Atlas FDA

2022

3,209 FDA 510(k) clearances · Clearance year

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RecordFirmDate
Nitrile Examination Gloves (K212929)Watchtower Ppe Supplies, Inc.2022-04-09
Pink Powder Free Nitrile Examination Glove With Bubblegum Scented, Chemotherapy Drugs And Fentanyl Test Claim (K220401)Riverstone Resources Sdn Bhd2022-04-09
visor2 system (K210109)Eemagine Medical Imaging Solutions GmbH2022-04-08
Bioabsorbable Anchor (K213958)Embody, Inc.2022-04-08
CD Horizon™ Spinal System and PASS LP™ Spinal System (K220724)Medicrea International2022-04-08
Oxygen Concentrator (K202389)Foshan Mic Medical Technology Co., Ltd.2022-04-08
Fitbit Irregular Rhythm Notifications (K212372)Fitbit, Inc.2022-04-08
TLX SRAs and TLX Gold Abutments (K213063)Institut Straumann AG2022-04-08
Prestige Coil System (K220699)Bait USA, LLC2022-04-08
Latex Examination Gloves, Powder Free (K213509)Shandong Intco Medical Products Co, Ltd.2022-04-08
ECHELON 3000 45mm Stapler, ECHELON 3000 60mm Stapler (K213633)Ethicon Endo-Surgery, LLC2022-04-08
Drive Rail System (K220809)OrthoPediatrics Corp.2022-04-08
Thermeo System (K212017)Pro3Dure Medical GmbH2022-04-08
Breast BI Coil Set 0.55T; Breast BI 7 MR Coil Set 1.5T; Breast BI 7 MR Coil Set 3T (K220144)Noras Mri Products GmbH2022-04-08
ImaCor Zura Handheld ZHH-010 (K220490)Imacor, Inc.2022-04-08
Non-sterile, Powder-Free Latex Examination Glove (K212309)Sri Trang Gloves (Thailand) Public Company Limited2022-04-08
SCOUT BX Delivery System (K212882)Merit Medical Systems, Inc.2022-04-08
Vantage Galan 3T, MRT-3020, V8.0 with AiCE Reconstruction Processing Unit for MR (K220192)Canon Medical Systems Corporation2022-04-08
INT Contour (K212274)Carina Medical, LLC2022-04-08
DORA Disposable A.V. Fistula Needle Sets (K213015)Bain Medical Equipment (Guangzhou) Co., Ltd.2022-04-08
Corin MetaFix™ Hip Stem (K212069)Corin U.S.A. Limited2022-04-07
Electrocardiograph (K212278)Edan Instruments, Inc.2022-04-07
Dong Hai Xiang Surgical Mask (K212203)Taizhou Donghaixiang Protective Equipment Co., Ltd.2022-04-07
Invisalign System (K220287)Align Technology, Inc.2022-04-07
Green OR Reprocessed Aquamantys Bipolar Sealer (K211203)Green Or, LLC2022-04-07
Comfort Guard Mask, level 1, Comfort Guard Mask, level 3 (K210860)Gri-Alleset, Inc.2022-04-07
ANGIOGUARD XP Emboli Capture Guidewire, ANGIOGUARD RX Emboli Capture Guidewire (K220654)Cordis Corporation2022-04-06
Onera Sleep Test System (Onera STS) (K210593)Onera B.V.2022-04-06
Disposable Medical Mask (K214085)Hubei Wanli Protective Products Co., Ltd.2022-04-06
NB 1 SA Implant System (K213506)Arum Dentistry Co., Ltd.2022-04-06
MTM301 Blood Glucose and Ketone Monitoring System (K202534)Apex BioTechnology Corp.2022-04-06
ClariPulmo (K203783)Claripi, Inc.2022-04-06
Extended Reservoir (K210714)Medtronic Minimed, Inc.2022-04-06
Balloon Dilatation Catheter (K213578)Hangzhou AGS MedTech Co., Ltd.2022-04-06
ALTMS Magnetic Stimulation Therapy System, Blossom TMS Therapy System (K220625)Remed Co., Ltd.2022-04-06
