meddevicedb.com FDA Device Reference

Review Panel

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

Cleared Devices
16,323
Product Codes (page)
44
Latest Decision
2012-12-21

Clearances · page 48 of 164

K-Number Trade Name Applicant / Manufacturer Product Code Class Decision Date
K122717 FACE MASK, SURGICAL MASK, PROCEDURE MASK, SURGICAL FACE MASK Tiger Medical Products, Ltd. FXX Class II 2012-12-21
K123260 DETACHATIP III Conmed Corporation GEI Class II 2012-12-21
K123172 KOGENT BIPOLAR FORCEPS Katalyst Surgical, LLC GEI Class II 2012-12-21
K121268 WANDY DISPERSVIE ELECTRODE Bio-Med USA, Inc. ODR Class II 2012-12-20
K123168 Q-PLUS T+ IPL LASER SYSTEM Quanta System Spa GEX Class II 2012-12-20
K121998 HM SURGICAL GOWN, NON REINFORCED HM SURGICAL GOWN, FABRIC REINFORCED HM SURGICAL GOWN, POLYERINFORCED Changzhou Holymed Products Co., Ltd. FYA Class II 2012-12-20
K122217 CERTUS 140 2.45GHZ ABLATION SYSTEM Neuwave Medical, Inc. NEY Class II 2012-12-19
DEN090007 BIO-SEAL LUNG BIOPSY TRACT SYSTEM Angiotech OMT Class II 2012-12-19
K122794 UPSYLON Y MESH Boston Scientific Corp OTO Class II 2012-12-18
K122968 NOVASILK MESH QTY 1 MODEL 93-6014, NOVASILK MESH QTY 3 MODEL 93-6015 Coloplast Corp. OTO Class II 2012-12-18
K122734 AESCULAP NOVOSYN ABSORBABLE SUTURE Aesculap, Inc. GAM Class II 2012-12-18
K123318 IDRIVE ULTRA POWERED HANDLE AND ENDO GIA ADAPTER Covidien, Formerly US Surgical A Divison of Tyco H GDW Class II 2012-12-18
K122875 ORICARE L2700 Oricare, Inc. FSY Class II 2012-12-18
K113018 APOLLO V+ MEDICAL PLATFORM, APOLLO IV+ MEDICAL PLATFORM, NICE STATION LIGHT BASED PLATFORM BEIJING SYNTECH LASER CO., LTD. GEX Class II 2012-12-14
K123257 EMVERA DIOLUX Emvera Technologies, Inc. GEX Class II 2012-12-14
K123385 MEDILAS H LASER FIBERS Dornier Medtech America, Inc. GEX Class II 2012-12-14
K121218 HYDRASOLVE CONSOLE STERILE TREATMENT KIT REUSABLE CANNULA, 4MM DIA, 26 CM LENGTH, 3 APERTURE REUSABLE CANNULA, 4MM DIA, Andrew Technologies, LLC QPB Class II 2012-12-13
K120844 MEDLINX SURGICAL MESH Medlinx Acala Pte, Ltd. FTL Class II 2012-12-13
K121508 LIGHTWALKER AT LIGHTWALKER DT LIGHTWALKER ST-E LIGHTWALKER ST-N Fotona D.D. PDZ Class II 2012-12-12
K122000 HM SURGICAL DRAPES HM SURGICAL EQUIPMENT COVER Changzhou Holymed Products Co., Ltd. KKX Class II 2012-12-12
K121152 SURGICAL GOWN, SMS Jiangsu Guangda Medical Material, Co., Ltd. FYA Class II 2012-12-12
K120791 AMBIENT TURBOFLASH 90 IFS Arthocare Corporation GEI Class II 2012-12-11
K123479 PROGRIP LAPAROSCOPIC SELF-FIXATING MESH Sofradim Production FTL Class II 2012-12-11
K120932 OPELASER PRO II AND THE OPELASER LITE II The Yoshida Dental Mfg. Co., Ltd. GEX Class II 2012-12-07
K121703 LIPOKIT WITH DISPOSABLE 50CC AFT SYRINGE Medi-Khan USA, Inc. MUU Class II 2012-12-07
K120454 SAFEAIR SMOKE PENCIL, Lna Medical Aps GEI Class II 2012-12-07
K123031 BWF-5 MEDICAL LASER SERIES Litecure, LLC GEX Class II 2012-12-03
K122762 ACCULIS ACCU21 PMTA MICROWAVE TISSUE ABLATION APPLICATOR Microsulis Medical Limited NEY Class II 2012-11-30
K123037 LIGHTSCALPEL Lightscalpel, LLC GEX Class II 2012-11-29
K121475 TXCELL SCANNING LASER DELIVERY SYSTEM Iridex Corp GEX Class II 2012-11-28
K121346 PICOSURE WORKSTATION Cynosure, Inc. GEX Class II 2012-11-27
K121216 STR GRAFT Soft Tissue Regeneration, Inc. OWW Class II 2012-11-21
