meddevicedb.com FDA Device Reference

Review Panel

General, Plastic Surgery FDA 510(k) Clearances & Devices

Cleared Devices
16,323
Product Codes (page)
35
Latest Decision
2015-10-29

Clearances · page 40 of 164

K-Number Trade Name Applicant / Manufacturer Product Code Class Decision Date
K143582 MOPYLEN, RESOPREN, SILK, POLYESTER, NYLON, RESOLON, POLYAMIDE PSEUDO, STEEL Resorba Medical GmbH GAW Class II 2015-10-29
K151758 ALAR Nasal Valve Stent Medtronic Xomed, Inc. GAT Class II 2015-10-29
K152795 RiverLon (Nylon) Suture Riverpoint Medical GAR Class II 2015-10-28
K141876 Pasture F550S Surgical N95 Respirator, Pasture F550CS Surgical N95 Respirator, Pasture A520S Surgical N95 Respirator, Pasture A520CS Surgical N95 Respirator, Pasture E520S Surgical N95 Respirator, Pasture E520CS Surgical N95 Respirator Pasture Pharma Pte, Ltd. MSH Class II 2015-10-28
K152095 Ultraviolet Lamps Intended for Use in Sunlamp Products (commonly known as metal halide sunlamps) Cosmedico Light, Inc. LEJ Class II 2015-10-28
K143306 ERBE WaterJet Model ERBEJET® 2 System with HybridAPC Probe Erbe USA, Inc. GEI Class II 2015-10-27
K151629 Guardian 1000 Quanta System Spa GEX Class II 2015-10-27
K151182 LiquiBand Exceed Advanced Medical Solutions (Plymouth), Ltd. MPN Class II 2015-10-26
K143235 RF20000a Controller, FLOW 50 Wand ArthroCare Corporation GEI Class II 2015-10-23
K151336 LightStim Professional 2-Panel Light Led Intellectual Properties, LLC OHS Class II 2015-10-23
K150936 SureClip Conmed Corporation FZP Class II 2015-10-23
K152096 DERMABOND Advanced Topical Skin Adhesive, High Viscosity DERMABOND Mini Topical Skin Adhesive ETHICON, Inc. MPN Class II 2015-10-22
K151386 C-QUR, C-QUR FX, C-QUR TacShield, C-QUR V-Patch, C-QUR CentriFX, C-QUR Mosaic Atrium Medical Corporation FTL Class II 2015-10-22
K151674 Ultraviolet Sun Tanning Lamp G.I.E.- Gesellschaft Fur Lichttechnische Erzeugnisse Mbh LEJ Class II 2015-10-20
K150156 Ranfac Fat Aspiration Transfer Syringe (FATS) Procedure Pack, Ranfac Fat Aspiration Transfer Syringe (FATS) Containment Vessel Ranfac, Corp. MUU Class II 2015-10-19
K150835 LigaSure Advance Monopolar Tip Laparoscopic Sealer/Divider, Pistol Grip Covidien GEI Class II 2015-10-15
K152668 truFreeze System CSA Medical, Inc. GEH Class II 2015-10-14
K150717 Megasorb, Mitsu, Mitsu FST, Filaxyn, Filapron M/s. Meril Endo Surgery Private Limited. GAM Class II 2015-10-14
K151044 CLICKLINE Scissor Insert for Single Use Karl Storz Endoscopy America, Inc. GEI Class II 2015-10-09
K152591 Medilas H RFID Laser Fibers Dornier Medtech America, Inc. GEX Class II 2015-10-08
K134036 WAVETRONIC 5000 DIGITAL HF SURGICAL UNIT Loktal Medical Electronics Ind. Com. Ltda- Epp GEI Class II 2015-10-08
K151261 Invia Foam Dressing Kit Small, Invia Foam Dressing Kit Medium, Invia Foam Dressing Kit Large Medela AG OMP Class II 2015-10-07
K151841 Ultraviolet Sunlamps Wolff System Technology Corp. LEJ Class II 2015-10-05
K142887 SIS Inguinal Hernia Repair Graft Cook Biotech Incorprated FTM Class II 2015-10-01
K151306 Solea Convergent Dental, Inc. GEX Class II 2015-09-23
K152317 Stretta Catheter Mederi Therapeutics, Inc. GEI Class II 2015-09-23
K151179 ZELTIQ CoolSculpting System Zeltiq Aesthetics, Inc. OOK Class II 2015-09-22
K150532 Universal Light Handle Cover, Light Handle Cover Key Surgical, Inc. FTA Class II 2015-09-22
K143743 ECHO 2.0 LAP SYSTEM with VENTRALIGHT ST MESH C.R. Bard, Inc. FTL Class II 2015-09-18
K151392 Sensiflex Plus Sterile Latex Green Surgical Glove Powder Free with Protein Content Labeling Claim with 50ug/dm2 or less Terang Nusa Sdn Bhd KGO Class I 2015-09-18
