Atlas FDA

2022

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

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RecordFirmDate
INTDose (K213137)Carina Medical, LLC2022-05-13
SMR TT Hybrid Glenoid, SMR 3-Pegs Cemented Glenoid (K213785)Limacorporate2022-05-13
Arthrex Self-Punching PushLock Suture Anchor (K221099)Arthrex, Inc.2022-05-13
MAGNETOM Skyra Fit (K220589)Siemens Medical Solutions USA, Inc.2022-05-13
Surgical Face Mask, Model Number-17.5X9.5CM EAR-LOOP (K220749)Unimax Medical Products Co., Ltd.2022-05-13
Violet Nitrile Powder-Free Patient Examination Glove, Non Sterile (K220429)One Glove Industrial Sdn Bhd2022-05-13
Sterile Safety Hypodermic Needles for Single Use (K213535)Zhejiang Kangkang Medical-Devices Co., Ltd.2022-05-13
Reprocessed LigaSure Curved, Small Jaw, Open Sealer/Divider (LF1212A) (K220411)Stryker Sustainability Solutions2022-05-13
Innova Vision Hydrogel (Hioxifilcon A) Soft (Hydrophilic) Contact Lens (K213119)Innova Vision, Inc.2022-05-13
Flow-Nail (K221115)Flow-Fx, LLC2022-05-13
Pre-Formed Penile Silicone Block (K220760)International Medical Devices, Inc.2022-05-13
Spectral CT on Rails (K212875)Philips Medical Systems Nederland B.V.2022-05-13
Capsulo (K220430)Quantel Medical2022-05-12
Motive Knee Wrap (K220738)Cymedica Orthopedics, Inc.2022-05-12
Sterile Hypodermic Syringes for Single Use (K213811)Berpu Medical Technology Co., Ltd.2022-05-12
Saige-Dx (K220105)DeepHealth, Inc.2022-05-12
Nitrile Powder Free Examination Gloves, Chemotherapy Nitrile Powder Free Examination Gloves (K220118)Kl-Kepong Rubber Products Sdn. Bhd.2022-05-12
Synguard Nitrile Exam Glove (K220442)Tianjin Aoshang Outdoor Equipment Co., Ltd.2022-05-12
Universal Pilot Guidance Instrument System (K213491)Ctl Medical Corporation2022-05-12
Citrasate Liquid Acid Concentrate, NaturaLyte Liquid Acid Concentrate (K212620)Fresenius Medical Care Renal Therapies Group, LLC2022-05-12
Laser hair growth helmet (K213025)Kam Yuen Plastic Products , Ltd.2022-05-12
Power Wheelchair (N5515B) (K220747)Zhejiang Innuovo Rehabilitation Devices Co.,Ltd2022-05-12
Electronic Thermometer, Model: AET-F101, AET-F221, AET-F231, AET-F241 (K210937)Alicn Medical Shenzhen, Inc.2022-05-12
IPL Home Use Hair Removal Device (K221001)Shenzhen Beauty Every Moment Intelligent Electric Co., Ltd.2022-05-12
ANSiStim-PP (K220397)Dyansys, Inc.2022-05-12
Power Wheelchair, W5907 (Q50 R Carbon) (K220740)Zhejiang Innuovo Rehabilitation Devices Co.,Ltd2022-05-12
Hand Trauma Screw System (K220723)Skeletal Dynamics, Inc.2022-05-12
VacuumCushions, FeetSupports, LEPS (Lower Extermities Positioning System), CouchStrips (K212909)Macromedics BV2022-05-11
Evis Exera III Duodenovideoscope Olympus TJF-Q190V (K220587)Olympus Medical Systems Corp.2022-05-11
Disposable Barrier Sleeves (K220662)Premium Plus (Dongguan) Limited2022-05-11
Plus Medical Cover Gown (K213177)Foshan Nanhai Plus Medical Co, Ltd.2022-05-11
Procedure Mask, Surgical Mask (K213001)A Plus International, Inc.2022-05-11
Wireless EEG System (K213299)Pascall Systems, Inc.2022-05-11
