Atlas FDA

2023

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

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RecordFirmDate
EMS Neck Massager (K233492)Xiamen Comfier Technology Co., Ltd.2023-12-20
TM Plating System (K233017)Tyber Medical, LLC2023-12-20
Blood Pressure Monitor (K233130)Guangdong Transtek Medical Electronics Co., Ltd.2023-12-20
Tactoset® Injectable Bone Substitute (K231968)Anika Therapeutics, Inc.2023-12-20
DEKA LILY (K233470)El.En S.P.A.2023-12-19
Conductive Silicone Electrode (model: Foot Pad Electrode, Cupping Electrode, Point Electrode) (K221199)Green Island International Tcm Group Limited2023-12-19
PMT Facet Fixation System, Lumbar (PMT FFS-LX) (K230840)Providence Medical Technology, Inc.2023-12-19
IntelliVue Patient Monitor MX750 (866471), IntelliVue Patient Monitor MX850 (866470), IntelliVue 4-Slot Module Rack FMX-4 (866468) (K231671)Philips Medizin Systeme Boeblingen GmbH2023-12-19
TD-7301 Peak Flow meter (K222810)Gostar Co., Ltd.2023-12-19
Bactiseal EVD Catheter Sets; Bactiseal Clear EVD Catheter Set (K233448)Integra Lifesciences Production Corporation2023-12-19
PRIMUS Healthcare Sterilizer (Model PSS11-HA & PSS11-HB) (K233132)Primus Sterilizer Company, LLC2023-12-19
Angled Abutment (K232560)Arum Dentistry Co., Ltd.2023-12-19
CORAIL Cemented Femoral Stem (K231526)Depuy Ireland UC2023-12-19
JETi™Hydrodynamic Thrombectomy System (K232458)ABBOTT MEDICAL2023-12-19
ZENEX Implant System_Short (K233163)Izenimplant Co., Ltd.2023-12-19
GORE® ACUSEAL Vascular Graft (K233551)W. L. Gore & Associates, Inc.2023-12-19
Access hsTnI (K222881)Beckman Coulter, Inc.2023-12-18
SiOxD Wound Matrix (K232847)Sioxmed, LLC2023-12-18
CuratOR EX3242-FD (K231066)Eizo Corporation2023-12-18
ClotTriever Sheath (K233815)Inari Medical, Inc.2023-12-18
S-Plant Dental Implant System (K231429)Idis Co., Ltd.2023-12-18
iQ-solutions (K231929)Sydney Neuroimaging Analysis Centre Pty, Ltd.2023-12-18
CC-Clip® Implant System (K232780)Cc-Instruments, Inc.2023-12-18
MAGNETOM Cima.X (K231587)Siemens Medical Solutions USA, Inc.2023-12-18
Ion Endoluminal System (IF1000) (K232984)Intuitive Surgical, Inc.2023-12-18
AMT G-Tube Balloon Gastrostomy Feeding Device (K222846)Applied Medical Technology, Inc.2023-12-18
FlexCath Cross Transseptal Solution (K233691)Acutus Medical, Inc.2023-12-17
Air Compression Recovery System (K233536)Shenzhen Dongjilian Medical Tech Co., Ltd.2023-12-16
Powder Free Nitrile Examination Gloves (Blue, White, Black and/or Violet Blue) (K233182)Zibo Kaiyue Mould Technology Co., Ltd.2023-12-15
Sterile and Non-Sterile Ultrasound Gels (K232957)Jianerkang Medical Co., Ltd.2023-12-15
Digital Blood Pressure Monitor (Model: YB-800) (K231478)Wenzhou Yosun Medical Technology Co.,Ltd2023-12-15
ConFirm 20 Minute Incubator (K233681)STERIS Corporation2023-12-15
Medline ReNewal Reprocessed ViewFlex Xtra ICE Catheter (K232130)Surgical Instrument Services and Savings, Inc.2023-12-15
