meddevicedb.com FDA Device Reference

Review Panel

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

Cleared Devices
16,323
Product Codes (page)
42
Latest Decision
2012-08-23

Clearances · page 49 of 164

K-Number Trade Name Applicant / Manufacturer Product Code Class Decision Date
K113552 FREEDOM INGUINAL HERNIA IMPLANT Insightra Medical FTL Class II 2012-08-23
K121695 ERCHONIA ZERONA Erchonia Corporation OLI Class II 2012-08-23
K122086 THERMAL LIGATING SHEARS Microline Surgical, Inc. GEI Class II 2012-08-23
K113128 MICROAIRE SURGICAL INSTRUMENTS LLC Microaire Surgical Instruments, LLC QPB Class II 2012-08-17
K121855 RESPROCESSED SERFAS ENERGY PROBE Stryker Sustainability Solutions NUJ Class II 2012-08-16
K120902 GID 700 The Gid Group, Inc. MUU Class II 2012-08-15
K112362 C100 WRINKLE REDUCTION DEVICE Silver Bay, LLC OHS Class II 2012-08-14
K122246 MIST 360 SINGLE USE APPLICATOR KIT, MIST 360 SINGLE USE APPLICATOR KIT, CASE OF 12 Celleration, Inc. NRB Class II 2012-08-13
K113795 SUCTION LIPOLASTY ACCESSORIES Norman M. Black Iii QPB Class II 2012-08-07
K121289 LTM-LABAROSCOPIC SURGICAL MESH Lifecell Corp. OXK Class II 2012-08-03
K121048 ULTRAFLEX TRACHEOBRONCHIAL STENT SYSTEM- STERILE UNCOVERED Boston Scientific Corp JCT Class II 2012-08-03
K121938 MEDILAS H RFID LASER FIBER Dornier Medtech America, Inc. GEX Class II 2012-08-01
K113199 KEVO NPWT-AHEMO30 AND A HEMO45 FOAM DRESSING KIT Kevo Medical Supplies OMP Class II 2012-07-30
K121897 PROTEXIS LATEX BASIC STERILE POWDER-FREE SURGICAL GLOVES Cardinal Health, Inc. KGO Class I 2012-07-27
K120926 ENDOBEAM HOLMIUM LASER FIBERS C.R. Bard, Inc. GEX Class II 2012-07-27
K113489 ORION Asclepion Laser Technologies GmbH GEX Class II 2012-07-27
K120377 ADVERL EVO ER: YAG LASER FOR DENTISTRY MEY-1-A J. Morita USA, Inc. GEX Class II 2012-07-25
K121510 IDRIVE ULTRA POWERED HANDLE ENDO GIA ADAPTER Covidien, Formerly US Surgical A Divison of Tyco H GDW Class II 2012-07-25
K113229 VENTRIO LIGHT HERNIA PATCH WITH TRM ANTIMICROBIAL COATING C.R. Bard, Inc. FTL Class II 2012-07-20
K121162 POLARIS Q-SWITCH RUBY SYSTEM Sandstone Medical Technologies, LLC GEX Class II 2012-07-18
K113311 TIO2MESH TM Biocer Entwicklungs GmbH FTL Class II 2012-07-17
K121600 ECHELON 60 ENDOSCPIC LINEAR CUTTER RELOAD, WHITE Ethicon Endo-Surgery, LLC GDW Class II 2012-07-16
K121474 DISPOSABLE LINEAR STAPLER, DISPOSABLE LINEAR CUTTER Changzhou Kangdi Medical Stapler Co., Ltd. GDW Class II 2012-07-16
K120827 QUILL PDO KNOTLESS TISSUE-CLOSURE DEVICE (POLYDIXANONE) Angiotech NEW Class II 2012-07-13
K121767 CARDIOBLATE GEMINI SURGICAL ABLATION DEVICE Medtronic, Inc. OCL Class II 2012-07-13
K113513 PLANCET Micropoint Technologies Pte, Ltd. FMK Class II 2012-07-13
K121306 SMARTSTITCH M-CONNECTOR ULTRA SMARTSTITCH SUTURE DEVICE HANDLE SMARTSTITCH SUTURE DEVICE HANDLE Arthocare Corporation GAT Class II 2012-07-12
K121113 BIOPSY SCIENCES, INC. HYDROMARK BREST BIOSY SITE MARKER Biopsy Sciences, LLC NEU Class II 2012-07-12
K121426 AYNERGETICS DISPOSABLE SPETZLER-MALIS STANDARD BIPOLAR FORCEPS Synergetics, Inc. GEI Class II 2012-07-10
K121471 LIGHTSCALPEL FAMILY OF HANDPIECE TIPS FOR CO2 SURGICAL LASERS Lightscalpel, LLC GEX Class II 2012-07-10