Sterile Powder Free Nitrile Examination Gloves (Blue), Tested for Use with Chemotherapy Drugs (K220250)Grand Work Plastic Products Co., Ltd.2022-05-11
Versana Balance (K220446)GE Medical Systems Ultrasound and Primary Care Diagnostics2022-05-11
Durex Condom with Benzocaine (K211152)Rb Health (Us), LLC2022-05-11
Overjet Caries Assist (K212519)Overjet, Inc.2022-05-10
BD CTGCTV2 (K210585)Becton, Dickinson and Company2022-05-10
Needle Free Connector (K213004)Medcaptain Life Science Co., Ltd.2022-05-10
White Nitrile Powder-Free Patient Examination Glove, Non Sterile (K220427)One Glove Industrial Sdn Bhd2022-05-10
inHEART MODELS (K220727)Inheart, Sas2022-05-10
SeaSpine Meridian System, SeaSpine Meridian Anterior Plate System (K220711)SeaSpine Orthopedics Corporation2022-05-10
Dental diode laser (K214008)Shenzhen Soga Technology Co., Ltd.2022-05-10
RadiForce MX243W (K221136)Eizo Corporation2022-05-10
Black Nitrile Powder-Free Patient Examination Glove, Non-Sterile (K220428)One Glove Industrial Sdn Bhd2022-05-10
Identity Imprint Knee Replacement System (including Identity Imprint Posterior Stabilized (PS) KRS and Identity Imprint Cruciate Retaining (CR) KRS) (K221059)Conformis, Inc.2022-05-10
Xpert GBS LB XC, GeneXpert Dx System, GeneXpert Infinity System (K203429)Cepheid2022-05-09
Immunalysis Tapentadol Urine HEIA (K203527)Lmmunalysis Corporation2022-05-09
VersaCross Connect Transseptal Dilator (K220414)Baylis Medical Company, Inc.2022-05-09
Compass BDS Biliary Stent (K213946)Cook Ireland, Ltd.2022-05-09
CEFLA Dental Micromotors: i-MMr, i-MMr L, i-MMs, i-XR3, i-XR3 L, i-XS4, handy POWER, handy POWER LED, implantor LED (K213022)Cefla S.C.2022-05-09
Sight OLO (K211840)S.D. Sight Diagnostics , Ltd.2022-05-09
Masimo O3 Regional Oximeter System (K214072)Masimo Corporation2022-05-06
TENS&EMS STIMULATOR (Model: KRES100D, KRES1010, KRES1020, KRES1080) (K213788)Dongguan Bohuikang Technology Co.,Ltd2022-05-06
Elecsys Testosterone II (K211685)Roche Diagnostics2022-05-06
Portable Folding Electric Wheelchair (Model: DC01) (K212092)Anhui Jbh Medical Apparatus Co., Ltd.2022-05-06
Medline Orbis Chemo Surgical Gown (K214108)Medline Industries, LP2022-05-06
KEOPS Balance Analyzer 3D (K213975)S.M.A.I.O2022-05-06
Quantum Heater-Cooler (K212657)Spectrum Medical , Ltd.2022-05-06
IWL2020 Blood Glucose Monitoring System (K203711)Roche Diabetes Care, Inc.2022-05-06
Astroglide Glycerin & Paraben Free (K220653)Biofilm, Inc.2022-05-06
Segment 3DPrint (K211966)Medviso AB2022-05-06
NeuroStar Advanced Therapy for adjunctive treatment of OCD, NeuroStar Advanced Therapy System, NeuroStar TMS Therapy System, NeuroStar Advanced Therapy for Mental Health, NeuroStar (K212289)Neuronetics, Inc.2022-05-06
Nellcor OxySoft Neonatal-Adult SpO2 Sensor, OxySoftN, Nellcor OxySoft Neonatal-Adult SpO2 Sensor, OxySoftNHC (K212555)Covidien, LLC2022-05-06
HM70 EVO Diagnostic Ultrasound System (K220269)Samsung Medison Co., Ltd.2022-05-06
Invu by Nuvo (K221046)Nuvo- Group , Ltd.2022-05-06
Quantum PureFlow Standard Heat Exchanger and Quantum PureFlow Cardioplegia Heat Exchanger (K220110)Qura S.R.L2022-05-06