K121977 PLASMAJET NEUTRAL PLASMA SURGERY SYSTEM Plasma Surgical Limited GEI Class II 2012-11-20
K123409 QUILL MONODERM KNOTLESS TISSUE-CLOSURE DEVICE, VARIABLE LOOP DESIGN Surgical Specialties Corp. Dba Angiotech GAM Class II 2012-11-20
K121085 HET BIPOLAR LIGATOR SYSTEM Het Systems, LLC GEI Class II 2012-11-20
K122440 RESTORELLE L Coloplast Corp. OTO Class II 2012-11-19
K113380 PROSTIVA RF THERAPY HAND PIECE PROSTIVA RF THERAPY RF GENERATOR Medtronic, Inc. GEI Class II 2012-11-15
K120857 EPI-SENSE GUIDED COAGULATION DEVICE WITH VISITRAX Ncontact Surgical, Inc. OCL Class II 2012-11-13
K112853 VOLTERA POWERED SUCTION PUMP Suzric Enterprise Co., Ltd. OMP Class II 2012-11-09
K122580 AEM DISPOSABLE SUCTION IRRIGATION HANDSET MODEL ES1700; AEM DISPOSABLE SUCTION IRRIGATION ELECTRODES MODEL ES077X SERIES Encision, Inc. GEI Class II 2012-11-09
K120479 MTF FASCIA Musculoskeletal Transplant Foundation OWY Class II 2012-11-08
K122278 BAYLIS MEDICAL COMPANY RADIOFREQUENCY PERFORATION GENERATOR Baylis Medical Company, Inc. GEI Class II 2012-11-07
K123268 SMARTSTITCH PERFECTPASSER SYSTEM Arthocare Corporation GAT Class II 2012-11-07
K112599 INSURGICAL SINGLE USE POWER EQUIPMENT Insurgical, LLC KIJ Class I 2012-11-06
K120560 TRINITY WRINKLE REMOVER Carol Cole Company OHS Class II 2012-11-06
K122425 VAPR P50 SUCTION ELECTRODE VAPR S90 SUCTION ELECTRODE VAPR P50 SUCTION ELECTRODE WITH HANDCONTROLS VAPRS90 SUCTION ELECT Depuy Mitek, A Johnson & Johnson Company GEI Class II 2012-11-05
K121562 ALTIS SINGLE INCISION CLING SYSTEM Coloplast A/S PAH Class II 2012-11-05
K121878 CARDIOBLATE CRYOFLEX SURGICAL ABLATION PROBES Medtronic, Inc. OCL Class II 2012-11-02
K122389 TRUSCULPT Cutera, Inc. PBX Class II 2012-11-02
K120909 EC 2.7 ENDOSCOPIC CUTTER Medtronic Advanced Energy, LLC GEI Class II 2012-11-02
K123179 AJUST HELICAL ADJUSTABLE SINGLE-INCISION SLING C.R. Bard, Inc. PAH Class II 2012-11-02
K122436 COMPOSIX L/P MESH WITH ECHO PS POSITIONING SYSTEM VENTRALIGHT ST MESH WITH ECHO PS POSITIONING SYSTEM C.R. Bard, Inc. FTL Class II 2012-11-02
K121315 STRYKER CMF MEDPOR CUSTOMIZED IMPLANT Howmedica Osteonics Corp. FWP Class II 2012-11-01
K122637 LITE DECOMPRESSION SYSTEM- LIGHT CABLE MODEL 48089999 Stryker Spine FST Class II 2012-11-01
K122446 LIQUIDBAND FLOW CONTROL Advanced Medical Solutions (Plymouth), Ltd. MPN Class II 2012-10-26
K123141 ENSEAL TRIO TISSUE SEALING DEVICE Ethicon Endo-Surgery, LLC GEI Class II 2012-10-25
K123109 ABSORBATACK 5MM SINGLE USE ABSORBABLE FIXATION DEVICE Covidien GDW Class II 2012-10-23
K122092 MEDRANGE ELECTROSURGICAL EXPANSION SYSTEM Medrange Corporation GEI Class II 2012-10-23
K122280 IPULSE SMOOTHSKIN HAIR REMOVAL SYSTEM Cyden Limited OHT Class II 2012-10-23
K122898 QUILL MONODERM KNOTLESS TISSUE-CLOSURE DEVICE, VARIABLE LOOP DESIGN Surgical Specialties Corp. Dba Angiotech GAM Class II 2012-10-22
K120728 PHASIX PLUG AND PATCH C.R. Bard, Inc. OWT Class II 2012-10-22
DEN090012 VIRULITE COLD SORE MACHINE Virulite, LLC OKJ Class II 2012-10-18
K121861 SMITH & NEPHEW ULTRA FAST-FIX MENISCAL REPAIR SYSTEM, SMITH & NEPHEW ULTRA FAST-FIX AB MENISCAL REPAIR SYSTEM, SMITH & N Smith & Nephew, Inc. GAT Class II 2012-10-18
K121805 AMS LARGE PORE POLYPROPHLENE MESH American Medical Systems OTO Class II 2012-10-16
K123066 ACCUMESH DEPLOYMENT SYSTEM Covidien, LLC ORQ Class II 2012-10-16
