Atlas FDA

2022

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

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Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free

RecordFirmDate
Vivix-S FW (Model: FXRD-2530FAW, FXRD-3643FAW, FXRD-4343FAW) (K221512)Vieworks Co., Ltd.2022-07-20
Libby Echo:Prio (K220956)Dyad Medical, Inc.2022-07-20
TruDi Shaver Blade (K221037)Acclarent, Inc.2022-07-20
Vario-Cup System (K221794)Waldemar Link GmbH & Co. KG2022-07-20
ZEUS System (Zio Watch) (K213409)iRhythm Technologies, Inc.2022-07-19
Selectra Lead Implantation System (K222037)Biotronik, Inc.2022-07-19
BrainInsight (K220815)Hyperfine, Inc.2022-07-19
Joule diVa System (K213761)Sciton, Inc2022-07-19
MAGIC Flow-Dependent Microcatheter (K213435)Balt USA, LLC2022-07-19
Dual Color Blue/White Powder Free Nitrile Examination Glove with Chemotherapy Drug and Fentanyl Test Claim (K220943)Eco Medi Glove Sdn. Bhd.2022-07-19
Tiche PTA Balloon Dilatation Catheter (K212215)Brosmed Medical Co., Ltd.2022-07-19
ARTIS icono (Ceiling Configuration) (K221516)Siemens Medical Solutions USA, Inc.2022-07-19
Study Watch with Irregular Pulse Monitor (Home), Study Watch with Irregular Pulse Monitor (K213357)Verily Life Sciences, LLC2022-07-19
Beauty LED Mask, Model: KFB265 (K221151)Hunan Guangye Biotechnology Co., Ltd.2022-07-19
Surgical face mask (K220777)Hubei Qianjiang Kingphar Medical Material Co., Ltd.2022-07-19
Planmed Clarity 2D, Planmed Clarify S (K211720)Planmed OY2022-07-18
Vivid T8, Vivid T9 (K221147)GE Medical Systems Ultrasound and Primary Care Diagnostics2022-07-18
KLS Martin Individual Patient Solutions (K210731)KLS-Martin L.P.2022-07-18
Ultrasonic Scalpel System (K212614)Surgnova Healthcare Technologies (Zhejiang) Co., Ltd.2022-07-18
OSSIX Breeze (K212509)Datum Dental, Ltd.2022-07-18
Vivid iq (K221148)GE Medical Systems Ultrasound & Primary Care Diagnostics, LLC2022-07-18
PHOENIX/AeroDR TX m01 and PHOENIX/mKDR Xpress. (K221803)Sedecal., Sa.2022-07-18
Powder Free Nitrile Examination Gloves, (Cobalt Blue and Violet Blue), Powder Free Latex Examination Gloves (K221229)Zibo Blue Sail Health Technology Co., Ltd.2022-07-16
0.9% Sodium Chloride Injection, USP, BD PosiFlush SafeScrub (K213955)Becton, Dickinson and Company2022-07-16
NxtGen Infant Transport Incubator (K220742)International Biomedical2022-07-15
Vivid S60N, Vivid S70N (K220619)GE Medical Systems Ultrasound and Primary Care Diagnostics2022-07-15
Tatum Surgical Dental Implant System (K213576)Suncoast Dental, Inc. Dba Tatum Surgical2022-07-15
Nerve Tape (K210665)Biocircuit Technologies, Incorporated2022-07-15
NeuroStar TMS Therapy System, NeuroStar Advanced Therapy System, NeuroStar, NeuroStar Advanced Therapy for Mental Health (K220127)Neuronetics, Inc.2022-07-15
Selecta Duet LED, Digital Duet, Selecta LED Trio, Digital Trio Laser Systems (K220877)Lumenis Be, Inc.2022-07-15
Facet 28G Universal Lancet (K221433)Facet Technologies, LLC2022-07-15
Kontact Dental Implant System (K213997)Biotech Dental, Sas2022-07-15
