Atlas FDA

General, Plastic Surgery

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

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RecordFirmDate
VIKINI Diode Laser System (K151232)Ilooda Co,., Ltd.2015-08-06
Force TriVerse Electrosugical Device, Holster, 10-foot, Force TriVerse Electrosurgical Device, Holster, 15-foot (K150735)Covidien2015-08-04
Bovie J-Plasma Handpiece (K151325)Bovie Medical Corporation2015-08-04
NUZONE X2G Polychloroprene Synthetic Green Surgical Gloves Powder Free, Tested for Use with Chemotherapy Drugs (K150973)Terang Nusa Snd Bhd2015-08-04
Venus Legacy CX (K143554)Venus Concept , Ltd.2015-08-04
GME ExSys 308 (K150752)Gme (German Medical Engineering) GmbH2015-07-31
XenMatrix AB Surgical Graft (K151177)C. R. Bard2015-07-30
Cellfina System (K150505)Ulthera, Inc.2015-07-29
Barrx Anorectal RFA Wand (K150251)Covidien, LLC2015-07-28
ULTRAPRO ADVANCED Macroporous Partically Absorbable Mesh (K150906)Ehicon, Inc.2015-07-24
RENASYS¿ EZ MAX Negative Pressure Wound Therapy Device, RENASYS¿ AB Abdominal Dressing Kit with Soft Port Device (K143133)Smith & Nephew, Inc.2015-07-23
Nutra Light Advanced (K150370)Nutra Luxe MD, LLC2015-07-22
Caiman Seal and Cut Technology (K151858)Aesculap, Inc.2015-07-21
NovoStitch Plus Meniscal Repair System (K143356)Ceterix Orthopaedics, Inc.2015-07-21
Cortex Laser System (K150587)Cynosure, Inc. Dba Ellman2015-07-21
Caiman Seal and Cut Technology (K151696)Aesculap, Inc.2015-07-20
ReliaTack Articulating Reloadable Fixation Device with Deep Purchase Reloadable Tacks (K151659)Covidien, LLC2015-07-17
SURGISEAL Topical Skin Adhesvie (K150866)Adhezion Biomedical, LLC2015-07-17
RENASYS¿ EZ PLUS Negative Pressure Wound Therapy Device (K151326)Smith & Nephew, Inc.2015-07-16
PROPENCIL Smoke Pencil (K143103)Bio Protech, Inc.2015-07-16
Polychloroprene Powder-free Surgical Glove (White) Tested for Use with Chemotherapy Drugs; Polychloroprene Powder-free Surgical Glove (Green) Tested for Use with Chemotherapy Drugs (K142190)Pt. Medisafe Technologies2015-07-14
Houva-NET Control System (K150912)National Biological Corporation2015-07-10
Coldplay Full CryoBalloon Ablation System and Coldplay Swipe CryoBalloon Ablation System (K151054)C2 Therapeutics, Inc.2015-07-07
Ellipse Nordlys/Ellipse Nordlys+, Ellipse Sirius, Ellipse Infinity, Ellipse Mjolner, Ellipse Nordlys Ultra (K150907)Ellipse A/S2015-07-07
LTM-Perforated Surgical Mesh (K150712)Lifecell Corporation2015-07-02
STRATAFIX Spiral PDS Plus Knotless Tissue Control Device (K150670)ETHICON, Inc.2015-07-02
SILKPRO laser hair removal system (K142845)Wuhan Lotuxs Technology Co., Ltd.2015-07-01
SculpSure (K150724)Cynosure, Inc.2015-07-01
The UltraPulse system (UltraPulse and UltraPulse DUO models,members of the modified Lumenis Family of UltraPulse SurgiTouch (K151331)Lumenis, Ltd.2015-06-30
BioZorb Marker (K143484)Focal Therapeutics2015-06-29
