Atlas FDA

2023

3,346 FDA 510(k) clearances · Clearance year

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RecordFirmDate
ITrack Advance Canaloplasty Microcatheter with Advanced Delivery System (K221872)Nova Eye Inc. (Business Name Nova Eye Medical)2023-03-30
Scanning Laser Ophthalmoscope Mirante [SLO/OCT Model] with Image Filing Software NAVIS-EX; Scanning Laser Ophthalmoscope Mirante [SLO Model] with Image Filing Software NAVIS-EX (K221320)Nidek Co., Ltd.2023-03-30
Emory Cardiac Toolbox 4.3 (K223422)Syntermed2023-03-30
InterView XP; InterView FUSION (K221984)Mediso Medical Imaging Systems, Lttd.2023-03-29
SiJoin®T3 (K213815)Vgi Medical, Inc.2023-03-29
EndoDrill® Model X (K212423)Bibbinstruments AB2023-03-29
RemeOs™ Screw LAG Solid (DEN220030)Bioretec, Ltd.2023-03-29
ROSA® Knee System (K230243)Orthosoft D/B/A Zimmer Cas2023-03-29
Stethophone v1 (K222871)Sparrow Acoustics, Inc.2023-03-29
Calibrate LTX Interbody System (K223611)Alphatec Spine, Inc.2023-03-29
KLS Martin Level One Rib Fixation System (K222397)KLS-Martin L.P.2023-03-29
SMARTRION COMBI/Alexandrite & Long Pulsed Nd:YAG Laser (K222485)Ids, Limited2023-03-29
PUMA-G System (K223916)Coaptech, Inc.2023-03-29
WishBone Medical Plate and Screw System (K230527)Wishbone Medical, Inc.2023-03-29
RayStation 12A (K222312)RaySearch Laboratories AB (PUBL)2023-03-29
Trevo NXT ProVue Retriever (K223305)Stryker Neurovascular2023-03-29
Tactoset (K223915)Anika Therapeutics, Inc.2023-03-29
Reprocessed LigaSure Curved, Small Jaw, Open Sealer/Divider (LF1212A) (K230251)Stryker Sustainability Solutions2023-03-28
KLS Martin Pure Pectus System (K221938)KLS Martin L.P.2023-03-28
MAGNETOM Amira; MAGNETOM Sempra (K223343)Siemens Medical Solutions USA, Inc.2023-03-28
SQUALE (K230026)Implanet, S.A.2023-03-28
Annalise Enterprise CXR Triage Trauma (K222179)Annalise-Ai Pty , Ltd.2023-03-28
Disposable Endoscopic Hemoclip (K222146)Jiangsu Vedkang Medical Science and Technology Co., Ltd.2023-03-28
Annalise Enterprise CXR Triage Trauma (K222268)Annalise-Ai Pty , Ltd.2023-03-28
Electrical Scooter, WT-T4QP2 (K222729)Wu’S Tech Co., Ltd.2023-03-28
X-Y Lubricating Jelly (K220226)R&R Medical Corporation, Ltd.2023-03-28
ISOLIS Cryoprobe (K230271)Varian Medical Systems, Inc.2023-03-28
CapnoSpot™ Pneumothorax Decompression Indicator (K223625)Pneumeric, Inc.2023-03-28
SYSTEM 1 endo Liquid Chemical Sterilant Processing System, Model P6900 (K230582)STERIS Corporation2023-03-28
Capenergy C Equipment RF System - C25, C50, C100, C200, C300, C400, C500 (K222260)Capenergy Medical S.L.2023-03-28
Intense Pulsed Light (IPL) System, model: T023K, T023A, T023B, T023C, T023D, T023E, T021K, T021A, T001A, T001B, T001M, T001N, T011C, T016K (K223928)Shenzhen Fansizhe Science and Technology Co., Ltd.2023-03-28
Remanufactured LigaSure Exact Dissector Without Nano-coating LF2019 (K230255)Stryker Sustainability Solutions2023-03-28
Carestation 750/750c (K213867)Datex-Ohmeda, Inc.2023-03-28
RadioLens v1.0 (K222174)Synapsica2023-03-28
Gas Insufflator (K221995)Surgnova Healthcare Technologies (Zhejiang) Co., Ltd.2023-03-28
DTX Studio Clinic 3.0 (K221921)Nobel Biocare AB2023-03-28
