Atlas FDA

2021

3,023 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
Dermatological Diode Laser Systems (K210663)Beijing HuaCheng Taike Technology Co., Ltd.2021-04-26
Surgical Mask (K202647)Ningbo Green Textile Co., Ltd.2021-04-26
VIVACE Electrosurgical Device (K193070)ShenB Co., Ltd.2021-04-26
ERISE Laser handpiece (K202258)El.En Electronic Engineering Spa2021-04-26
da Vinci Fluorescence Imaging Vision System, da Vinci Firefly Imaging System (K210918)Intuitive Surgical, Inc.2021-04-26
MicroDose Injector (K203264)Medone Surgical, Inc.2021-04-26
Illusion Aligners (K211010)Laxmi Dental Exports Pvt, Ltd.2021-04-26
Powder Free Blue Nitrile Examination Glove (K203512)Vip Glove Sdn Bhd2021-04-26
Percuflex Ureteral Stent System, Percuflex Ureteral Stent System Kit, Percuflex Nephroureteral Stent System, Amplatz Anchor Catheter System (K200260)Boston Scientific Corporation2021-04-26
VSP System (K210347)3D Systems2021-04-26
Vital Sign Monitoring Sensor (Model :XK300) (K202464)Xandar Kardian, Inc.2021-04-26
SIGMA Sterilization Pouch and Roll (K202462)Sigma Medical Supplies Corporation2021-04-23
Dayspring (K210885)Koya Medical, Inc.2021-04-23
MIS Solution (K203835)Next Science, LLC2021-04-23
Disposable Surgical Face Mask (K202387)Guangdong Bida Medical Technology Co., Ltd.2021-04-23
Cartesion Prime (PCD-1000A/3) V10.8 (K203314)Canon Medical Systems Corporation2021-04-23
Face Mask (K210007)Jinhua Jingdi Medical Supplies Co., Ltd.2021-04-23
SABER .035 Percutaneous Transluminal Angioplasty (PTA) Dilatation Catheter (K210626)Cordis Corporation2021-04-23
Naton Disposable Surgical Face Mask (K201853)Naton Biotechnology (Beijing) Co., Ltd.2021-04-23
Secret Duo (K202043)Ilooda Co,., Ltd.2021-04-23
Dermatological Diode Laser Systems (K202257)Zhuolu Jontelaser Manufacturing Technology Co., Ltd.2021-04-23
SteriTrak (K203605)Arbutus Medical, Inc.2021-04-23
Pulse Oximeter (K203854)Shenzhen Hexin Zondan Medical Equipment Co., Ltd.2021-04-23
MEDO-Thyroid (K203502)Medo DX Pte. , Ltd.2021-04-23
GPS Cervical Spacers (K210890)G Surgical, LLC2021-04-23
Medical Surgical Mask (K210030)Tianjin Aoshang Outdoor Equipment Co., Ltd.2021-04-23
3M Clarity Aligners (3M Clarity Aligners-Force, 3M Clarity Aligners-Flex) (K211190)3M Company, Unitek Orthodontic Products2021-04-23
Neurolutions Upper Extremity Rehabilitation System (DEN200046)Neurolutions, Inc.2021-04-23
IRIS Thermocoagulator and Digital Colposcope (K202915)Liger Medical, LLC2021-04-23
PlutoX Digital Intraoral X-Ray Imaging System (K210312)Iray Technology Taicang , Ltd.2021-04-23
Brainsway Deep TMS System (K203735)Brainsway , Ltd.2021-04-23
ZOOM (71, 55, 45, 35) Reperfusion Catheters; ZOOM Aspiration Tubing (K210996)Imperative Care, Inc.2021-04-23
2MP Monochrome LCD Monitor MS-S200 (K210345)Jvckenwood Corporation2021-04-23
Solax Electric Scooter (K192190)Dongguan Prestige Sporting Goods Co., Ltd.2021-04-23
Surgical Mask - Level 3 - Blue - 50 pcs, Surgical Mask - Level 3 - White - 50 pcs, Procedure Mask - Level 3 - Blue - 50 pcs, Procedure Mask - Level 3 - White - 50 pcs (K202607)String King Lacrosse, LLC2021-04-23
IDCAM Dental Implants (K200329)Implants Diffusion International2021-04-22
Disposable Medical Face Mask (K203646)Guangzhou Mei YI Kang Medical Technology Co., Ltd.2021-04-22
Medline UNITE REFLEX Nitinol Staple System (K210482)Medline Industries, Inc.2021-04-22
ARx Spinal System (K210549)Life Spine, Inc.2021-04-22
Restoration Anatomic Shell (K210893)Howmedica Osteonics Corp. A.K.A. Stryker Orthopaedics2021-04-22
DVT-PRO (K203353)Daesung Maref Co., Ltd.2021-04-22
Mya Joy PLUS Breast Pump (K203570)Ameda, Inc.2021-04-22
MY01 Continuous Compartmental Pressure Monitor (K210525)MY01, Inc.2021-04-22
Verifine Safety Type Insulin Pen Needle (K210065)Promisemed Hangzhou Meditech Co., Ltd.2021-04-22
Shockwave Intravascular Lithotripsy (IVL) System with the Shockwave M5+ Peripheral IVL Catheter (K203365)Shockwave Medical, Inc.2021-04-22
Nitronox Plus 0-70, Nitronox 0-50, Nitronox Plus 50/50 (K202480)Parker Hannifin2021-04-22
InnovaMatrix FS (K210580)Triad Life Sciences, Inc.2021-04-21
NuEra Tight RF, NuEra Tight RF Plus (K210867)Bios S.R.L.2021-04-21
Preview Shoulder (K210556)Genesis Software Innovations2021-04-21
