meddevicedb.com FDA Device Reference

Review Panel

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

Cleared Devices
16,323
Product Codes (page)
38
Latest Decision
2011-05-26

Clearances · page 52 of 164

K-Number Trade Name Applicant / Manufacturer Product Code Class Decision Date
K111042 ATRICURE CRYO MODULE AtriCure, Inc. GEH Class II 2011-05-26
K101128 BIOFRIEND BIOMASK SURGICAL FACEMASK, MODELS UNIVERSAL BF-200-2001 AND PREMIUM BF-200-3013 Filligent Limited OUK Class II 2011-05-26
K111153 SORBAFIX (TM) ABSORBABLE FIXATION SYSTEM, PERMAFIX (TM) FIXATION SYSTEM C.R. Bard, Inc. GDW Class II 2011-05-24
K092801 ABS BLOWER, ABS NOZZLE, MODEL 1001 Nimbic Systems, LLC ORC Class II 2011-05-20
K103560 SHASER IPL HAIR REMOVAL SYSTEM Shaser, Inc. ONF Class II 2011-05-18
K111064 TIGERPAW SYSTEM II Laax, Inc. GDW Class II 2011-05-18
K110225 ANGIODYNAMICS, INC. VENACURE 1470 LASER AngioDynamics, Inc. GEX Class II 2011-05-13
K111121 VITAMESH (TM) BLUE LIGHTWEIGHT MACROPOROUS PP SURGICAL MESH Proxy Biomedical , Ltd. FTL Class II 2011-05-13
K102788 TORNIER BIOFIBER SCAFFOLD Tornier, Inc. FTL Class II 2011-05-10
K102913 FORCETRIAD Covidien, Formerly Valleylab, A Division of Tyco H GEI Class II 2011-05-06
K111015 STERILE LATEX POWDER FREE SURGICAL GLOVES WITH HYDROGEL COATING Cardinal Health, Inc. KGO Class I 2011-05-06
K110349 CLEAR+BRILLIANT LASER SYSTEM Solta Medical, Inc. ONG Class II 2011-05-03
K110455 KIMBERLY-CLARK LOW BARRIER, ASTM 2100 FACE MASKS Kimberly-Clark Corp. FXX Class II 2011-04-29
K103455 SPECTRA LASER SYSTEM Lutronic Corporation GEX Class II 2011-04-28
K110502 TRIPLEX ER. YAG / ND: YAG SYSTEM Sandstone Medical Technologies, LLC GEX Class II 2011-04-27
K103204 SOLARC / SOLRX E-SERIES ULTRAVIOLET PHOTOTHERAPY LAMP UNIT FAMILY Solarc Systems, Inc. FTC Class II 2011-04-27
K110355 VENX REVOLUTION Venx, LLC GAH Class I 2011-04-22
K110434 TRIXEL CO2 LASER BEIJING SYNTECH LASER CO., LTD. GEX Class II 2011-04-19
K110815 PARIETEX OPTIMIZED COMPOSTIE MESH Sofradim Production FTL Class II 2011-04-19
K110816 PARIETEX OPTIMIZED COMPOSITE MESH (PCO-OSX REFERENCES) Sofradim Production FTL Class II 2011-04-19
K103042 ATMOS E 201 THORAX AND ATMOS S 201 THORAX Atmos, Inc. BTA Class II 2011-04-15
K101468 3M BASIC DISPOSABLE SURGICAL GOWN, 3M HP DISPOSABLE SURGICAL GOWN, 3M REINFORCED DISPOSABLE SURGICAL GOWN, 3M DISPOSABLE 3M Company Corp FYA Class II 2011-04-14
K110117 ATRICURE BIPOLAR SYSTEM AtriCure, Inc. OCL Class II 2011-04-08
K110304 APEX ER. YAG / IPL SYSTEM Sandstone Medical Technologies, LLC GEX Class II 2011-04-08