K152031 New Deantronics Smoke Evacuation Adapter with 10mm connector. New Deantronics Smoke Evacuation Adapter with 22mm connector. New Deantronics Button Switch Electrosurgical Pencil with SA01 Adapter. New Deantronics Button Switch Electrosurgical Pencil with SA02 Adapter. New Deantronics Taiwan , Ltd. GEI Class II 2015-09-17
K152032 ELUMI 810 + 980 Soft Tissue Laser Azena Medical, LLC GEX Class II 2015-09-16
K150720 XP3000 BTL Industries, Inc. PBX Class II 2015-09-16
K151400 Ergoline, Sun Angel, Soltron, Sundash and Palm Beach Tan Sunlamp Products Jk Holding GmbH LEJ Class II 2015-09-16
K151655 CO2RE System Syneron Medical, Ltd. GEX Class II 2015-09-15
K143644 Premium Surgiclip¿; Endo Clip¿; AcuClip¿ Covidien FZP Class II 2015-09-14
K143413 J+PRAS YOUNG'S Thread Y. Jacobs Medical, Inc. NEW Class II 2015-09-11
K151112 Quill Polypropylene Knotless Tissue-Closure Device, Variable Loop Design Angiotech GAW Class II 2015-09-10
K150840 Ligaclip 10mm M/L Endoscopic Rotating Multiple Clip Applier Ethicon Endo-Surgery, LLC FZP Class II 2015-09-10
K150959 Sutter Bipolar Forceps-Calvian Sutter Medizintechnik GmbH GEI Class II 2015-09-10
K151649 Valleylab FT10 Electrosurgical Platform Covidien GEI Class II 2015-09-10
K151795 ML24000 UVA-1 Phototherapy Cabinet Daavlin Distributing Co. FTC Class II 2015-09-10
K150112 HS AMICA DEVICES FAMILY H.S Hospital Service S.P.A GEI Class II 2015-09-10
K151968 Cryocare CS-3 Surgical System version 5 Healthtronics GEH Class II 2015-09-09
K152286 LigaSure Curved, Small Jaw, Open Sealer/Divider Covidien GEI Class II 2015-09-08
K152220 MH01 Quanta System Spa GEX Class II 2015-09-03
K150124 Cardinal Health NPWT PRO HC Cardinalhealth OMP Class II 2015-09-02
K151473 NaturaLase PiQo4 - NaturaLase Nd:Y AG 1064 Q-switched Laser with 532 nm accessory and Pulse Slicing Module Focus Medical, LLC GEX Class II 2015-09-01
K150146 Biogel PI Micro Indicator Underglove Molnlycke Health Care Us, LLC KGO Class I 2015-08-31
K152133 IcePearl 2.1 CX Cryoablation Needle, IcePearl 2.1 CX Prostate Cryoablation Kit Visual-ICE System, IceFORCE 2.1 CX Cryoablation Needle, IceFORCE 2.1 CX Prostate Cryoablation Kit Visual-ICE System Galil Medical , Ltd. GEH Class II 2015-08-28
K151437 ProLite Mesh, ProLite Ultra Mesh, ProLoop Mesh Plug Atrium Medical Corporation FTL Class II 2015-08-27
K152070 BioZorb LP Marker Focal Therapeutics NEU Class II 2015-08-26
K143203 AveCure Microwave Coagulation-Ablation Generator, AveCure Microwave Large Antenna-Probe, AveCure Microwave Medium Antenna-Probe, AveCure Microwave Small Antenna-Probe, AveCure Microwave Mini Antenna-Probe Medwaves Incorporated NEY Class II 2015-08-26
K152081 Weck Auto Endo5 Hem-o-lok Ligating Clip Applier Teleflexmedical, Inc. FZP Class II 2015-08-26
K141017 PREVENA INCISION MANAGEMENT SYSTEM WITH PEEL & DRESSING, PREVENA INCISION MANAGEMENT SYSTEM WITH CUSTOMIZABLE DRESSING, Kci USA, Inc. (Kinetic Concepts, Inc.) OMP Class II 2015-08-20
K151998 TraceIT Tissue Marker - 3mL Augmenix, Inc. NEU Class II 2015-08-19
K151009 Nexus Suture Baylis Medical Company, Inc. GAT Class II 2015-08-18
K151309 Wartie Advanced Wart Remover or other proprietary name Youmedical Corp BV GEH Class II 2015-08-14
K150584 Stryker Suture Tape Stryker GAT Class II 2015-08-13
K151200 STRATAFIX Spiral MONOCRYL Knotless Tissue Control Device, STRATAFIX Spiral MONOCRYL Plus Knotless Tissue Control Device ETHICON, Inc. GAM Class II 2015-08-13
K151947 LightSheer Desire Light Laser System Lumenis, Ltd. GEX Class II 2015-08-12
K151232 VIKINI Diode Laser System Ilooda Co,., Ltd. GEX Class II 2015-08-06
K150735 Force TriVerse Electrosugical Device, Holster, 10-foot, Force TriVerse Electrosurgical Device, Holster, 15-foot Covidien GEI Class II 2015-08-04
K151325 Bovie J-Plasma Handpiece Bovie Medical Corporation GEI Class II 2015-08-04
