Atlas FDA

General, Plastic Surgery

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

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RecordFirmDate
Medical Face Mask (M001) (K221273)Xingyu Medical Tech Co., Ltd.2022-06-28
CiRX Single use electrosurgical pencil with non-coated and coated electrode (K213786)Ningbo Shun YE Medical Company, Ltd.2022-06-27
Secret Duo (K213250)Ilooda Co,., Ltd.2022-06-24
Procedure Mask (K220377)Little Rapids Corporation2022-06-24
maxmorespine Bipolar Electrodes (K211173)Hoogland Spine Products, GmbH2022-06-23
SYLFIRM X (K213612)VIOL Co., Ltd.2022-06-23
Symbotex Composite Mesh, ProGrip Self-Gripping Polyester Mesh, Parietex Hydrophilic 2D 3D Anatomical Mesh, Versatex Monofilament Mesh (K220586)Sofradim Production2022-06-22
Esophageal TTS Stent (K221482)Taewoong Medical Co., Ltd.2022-06-22
Lumenis Y&R Laser System (K211979)Lumenis, Inc.2022-06-21
Aliya(TM) System, Aliya(TM) Generator, Aliya(TM) Needle, Aliya(TM) Electrode (K212871)Galvanize Therapeutics, Inc.2022-06-17
Freeze’n Clear Skin Clinic Warts & Tags (K211099)Cryoconcepts LP2022-06-17
Disposable Surgical Face Mask (M663BE, M663BT) (K220550)Makrite Industries, Inc.2022-06-14
PAL System (K212024)Microaire Surgical Instruments, LLC2022-06-10
Surgical Isolation Cover Gown (K220528)Wuhan Dymex Healthcare Co., Ltd.2022-06-10
Promisemed Blood Lancet, VeriFine Safety Lancet, VeriFine Mini-Safety Lancet (K221368)Promisemed Hangzhou Meditech Co., Ltd.2022-06-09
The Luminance RED Acne Device (K220729)Luminance Medical Ventures, Inc.2022-06-09
HELIOS IV 785 (K212663)Laseroptek Co., Ltd.2022-06-09
ACUTRON (K211000)Ilooda Co,., Ltd.2022-06-09
Promisemed Heel Blood Lancet (K221371)Promisemed Hangzhou Meditech Co., Ltd.2022-06-08
Surgical Face Mask (HNFM0304) (K221222)Shanghai Hua EN Industrial Co, Ltd.2022-06-06
Diacare 7000 (K211207)Globus Sport and Health Technologies, LLC2022-06-06
MICROLET NEXT lancing device, MICROLET Lancet (K220633)Ascensia Diabetes Care U.S., Inc.2022-06-03
Multifrax Laser System (K213332)Paradigm Medical Corporation2022-06-03
SILKRO (K210084)Hironic Co., Ltd.2022-06-03
Surgical Gown, Blue, Sterile; Surgical Gown, Blue, Non-Sterile (K220665)Excellent Medical Technology Group Co., Ltd.2022-06-03
EpilME (K213261)Neauvia North America2022-06-02
IPL Hair Removal (K220927)Shenzhen Qiaochengli Technology Co., Ltd.2022-06-02
Leaseir MHR Xcell (K214049)Leaseir Technologies, Slu2022-06-02
IPL Hair Removal Device, Model(s): UI04A, UI04B, UI04C (K221002)Shenzhen Ulike Smart Electronics Co., Ltd.2022-06-01
Genadyne UNO Plus (UNO+) Negative Pressure Wound Therapy System (K210107)Genadyne Biotechnologies, Inc.2022-06-01
Small Foam Kit, Medium Foam Kit, Large Foam Kit, Extra Large Foam Kit (K211571)Zhejiang Longterm Medical Technology Co., Ltd.2022-05-31
Disposable Surgical Face Mask (FM-34EE,FM-44EE) (K220597)Qingdao Bestex Rubber & Plastic Products Co., Ltd.2022-05-26
Latex Powder Free Surgical Glove with Protein Labeling Claim of 50 Microgram or Less per Gram of Glove and Tested for Use with Chemotherapy Drugs (K214074)Hartalega NGC Sdn. Bhd.2022-05-26