IPL Hair Removal Device (K232939)Shenzhen Borria Technology Co., Ltd.2023-12-15
Internal Locking Plate and Screw Fixation System (K232394)Changzhou Geasure Medical Apparatus and Instruments Co., Ltd.2023-12-15
SeptiCyte RAPID (K232095)Immunexpress, Inc.2023-12-15
Videa Dental Assist (K232384)Videahealth, Inc.2023-12-15
MagnetOs Easypack Putty (K233607)Kuros Biosciences B.V2023-12-15
Precice Max System (K232267)Nuvasive Specialized Orthopedics, Incorporated2023-12-15
VERIFY SPORE TEST STRIP for S40 STERILANT CONCENTRATE (K233682)STERIS Corporation2023-12-15
Masimo Stork (K223721)Masimo Corporation2023-12-15
Ova+ (K-OVAP-USA) (K230926)Tenscare, Ltd.2023-12-15
ARTIS pheno (VE30A) (K230949)Siemens Medical Solutions USA, Inc.2023-12-15
Invisalign Palatal Expander System (K232887)Align Technology, Inc.2023-12-15
Panther TPS (K231825)Prowess, Inc.2023-12-15
Unscented Menstrual Tampon (K232598)Unibeauty (Hubei) Technology Co., Ltd.2023-12-15
Cardio Q50, Cardio Q70 (K231160)Bionet Co., Ltd.2023-12-15
Ziehm Vision FD (K231700)Ziehm Imaging GmbH2023-12-15
Spirobank Oxi (K230501)Mir Medical International Research USA2023-12-15
xeo+ Family (K233237)Cutera, Inc.2023-12-15
Double Internal Joint Stabilizer- Elbow (K231447)Skeletal Dynamics, Inc.2023-12-15
EW10-EC02 Endoscopy Support Program (K230751)Fujifilm Corporation2023-12-15
Hp Detect™ Stool Antigen ELISA (K232892)Biomerica, Inc.2023-12-15
Body Temperature Software (BTS) (DEN230050)Fitbit, LLC2023-12-15
Auryon Atherectomy Catheter 1.5 mm XL, Hydrophilic Coating (EXM-4010-H000), Auryon Atherectomy Catheter 0.9 mm XL, Hydrophilic Coating (EXM-4011-H000), Auryon Atherectomy Catheter 1.5 mm XL (EXM -4010-0000), Auryon Atherectomy Catheter 0.9 mm XL (EXM-4011-0000) (K233668)Eximo Medical, Ltd.2023-12-15
FLUOBEAM® LX Imaging System (FB-LX); FLUOBEAM® LX Red Imaging System (FB-LXR) (K233564)Fluoptics Sas (A Getinge Group Company)2023-12-15
PhySoftAMS® (K232283)Physician Software Systems, LLC2023-12-14
Secret Pro (K233374)Ilooda Co,., Ltd.2023-12-14
ARTIS icono (VE30A) (K230950)Siemens Medical Solutions USA, Inc.2023-12-14
MedHealth DVT compression Devices MHH900S/MHH900E (K231801)Medhealth Medical Limited2023-12-14
Disposable Hot Biopsy Forceps (K231721)Beijing Zksk Technology Co., Ltd.2023-12-14
Disposable Veress Needles (K232401)Hangzhou Kangji Medical Instrument Co., Ltd.2023-12-14
StrokeViewer Perfusion (K231570)Nico-Lab B.V.2023-12-14
VersaCross Connect™ Transseptal Dilator (K233647)Baylis Medical Company, Inc.2023-12-14
Millipede 088 Access Catheter (K233648)Perfuze, Ltd.2023-12-14
SofWave System (K232455)Sofwave Medical, Ltd.2023-12-14
Disposable Endobronchial Blocker Tube (K232580)Shenzhen Insighters Medical Technology Co., Ltd.2023-12-14
PherDal® At-Home Insemination Kit (K231645)Pherdal Fertility Science, Inc.2023-12-14
Ascension Silicone MCP; Ascension Silicone PIP (K233670)Ascension Orthopedics, Inc.2023-12-14
