Atlas FDA

2016

2,956 FDA 510(k) clearances · Clearance year

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RecordFirmDate
iPulse SmoothSkin Gold Hair Removal Device (K160968)Cyden Limited2016-04-14
MX30N(MX30TQS) (K160346)Wide Corporation2016-04-14
Nutraseb Facial Cream (K143605)Isdin Corp.2016-04-14
The Nanostim Introducer Kit (K160716)St. Jude Medical, Inc.2016-04-14
Tenso TS-101S and TS-101D Disposable Blood Pressure Cuff (K153251)Ningbo Free Trade Zone Tenso Medical Instruments Co., Ltd.2016-04-14
Nitrile Patient Examination gloves, Powderfree, Blue color (K143477)Primus Gloves Pvt Limited2016-04-14
Sealapex tubes, Sealapex bulk package, Sealapex Xpress dual-barrel syringes (K152959)Sybron Dental Specialties2016-04-14
Chattanooga Revolution Wireless (K153696)Djo, LLC2016-04-14
uwe sun tanning beds/booths P90, iBED EVG, iSUN HP, SILVERBULLET SE, LOTUS (K152364)Pc Marketing, Inc.2016-04-14
Juno VPAP ST-A (K153061)Resmed, Ltd.2016-04-13
Diplomat® Spinal System (K151704)Signus Medizintechnik GmbH2016-04-13
Aero Chrome* Breathable Performance Surgical Gown (K153255)Halyard Health, Inc.2016-04-13
Coldplay Cryoballoon; Focal Ablation System, Full Ablation System; Swipe Ablation System (K152329)C2 Therapeutics, Inc.2016-04-13
Ketac Universal Aplicap (K153174)3M Deutschland GmbH2016-04-13
A&D Medical TM-2657 Family of Digital Blood Pressure Monitors (K151953)A&D Company, Ltd.2016-04-13
DICOM Viewer (K153653)Brainlab AG2016-04-13
4plus6Line Abutment System (K151608)Ot Medical GmbH2016-04-13
NormaTec Pulse and NormaTec Pulse Pro (K160608)NormaTec Industries, LP2016-04-13
NuVasive CoRoent Thoracolumbar System (K153419)Nu Vasive, Incorporated2016-04-13
Varian Sterilization Boxes (K160021)Varian Medical Systems, Inc.2016-04-13
Neptune E-SEP Smoke Evacuation Pencil (K160693)Stryker Corporation2016-04-13
SUSTAIN R TPS Spacers, PATRIOT TPS Spacers, CALIBER TPS Spacer, COALITION TPS Spacers, INDEPENDENCE TPS Spacer, FORTIFY -R TPS Corpectomy Spacer, FORTIFY I-R TPS Corpectomy Spacer, XPand -R TPS Corpectomy Spacer, NIKO TPS Corpectomy Spacer (K143578)Globus Medical, Inc.2016-04-13
Everest 20 Disposable Inflation Device, Everest 20 Survival Kit, Everest 30 Disposable Inflation Device, Everest 30 Survival Kit (K153038)Medtronic, Inc.2016-04-13
JRP Wound Spreader (K152538)J.R. Parker, LLC2016-04-13
Orbit Infusion Set (K150921)Ypsomed AG2016-04-12
ARIES System (K160517)Luminex Corporation2016-04-12
Arthrex iBalance BiCompartmental Arthroplasty System (K160461)Arthrex, Inc.2016-04-12
TelioCAD Multi (K153753)Ivoclar Vivadent, Inc.2016-04-12
EndoSize (K160376)Therenva Sas2016-04-12
Superbium (K153229)Bios S.R.L.2016-04-12
HealthChek Network Health Station (K152107)Healthchek Network, LLC2016-04-12
icotec Pedicle System (K151977)Icotec AG2016-04-12
All Poly Tibial Component (K152430)United Orthopedic Corporation2016-04-12
