Atlas FDA

2023

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

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RecordFirmDate
DOUBLEFLO INFLOW/OUTFLOW PUMP, accessories and tubing sets (K221919)Hemodia Sas2023-03-09
LED Lip Perfector, model: ZC-05 (K223642)Light Tree Ventures Europe B.V.2023-03-09
Essenz HLM (K221373)Livanova Deutschland, GmbH2023-03-09
AutoPulse NXT Resuscitation System (K221700)Zoll Circulation, Inc.2023-03-09
Enhanced AURORA™ Medical Diode System, and related accessories (K230076)Psoria-Shield, Inc.2023-03-08
Persona™ Personalized Knee System (K230321)Zimmer, Inc.2023-03-08
Respiree Cardio-Respiratory Monitor (K223681)Respiree Pte, Ltd.2023-03-08
SINEFIX (K220966)BAAT Medical Products B.V.2023-03-08
Sofia 2 SARS Antigen+ FIA, Sofia 2 SARS Antigen+ FIA Control Swab Set (DEN220039)Quidel Corporation2023-03-08
Arthrex Virtual Implant Positioning (VIP) System (K222007)Arthrex, Inc.2023-03-08
Pulse Oximeter (K220101)Beijing Choice Electronic Technology Co., Ltd.2023-03-08
PRECISION ECO Compostable / Plant Based Procedural Mask with Earloops (K221209)Padm Medical, Inc.2023-03-08
Cryo-Thermo Compression Device (FGK002) (K222136)Suzhou Microport Rehabtech (Group) Co., Ltd.2023-03-08
ManaSport+ (K222098)Manamed, Inc.2023-03-08
Dental Ceramic Blocks (K223742)Aidite (Qinhuangdao) Technology Co., Ltd.2023-03-08
CONDUIT™ Lateral Lumbar Intervertebral Fusion Cage, CONDUIT™ Instruments (K223688)Medos International Sàrl2023-03-08
PathKeeper System (K222355)Pathkeeper Surgical , Ltd.2023-03-08
extriCARE 1000 Negative Pressure Wound Therapy System (K213906)Alleva Medical, Ltd.2023-03-08
Bausch + Lomb (kalifilcon A) Soft (hydrophilic) Contact Lens, Bausch + Lomb (kalifilcon A) Soft (hydrophilic) Contact Lens for Astigmatism, and, Bausch + Lomb (kalifilcon A) Soft (hydrophilic) Contact Lens for Presbyopia (K220613)Bausch & Lomb, Incorporated2023-03-08
Visby Medical Sexual Health Test (K220407)Visby Medical2023-03-07
Solero Microwave Tissue Ablation (MTA) System and Accessories (K221883)AngioDynamics, Inc.2023-03-07
Tyber Medical Anatomical Plating System (K222465)Tyber Medical, LLC2023-03-07
Protrieve Sheath (K230331)Inari Medical, Inc.2023-03-07
Disposable Surgical Gowns (S,M,L,XL,XXL,XXXL) (K223401)Xiamen Probtain Medical Techology Co., Ltd.2023-03-07
Grosz Warming Liquid, Grosz Play Tingling, Grosz KY Yours & Mine (K213892)Rb Health (Us), LLC2023-03-07
Athena III Cervical Plate System (K230301)Medyssey USA, Inc.2023-03-07
MINT Product Family (Including MINT, MINT Lift, and MINT-I Sutures), MINT Lift ML 1043, MINT Lift ML 1013, MINT Lift 1019, MINT Lift Mini 1014 (K220549)Hans Biomed Corporation2023-03-07
MedCAD AccuPlan System (K223024)Medcad2023-03-07
Aquilion Precision (TSX-304A/4) V10.14 with AiCE (K223726)Canon Medical Systems Corporation2023-03-07
Enlight 2100 (K222897)Timpel S.A.2023-03-07
Pro-X1™ Trochanteric Nailing System (K221621)X-Bolt Orthopedics2023-03-06
