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
AltiVate® Anatomic Shoulder AG e+™ with Markers (K213387)Encore Medical L.P.2022-07-07
SkyWalker Total Knee System (K213873)Microport Navibot International, LLC2022-07-07
IPL Hair Remover, Model: G993, G996, G998 and G885 (K221679)Shenzhen Mywin Technology Co., Ltd.2022-07-07
LED Facial Mask (K213056)Shenzhen Osto Technology Company Limited2022-07-07
AgeJet (K212472)Triworks Group Srl2022-07-07
medi pneumatic compression system (pcs)-genius (Model 652) (K221654)Medi USA, LP2022-07-07
UniPrime A, UniPrime E, UniPrime E/C (K221033)S&C Polymer Silicon- Und Composite Spezialitäten GmbH2022-07-06
Minuteful - kidney test (K210069)Healthy.Io, Ltd.2022-07-06
Disposable Semi Automatic Biopsy Instrument (K212820)Suzhou Leapmed Healthcare Corporation2022-07-06
Lancet (I, II, III, V, VI); Lancing device (HH-X-T, HH-XIII-T, HH-XV-T, HH-XVI-T, HH-XVII-T, HH-XVIII-T, HH-XIX, HH-XXI-T, HH-XXII-T, HH-XXIII-T, HH-XXIV-T) (K220475)Tianjin Huahong Technology Co., Ltd.2022-07-06
Surgical Mask (Model: 0868F, 0866F) (K221173)Jiangxi Sanhao Medical Instruments Co.,Ltd2022-07-06
My3D® Personalized Pelvic Reconstruction (K212815)Onkos Surgical2022-07-06
Disposable Biopsy Refill Needle (K212819)Suzhou Leapmed Healthcare Corporation2022-07-06
Functional MR V1.0 (K221426)Olea Medical S.A.S.2022-07-06
Cerebra Sleep System (K213007)Cerebra Medical , Ltd.2022-07-06
SURGIVISIO Device (K221028)Ecential Robotics2022-07-06
Disposable Coaxial Biopsy Needle (K212822)Suzhou Leapmed Healthcare Corporation2022-07-06
ChoiceSpine Navigation System (K220024)Choice Spine, LLC2022-07-06
cobas Influenza A/B & RSV nucleic acid test for use on the cobas Liat System (K213822)Roche Molecular Systems, Inc.2022-07-06
Oscar Peripheral Multifunctional Catheter system (K214038)Biotronik, Inc.2022-07-06
Materialise TKA Guide System (K221337)Materialise NV2022-07-05
Osteon Precision Milled Suprastructure (K221019)Implant Solutions Pty Ltd (Aka Osteon Medical)2022-07-05
CediTEC (K220743)Voco GmbH2022-07-05
Electric Wheelchair (K220827)Foshan Dahao Medical Technology Co., Ltd.2022-07-05
SleepCheckRx (K213360)Resapp Health2022-07-05
Insulin Pen Needle (K221176)Tianjin Huahong Technology Co., Ltd.2022-07-01
PuraPly Micronized Wound Matrix (PuraPly MZ) (K220317)Organogenesis, Inc.2022-07-01
NES Reprocessed 0.9mm Turbo Elite Laser Atherectomy Catheter (K220171)Northeast Scientific, Inc.2022-07-01
Prevena Restor Adapti-Form Dressing (K220660)3M Healthcare Business Group2022-07-01
Ergoline Vitality Total Light 3, Planet Fitness 50/4 TLT by Ergoline, Planet Fitness 42/3 TLT by Ergoline, Ergoline Vitality Hybrid Light 3, Ergoline Vitality Hybrid Light, Planet Fitness 50/4 HLT by Ergoline, Planet Fitness 46/3 HLT by Ergoline, Ergoline Vitality Pure Light 3, Ergoline Vitality Pure Light, Planet Fitness 50/4 PLT III by Ergoline, Planet Fitness 50/4 PLT by Ergoline, Planet Fitness 46/3 PLT by Ergoline, Planet Fitness 42/3 PLT by Ergoline (K220500)Jk-Holding GmbH2022-07-01