Cytosponge Cell Collection Device (K152794)Covidien, LLC2016-04-12
Winco Model S550 Stretchair (K152056)Winco Manufacturing, LLC2016-04-11
Noris Medical MBI Dental Implant System (K153043)Noris Medical , Ltd.2016-04-11
QUANTA Flash dsDNA, QUANTA Flash dsDNA Calibrators and QUANTA Flash dsDNA Controls (K152013)Inova Diagnostics, Inc.2016-04-11
BioMonitor 2-AF, BioMonitor 2-S (K152995)Biotronik, Inc.2016-04-11
HemiCAP MTP Resurfacing Hemi-Arthroplasty System (K152454)Arthrosurface, Inc.2016-04-11
LifeGlobal Micro Tips (K152581)Life Global Group, LLC2016-04-11
TREFOIL System (K152836)Nobel Biocare AB2016-04-11
Hoffmann LRF (Limb Reconstruction Frame) System (K153377)Stryker GmbH2016-04-11
Map-it Diagnostic Mapping Catheters (K160390)Access Point Technologies Ep, Inc.2016-04-11
Nephros S100 (K153084)Nephros, Inc.2016-04-08
RayStation (K160093)RaySearch Laboratories AB (PUBL)2016-04-08
Elecsys Digoxin Immunoassay, Elecsys PreciControl Cardiac II (K153301)Roche Diagnostics2016-04-08
EyeYon (hioxirilcon D) Soft (hydrophillc) ContactLensesfor Daily Wear, Hyper-CL (hioxirilcon D)TherapeuticSoft (hydrophillc) Contact Lensesfor Daily Wear (K153305)Eyeyon Medical2016-04-08
Xmaru View V1 and Xmaru PACS, Medical Image Processing Software (K160579)Rayence Co., Ltd.2016-04-08
First Ray Internal Bone Staple System (K153622)First Ray, LLC2016-04-08
FDR D-EVO flat Panel Detector System (K153464)Fujifilm Medical Systems U.S.A, Inc.2016-04-08
PERCUVANCE PERCUTANEOUS SURGICAL SYSTEM (K153063)Teleflexmedical, Inc.2016-04-08
Bladder Scanner (K153581)Caresono Technology Co., Ltd.2016-04-08
Noris Medical Zygomatic Dental Implant System (K151909)Noris Medical , Ltd.2016-04-08
KLOCKNER VEGA DENTAL IMPLANT SYSTEM (K153098)SOADCO, S.L.2016-04-08
OLYMPIC Posterior Spinal Fixation System (K153446)Astura Medical2016-04-08
LifeCare PCA Infusion System (K143612)Hospira, Inc.2016-04-08
geko(TM) Plus R-2 Neuromuscular Stimulator (K160299)Firstkind Limited2016-04-08
Clalen 54 (hioxifilcon D) Soft (hydrophilic) Contact Lens for Daily Wear, Clalen 58 (hioxifilcon A) Soft (hydrophilic) Contact Lens for Daily Wear (K153766)INTEROJO, Inc.2016-04-08
MagView BIOMAGNETOMETER SYSTEM (K152184)Tristan Technologies, Inc.2016-04-08
Nihon Kohden Afib Detection Program QP-039P (K152305)Nihon Kohden Corporation2016-04-08
OneQ-SL s-Clean Implant System (K153639)Dentis Co., Ltd.2016-04-08
430 Torque High-Speed Handpiece Series - 430 SWL Torque High Speed Handpiece, 430 SW Torque High Speed Handpiece (K153411)Dentalez, Inc.2016-04-08
ICONACY(TM) I-Hip(TM) (K160266)Iconacy Orthopedic Implants, LLC2016-04-08
Philips Multislice CT System with Low Dose CT Lung Cancer (K153444)Philips Medical Systems (Cleveland), Inc.2016-04-08
VentriClear Ventricular Drainage Catheter Set with Cook Spectrum Antibiotic Impregnation, VentriClear II Ventricular Drainage Catheter (K160223)Cook Incorporated2016-04-08
