Atlas FDA

General, Plastic Surgery

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

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RecordFirmDate
NeuroBlate System (K172881)Monteris Medical,2017-10-20
Discovery Pico, Discovery Pico Plus (K172376)Quanta System Spa2017-10-19
Medline ReNewal Reprocessed Stryker SERF AS Energy Probes (K172608)Surgical Instrument Service and Savings, Inc.2017-10-18
585 (K172198)Quanta System Spa2017-10-17
X-SURGE (K171752)Genicon, Inc.2017-10-17
micro IPL (K172181)El Global Trade, Ltd.2017-10-13
PAL Multi-Use Cannulas and PAL Manual Wand (K171286)Microaire Surgical Instruments, LLC2017-10-13
Exciplex308nm (K171702)Clarteis2017-10-13
CELFIRM (K172023)VIOL Co., Ltd.2017-10-13
Sterile Nitrile Surgical Powder Free Gloves Tested for Use with Chemotherapy Drugs and Sterile Latex Surgical Powder Free Gloves (K171279)Top Glove Sdn. Bhd.2017-10-12
AtriClip LAA Exclusion System with preloaded Gillinov-Cosgrove Clip (PRO2) (K172742)AtriCure, Inc.2017-10-11
InMode RF System (K171593)Inmode MD , Ltd.2017-10-10
MT ONE (K172413)M&T S.R.L.2017-10-06
PROLENE Soft Polypropylene Mesh (K172089)ETHICON, Inc.2017-10-05
HelixAR Electrosurgical Generator with Argon Beam Coagulation, HelixAR Mobile Pedestal (K172671)Conmed Corporation2017-10-04
Force Fiber Fusion Suture (K172016)Teleflex Medical Incorporated2017-10-03
iSurg (K170054)Jaco, LLC Dba Macan Manufacturing and Bna Burz North America2017-10-02
SecurePortIV Catheter Securement Adhesive (K170505)Adhezion Biomedical, LLC2017-09-29
Sterile Powder Free Nitrile Surgical Glove, White Colored. Tested for Use with Chemotherapy Drugs, with Non-Pyrogenic Labeling Claim (K172420)Wear Safe (Malaysia) Sdn. Bhd.2017-09-29
CARESORB-Polyglactin 910 Surgical Suture, CARESORB-Polyglactin 910 (fast absorbing) Surgical Suture (K170166)Cpt Sutures Co., Ltd.2017-09-29
SurgiCube (K163455)Surgicube International B.V.2017-09-28
Photon Vibrating massage Facial Aesthetic Device (Model: UI-200) (K161434)Li-Tek Electronics Technologies2017-09-28
Single Use Micro Electrode (Brass with gold plated shaft); Single Use Micro Electrode (Stainless Steel shaft) (K163442)Modern Medical Equipment Manufacturing Limited2017-09-28
MEGASORB - Natural absorbable Polyglycolic Acid Surgical Suture, MITSU - Absorbable Polyglactin 910 Surgical Sutures, MITSU FST - Absorbable Polyglactin 910 Surgical Suture, FILAXYN - Absorbable Polydioxanone Surgical (PDS), FILAPRON - Absorbable poly(glycolide-co-caprolactone) Surgical Suture (K172659)M/s. Meril Endo Surgery Private Limited.2017-09-28
CRYOFOS (K170810)Cryofos Medical GmbH2017-09-27
SculpSure (K171992)Cynosure, Inc.2017-09-26
Exofin Fusion Skin Closure System (K171442)Chemence Medical, Inc.2017-09-25
Thermage FLX System and Accessories (K170758)Solta Medical2017-09-22
Sterling Supreme Diode Laser (K171986)CAO Group, Inc.2017-09-22
SERI Contour (K172545)Sofregen Medical, Inc.2017-09-22
TempSure (K171262)Cynosure, Inc.2017-09-22
Occlusion Detection Dressing Kit (K171499)Cardinalhealth2017-09-22
PICO Single Use Negative Pressure Wound Therapy System (K172521)Smith & Nephew Medical Limited2017-09-20
LightSheer Desire; LightSheer Desire Light; LightSheer Duet; LightSheer Infinity (K170179)Lumenis, Ltd.2017-09-18
Winback Back 3SE (K162828)Winback USA Corp2017-09-18
PICO Single Use Negative Pressure Wound Therapy System (K172519)Smith & Nephew Medical Limited2017-09-15
Amsel Occluder Device (K172479)Amsel Medical2017-09-14
IntelliCart System (K172481)Dornoch Medical Systems2017-09-14
MediClear PreOp (K163556)Covalontechnologies, Inc.2017-09-14
Pollogen Legend+ System (K171359)Pollogen, Ltd.2017-09-13
PASCAL Synthesis Twinstar Ophthalmic Scanning Laser System (K170409)Topcon Medical Laser Systems, Inc. (Tmls)2017-09-12
BM.IRIS (K171648)Bluecore Co., Ltd.2017-09-08
Minimally Invasive Sealer (MIS) Flex, Minimally Invasive Sealer (MIS) Flex Mini (K170381)Medtronic Advanced Energy2017-09-07
Epilaser (K170970)Epilady 2000, LLC2017-09-01
BIOPHOTAS CELLUMA3 (K171323)Biophotas, Inc.2017-09-01
Emprint SX Ablation Platform and Accessories (K171358)Coviden, LLC2017-09-01
truFreeze System (K171626)CSA Medical, Inc.2017-08-30
CryoIQ DERM, CryoIQ PRO, CryoIQ EquiMED (K172049)Cry IQ AB2017-08-30
Assut Filbloc Permanent Sutures (K171039)Assut Europe S.P.A.2017-08-29