GEM (K213385)Obsidio, Inc.2022-07-01
Power Wheelchair (K221026)Zhejiang Innuovo Rehabilitation Devices Co.,Ltd2022-07-01
Smith & Nephew Hip Systems (K211176)Smith & Nephew, Inc.2022-07-01
AcQMap High Resolution Imaging and Mapping System (K220784)Acutus Medical, Inc.2022-07-01
Dental diode laser, SOGA Laser, ILaser II (K211150)Shenzhen Soga Technology Co., Ltd.2022-07-01
Ennovate Cervical Spinal and Occiput System (K213871)Aesculap Implant Systems, LLC2022-07-01
Nihon Kohden NKV-330 Ventilator System (K213521)Nihon Kohden Orangemed, Inc.2022-07-01
NovaCore Semi-Automatic Biopsy Instrument (K213232)Argon Medical Devices2022-07-01
BD Perisafe Tuohy Epidural Needle, BD Perisafe Weiss Epidural Needle (K211085)Becton, Dickinson and Company2022-07-01
Home use hair removal device (K220248)Shenzhen Mareal Tech Co., Ltd.2022-07-01
Hanger Cranial Band 3D (K203134)Symbion Logistics, LLC2022-07-01
i_ Field 1.5T Superconducting Magnetic Resonance Imaging System (K221025)Mri Division,Beijing Wandong Medical Technology Co., Ltd.2022-07-01
CROSSLEAD Peripheral Guide Wire (K213315)Asahi Intecc Co., Ltd.2022-07-01
ENT Nasopharyngoscope and Accessories (K214050)Medimaging Integrated Solution, Inc (Miis)2022-07-01
2-Way 100% Silicone ClearTract Catheter (K221625)Silq Technologies Corporation2022-07-01
Footmotion Plating System (K221395)Newclip Technics2022-07-01
Astroglide Warming (K221036)Biofilm, Inc.2022-07-01
CerroZone Mobile (K220298)Cerrozone2022-07-01
Bladder Scanner, Model Name:M5 (K213488)Suzhou Peaksonic Medical Technology Co., Ltd.2022-07-01
J-Temp (K221909)Ultradent Products, Inc.2022-07-01
InMode Multi-system (K221571)InMode , Ltd.2022-06-30
NC TREK NEO Coronary Dilatation Catheter (K220634)Abbott Vascular2022-06-30
Wrist Type Blood Pressure Monitor (K220651)Shenzhen Jamr Medical Technology Co., Ltd.2022-06-30
Cholesterol2 (K203597)Abbott Ireland Diagnostics Division2022-06-30
Intense Pulsed Light (IPL) System, model: T013C, T015C, T015K (K221569)Shenzhen Fansizhe Science and Technology Co., Ltd.2022-06-30
leva Pelvic Health System (K213913)Renovia, Inc.2022-06-30
Epicardial Access System (K213582)Baylis Medical Company, Inc.2022-06-30
hCG One Step Pregnancy Test (K212418)Healstone Biotech, Inc.2022-06-30
Blue Sky Bio Multi One Implant System, Blue Sky Bio Long Implant System, Blue Sky Bio PEEK temporary abutments (K212785)Blue Sky Bio, LLC2022-06-30
ZESPIN SI Joint Fusion System, Paeon Posterior Cervical Fixation System, Paeon Anterior Cervical Plate System, Spinema Lumbar Plate System (K221050)Aegis Spine, Inc.2022-06-30
VASSALLO GT 018 Floppy (K213949)Filmecc Co., Ltd.2022-06-30
CPS AIM Universal II Slittable Inner Catheter (K221750)ABBOTT MEDICAL2022-06-30
Sparta 3-Ply Surgical Disposable Face Mask (K220378)Sparta East, LLC2022-06-30
