Atlas FDA

2023

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

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RecordFirmDate
Sterile Aesthetic Cannula and Hypodermic Needle (K223327)Shanghai Kindly Enterprise Development Group Co., Ltd.2023-02-16
uMR 680 (K222755)Shanghai United Imaging Intelligence Co., Ltd.2023-02-16
Bambino 3, S3 and S3 Swing, U3 and U3 Light, X (K220698)Panthera AB2023-02-16
NUVISION™ NAV Ultrasound Catheter (K223766)Biosense Webster, Inc.2023-02-16
Single-use Video Pancreaticobiliary Scope, PB Digital Controller (K221784)Micro-Tech (Nanjing) Co., Ltd.2023-02-16
uCT ATLAS Astound with uWS-CT-Dual Energy Analysis (K223028)Shanghai United Imaging Healthcare Co., Ltd.2023-02-16
Disposable Infusion Bag for Parenteral Nutrition (K222622)Beijing L&Z Medical Technology Development Co., Ltd.2023-02-16
Stryker Q Guidance System with Cranial Guidance Software, CranialMask Tracker and Microscope Tracker, Passive Optical Navigation Instruments, Mayfield Base with Articulating Arm, and Navigated Biopsy Needle, Electromagnetic Navigation Instruments, Precision Targeting System (K212194)Stryker Corporation2023-02-16
IPL Hair Removal, Model(s): SB01, SB01A, SB01B, SB01C, SN02, SN03 (K223524)Morlaser Shenzhen Co., Ltd.2023-02-16
ZEUS System (K222389)iRhythm Technologies, Inc.2023-02-15
Tanning Lamp (K221523)Unilam Co., Ltd.2023-02-15
Xpert® FII & FV (K223046)Cepheid®2023-02-15
SC HONKYTONK PTCA Balloon Dilatation Catheter (K223022)Sino Medical Sciences Technology, Inc.2023-02-15
ONE DROP Lancing Device (K223815)Stat Medical Devices2023-02-15
Verisafe Safety sterile needles (K222271)Promisemed Hangzhou Meditech Co., Ltd.2023-02-15
Digital Radiography CXDI-CS01 (K230175)Canon, Inc.2023-02-15
ReShape Calibration Tubes (K230131)Reshape Lifesciences2023-02-15
Versana Essential (K223407)GE Medical Systems Ultrasound and Primary Care Diagnostics2023-02-15
Altis Single Incision Sling System (K221874)Coloplast A/S2023-02-15
LIGHTSCALPEL LS-4020 (K213669)Lightscalpel, Inc.2023-02-15
Cobra Catheter System (K223891)Endovascular Engineering2023-02-15
Arm Blood Pressure Monitor (K222869)Andon Health Co, Ltd.2023-02-15
Endocem MTA Premixed Regular (K213757)Maruchi2023-02-14
Citregen™ Tendon Interference Screw (TIS), Citrelock™ Tendon Fixation Device, Citrespline™ and Citrelock™ ACL Implants (K221468)Acuitive Technologies, Inc.2023-02-14
StitchKit (K221527)Origami Surgical Inc .2023-02-14
X-Pac Expandable LLIF Cage System (K223174)Expanding Innovations, Inc.2023-02-14
8ch T/R Knee Coil (K223225)Shenzhen RF Tech Co., Ltd.2023-02-14
Tritanium C Anterior Cervical Cage, Tritanium PL Cage, Tritanium TL Curved Posterior Lumbar Cage, Tritanium X PL Expandable Posterior Lumbar Cage, Tritanium X TL Expandable Curved Posterior Lumbar Cage, Stryker Spine VLIFT Vertebral Body Replacement System, VLIFT-s Vertebral Body Replacement System, Ascential IBD PEEKc Spacer, Aero-AL Lumbar Cage System, Aero-LL Lumbar Cage System, Aero-C Cervical Cage System, AVS Aria PEEK Spacer, AVS Anchor-C Cervical Cage System, AVS Anchor-L Spacer (K221490)Stryker Spine2023-02-14
Creo Electrosurgical System with NP1 Instrument (K221672)Creo Medical, Ltd.2023-02-14
NeatNick Heel Safety Lancet (K223370)Facet Technologies, LLC2023-02-13