bright CT (K231181)Dentium Co., Ltd (Ict Branch)2023-12-14
C50 (K223470)Sopro2023-12-14
Vial Adapter 20mm (K232875)West Pharma. Services IL, Ltd.2023-12-14
VELYS™ Robotic-Assisted Solution (K233227)Depuy Ireland UC2023-12-14
ARIX Ankle Distal Tibia System (K231887)Jeil Medical Corporation2023-12-14
Endoscopic Ultrasonic Probe (P2612S-L); Endoscopic Ultrasonic Probe (P2620S-L) (K231666)FUJIFILM Healthcare Americas Corporation2023-12-13
ACCLARENT AERA Eustachian Tube Dilation System (K230742)Acclarent, Inc.2023-12-13
Power Wheelchair (N5909) (K230964)Zhejiang Innuovo Rehabilitation Devices Co.,Ltd2023-12-13
Kalitec Navigated Instrument System (K232572)Kalitec Direct, LLC Doing Business AS Kalitec Medical2023-12-13
QP-Brain® (K232231)Quibim S.L.2023-12-13
DT Controlled Phototherapy Equipment (K233811)Daavlin Distributing Co.2023-12-13
FaSet Fixation System, UNITY Sacroiliac Joint Fixation System, Huvex Interspinous Fixation System, and AEON-C™ Stand Alone System (K232877)K&J Consulting Corporation2023-12-13
HemosIL Chromogenic Factor IX (K230852)Instrumentation Laboratory Company2023-12-13
CASE V7.0 Cardiac Testing System and CardioSoft V7.0 Cardiac Testing System (K231870)Ge Medical Systems Information Technologies, Inc.2023-12-13
NeuroStar Advanced Therapy System (Version 3.8) (K233621)Neuronetics2023-12-13
Sofia 2 SARS Antigen+ FIA; Sofia 2 SARS Antigen+ FIA Control Swab Set (K233688)Quidel Corporation2023-12-13
SaliPen (K232063)Saliwell , Ltd.2023-12-13
EndeavorRx (K231337)Akili Interactive Labs, Inc.2023-12-13
Anatomical Plating System (various) (K232652)Tyber Medical, LLC2023-12-13
Tyto Insights for Wheeze Detection (K232237)Tyto Care , Ltd.2023-12-13
fMRI Hardware System (K232680)Nordicneurolab AS2023-12-13
MiroTract Wound Matrix (K231614)Reprise Biomedical, Inc.2023-12-13
Dochek® Multi-Drug Urine Test Cup Rx, Dochek® Multi-Drug Urine Test Cup (K232659)Guangzhou Decheng Biotechnology Co., Ltd.2023-12-13
Radiant Renewal Skincare Wand (HD-15, HD-15A) (K232863)Shenzhen Kaiyan Medical Equipment Co., Ltd.2023-12-13
AllTest Multi-Drug Rapid Test Cup; AllTest Multi-Drug Rapid Test Panel; AllTest Multi-Drug Rapid Test Cup Rx; AllTest Multi-Drug Rapid Test Panel Rx (K233019)Hangzhou AllTest Biotech Co., Ltd.2023-12-13
Neodent Implant System - Zirconia Implant System (K231803)JJGC Indústria e Comércio de Materiais Dentários S.A.2023-12-13
Atalante X (K232077)Wandercraft SAS2023-12-13
N Antisera to Human Immunoglobulins (IgG, IgA, and IgM) (K233663)Siemens Healthcare Diagnostics Products GmbH2023-12-13
Genesys Spine 3DP AIS-C II Cervical Interbody System (K233594)Genesys Spine2023-12-13
CLEARFIL Universal Bond Quick 2 (K231039)Kuraray Noritake Dental, Inc.2023-12-13
TeleScan (K233634)Bb Imaging2023-12-12
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Every clearance here is in the API, with alerts when new ones post.