Atlas FDA

General, Plastic Surgery

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

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RecordFirmDate
CoolSeal Generator/CSL-200-50, CoolSeal Trinity (30 cm shaft)/CSL-TR105-30, CoolSeal Trinity (37 cm shaft)/CSL-TR105-37, CoolSeal Trinity (44 cm shaft)/CSL-TR105-44, CoolSeal Mini (20cm shaft)/CSL-MN103-20 (K202114)Bolder Surgical, LLC2020-10-06
Latex Powder Free Surgical Glove with Protein Labelling Claim of 50 Microgram or Less per Gram of Glove and Tested for use with Chemotherapy Drugs (K201748)Hartalega Sdn Bhd2020-10-02
Arthrex SoftStitch (K190707)Arthrex, Inc.2020-10-02
Electrosurgical Generator (K201221)New Deantronics Taiwan , Ltd.2020-09-28
Surgical Face Mask (K202277)Jiangxi 3l Medical Products Group Co., Ltd.2020-09-25
Dermal Cooling System (K201260)R2 Technologies, Inc.2020-09-24
Electrosurgical Generator and Accessories (K201224)Medrange2020-09-18
Disposable Surgical Mask (K202463)Unisources Group, LLC2020-09-18
Single-Use Surgical Mask With Ear Loop (K201691)Qiqihar Hengxin Medical Supplies, Ltd.2020-09-17
GYNECARE TVT™ System, GYNECARE TVT™ with Abdominal Guides System, GYNECARE TVT™ Introducer and Catheter Guide, GYNECARE TVT EXACT™ Continence System and Trocar, GYNECARE TVT™ Obturator System and Passers and Winged Guide, GYNECARE TVT ABBREVO™ Continence System and Passers and Winged Guide (K201686)ETHICON, Inc.2020-09-17
Polychloroprene Powder Free Sterile Surgical Gloves, Low Dermatitis Potential and Tested for Use with Chemotherapy Drugs (K201774)Pt. Medisafe Technologies2020-09-16
HS Fiber (K202242)Riverpoint Medical, LLC2020-09-10
SubNovii Advanced Plasma Technology (K201738)Cartessa Aesthetics2020-09-10
Diode Laser Body Sculpture System (K201731)Shanghai Apolo Medical Technology Co., Ltd.2020-09-10
MINT Product Family (K192423)Hans Biomed Corporation2020-09-09
SensiCare PI Evolution Surgical Glove (Tested for Use with Chemotherapy Drugs) (K201829)Medline Industries, Inc.2020-09-09
Surgical Mask-Model Number CW01 (K202354)Hunan Heng Chang Pharmaceutical Co., Ltd.2020-09-08
Disposable Medical Face Mask (K201470)Jkh USA, LLC2020-09-08
Protective Face Mask for Medical Use (K201537)Shandong Shengquan New Material Co., Ltd.2020-09-04
Plain Surgical Mask (K201517)Aok Tooling Limited2020-09-04
Lyograft (K192452)B. Bruan Surgical, SA2020-09-03
Cliq Aspirator (K201203)Anest Iwata Sparmax Co., Ltd.2020-09-03
Aesculap PAS-Port Proximal Anastomosis System (K202124)Aesculap, Inc.2020-09-02
OrthoGold 100 (K200926)Tissue Regeneration Technologies, LLC2020-08-28
APTOS Threads – Polypropylene Surgical Sutures (K192953)Aptos, LLC2020-08-27
Motex Anti-Fog Surgical Face Mask (K201549)Modern Healthcare Corp.2020-08-26
Emprint Ablation System with Thermosphere Technology (K200796)Covidien, LLC2020-08-26
Single-use Surgical Mask (K200923)Byd Precision Manufacturer Co., Ltd.2020-08-26
NeuroBlate System (K201056)Monteris Medical, Inc.2020-08-21
BTL-785F (K193201)Btl2020-08-21
invisa-RED ELITE (K192275)IR Technology, LLC2020-08-19
Asept Surgical Face Mask (K201137)Pfm Medical, Inc.2020-08-19
