meddevicedb.com FDA Device Reference

Review Panel

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

Cleared Devices
16,323
Product Codes (page)
34
Latest Decision
2002-08-20

Clearances · page 78 of 164

K-Number Trade Name Applicant / Manufacturer Product Code Class Decision Date
K021745 VASCLIP Vmbc, LLC NJC Class II 2002-08-20
K021724 DORNIER DIODE LASER FAMILY, INCLUDING MEDILAS D FIBERTOM, MEDILAS D SKINPULSE & MEDILAS D SKINPULSE S LASER SYSTEMS Dornier Medtech America, Inc. GEX Class II 2002-08-19
K013958 INDUS TEXTILES TOWEL-STERILE AND NON-STERILE Indus Textiles, Inc. KKX Class II 2002-08-19
K021765 CEMENT RESTRICTOR, SMALL AND LARGE Exactech, Inc. JDK Class II 2002-08-16
K021650 ATHOSCAN FOR THE ATHOS LASER CONSTANS COOLING HAND PIECE FOR THE ATHOS LASER Quantel Medical GEX Class II 2002-08-16
K013623 CLEARLIGHT PHOTOTHERAPHY SYSTEM, MODEL CL 420 Curelight, Ltd. GEX Class II 2002-08-16
K021719 FORTITUDE CEMENT RESTRICTOR Spinal Concepts, Inc. JDK Class II 2002-08-15
K020597 SERRALGUT Serral, S.A. DE C.V. GAL Class II 2002-08-14
K021808 WECK HEM-O-LOK AUTOMATIC LIGATING CLIP APPLIER Weck FZP Class II 2002-08-14
K013691 CERALAS D DIODE LASER SYSTEM, MODEL # D50 Biolitec, Inc. GEX Class II 2002-08-13
K022218 CADENCE CEMENT RESTRICTOR Spinal Concepts, Inc. JDK Class II 2002-08-12
K021550 LUMENIS SELECTA DUET Ellex Medical Pty, Ltd. GEX Class II 2002-08-09
K021508 OPUSDUO EC DENTAL LASER SYSTEM Opusdent , Ltd. GEX Class II 2002-08-07
K022162 STRYKER T4 URETHANE HOOD; STRYKER T4 URETHANE ZIPPER TOGA; STRYKER T4 URETHANE PULLOVER TOGA Stryker Instruments FYA Class II 2002-08-01
K021387 POLAR WAND Chek-Med Systems GEH Class II 2002-07-31
K022296 MODIFICATION TO EN-BLOC BIOPSY SYSTEM Neothermia Corp. GEI Class II 2002-07-30
K021784 PROFEEL POWDER FREE POLYMER COATED BROWN LATEX SURGICAL GLOVES, STERILE (PROTEIN LABELING CLAIM) Wrp Asia Pacific Sdn. Bhd. KGO Class I 2002-07-24
K020474 MAKRITE TYPE N95 RESPIRATOR AND SURGICAL MASK MODEL 910-N95 Makrite Industries, Inc. MSH Class II 2002-07-23
K021304 PROLITE PULSED LIGHT SYSTEM Big Sky Laser Technologies, Inc. GEX Class II 2002-07-23
K011591 ESOPHAGEAL Z-STENT WITH DUA ANTI-REFLUX VALVE Wilson-Cook Medical, Inc. ESW Class II 2002-07-19
K022165 THERALIGHT UV120-2 UVA/UVB PHOTOTHERAPY SYSTEM, MODEL UV120-2 Theralight, Inc. FTC Class II 2002-07-18
K021736 BARD VENTRALEX HERNIA PATCH, MODELS 0010302, 0010301 C.R. Bard, Inc. FTL Class II 2002-07-16
K012018 BICAP COAG BIPOLAR LAPAROSCOPY PROBE, MODEL 006908-910 Acmi Corporation GEI Class II 2002-07-16
K020585 ZIP OPEN FORCEPS WITH ELECTROSURGICAL CUT Gyrus Medical, Inc. GEI Class II 2002-07-13
K021817 AARON A950 HIGH FREQUENCY ELECTROSURGICAL GENERATOR, AARON A950 ELECTROSURGICAL GENERATOR, 240V Aaron Medical Industries GEI Class II 2002-07-11
K021616 DELIGHT DENTAL ER: YAG LASER SYSTEM Continuum Electro-Optics, Inc. GEX Class II 2002-07-11
K013873 COBRA CARDIAC ELECTROSURGICAL SYSTEM Boston Scientific Corp GEI Class II 2002-07-11
K021149 AURORA DS Syneron Medical, Ltd. GEX Class II 2002-07-09
K021901 WALLGRAFT TRACHEOBRONCHIAL ENDOPROTHESIS WITH UNISTEP PLUS DELIVERY SYSTEM Boston Scientific Scimed, Inc. JCT Class II 2002-07-09
K021119 POWDERED BROWN LATEX SURGICAL GLOVES, STERILE WITH EXPIRATION DATE LABELING CLAIM & PROTEIN CONTENT LABELING CLAIM Wrp Asia Pacific Sdn. Bhd. KGO Class I 2002-07-05
K021407 COALESCENT SURGICAL U-CLIP - OR OTHER TBD AND ACCESSORIES Coalescent Surgical FZP Class II 2002-07-03
