Atlas FDA

2022

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

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RecordFirmDate
Electronic Thermometer, Model: AET-E201, AET-E211, AET-E221, AET-E231, AET-E241, AET-E251, AET-E301, AET-E311 (K212257)Alicn Medical Shenzhen, Inc.2022-05-04
WaveForm L System, WaveForm TO System, WaveForm TA System (K213420)SeaSpine Orthopedics Corporation2022-05-04
Vista Ophthalmics Vitrectomy Probe (K220030)Vista Ophthalmics, LLC2022-05-04
MyKnee R Pin Positioners (K220705)Medacta International S.A.2022-05-04
exoplan (K213302)Exocad GmbH2022-05-03
ECGenius System (K220306)Cath Vision Aps2022-05-03
MVision AI Segmentation (K212915)MVision AI2022-05-03
Cardiovascular Angiography System (K220311)Allengers Medical Systems Limited2022-05-03
ECHOLASER X4 (K213594)Elesta S.P.A2022-05-03
LINK Endo-Model EVO Knee System (K220628)Waldemar Link GmbH & Co. KG2022-05-03
Intra.Ox 2.0 Handheld Tissue Oximeter (K221010)Vioptix, Inc.2022-05-03
X100HT with Slide Loader with Full Field Peripheral Blood Smear (PBS) Application (K220013)Scopio Labs , Ltd.2022-05-03
Surgical and Prosthetic Trays (K220791)Dentsply Sirona2022-05-03
Orchid Safety Release Valve(TM) (K212064)Linear Health Sciences, LLC2022-05-03
Arthrx Fracture Plates (K213837)Arthrex, Inc.2022-05-02
ExactechGPS® System (K213877)Blue Ortho2022-05-02
Kerasave (DEN200063)Al.Chi.Mi.A. S.R.L2022-05-02
ALPHALOK™ Plating System (K212348)Vilex, LLC2022-05-02
ARx Modular Spinal System (K220341)Life Spine, Inc.2022-05-02
TENS & PMS (Model:SM9009, SM9021, SM9128H, SM9015, SM9055, SM9033) (K220283)Hong Qiangxing (Shenzhen) Electronics Limited2022-05-02
Liver Suite (K211180)GE Medical Systems SCS2022-05-02
Ultiri Measurement System (K220243)ABBOTT MEDICAL2022-04-30
BioFire Joint Infection (JI) Panel (DEN200066)Biofire Diagnostics, LLC2022-04-29
BONREE Nelaton Catheter (K212430)Bonree Medical Co., Ltd.2022-04-29
SteriTite Container System with MediTray Products (K212711)Case Medical, Inc.2022-04-29
Accu-Chek FastClix Blood Lancing System (K220608)Roche Diabetes Care, Inc.2022-04-29
Bindex BI-2 (K211350)Bone Index Finland , Ltd.2022-04-29
Camber Spine Navigation System (K220038)Camber Spine Technologies2022-04-29
Elite Biomedical Solutions Dose Request Cord (K220695)Elite Biomedical Solutions2022-04-29
EEA Circular Stapler with Tri-Staple Technology (K221005)Covidien2022-04-29
LISA Laser Surgical Fibers (K220189)Omni-Guide Holdings, Inc.2022-04-29
Monarch Platform, Urology (K213334)Auris Health, Inc.2022-04-29
Oxehealth Vital Signs (K220899)Oxehealth Limited2022-04-29
Disposable Surgical Isolation Gown (K212422)Crown Name Disposable Hygiene Products Fty., Ltd.2022-04-29
Safety Pen Needle for Single Use, Insulin Pen Needles (K212514)Berpu Medical Technology Co., Ltd.2022-04-29
FreedomEdge Syringe Infusion System (K214045)Repro-Medical System, Inc., Dba Koru Medical Systems2022-04-29
Alinity m STI Assay (K202977)Abbott Molecular, Inc.2022-04-29
Zeus IFA ANA HEp-2 Test System, Zeus dIFine (K201956)Zeus Scientific, Inc.2022-04-29
LOBO Vascular Occlusion System (models LOBO-7 and LOBO-9) (K220383)Okami Medical2022-04-29
Spectrum IQ Infusion System with Dose IQ Safety Software (K220417)Baxter Healthcare Corporation2022-04-29
ARIETTA 50 (K220295)Fujifilm Healthcare Corporation2022-04-29
aPROMISE X (K220590)Exini Diagnostics AB2022-04-29
Hand Diagnostic Radiography Imaging System (K220271)Nanoray Biotech Co., Ltd.2022-04-29
GIA Stapler with Tri-Staple Technology (K221006)Covidien2022-04-29
ExacTrac Dynamic (K220338)Brainlab AG2022-04-29
TIA Tip, Cariosity, Transillumination Accessory Tip (K213482)D4D Technologies, LLC2022-04-29
BodyTom 64 (K213649)Neurologica Corporation2022-04-29
MAGNETOM Lumina and MAGNETOM Vida Fit with syngo MR XA50A (K220939)Siemens Medical Solutions USA, Inc.2022-04-29
Oryx Cloud Imaging (K220684)Oryx Dental Software, Inc.2022-04-29
Digital flat panel detector (K220536)Iray Technology Taicang , Ltd.2022-04-28
AngioCloud Service (K211713)Angiocloud, LLC2022-04-28
Ortholock Anchorage Devices (K202691)Craniofacial Technologies, Inc.2022-04-28
EFAI RTSuite CT HN-Segmentation System (K220264)Ever Fortune.Ai, Co., Ltd.2022-04-28
RetinAI Discovery (K211715)Retinai Medical AG2022-04-28
