Cardinal Health Sterilization Wrap (K161910)Cardinal Health200, LLC2017-04-20
Sniper Staple System (K162354)Trilliant Surgical, Ltd.2017-04-20
PENTAX Medical ENT Video Imaging System (K162151)Pentax of America, Inc.2017-04-20
QiF Blood and Fluid Warmer (K163708)Quality IN Flow , Ltd.2017-04-20
Ax Stand-Alone ALIF System (K162236)Innovasis, Inc.2017-04-20
DC-70/DC-70T /DC-70 Pro/DC-70 Exp/DC-75/DC-78/DC-70S Diagnostic Ultrasound System (K163690)Shenzhen Mindray Bio-Medical Electronics Co., Ltd.2017-04-20
SlimShape System (K163415)Syneron Medical, Ltd.2017-04-20
BeneVision Central Monitoring System (K162607)Shenzhen Mindray Bio-Medical Electronics Co., Ltd.2017-04-20
Ross Ru Wound Dressing Gel (K162017)Biotd S.A.2017-04-20
GREENS BRAND Locking Bone Plates and Screws Osteosynthesis Plating System, GREENS BRAND Of DHS/Dynamic Condylar Plate Plating System (K163383)Greens Surgicals Pvt. , Ltd.2017-04-19
LaserDock, HolmiumDock, CO2Dock,OmniDock, KTPDock (K170215)Patient Pocket, LLC2017-04-19
Ortho System (K161884)3Shape A/S2017-04-19
TEG 6s Hemostasis System (K160502)Haemonetics Corporation2017-04-19
Stellaris Elite vision enhancement system (K170052)Bausch+Lomb2017-04-19
VisioFocus Mini, VisioFocus Smart (K160680)Tecnimed S.R.L.2017-04-19
Finapres Nova Noninvasive Hemodynamic Monitor (K160967)Finapres Medical Systems B.V.2017-04-18
NovoGro (K162087)Osteonovus, Inc.2017-04-18
EndoRotor (K170120)Interscope, Inc.2017-04-18
Mako Total Hip Application (K170593)Mako Surgical Corp.2017-04-18
Lacriflow CL (K170247)Kaneka Pharma America, LLC2017-04-18
Diazyme Procalcitonin (PCT) Assay, Diazyme Procalcitonin (PCT) Calibrator Set, Diazyme Procalcitonin (PCT) Control Set (K162297)Diazyme Laboratories2017-04-18
ECHELON CIRCULAR Powered Stapler (K163523)Ethicon Endo-Surgery, LLC2017-04-18
OmniPod Insulin Management System (K162296)Insulet Corporation2017-04-18
PICO Single Use Negative Pressure Wound Therapy System (K163387)Smith & Nephew Medical Limited2017-04-18
Plato MICROCATH 27B Microcatheter (K170406)Scientia Vascular, LLC2017-04-18
Model 330 Multifunction Aspirator (K170533)ZOLL Medical Corporation2017-04-18
Invacare Tracer SX5 Manual Wheelchair, Invacare Tracer IV Heavy Duty/Extra Wide Manual Wheelchair (K162621)Invacare Corporation2017-04-17
Pressio 2 ICP Monitoring System (K162108)Sophysa SA2017-04-17
EndoFLIP® System with FLIP Topography module (K170833)Crospon, Ltd.2017-04-17
Paxman Scalp Cooler (K163484)Paxman Coolers Limited2017-04-17
Soft Plug Extended Duration 180 Canalicular Plug (K162361)Oasis Medical, Inc.2017-04-17
PowerFlow Apheresis I.V. Port (K163001)C.R. Bard, Inc.2017-04-17
CeraClean (K163171)Bisco, Inc.2017-04-14
Saf-T-Vac Smoke and Fluid Evacuator (K170582)Surgical Technology Laboratories, Inc.2017-04-14
CENTURION Vision System (Active SentryTM) (K161794)Alcon Research, Ltd.2017-04-14
Interbody Fusion (IBF)/Vertebral Body Replacement (VBR) System (K170643)Rti Surgical, Inc. Dba Rti Biologics2017-04-14
Velox Nebulizer System (K162785)Pari Respiratory Equipment, Inc.2017-04-14
Smart Dongle Blood Glucose Monitoring System (K162382)Taidoc Technology Corporation2017-04-14
Fortress™ Pedicular Fixation System (K170268)Spineology, Inc.2017-04-14
HemoSphere Advanced Monitor, HemoSphere Swan-Ganz Module, HemoSphere Oximetry Cable (K163381)Edwards Lifesciences, LLC2017-04-14
Sofia Influenza A+B FIA on Sofia 2 (K162438)Quidel Corporation2017-04-14
Threshold™ V2 Pedicular Fixation System (K170255)Spineology, Inc.2017-04-14
Complete Control System (K162891)Coapt, LLC2017-04-14
Navigated ELEVATE Inserter, Navigated Disc Prep Instruments (K163581)Medtronic Sofamor Danek USA, Inc.2017-04-14
Hoffmann LRF System (K163656)Stryker GmbH2017-04-14
Marco Ultra M3, Marco Ultra M4 (K162636)Takagi Seiko Co., Ltd.2017-04-14
gammaCore Non-invasive Vagus Nerve Stimulator (DEN150048)Electrocore, LLC2017-04-14
Pulsaderm Wrinkle Mask 28, Pulsaderm Wrinkle Mask 72 (K163329)Pulsaderm, LLC2017-04-14
Palisade™ Pedicular Fixation System (K170266)Spineology, Inc.2017-04-14
Threshold™ Pedicular Fixation System (K170251)Spineology, Inc.2017-04-14
Electronic Pulse Stimulator Model: PL-029K12 and PL-029K13 (K162517)Jkh Health Co., Ltd.2017-04-14