3M Attest Super Rapid Steam Biological Indicator, 3M Attest Super Rapid Steam Challenge Pack, 3M Attest Auto-reader, 3M Attest Mini Auto-reader (K213809)3M Company2022-04-06
Prodigy Thrombectomy System (K214114)Truvic Medical, Inc.2022-04-06
Plasmage System (K202106)Brera Medical, Inc.2022-04-06
Infrared Thermometer (model: E201) (K213011)Bioland Technology, Ltd.2022-04-05
Verifine Safety Syringe with Fixed Needle (K213560)Promisemed Hangzhou Meditech Co., Ltd.2022-04-05
Accu-Chek Safe-T-Pro Uno Lancing Device (K220364)Roche Diabetes Care, Inc.2022-04-05
DRPx Locking Distal Radius Plate System (K212601)Orthopaedic Implant Company2022-04-05
MRCAT Head & Neck (K214081)Philips OY2022-04-05
HERA W10 Diagnostic Ultrasound System, HERA W9 Diagnostic Ultrasound System (K220043)Samsung Medison Co., Ltd.2022-04-05
Clever Forehead Thermometer / Clever Medical Forehead Thermometer (Model TD-1241) (K200946)Taidoc Technology Corporation2022-04-05
Geistlich Bio-Gide, Geistlich Bio-Gide Shape, Geistlich Bio-Gide Compressed, Geistlich Bio-Gide Perio, Geistlich Combi-Kit Collagen and Geistlich Perio-System Combi Pack (K212463)Geistlich Pharma AG2022-04-05
Apyx (K213783)Escala Medical2022-04-05
Medical surgical mask (Black mask, Level 1 and Level 3) (K213450)Guangdong Kingfa Sci. & Tech.Co., Ltd.2022-04-05
Co-Innovation One Step Human Chorionic Gonadotropin (HCG) Test Strip, Co-Innovation One Step Human Chorionic Gonadotropin (HCG) Test Cassette, Co-Innovation One Step Human Chorionic Gonadotropin (HCG) Test Midstream (K213808)Co-Innovation Biotech Co., Ltd.2022-04-05
Vantage Fortian/Orian 1.5T, MRT-1550, V8.0 with AiCE Reconstruction Processing Unit for MR (K220335)Canon Medical Systems Corporation2022-04-05
Digital thermometer, Model DT101, DT102 (K213746)Guangzhou Berrcom Medical Device Co., Ltd.2022-04-05
AlphaVac Multipurpose Mechanical Aspiration (MMA) F1885 System (K213388)AngioDynamics, Inc.2022-04-04
MediExpand Cervical Expandable VBR System (K212126)Cmf Medicon Surgical, Inc.2022-04-04
ERI Handheld Dental X-ray System (Model AG100) (K213282)Energy Resources International Co., Ltd. Hsinchu Branch2022-04-04
Invictus® Spinal Fixation System (K214006)Alphatec Spine, Inc.2022-04-04
TRATE Dental Implant System (K220022)Trate AG2022-04-04
EFAI Intelligent Cardiothoracic Ratio (iCTR) Assessment System (K212624)Ever Fortune.Ai, Co., Ltd.2022-04-04
ELAZ Nitrile Powder Free Examination Glove (K213604)Protect Gloves Co., Ltd.2022-04-03
Medical Nitrile Examination Gloves (K220066)Hunan Zhenheyikang Medical Instrument Co., Ltd.2022-04-03
Nitrile Examination Gloves (K220343)Nb Medical Co., Ltd.2022-04-02
Trinity Plus Wrinkle Reducer (K212947)Carol Cole Company Dba Nuface2022-04-02
LiteAire Basic Dual-Valved, Collapsible MDI Holding Chamber (K210558)Thayer Medical Corporation2022-04-01
SKANRAD 400 (K220518)Skanray Technologies Limited2022-04-01
Wireless Digital Flat Panel Detector (K220668)Iray Technology Taicang , Ltd.2022-04-01
Aveir Retrieval Catheter (K213494)ABBOTT MEDICAL2022-04-01
PuraStat-RM (K213552)3-D Matrix, Inc.2022-04-01