RODIN Palette Naturalizing Kit (K223365)Belport Company, Inc., Gingi-Pak2023-03-27
XT Stain/Glaze (K223192)Shenzhen Xiangtong Co., Ltd.2023-03-27
Meril-Bonewax (K200452)M/s. Meril Endo Surgery Private Limited.2023-03-27
Solero Microwave Tissue Ablation (MTA) System and Accessories (K223581)AngioDynamics, Inc.2023-03-27
Disposable Surgical Face Mask (K223823)Efofex, Inc.2023-03-27
Narrowband UV Phototherapy Light Lamp (Model: HB-UPLL-01, HB-UPLL-02) (K223882)Shenzhen Honpal Optoelectronic Technology Co., Ltd.2023-03-27
Overjet Caries Assist (K222746)Overjet, Inc.2023-03-27
Non-sterile, Powder Free, ambidextrous, textured, beaded cuff, single use, Doffy® Nitrile Examination Glove, Tested for use with Chemotherapy Drugs (K220644)Yty Industry (Manjung) Sdn Bhd2023-03-25
Vinyl examination gloves (K230046)Guangdong Kingfa Sci. & Tech.Co., Ltd.2023-03-25
Quantra Hemostasis Analyzer (K230461)Hemosonics, LLC2023-03-24
Blood Collection Needle (with/without Needle Holder) (K223323)Anhui Hongyu Wuzhou Medical Manufacturer Co., Ltd.2023-03-24
BD Vacutainer® Push Button Blood Collection Set, BD Vacutainer® Push Button Blood Collection Set with Pre-Attached Holder (K220212)Becton, Dickinson and Company2023-03-24
Entarik Feeding Tube System; Entarik Feeding Tube (K230206)Gravitas Medical, Inc.2023-03-24
SmartMTA Capsule (K230797)Sprig Oral Health Technologies, Inc.2023-03-24
BD Texium™ Closed Male Luer (K223076)Care Fusion2023-03-24
Nitrile Powder Free Black Patient Examination Gloves, Non-sterile, Tested for Use with Chemotherapy Drugs (K230002)Mah Sing Healthcare Sdn. Bhd.2023-03-24
Medline Surgical Face Mask and Medline Procedural Face Mask (K223236)Medline Industries, LP2023-03-24
Starly pad (K221589)Shenzhen Xingyuanli Technology Co., Ltd.2023-03-24
3 Series NeoLux (K230382)Daavlin Distributing Co.2023-03-24
BD BACTEC™ Plus Aerobic/F Culture Vials (K222591)Becton, Dickinson and Company2023-03-24
Canary Tibial Extension (CTE) with Canary Health Implanted Reporting Processor (CHIRP) System (K223803)Canary Medical USA, LLC2023-03-24
BD BACTEC™ Myco/F Lytic Culture Vials (K222559)Becton, Dickinson and Company2023-03-24
EVA5 Insufflator (K230474)Palliare , Ltd.2023-03-24
3M V.A.C. Veraflo Cleanse Choice Dressing Kit, 3M Veraflo Cleanse Choice Complete Dressing Kit (K221585)3M Healthcare Business Group2023-03-23
Endo Ultrasonic Activator (K222096)Foshan Coxo Medical Instrument Co., Ltd.2023-03-23
Sterile Hypodermic Syringe for Single Use (K212207)Shandong Weigao Group Medical Polymer Co., Ltd.2023-03-23
VHT-200 Wound Treatment System (K212121)Vaporox, Inc.2023-03-23
SAVE GBR (K222367)Dentis Co., Ltd.2023-03-23
SpaceFlex Acetabular Cup (K223441)G21, S.R.L.2023-03-23
Fixone All Suture Anchor (K222423)Aju Pharm Co., Ltd.2023-03-23
Triever16 Curve (K223419)Inari Medical2023-03-23
Sterilization Wrap (K222151)Kenpax International Limited2023-03-23
Swedge™ Pedicle Screw Fixation System (K230482)Spinal Resources, Inc.2023-03-23
Sterilized Latex Surgical Gloves (K222620)Suzhou Colour-Way New Material Co., Ltd.2023-03-23
Disposable Medical Nitrile Examination Gloves (K223895)Hebei Titans Hongsen Medical Technology Co., Ltd.2023-03-23
