Atlas FDA

General, Plastic Surgery

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

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RecordFirmDate
Surgical Face Masks (Ear Loops And Tie-On) (K221534)San-M Package Co., Ltd.2022-09-16
Nexpowder (K202929)Nextbiomedical Co., Ltd.2022-09-16
OptaBlate RF Generator, OptaBlate Probes, OptaBlate Microinfuser Infusion Device (K221074)Stryker Corporation2022-09-16
ECHELON ENDOPATH Staple Line Reinforcement (K221343)Ethicon Endo-Surgery, LLC2022-09-16
AllureTM Surgical Mask (K212926)Allure Gift Wraps Private Limited2022-09-16
ArcTO Transobturator Sling System (K222468)Urocure, LLC2022-09-15
CO2 Laser System (K221597)Smedtrum Medical Technology Co., Ltd.2022-09-15
Diamond Air+ (UI04A, UI04B, UI04C) (K221553)Ulike Co., Ltd.2022-09-15
Solea (K221761)Convergent Dental, Inc.2022-09-14
Arthrex SoftStitch (K222078)Arthrex, Inc.2022-09-14
LAITEST Medical Face Mask (K214035)R&R Medical Corporation, Ltd.2022-09-13
Medispo Rubber Surgical Gloves, Medispo Polyisoprene Surgical Gloves (K221748)Guilin Hbm Health Protections, Inc.2022-09-13
PointCore Surgical Mask (K220944)Pointcore, Inc.2022-09-09
Ellusa Reusable Bipolar Cable (K222429)Ellusa, LLC2022-09-09
Arthrex SutureTape (K221354)Arthrex, Inc.2022-09-09
Ellusa Reusable Neutral Plates (K222425)Ellusa, LLC2022-09-08
Dynamis Pro Family (K213267)Fotona D.O.O.2022-09-08
Unistik Touch Single-Use Safety Lancets - 16G, 21G, 23G, 28G and 30G (K222111)Owen Mumford, Ltd.2022-09-07
RightLance Blood Lancing System (K222034)Beijing Ruicheng Medical Supplies Co., Ltd.2022-09-07
DURAMESH Mesh Suture (K211178)Msi2022-09-02
Soniquence Reusable 3 Button Fingerswitch Wand (K212222)Soniquence, LLC2022-09-02
Mygen M-3004 RF Generator M-3004 (K221277)RF Medical Co., Ltd.2022-09-02
CellFX System (K222075)Pulse Biosciences, Inc.2022-09-02
Savewo ClassicMASK (K221957)Savewo Limited2022-09-02
Perfetta Moderate Medical Face Mask (K222426)Phu Bao Group Company Limited2022-09-02
FOX 810, FOX 980 (K220531)A.R.C Laser GmbH2022-09-01
Disposable Medical Masks (K221038)Hantech Medical Device Co., Ltd.2022-09-01
Ambient HipVac 50 Wand with Integrated Finger Switches, RF20000 COBLATION System, WEREWOLF COBLATION System, WEREWOLF+ COBLATION System (K220563)ArthroCare Corporation2022-09-01
Disposable Blood Lancet (K221507)SteriLance Medical (Suzhou), Inc.2022-08-31
IPL sapphire ice cooling hair remove device (K221635)Shenzhen Desida Technology Co., Ltd.2022-08-31
Lancing device (K221970)SteriLance Medical (Suzhou), Inc.2022-08-30
Medical Surgery Mask, Model:2626-7 (K220067)Dongguan Missadola Technology Co., Ltd.2022-08-30
NEOVEIL Staple Line Reinforcement (K221487)Gunze Limited2022-08-26
Beamer AVEO Electrosurgical Generator, Beamer AVEO Argon Module, Beamer AVEO Cart, Beamer AVEO Wired Foot Pedal, Beamer AVEO Argon Pressure Reducer (K214058)Conmed Corporation2022-08-26
Poly-Tape/Infinity-Lock Soft Tissue Reinforcement Device (K220091)Xiros, Ltd.2022-08-26
Apollo Duet (Model : APD-4000) (K212253)Weero Co.2022-08-25
V-Laser (K221427)Wontech Co., Ltd.2022-08-24
The GOOD High Fluid-Resistant Surgical Mask, The GOOD High Fluid-Resistant Surgical Procedure KF Mask, The GOOD Super Guard Design High Fluid-Resistant Surgical Mask, The KOEASY High Fluid-Resistant Surgical Mask, The KOEASY High Fluid-Resistant Surgical Procedure KF Mask, The KOEASY Super Guard Design High Fluid-Resistant Surgical Mask (K211771)The Good Corporation2022-08-24
OneTouch Delica Plus Lancing System (K221546)Asahi Polyslider Co., Ltd.2022-08-23
Picosecond Laser System (Model PS10-A and PS10-B) (K220268)Beijing Adss Development Co., Ltd.2022-08-23
SafetiHeel, MediHeel, Novaplus (K221604)Nsp Tech Pte, Ltd.2022-08-22
CAREWE Surgical Face Mask Models N001-AW, N002-AW, and N003-AW (K203078)Huizhou Tianchang Industrial Co., Ltd.2022-08-19
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 (K222272)STERIS Corporation2022-08-18
Surgical Face Mask (HNFM0103) (K221838)Shanghai Hua EN Industrial Co, Ltd.2022-08-17
Cross Protection ResQ300 Plus Surgical Face Mask (K212273)Cross Protection (M) Sdn Bhd2022-08-17
