Atlas FDA

2015

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

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RecordFirmDate
Microlife Upper Arm Automatic Digital Blood Pressure Monitor (K143341)Microlife Intellectual Property GmbH2015-04-21
Melodi Prime Breast Pump (K143574)Genadyne Biotechnologies, Inc.2015-04-21
Portrait GBS Assay (K143312)Great Basin Corporation2015-04-21
Basic, Dominant Flex, KV-6 (K150134)Medela AG2015-04-21
Freestyle Deluxe, Freestyle Solution Set, Freestyle Basic, Freestyle Motor Warranty (K150499)Medela AG2015-04-21
Air Compressible Limb Therapy System (K150033)Daesung Maref Co., Ltd.2015-04-20
RHINOGUARD (K141747)Davis Medical2015-04-20
I-QARE DS-W BLOOD GLUCOSE MONITORING SYSTEM (K132663)Alliance International Co., Ltd.2015-04-20
IPM Wound Gel Bio, IPM Derm Gel Bio (K143527)Glycobiosciences, Inc.2015-04-20
G-Premio BOND (K143140)GC America, Inc.2015-04-20
POLARSTEM Collared (Standard and Lateral) and Valgus Femoral Stem with Ti/HA (K143739)Smith & Nephew, Inc.2015-04-20
DeScribe Transparent PFD Patch (K150212)On Light Sciences, Inc.2015-04-20
PROFEMUR Preserve Size 1-3 Hip Stems (K150133)Microport Orthopedics, Inc.2015-04-20
Natus Quantum (K143440)Natus Medical Incorporated2015-04-20
Cardinal Health NPWT PRO, Cardinal Health NPWT PRO to Go, Cardinal Health NPWT PRO at Home (K143016)Cardinalhealth2015-04-20
Tosama 100% Cotton Menstrual Tampon (K150897)Tosama, D.O.O.2015-04-20
TensCare KegelFit (K142506)Tenscare, Ltd.2015-04-20
MALE CIRCUMCISION KITS:RAPIDECLAMP (K142163)Medicfit Technology Sdn Bhd2015-04-20
Dilapan-S (K143447)Medicem Technology S.R.O2015-04-17
GammaBeam 500 (K150191)Best Theratronics Limited2015-04-17
OSTEOTEC SILICONE FINGER IMPLANT (K140453)Osteotec, Ltd.2015-04-17
SagiNova (K142986)Eckert & Ziegler Bebig GmbH2015-04-17
Chemtrue Drug Screen Cup Tests and Chemtrue Drug Screen Cup Tests with OPI 2000 (K143599)Chemtron Biotech, Inc.2015-04-17
TRUE FLOW VALVULOPLASTY PERFUSION CATHETER (K142083)C.R. Bard, Inc.2015-04-17
MindChild Meridian M100 Fetal Heart Rate Monitor (K142883)Mindchild Medical2015-04-17
DIODE LASER HAIR REMOVAL SYSTEM (K142186)Shenzhen Gsd Tech Co., Ltd.2015-04-17
OXYTOTE INFINITY SERIES VIPR SYSTEMS (K142149)Western/Scott Fetzer Co.2015-04-17
JOY DROPS (TM) NATURAL PERSONAL LUBRICANT GEL (K140506)Turkuaz Saglik Hizmetleri Medikal Temizlik Kimyasa2015-04-17
Vitrea CT Myocardial Perfusion (K150104)Vital Images, Inc.2015-04-17
EUROIMMUN IFA 40: HEP-20-10; EUROPATTERN MICROSCOPE AND SOFTWARE (K141827)Euroimmun Us, Inc.2015-04-17
ProCinch Adjustable Loop Device (K150416)Stryker Endoscopy2015-04-17
UnicLine Mobile (K150490)Heka Dental A/S2015-04-17
Vantage Titan 1.5T, V3.1, MRT-1510 (K150427)Toshibamedical Systems Corporation2015-04-17
SCANIP; SCANIP: MEDICAL EDITION; SCANIP: MED (K142779)Simpleware , Ltd.2015-04-17
Arm Blood Pressure Monitor, Wrist Blood Pressure Monitor (K150430)Fudakang Industrial Co., Ltd.2015-04-17