Prevena Plus 125 Therapy Unit (K223263)3M2023-02-13
Ortho Guidance Precision Knee Software, Ortho Guidance Express Knee Software, Ortho Guidance Versatile Hip Software, Ortho Q Guidance System (K223767)Stryker Leibinger GmbH & Co KG2023-02-13
Indigo® Aspiration System – Lightning Bolt Aspiration Tubing (K223186)Penumbra, Inc.2023-02-13
Arrow 0.2 Micron Flat Filter, GVS (K222341)Arrow International, LLC2023-02-13
SIGNA Victor (K223439)Ge Healthcare (Tianjin) Company Limited2023-02-13
AmeriWater MediQA Reverse Osmosis System (MSP3HF) (K223656)AmeriWater, LLC2023-02-13
Sterilization Pouch and Roll (K221875)Qianjiang Kingphar Medical Packaging & Printing Co., Ltd.2023-02-13
Curiteva Porous PEEK Cervical Interbody Fusion System (K213030)Curiteva, Inc.2023-02-13
Bloomlife MFM-Pro (K222327)Bloom Technologies NV2023-02-13
V8 Diagnostic Ultrasound System, V7 Diagnostic Ultrasound System (K223387)Samsung Medison Co., Ltd.2023-02-13
ACUSON Juniper Diagnostic Ultrasound System, ACUSON Juniper Select Diagnostic Ultrasound System (K230207)Siemens Medical Solutions USA, Inc.2023-02-13
Sofjec (K212635)Hwajin Medical Co., Ltd.2023-02-13
syngo.via View&GO VA40A (K230196)Siemens Healthcare GmbH2023-02-13
OIC Intramedullary Screw System (K223761)Orthopaedic Implant Company2023-02-13
EMPOWR™ blade stem (K223779)Encore Medical, LLC2023-02-13
Rhino Non-sterile Powder-Free Nitrile Exam Glove – Periwinkle Color Tested for Use with Chemotherapy Drugs and Fentanyl (K223859)Rhino Health, Inc.2023-02-13
SMILE (K213629)Nu Eyne Co., Ltd.2023-02-12
SEJONG Surgical Gown Soft (K220435)Sejong Healthcare Co., Ltd.2023-02-10
Pisces™-SA STANDALONE ALIF Interbody System (K223413)Osseus Fusion Systems2023-02-10
Glass Ceramics (K222513)Yilink (Tianjin) Biotechnology Co., Ltd.2023-02-10
S90 Exp Series Digital Color Doppler Ultrasound System (K222596)Sonoscape Medical Corp.2023-02-10
ARTSMedia In Vitro Culture Medium (AM-IVC Medium) (K220715)Artsmedia Denmark Aps2023-02-10
PRIMUS Healthcare Sterilizer (Model PSS11-HC) (K221474)Primus Sterilizer Company, LLC2023-02-10
Safety Lancet (K223208)Suzhou Zhenwu Medical Co., Ltd.2023-02-10
Disposable Isolation Gown (K223467)Nanning Tecbod Biological Technology Co., Ltd.2023-02-10
Eneka Pro (K223680)Termosalud2023-02-10
Perifit (K221476)X6 Innovations2023-02-10
MD.ai Viewer (K223425)Mdai, Inc.2023-02-10
TELIGEN System Peripheral Motor Nerve Stimulation Indications (K223438)Medos International SARL2023-02-10
Glass Ceramic (K223194)Shenzhen Xiangtong Co., Ltd.2023-02-10
Medical Infrared Thermometer (Model: RST-TC59-1001, RST-TC60-1001) (K220657)Zhejiang Rongsheng Industrial Co., Ltd.2023-02-10
Orthex External Fixation System (K223786)OrthoPediatrics Corp.2023-02-10
RENASYS™-WF White Foam NPWT Dressing Small; RENASYS™-WF White Foam NPWT Dressing Large (K213853)Smith and Nephew Medical Limited2023-02-10
DiLumen C1, EZ1 and Tool Mount (K221452)Lumendi, LLC2023-02-10
Pro-Tx Endorectal Balloon (PROT-25) (K223249)Dxtx Medical, Inc.2023-02-10
Nitrile Examination Powder Free Glove, Blue Tested For Use With 32 Chemotherapy Drugs and Fentanyl Permeation Resistance Claim, Nitrile Examination Powder Free Glove, Black Tested For Use With 32 Chemotherapy Drugs and Fentanyl Permeation Resistance Claim (K222129)Top Glove Medical (Thailand) Co., Ltd.2023-02-10