Disposable Blood Lancets (K220387)Suzhou Kyuan Medical Apparatus Co., Ltd.2022-08-17
XLase Plus (K212790)Biotec Italia, Srl2022-08-15
IPL Hair Removal Device, model: AI01, AI06, AI08, AI16, AI17 (K221466)Shenzhen Century Dongyuan Technology CO , Ltd.2022-08-12
Intense Pulsed Light Equipment (K220385)Beijing Globalipl Development Co., Ltd.2022-08-12
Unistik® 3, sterile single-use safety lancets; Unistik® 3 Value, sterile single-use safety lancets; Abbott SF sterile single-use safety lancets (K221126)Owen Mumford, Ltd.2022-08-12
Isolation Gown (S, M, L, XL, XXL (Yellow, Blue)) (K221027)Allmed Medical (Hubei) Protective Products Co., Ltd.2022-08-12
Tasso+ (K221131)Tasso, Inc.2022-08-12
NEUWAVE Microwave Ablation System and Accessories (K220472)Neuwave Medical, Inc.2022-08-11
IRIS Pi Q switched Nd YAG laser (K221789)Bio-Med USA, Inc.2022-08-09
Avéli (K221336)Revelle Aesthetics, Inc.2022-08-05
MONOFIX PGCL, knotless wound closure device (K212810)Samyang Holdings Corp., Ltd.2022-08-05
IPL hair removal (K221451)Shenzhen Lizbella Technology Co.,Ltd2022-08-01
CellFX® System (K221671)Pulse Biosciences, Inc.2022-08-01
RhinAer® Stylus (FG1393) (K221907)Aerin Medical, Inc.2022-07-29
Beamer AVEO FILTER INTEGRATED ARGON PROBE 1.8mm x 160 cm, Beamer AVEO FILTER INTEGRATED ARGON PROBE 1.8 mm X 320 cm, Beamer AVEO FILTER INTEGRATED ARGON PROBE 2.3 mm X 230 cm, Beamer AVEO FILTER INTEGRATED ARGON PROBE 2.3 mm x 320 cm, Beamer AVEO FILTER INTEGRATED ARGON SIDEFIRE PROBE 2.3 mm x 230 cm (K221945)Conmed Corporation2022-07-28
AOK 95A Medical Mask (20200049) (K220876)Aok Tooling Limited2022-07-27
Dornier Thulio (K213252)Dornier Medtech America, Inc.2022-07-27
reVive Light Therapy LED Cleansing System (K221430)Led Technologies, Inc.2022-07-27
Invia Ease Negative Pressure Wound Therapy (NPWT) System (K214112)Medela AG2022-07-26
Paneffort 3-ply Surgical and Procedural Masks (K221409)Paneffort, LLC2022-07-25
TargetCool (K221234)Recensmedical, Inc.2022-07-22
Disposable Medical Face Mask (ear loop) (K221196)Xiantao Topmed Nonwoven Protective Products Co., Ltd.2022-07-22
Sterile Level 3 Surgical Gown (K211399)Barco Tekstil Sanayi VE Ticaret A.S.2022-07-22
DuraFuse Clip and Applier System (K213813)Neuramedica, Inc.2022-07-22
Synergy Marble (Model: Opasm) (K220064)Yrs Group, Inc.2022-07-22
AF Laser (K221363)ShenB Co., Ltd.2022-07-20
Joule diVa System (K213761)Sciton, Inc2022-07-19
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
Facet 28G Universal Lancet (K221433)Facet Technologies, LLC2022-07-15
Renuvion APR Handpiece (K220970)Apyx Medical Corporation(Formerly Bovie Medical Corporation)2022-07-15
Alma Diode Tabletop Laser (K212073)Alma Lasers , Ltd.2022-07-14
Dermatac Drape (K220560)3M2022-07-14
AGNES (K203013)Agnes Medical Co., Ltd.2022-07-14
truSculpt iD (K221407)Cutera, Inc.2022-07-13
Smartlux Mini (K221083)Medmix Co., Ltd.2022-07-12
Through the Scope Tracheal Stent System (K220424)Micro-Tech (Nanjing) Co., Ltd.2022-07-08
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
IPL Hair Removal (Model: SL-B080, SL-B126, SL-B136) (K221246)Shenzhen Semlamp Intelligent Technology Co., Ltd.2022-07-07
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
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
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
Dental diode laser, SOGA Laser, ILaser II (K211150)Shenzhen Soga Technology Co., Ltd.2022-07-01
Home use hair removal device (K220248)Shenzhen Mareal Tech Co., Ltd.2022-07-01
InMode Multi-system (K221571)InMode , Ltd.2022-06-30
Intense Pulsed Light (IPL) System, model: T013C, T015C, T015K (K221569)Shenzhen Fansizhe Science and Technology Co., Ltd.2022-06-30
Sparta 3-Ply Surgical Disposable Face Mask (K220378)Sparta East, LLC2022-06-30
Diode Laser Hair Removal Device (K221312)Guangzhou Chuang Zao Mei Technology Co., Ltd.2022-06-29
Magnum (K220670)Magnum Health and Safety Pvt, Ltd.2022-06-28
PL-1 Skin Treatment System (K213726)AVAVA, Inc.2022-06-28
Medical Face Mask (K221272)Shandong Xingyu Gloves Co., Ltd.2022-06-28
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