Microthin Natural Rubber Latex Condom (K213921)Suretex Limited2022-04-28
EARP Interbody System (K212477)Nvision Biomedical Technologies, Inc.2022-04-28
DVR® Crosslock Wrist Spanning Plate (131849181) (K220244)Pioneer Surgical Technology, Inc D.B.A Resolve Surgical Tech2022-04-28
Planmed Verity (K213278)Planmed OY2022-04-28
G7® Vivacit-E® Freedom® Constrained Liner (K212512)Zimmer, Inc.2022-04-28
Geistlich Wound Matrix PLUS (K213607)Geistlich Pharma AG2022-04-28
Nitrile Patient Examination Gloves Blue Tested For Use With Chemotherapy Drugs, Nitrile Patient Examination Gloves Blue Violet Tested For Use With Chemotherapy Drugs,Nitrile Patient Examination Gloves Black Tested For Use With Chemotherapy Drugs (K213040)Guangdong Kingfa Sci. & Tech.Co., Ltd.2022-04-27
Automatically Retractable Safety Syringe (K213077)Zhejiang Lingyang Medical Apparatus Co., Ltd.2022-04-27
Diamondback 360 Peripheral Orbital Atherectomy System, Stealth 360 Peripheral Orbital Atherectomy System, Diamondback 360 Peripheral Orbital Atherectomy System Exchangeable Series (K220568)Cardiovascualr Systems, Inc.2022-04-27
Philips Incisive CT (K212441)Philips Healthcare (Suzhou) Co., Ltd.2022-04-27
Venus BlissMAX (K220592)Venus Concept USA, Inc.2022-04-27
Hand-held IPL device (JOVS Hair Removal Device) (K220645)Shenzhen Qianyu Technology Co., Ltd.2022-04-27
GyroStim (K220231)Ultrathera Technologies, Inc.2022-04-27
EXTesia Introducer Sheath Set (K220604)Curatia Medical Co.2022-04-27
Tomey Cornea/Anterior Segment OCT CASIA2 (K213265)Tomey Corporation2022-04-27
ExsoMed INnate NanoTM Lag Screw System (K220892)Exsomed Corp.2022-04-27
NOxBOXi Nitric Oxide Delivery System (K220898)Linde Gas & Equipment, Inc.2022-04-27
ePlex Blood Culture Identification Gram Negative (BCID-GN) Panel (K213236)Genmark Diagnostics, Incorporated2022-04-27
Strados Remote Electronic Stethoscope Platform (RESP) (K220893)Strados Labs, Inc.2022-04-27
M.U.S.T. MINI Posterior Cervical Screws System Extension (K220570)Medacta International S.A.2022-04-26
SpeedCath Compact Male (K210250)Coloplast2022-04-26
IPL Hair Removal Device, model(s): S1-A, S2-A, S1, S2, S3, S4 (K220222)Shenzhen Yuwei Electronic Technology Co., Ltd.2022-04-26
Legion Inserts with JRNY Lock (K220896)Smith & Nephew, Inc.2022-04-26
BriefCase (K213886)Aidoc Medical , Ltd.2022-04-26
SnapLoc Wire Lock (K213483)Wilson Cook Medical2022-04-26
ManaSport (K210284)Manamed, Inc.2022-04-26
Disposable Medical Face Mask (K220487)Hubei Mediunion Medical Products Co., Ltd.2022-04-26
PERMALOOP Suture, PERMATAPE Suture (K220219)Medos International SARL2022-04-26
AliveCor QT Service (K212662)AliveCor, Inc.2022-04-26
Disposable Surgical Face Mask (M01, M02) (K220512)Fomed Industries, Inc.2022-04-25
CER-S (K213861)Cardiocalm Srl2022-04-25
Shockwave Medical Peripheral Intravascular Lithotripsy (IVL) System (K221041)Shockwave Medical, Inc.2022-04-25
MyoCycle MC-2 (Home / Home + / Pro / Pro +) (K213925)Myolyn, LLC2022-04-25
Glovatex™ White Latex Gloves, Glovanil™ Blue Nitrile Gloves (K213775)Avecena Gloves Sdn Bhd2022-04-24
IVX Fluid Transfer Set (K212530)Omnicell, Inc.2022-04-24
TENS device-EmeTerm 2, Model: YF-ZTY-E2 (K220503)Wat Medical Technology, Inc.2022-04-23
Electric Scooter (K212090)Anhui Jbh Medical Apparatus Co., Ltd.2022-04-22
F&P 850 AirSpiral Adult NIV and NHF Circuit Kit (K212031)Fisher & Paykel Healthcare, Ltd.2022-04-22
LUOFUCON Silver Wound Gel, LUOFUCON Silver Antimicrobial Wound Gel (K211123)Huizhou Foryou Medical Devices Co., Ltd.2022-04-22
SONON Ultrasound Imaging System, Model: SONON 500L (K212400)Healcerion Co., Ltd.2022-04-22
Promisemed Fine Biopsy Needle (K213683)Promisemed Hangzhou Meditech Co., Ltd.2022-04-22
Avanos* CORTRAK* 2 Enteral Access System (EAS) (K220588)Avanos Medical, Inc.2022-04-22
HYBRID S70 (K220574)Digimed Co., Ltd.2022-04-22
1688 4K Camera Control Unit with Advanced Imaging Modality (1688010000), 1688 4K Pendulum Camera Head (1688310130) (K220895)Stryker2022-04-22
PicoStar (K213889)Asclepion Laser Technologies GmbH2022-04-22
ROSA® Knee System (K213708)Orthosoft Inc (D/B/A Zimmer Cas)2022-04-22
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Every clearance here is in the API, with alerts when new ones post.