K103672 REUSABLE PPH CIRCULAR STAPLER HANDLE, PPH CIRCULAR STAPLER RELOAD & ACCESSORY SET Ethicon Endo-Surgery, LLC GDW Class II 2011-04-08
K101377 SMITH & NEWPHEW ULTRABRAID II SUTURE Smith & Newphew, Inc. GAT Class II 2011-04-08
K100669 CANADY PLASMA ELECTROSURGICAL UNIT SERIES WITH ACCESSORY PROBES AND BLADES Us Medical Innovations, LLC GEI Class II 2011-04-06
K103654 VELA XL Starmedtec GmbH GEX Class II 2011-04-06
K103626 CUTERA GENESISPLUS LASER SYSTEM Cutera, Inc. PDZ Class II 2011-04-05
K101057 AQUAMANTYS DOUBLE CONE BIPOLAR SEALER MODEL: 23-310-1 Salient Surgical Technologies GEI Class II 2011-04-05
K110255 SOUND SURGICAL TECHNOLOGIES LLC POWERX LIPO SYSTEM Sound Surgical Technologies, LLC QPB Class II 2011-04-04
K110820 VENTRALIGHT (TM) ST MESH WITH ECHO PS (TM) POSITIONING SYSTEM C.R. Bard, Inc. FTL Class II 2011-04-01
K101722 ALYTE Y-MESH GRAFT C.R. Bard, Inc. OTO Class II 2011-04-01
K101530 EVOLUTION DUODENAL STENT SYSTEM, MODEL EVO-22-27-6-D, EVO-22-27-9-D, EVP-22-27-12-D Cook Ireland, Ltd. MUM Class II 2011-03-29
K110685 FLEXIVA TRACTIP Boston Scientific Corp GEX Class II 2011-03-29
K110686 ACCUTRAC Boston Scientific Corp GEX Class II 2011-03-28
K110385 ECHELON FLEX 45 / 60 POWERED ARTICULATING ENDOSCOPIC LINEAR CUTTER Ethicon Endo-Surgery, Inc. GDW Class II 2011-03-25
K110699 LIGAMAX 5 Ethicon Endo-Sugery, LLC FZP Class II 2011-03-25
K102275 THERMEDX 37-5 ELECTROCAUTERY PROBES, MODELS MPJ200, MPJ210, MPS220, MPN230, BPH240 Thermedx, LLC GEI Class II 2011-03-25
K101928 VENTRALEX ST HERNIA PATCH C.R. Bard, Inc. FTL Class II 2011-03-23
K101920 VENTRIO ST HERNIA PATCH C.R. Bard, Inc. FTL Class II 2011-03-23
K101916 JOULE MULTI-PLATFORM SYSTEM Sciton, Inc GEX Class II 2011-03-18
K103664 PRIMUS AESTHETIC PLATFORM Palomar Medical Technologies, Inc. ONG Class II 2011-03-17
K103375 PLUMEPEN INTEGRATED SMOKE EVACUATION PENCIL Medtek Devices, Inc. GEI Class II 2011-03-16
K103156 V.A.C. VERAFLO CLEANSE DRESSING SYSTEM Kci USA, Inc. (Kinetic Concepts, Inc.) OMP Class II 2011-03-14
K102692 SMS GOWNS (REINFORCED AND REINFORCED WITH GUIDER), SPUNLACE GOWNS (REGULAR, REGULAR WITH GUIDER), SPUNLACE GOWNS (REINFO Hangzhou Jincheng Medical Supplier Manufacture Co. FYA Class II 2011-03-11
K101901 IPL THERAPY SYSTEM Beijing Starlight Science & Technology Development ONF Class II 2011-03-08
K103682 PARIETEX PROGRIP Sofradim Production FTL Class II 2011-03-04
K102403 SAM CHEST SEAL WITH VAVLE; SAM CHEST SEAL Sam Medical Products NAD Class I 2011-03-03
K103840 CURVED / STRAIGHT / MINI / HOOK SCISSOR TIP, DISSECTOR TIP, SURGICAL HANDLE Flexbar Machine Corp. GEI Class II 2011-02-28
