Atlas FDA

2018

3,062 FDA 510(k) clearances · Clearance year

Sort:Newest firstOldest first

Download CSV table Client report (share link) ◉ Watch

Both buttons carry the same predicate table: the CSV downloads for your worksheet, the report is a shareable page for clients. Exports: 3 free/month with an account · reports & watching free.

RecordFirmDate
CorPath GRX System (K173288)Corindus, Inc.2018-02-15
Rösch Thurmond Fallopian Tube Catheterization Set, Fallopian Tube Catheterization Set, and Fallopian Tube Catheterization Wire Guide with Platinum Tip (K171604)Cook Incorporated2018-02-15
AtriCure cryoICE cryo-ablation probe (CRYO3), AtriCure cryoICE cryoFORM cryo-ablation probe (CRYOF) (K180137)AtriCure, Inc.2018-02-15
Surgical Laser fibers (K180158)Quanta System Spa2018-02-14
Banyan BTI (DEN170045)Banyan Biomarkers, Inc.2018-02-14
TEMED Gas Diffuser (K173545)Temed2018-02-14
Sunrise 6200, Sunrise 7200 (K173565)Jk-Holding GmbH2018-02-14
SEURAT™ Universal Pedicle Screw System (K173185)Ctl Medical Corporation2018-02-14
Siberian Fit (K172439)Vydence2018-02-14
Multiple Tubing Segment Set with stay safe PIN Connectors, stay safe Drain Set (K173651)Fresenius Medical Care Renal Therapies Group, LLC2018-02-14
Sera (K173567)Interacoustics A/S2018-02-14
SupaChair Powered Wheelchair (K173315)Eurogreen International, Inc.2018-02-13
Endoskeleton® TAS Interbody Fusion Device, Endoskeleton® TAS Hyperlordotic Interbody Fusion Device and Endoskeleton® TCS Interbody Fusion Device (K173535)Titan Spine, LLC2018-02-13
QuickVue Influenza A+B (K180288)Quidel Corporation2018-02-13
ENDOSOLV (K172839)Septodont2018-02-13
DRI Hydrocodone Assay (K173195)Microgenics Corporation2018-02-13
CT6485, CT12885 (K172058)Analogic Corporation2018-02-13
SupaChair Powered Wheelchair: COMBI 18, COMBI 18SP, COMBI 20, COMBI 20SP (K173313)Eurogreen International, Inc.2018-02-13
Voyant 5mm Fusion Device (K172624)Applied Medical Resources Corporation2018-02-13
Disposable Endoscopic Surgical Instrument, Reusable Endoscopic Surgical Instrument (K171825)Hunan Handlike Minimally Invasive Surgery Co., Ltd.2018-02-13
ContaCT (DEN170073)Viz.Al, Inc.2018-02-13
MAGNETOM Aera, MAGNETOM Skyra/Skyrafit, MAGNETOM Prisma/Prismafit, MAGNETOM Avantofit (K173592)Siemens Medical Solutions USA, Inc.2018-02-13
Infra-red ear thermometer model: ET-100A, ET-100B, ET-100D, ET-100E, ET-100G, ET-100I, ET-100J (K172870)Hangzhou Hua'An Medical&Health Instruments Co.,Ltd2018-02-13
MotoBAND CP Implant System (K173710)Crossroads Extremity Systems, LLC2018-02-12
SuRgical Planner (SRP) (K170793)Surgical Theater, LLC2018-02-12
Home Use Hair Removal Device/T1, T2, T3 (K172883)Shenzhen Mareal Tech Co., Ltd.2018-02-12
Thorecon™ Fixation System (K173579)A & E Medical Corporation2018-02-12
ASAHI PTCA Guide Wires, ASAHI Corsair Microcatheter, ASAHI Corsair Pro Microcatheter (K171933)Asahi Intecc Co., Ltd.2018-02-12
Digitex Delivery Device (K173527)Coloplast A/S2018-02-12
Zyston Strut Open Titanium Spacer System (K171495)Zimmer Biomet Spine, Inc.2018-02-12