Dunamis Force DFX Suture, Size 5, Dunamis Force DFX Suture Size 2 (K150327)Dunamis, LLC2015-06-29
CRYOCARE CS SURGICAL SYSTEM (K141110)Healthtronics2015-06-25
Reprocessed LigaSure ImpactTM Curved, Large Jaw, Open Sealer/Divider (K150538)Stryker Sustainability Solutions2015-06-25
Plus Surgical Gowns (EO Sterilized), PMGB-XXX (K133075)Foshan Nanhai Plus Medical Co, Ltd.2015-06-24
Plus Surgical Drapes (EO Sterilized), PMDB-XXX (K133080)Foshan Nanhai Plus Medical Co, Ltd.2015-06-24
Habib EUS RFA (K150029)Emcision , Ltd.2015-06-24
SURGICAL FACE MASK (Ear Loops and Tie-on) (K133070)Bh Medical Products Co., Ltd.2015-06-22
XLR8 PLUS (XLR8+) (K143726)Genadyne Biotechnologies, Inc.2015-06-19
miraDry System MD4000 (K150419)Miramar Labs, Inc.2015-06-19
iPulse Smooth Skin Gold Hair Removal System (K143003)Ipulse Limited2015-06-18
NanoKnife System (K150089)AngioDynamics, Inc.2015-06-18
truFreeze System (K150920)CSA Medical, Inc.2015-06-17
AtriClip LAA Exclusion System with preloaded Gillinov-Cosgrove Clip (K150996)AtriCure, Inc.2015-06-17
Matristem Surgery Matrix RS, PSM, PSMX, Matristem Pelvic Floor Matrix (K141084)Acell, Inc.2015-06-17
Edwards Suture Fastening System (K150882)Edwards Lifesciences, LLC2015-06-16
OsteoCool V-2 RF Ablation System (K142480)Baylis Medical Company, Inc.2015-06-16
Invia Liberty Negative Pressure Wound Therapy System, Invia Liberty Tubing Set, Y-connector, Drain Adaptor, Invia Liberty Canisters (K142626)Medela AG2015-06-12
XP1000 RF (K143559)BTL Industries, Inc.2015-06-11
PANTHER Endo Linear Cutter Staplers with Single Use Loading Units (K142577)B.J.ZH.F.PANTHER MEDICAL EQUIPMENT CO., Ltd.2015-06-11
extriCARE Negative Pressure Wound Therapy Gel Strip - 8pc, extriCARE Negative Pressure Wound Therapy Gel Strip - 7pc, extriCARE Negative Pressure Wound Therapy Gel Strip - 6pc, extriCARE Negative Pressure Wound Therapy Gel Strip - 5pc, extriCARE Negative Pressure Wound Therapy Gel Strip - 4pc (K151240)Devon Medical Products2015-06-09
Phasix ST Mesh (K143380)C.R. Bard, Inc.2015-06-05
MCL 31 Dermablate (K150140)Asclepion Laser Technologies GmbH2015-06-05
INTRAGen (K142833)Jeisys Medical, Inc.2015-06-04
PleuraFlow System (K150042)Clearflow, Inc.2015-06-02
Various Brands of Ultraviolet Lamps (K150778)Cosmedico Light, Inc.2015-05-29
Signia Loading Unit, Tri-Staple 2.0 Cartridge (K151163)Covidien, LLC2015-05-29
TD-Wand (K150824)Tdm Surgitech, Inc.2015-05-28
Shaser Skin Beauty Intense Pulsed Light System Family for Acne (K150282)Shaser, Inc.2015-05-27
LUMINA 24 (K140386)Rogers Sciences, Inc.2015-05-26
Versatex Monofilament Mesh (K150091)Sofradim Production2015-05-26
Cautery Tip Cleaner (K151222)Key Surgical, Inc.2015-05-22
Whisper Pump System (K142385)Wound RX Medical, LLC2015-05-22
LipoFilter - Hospital Pack, LipoFilter - Clinic Pack (K150779)Microaire Surgical Instruments, LLC2015-05-22
PlasmaBlade UPPP and Suction Coagulator (K150297)Medtronic Advanced Energy2015-05-21