OK Handpiece (K221814)Jaintek Co.,Ltd2022-07-15
Alinity m EBV AMP Kit (List No. 09N43-095), Alinity m EBV CTRL Kit (List No. 09N43-085), Alinity m EBV CAL Kit (List No. 09N43-075) (K212778)Abbott Molecular, Inc.2022-07-15
NomadAir PMU810 (K220631)Neurotronics, Inc.2022-07-15
ers2 - ergoline Rehabilitation System (K212883)Ergoline GmbH2022-07-15
Hailie Sensor NF0106 (K220622)Adherium (Nz), Ltd.2022-07-15
Digital Radiography CXDI-Pro, Digital Radiography D1 (K221876)Canon, Inc.2022-07-15
Model 9100 PFT/DICO (K221030)Vitalograph Ireland, Ltd.2022-07-15
ComPAS2 (K213872)Morgan Scientific, Inc.2022-07-15
CUSA Clarity Ultrasonic Surgical Aspirator System (K221763)Integra LifeSciences Corporation2022-07-15
Renuvion APR Handpiece (K220970)Apyx Medical Corporation(Formerly Bovie Medical Corporation)2022-07-15
Anatase Spine Surgery Navigation System, Model number: SNS-Spine2-S and SNS-spine2-V (K220348)Remex Medical Corporation2022-07-14
TruAbutment DS, TruBase (K213961)Truabutment, Inc.2022-07-14
CEREPAK Uniform, Uniform XL, Uniform 3D, Heliform Soft, Heliform XtraSoft, Heliform XL, Heliform XtraSoft XL, Freeform, Freeform Mini, and Freeform XtraSoft Detachable Coil Systems (K220040)Medos International SARL2022-07-14
PELNAC Meshed Bilayer Wound Matrix (K213498)Gunze Limited2022-07-14
Examination gloves-Type A(Latex gloves) (K214017)Jiangxi Kemei Medical Apparatus & Instruments Group Co., Ltd.2022-07-14
SmileSeries (K221097)Ordont Orthodontic Laboratories, Inc.2022-07-14
20G Open-System Ally Device Kit (AV100000), 22G Open-System Ally Device Kit (AV110000) (K220258)Avia Vascular2022-07-14
TROJAN(TM) Her Pleasure Warming male natural rubber latex condom with warming lubricant (K221431)Church & Dwight Co., Inc.2022-07-14
Alma Diode Tabletop Laser (K212073)Alma Lasers , Ltd.2022-07-14
AHI System (K221203)Fifth Eye, Inc.2022-07-14
E-GPS Navigated Instruments (K220862)Precision Spine, Inc.2022-07-14
KDF Zirconia Disc (K221429)Denken-Highdental Co., Ltd.2022-07-14
LIAISON MeMed BV, LIAISON MeMed BV Control Set (K213936)DiaSorin, Inc.2022-07-14
Normatec Go (K221666)NormaTec Industries, LP2022-07-14
Disposabel Syringe with permanently attached needle, Safety Syringe with permanently attached needle (K220204)Anhui Tiankang Medical Technology Co., Ltd.2022-07-14
Dermatac Drape (K220560)3M2022-07-14
AGNES (K203013)Agnes Medical Co., Ltd.2022-07-14
17HQ701G-B (K221434)Lg Electronics.Inc2022-07-13
truSculpt iD (K221407)Cutera, Inc.2022-07-13
syngo.CT Extended Functionality (K221727)Siemens Medical Solutions USA, Inc.2022-07-13
SNUCONE Bone Level Implant System (K210354)Snucone Co., Ltd.2022-07-13
Disposable Medical Nitrile Examination Gloves - Non Sterile (K221454)Guangzhou Kangling Biotechnology Co., Ltd.2022-07-12
Hemoclip (K213143)Hangzhou AGS MedTech Co., Ltd.2022-07-12
Nitrile Medical Examination Gloves (K221108)Anhui Fulewei Electronic Technology Co.,Ltd2022-07-12
Protrieve Sheath (K220415)Inari Medical, Inc.2022-07-12