K120244 SPECTRASHIELD 9500 SURGICAL N95 RESPIRATOR Nexera Medical, Inc. ONT Class II 2012-07-05
K111454 ILUMINAGE DIODE LASER Cynosure, Inc. OHS Class II 2012-07-05
K112634 NATROX TOPICAL OXYGEN DELIVERY SYSTEM WITH IODP Inotec Amd , Ltd. KPJ Class II 2012-07-03
K120581 SC TIP CLEANER Nsi GEI Class II 2012-06-29
K120897 PROGRIP LAPARSCOPIC SELF-FIXATING MESH Sofradim Production FTL Class II 2012-06-29
K111949 AC WOUND TREATMENT SYSTEM Nanovibronix, Inc. OMP Class II 2012-06-29
K120810 FIBEROPTIC LASER DELIVERY SYSTEM Fiberoptic Fabrications, Inc. GEX Class II 2012-06-28
K120025 SURGIMESH XB - SKIRTED Aspide Medical FTL Class II 2012-06-26
K121290 AQUAMANTRYS3 BSC 9.1S Medtronic, Inc. GEI Class II 2012-06-25
K121031 WAVELIGHT FS200 PATIENT INTERFACE 1505 Alcon Research, Ltd. GEX Class II 2012-06-21
K120527 ALPHA ORTHOPAEDICS AT2 SYSTEM Alpha Orthopaedics, Inc. GEI Class II 2012-06-18
K120870 GREENLIGHT MOXY FIBER OPTIC American Medical Systems GEX Class II 2012-06-15
K121451 CARDIOBLATE MAPS SURGICAL MAPPING, ABLATION, PACING , AND SENSING DEVICE Medtronic, Inc. OCL Class II 2012-06-14
K120573 MEDART 620 Medart A/S GEX Class II 2012-06-13
K120506 PARIETEX COMPOSITE VENTRAL PATCH Sofradim Production FTL Class II 2012-06-13
K120476 MACROLYTE DISPERSIVE ELECTRODE Conmed Corporation GEI Class II 2012-06-12
K120045 EMM HIGH PERFORMANCE SURGICAL GOWN WITH AAMI LIQUID BARRIER LEVEL IV Exact Medical Manufacturing, Inc. FYA Class II 2012-06-12
K120322 CONMED SUREFIT DUAL DISPERSIVE ELECTRODE Conmed Corporation GEI Class II 2012-06-12
K113205 ARTISYN Y-SHAPED MESH ETHICON, Inc. OTO Class II 2012-06-11
K113868 EPLUS SKIN TREATMENT SYSTEM Syneron, Ltd. GEX Class II 2012-06-11
K121507 ATRICURE CRYO MODULE SYSTEM (ACM, CRYO1, AND CRYOICE) AtriCure, Inc. GEH Class II 2012-06-06
K121515 ISOLAZ 2 INTENSE PULSED LIGHT SYSTEM Solta Medical, Inc. ONF Class II 2012-06-05
K120775 LIGHT FOR WRINKLES Led Intellectual Properties, LLC OHS Class II 2012-06-04
K121413 CROSSFIX II MEMISCAL REPAIR DEVICE Cayenne Medical, Inc. GAT Class II 2012-06-04
K113597 MINI-LAP BIPOLAR ELECTROCAUTERY DEVICES Minilap Technologies GEI Class II 2012-06-03
K120033 ACTIVAC THERAPY UNIT AND INFOVAC THERAPY UNIT, VAC ATS THERAPY UNIT AND VAC FREEDOM THERAPY UNIT, VAC VIA THERAPY UNIT Kci USA, Inc. OMP Class II 2012-05-31
K120080 SHASER HRS2 HAIR REMOVAL SYSTEM Shaser, Inc. ONF Class II 2012-05-25
K111049 MOBILE VERSA LIGHT Medtek Lighting Corp FTC Class II 2012-05-25
K111262 ELECTROSURGICAL MONOPOLAR CABLE/ADAPTERS, ELECTROSURGICAL BIPOLAR CABLE/ ADAPTERS, BIPOLAR ELECTROSURGICAL CABLES, MONOP Olsen Medical GEI Class II 2012-05-23
K120284 DIGITEX SUTURE DELIVERY SYSTEM, DIGITEXPOLYPROPYLENE SUTURE CARTRIDGE SIZE 0, WITH NEEDLE AND WITHOUT NEEDLE, DIGITEX Coloplast A/S NEW Class II 2012-05-23
K120556 VILET VILET QUICK Riverpoint Medical GAM Class II 2012-05-23
K120622 PALOMAR VECTUS LASER Palomar Medical Technologies, Inc. GEX Class II 2012-05-23
K120934 PROTEXIS LATEX BASIC STERILE LATEX POWDER-FREE SURGICAL GLOVE WITH PROTEIN CONTENT LABEL CLAIM OF 50 UG/DM OR LESS Cardinal Health, Inc. KGO Class I 2012-05-23
K120179 REACH SURGICAL STAPLERS Reach Surgical, Inc. GDW Class II 2012-05-23