spineEOS (K160407)Onefit Medical2016-04-08
Merge Hemo (K152864)Merge Healthcare Incorporated2016-04-07
StrataMR Valves and Shunts (K152700)Medtronic Neurosurgery2016-04-07
EM ENT Navigated Suctions (K153555)Medtronic Navigation, Inc.2016-04-07
Surearly Pregnancy Test Strip, Surearly Digital Pregnancy Test (K142754)Sugentech, Inc.2016-04-07
ReGrasp (K153163)Rehabtronics, Inc.2016-04-07
ASAHI CHIKAI Neurovascular Guide Wire (Round Curve) (K160659)Asahi Intecc Co., Ltd.2016-04-07
CX50N, CX50YQS (K160351)Wide Corporation2016-04-07
BD FlowSmart Set, MiniMed Pro-Set (K160651)Becton, Dickinson and Company2016-04-07
PneumoLiner (DEN150028)Advanced Surgical Concepts, Ltd.2016-04-07
SIGMA P5/ OMEGA P7/ LAMBDA P9 Portable Ultrasound Diagnostic Scanner (K160343)Beijing East Whale Imaging Technology Co., Ltd.2016-04-07
CX20N(CX20PUX) (K160355)Wide Corporation2016-04-07
FIRMap Catheter (K153093)Abbott Electrophysiology2016-04-07
U2 Bipolar Implant and 22mm Femoral Head (K152439)United Orthopedic Corporation2016-04-07
transGlide Expandable Introducer (K152194)Transaortic Medical, Inc.2016-04-07
Extension Set (K153293)B.Braun Medical, Inc.2016-04-06
EPIQ 5 Diagnostic Ultrasound System, EPIQ 7Diagnostic Ultrasound System, Affiniti 50 Diagnostic Ultrasound System, Affiniti 70 Diagnostic Ultrasound System (K160807)Philips Ultrasound, Inc.2016-04-06
KLS Martin LSS Plating System (K151983)KLS Martin L.P.2016-04-06
Wireless Earlens Light Driven Hearing Aid (K153634)Earlens Corporation2016-04-06
Magma System (K153566)Formatk Systems , Ltd.2016-04-06
SMR 3-Pegs Glenoids (K153722)Lima Corporate S.P.A.2016-04-06
KLS Martin Thoracic Plating System (K153482)KLS-Martin L.P.2016-04-06
ULTRA Telescopes (K153009)Olympus Winter & Ibe GmbH2016-04-05
SleepWeaver Advance Pediatric Nasal CPAP Mask (K151683)Circadiance, LLC2016-04-05
Non-Telescopic PenEvac (K160160)I.C Medical, Inc.2016-04-05
NUTRICARE-ISOSAF NASO-GASTRIC FEEDING TUBE (K151503)Gbuk Enteral Limited2016-04-05
SonoSite SII Ultrasound System (K160734)FUJIFILM Sonosite, Inc.2016-04-05
Medline ReNewal Reprocessed Versaport V2 Bladeless Optical Trocars (K153258)Surgical Instrument Service and Savings (Dba Medline Renewal2016-04-05
Disposable Temporary Pacing Cable (K152947)Tiger Medical Products2016-04-05
EVO platform (K160368)Quanta System Spa2016-04-05
PackFil Dual Cured Resin Modified Glass Ionomer Restorative Cement (K152652)Gaia Dental Products, Inc.2016-04-05
Barrx FLEX RFA Energy Generator (K160360)Covidien, LLC2016-04-05
LUMIS Cannulated Pedicle Screw Fixation System, U.L.I.S. Pedicle Screw Fixation System (K160124)Spinevision S.A.2016-04-04
HG Pro Nitrile Powder Free Examination Gloves (K152479)Healthy Glove Co., Ltd.2016-04-04
SMARTez elastomeric infusion pump (K151650)Epic Medical Pte. , Ltd.2016-04-04
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Every clearance here is in the API, with alerts when new ones post.