Remanufactured LigaSure Exact Dissector, Without Nano-coating (LF2019) (K220481)Stryker Sustainability Solutions2022-05-25
Micro-current facial cold and hot service (model: TPML-100) (K213039)Li-Tek Electronics Technology C0., Ltd.2022-05-25
Disposable Sterilized Latex Surgical Gloves (K211953)Jiangxi Kemei Medical Apparatus & Instruments Group Co., Ltd.2022-05-25
InnoVoyce Laser Fiber (K220793)Innovoyce, LLC2022-05-25
Renuvion Dermal Handpiece, Renuvion Dermal System (K211652)Apyx Medical Corporation (Formerly Bovie Medical Corporation2022-05-25
Medline General Surgery Tray (K213481)Medline Industries, Inc.2022-05-24
Disposable Face Mask (K220191)Jiujiang Taixin Technology Co., Ltd.2022-05-24
LiquiBand XL (K211878)Advanced Medical Solutions Limited2022-05-23
Tapestry Biointegrative Implant (K220867)Embody, Inc.2022-05-23
Disposable surgical mask (K220532)Xiamen Blue Star Enterprise Co., Ltd.2022-05-23
Artisan Bone Plug, Universal Cement Restrictor (K220838)Howmedica Osteonics, Dba Stryker Orthopaedics2022-05-20
Infrared Red blue LED light heat beauty machine, Infrared Red blue LED light heat beauty machine, Infrared Red blue LED light heat beauty machine (K210545)Marci Beauty, Inc.2022-05-20
Diode Laser Therapy Systems (K220381)Beijing Lasertell Medical Co., Ltd.2022-05-20
Procedure Mask with Ear Loops and Surgical Mask with Ties (K221134)Safesource Direct, LLC2022-05-19
Medical Surgical Mask (Planar type) (K220824)Hunan Chopard Medical Devices Co., Ltd.2022-05-19
RevoLix HTL (K211534)Lisa Laser Products GmbH2022-05-19
Accu-Chek Safe-T-Pro Plus Lancing Device (K220849)Roche Diabetes Care, Inc.2022-05-19
Safety Lancet (XIII, XVII, XXI, XXII, XXIII, XXIV, XXV, XXVI) (K220370)Tianjin Huahong Technology Co., Ltd.2022-05-19
gentleheel Micro-Preemie, gentleheel Preemie, gentleheel Newborn, gentleheel Toddler (K220917)Gri-Alleset, Inc.2022-05-18
Medline Orbis LVL 3 Surgical Gown (K220333)Medline Industries, LP2022-05-18
MolecuLight I:X (K213840)MolecuLight, Inc.2022-05-18
The Family of UltraPulse CO2 Surgical and Aesthetic Lasers, Delivery Devices and Accessories (K220467)Lumenis Be, Ltd.2022-05-18
Heel Stick Safety Lancet (HHZ-II, HHZ-III) (K220372)Tianjin Huahong Technology Co., Ltd.2022-05-17
Skin Care Beauty Mask (Model: MJ-06) (K220168)Shenzhen Kaiyan Medical CO , Ltd.2022-05-17
Procedure mask/Surgical mask/Face mask (K220194)Winner Medical Co., Ltd.2022-05-17
IPL HAIR REMOVAL HANDSET, Model: IPL-666 (K220669)Shenzhen Junbobeauty Technology Co., Ltd.2022-05-16
AAMI3 Isolation Gown (K213832)Hubei Xinxin Non-Woven Co., Ltd.2022-05-16
Zone Specific AIM (K220186)Conmed Corporation2022-05-13
Surgical Face Mask, Model Number-17.5X9.5CM EAR-LOOP (K220749)Unimax Medical Products Co., Ltd.2022-05-13
Reprocessed LigaSure Curved, Small Jaw, Open Sealer/Divider (LF1212A) (K220411)Stryker Sustainability Solutions2022-05-13
IPL Home Use Hair Removal Device (K221001)Shenzhen Beauty Every Moment Intelligent Electric Co., Ltd.2022-05-12
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