K090414 SPECTRASHIELD 9500 SURGICAL MASK Nexera Medical, Inc. ONT Class II 2011-02-24
K103535 VACPLUS SUCTION UNIT Apex Medical Corp. JCX Class II 2011-02-24
K110080 RADIAL-EMITTING SHAPED FIBER OPTIC DELIVERY SYSTEM Biolitec, Inc. GEX Class II 2011-02-24
K102971 FREEDOMAIRE III SURGICAL HELMET SYSTEM MODEL 10322STK Microtek Medical, Inc. FYA Class II 2011-02-23
K103445 ALACER SURGICAL SCAFFOLD Alacer Biomedical, Inc. FTL Class II 2011-02-22
K103708 ML24000 UVA-1 PHOTOTHERAPY UNIT The Daavlin Distributing Company FTC Class II 2011-02-22
K102076 LIQUIBAND DUAL, MODEL LBD 001 Medlogic Global Limited MPN Class II 2011-02-18
K101510 FRACTIONAL SKIN RESURFACING (FSR) APPLICATOR Endymed Medical, Ltd. OUH Class II 2011-02-17
K103665 CONMED R SABRE GENESIS TM ELECTROSURGICAL UNIT; CONED R SABRE GENESIS TM ELECTROSURGICAL UNIT (230V); CONMED HYFRESURG O Conmed Corporation GEI Class II 2011-02-16
K103753 SIROLASER ADVANCE, SIROLASER XTEND, SIROLASER XTEND UPGRADED, FONALASER Sirona Dental Systems GmbH GEX Class II 2011-02-15
K110110 ATRIUM CENTRILFX MESH Atrium Medical Corporation FTL Class II 2011-02-15
K103540 PSORIA-LIGHT Psoria-Shield, Inc. FTC Class II 2011-02-10
K110049 REUSABLE LINEAR STAPLER HANDLE Ethicon Endo-Surgery, LLC GDW Class II 2011-02-10
K110079 SPPHINE PLUS STM 3W DIODE LASER Den-Mat Holdings, LLC GEX Class II 2011-02-10
K093661 COLONRING Niti Surgical Solutions, Ltd. FZP Class II 2011-02-10
K103310 CRYONIZE TM 3jt Enterprises, LLC GEH Class II 2011-02-09
K103787 MEDEOR MATRIX Kensey Nash Corp. FTM Class II 2011-02-07
K102470 LUGASURE CURVED, SMALL JAW, OPEN SEALER/DIVIDER Covidien, Formerly Valleylab, GEI Class II 2011-02-07
K103707 VECTEC DISPOSABLE MONOPOLAR CONNECTOR CABLE Vectec GEI Class II 2011-02-04
K093835 BAM STANDARD SURGICAL GOWN, BAM REINFORCED SURGICAL GOWN, BAM ULTRA REINFORCED SURGICAL GOWN Bam Corp., Ltd. FYA Class II 2011-02-04
K102592 SUTRAZORB Visionary Medical Supplies, Inc. GAM Class II 2011-02-03
K102652 NON REINFORCED SURGICAL GOWNS, FILM REINFORCED SURGICAL GOWNS, FABRIC REINFORCED SURGICAL GOWNS Gri Medical & Electronic Technology Co., Ltd. FYA Class II 2011-02-03
K103288 DEKA SYNCHRO FT El.En Electronic Engineering Spa GEX Class II 2011-01-31
K103014 MIRADRY SYSTEM Miramar Labs, Inc. OUB Class II 2011-01-28
K102713 TIGER FLAT SURGICAL MASK Tiger Medical Products, Ltd. FXX Class II 2011-01-25
K100823 WOUND PRO APEX Accuro Medical Products, LLC OMP Class II 2011-01-24
K101147 MODIFIED ALMA LASERS FAMILY OF ACCENT RADIOFREQUENCY (RF) SYSTEM Alma Lasers, Inc. NUV Class II 2011-01-21
