Atlas FDA

General, Plastic Surgery

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

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RecordFirmDate
3M™ Ioban™ CHG Chlorhexidine Gluconate Incise Drape (contains 2% w/w CHG) (K222578)3M Company2023-05-18
Claritag Advanced (K222356)Dgi Technologies2023-05-18
DeepX DermoSight Dermatoscope (K230448)Deepx Health, LLC2023-05-17
Infrared Heat (Model: E0221) (K223893)Light Tree Ventures Europe B.V.2023-05-16
myLEDmask (K223147)Myblend2023-05-14
Sterile Polyisoprene Powder Free Surgical Glove, Tested for Use with Chemotherapy Drugs (K230217)Grand Work Plastic Products Co., Ltd.2023-05-13
SOMAVAC® 100 Sustained Vacuum System (K231063)Somavac Medical Solutions, Inc.2023-05-12
Regeneten Bioinductive Implant (K222501)Smith and Nephew, Inc.2023-05-11
Anika Tissue Tack Fixation System (K222487)Anika Therapeutics, Inc.2023-05-08
LED Facial Mask (K230351)Shenzhen Sungpo Hi-Tech Electronic Co., Ltd.2023-05-05
Agnes (K223805)Agnes Medical Co., Ltd.2023-05-04
Lucas Plus (K230340)Amt Engineering Co., Ltd.2023-05-04
Pollogen STOP U Model UXV Device (K220322)Pollogen, Ltd.2023-05-04
swiftPro System (K222388)Emblation , Ltd.2023-05-04
NuEra Tight RF Model APMD145.M70-US (K223907)Bios S.R.L.2023-05-02
Weck Auto Endo5 5mm Automatic Endoscopic 35cm Applier (AE05ML) (K230480)Teleflex Medical2023-04-28
Q-Rejuvalight Pro Facewear (Model: P19-0023) (K230042)Light Tree Ventures Europe B.V.2023-04-28
ArtiSential Laparoscopic Instruments-Electrodes (K230539)Livsmed, Inc.2023-04-27
Renuvion® APR Handpiece (K230272)Apyx Medical Corporation2023-04-27
Epildream HP 4000 MED (K222352)D.E.A Project S.R.1.2023-04-27
PlumePen Elite Surgical Smoke Evacuation Pencils, PlumePen Pro Surgical Smoke Evacuation Pencil, PlumePen Ultra Surgical Smoke Evacuation Pencils, PenAdapt Electrosurgical Pencil Adapter, SnapEvac Electrosurgical Pencil Adapter (K230547)Conmed Corporation2023-04-27
Braun Skin i.expert (K230911)Cyden Limited2023-04-27
ArtiSential Laparoscopic Instruments-Electrodes (K230499)Livsmed, Inc.2023-04-26
SafeAir combi (SFR-combi-US) (K223932)Lina Medical Aps2023-04-26
IPL Hair Removal Device, Model(s): FY-B505AL, FY-B505AG, FY-B505BL, FY-B505BG, FY-B507AL, FY-B507AG, FY-B507BL, FY-B507BG, FY-B508AL, FY-B508AG, FY-B508BL, FY-B508BG, FY-B509AL, FY-B509AG, FY-B509BL, FY-B509BG (K230549)Shenzhen Xiazhifeng Electronic Co., Ltd.2023-04-25
AEON Endoscopic Stapler (K222210)Lexington Medical, Inc.2023-04-21
OmniGuide RFID Surgical Laser Fibers (K230819)Omni-Guide Holdings, Inc.2023-04-21
Intense Pulsed Light Treatment System (K230816)Shangdong Huamei Technology Co., Ltd.2023-04-21
Breast Implant Removal Device (BIRD) (DEN220082)Gaylord Solutions, LLC2023-04-20
TAP Lancet (K223201)Yourbio Health, Inc.2023-04-19
Renova RP Centesis Pump (K221042)Gi Supply, Inc.2023-04-19
Diode Laser Hair Removal (K230090)Wuhan Lotuxs Technology Co., Ltd.2023-04-19
SofWave System (K230820)Sofwave Medical, Ltd.2023-04-18
Precision TC2, Precision TC3, Precision TC4, SEG 100, SEG 150, SEG200 (K223784)Deltronix Equipamentos Ltda2023-04-18
Symmed Elite Aesthetic (K230412)Termosalud2023-04-13
