Atlas FDA

2017

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

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RecordFirmDate
Sterile Nitrile Surgical Gloves, Powder-free (K170515)Primus Gloves Pvt Limited2017-06-09
JAZZ System, including JAZZ Band (K170730)Implanet, S.A.2017-06-09
PRECICE Intramedullary Limb Lengthening System (K170169)Nuvasive Specialized Orthopedics, Inc.2017-06-09
Diamondback 360 Peripheral Orbital Atherectomy System (K170792)Cardiovascular Systems, Inc.2017-06-09
syngo Application Software (K170747)Siemens Medical Solutions USA, Inc.2017-06-09
YES oil-based Personal Lubricant, YES Water-based Personal Lubricant, YES Vaginal Moisturizer (K162569)Biotech Lubricants, Ltd.2017-06-09
ASTRA TEE Transesophageal Probe Reprocessor, ASTRA VR Endovaginal/Endorectal Probe Reprocessor (K163313)CIVCO Medical Instruments Co., Inc.2017-06-09
ePlex Instrument (K163652)Genmark Diagnostics, Incorporated2017-06-09
ePlex Respiratory Pathogen Panel (K163636)Genmark Diagnostics, Incorporated2017-06-09
2-Piece Hammertoe Correction System (K162685)Life Spine, Inc.2017-06-09
1717SCC_127um and 1717SCC_140um (K171420)Rayence Co., Ltd.2017-06-09
iVue (K163475)Optovue, Inc.2017-06-09
Cardinal Health Non-Reinforced Surgical Gown (K170762)Cardinal Health200, LLC2017-06-09
Wingman 14C Crossing Catheter (K170996)Reflow Medical, Inc.2017-06-09
CompuFlo Epidural Computer Controlled Anesthesia System (K161883)Milestone Scientific, Inc.2017-06-09
Vibrance Pelvic Trainer (K162689)Bioinfinity (M) Sdn. Bhd.2017-06-08
SYNTEC HUMERAL NAIL SYSTEM (K161327)Syntec Scientific Corporation2017-06-08
Quingo Flyte Mobility Scooter (K171256)Agile Distributors, LLC2017-06-08
Laser Peripherals, LLC Family of Bare Laser Fibers (K170366)Laser Peripherals, LLC2017-06-08
UTF Stem, reduced, #0, #00 (K163193)United Orthopedic Corporation2017-06-08
Accuray Precision Treatment Planning System (K171086)Accuray Incorporated2017-06-08
Novosyn Quick Absorbable Suture (K170661)Aesculap, Inc.2017-06-08
Gentrix Surgical Matrix Thick; Gentrix Surgical Matrix Extend (K170763)Acell, Inc.2017-06-08
NEXA Negative Pressure Wound Therapy System (K162610)Nexa Medical , Ltd.2017-06-08
Sorin Connect (K170460)Sorin Group Deutschland GmbH2017-06-08
INVISIKNOT Ankle Syndesmosis Repair Kit (K162996)Smith & Nephew, Inc.2017-06-08
Intraskan DC Plus (K170967)Skanray Technologies Private Limited2017-06-08
Valiant Curing Light (K170101)Inter-Med/Vista Dental Products2017-06-08
Trifore(tm) Cervical Plating System (K171112)Neurostructures, Inc.2017-06-08
ASD Oral Appliances (K163580)American Sleep Dentistry2017-06-08
ChoiceSpine™ Proliant® Posterior Pedicle Screw and Hook Fixation System (K170821)Choicespine, LP2017-06-08
Continuous Single Culture -NX (CSCM-NX) (K170681)Irvine Scientific Sales Co., Inc.2017-06-08
NuVasive CoRoent Small Interlock II System (K170961)Nu Vasive, Incorporated2017-06-08
Vitrea Software Toshiba Package; VSTP-001A (K171222)Toshibamedical Systems Corporation2017-06-08
BiZact Tonsillectomy Device Advanced Bipolar Tissue Sealer/Divider (K171066)Covidien, LLC2017-06-08
Vantage Titan 1.5T, MRT-1510, M-Power GX (K170412)Toshibamedical Systems Corporation2017-06-07
CMDR 2ST (Multiple Models), CMDR 2SPE (Multiple Models), Integris (K171353)Minxray, Inc.2017-06-07
HySil Impression Materials (K170736)Osstem Implant Co., Ltd.2017-06-07
Venture 038 catheter (K171335)Vascular Solutions, Inc.2017-06-07
Kwart Retro-Inject Ureteral Stent (K162109)Cook Incorporated2017-06-07
SurgiMend PRS Meshed, Revize-X (K171357)Integra Lifesciences Corporation (Owner of Tei Biosciences)2017-06-07
StentBoost Live (K170144)Philips Medical Stystems Nederland BV2017-06-07
Liofilchem MIC Test Strip (MTS)- Clindamycin 0.016 - 256 µg/mL (K170772)Liofilchem s.r.l.2017-06-07
SmartTarget (K170250)Smarttarget, Ltd.2017-06-07
Medisign GH81 Blood Glucose Monitoring System, Medisign GH82 Blood Glucose Monitoring System, Medisign GH83 Blood Glucose Monitoring System, Medisign GH81 BT Blood Glucose Monitoring System, Medisign GH82 BT Blood Glucose Monitoring System, Medisign GH83 BT Blood Glucose Monitoring System (K162564)Tianjin Empecs Medical Device Co., Ltd.2017-06-07
MRIdian Linac System with 138-leaf Collimator (K170751)Viewray, Incorporated2017-06-07
Cochlear Baha SoundArc (K171088)Cochlear Americas2017-06-07