Radical-7 Pulse CO-Oximeter and Accessories, Rad-97 and Accessories (K212161)Masimo Corporation2023-03-06
BD Vaginal Panel (K223653)Becton, Dickinson and Company2023-03-06
Materialise Shoulder System™ Materialise Shoulder Guide and Models SurgiCase Shoulder Planner (K230315)Materialise NV2023-03-06
Lenire Tinnitus Treatment Device (DEN210033)Neuromod Devices Limited2023-03-06
Savvy Surgical Mask - Level 3 (K230383)Alg Health, LLC2023-03-06
Provata Implant System (K222457)Southern Implants (Pty), Ltd.2023-03-06
Procedure mask/Surgical mask/Face mask (K223232)Winner Medical Co., Ltd.2023-03-06
Single-Use Video Flexible Ureterorenoscope System (K221158)Guangzhou Red Pine Medical Instrument Co., Ltd.2023-03-06
LC ChromeFlow (K222445)S&C Polymer Silicon- Und Composite Spezialitaten GmbH2023-03-06
A1417MCW/A1717MCW/F1417MCW (K223930)H&abyz Co., Ltd.2023-03-06
Disposable Insulin Syringe (K222672)Hantech Medical Device Co., Ltd.2023-03-06
Nitronox Scavenger Plus (K223452)Parker Hannifin Corporation2023-03-05
Lyra Influenza A+B Assay (K230236)Quidel Corporation2023-03-03
Grappler Suture Anchor R3FLEX IOL System (K223589)Paragon 28, Inc.2023-03-03
Aquilion Serve (TSX-307A/1) V1.2 with AiCE-i (K222819)Canon Medical Systems Corporation2023-03-03
Alinity m STI Assay (K222379)Abbott Molecular, Inc.2023-03-03
Polypectomy Snare (K221713)Hangzhou AGS MedTech Co., Ltd.2023-03-03
Light Based Hair Removal Device GP592 (K230060)Shenzhen Gsd Tech Co., Ltd.2023-03-03
EZ Bond Universal (K230009)Meta Biomed Co., Ltd.2023-03-03
Rebellion, Phantom Multi-Bite Kerrison Rongeur (K230256)Morpheus AG2023-03-03
Abdominal Aortic and Junctional Tourniquet - Stabilized (AAJT-S) (K221661)Compression Works, Inc.2023-03-03
INJECTION PIN (KIP(02031-02061) (03031-03061)) (K221697)Slk Ortho, LLC2023-03-03
PEEK Spinal Infusion Cage (K223776)Changzhou Geasure Medical Apparatus and Instruments Co., Ltd.2023-03-03
DHX-70H, XTG-70H (K221587)Digimed Co., Ltd.2023-03-03
imani i2Plus Breast Pump (K222573)Imani Co.2023-03-03
FreeStyle Libre 2 Flash Glucose Monitoring System; Freestyle Libre 3 Continuous Glucose Monitoring System (K222447)Abbott Diabetes Care, Inc.2023-03-03
CoverScan (CoverScan v1.1) (K230294)Perspectum2023-03-03
Aspira Pleural Drainage System (K212696)Merit Medical Systems, Inc.2023-03-03
Endolumik Fluorescence Guided Gastric Calibration Tube (FG Bougie) (K222880)Endolumik, Inc.2023-03-03
NIKKICART (K221652)Renal Care Dialysis Solutions, S.A. DE C.V.2023-03-03
Dyna Locking Trochanteric Nail™ (K221084)Innosys2023-03-03
Electronic Sphygmomanometers (K222394)Qingdao Yasee Medical Device Co., Ltd.2023-03-03
Plasma Pen (Plasma MD); Plasma Pen (Plasma +) (K223440)Plasma Concepts2023-03-02
ReWalk P6.0 (K221696)Re Walk Robotics , Ltd.2023-03-02
Disposable 4 Layers Surgical Face Mask (K230093)Social Medical Supply, LLC2023-03-02
FibroScan® device (Models: 502 Touch, 530 Compact, 430 Mini+, 230, and 630) (K223902)Echosens2023-03-02