Sterile Syringes for Single Use (K223678)Shanghai Kindly Enterprise Development Group Co., Ltd.2023-02-09
Okti (K230073)Compumedics Limited2023-02-09
External Drainage System (K221694)Jmed(Shenzhen) Technology Limited2023-02-09
Nephron Nitrile Powder-Free Nitrile Examination Gloves (Tested For Use With Chemotherapy Drugs) (K223559)Nephron Pharmaceuticals Corporation2023-02-09
Insulin syringe with integrated needle DL (K203211)Dlp Medical Products, Corp.2023-02-09
CYGNUS-C Standalone ACIF System (K222041)GS Medical Co., Ltd.2023-02-09
hygh-tec drainage (K221400)Creative Balloons GmbH2023-02-09
extriCARE® 3000 Negative Wound Pressure Therapy System (K221223)Alleva Medical Devices2023-02-09
ETHICON LINX® Esophagus Sizing Tool (K230089)Torax Medical, Inc.2023-02-09
ATTIVA (K220505)Italian Engineering S.R.L.2023-02-09
G Surgical Marksman Spinal Deformity System (K230063)G Surgical, LLC2023-02-09
Toothsi, Smilealigners (K223338)Makeo Healthcare Technologies Private Limited2023-02-09
VITEK 2 AST-Gram Negative Cefazolin (<=1 - >=32 ug/mL) (K222073)bioMerieux, Inc.2023-02-09
Disposable Isolation Gowns (S,M,L,XL,XXL,XXXL) (K223304)Xiamen Probtain Medical Technology Co., Ltd.2023-02-08
NIRA Model 2 (K222685)Dermal Photonics Corp2023-02-08
Access Cortisol (K223038)Beckman Coulter, Inc.2023-02-08
Filter and HME/Filter (K221472)Ningbo Huakun Medical Equipment Co., Ltd.2023-02-08
Hailie Sensor NF0110 (K222247)Adherium (Nz), Ltd.2023-02-08
Resona R9/ Resona R9 Exp/ Resona R9 Pro/ Resona R9S/ Nuewa R9/ Nuewa R9 Exp Diagnostic Ultrasound Sysem, Nuewa R9 Pro/ Nuewa R9S/ Resona 7/ Resona 7CV/Resona 7EXP/Resona 7S/ Resona 70B Diagnostic Ultrasound System, Resona 7PRO/Imagyn 7/ Resona Y/Resona R9W/Resona R7W Nuewa R9W/Nuewa R7W Diagnostic Ultrasound System (K222928)Shenzhen Mindray Bio-Medical Electronics Co., Ltd.2023-02-07
EVOLUTION SPINE Interbody System (K223146)Evolution Spine2023-02-07
Medical Protective Masks (K223686)Qinhuangdao Taizhi Medical Technology Co., Ltd.2023-02-07
SAVE GBR (K222451)Dentis Co., Ltd.2023-02-07
Eminent Spine 3D Cervical Interbody Fusion System (K212701)Eminent Spine2023-02-06
ScanX Swift 2.0, ScanX Swift View 2.0 (K230095)Durr Dental SE2023-02-06
3M™ VitCal Liner/Base (K230270)3M Espe Dental Products2023-02-06
ClotTriever Thrombectomy System (K221531)Inari Medical, Inc.2023-02-06
Powder Free Blue Nitrile Examination Glove (K223444)S&S Glove Corporation2023-02-06
Disposable Powder Free Vinyl Examination Gloves, Beige/Clear (K221980)Ever Global (Vietnam) Enterprise Corporation2023-02-06
ACUSON Sequoia Diagnostic Ultrasound System, ACUSON Sequoia Select Diagnostic Ultrasound System (K223735)Siemens Medical Solutions USA, Inc.2023-02-06
Videa Perio Assist (K223296)Videahealth, Inc.2023-02-06
Nerivio (K223169)Theranica Bioelectronics , Ltd.2023-02-06
Care Team Portal (K222398)Vivify Health, Inc.2023-02-06
Xenta Drug Screen Cup, Xenta Drug Screen Dipcard (K222955)Xenta Biomedical Science Co., Ltd.2023-02-06
Simparo Anchor Line Fixation System (K222574)Simparo, Inc.2023-02-04
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Every clearance here is in the API, with alerts when new ones post.