Dental diode laser (K214008)Shenzhen Soga Technology Co., Ltd.2022-05-10
Medline Orbis Chemo Surgical Gown (K214108)Medline Industries, LP2022-05-06
GIA Auto Suture Stapler with DST Series Technology (K221013)Covidien2022-05-05
HandPICO (K220041)Vydence Medical Industria E Comercio Ltda2022-05-05
Plus Medical Chemotherapy Gown (K211036)Foshan Nanhai Plus Medical Co, Ltd.2022-05-04
ECHOLASER X4 (K213594)Elesta S.P.A2022-05-03
Accu-Chek FastClix Blood Lancing System (K220608)Roche Diabetes Care, Inc.2022-04-29
EEA Circular Stapler with Tri-Staple Technology (K221005)Covidien2022-04-29
LISA Laser Surgical Fibers (K220189)Omni-Guide Holdings, Inc.2022-04-29
Disposable Surgical Isolation Gown (K212422)Crown Name Disposable Hygiene Products Fty., Ltd.2022-04-29
GIA Stapler with Tri-Staple Technology (K221006)Covidien2022-04-29
Venus BlissMAX (K220592)Venus Concept USA, Inc.2022-04-27
Hand-held IPL device (JOVS Hair Removal Device) (K220645)Shenzhen Qianyu Technology Co., Ltd.2022-04-27
IPL Hair Removal Device, model(s): S1-A, S2-A, S1, S2, S3, S4 (K220222)Shenzhen Yuwei Electronic Technology Co., Ltd.2022-04-26
Disposable Medical Face Mask (K220487)Hubei Mediunion Medical Products Co., Ltd.2022-04-26
PERMALOOP Suture, PERMATAPE Suture (K220219)Medos International SARL2022-04-26
Disposable Surgical Face Mask (M01, M02) (K220512)Fomed Industries, Inc.2022-04-25
PicoStar (K213889)Asclepion Laser Technologies GmbH2022-04-22
1 Series Phototherapy Equipment (K220840)Daavlin Distributing Co.2022-04-22
CoNextions TR Tendon Repair System (K203855)Conextions Medical2022-04-22
Waterlase iPLus (K210183)Biolase, Inc.2022-04-21
HydroMARK Breast Biopsy Site Marker (K212158)Devicor Medical Products, Inc.2022-04-21
SmoothCool HR System (K213484)Jeisys Medical, Inc.2022-04-20
mJOULE System and Accessories (K213350)Sciton, Inc2022-04-15
MCL 31 Dermablate System (K210634)Asclepion Laser Technologies GmbH2022-04-13
Flosteril Poly-reinforced Isolation Gowns Model 8120 (Catalogue Number 8120400), Flosteril Poly-reinforced Isolation Gowns Model (Catalogue Number 8120410), Flosteril Poly-reinforced Isolation Gowns Model (Catalogue Number 8120430), Flosteril Poly-reinforced Isolation Gowns Model (Catalogue Number 8120450), Flosteril Poly-reinforced Isolation Gowns Model (Catalogue Number 8120460) (K210148)Flomak Tekstil Makine Muh. Mum. Taah. San. Tic. Ltd. Sti.2022-04-13
Disposable Surgical Gown (K214088)Weihai Hongyu Nonwoven Fabric Products Co., Ltd.2022-04-12
LED Therapy Device (Planar LED/Planar LED mini) (K220103)Shenzhen Leaflife Technology Co., Ltd.2022-04-12
Finexel (K213557)SNJ Co., Ltd.2022-04-12
Intense Pulsed Light (IPL) System (K212881)Shenzhen Fansizhe Science and Technology Co., Ltd.2022-04-11
SCOUT BX Delivery System (K212882)Merit Medical Systems, Inc.2022-04-08
Dong Hai Xiang Surgical Mask (K212203)Taizhou Donghaixiang Protective Equipment Co., Ltd.2022-04-07
Green OR Reprocessed Aquamantys Bipolar Sealer (K211203)Green Or, LLC2022-04-07
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