MiniLap System with MiniGrip Handle, MiniLap System with ThumbGrip Handle (K172775)Teleflexmedical, Inc.2018-02-12
Vinyl Patient Examination Glove (Yellow) (K173561)Yurun Glove Co., Ltd.2018-02-12
CELERITY 20 Steam Biological Indicator (K173634)STERIS Corporation2018-02-12
Arthrex NanoSuture Anchor (K180118)Arthrex, Inc.2018-02-12
CASCADIA Interbody System (K172941)K2m2018-02-12
CELERITY 20 Steam Incubator (K173670)STERIS Corporation2018-02-12
geko T-2 and geko Plus R-2 (K180082)Firstkind, Ltd.2018-02-11
TAV Medical Dental Implants System (K170131)Tav Medical , Ltd.2018-02-10
PRO-LITE Sterilization Trays (K172755)STERIS Corporation2018-02-09
OSCAR 15 (K172180)Genoray Co., Ltd.2018-02-09
CELERITY 20 HP Biological Indicator (K172752)STERIS Corporation2018-02-09
BR Type Implant System (K171179)Biotem Co., Ltd.2018-02-09
CS-series-FP with MX CFP 3131 or MX CFP 2222 Option Radiographic/Fluoroscopy System (K171755)Omega Medical Imaging, LLC2018-02-09
Jade PTA Balloon Dilatation Catheter (K173894)Orbusneich Medical Trading, Inc.2018-02-09
ORISE Tissue Retractor System (K173400)Boston Scientific2018-02-09
ChlorCid, ChlorCid V, ChlorCid Surf (K173163)Ultradent Products, Inc.2018-02-09
Amrad Medical AAU Digital Radiography System; Amrad Medical AAU Plus Digital Radiography System; Amrad Medical DFMT Digital Radiography System; Amrad Medical FMT Digital Radiography System (K173823)Summit Industries, LLC2018-02-09
Meridian Vaginal Positioning System (VPS) (K173501)Coloplast2018-02-09
Tosama Biobased Applicator Tube Menstrual Tampon (K172504)Tosama, D.O.O.2018-02-09
Blue Sky Bio Aligner (K180107)Blue Sky Bio, LLC2018-02-09
BD Phoenix Automated Microbiology System - GN Meropenem-vaborbactam (0.125/8-32/8 ug/mL) (K173523)Becton, Dickinson and Company2018-02-09
3M Attest Rapid Readout Biological Indicator (K173435)3M Company2018-02-09
Vis-U-All Low Temperature Sterilization Pouch/Tubing (K172749)STERIS Corporation2018-02-09
VERIFY VH2O2 Indicator Tape (K172753)STERIS Corporation2018-02-09
Kohli Urinary Drainage Catheter (K172422)Nellie Medical, LLC2018-02-09
Standard Catheter Set (K171631)Varian Medical Systems, Inc.2018-02-09
Southern Implants PEEK Abutments (K172160)Southern Implants (Pty), Ltd.2018-02-09
VERIFY® HPU Chemical Indicator and VERIFY® Vaporized VH2O2 Process Indicator Adhesive Label (K172746)STERIS Corporation2018-02-09
Leksell GammaPlan (K173791)Elekta Instrument AB2018-02-09
Ergonomic Handle (K173272)Symmetry Surgical, Inc.2018-02-09
AT-6XX Series Infrared Thermometer (K171455)Xiamen Acurio Instruments Co., Ltd.2018-02-09
VERIFY V24 Self-Contained Biological Indicator, VERIFY V24 Biological Indicator Challenge Pack (K172748)Steris Corporations2018-02-09
iVitri Straw (K172751)Reprobitech Corp.2018-02-09
V-PRO maX 2 Low Temperature Sterilization System (K172754)STERIS Corporation2018-02-09
NAPA LP-15 Airway Pressure Monitor (K172284)Drw Medical, LLC2018-02-09
SENYINT Remote Consultation System (K162727)Dalian Senyint Digital Medical System Co., Ltd.2018-02-08
UNiD Spine Analyzer (K180091)Medicrea International2018-02-08
Ultrasound System SONIMAGE MX1 (K180084)Konica Minolta, Inc.2018-02-08
