meddevicedb.com FDA Device Reference

Review Panel

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

Cleared Devices
16,323
Product Codes (page)
41
Latest Decision
2013-05-14

Clearances · page 47 of 164

K-Number Trade Name Applicant / Manufacturer Product Code Class Decision Date
K131107 ATRICLIP GILLINOV-COSGROVE LAA CLIP AtriCure, Inc. FZP Class II 2013-05-14
K123629 FINESSIS POLYISOPRENE POWDERFREE SURGICAL GLOVES Lucenxia Prescience AG KGO Class I 2013-05-13
K131099 AG MASS Hospitech Respiration , Ltd. JCX Class II 2013-05-13
K123478 STINGRAY BIPOLAR FORCEPS Stingray Surgical Products GEI Class II 2013-05-10
K130763 BEACON TISSUE MARKER Scion Medical Technologies, LLC NEU Class II 2013-05-08
K130513 VOLISTA 400; VOLISTA 600 Maquet S.A.S. FTD Class II 2013-05-08
K130326 TEPHAFLEX MELTBLOWN CONSTRUCT Tepha, Inc. OOD Class II 2013-05-07
K130250 QYAG LASER SYSTEM Palomar Medical Technologies, Inc. GEX Class II 2013-05-03
K122368 WATERLASE IPLUS ALL TISSUE LASER Biolase Technology, Inc. GEX Class II 2013-05-02
K130968 VENTRALIGHT ST MESH WITH ECHO PS POSITIONING SYSTEM C.R. Bard, Inc. FTL Class II 2013-05-01
K123028 VERTESSA LITE 10 X20CM, VERTESSA LITE 11 X 30CM, VERTESSA LITE Y-MESH Caldera Medical, Inc. OTO Class II 2013-04-25
K123128 SERI SURGICAL SCAFFOLD Allergan OXF Class II 2013-04-25
K123936 SURGISEAL TOPICAL SKIN ADHESIVE Adhezion Biomedical, LLC MPN Class II 2013-04-24
K123483 DIODE LASER BEIJING SYNTECH LASER CO., LTD. GEX Class II 2013-04-21
K130717 ENDO GIA RELOAD Covidien, Formerly US Surgical A Divison of Tyco H GDW Class II 2013-04-18
K122200 A3F FRATIONAL Pollogen, Ltd. GEI Class II 2013-04-18
K130152 HYDRASOLVE LIPOPLASTY SYSTEM Andrew Technologies, LLC MUU Class II 2013-04-18
K122716 PLASMATRODE SALINE SAFE TUR ELECTRODE Cook Ireland, Ltd. GEI Class II 2013-04-17
K130817 LTN - LAPAROSCOPIC SURGICAL MESH Lifecell Corp. OXK Class II 2013-04-17
K123573 YOULASER CO2 LASER Quanta System Spa GEX Class II 2013-04-15
K130465 EPIC 10S Biolase Technology, Inc. GEX Class II 2013-04-11
K123777 MULTILASER SYSTEM Ultralight Laser Technologies, LLC GEX Class II 2013-04-11
K123293 PASTELLE Q-SWITCHED ND: YAG LASER Won Technology Co., Ltd. GEX Class II 2013-04-11
K122966 XP200 Btl Industries, Ltd. GEI Class II 2013-04-08
K130744 LIGASURE 5MM BLUNT TIP LAPAROSCOPIC SEALER/DIVIDER Covidien GEI Class II 2013-04-05
K130521 ISOLATOR LINEAR PEN AtriCure, Inc. OCL Class II 2013-04-05
K123429 OLYMPUS ENERGY POWER SYSTEM (EPS) Gyrus Acmi, Inc. GEI Class II 2013-04-05
K123353 CIQ CONTROLLER, CIQ WANDS ArthroCare Corporation GEI Class II 2013-04-05
K130782 ACCUMESH DEPLOYMENT SYSTEM Covidien, LLC ORQ Class II 2013-04-05
K130422 PHANTOM FIBER BIOFIBER SUTURE Tornier, Inc. NWJ Class II 2013-04-04
K123507 KCI NPWT GAUZE DRESSING Kci USA, Inc. OMP Class II 2013-04-04
K124042 TANDA MINI SKINCARE SYSTEM Syneron Beauty OLP Class II 2013-04-02
K123860 INMODE SR IPL DEVICE Inmode MD , Ltd. ONF Class II 2013-04-02
K123733 CARDIOBLATE CRYOFLEX SURGICAL ABLATION SYSTEM Medtronic, Inc. OCL Class II 2013-04-01
K120561 NEUROBLATE SYSTEM Monteris Medical, Inc. GEX Class II 2013-04-01