Dextera MicroCutter 30 Blue Reload, Dextera MicroCutter 30 Curved Tip Blue Reload, Dextera MicroCutter 30 White Reload, Dextera MicroCutter 30 Curved Tip White Reload (K171561)Dextera Surgical, Inc.2017-08-28
Revolve Envi 600 Advanced Adipose System (K163647)Lifecell Corporation2017-08-25
VenaCure EVLT NeverTouch Procedure Kit (K171921)AngioDynamics, Inc.2017-08-24
LG BEAUTY LED MASK (K170984)Lg Electronics2017-08-23
Stryker Integrated Bipolar Cord and Tubing Sets (K172367)Stryker Instruments2017-08-22
Monopolar Single Use Laparoscopic Instrument (K171523)Getsch+Hiller Medizintechnik GmbH2017-08-22
GRAVITY™ Soft Tissue Repair System (K170642)Wrightmedicaltechnologyinc2017-08-22
Sterile Polyisoprene Surgical Powder Free Glove Tested for Use with Chemotherapy Drugs (K171276)Tg Medical Sdn. Bhd.2017-08-21
Sterile Polyisoprene Powder Free Surgical Gloves, Tested for Use With Chemotherapy Drugs (K171898)Better Care Plastic Technology Co., Ltd.2017-08-18
StarWalker (K171227)Fotona D.O.O.2017-08-18
Surgical Earloop Face Mask with Bottom Gap Shield and Surgical Tie-On Face Mask with Bottom Gap Shield (K171162)Prestige Ameritech2017-08-15
Silk'n Infinity (K171433)Home Skinovations , Ltd.2017-08-11
3M™ VFlex™ Health Care Particulate Respirator and Surgical Mask , Models 1804/1804S (K171116)3M Healthcare2017-08-10
M22 and ResurFx Systems (K170060)Lumenis, Ltd.2017-08-09
Fraxis (K172096)Ilooda Co,., Ltd.2017-08-09
Reperen Surgical Mesh (K170134)Iconlab, Inc.2017-08-09
GA-B, GA-C, GA-E, GA-I, GA-S, GA-W3A, GA-F3A, GA-IL, GA-SL, GA-W3B, GA-F1A (K171707)Gowoonsesang Cosmetics Co., Ltd.2017-08-08
dpl SpectraLite (K171386)Led Technologies, Inc.2017-08-07
InMode Diolaze XL (K170738)Inmode MD , Ltd.2017-08-07
Epix Electrosurgical Probe with Smoke Evacuation (K171684)Applied Medical Resources Corporation2017-08-07
dpl II Panel (K171390)Led Technologies, Inc.2017-08-03
Medline ReNewal Reprocessed Stryker Neptune 2 Manifolds (K161358)Surgical Instrument Service and Savings, Inc.2017-08-03
truSculpt (K172004)Cutera, Inc.2017-08-02
AUTOCON III 400 (K171717)KARL STORZ Endoscopy-America, Inc.2017-08-02
Q-Switched Nd:YAG Laser System (K171079)Ids, Ltd.2017-08-01
Litho 60 (K172025)Quanta System Spa2017-07-31
WEGO-PTFE (K170842)Foosin Medical Supplies Inc., Ltd.2017-07-31
Discovery Pico, Discovery Pico Plus (K171945)Quanta System Spa2017-07-28
Photodynamic Therapy Device (K170187)Uvbiotek, LLC2017-07-28
TIGR Matrix Surgical Mesh (K163005)Novus Scientific AB2017-07-27
truFreeze System (K172041)CSA Medical, Inc.2017-07-27
LightMed Dental Laser System (K170073)Lightmed Dentaltechnology Corp.2017-07-25
Monteris Medical NeuroBlate System (K171255)Monteris Medical, Inc.2017-07-25
truFreeze Rapid AV Spray Kit (K171522)CSA Medical, Inc.2017-07-14
Alma LipoFlow System (K171242)Alma Lasers, Inc.2017-07-14
Single Use Circular Stapler, Single Use Hemorrhoidal Circular Stapler, Single Patient Use Linear Stapler and Reload, Single Patient Use Linear Cutter and Reload, Single Patient Use Endo Cutter and Reload, Single Patient Use Transverse Cutter and Reload (K162707)Golden Stapler Surgical Co., Ltd.2017-07-14
sensiFirm (K170637)El Global Trade, Ltd.2017-07-14
NIRA Beauty Skin Laser (K163137)Dermal Photonics Corporation2017-07-12
Biodesign Parastomal Hernia Repair Graft (K162934)Cook Biotech Incorporated2017-07-10
ZELTIQ CoolSculpting System (K171069)Zeltiq Aesthetics, Inc.2017-07-07
Safecare Open Back Protective Gowns and ValueCare Open Back Protective Gowns (K160337)Bam Corporation Limited2017-07-07
Thunder, Thunder VT, Thunder HR (K171711)Quanta System Spa2017-07-07
Dermal Cooling System (K171398)R2 Dermatology ,Inc2017-07-06
CO2 Laser Therapy Systems (K162398)Beijing Sincoheren Science and Technology Development Co.2017-07-06
HPO Exotic, LP1, LP2, LP3, Mastersun 360, Mastersun 360 New Reflector, Vega Lux (K161394)Sportarredo Group S.C.2017-07-06
Philips BlueControl (K171055)Philips Electronics Nederland B.V.2017-07-06
DigniCap Scalp Cooling System (K170871)Dignitana AB2017-07-03
D2 Dressing (DEN160012)Z-Medica, LLC2017-06-30
Infinity-Lock 3, Infinity-Lock 5 (K171680)Xiros, Ltd.2017-06-30
Parietene DS Composite Mesh (K163212)Sofradim Production2017-06-29
LASEMD Laser System (K171009)Lutronic Corporation2017-06-23
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