APOLLO ESG System, APOLLO ESG SX System, APOLLO REVISE System, APOLLO REVISE SX System (DEN210045)Apollo Endosurgery, Inc.2022-07-12
Nitrile Vinyl Blend Powder Free Examination Gloves (Black) (K213574)Grand Work Plastic Products Co., Ltd.2022-07-12
N Series Patient Monitors (K213799)Shenzhen Mindray Bio-Medical Electronics Co., Ltd.2022-07-12
Smartlux Mini (K221083)Medmix Co., Ltd.2022-07-12
NAEOTOM Alpha, Scan&GO Software (K220814)Siemens Medical Solutions USA, Inc.2022-07-12
Scopis ENT Software, Scopis ENT Software with TGS, Scopis Planning Software, Electromagnetic Navigation Unit (K221098)Stryker Corporation2022-07-12
VITEK 2 AST-Yeast Caspofungin (<=0.125 - >=8 µg/mL), VITEK 2 AST-YS Caspofungin (<=0.125 - >=8 µg/mL), VITEK 2 AST-YS Caspofungin (K213899)bioMerieux, Inc.2022-07-12
Veuron-Brain-mN1 (K203279)Heuron Co., Ltd.2022-07-12
ANNE Sleep (K220095)Sibel, Inc.2022-07-11
DolorClast Radial (K220538)E.M.S Electro Medical Systems S.A2022-07-11
Artix Ballon Guiding Sheath (K221846)Inari Medical2022-07-11
Mitek TIGHT-N Anchor (K221364)Medos International SARL2022-07-11
Revogene (K220480)Meridian Bioscience, Inc.2022-07-11
MINE ALNU (Model: Mine 2.1) (K213405)Hdt Co., Ltd.2022-07-10
Noodle (K220573)Pourang Bral, Dds, LLC2022-07-09
ZIP™ MIS Interspinous Fusion System (K221399)Aurora Spine, Inc.2022-07-08
Dental Zirconia Blank & Dental Zirconia Pre-Shaded Blank (K221051)Changsha Honchon Technology Co., Ltd.2022-07-08
VIDAS NEPHROCHECK (K210793)Biomérieux SA2022-07-08
Through the Scope Tracheal Stent System (K220424)Micro-Tech (Nanjing) Co., Ltd.2022-07-08
ROTEM sigma Thromboelastometry System (K201440)Tem Innovations GmbH2022-07-08
Transcranial Doppler Ultrasound System (K213009)Shenzhen Delica Medical Equipment Co., Ltd.2022-07-08
Stryker VariAx 2 MIS Calcaneus (K221346)Stryker GmbH2022-07-08
DropSafe Acti-Lance Safety Lancets; droplet ACTI-LANCE Safety Lancets, DropSafe Medlance Plus Safety Lancets; droplet MEDLANCE PLUS Safety Lancets, DropSafe ergoLance Safety Lancets, DropSafe Prolance Safety Lancets, DropSafe Medisafe Solo Safety Lancets; DropSafe Haemolance Plus Safety Lancets (K220643)Htl-Strefa S.A2022-07-08
Sapphire Pro Powder-Free Royal Blue Nitrile Exam Gloves (K220825)American Nitrile Operations, LLC2022-07-08
Single-Use Video Bronchoscopes, Digital Controller (K213782)Micro-Tech (Nanjing) Co., Lts2022-07-08
ProstatID (K212783)Scanmed, LLC2022-07-08
KLS Martin IPS Preprosthetic (K210228)KLS-Martin L.P.2022-07-08
Adin Short Implants (K212775)Adin Dental Implants Systems , Ltd.2022-07-08
Powder Free Nitrile Examination Gloves (Blue) (K220284)Kgm Gloves Sdn. Bhd.2022-07-08
Stratasys TrueDent (K220771)Stratasys, Ltd.2022-07-07
IPL Hair Removal (Model: SL-B080, SL-B126, SL-B136) (K221246)Shenzhen Semlamp Intelligent Technology Co., Ltd.2022-07-07
Wet Essential95 Personal Lubricant (K220534)Trigg Laboratories, Inc.2022-07-07
E-Brik Visualization Assistant (K221293)Jdi Surgical, Inc.2022-07-07
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Every clearance here is in the API, with alerts when new ones post.