K123407 CELLULAZE LASER Cynosure, Inc. OYW Class II 2013-03-29
K123014 LITECURE THERAPY SYSTEM MODEL LTS-1500 Litecure, LLC PDZ Class II 2013-03-29
K130537 BIOPSY SCIENCES LLC HYDROMARK BREAST BIOPSY SITE MARKER Biopsy Sciences, LLC NEU Class II 2013-03-29
K130653 ECHELON FLEX 45 POWERED ARTICULATING ENDOSCOPIC LINEAR CUTTER; ECHELON FLEX 60 POWERED ARTICULATING ENDOSCOPIC LINEAR CU Ethicon Endo-Surgery, LLC GDW Class II 2013-03-29
K124029 MICROLINE FLEXIBLE LIGATING SHEARS Microline Surgical, Inc. GEI Class II 2013-03-27
K130671 VENACURE EVLT NEVERTOUCH PROCEDURE KIT AngioDynamics, Inc. GEX Class II 2013-03-26
K130164 FIBERLASE ENDURE CO2 FIBER Lumenis, Ltd. GEX Class II 2013-03-24
K130596 CAIMAN SEAL AND CUT TECHNOLOGY Aesculap, Inc. GEI Class II 2013-03-22
K130344 DORNIER MEDILAS UROPULSE Dornier Medtech America, Inc. GEX Class II 2013-03-21
K130413 PINPOINTE FOOTLASER Nuvolase, Inc. GEX Class II 2013-03-21
K122702 BIOFRIEND BIOMASK N95 SURGICAL RESPIRATOR Filligent Limited ONT Class II 2013-03-18
K123628 STERILE LATEX SURGICAL GLOVE Lucenxia Prescience AG KGO Class I 2013-03-18
K130210 MEDELA THOPAZ Medela AG BTA Class II 2013-03-15
K123776 POLARIS 100/200 Drager Medical GmbH FTD Class II 2013-03-08
K123212 ETHICON ENDO-SURGERY ENSEAL G2 CORDLESS TISSUE SEALERS Ethicon Endo-Surgery, LLC PDG Class II 2013-03-08
K130283 EVRF SYSTEM F Care Systems NV ONQ Class II 2013-03-07
K123914 RESTORELLE Y CONTOUR Coloplast A/S OTO Class II 2013-03-05
K123980 SONICONE PLUS ULTRASOUND WOUND CARE SYSTEM AND ACCESSORIES Misonix, Inc. NRB Class II 2013-03-05
K123356 FORTIVA PORCINE DERMIS Rti Biologics, Inc. FTM Class II 2013-03-05
K123889 ACLEARA, THERACLEAR Theravant Corporation ONF Class II 2013-03-04
K123188 DORNOCH DUO SUCTION CART WITH DL2800 LID MODEL UL-DU2800, DORNOCH DUO SUCTION CART WITH CL500 LID MODEL UL-DU500, DORNOC Dornoch Medical Systems, Inc. JCX Class II 2013-03-04
K130131 EDRAIN CHEST DRAINAGE SYSTEM Atrium Medical Corp. BTA Class II 2013-02-28
K130078 QUILL POLYPROPYLENE KNOTLESS TISSUE-CLOSURE DEVICE, VARIABLE LOOP DESIGN Surgical Specialties Corp. Dba Angiotech GAW Class II 2013-02-28
K123682 INMODE HAIR REMOVAL (HR) DEVICE Inmode MD , Ltd. GEX Class II 2013-02-27
K123668 ORTHOCORD Depuy Mitek, Inc., A Johnson and Johnson Company NEW Class II 2013-02-26
K121435 SILKN BLUE Home Skinovations , Ltd. OLP Class II 2013-02-22
K123337 VERTESSA LITE 10 X 20CM, VERTESSA LITE 11 X 30CM Caldera Medical OTO Class II 2013-02-21
K121928 DESARA SL Caldera Medical, Inc. OTN Class II 2013-02-19
K110941 REVOLIX JR 30, REVOLIX JR 50, REVOLIX JR 160, REVOLIX FR 200 Allmed Systems, Inc. GEX Class II 2013-02-19
K121919 SURGICAL DRAPE WITH AAMI LIQUID BARRIER LEVEL IV Exact Medical Manufacturing, Inc. KKX Class II 2013-02-14
K113236 FORYOU NPWT DEVICE Foryou Medical Electronics Co, Ltd. OMP Class II 2013-02-12
K121069 3M VFLEX HEALTH CARE PARTICULATE RESPIRATOR AND SURGICAL MASK 3M Company MSH Class II 2013-02-11
K130132 BABYLANCE HEEL INCISION DEVICE Medipurpose Pte. , Ltd. FMK Class II 2013-02-11
K123435 IPL THERAPY SYSTEM Beijing Sincoheren S&T Development Co, Ltd. ONF Class II 2013-02-11
K123494 SOLEA Convergent Dental, Inc. GEX Class II 2013-02-11