Tenderfoot (K223352)Accriva Diagnostics, Inc.2023-03-02
iNod Ultrasound Guided Biopsy Needle (UPN: M00502060), iNod Ultrasound Guidance Console (UPN: M00503210) (K221340)Boston Scientific Corporation2023-03-02
Insulin Syringe (K223453)Promisemed Hangzhou Meditech Co., Ltd.2023-03-02
Artix AX (K223436)Inari Medical2023-03-02
6F Wallaby Long Sheath (K222603)Wallaby Medical, Inc.2023-03-02
BoneView (K222176)Gleamer2023-03-02
NEBA® Compact EEG2R Mobile Headset (K223628)Neba Health, LLC2023-03-02
AccuFFRangio Plus (K230303)ArteryFlow Technology Co., Ltd.2023-03-02
1.5T 24E Posterior Array (K223203)Shenzhen RF Tech Co., Ltd.2023-03-02
Rapid NCCT Stroke (K222884)Ischemaview, Inc.2023-03-02
Traumatic brain injury (TBI) test (K223602)Abbott Laboratories2023-03-02
OPTRELL™ Mapping Catheter with TRUEref™ Technology (K230253)Biosense Webster, Inc.2023-03-02
Galaxy System (K223144)Noah Medical Corp.2023-03-01
Endo SmartCap (K223040)Medivators, Inc.2023-03-01
Bigfoot Unity® Diabetes Management System (K222280)Bigfoot Biomedical, Inc.2023-03-01
Multistage Balloon Dilatation Catheter (K222187)Dongguan TT Medical, Inc.2023-03-01
RSHOCK (K220014)Swims America Corp2023-03-01
Magnes-C Anterior Cervical Plate System (K221053)Fellowship of Orthopaedic Researchers, Inc.2023-03-01
Alma Harmony (K230308)Alma Lasers, Inc.2023-03-01
Peel-Away Introducer (405104, 405108, 405112, 405116, 405118, 405119, 405120, 405122, 405124, 405128, 405129, 405136, 405144, 405145, 405146, 405147, 405149, 405153, 405154, 405254, 405269, 405270, 405404, 405408, 405412, 405416, 405418, 405420, 405422, 405424, 405428) (K230283)ABBOTT MEDICAL2023-03-01
Advantis Platform (K222975)Advantis Medical Imaging Single Member P.C.2023-03-01
Xeleris V Processing and Review System (K221680)GE Healthcare2023-03-01
ProTrack Pigtail Wire (K213898)Baylis Medical Company, Inc.2023-03-01
32HQ713D (K223423)Lg Electronics.Inc2023-03-01
8X-10-6XXX Camera Head (K223116)Santa Barbara Imaging Systems2023-02-28
U2 Total Knee System-PF+ (K221705)United Orthopedic Corporation2023-02-28
HARMONIC 700 Shears (K221790)Ethicon Endo-Surgery, LLC2023-02-28
IPL Hair Removal Device, Model(s): UI06 PN, UI06 PL, UI06 JL, UI06 BR, UI06 DB, UI06 PR, UI06 OG, UI06 RD (K223618)Shenzhen Ulike Smart Electronics Co., Ltd.2023-02-28
PuraStat (K222481)3-D Matrix, Inc.2023-02-28
Mobility Scooter (Models: W3431Q, W3431R) (K222507)Zhejiang Innuovo Rehabilitation Devices Co.,Ltd2023-02-28
EXPLORER AIR® II (K222240)Surgvision GmbH2023-02-28
Terragene® Bionova® Hyper Biological Indicator (BT98), Terragene® Bionova® Hyper Auto-reader Incubator (BHY), Terragene® Bionova® NanoBio Auto-reader Incubator (BNB) (K221641)Terragene S.A.2023-02-28
REVCON (TM) Screw System (K223392)Voom Medical Devices, Inc.2023-02-28
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Every clearance here is in the API, with alerts when new ones post.