meddevicedb.com FDA Device Reference

Review Panel

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

Cleared Devices
16,323
Product Codes (page)
33
Latest Decision
2015-02-24

Clearances · page 42 of 164

K-Number Trade Name Applicant / Manufacturer Product Code Class Decision Date
K150336 Photonica Professional Ward Photonics, LLC GEX Class II 2015-02-24
K143260 Reprocessed Covidien LigaSure 5mm, Blunt Tip, Laparoscopic Sealer/Divider Sterilmed, Inc. NUJ Class II 2015-02-23
K143105 Picosure Workstation Cynosure, Inc. GEX Class II 2015-02-23
K143191 IntelliSense Drill Mcginley Innovations HWE Class I 2015-02-20
K142248 Prostiva RF Therapy Generator, Prostiva RF Therapy Hand Piece, Prostiva RF Therapy Return Electrode, Prostiva RF Therapy Tubing System, Prostiva RF Therapy Telescope Urologix, Inc. GEI Class II 2015-02-20
K150024 Bissinger Monopolar Cables Guenter Bissinger Medizintechnik GmbH GEI Class II 2015-02-20
K143457 NeuroBlate System Monteris Medical, Inc. GEX Class II 2015-02-19
K141587 E-Z CLEAR SMOKE EVACUATION ELECTROSURGICAL PENCIL;CLEAR NOZZLE EXTENTION, ULPA FILTER, CHARCOAL FILTER, ADAPTER Megadyne Medical Products, Inc. GEI Class II 2015-02-18
K142924 Shaser Skin Beauty SkinREJUV Intense, Pulsed Light System Family Shaser, Inc. GEX Class II 2015-02-13
K143362 extriCARE 3600 Negative Pressure Wound Therapy System 1000cc canister Devon Medical Products OMP Class II 2015-02-03
K141986 ELUX 810 LASER Equipmed North America, Inc. GEX Class II 2015-01-30
K133891 MULTIPULSE TM+1470 Asclepion Laser Technologies GmbH GEX Class II 2015-01-30
K142246 LightStim for Acne/ LightStim for Acne Mini Led Intellectual Properties, LLC OLP Class II 2015-01-29
K142656 Surgical Gut Suture Covidien GAL Class II 2015-01-29
K143129 easyEndo Linear Cutting Stapler and Loading Unit for Single Use(Stapler;Loading Unit) Ezisurg Medical Co., Ltd. GDW Class II 2015-01-29
K142929 Ligasure Blunt Tip Sealer/Divider Covidien GEI Class II 2015-01-27
K142491 ZEL TIQ CoolSculpting System Zeltiq Aesthetics, Inc. OOK Class II 2015-01-26
K140932 AMSEL OCCLUDER DEVICE Amsel Medical Corporation FZP Class II 2015-01-23
K141511 SIDELAZE800 LASER BEAM DELIVERY ACCESSORY FOR CYNOSURE 1440MM WAVELENGTH LASERS Cynosure, Inc. GEX Class II 2015-01-23
K141722 CAREFUSION GOLD TISSUE MARKER Care Fusion NEU Class II 2015-01-23
K142860 Lumenis M22 System Lumenis, Ltd. GEX Class II 2015-01-21
K141206 EDWARDS LIFESCIENCES THRUPORT KNOTTING SYSTEM Edwards Lifesciences, LLC GAW Class II 2015-01-16
K143589 GEM Flow COUPLER Device and System Synovis Life Technologies, Inc. MVR Class II 2015-01-16
K143007 Erchonia Zerona Z6 OTC Erchonia Corporation OLI Class II 2015-01-15
K143040 Exilis XP BTL Industries, Inc. PBX Class II 2015-01-15
K143625 truFreeze System CSA Medical, Inc. GEH Class II 2015-01-15
K140471 PRO X OTC 5 La Lumiere, LLC OHS Class II 2015-01-15
K142335 RapidVac Smoke Evacuator System Covidien FYD Class II 2015-01-14
K142759 PK Cutting Forceps for ESG-400 Workstation Gyrus Acmi, Inc. GEI Class II 2015-01-13
K142952 InMode Diolaze Device Inmode MD , Ltd. GEX Class II 2015-01-13
K142350 PK J-HOOK Gyrus Acmi, Inc. GEI Class II 2015-01-08
K141852 IFS ADVANCED FEMTOSECOND LASER SYSTEM Amo Manufacturing USA, LLC GEX Class II 2015-01-06