K120192 DISPOSABLE SURGICAL GOWNS Weihai Hongyu Nonwoven Fabric Products Co., Ltd. FYA Class II 2012-10-16
K121598 ME HAIR2GO Syneron Medical, Ltd. ONF Class II 2012-10-12
K121883 PREVENA INCISION MANAGEMENT SYSTEM WITH CUSTOMIZABLE DRESSING, PREVENA CUSTOMIZABLE DRESSING KIT Kci USA, Inc. (Kinetic Concepts, Inc.) OMP Class II 2012-10-11
K121754 BLUE SUI SLING Boston Scientific Corp OTN Class II 2012-10-10
K120499 ABTHERA OPEN ABDOMEN NEGATIVE PRESSURE THERAPY SYSTEM Kci USA, Inc. (Kinetic Concepts, Inc.) OMP Class II 2012-10-05
K120040 REPROCESSED SURGICAL ELECTRIC INSTRUMENT Sterilmed, Inc. NUJ Class II 2012-10-05
K121700 ULTHERA SYSTEM Ulthera, Inc. OHV Class II 2012-10-02
K122619 EPIX IRRIGATION PUMP, EPIX SUCTION IRRIGATION TUBING SET Applied Medical BTA Class II 2012-10-02
K122756 PENUMBRA PUMP MAX (110VAC), PENUMBRA PUMP MAX (230VAC), PENUMBAR PUMP MAX CANISTER/TUBING Penumbra, Inc. JCX Class II 2012-10-02
K120116 SERF ABLATION SYSTEM SERF ABLATION NEEDLE Thermedical GEI Class II 2012-10-01
K113678 INVIA MOTION NEGATIVE PRESSURE WOUND THERAPY SYSTEM Medela AG OMP Class II 2012-10-01
K120460 SMARTLUX Medmix Co., Ltd. GEX Class II 2012-10-01
K121286 EPIC 10 Biolase Technology, Inc. GEX Class II 2012-09-28
K113843 FREEDOM ND: YAG LASER SYSTEM Lutronic Corporation PDZ Class II 2012-09-27
K122611 COOLRAIL LINEAR PEN MODEL MCRI AtriCure, Inc. OCL Class II 2012-09-26
K122374 ARTHREX SUTURE (UHMWPE) Arthrex, Inc. GAT Class II 2012-09-25
K121580 SURELASE CO2 LASER SYSTEM Clinicon Corp. GEX Class II 2012-09-25
K120938 THE PL-1064 LASER SYSTEM Sheaumann Laser, Inc. PDZ Class II 2012-09-24
K121150 ALMA LASERS FAMILY OF PIXEL RF TIPS Alma Lasers, Inc. GEI Class II 2012-09-21
K121005 ADIPREP ADIPOSE TRANSFER SYSTEM Harvest Technologies, Corp. MUU Class II 2012-09-21
K120235 MODEL FAMILY OF AEROLASE ND:YAG LASERS: FRIENDLYLIGHT ND: YAG LASERS, FRIENDLYLIGHT NEO, LIGHTPOD ND: YAG LASERS, LIGHTP Aerolase Medical Lasers, LLC GEX Class II 2012-09-17
K120328 ORIGINS LIPOHARVESTING SYSTEM Sound Surgical Technologies, LLC MUU Class II 2012-09-17
K122487 BIOFIBER SYTURE Tornier, Inc. NWJ Class II 2012-09-17
K121335 G-DERM POWDER-FREE SYNTHETIC SURGICAL GLOVE Hutchinson Sante S.N.C. KGO Class I 2012-09-13
K122579 VELASHAPE Syneron Medical, Ltd. NUV Class II 2012-09-13
K120737 TRIA LASER HAIR REMOVAL SYSTEM Tria Beauty, Inc. GEX Class II 2012-09-13
K113407 SNOWDEN PENCER LAPAROSCOPIC ERGONOMIC REPOSABLE SCISSORS Carefusion 2200, Inc. GEI Class II 2012-09-07
K121641 MINIARC PRO SINGLE-INCISION SLING SYSTEM American Medical Systems PAH Class II 2012-09-07
K113572 LIGASURE CURVED, SMALL JAW, OPEN SEALER/DIVIDER Covidien, Formerly Valleylab, A Division of Tyco H GEI Class II 2012-09-05
K113291 SIMEX NEGATIVE PRESSURE WOUND THERAPY POWERED SUCTION PUMPS SERIES: SIM-EX200 AND SIM-EX300 Simex Medizintechnik GmbH OMP Class II 2012-08-30
K113472 PRECISE SHP DIODE LASER CAO Group, Inc. GEX Class II 2012-08-30
K122276 ATRICLIP LAA EXCLUSION SYSTEM WITH PRELOADED GILLINOV-COSGROVE CLIP AtriCure, Inc. FZP Class II 2012-08-29
K122528 ULTHERA SYSTEM Ulthera, Inc. OHV Class II 2012-08-28
K121251 ICEROD CX CRYOABLATION NEEDLE ICEROD CX CRYOABLATION NEEDLE MULTIPACK Galil Medical , Ltd. GEH Class II 2012-08-28
K121690 ETCHONIA ZERONA ARMS Erchonia Corporation OLI Class II 2012-08-23

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