WallFlex Colonic Stent System with Anchor Lock Delivery System (K201159)Boston Scientific Corporation2020-08-17
SNA-001 Silver Photoparticle Topical Gel (K192620)Sienna Biopharmaceuticals, Inc.2020-08-12
Aurora Evacuator +Coag (K201637)Rebound Therapeutics2020-08-12
Surgical Mask (K201871)C & S Paper Yunfu Co., Ltd.2020-08-12
NuEra Tight, NuEra Tight EMS (K200359)Bios S.R.L.2020-08-11
CRYOCARE TOUCH System and Accessories, Endocare 1.7mm Round Ice PerCryo Cryoprobe, Short, Round Ice (K201588)Varian Medical Systems, Inc.2020-08-11
VICRYL Mesh (K201143)ETHICON, Inc.2020-08-06
Modular Toga (K200977)Operating Room Innovations, Inc.2020-08-05
Electrodes Handpieces for Mygen V-1000 RF System (K193355)RF Medical Co., Ltd.2020-08-03
BiPad Hand Activated, Disposable Bipolar Electrocautery Cords (K201833)Bipad Surgical, Inc.2020-07-31
Kendall NPWT Incision Management Dressing Kit (K191101)Cardinalhealth2020-07-31
Cardinal Health SMARTGOWN Breathable Surgical Gown, Cardinal Health SMARTGOWN AIR Breathable Surgical Gown (K200824)Cardinal Health200, LLC2020-07-29
Ethicon Circular Stapler, Ethicon Circular Stapler -XL Sealed (K201280)Ethicon Endo-Surgery, LLC2020-07-27
Arthrex SutureTape (K193575)Arthrex, Inc.2020-07-24
DemeMASK (K201479)Demetech Corporation2020-07-24
Single Use Electrosurgical Knife (K193601)Micro-Tech (Nanjing) Co., Ltd.2020-07-24
InMode RF Multi-System (K201150)InMode , Ltd.2020-07-22
Picowon (K201406)Wontech Co., Ltd.2020-07-22
Signia Stapler (with new software) (K201672)Covidien2020-07-17
3DMax MID Anatomical Mesh (K200818)C.R. Bard, Inc.2020-07-17
AcuPulse W CO2 Laser Systems, Delivery Devices and Accessories (K201663)Lumenis, Ltd.2020-07-16
CO2 Laser Therapy System (K201109)Shanghai Apolo Medical Technology Co., Ltd.2020-07-15
V30 System, V20 System, V10 System, V-FR Handpiece (K201064)Viora , Ltd.2020-07-15
Encision AEM enTouch 2X Scissor (K201018)Encision, Inc.2020-07-15
Biodesign Staple Line Reinforcement (K201000)Cook Biotech Incorporated2020-07-13
HEATfx Microwave Ablation System, HEATfx Microwave Ablation System Cart, HEATfx 2.1 Needle, HEATfx 2.1 S Needle, Multi-Point Thermal Sensor (MTS) (K200061)Galil Medical, Inc.2020-07-09
ACTIV.A.C. Negative Pressure Wound Therapy System (K201571)Kci USA, Inc.2020-07-08
REXSIN (K200392)Sm Eng Co., Ltd.2020-07-07
InMode System with the Morhpeus8 Applicators (K200947)InMode , Ltd.2020-07-02
Psoria-Shield AURORA (K192411)Psoria-Shield2020-07-02
TruView Light Cable, TruView Lateral Retractor Light Cable, Bifurcated Light Cable With Universal End (K200874)Innovasis, Inc.2020-06-30
Litho 150, Cyber Ho 150 (K201455)Quanta System Spa2020-06-30
Echelon Contour Curved Cutter with blue reload, Echelon Contour Curved Cutter with green reload, Echelon Contour Curved Cutter reload, Blue, Echelon Contour Curved Cutter reload, Green (K200420)Ethicon Endo-Surgery, LLC2020-06-29
Venus Viva MD Device (K201164)Venus Concept USA, Inc.2020-06-26
Megadyne Smoke Evacuator, Megadyne Filter, Megadyne Fluid Trap, Megadyne Connect Cable, 1 m and 2.1 m, Megadyne RF Sensor (K200250)Megadyne Medical Products, Inc.2020-06-26