K120605 PERMACOL SURGICAL IMPLANT Covidien, LLC FTM Class II 2012-05-18
K112322 RESTORELLE POLYPROPYLENE Y MESH Coloplast A/S OTO Class II 2012-05-17
K113510 EVOLUTION COLONIC STENT SYSTEM Cook Ireland, Ltd. MQR Class II 2012-05-17
K112127 PICO SINGLE USE NEGATIVE PRESSURE WOUND THERAPY SYSTEM Smith & Nephew, Inc. OMP Class II 2012-05-16
K120257 MLS, ZERONA-AD Erchonia Medical, Inc. OLI Class II 2012-05-14
K121127 SIDELAZE LASER BEAM DELIVERY ACCESSORY FOR CYNOSURE 1440NM WAVELENGTH LASERS Cynosure, Inc. GEX Class II 2012-05-13
K112669 TATTOOSTAR EFFECT Y Asclepion Laser Technologies GmbH GEX Class II 2012-05-11
K120537 AQUAMANTYS3 9.5 XL BIPOLAR SEALER Medtronic, Inc. GEI Class II 2012-05-10
K120327 VERTESSA Caldera Medical, Inc. OTO Class II 2012-05-10
K112378 COBES SURGICAL DRAPE Cobes Industries Co., Ltd. KKX Class II 2012-05-08
K120513 GLOW BY ENDYMED Endymed Medical, Ltd. OUH Class II 2012-05-08
K110420 OPHIRA MINI SLING SYSTEM Promedon S.A PAH Class II 2012-05-08
K112334 VEIN-GOGH INSTRUMENT Refine USA, LLC ONQ Class II 2012-05-08
K113340 KIMBERLY-CLARK CHILD'S FACEMASK Kimberly-Clark OXZ Class II 2012-05-04
K121194 ENDO CLIP III 5MM CLIP APPLIER Covidien FZP Class II 2012-05-03
K120431 HALO90 ULTRA ABLATION CATHETER Barrx Medical, Inc. GEI Class II 2012-05-03
K121139 ACCUMESH DEPLOYMENT SYSTEM Covidien, LLC ORQ Class II 2012-05-02
K120023 ZELTIQ COOLSCULPTING Zeltiq Aesthetics, Inc. OOK Class II 2012-05-02
K120983 ULTRAFLEX ESOPHAGEAL NG STENT SYSTEM Boston Scientific Corporation ESW Class II 2012-05-02
DEN110016 PERCUTANEOUS SURGICAL SET WITH 5MM OR 10MM ATTACHMENTS Ethicon Endo-Surgery OXT Class II 2012-04-30
K120764 EPIFLO(R) Neogenix, LLC KPJ Class II 2012-04-27
K113707 STERILE NEOPRENE POWDER-FREE SURGICAL GLOVES WITH NITRILE COATING Cardinal Health-Medical Products and Services KGO Class I 2012-04-27
K111895 ECHOTIP(R) ULTRA FIDUCIAL NEEDLE Wilson-Cook Medical Inc./Cook Endoscopy NEU Class II 2012-04-27
K120437 TWISTER SIDE-FIRE FIBER OPTIC DELIVERY SYSTEM Biolitec Sia (Latvia) GEX Class II 2012-04-26
K121070 C-QUR RPM MESH Atrium Medical Corp. FTL Class II 2012-04-26
K120231 EVOLVE HPD 980/ 1470NM MULTIWAVELENGTH DIODE LASER (EVOLVE DUAL) Biolitec Medical Devices, Inc. GEX Class II 2012-04-24
K113494 NOBLESTITCH EL NOBLESTITCH MR NOBLESTITCH TA Nobles Medical Technologies Ii, Inc. GAW Class II 2012-04-19
K113332 ON CALL CHOSEN LANCING DEVICE ACON Laboratories, Inc. FMK Class II 2012-04-18
K112141 SMARTEPIL,DEPILASE YAG LASE PLUS Castle Laser Systems, Limited GEX Class II 2012-04-13
K110333 NATURALASE CO2 LASER SYSTEM Focus Medical, LLC ONG Class II 2012-04-12
K112899 ARTHREX BIO-SUTURE Arthrex, Inc. GAT Class II 2012-04-06
K112505 ETHEREA Regulatory Insight, Inc. GEX Class II 2012-04-06
K120095 SIDE EFFECT WITH HAND CONTROLS, HOOK ELECTRODE WITH HAND CONTROLS, 2.3 WEDGE ELECTRODE WITH HAND CONTROLS, S90 WITH HAND Depuy Mitek, A Johnson & Johnson Company GEI Class II 2012-04-06
K113502 ADVANTAGE LASER SYSTEM Lutronic Corporation GEX Class II 2012-04-05
K120065 PLAXTRON SUCTION UNIT, MODEL 88AA51/88AA61 SERIES Plaxtron Industrial (M) Sdn. Bhd. JCX Class II 2012-04-03
K113115 EPICARE YAG Light Age, Inc. GEX Class II 2012-04-03

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