SI-BONE iFuse Implant System (K150714)SI-BONE, Inc.2015-04-17
RAYSCAN A-EXPERT 3D (K142247)Ray Co., Ltd.2015-04-17
Exam Vue DR (K142930)Jpi Healthcare Co, Ltd.2015-04-17
SOMATOM Definition Flash (VA48) (K143416)Siemens Medical Solutions USA, Inc.2015-04-16
i-STAT Total beta-hCG Test, i-STAT Total beta-hCG Controls, i-STAT Total beta-hCG Calibration Verification Materials (K133002)Abbott Point of Care, Inc.2015-04-16
Alcyone MEMS Cannula (AMC) System (K150660)Alcyone Lifesciences, Inc.2015-04-16
QANS (Quantitative Autonomic Nervous System) Monitoring System (K142551)Hhssystems, LLC2015-04-16
Nitroglycerin Sets with DUO-VENT Spike (K150860)Baxter Healthcare Corporation2015-04-16
Option (TM) ELITE Vena Cava Filter 100cm System (K143405)Rex Medical, L.P.2015-04-16
Voyant Fine Fusion Device (K143536)Applied Medical Resources2015-04-16
BIOPOR AOC POROUS POLYETHYLENE, CEREPOR (K141880)Ceremed , Inc.2015-04-16
PicoWay Laser System (K150326)Candela Corporation2015-04-16
FlexPointer 1.5 mm (K150473)Fiagon GmbH2015-04-16
BIS STANDARD SENSOR,1-CHANNEL (3 ELECTRODES); BIS PEDI SENSOR,1-CHANNEL,3 ELECTRODES; BIS QUATRO SENSOR; BIS PEDI-XP SENSOR,2-CHANNEL (4 ELECTRODES); BIS EXTEND SENSOR; BIS BILATERAL SENSOR,4-CHANNEL (6 ELECRODES); BIS INSIGHT SENSOR,CVI-ENABLED,2-CHANNEL (4 ELECTRODES) (K143506)Covidien2015-04-16
Integra (R) Jarit (R) Kerrison Rongeurs, Integra (R) Ruggles (TM)-Redmons (TM) Kerrison Rongeurs, Integra (R) Miltex (R) Kerrison Rongeurs, Integra (R) Meisterhand (R) Kerrison Rongeurs (K150428)Integra Lifesciences Corp.2015-04-16
GAMMA PHAGE LYSIS ASSAY FOR THE IDENTIFICATION OF BACILLUS ANTHRAC (K143592)The Surgeon General, Department of the Army2015-04-16
RUSCH ENDOBRONCHIAL TUBES (K141888)Teleflexmedical, Inc.2015-04-15
PRODIGY AUTOCODE EJECT BLOOD GLUCOSE MONITORING SYSTEM (K141914)Ok Biotech Co., Ltd.2015-04-15
Dorsal Appliance (K143591)Gergens Orthodontic Lab2015-04-15
EZvue UV, Soft Daily Wear Contact Lenses (ocufilcon D), EZvue Colors, Soft Daily Wear Contact Lenses (ocufilcon D) (K150293)I-See Vision Technology, Inc.2015-04-15
InterActive Complete Surgical Tray (K142519)Implant Direct Sybron Manufacturing, LLC2015-04-15
JUSHA-M52C Medical Display (K150746)Nanjing Jusha Display Technology Co., Ltd.2015-04-14
TheyFit Male Condom (K150072)Theyfit2015-04-14
Acrylic Block (K143265)Sun Medical Co., Ltd.2015-04-14
Sidecar External Working Channel (K150083)C2 Therapeutics2015-04-14
MicroCross Catheter (K143744)Roxwood Medical, Inc.2015-04-14
Revital-Ox RESERT Solution Test Strip (K143333)STERIS Corporation2015-04-14
Delivery Analysis (K143269)Accuray Incorporated2015-04-14
HONGYU DISPOSABLE SURGICAL DRAPES (K141324)Weihai Hongyu Nonwoven Fabric Products Co., Ltd.2015-04-14
IMPLANET Spine System (ISS) (K143731)Implanet, S.A.2015-04-14
LC CALCIUMHYDROXIDE LINER (K141047)S&C Polymer Silicon- Und Composite Spezialitaeten2015-04-14
LX-100 Hair Growth Stimulation System (K142824)Hairlabs International, Inc.2015-04-14