Stardust Med (K200736)I.T.S. Group S.R.L.2020-06-26
Nd: YAG Laser Therapy Systems (K193477)Beijing Kes Biology Technology Co., Ltd.2020-06-24
Opera Lebody (Gold), Opera Lebody (Zafiro) (K201107)Gtg Wellness Co., Ltd.2020-06-22
ArtiSential Laparoscopic Instruments - Electrodes (K200875)Livsmed, Inc.2020-06-17
Foot Control Electrosurgical Pencil, Push Button Electrosurgical Pencil, Rocker Switch Electrosurgical Pencil, Holster, Electorde (K192542)Modern Medical Equipment Manufacturing, Ltd.2020-06-16
CanGaroo Envelope (small), CanGaroo Envelope (medium), CanGaroo Envelope (large), CanGaroo Envelope (extra large), CanGaroo Enevlope (extra extra large) (SubQ) (K201313)Aziyo Biologics, Inc.2020-06-15
E>EyeC (K200616)E-Swin2020-06-11
Hemospray Endoscopic Hemostat (K200972)Wilson-Cook Medical, Inc.2020-06-10
Venus Epileve (K200786)Venus Concept USA, Inc.2020-06-09
DANNIK Disposable Monopolar Laparoscopic Instrument (K201063)Dannik2020-06-09
CO2 Laser System (K200042)Beijing Superlaser Technology Co., Ltd.2020-06-09
Exofin Fusion Skin Closure System (K191461)Chemence Medical, Inc.2020-06-05
Voyant Open Fusion Device (K201212)Applied Medical Resources Corp.2020-06-05
Oxylight (K200104)Raja Trading Company, Inc.2020-06-04
Cardioblate Gemini-s Surgical Ablation Device (K200514)Medtronic2020-06-03
Polyisoprene Powder Free Surgical Underglove for Use with Chemotherapy Drugs (Blue), Polyisoprene Powder Free Surgical Glove for Use with Chemotherapy Drugs (Natural) (K200897)Hartalega Sdn Bhd2020-06-01
Crownjun Nylon Suture (K192420)Kono Seisakusho Co., Ltd.2020-05-29
REVOLVE ENVI 600 Advanced Adipose System (K193539)Lifecell Corporation2020-05-28
PicoSecond Nd: YAG Laser System (K200116)Shanghai Apolo Medical Technology Co., Ltd.2020-05-28
Frozen N (K193665)Yozma Bmtech Co., Ltd.2020-05-28
Megadyne Telescoping Smoke Evacuation Pencil - 10ft tubing, Megadyne Telescoping Smoke Evacuation Pencil - 15ft tubing, Megadyne Telescoping Smoke Evacuation Soft Tissue Dissector, Megadyne Telescoping Soft Tissue Dissector (K200253)Ethicon Endo-Surgery2020-05-27
Medical Diode Laser Hair Removal System (K200525)Weifang Mingliang Electronics Co., Ltd.2020-05-27
NPseal (K200305)Guard Medical, Inc.2020-05-26
GentleMax Pro Plus (K201111)Candela Corporation2020-05-26
Surgical Gown (K192560)Shandong Kangli Medical Equipment Technology Co., Ltd.2020-05-22
Adeor Medical nxt Non-stick Bipolar Forceps, Adeor Medical nxt Single-Use Non-stick Bipolar Forceps (K191847)Adeor Medical AG2020-05-22
V30 system, V20 system, V10 system, V-FC Handpiece (K200468)Viora , Ltd.2020-05-21
Photodynamic Therapy (PDT) Equipment (K200751)Shangdong Huamei Technology Co., Ltd.2020-05-21
gi-4000 Electrosurgical Generator (K192265)United States Endoscopy Group, Inc.2020-05-21
HANAROSTENT Esophagus TTS (CCC), HANAROSTENT Esophagus TTS (NCN) (K200860)M.I.Tech Co., Ltd.2020-05-20
V.A.C. DERMATAC Drape (K200390)Kci USA, Inc.2020-05-18
IPL Treatment Systems (K200746)Shanghai Apolo Medical Technology Co., Ltd.2020-05-15
VFS1 Bipolar Electrosurgical Generator (K200169)FHC, Inc.2020-05-14
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