K113268 ALEXIS O WOUND PROTECTOR/RETRACTOR Applied Medical Resources Corp. KGW Class II 2013-02-08
K123865 VISUAL-ICE CRYOABLATION SYSTEM Galil Medical, Inc. GEH Class II 2013-02-06
K123114 ETHICON SECURESTRAP OPEN ABSORBABLE STRAP FIXATION DEVICE ETHICON, Inc. GDW Class II 2013-02-05
K122781 RELIAMAX GASTROINTESTINAL ANASTOMOSIS AND RELOAD Covidien, Formerly US Surgical A Divison of Tyco H GDW Class II 2013-02-05
K120804 CIANNA MEDICAL TISSUE MARKER AND DELIVERY SYSTEM Cianna Medical PBY Class II 2013-02-04
K122159 DORNIER MEDILAS H30 SOLVO Dornier Medtech America, Inc. GEX Class II 2013-02-01
K121327 DIOLASE 10S Biolase Technology, Inc. GEX Class II 2013-02-01
K113504 DEKA SMARTXIDE AND DELIVERY ACCESSORIES El.En Electronic Engineering Spa GEX Class II 2013-02-01
K123444 LIGASURE IMPACT CURVED, LARGE JAW, OPEN SEALER / DIVIDER Covidien, Formerly Valleylab, A Division of Tyco H GEI Class II 2013-01-30
K122797 ENSEAL G2 ARTICULATING TISSUE SEALERS, STRAIGHT JAW, ENSEAL G2 ARTICULATING TISSUE SEALERS, CURVED JAW Ethicon Endo-Surgery, LLC GEI Class II 2013-01-25
K123237 ZERONA 2.0 LASER Erchonia Corporation OLI Class II 2013-01-25
K123096 REPROCESSED VESSEL SEALER Sterilmed, Inc. NUJ Class II 2013-01-25
K122251 VITRA MULTISPOT Quantel Medical GEX Class II 2013-01-24
K123310 FINESSE 3RD GENERATION (MODELS FINESSE+ AND FINESSEII+) Utah Medical Products, Inc. GEI Class II 2013-01-23
K121964 MARKIT TISSUE MARKER-1ML MARKIT TISSUE MARKER-3ML MARKIT TISSUE MARKER-10ML Augmenix, Inc. NEU Class II 2013-01-23
K122995 INTENSE PULSED LIGHT (IPL) SYSTEMS Beijing Kes Biology Technology Co., Ltd. ONF Class II 2013-01-22
K123718 PERMASORB DISPOSABLE FIXATION DEVICE C.R. Bard, Inc. GDW Class II 2013-01-22
K122132 AVANCE FOAM DRESSING KIT INCL. TRANSPARENT FILM, TRANSFER PAD (SMALL, MEDIUM, LARGE) AVANCE TRANSPARENT FILM AVANCE FOAM Molnlycke Health Care OMP Class II 2013-01-17
K124003 MED-FIBERS SURGICAL LASER FIBER, MED-FIBERS ENDO-ENT LASER PROBES, MED-FIBERS END- AND ASPIRATING LASER PROBES, MED-FIBE Med-Fibers, Inc. GEX Class II 2013-01-17
K121570 AURIGA QI Starmedtec GmbH GEX Class II 2013-01-16
K123004 MIRA LASERS Mira Lasers, LLC GEX Class II 2013-01-15
K123878 PREVENA INCISION MANAGEMENT SYSTEM WITH CUSTOMIZABLE DRESSING Kci USA, Inc. (Kinetic Concepts, Inc.) OMP Class II 2013-01-15
K123201 AQUAMANTYS ENDO DBS 8.7 DISSECTING BIPOLAR SEALER Medtronic Advanced Energy, LLC GEI Class II 2013-01-10
K123911 SENOMARK ULTRA BREAST TISSUE MARKER C.R. Bard, Inc. NEU Class II 2013-01-10
K122383 EM3 AEM MONITOR AEM CONNECTORS Encision, Inc. GEI Class II 2013-01-10
K123845 ME Syneron Beauty , Ltd. ONF Class II 2013-01-10
K122922 E-BEAM ND: YAG LASER Eclipse Aesthetics, LLC GEX Class II 2013-01-10
K122048 COLLAGEN TENDON SHEET-D Rotation Medical, Inc. FTM Class II 2013-01-08
K123877 QUILL PDO KNOTLESS TISSUE-CLOSURE DEVICE, VARIABLE LOOP DESIGN Surgical Specialties Corp. Dba Angiotech NEW Class II 2013-01-02
K123836 QUILL MONODERM KNOTLESS TISSUE-CLOSURE DEVICE, VARIABLE LOOP DESIGN Surgical Specialties Corp. Dba Angiotech GAM Class II 2012-12-21

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