K150973 NUZONE X2G Polychloroprene Synthetic Green Surgical Gloves Powder Free, Tested for Use with Chemotherapy Drugs Terang Nusa Snd Bhd KGO Class I 2015-08-04
K143554 Venus Legacy CX Venus Concept , Ltd. PBX Class II 2015-08-04
K150752 GME ExSys 308 Gme (German Medical Engineering) GmbH FTC Class II 2015-07-31
K151177 XenMatrix AB Surgical Graft C. R. Bard PIJ Class II 2015-07-30
K150505 Cellfina System Ulthera, Inc. OUP Class II 2015-07-29
K150251 Barrx Anorectal RFA Wand Covidien, LLC GEI Class II 2015-07-28
K150906 ULTRAPRO ADVANCED Macroporous Partically Absorbable Mesh Ehicon, Inc. FTL Class II 2015-07-24
K143133 RENASYS¿ EZ MAX Negative Pressure Wound Therapy Device, RENASYS¿ AB Abdominal Dressing Kit with Soft Port Device Smith & Nephew, Inc. OMP Class II 2015-07-23
K150370 Nutra Light Advanced Nutra Luxe MD, LLC OLP Class II 2015-07-22
K143356 NovoStitch Plus Meniscal Repair System Ceterix Orthopaedics, Inc. GAT Class II 2015-07-21
K151858 Caiman Seal and Cut Technology Aesculap, Inc. GEI Class II 2015-07-21
K150587 Cortex Laser System Cynosure, Inc. Dba Ellman GEX Class II 2015-07-21
K151696 Caiman Seal and Cut Technology Aesculap, Inc. GEI Class II 2015-07-20
K150866 SURGISEAL Topical Skin Adhesvie Adhezion Biomedical, LLC MPN Class II 2015-07-17
K151659 ReliaTack Articulating Reloadable Fixation Device with Deep Purchase Reloadable Tacks Covidien, LLC GDW Class II 2015-07-17
K151326 RENASYS¿ EZ PLUS Negative Pressure Wound Therapy Device Smith & Nephew, Inc. OMP Class II 2015-07-16
K143103 PROPENCIL Smoke Pencil Bio Protech, Inc. GEI Class II 2015-07-16
K142190 Polychloroprene Powder-free Surgical Glove (White) Tested for Use with Chemotherapy Drugs; Polychloroprene Powder-free Surgical Glove (Green) Tested for Use with Chemotherapy Drugs Pt. Medisafe Technologies KGO Class I 2015-07-14
K150912 Houva-NET Control System National Biological Corporation FTC Class II 2015-07-10
K150907 Ellipse Nordlys/Ellipse Nordlys+, Ellipse Sirius, Ellipse Infinity, Ellipse Mjolner, Ellipse Nordlys Ultra Ellipse A/S GEX Class II 2015-07-07
K151054 Coldplay Full CryoBalloon Ablation System and Coldplay Swipe CryoBalloon Ablation System C2 Therapeutics, Inc. GEH Class II 2015-07-07
K150670 STRATAFIX Spiral PDS Plus Knotless Tissue Control Device ETHICON, Inc. NEW Class II 2015-07-02
K150712 LTM-Perforated Surgical Mesh Lifecell Corporation FTM Class II 2015-07-02
K150724 SculpSure Cynosure, Inc. PKT Class II 2015-07-01
K142845 SILKPRO laser hair removal system Wuhan Lotuxs Technology Co., Ltd. OHT Class II 2015-07-01
K151331 The UltraPulse system (UltraPulse and UltraPulse DUO models,members of the modified Lumenis Family of UltraPulse SurgiTouch Lumenis, Ltd. GEX Class II 2015-06-30
K150327 Dunamis Force DFX Suture, Size 5, Dunamis Force DFX Suture Size 2 Dunamis, LLC GAT Class II 2015-06-29
K143484 BioZorb Marker Focal Therapeutics NEU Class II 2015-06-29
K141110 CRYOCARE CS SURGICAL SYSTEM Healthtronics GEH Class II 2015-06-25
K150538 Reprocessed LigaSure ImpactTM Curved, Large Jaw, Open Sealer/Divider Stryker Sustainability Solutions NUJ Class II 2015-06-25
K150029 Habib EUS RFA Emcision , Ltd. GEI Class II 2015-06-24
K133080 Plus Surgical Drapes (EO Sterilized), PMDB-XXX Foshan Nanhai Plus Medical Co, Ltd. KKX Class II 2015-06-24
K133075 Plus Surgical Gowns (EO Sterilized), PMGB-XXX Foshan Nanhai Plus Medical Co, Ltd. FYA Class II 2015-06-24
K133070 SURGICAL FACE MASK (Ear Loops and Tie-on) Bh Medical Products Co., Ltd. FXX Class II 2015-06-22
K143726 XLR8 PLUS (XLR8+) Genadyne Biotechnologies, Inc. OMP Class II 2015-06-19
K150419 miraDry System MD4000 Miramar Labs, Inc. OUB Class II 2015-06-19

16,323 clearances in the General, Plastic Surgery panel. Data: openFDA.