GMK UNI (K161741)Medacta International S.A.2017-04-14
Etgar Dental Implant System (K161743)Etgar Medical Instruments, Ltd.2017-04-14
Coolief* Cooled RF Probe (K163461)Halyard Health, Inc.2017-04-13
Interson USB Ultrasound System (K163443)Interson Corporation2017-04-13
CAPRI Corpectomy Cage System (K170055)K2m2017-04-13
MICATM Screw System (K162353)Wrightmedicaltechnologyinc2017-04-13
Patient Positioning System (K170502)Forte Automation Systems, Inc.2017-04-13
Additive Orthopaedics Locking Lattice Plate (K170214)Additive Orthopaedics, LLC2017-04-13
Endoskeleton(R) TAS Interbody Fusion Device / Endoskeleton(R) TAS Hyperlordotic Interbody Fusion Device (K163269)Titan Spine, LLC2017-04-13
PlasmaBlade T (K170610)Medtronic Advanced Energy2017-04-13
Intelli-Ox (K161179)Air Liquide Healthcare America Corporation2017-04-13
PENTAX Medical Endoscopic Ultrasound System, EG-3270UK Upper G.I. Video Scope (Convex Array Type) with EPK-i5010 Video Processor and HI VISION Preirus Ultrasound Scanner (K162447)Pentax of America, Inc.2017-04-13
Philips IntelliSite Pathology Solution (DEN160056)Philips Medical Systems Nederland B.V.2017-04-12
BD Ultra-Fine™ Insulin Syringe, BD Ultra-Fine™ II Insulin Syringe, BD Insulin Syringes with the BD Ultra-Fine™ needle and BD Insulin Syringes with Micro-Fine™ IV Needle (K170386)Becton Dickinson & Company2017-04-12
HIGH V+ (K161114)Teknimed Sas2017-04-12
Depth Electrodes, Foramen Ovale Depth Eletrodes, Marco-Micro Depth Electrodes, Spencer Probe Depth Electrodes (K163355)Ad-Tech Medical Instrument Corporation2017-04-12
OptiFix Open Absorbable Fixation System - 20 absorbable fasteners (K163698)C.R. Bard, Inc.2017-04-11
Nova Max Uric Acid Monitoring System (K160990)Nova Biomedical Corporation2017-04-11
MaxxiGold Electrode 48, MaxxiGold Electrode 60, MaxxiGold Electrode 96 (K163547)Neurovirtual USA, Inc.2017-04-11
Carestream Vue PACS (K170580)Carestream Health, Inc.2017-04-11
HAAG-STREIT FUNDUS MODULE 300 (K163021)Optomed OY2017-04-11
REMbrandt (K163617)Embla Systems2017-04-11
LOGIQ S8 (K170445)GE Healthcare2017-04-11
MINNE TIES MMF Suture System (K162046)Summit Medical, Inc.2017-04-11
CyberKnife Treatment Delivery System (K170788)Accuray Incorportaed2017-04-11
Bausch + Lomb Sensitive Eyes Plus Saline Solution (K170483)Bausch & Lomb, Incorporated2017-04-11
i-Stat Alinity System with i-Stat Glucose test (K163271)Abbott Point of Care, Inc.2017-04-10
ARROW Anatomical Porous glenoid (K162068)Fournitures Hospitalieres Industrie2017-04-10
VORTRAN GO2VENT (K162968)Vortran Medical Technology 1, Inc.2017-04-10
Keos Lumbar IBFD (K163386)Keos2017-04-10
Alere BinaxNOW Influenza A & B Card 2, Alere Reader, Alere BinaxNOW Influenza A & B Card 2 Control Swab Kit (K162642)Alere Scarborough, Inc.2017-04-10
Comfort EC710 (K163192)Alltech Medical Systems America, Inc.2017-04-10
geko™ T-2 and geko™ Plus R-2 Neuromuscular Stimulators (K163125)Firstkind Limited2017-04-10
MEDICAL DIODE LASER SYSTEMS (K160549)Wuhan Gigaa Optronics Technology Co., Ltd.2017-04-07
Philips iCT CT System (K162838)Philips Medical Systems (Cleveland), Inc.2017-04-07
ORTHOPANTOMOGRAPH OP 3D (K170813)Palodex Group OY2017-04-07
ANTHEM™ Fracture System (K163361)Globus Medical, Inc.2017-04-07
Spectranetics Turbo-Elite Laser Atherectomy Catheters (K170059)Spectranetics, Inc.2017-04-07
LED Curing Light (K152192)Monitex Industrial Co., Ltd.2017-04-07
RX Takeru Balloon Dilatation Catheter (K163372)KANEKA Corporation2017-04-07
Disposable Endotracheal tube, sterile, AccuCuff (K160694)Tianjin Medis Medical Device Co., Ltd.2017-04-07
gke Steri-Record Steam Mini-Bio-Plus self-contained biological indicator (SCBI) (K163144)Gke-GmbH2017-04-07
ZeroWire Mobile (K170598)Nds Surgical Imaging, LLC2017-04-07
VOCSN Unified Respiratory System (K162877)Ventec Life Systems, Inc.2017-04-07
NeuroBlate System (K170724)Monteris Medical,2017-04-07
Kepler II (K163265)Orbbo Surgical, LLC2017-04-07
CORE M2 Vascular System (K170385)Volcano Corporation2017-04-06
PRECICE UNYTE CoCr System (K162927)Nuvasive Specialized Orthopedics, Inc.2017-04-06
Huvitz Imaging System (K161829)Huvitz Co., Ltd.2017-04-06
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Every clearance here is in the API, with alerts when new ones post.