DiLumen Endolumenal Interventional Platform (DiLumen) (K210851)Lumendi, LLC2021-04-21
Knee+ (K202750)Pixee Medical2021-04-21
si-Mochi (K202639)Biostone, Ltd.2021-04-21
Yushan X-Ray Flat Panel Detector with DROC (K210988)Innocare Optoelectronics Corp.2021-04-21
Nitrile Glove Powder Free Blue (K210145)Changzhou Universal Medical Equipment Co., Ltd.2021-04-21
U2 Total Knee System, XPE Tibial Insert, PS PLUS (K210961)United Orthopedic Corporation2021-04-21
VASSALLO GT (K203533)Filmecc Co., Ltd.2021-04-21
MOBIO Total Knee System (K210483)B-One Ortho, Corp.2021-04-21
Disposable medical surgical mask (K202759)Chongqing Coe Display Technology Co., Ltd.2021-04-21
Identify (K210835)Varian Medical Systems, Inc.2021-04-20
Disposable Nitrile Examination Gloves (K203805)Jiangsu Yanfang Medical Technology Co., Ltd.2021-04-20
Bead Block (100 - 300µm, 1ml), Bead Block (300 - 500µm, 1ml), Bead Block (500 - 700µm, 1ml), Bead Block (700 - 900µm, 1ml), Bead Block (900 - 1200µm, 1ml), Bead Block (100 - 300µm, 2ml), Bead Block (300 - 500µm, 2ml), Bead Block (500 - 700µm, 2ml), Bead Block (700 - 900µm, 2ml), Bead Block (900 - 1200µm, 2ml) (K203276)Biocompatibles UK Ltd (Part of Boston Scientific Corporation2021-04-20
SEFRIA PCP Oral Fluid Enzyme Immunoassay (K203489)Immunalysis Corporation2021-04-20
M.U.S.T. Midline Cortical (MC) Screw System (K210427)Medacta International S.A.2021-04-20
Panthera Occlusal Appliance (K203596)Panthera Dental, Inc.2021-04-20
SoundBite Crossing System - Peripheral (14P) (K210839)Soundbite Medical Solutions, Inc.2021-04-20
Automatic Anatomy Recognition (AAR) (K203610)Quantitative Radiology Solutions, LLC2021-04-20
Servo-u Ventilator System 4.1, Servo-n Ventilator System 4.1, Servo-u MR Ventilator System 4.1 (K201874)Maquet Critical Care AB2021-04-20
SOLE Medial Column Fusion Plate (K210157)Orthofix Srl2021-04-20
Solevy Co. LLC Silicone Based Personal Lubricant (K203644)Solevy Co., LLC2021-04-19
AI Segmentation (K203469)Varian Medical Systems, Inc.2021-04-19
Triathlon AS-1 (K203421)Conformis, Inc.2021-04-19
ROSA Partial Knee System (K210121)Orthosoft D/B/A Zimmer Cas2021-04-19
Karma Powered Wheelchair (K202506)Karma Medical Products Co., Ltd.2021-04-19
SOZO (K203473)ImpediMed Limited2021-04-19
Solevy Co. LLC Water-Based Personal Lubricant (K203654)Solevy Co., LLC2021-04-19
Dentis s-Clean s-Line (K210134)Dentis Co., Ltd.2021-04-19
VPS Impression Material (K203824)Hygedent, Inc.2021-04-19
Goblin and Goblin LS Pedicle Screw Systems (K210420)Medynus, Inc.2021-04-19
Arthrex SwiveLock Anchor (K203495)Arthrex, Inc.2021-04-19
rainbow MCT (K200270)Dentium Co., Ltd (Ict Branch)2021-04-16
MOLLI (K210600)Molli Surgical, Inc.2021-04-16
rainbow CT (K200271)Dentium Co., Ltd (Ict Branch)2021-04-16
Saige-Q (K203517)DeepHealth, Inc.2021-04-16
Brainsway Deep (DTMS) System (K203616)Brainsway , Ltd.2021-04-16
Looper (Model: ZX-579S) (K202055)Heat IN A Click, LLC2021-04-16
Hair Growth Device (K210169)Dongguan Lescolton Intelligent Electrical Appliance Co., Ltd.2021-04-16
Fusion Taper System (K201047)Signature Orthopaedics Pty, Ltd.2021-04-16
Infrared Thermometer Models: DT-8806S, DT-8807S (K203170)Shenzhen Everbest Machinery Industry Co., Ltd.2021-04-16
Electric Wheelchair (Model: S7110) (K200978)Dongguan Prestige Sporting Goods Co., Ltd.2021-04-16
Disposable Nitrile Gloves (K210276)Fujian Ercon Medical Management Co., Ltd.2021-04-16
BIOTECH Nitrile Examination Gloves (K202419)Tk Hitech Technology Co., Ltd.2021-04-16
Locator Overdenture Implant System (K203701)Ivory Super Holdco Inc. / Zest Anchors, LLC2021-04-15
SKORE (Colors & Flavors), SKORE (Colors) (K202403)Ttk Healthcare Limited2021-04-15
BLUEPRINT™ Patient Specific Instrumentation (K203315)Tornier S.A.S.2021-04-15
Verrata PLUS Pressure Guide Wire (K210235)Volcano Corporation2021-04-15
AXIOS Stent and Electrocautery Enhanced Delivery System (K203132)Boston Scientific Corporation2021-04-15
Instylla Microcatheter 1.2 (K210808)Instylla, Inc.2021-04-15
MDPC-8127 (K203364)Barco N.V.2021-04-15
Axiostat Patch (K202830)Advamedica, Inc.2021-04-15
Edge Insulated Blade Electrode (K210338)Covidien, LLC2021-04-15
← Previous Next →

Track 2021 automatically

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