SmartGownTM surgical gown (K150151)Cardinal Health 200, Inc.2015-05-21
Erchonia Zerona 6 headed scanner EZ6 (K150446)Erchonia Corporation2015-05-21
Endopath ETS-Flex45 Endoscopic Articulating Linear Cutter, Endopath ETS-Flex45 No-Knife Articulating Linear Stapler (K150026)Ethicon Endo-Surgery, LLC2015-05-18
SculpSure (K150230)Cynosure, Inc.2015-05-15
Venus Viva SR Device (K150161)Venus Concept , Ltd.2015-05-12
Miromatrix Biological Mesh RS (K150341)Miromatrix Medical, Inc.2015-05-12
Aspen Laser Systems Therapy Laser System (K150138)Aspen Laser Systems, LLC2015-05-08
Insightra Freedom Ventral Hernia Repair System (K142192)Insightra Medical2015-05-07
Pasture 60S Surgical Mask (K141875)Pasture Pharma Pte, Ltd.2015-05-05
ERBECRYO 2 Cryosurgical Unit with accessories (K151041)Erbe USA, Inc.2015-05-04
2D Mercy TAPE & 3D Mercy TAPE (K142469)Children'S Mercy Hospital2015-05-01
V10 system (K150035)Viora , Ltd.2015-05-01
XLR8 White Foam Dressing Kit and XLR8 White Foam Small Dressing Kit and (K142646)Genadyne Biotechnologies, Inc.2015-04-30
ST'RIM (K142073)Thiebaud Sas2015-04-29
RENASYS; EZ MAX Negative Pressure Wound Therapy; Foam NPWT Wound Dressing Kits with Soft Port; Gauze NPWT Wound Dressing Kits with Soft Port; EZ PLUS/EZ MAX Canisters (K142979)Smith & Nephew, Inc.2015-04-29
Lipofina Laser System (K143741)Yolo Medical, Inc.2015-04-24
SILHOUETTE INSTALIFT (K142061)Silhouette Lift, Inc.2015-04-24
Noblex Long Pulse Alexandrite Laser (K143666)Finemec Co., Ltd.2015-04-23
NICO TRIOwand (K150993)Nico Corporation2015-04-23
Tranberg CLS Thermal Therapy System (K142216)Clinical Laserthermia Systems, AB2015-04-21
Basic, Dominant Flex, KV-6 (K150134)Medela AG2015-04-21
DeScribe Transparent PFD Patch (K150212)On Light Sciences, Inc.2015-04-20
Cardinal Health NPWT PRO, Cardinal Health NPWT PRO to Go, Cardinal Health NPWT PRO at Home (K143016)Cardinalhealth2015-04-20
DIODE LASER HAIR REMOVAL SYSTEM (K142186)Shenzhen Gsd Tech Co., Ltd.2015-04-17
Voyant Fine Fusion Device (K143536)Applied Medical Resources2015-04-16
BIOPOR AOC POROUS POLYETHYLENE, CEREPOR (K141880)Ceremed , Inc.2015-04-16
PicoWay Laser System (K150326)Candela Corporation2015-04-16
HONGYU DISPOSABLE SURGICAL DRAPES (K141324)Weihai Hongyu Nonwoven Fabric Products Co., Ltd.2015-04-14
DEKA SYNCHRO REPLA:Y FAMILY OF LASER SYSTEMS (K150516)El.En Electronic Engineering Spa2015-04-13
Monopolar Laparascopic Accessories (K142208)Unimicro Medical Systems (Shenzhen) Co., Ltd.2015-04-13
BREAST-MED TISSUE MARKER (K133697)Breast-Med, Inc.2015-04-10
SP Dynamis, SP Spectro, XS Dynamis, XP Dynamis, XP Spectro (K143723)Fotona D.D.2015-04-09
LightStim Professional 2-Panel Light (K150098)Led Intellectual Properties, LLC2015-04-09
KOGENT SPETZLER LIGHTED SUCTION TUBES (K141781)Katalyst Surgical, LLC2015-04-09
Exilite (K150051)BTL Industries, Inc.2015-04-08
Vertessa Lite Y-Mesh (K150023)Caldera Medical, Inc.2015-04-06
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