ENSEAL X1 Curved Tissue Sealers, 25 cm shaft length (NSLX125C); ENSEAL X1 Curved Tissue Sealers, 37 cm shaft length (NSLX137C); ENSEAL X1 Curved Tissue Sealers, 45 cm shaft ength (NSLX137C); ENSEAL X1 Straight Tissue Sealers, 25 cm shaft length (NSLX125S); ENSEAL X1 Straight Tissue Sealers, 37 cm shaft length (NSLX137S) (K230387)Ethicon Endo-Surgery, LLC2023-04-13
Sterile Nitrile Surgical Gloves Powder Free (K222350)Jr Engineering & Medical Technologies (M) Sdn. Bhd.2023-04-13
IPL Hair Removal Device, Model(s): UI04 SD, UI04 DG (K230122)Shenzhen Ulike Smart Electronics Co., Ltd.2023-04-10
IPL Cooling Hair Removal Device, Model(s): NBB01, NBB02 (K230360)Shenzhen Jizhimei Technology Co., Ltd.2023-04-10
Peri-Guard and Supple Peri-Guard (K223052)Synovis Life Technologies, Inc.2023-04-07
The N-SWEAT Patch (DEN210055)Candesant Biomedical, Inc.2023-04-07
Enivo™ (K223373)Aroa Biosurgery , Ltd.2023-04-07
IPL Hair Removal Device, Model(s): BSXT101, BSXT102, BSXT103, BSXT105, BSXT106, BSXT108 (K230097)Shenzhen Bsx Technology Electronics Co., Ltd.2023-04-06
Aimanfun Lumea Comfort, Model: A-2788, A-2789 and A-3588 (K230107)Kam Yuen Plastic Products , Ltd.2023-04-05
FAQ 101 (K222012)Foreo, Inc.2023-04-05
IPL Hair Removal Device, Model(s): AP10, AP20, AP30, AP32 (K230021)Shenzhen Yangyi Technology ., Ltd.2023-03-31
Medical Diode Laser (M2) (K230274)Wuhan Pioon Technology Co., Ltd.2023-03-31
Diode Laser Hair Removal System (RD-SLD600) (K223778)Shanghai Omni Laser Skinology Co., Ltd.2023-03-31
SMARTRION COMBI/Alexandrite & Long Pulsed Nd:YAG Laser (K222485)Ids, Limited2023-03-29
Reprocessed LigaSure Curved, Small Jaw, Open Sealer/Divider (LF1212A) (K230251)Stryker Sustainability Solutions2023-03-28
ISOLIS Cryoprobe (K230271)Varian Medical Systems, Inc.2023-03-28
CapnoSpot™ Pneumothorax Decompression Indicator (K223625)Pneumeric, Inc.2023-03-28
Capenergy C Equipment RF System - C25, C50, C100, C200, C300, C400, C500 (K222260)Capenergy Medical S.L.2023-03-28
Intense Pulsed Light (IPL) System, model: T023K, T023A, T023B, T023C, T023D, T023E, T021K, T021A, T001A, T001B, T001M, T001N, T011C, T016K (K223928)Shenzhen Fansizhe Science and Technology Co., Ltd.2023-03-28
Remanufactured LigaSure Exact Dissector Without Nano-coating LF2019 (K230255)Stryker Sustainability Solutions2023-03-28
Solero Microwave Tissue Ablation (MTA) System and Accessories (K223581)AngioDynamics, Inc.2023-03-27
Disposable Surgical Face Mask (K223823)Efofex, Inc.2023-03-27
Narrowband UV Phototherapy Light Lamp (Model: HB-UPLL-01, HB-UPLL-02) (K223882)Shenzhen Honpal Optoelectronic Technology Co., Ltd.2023-03-27
Medline Surgical Face Mask and Medline Procedural Face Mask (K223236)Medline Industries, LP2023-03-24
3 Series NeoLux (K230382)Daavlin Distributing Co.2023-03-24
3M V.A.C. Veraflo Cleanse Choice Dressing Kit, 3M Veraflo Cleanse Choice Complete Dressing Kit (K221585)3M Healthcare Business Group2023-03-23
VHT-200 Wound Treatment System (K212121)Vaporox, Inc.2023-03-23
Sterilized Latex Surgical Gloves (K222620)Suzhou Colour-Way New Material Co., Ltd.2023-03-23
3M V.A.C. Peel and Place Dressing Kit, Small (EZ10SML), 3M V.A.C. Peel and Place Dressing Kit, Medium (EZ10MED), 3M V.A.C. Peel and Place Dressing Kit, Large (EZ10LRG) (K222859)3M2023-03-23
ClosureFast™ Endovenous Radiofrequency Ablation Catheter (K223488)Medtronic, Inc.2023-03-23
HF Surgery Generator 400KHZ (K230194)Richard Wolf Medical Instruments Corporation2023-03-22