CoolTone (K220601)Zimmer Medizinsysteme GmbH2022-04-01
MIS Angulated multi-unit abutments (K213432)Dentsply Sirona2022-04-01
Prismaflex ST60 Set, Prismaflex ST100 Set, Prismaflex ST150 set (K212216)Baxter Healthcare Corporation2022-04-01
EMPOWR Revision Knee (K213793)Encore Medical L.P.2022-04-01
Intri24 Sheath (K212392)Inari Medical, Inc.2022-04-01
Saneso Colonoscope 360-A (Model: with/without Select Band Imaging (SBI) and with/without Dual Band Imaging(DBI)), Saneso Single Camera Colonoscope-A (Model: with/without Select Band Imaging (SBI)), Saneso Gastroscope 360-A (Model: with/without Select Band Imaging (SBI) and with/without Dual Band Imaging(DBI)), Saneso Single Camera Gastroscope-A (Model: with/without Select Band Imaging (SBI)) (K210052)Saneso, Inc.2022-04-01
Monitor B105M, Monitor B125M, Monitor B155M, Monitor B105P, Monitor B125P (K213490)Ge Medical Systems Information Technologies, Inc.2022-04-01
TENS and EMS Stimulation (OTC) (K212184)Changsha Yuwen Medical Equipment Co., Ltd.2022-04-01
HD-550 Video Endoscope System (K211882)Sonoscape Medical Corp.2022-04-01
DEEPVESSEL FFR (K213657)Keyamed Na, Inc.2022-04-01
Dakota ALIF System (K213118)Precision Spine, Inc.2022-04-01
TENS & PMS Unit (K220005)Shenzhen Yuehua Xinsen Technology Co., Ltd.2022-04-01
MAGNETOM Avanto Fit (K220151)Siemens Medical Solutions USA, Inc.2022-04-01
Disposal Medical Nitrile Examination Gloves-Tested for Use with Chemotherapy Drugs (K220353)Niujian Technology Co., Ltd.2022-03-31
Elecsys proBNP II, Elecsys proBNP II STAT (K210546)Roche Diagnostics2022-03-31
PhasTIPP (K212894)LeMaitre Vascular, Inc.2022-03-31
NEXXT SPINE NAVIGATION System (K220291)Nexxt Spine, LLC2022-03-31
Air Compression Therapy Device, model: ST-502 (K213745)Shenzhen Future Electronic Co., Ltd.2022-03-31
Uterine ElevatOR PRO with OccludOR Balloon (K220202)The O R Company Pty, Ltd.2022-03-31
PediGuard Threaded (K220160)Spineguard S.A.2022-03-31
BD Cathena Safety IV Catheter (K220584)Becton Dickinson Infusion Therapy Systems, Inc.2022-03-31
Alexis Contained Extraction System (K211043)Applied Medical Resources Corporation2022-03-31
Hercules Syndesmosis Implant System (K220260)In2bones USA, LLC2022-03-31
ARx® Spinal System (K220025)Life Spine, Inc.2022-03-31
STATIM 6000B Vacuum Autoclave (K214057)Scican , Ltd.2022-03-31
TargetCool (K220674)Recensmedical, Inc.2022-03-31
Golnit Nylon Monofilament Suture (K212888)Antarma, LLC Dba Golnit Sutures2022-03-31
Nitrile Examination Gloves (K213843)Dong Tai City Huayi Gloves Co., Ltd.2022-03-31
ERIC Retrieval Device (K211120)MicroVention, Inc.2022-03-31
Vinyl Co-Polymer Powder-free Examination Gloves, Black (K220240)Grand Work Plastic Products Co., Ltd.2022-03-31
APX-24 Portable X-ray System (K220678)Aspenstate, Inc.2022-03-31
Medical Face Mask (K213736)Hangzhou Runheng Medical Co., Ltd.2022-03-31
BD Trek Powered Bone Biopsy System (K213896)Bard Peripheral Vascular2022-03-30
Shield System (K212159)Radiaction , Ltd.2022-03-30
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Every clearance here is in the API, with alerts when new ones post.