K090754 LIPOCONTROL Osyris Medical ORK Class II 2011-01-21
K103017 MEDERI THERAPEUTICS RF GENERATOR CONTROL MODULE Mederi Therapeutics, Inc. GEI Class II 2011-01-20
K102743 ORTHO SOLUTIONS - STERILE, DRILLS, TAPS, GUIDE PINS & WIRES Ortho Solutions Limited HWE Class I 2011-01-20
K103539 QUANTA SYSTEM DUOLITE Quanta System Spa GEX Class II 2011-01-20
K100610 LUTRONIC CORPORATION ECO2 PLUS, DENTA III AND III+ AND SP III LASER SYSTEMS Lutronic Corporation ONG Class II 2011-01-20
K093627 IPULSELIGHT IPL SYSTEM, MODELS HS 300C AND HS 650 Shanghai Apolo Medical Technologies Co., Ltd. ONF Class II 2011-01-18
K103501 ALMA LASERS PIXEL CO2 LASER SYSTEM, DELIVERY DEVICE AND ACCESSORIES Alma Lasers, Inc. GEX Class II 2011-01-14
K103032 ESG-400 MODEL WB95051N, FOOTSWITCH DOUBLE PEDAL MODEL WB50402W, FOOTSWITCH SINGLE PEDAL MODEL WB50403W, P-CORD MODEL MAJ Olympus Winter & Ibe GmbH GEI Class II 2011-01-14
K102857 AHWON'S IPL SYSTEM Ahwon Medi Instrument Co., Ltd. ONF Class II 2011-01-14
K102861 SURGIPLUS SMS SURGICAL DRAPE (STERILE/NON-STERILE), SURGIPLUS SPP WITH PE LAMINATED SURGICAL DRAPE (STERILE/NON-STERILE) A Plus International, Inc. KKX Class II 2011-01-13
K101904 SMARTXIDE 50 HS/MS El.En Electronic Engineering Spa GEX Class II 2011-01-12
K102506 MIXED MEDIA MARKER Cortex Manufacturing, Inc. NEU Class II 2011-01-12
K103470 PANTHER GROUP OF SURGICAL INCLUDES: OANTHER CIRCULAR STAPLER; PANTHER HEMORRHOIDAL CIRCULAR STAPLER; PANTHER LINEAR STAP B.J.ZH.F.PANTHER MEDICAL EQUIPMENT CO., Ltd. GDW Class II 2011-01-11
K102698 PELLEVE GLIDESAFE NON-ABLATIVE WRINKLE TREATMENT SYSTEM MODEL PELLEVE GLIDESAFE Ellman Int'L, Inc. GEI Class II 2011-01-05
K101350 RADSCAN EQUIPMENT SLICKER Radscan Medical Equipment, Inc. KKX Class II 2011-01-04
K103415 TANDA MAX Pharos Life Corporation ONE Class II 2011-01-03
K103667 SAPPHIRE ST PORTABLE DIODE LASER Den-Mat Holdings, LLC GEX Class II 2010-12-29
K103303 CROSSTEX SURGICAL EARLOOP MASK- WHITE, CROSSTEX SURGICAL EARLOOP NO FOG MASK-WHITE, NO FOG MASK WITH SPLASH VISOR-WHITE Crosstex International, Inc. FXX Class II 2010-12-23
K103406 MICROCOOL BREATHABLE HIGH PERFORMANCE SURGICAL GOWNS Kimberly-Clark Corp. FYA Class II 2010-12-23
K103568 RESTORELLE POLYPROPYLENE MESH; RESTORELLE POLYPROPYLENE MESH Coloplast A/S FTL Class II 2010-12-22
K102709 PEAK PLASMABLADE PLUS TISSUE DISSECTION DEVICE Peak Surgical, Inc. GEI Class II 2010-12-17
K101563 SMARTO Jeil Medical Corporation KIJ Class I 2010-12-17
K102766 COMPOSIX L/P MESH WITH ECHO PS POSITIONING SYSTEM C.R. Bard, Inc. FTL Class II 2010-12-16

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