K143154 IRIDEX CycloG6 Laser System, MicroPulse P3 Drive, G-Probe(RFID) Iridex Corporation GEX Class II 2015-01-02
K141851 NAVILAS LASER SYSTEM Od-Os GmbH GEX Class II 2015-01-02
K142229 Laparoscopic FMsealer Domain Surgical, Inc. GEI Class II 2015-01-02
K142289 PK Spatula Gyrus Acmi, Inc. GEI Class II 2014-12-31
K142611 TYRX Neuro Absorbable Antibacterial Envelope Medtronic Tyrx, Inc. FTL Class II 2014-12-31
K143175 AEx Generator; PlasmaBlade T Medtronic Advanced Energy GEI Class II 2014-12-31
K133333 UNI NPWT FOAM DRESSING KIT, UNI NPWT FOAM DRESSING KIT, UNI NPWT FOAM DRESSING KIT Blue Ocean Medical Product, LLC OMP Class II 2014-12-31
K141868 TRIA FANP Tria Beauty, Inc. ONG Class II 2014-12-30
K141046 MIDI-SRS Srmc Co., Ltd. ONG Class II 2014-12-24
K142326 HP Tissue Matrix Lifecell Corporation FTM Class II 2014-12-23
K141721 BOVINE PERICARDIUM PATCH Collafirm, LLC FTM Class II 2014-12-22
K140989 POWDER FREE NITRILE SURGICAL GLOVES, WHITE COLOR (BRAND NAME: TITANFINE) Hebei Hongsen Plastics Technology Co, Ltd. KGO Class I 2014-12-22
K142682 The Lipogems System Lipogems International Spa MUU Class II 2014-12-22
K142910 Legacy BX Venus Concept USA, Inc. GEI Class II 2014-12-19
K143339 Mini me Iluminage Ltd.(Formerly Syneron Beauty Ltd.) ONF Class II 2014-12-19
K143161 Force FX-8(S), Force FX-8C(S), Force FX-8CA(S) Covidien GEI Class II 2014-12-19
K140668 PLATINUMGMT IPL SYSTEM CLOUD Global Medical Technology S.L. ONF Class II 2014-12-19
K141926 INVIA ENDURE NEGATIVE PRESSURE WOUND THERAPY SYSTEM Medela AG OMP Class II 2014-12-19
K142638 ProFlex Laser Fibers (ProFlex 200) and ProFlex Laser Fibers (PRoFlex 273) Innovaquartz, LLC GEX Class II 2014-12-19
K142777 Weck Hem-o-lok Auto Endo5 Ligating Clip Applier Teleflexmedical, Inc. FZP Class II 2014-12-19
K142154 PK NEEDLE Gyrus Acmi, Inc. GEI Class II 2014-12-19
DEN130004 MOERAE SURGICAL MARKING PEN Moerae Matrix, Inc. PDW Class II 2014-12-18
K142639 StitchKit Origami Surgical, LLC GAW Class II 2014-12-16
K141330 ENDO-CORD Enroxtech, Inc. FST Class II 2014-12-15
K142975 Bovie Ultimate High Frequency Electrosurgical Generator Bovie Medical Corporation GEI Class II 2014-12-12
K141053 OVINE TISSUE MATRIX(OTM) TELA Bio, Inc. FTM Class II 2014-12-11
K140624 HICURA HAND INSTRUMENTS Olympus Winter & Ibe GmbH GEI Class II 2014-12-10
K141507 TWO SKIN TREATMENT SYSTEM Syneron Medical, Ltd. GEI Class II 2014-12-08
K143145 SafeAir Smoke Pencil Lina Medical Aps GEI Class II 2014-12-04
K140926 INMODE WMFACE DEVICE Inmode MD , Ltd. GEI Class II 2014-12-03
K142272 SNaP Wound Care System Spiracur, Inc. OKO Class II 2014-11-25
K140382 AEROMINI TRACHEOBRONCHIAL STENT TECHNOLOGY Merit Medical Systems, Inc. JCT Class II 2014-11-25
K141952 ECHELON FLEX POWERED VASCULAR STAPLER WITH ADVANCED PLACEMENT TIP, ENDOPATH ECHELON VASCULAR WHITE RELOADS FOR ADVANCED Ethicon Endo-Surgery, Inc. GDW Class II 2014-11-24
K142868 5mm Laparoscopic Electrode with J Hook, 5mm Laparoscopic Electrode with L Hook, 5mm Laparoscopic Electrode with Spatula, Monopolar cable with 4mm pin, Monopolar cable with 8mm pin Purple Surgical International Limited GEI Class II 2014-11-21
K134006 DISPOSABLE LAPAROSCOPIC ELECTRODE, DISPOSABLE LAPAROSCOPIC ELECTRODE Modern Medical Equipment Manufacturing Limited GEI Class II 2014-11-21
