Atlas FDA

General, Plastic Surgery

16,262 FDA 510(k) clearances · Medical specialty

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RecordFirmDate
The Alma Soprano Titanium (K230371)Alma Lasers, Inc.2023-02-22
Verifine® Ease Lancing Device, Verifine® Lancing Device (K223643)Promisemed Hangzhou Meditech Co., Ltd.2023-02-21
Painless IPL System - KDT750 (K220214)Shanghai Omni Laser Skinology Co., Ltd.2023-02-18
Doctor Tecar Plus, Doctor Tecar Smart (K221043)Mectronic Medicale S.R.L.2023-02-17
EON (K222226)Dominion Aesthetic Technologies, Inc.2023-02-17
Surgical Gown (K213844)Bayteks Teknik Tekstil San. VE Tic. A.S.2023-02-16
IPL Hair Removal, Model(s): SB01, SB01A, SB01B, SB01C, SN02, SN03 (K223524)Morlaser Shenzhen Co., Ltd.2023-02-16
Tanning Lamp (K221523)Unilam Co., Ltd.2023-02-15
ONE DROP Lancing Device (K223815)Stat Medical Devices2023-02-15
Altis Single Incision Sling System (K221874)Coloplast A/S2023-02-15
LIGHTSCALPEL LS-4020 (K213669)Lightscalpel, Inc.2023-02-15
StitchKit (K221527)Origami Surgical Inc .2023-02-14
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
SEJONG Surgical Gown Soft (K220435)Sejong Healthcare Co., Ltd.2023-02-10
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
RENASYS™-WF White Foam NPWT Dressing Small; RENASYS™-WF White Foam NPWT Dressing Large (K213853)Smith and Nephew Medical Limited2023-02-10
extriCARE® 3000 Negative Wound Pressure Therapy System (K221223)Alleva Medical Devices2023-02-09
ATTIVA (K220505)Italian Engineering S.R.L.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
Medical Protective Masks (K223686)Qinhuangdao Taizhi Medical Technology Co., Ltd.2023-02-07
Duoblade (K220996)Cnc Technologies2023-02-03
Geonic Nasal Aspirator, Geonic Nasal Cleaner (K220126)Geon Corporation2023-02-02
LED Light Therapy Device, KN-7000L (K222751)Xuzhou Kernel Medical Equipment Co., Ltd.2023-02-01
SOLTIVE Pro SuperPulsed Laser, SOLTIVE Premium SuperPulsed Laser, SOLTIVE SuperPulsed Laser Fibers, and Accessories (K221306)Gyrus Acmi, Inc.2023-01-27
Sterile Surgical Powder Free Latex Glove (K221424)New Era Medicare Sdn. Bhd.2023-01-26
Surgical Gown (K222403)Guangzhou Fuzelong Hygiene Material Co., Ltd.2023-01-26
PALLAS Premium (K223588)Laseroptek Co., Ltd.2023-01-26
Safety Lancet (K222801)Sarstedt AG & CO KG2023-01-25
Disposable Blood Lancets (K223314)Huaian Hening Medical Instruments Co., Ltd.2023-01-25
LigaSure™ XP Maryland Jaw Sealer/Divider (K223158)Covidien, LLC2023-01-23
Disposable Safety Lancets (K223313)Huaian Hening Medical Instruments Co., Ltd.2023-01-23
Sentimag System (K222832)Endomagnetics Ltd.,2023-01-21
TD-5010 Lancing Device and TD-5084 Sterile Lancets (K221419)Gostar Co., Ltd.2023-01-20
Duetto Suprema; Domino Suprema; Suprema VT; Suprema VT+; Suprema 4V (K223404)Quanta System Spa2023-01-20
HF-cables (resusable) (K221522)Olympus Winter & Ibe GmbH2023-01-19
AvalancheLase Family (K223540)Fotona D.O.O.2023-01-19
Disposable Endoscopic Cutter Stapler and Cartridge (K211197)Changzhou Waston Medical Appliance Co., Ltd.2023-01-19
MOLLI 2 (K223107)Molli Surgical, Inc.2023-01-18
Plasma IQ (K223222)Neauvia North America, Inc.2023-01-17
Ideal Med Pro 3-Ply Disposable Face Mask (K221682)Jsn Holdings, LLC2023-01-13
Medipoint Blood Lancets (K223480)Medipoint Holdings, LLC2023-01-13
Light-Guide Cables (K223183)Olympus Winter & Ibe GmbH2023-01-13
NeoGen PSR System (K221873)Energist Limited2023-01-12
Disposable Surgical Face Mask (K203380)Shandong Pop Jeans Intelligent Manufacturing Co., Ltd.2023-01-06
Ax-Surgi Surgical Hemostat (K213198)Advamedica, Inc.2023-01-05
DEKA HELIX (K222221)El.En Electronic Engineering Spa2023-01-04
Surgical Face Mask (K222483)Hubei Woozon Healthcare Co., Ltd.2023-01-04
SmoothCool HR System (K223685)Jeisys Medical, Inc.2023-01-04
Disposable Isolation Gowns (S,M,L,XL,XXL,XXXL) (K223411)Xiamen Probtain Medical Techology Co., Ltd.2023-01-04
Medical Disposable Face Masks (K222809)Anqing Mayfield Medical Limited2023-01-03
Isolator® Linear Pen (MLP1); Isolator® Transpolar™ Pen (MAX1, MAX5), Coolrail® Linear Pen (MCR1); Isolator® Synergy Surgical Ablation System (EMR2, EML2); Isolator® Synergy™ EnCompass Clamp (OLH, OSH) and Guide System; Isolator® Synergy Access Clamp (EMT1) (K221358)AtriCure, Inc.2022-12-30