3M V.A.C. Peel and Place Dressing Kit, Small (EZ10SML), 3M V.A.C. Peel and Place Dressing Kit, Medium (EZ10MED), 3M V.A.C. Peel and Place Dressing Kit, Large (EZ10LRG) (K222859)3M2023-03-23
ClosureFast™ Endovenous Radiofrequency Ablation Catheter (K223488)Medtronic, Inc.2023-03-23
AccurSound Electronic Stethoscope AS-101 (K221805)Heroic Faith International , Ltd.2023-03-23
Implant-One Multi-Unit Abutment (K212394)Implant Logistics, Inc.2023-03-23
ATEC Lateral Navigation Instruments (K223765)Alphatec Spine, Inc.2023-03-23
MeMed BV (K222332)MeMed Diagnostics, Ltd.2023-03-23
RESPONSE 5.5/6.0 Cannulated Screw System (K222105)OrthoPediatrics Corp.2023-03-23
POLARSHEATH™ Steerable Sheath 12F (UPN:M004CRBS3150), POLARMAP™ Circular Mapping Catheter (UPN:M004CRBS7210), POLARMAP™ EP Electrical Cable (UPN:M004CRBS62000), SMARTFREEZE™ Esophageal Temperature Sensor (ETS) Cable: -SMARTFREEZE™ Esophageal Temperature Sensor (ETS) Cable (UPN: M004CRBS6310), -SMARTFREEZE™ 16 PIN Esophageal Temperature Sensor (ETS) Cable (UPN: M004CRBS6320), -SMARTFREEZE™ CIRCA Esophageal Temperature Sensor (ETS) Cable (UPN: M004CRBS6340), SMARTFREEZE™ Pressure Sensor (K223824)Boston Scientific Corporation2023-03-22
Stativ® Knotted UHMWPE Suture Anchor (K223889)Healthium Medtech Limited2023-03-22
Epi-Stop Nasal Gel/epistaxis pack (K230142)Biomed Ent, Inc.2023-03-22
HF Surgery Generator 400KHZ (K230194)Richard Wolf Medical Instruments Corporation2023-03-22
BioFire Global Fever Special Pathogens Panel; BIOFIRE SHIELD Control Kit for the BioFire Global Fever Special Pathogens Panel (K213362)Biofire Defense, LLC2023-03-22
Tigon Medical Gryphon Anchor Line (K220464)Tigon Medical2023-03-22
Inno-Port Disposable Bladeless Trocar, Inno-Port Disposable Optical Trocar (K223593)Taiwan Surgical Corporation2023-03-22
CardioSTAT® ECG Test Solution (K223049)Icentia, Inc.2023-03-22
MPXA-2000 (K222036)Medipixel, Inc.2023-03-22
Motive™ Electrode (K230533)Cymedica Orthopedics, Inc.2023-03-22
SPIRA®-C Integrated Fixation System (K223837)Camber Spine Technologies2023-03-22
Arise™ UHP Dilatation Catheter (K230191)Creagh Medical, Ltd.2023-03-22
CEREC Tessera Abutment Block, CEREC Tessera Abutment System (K221402)Dentsply Sirona, Inc.2023-03-22
Tryptik Ti (K230583)Spineart SA2023-03-22
Ceribell Instant EEG Headcap (K223086)Ceribell, Inc.2023-03-22
DSM Biomedical Calcium Phosphate Cement (K230054)Dsm Biomedical2023-03-21
Instrument Case P1340904 (K223672)Cochlear2023-03-21
EasyTouch Lancing Device (K222617)Stat Medical Devices2023-03-21
Syngo Carbon Space VA30A (K230561)Siemens Healthcare GmbH2023-03-21
OviTex PRS (Long Term Resorbable) (K214070)Tela Bio2023-03-21
Sensititre 20-24-hour Haemophilus influenzae/Streptococcus pneumoniae MIC or Breakpoint Susceptibility System with Delafloxacin in the dilution range of 0.00025-8ug/ml (Streptococcus species) and 0.000125-8ug/ml (Haemophilus influenzae) (K223844)Thermo Fisher Scientific2023-03-21
Nio Color 2MP (MDNC-2521); Nio Color 3MP (MDNC-3521) (K230520)Barco N.V.2023-03-21
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Every clearance here is in the API, with alerts when new ones post.