EasyTouch Lancing Device (K222617)Stat Medical Devices2023-03-21
OviTex PRS (Long Term Resorbable) (K214070)Tela Bio2023-03-21
Retraction, CWM-910T, APOLEX Tite (K222709)Chungwoo Co., Ltd.2023-03-21
HPR45i (K220725)F Care Systems USA, LLC2023-03-20
ECHELON LINEAR™ 60 mm Cutter (GLC60);ECHELON LINEAR™ 80mm Cutter (GLC80);ECHELON LINEAR™ 100 mm Cutter (GLC100);ECHELON LINEAR™ Cutters 60mm Blue Reload (GLCR60B);ECHELON LINEAR™ Cutters 60mm Green Reload (GLCR60G);ECHELON LINEAR™ Cutters 80mm Blue Reload (GLCR80B);ECHELON LINEAR™ Cutters 80mm Green Reload (GLCR80G);ECHELON LINEAR™ Cutters 100mm Blue Reload (GLCR100B);ECHELON LINEAR™ Cutters 100mm Green Reload (GLCR100G) (K223760)Ethicon Endo-Surgery2023-03-15
LUSTRE ClearSkin Renew Pro Facewear Mask(Model: PR4001) (K230124)Light Tree Ventures Europe B.V.2023-03-15
NeuroBlate Fusion-S Software V3.17 (K222983)Monteris Medical,2023-03-15
SofWave System (K230019)Sofwave Medical, Ltd.2023-03-14
JETT PLASMA Medical II (K213247)Compex, Spol, S.R.O.2023-03-14
Surgical Face Mask (K221352)Wuhan Huashida Protective Products Co., Ltd.2023-03-13
High Protection Surgical Gown (K222456)3A Medical Products Co., Ltd.2023-03-12
FlexSys, FlexSys UVB EPL 308 nm, FlexSys UVB EPL lite 308 nm, FlexSys IR 1550 nm (K221623)Gme German Medical Engineering GmbH2023-03-10
Enhanced AURORA™ Medical Diode System, and related accessories (K230076)Psoria-Shield, Inc.2023-03-08
PRECISION ECO Compostable / Plant Based Procedural Mask with Earloops (K221209)Padm Medical, Inc.2023-03-08
extriCARE 1000 Negative Pressure Wound Therapy System (K213906)Alleva Medical, Ltd.2023-03-08
Solero Microwave Tissue Ablation (MTA) System and Accessories (K221883)AngioDynamics, Inc.2023-03-07
Disposable Surgical Gowns (S,M,L,XL,XXL,XXXL) (K223401)Xiamen Probtain Medical Techology Co., Ltd.2023-03-07
MINT Product Family (Including MINT, MINT Lift, and MINT-I Sutures), MINT Lift ML 1043, MINT Lift ML 1013, MINT Lift 1019, MINT Lift Mini 1014 (K220549)Hans Biomed Corporation2023-03-07
Savvy Surgical Mask - Level 3 (K230383)Alg Health, LLC2023-03-06
Procedure mask/Surgical mask/Face mask (K223232)Winner Medical Co., Ltd.2023-03-06
Light Based Hair Removal Device GP592 (K230060)Shenzhen Gsd Tech Co., Ltd.2023-03-03
Plasma Pen (Plasma MD); Plasma Pen (Plasma +) (K223440)Plasma Concepts2023-03-02
Disposable 4 Layers Surgical Face Mask (K230093)Social Medical Supply, LLC2023-03-02
Tenderfoot (K223352)Accriva Diagnostics, Inc.2023-03-02
RSHOCK (K220014)Swims America Corp2023-03-01
Alma Harmony (K230308)Alma Lasers, Inc.2023-03-01
IPL Hair Removal Device, Model(s): UI06 PN, UI06 PL, UI06 JL, UI06 BR, UI06 DB, UI06 PR, UI06 OG, UI06 RD (K223618)Shenzhen Ulike Smart Electronics Co., Ltd.2023-02-28
PuraStat (K222481)3-D Matrix, Inc.2023-02-28
SurBlate Ablation System (K223272)Mima-Pro Scientific, Inc.2023-02-28
babyLance Safety Heelstick (BLM, BLN, BLP) (K223900)Clinical Innovations, LLC2023-02-24
Disposable Surgical Gown, Level 4; Disposable Surgical Gown, Level 3 (K221559)Stringking2023-02-23
Renuvion® APR Handpiece (K223262)Apyx Medical Corporation2023-02-23
LED light therapy mask (FM-01, FM-02, FM-03) (K223544)Guangdong Newdermo Biotech Co., Ltd.2023-02-23
T-Line Hernia Mesh (K230227)Deep Blue Medical Advances, Inc.2023-02-23
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