CLEAR+BRILLIANT TOUCH® Laser System (K223647)Solta Medical, Inc.2022-12-29
Poly-Tape/Infinity-Lock Soft Tissue Reinforcement Device (K222978)Xiros, Ltd.2022-12-27
Cardioblate Gemini-s 49260 Surgical Ablation Device; Cardioblate Gemini-s 49351 Surgical Ablation Device (K223508)Medtronic, Inc.2022-12-22
Comfort Gown, Safewear Gown (K213893)Xuchang Zhengde Environstar Medical Products Co., Ltd.2022-12-21
reVive Light Therapy® Wrinkle and Acne LED Device (K223482)Led Technologies, Inc.2022-12-21
DP4 Microneedling device (K221070)Equipmed USA, LLC2022-12-20
AI.ME System (K221011)Venus Concept USA, Inc.2022-12-20
LED Light Therapy Mask (model: MK-78, MK-04, MK66-H, MK66R-B, EL00003) (K221775)Light Tree Ventures Europe B.V.2022-12-20
GORE® ENFORM Biomaterial (K222919)W. L. Gore and Associates, Inc.2022-12-19
BD Microtainer® Contact-Activated Lancets; BD Microtainer® Quikheel™ Lancets (K223243)Becton, Dickinson and Company2022-12-16
Surgical Mask (K213601)Wuhan Zonsen Medical Products Co., Ltd.2022-12-16
SofWave System (K223237)Sofwave Medical, Ltd.2022-12-16
PM Excellence SEQUR 100 Surgical Face Mask (K220520)Pm Excellence, LLC2022-12-15
UNO Negative Pressure Wound Therapy System (K221891)Genadyne Biotechnologies, Inc.2022-12-14
QuikClot Control+ Hemostatic Dressing (K220971)Z-Medica, LLC2022-12-14
Surgical Face Mask (K222651)Xiantao Sanda Industrial Co., Ltd.2022-12-13
Epilaser Absolute (K213105)Epilady 2000, LLC2022-12-13
120V Neptune S Rover (0711-001-000);V2 4-Port Manifold (0750-400-000);V2 Specimen Collection Manifold Kit (0750-200-000);V2 Specimen Collection Tray (0750-210-000) (K222552)Stryker Instruments2022-12-09
Vesseal (K221280)Lydus Medical , Ltd.2022-12-09
US 450 Diode Laser Equipment (K222916)Beijing Globalipl Development Co., Ltd.2022-12-09
LED Eye Perfector, model: EY-36A, EY-36B (K221444)Light Tree Ventures Europe B.V.2022-12-08
3-Ply Disposable Medical Mask (K223045)Wealth Lead Industrial Limited2022-12-07
Disposable Medical Face Mask (K223055)Xiantao Zhuobo Industrial Co., Ltd.2022-12-05
truFreeze Console, PN CC301; Aire PV Passive Venting Catheter, PN CO840703; 16 Fr CDT 5 Pack, PN 2000181; 20Fr CDT 5 Pack, PN ACCCC3CDT05; Active Venting Spray Kit, 20 Fr CDT, PN 2000177; Active Venting Spray Kit 16 Fr CDT, PN 20000516; Rapid AV Catheter 5 Pack, PN 2000184 (K223369)STERIS Corporation2022-12-02
Maestro Platform (K221410)Moon Surgical2022-12-02
Parietene Macroporous Mesh (K223218)Sofradim Production2022-12-02
IPL Cooling Hair Removal Device (K222710)Shenzhen Siken 3D Technology Development Co., Ltd.2022-12-01
Lancing System, Sterile Lancet for Single Use, Lancing Device (K222472)Shandong Lianfa Medical Plastic Products Co. , Ltd.2022-11-30
EEA Circular Stapler with Tri-Staple Technology (K221771)Covidien2022-11-30
Paneffort AAMI Level 3 Isolation Gown (K212717)Paneffort, LLC2022-11-30
Disposable Safety Lancet (K222408)Beijing Ruicheng Medical Supplies Co., Ltd.2022-11-29
Signia™ Small Diameter Reloads Including Regular (Round) Tip Version (K222641)Covidien2022-11-29
da Vinci E-200 Electrosurgical Generator (K223039)Intuitive Surgical2022-11-28
Facet Manatee Reusable Lancing Base (K223099)Facet Technologies, LLC2022-11-28
T-Line Hernia Mesh (K221556)Deep Blue Medical Advances, Inc.2022-11-28
Electrosurgical Pencil (OBS-Db, OBS-Dr, OBS-Dc, OBS-Df, OBS-Di, OBS-De); Electrosurgical Pencil (OBS-Dt, OBS-Dd, OBS-Ds, OBS-Dl, OBS-Da) (K221815)Baisheng Medical Co., Ltd.2022-11-23
LDE4 Lancing Device (K222656)I-Sens, Inc.2022-11-23
TempSure System (K223292)Cynosure, LLC2022-11-23
Medical Protective Mask (model: 8862, 8862A, 8862B, 8862C, 8862D, 8862E) (K223068)Guangdong Golden Leaves Technology Development Co., Ltd.2022-11-23
PRIMED Pediatric Facemask (K213427)Primed Medical Products, Inc.2022-11-22
LED Light Therapy Mask (model: MK66R-B) (K221946)Light Tree Ventures Europe B.V.2022-11-22
Renasys Edge (66803126) (K223041)Smith & Nephew Medical Limited2022-11-22
SR-1 Skin Treatment System (K221268)AVAVA, Inc.2022-11-21
Disposable Sterile Lancet (K222246)Tianjin Rilifine Medical Device Co., Ltd.2022-11-21
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