Vatech Clismile (K220689)Rayence Co., Ltd.2022-05-06
Electric Breast Pump (K212564)Guangdong Horigen Mother & Baby Products Co., Ltd.2022-05-06
PISCES-SA Standalone ALIF Interbody System (K213935)Osseus Fusion Systems2022-05-06
Disposable EEG cable (K213884)Shenzhen Changke Connect Electronics Co., Ltd.2022-05-06
WAVi SCAN EEG System and Accessories (K213900)Wavi Co.2022-05-06
NewTom 7G (K220664)Cefla S.C.2022-05-06
SpyGlass Discover Balloon Dilation Catheter (K212582)Boston Scientific Corporation2022-05-06
Sterile Biliary Stone Retrieval Balloon Catheter, Retrieval Balloon / short-wire compatible (K211021)Micro-Tech (Nanjing) Co., Ltd.2022-05-06
GIA Auto Suture Stapler with DST Series Technology (K221013)Covidien2022-05-05
PosiSep EAR Fragmentable Ear Dressing (K210411)Hemostasis, LLC2022-05-05
Infrared Thermometer, Model: AET-R1B1, AET-R161, AET-R171, AET-R1D1, AET-R1D2, AET-R1F1, AET-R701, AET-R711 (K210565)Alicn Medical Shenzhen, Inc.2022-05-05
NAVIRFA Scope (K211529)Navifus Corporation2022-05-05
Infrared Thermometer, Model: PG-IRT1612, PG-IRT1613, PG-IRT1615, PG-IRT1618 (K212346)Shenzhen Pango Medical Electronics Co., Ltd.2022-05-05
Neuromuscular Transmission Monitor TOF3D (K212434)MIPM Mammendorfer Institut für Physik und Medizin GmbH2022-05-05
HandPICO (K220041)Vydence Medical Industria E Comercio Ltda2022-05-05
AcQGuide® VUE Steerable Sheath (K221044)Acutus Medical, Inc.2022-05-05
Discectomy Navigation Ready Instruments and Universal Navigation Adaptor Set (K212756)Medos International SARL2022-05-05
Viatrac 14 Plus Peripheral Dilatation Catheter (K221057)Abbott Vascular2022-05-05
Spartan SC 069 (K220716)Spartan Micro, Inc.2022-05-05
17HQ901G-B (K220559)Lg Electronics.Inc2022-05-05
LiquID 061 Guide Catheter Extension, LiquID 071 Guide Catheter Extension (K220691)Seigla Medical, Inc.2022-05-05
HIGHTOP Multi-Drug Urine Test Cup, HIGHTOP Multi-Drug Urine Test Cup Rx (K220685)Qingdao Hightop Biotech Co., Ltd.2022-05-05
Steriking Packaging for Medical Devices (K221016)Wipak OY2022-05-05
LiveOne (K201302)Livemetric (Medical) S.A.2022-05-04
Plus Medical Chemotherapy Gown (K211036)Foshan Nanhai Plus Medical Co, Ltd.2022-05-04
ROSA ONE Brain application (K214065)Medtech S.A.S2022-05-04
Lumipulse G ß-Amyloid Ratio (1-42/1-40) (DEN200072)Fujirebio Diagnostics,Inc.2022-05-04
BioTeke Sterile Disposable Virus Sampling Kit (K211707)Bioteke Corporation (Wuxi) Co., Ltd.2022-05-04
Serranator PTA Serration Balloon Catheter (K220704)Cagent Vascular, LLC2022-05-04
Aurora-RT (K213526)Magnettx Oncology Solutions , Ltd.2022-05-04
HydroPICC 5F Dual Lumen Catheter (K213550)Access Vascular, Inc.2022-05-04
Heart5R-110 Portable X-Ray Machine, Heart3R-110 Portable X-ray Machine (K220700)Yian Medical Technology (Haining) Co., Ltd.2022-05-04
Conquest 40 PTA Dilatation Catheter, Atlas Gold PTA Dilatation Catheter, Vida PTV Dilatation Catheter, Vida BAV Balloon Valvuloplasty Catheter (K212588)C.R. Bard, Inc.2022-05-04
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Every clearance here is in the API, with alerts when new ones post.