RADIFOCUS Torque Device (K220934)Terumo Medical Products (Hangzhou) Co., Ltd.2022-06-29
CLAROX (K221286)Vsi Co., Ltd.2022-06-29
FridaMom Anti-Nausea Bands (K220289)Fridababy, LLC2022-06-29
V8 Diagnostic Ultrasound System, V7 Diagnostic Ultrasound System (K220975)Samsung Medison Co., Ltd.2022-06-29
Flat Panel Detector (K221714)Iray Technology Taicang , Ltd.2022-06-29
ARTIS pheno (VE21) System (K220409)Siemens Medical Solutions USA, Inc.2022-06-29
Diode Laser Hair Removal Device (K221312)Guangzhou Chuang Zao Mei Technology Co., Ltd.2022-06-29
Eko Murmur Analysis Software (EMAS) (K213794)Eko Devices, Inc.2022-06-29
Coloring Liquid (K220017)Dongguan Xiangtong Co., Ltd.2022-06-29
DABRA Excimer Laser System (DABRA Laser model RA-308 and DABRA Catheter model 2.0) (K220544)Ra Medical Systems,Inc2022-06-29
Powered Breast Pump (Models 7V and 7X) (K211016)Haenim Co., Ltd.2022-06-29
Ebony HP PTA OTW 0.035 Catheter (K220410)Natec Medical , Ltd.2022-06-29
BruxZir Opaque Coloring Liquid (K220960)Prismatik Dentalcraft, Inc.2022-06-29
780 nm L11 LED Light Source with AIM (K221611)Stryker2022-06-29
ARTIS icono (VE21) System (K220432)Siemens Medical Solutions USA, Inc.2022-06-29
Kerecis Silicone (K213231)Kerecis Limited2022-06-29
Arthrex Mini Fragment System (K220937)Arthrex, Inc.2022-06-29
Powder Free Nitrile Examination Glove (K220834)Daxwell, LLC2022-06-29
Med-link Disposable ECG Cable and Leadwires (K220447)Shenzhen Med-Link Electronics Tech Co., Ltd.2022-06-28
Magnum (K220670)Magnum Health and Safety Pvt, Ltd.2022-06-28
Mg OSTEOINJECT (K221256)Bone Solutions, Inc.2022-06-28
OsteoProbe (K221195)Active Life Scientific, Inc.2022-06-28
Patient Specific Marking Guides (K211076)Additive Orthopaedics, LLC2022-06-28
Venus Cervical Plate System (K211718)Artfx Medical, LLC2022-06-28
DePuy CONDUIT LLIF SQUID Inserter (K220449)Enztec Limited2022-06-28
PL-1 Skin Treatment System (K213726)AVAVA, Inc.2022-06-28
3M Attest Rapid Readout Biological Indicator, 1295 (K211705)3M Company2022-06-28
VenAir, Sequential Compression System (K213577)Apex Medical Corp.2022-06-28
Medical Face Mask (K221272)Shandong Xingyu Gloves Co., Ltd.2022-06-28
BD Pen Needle (K213478)Becton, Dickinson and Company2022-06-28
Medical Face Mask (M001) (K221273)Xingyu Medical Tech Co., Ltd.2022-06-28
Disposable Polypectomy Snare, Disposable Polypectomy Hybrid Snare (K220790)Yangzhou Fartley Medical Instrument Technology Co., Ltd.2022-06-27
Venue (K220851)GE Medical Systems2022-06-27
CiRX Single use electrosurgical pencil with non-coated and coated electrode (K213786)Ningbo Shun YE Medical Company, Ltd.2022-06-27
Navident (K210947)Claronav, Inc.2022-06-27
Venue Fit (K220848)GE Medical Systems2022-06-27
Wearable Breast Pump (Model S10) (K220309)Shenzhen Lutejiacheng Technology Co., Ltd.2022-06-27
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Every clearance here is in the API, with alerts when new ones post.