K142999 EVac 70 Xtra Plasma Wand with Integrated Cable, PROcise XP Plasma Wand with Integrated Cable ArthroCare Corporation GEI Class II 2014-11-19
K141606 SURGICAL GOWN Cobes Industries Co., Ltd. FYA Class II 2014-11-17
K142093 V20 SYSTEM Viora , Ltd. GEX Class II 2014-11-14
K142810 WEGO-PGCL Absorbable Surgical Monofilament Suture Foosin Medical Supplies Inc., Ltd. GAM Class II 2014-11-14
K142908 Parietex Monofilament Polyester Mesh (new name: Parietex Lightweight Mesh), Parietex Composite Mono PM Mesh (new name: Parietex Composite Parastomal Mesh), Parietex Composite Ventral Patch, Symbotex Composite Mesh Sofradim Production FTL Class II 2014-11-14
K133896 REJUVALITE MD Trophy Skin, Inc. OHS Class II 2014-11-13
K140732 CANDELA GENTLELASE FAMILY OF LASER SYSTEMS Candela Corp. GEX Class II 2014-11-07
K141555 ADVANTAGE Lutronic Corporation GEX Class II 2014-11-06
K140355 SENSIFLEX PLUS STERILE LATEX SURGICAL GLOVE POWDERFREE WITH PROTEIN CONTENT LABELING CLAIM Terang Nusa Sdn Bhd KGO Class I 2014-11-06
K140727 CUTERA PICOSECOND LASER SYSTEM Cutera, Inc. GEX Class II 2014-11-06
K140008 VIRTUOSAPH PLUS ENDOSCOPIC VESSEL HARVESTING SYSTEM Terumo Cardiovascular Systems Corporation GEI Class II 2014-10-31
K142286 NS3000 Holmium Laser System New Star Lasers, Inc. GEX Class II 2014-10-31
K142869 Premium Surgiclip III Covidien FZP Class II 2014-10-30
K142372 Pico Way Laser System Candela Corpation GEX Class II 2014-10-30
K142441 cryoICE croablation probe AtriCure, Inc. GEH Class II 2014-10-29
K142984 Leo Minor Sunnex, Inc. FSY Class II 2014-10-29
K142900 Parietex Progrip Mesh (new name: Progrip Self-Gripping Polyester Mesh), Parietex Plug and Patch (new name : Parietex Plug and Patch System), Progrip Laparoscopic Self-Fixating Mesh Sofradim Production FTL Class II 2014-10-28
K141713 SMARTGRAFT 200 SYSTEM Ingeneron, Inc. MUU Class II 2014-10-28
K142084 EPI-SENSE GUIDED COAGULATION DEVICE WITH VISITRAX Ncontact Surgical, Inc. OCL Class II 2014-10-28
K132771 KINGSTON ENDOSCOPIC SURGICAL INSTRUMENTS Qingdao Kingston Medical Devices, Ltd. GEI Class II 2014-10-28
K142070 FORTIVA PORCINE DERMIS, TUTOPLAST PORCINE DERMIS Rti Surgical, Inc. FTM Class II 2014-10-27
K140022 NISUS NEGATIVE PRESSURE WOUND THERAPY PUMP, NISUS NPWT CANISTER 250-ML, NISUS NPWT CANISTER 500-ML, CORK MEDICAL PRODUCT Cork Medical Products, LLC OMP Class II 2014-10-24
K142757 LiNA PowerBlade Plus HC Lina Medical Aps GEI Class II 2014-10-23
K141560 ETHICON PHYSIOMESH OPEN FLEXIBLE COMPOSITE MESH DEVICE ETHICON, Inc. FTL Class II 2014-10-23
K141908 DUAL SWITCH Laser Engineering, Inc. GEX Class II 2014-10-22
K141658 LIGHT SCALPEL Lightscalpel, LLC GEX Class II 2014-10-22
K142042 ERCHONIA SHL Erchonia Corporation OLI Class II 2014-10-21
K141904 VIORA V-TOUCH Viora , Ltd. GEI Class II 2014-10-21
K140472 BONASTENT TRACHEAL / BRONCHIAL Endochoice, Inc. JCT Class II 2014-10-17
K142091 PARIETENE MACROPOROUS MESH Sofradim Production FTL Class II 2014-10-17
K141242 GLIDE DEVICE Home Skinovations , Ltd. OHT Class II 2014-10-17
K141584 ULTRAFLEX TRACHEOBRONCHIAL COVERED STENT SYSTEM Boston Scientific Corporation JCT Class II 2014-10-16
K140470 OBERON: LASER SURGERY FIBER, ATRAUMATIC SURGERY FIBER, SIDE FIRE FIBER, RADIAL EMISSION FIBER, DENTAL SURGERY FIBER Oberon GmbH Fiber Technologies GEX Class II 2014-10-15

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