LUCAS 3 Chest Compression System (K173553)Jolife AB2018-02-08
NexSite HD Hemodialysis Symmetric Tip Catheter for long term use (19cm), NexSite HD Hemodialysis Symmetric Tip Catheter for long term use (23cm), NexSite HD Hemodialysis Symmetric Tip Catheter for long term use (27cm), NexSite HD Hemodialysis Symmetric Tip Catheter for long term use (31cm),NexSite HD Hemodialysis Symmetric Tip Catheter for long term use (35cm), NexSite HD Hemodialysis Symmetric Tip Catheter for long term use (55cm) (K173805)Marvao Medical Devices, Ltd.2018-02-08
Gazelle PTFE and Suture Delivery Device (K173335)Dura Tap, LLC2018-02-08
superDimension Navigation System V7.2 (K173244)Covidien, LLC2018-02-08
Comprehensive Segmental Revision System (SRS) (K173411)Biomet Manufacturing Corp2018-02-08
CONCORDE LIFT™ (K173537)Medos International SARL2018-02-08
NuVasive® MLX® – Medial Lateral Expandable Lumbar Interbody System; NuVasive® AP Expandable XLIF System (K173025)Nu Vasive, Incorporated2018-02-08
CAPILLARYS Hb A1c (K171861)Sebia2018-02-07
THP Hip Fracture Plating System (K173826)Biomet, Inc.2018-02-07
PicoSure Workstation (K173199)Cynosure, Inc.2018-02-07
ACUSON X800 Diagnostic Ultrasound System (K180067)Siemens Medical Solutions USA, Inc.2018-02-07
SteriZign Signatur Device Protection System (K171520)Sterizign Precision Technologies, LLC2018-02-07
PRESS DUO elite, PRESS DUO elite AG (K173450)Nemoto Kyorindo Co., Ltd.2018-02-07
PENTAX MEDICAL ED-3490TK, Video Duodenoscope (K161222)Pentax Medical2018-02-07
G-Beam Fusion Beaming System (K172698)Orthofix Srl2018-02-07
Acid Etchant (K172953)American Orthodontics2018-02-06
Accula Flu A/Flu B Test (K171641)Mesa Biotech, Inc.2018-02-06
SeaSpine Mariner Pedicle Screw System (K173882)SeaSpine Orthopedics Corporation2018-02-06
eUnity (K172490)Client Outlook, Inc.2018-02-06
AcQRef Introducer Sheath (K171557)Acutus Medical, Inc.2018-02-06
Insight BD (K172832)Siemens Medi Cal Solutions, Inc.2018-02-06
Gammex PI Breach Detect Powder Free Surgical Glove (K171375)Ansell Healthcare Products, LLC2018-02-06
Devon 24R Deep Vein Thrombosis (DVT) Prevention Therapy System (K173528)Devon Medical Products (Jiangsu), Ltd.2018-02-06
RS85 Diagnostic Ultrasound System (K173204)Samsung Medison Co., Ltd.2018-02-05
Flip Lube (K171516)Imquest Biosciences, Inc.2018-02-05
BETTERCARE PLATFORM - ADVANCED WEB CLIENT (K171361)Better Care S.L.2018-02-05
ProxiDiagnost N90 (K173433)Philips Medical Systems Dmc GmbH2018-02-05
MFI-Cardiac (K173512)Multifunctional Imaging, LLC2018-02-05
Aquilex Fluid Control System AQL-100S (K172040)W.O.M. World of Medicine GmbH2018-02-05
DRX-Revolution Nano Mobile X-ray System (K173924)Carestream Health, Inc.2018-02-05
FlowTriever Retrieval/Aspiration System, Aspiration Guide Catheter (K173672)Inari Medical2018-02-05
First Sign Multi-Drug Dip Card Test, First Sign Multi-Drug Cup Test, First Sign Drug of Abuse Dip Card Test Marijuana, First Sign Drug of Abuse Cup Test Marijuana (K171695)W.H.P.M., Inc.2018-02-05
← Previous Next →

Track 2018 automatically

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