Digital Automatic Blood Pressure Monitor MD3600 (K163679)Grandway Technology (Shenzhen) Limited2017-06-07
OneTouch Via On-Demand Insulin Delivery System (K163357)Lifescan Europe, A Division of Cilag GmbH2017-06-07
Straumann Variobase Abutments (K170356)Institut Straumann AG2017-06-07
Insulin Algorithms System (K160673)Insulin Algorithms2017-06-07
Straumann Variobase Abutments (K170354)Institut Straumann AG2017-06-07
Continuous Single Culture-NX Complete (CSCM-NXC) (K170602)Irvine Scientific Sales Co., Inc.2017-06-07
Advanced Perfusion System 1 (K163531)Terumo Cardiovascular Systems Corporation2017-06-07
E. HISTOLYTICA QUIK CHEK (K170728)Techlab, Inc.2017-06-07
Bi-Funnel and Tri-Funnel Gastrostomy Feeding Tubes with ENFit Connection, Entuit Gastrostomy BR Balloon Retention Feeding Tube with ENFit Connection (K171347)Xeridiem Medical Devices2017-06-06
Digital Thermometer (K163603)Guangzhou Jinxinbao Electronic Co., Ltd.2017-06-06
Inclusive Titanium Abutments compatible with: MegaGen AnyRidge Implant System (K170044)Prismatik Dentalcraft, Inc.2017-06-06
CURVE Laser System (K170709)Yolo Medical, Inc.2017-06-06
Flower Bone Screw Set (K170687)Flower Orthopedics Corporation2017-06-06
Magnetic Surgical System (K171429)Levita Magnetics International Corp2017-06-06
Altomed Malhotra Platinum Segments (K170591)Altomed Limited2017-06-06
EK12 Algorithm (K170155)Ge Medical Systems Information Technologies, Inc.2017-06-06
MOVES SLC (K161420)Thornhill Research, Inc.2017-06-06
SonoBook Series Diagnostic Ultrasound System (K170374)Chison Medical Imaging Co., Ltd.2017-06-06
QT Ultrasound Breast Scanner-1 (K162372)Qt Ultrasound, LLC2017-06-06
LiDCOunity v2 Hemodynamic Monitor (K163334)Lidco, Ltd.2017-06-05
Revolution ACT (K171013)Ge Hangwei Medical Systems Co., Ltd.2017-06-05
APVolution System (K163228)Aesthetic-Press, LLC2017-06-05
ElectroTek (K170441)Mobilemedtek2017-06-05
KeraStat(R) Gel (K162759)Keranetics, LLC2017-06-02
MP DOA-10 Panel Test Cup, MP DOA-11 Panel Test Cup (K162395)Mp Biomedicals, LLC2017-06-02
Reprocessed Agilis NxT Steerable Introducer (K170311)Innovative Health, LLC2017-06-02
TELIX K Interbody System (K170890)Biedermann Motech GmbH & Co. KG2017-06-02
Acuity 85 (Oprifocon A) Rigid Gas Permeable Contact Lens (K170001)Acuity Polymers, Inc.2017-06-02
Dynamic Coronary Roadmap (K170130)Philips Medical Systems Nederland B.V.2017-06-02
Closed Male Luer (K171101)Yukon Medical2017-06-02
Zio AT ECG Monitoring System (K163512)iRhythm Technologies, Inc.2017-06-02
OrthoButton AL (K171060)Riverpoint Medical2017-06-02
Talos® Lumbar (HA) PEEK IBF Devices (K170395)Meditech Spine, LLC2017-06-02
LS-5 ePTFE Suture (K163639)Lsi Solutions2017-06-02
Galvanic Spa, Model: SKB-1405 (K163470)Shenzhen Siken 3D Technology Development Co., Ltd.2017-06-02
Enobio Wireless EEG (K162681)Neuroelectrics Barcelona S.L.U.2017-06-02
Zepto (K170655)Mynosys Cellular Devices, Inc.2017-06-02
VitalWatch Software User Interface (K170973)Vitalconnect, Inc.2017-06-02
Responsive Orthopedics Total Hip Arthroplasty System (K163585)Responsive Orthopedics, LLC2017-06-02
Parcus SLiK Fix Screw (K170877)Parcus Medical2017-06-02
Tubing Pack (K171308)Medtronic, Inc.2017-06-02
Radiopaque Tissue Marker (K170026)Viscus Biologics, LLC2017-06-02
Electrocardiograph (K170995)Edan Instruments, Inc.2017-06-02
Palisade™ Pedicular Fixation System (K171438)Spineology, Inc.2017-06-02
PolyDev Soft Contact Lenses (K171157)Polydev , Ltd.2017-06-02
Biopsy Forceps (K170726)Fehling Instruments GmbH & Co. KG2017-06-02
Sentinel Cerebral Protection System (DEN160043)Claret Medical, Inc.2017-06-01
Pall QPoint Water Filter Capsule (Shower), Pall QPoint Water Filter Capsule (Faucet) (K163609)Pall International Sarl2017-06-01
Reinforced Flexible Collagen Nerve Cuff (K170656)Collagen Matrix, Inc.2017-06-01
Xenocor Xenoscope Laparoscopic System (K171344)Xenocor, Inc.2017-06-01
Biograph Horizon PET/CT (K170904)Siemens Medical Solutions USA, Inc.2017-06-01
ASHCOM Shoulder System, Anatomical Shoulder System and Anatomical Shoulder Combined System (K170711)Zimmer GmbH2017-06-01
Medcomp Vessel Dilator (K162389)Medcomp ( Medical Components)2017-06-01
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Track 2017 automatically

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