HeartSee (K143664)University of Texas Medical School AT Houston2015-04-14
Fast Sphyg by Koven (K143332)Koven Technology, Inc.2015-04-14
DEKA SYNCHRO REPLA:Y FAMILY OF LASER SYSTEMS (K150516)El.En Electronic Engineering Spa2015-04-13
PINPOINT GT SAFETY INTRODUCER NEEDLE (K142445)C.R. Bard, Inc.2015-04-13
SoundCure Serenade Tinnitus Treatment System (K150065)Soundcure, Inc.2015-04-13
mint Lesion (K142647)Mint Medical GmbH2015-04-13
IMMULITE IGF Control Module, IMMULITE Gastrin Control Module (K150132)Siemens Healthcare Diagnostics2015-04-13
Pulse Oximeter (K142687)Shanghai Berry Electronic Tech Co., Ltd.2015-04-13
Lubricating Jelly (K142473)Sion Biotext Medical , Ltd.2015-04-13
Diamondback 360 Peripheral Orbital Atherectomy System (K150732)Cardiovascular Systems, Inc.2015-04-13
Neoss Ti Reinforced Membrane (K143327)Neoss, Ltd.2015-04-13
FloShield 10mm Endoscopic Cannula and Conical Blunt Obturator, FloShield 10mm Endoscopic Cannula, FloShield 10mm Conical Blunt Obturator (K150705)Minimally Invasive Devices, Inc.2015-04-13
MDT Navigable Brain Biopsy Cannula (K143241)Izi Medical Products, LLC2015-04-13
Monopolar Laparascopic Accessories (K142208)Unimicro Medical Systems (Shenzhen) Co., Ltd.2015-04-13
Disposable sterile needle retractable safety syringe (K141349)Guangdong Haiou Medical Apparatus Stock Co., Ltd.2015-04-10
FortiBridge Anterior Cervical Plate System (K143706)Nanovis Spine, LLC2015-04-10
AQUIOS CL FLOW CYTOMETER, AQUIOS TETRA-1 PANEL,AQUIOS TETRA-2+PANEL, AQUIOS IMMUNO-TROL, AQUIOS IMMUNO-TROL LOW, AQUIOS (K141932)Beckman Coulter, Inc.2015-04-10
ZM Powder Free Vinyl Patient Examination Gloves, Clear (non-colored) (K142911)Huailai ZM Plastic Products Co., Ltd.2015-04-10
PROFEMUR Preserve Classic Stem (K150302)Microport Orthopedics, Inc.2015-04-10
COPAN FECALSWAB COLLECTION, TRANSPORT AND PRESERVATION SYSTEM (K142094)Copan Italia Spa2015-04-10
HEALTH KIOSK (K140360)Engagementhealth, LLC2015-04-10
BREAST-MED TISSUE MARKER (K133697)Breast-Med, Inc.2015-04-10
DC-70/DC-70T/DC-70 PRO/DC-70 EXP Diagnostic Ultrasound Systems (K150204)Shenzhen Mindray Bio-Medical Electronics Co., Ltd.2015-04-10
MDNG-3220 (Nio 3MP LED) (K150821)Barco2015-04-10
GPS Spacers (K142456)G Surgical, LLC2015-04-10
FORE-SIGHT Elite Absolute Tissue Oximeter (K143675)Cas Medical Systems, Inc.2015-04-10
AlfaSight 9000 Thermographic System (K150457)Alfa Thermodiagnostics, Inc.2015-04-10
AUTION CHECK PLUS (K142262)Quantimetrix Corp.2015-04-10
BD INTIMA II CLOSED IV CATHETER (K143610)Becton Dickinson Infusion Therapy Systems, Inc.2015-04-09
MASTERmatic LUX (K143465)Kaltenbach & Voigt GmbH2015-04-09
Chocolate PTCA Balloon Catheter (K150292)Trireme Medical, LLC2015-04-09
Prelude SNAP Splittable Sheath Introducer (K143255)Merit Medical Systems, Inc.2015-04-09
LIOLI IOL DELIVERY SYSTEM (K142056)Ast Products, Inc.2015-04-09
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Every clearance here is in the API, with alerts when new ones post.