K021261 SEEDNET SYSTEM AND SEEDNETGOLD SYSTEM, MODELS GP6T5, GP5T5, GP5T3, HP5T5 & HP5T3 Galil Medical , Ltd. GEH Class II 2002-07-03
K021159 POWDERED LATEX SURGIACAL GLOVES, STEERILE WITH EXPIRATION DATE LABELING CLAIM Wrp Asia Pacific Sdn. Bhd. KGO Class I 2002-07-03
K021418 AART NASAL IMPLANT Aesthetic and Reconstructive Technologies, Inc. FZE Class II 2002-07-02
K020021 LYRA SURGICAL LASER SYSTEM AND ACCESSIORIES (ND:YAG CONFIGURATION) Laserscope GEX Class II 2002-07-02
K021419 AART MALAR IMPLANT Aesthetic and Reconstructive Technologies, Inc. LZK Class II 2002-07-02
K021180 CANDELA VBEAM PULSED DYE LASER SYSTEM Candela Corp. GEX Class II 2002-07-02
K021417 AART CHIN IMPLANT Aesthetic and Reconstructive Technologies, Inc. FWP Class II 2002-07-02
K011220 LEVEEN REFLECT MONOPOLAR/BIPOLAR NEEDLE ELECTRODE Radiotherapeutics Corp. GEI Class II 2002-07-01
K021079 ABCSNARE ELECTROSURGICAL PROBE FOR FLEXIBLE ENDOSCOPES, MODEL 1336XX Conmedcorp GEI Class II 2002-07-01
K012669 REPROCESSED ELECTROSURGICAL ELECTRODES Surgical Instruments Service and Savings, Inc. GEI Class II 2002-06-27
K021299 CONMED HEATWAVE HAND-CONTROLLED ELETRODE Conmedcorp GEI Class II 2002-06-26
K021227 SOFTLASE G2-SURGICAL DIODE LASER SYSTEM Zap Lasers, LLC GEX Class II 2002-06-26
K021211 MODIFICATION TO SANARUS VISICA TREATMENT SYSTEM Sanarus Medical, Inc. GEH Class II 2002-06-26
K020958 CANDELA CBEAM PULSED DYE LASER SYSTEM Candela Corp. GEX Class II 2002-06-21
K021701 SURGASSIST RIGHT ANGLE LINEAR CUTTER 30MM, 45MM & 60MM, MODELS RALC30, RALC45 & RALC60 Power Medical Interventions, Inc. GDW Class II 2002-06-21
K021043 GRAMS ABSORBABLE SURGICAL GUT SUTURE PLAIN & CHROMIC Gramsmed, LLC GAL Class II 2002-06-21
K020941 PALOMAR LUXG HANDPIECE Palomar GEX Class II 2002-06-19
K021019 COTTONY II, SILKY II POLYDEK & TEVDEK II POLYESTER SUTURE Genzyme Corp. GAT Class II 2002-06-18
K011676 VIVAWAVE MICROWAVE SYSTEM Vivant Medical, Inc. NEY Class II 2002-06-18
K020856 SPATOUCH PHOTOEPILATION SYSTEM Radiancy (Israel) , Ltd. GEX Class II 2002-06-13
K021632 GP GENERAL PURPOSE DRAINAGE CATHETER; MINI-PIGTAIL DRAINAGE CATHETER WITH LOCKING PIGTAIL; GP GENERAL PURPOSE DRAINAGE C Uresil, L.P. GBO Class I 2002-06-13
K020853 NUVASIVE MESH Nuvasive, Inc. EZX Class II 2002-06-13
K021160 DERMMATRIX SURGICAL MESH Carbon Medical Technologies, Inc. FTM Class II 2002-06-12
K020835 CERALAS D10-60 810NM DIODE LASER, MODELCERALAS DIO-60 Biolitec, Inc. GEX Class II 2002-06-12
K014183 AFB (ABSORBABLE FOAM BUTTRESS) J&J Corporate Biomaterials Center FTL Class II 2002-06-12
K020836 RABEA CEMENT RESTRICTOR Signus Medical, LLC JDK Class II 2002-06-11
K021598 ELASTYLITE SYNTHETIC POWDERED SURGICAL GLOVE Eci Medical Technologies, Inc. KGO Class I 2002-06-10
K021010 MODIFIED CARDIAC CRYOSURGICAL SYSTEM, MODELS 6TCS1 & 6TCSE Endocare, Inc. OCL Class II 2002-06-06
K021519 ARTHROCARE CONTROLLER, AUTHROCARE CABLE, FOOT CONTROL, POWER CORD, WANDS Arthrocare Corp. GEI Class II 2002-06-06
K020779 PROXIMATE AND ENDOPATH LINEAR CUTTERS AND STAPLERS Ethicon Endo-Surgery, Inc. GDW Class II 2002-06-05
K020729 NLITE SYSTEM,MODEL A00-1051 Icn Photonics , Ltd. GEX Class II 2002-06-04
K014040 FAMILY OF ALTUS MEDICAL MODIFIED COOLGLIDE AESTHETIC LASERS, MODELS COOLGLIDE I, II AND FUTURE MODELS Altus Medical, Inc. GEX Class II 2002-06-03
K020711 WALLACH LOOP ELECTRODE Wallach Surgical Devices, Inc. GEI Class II 2002-06-03
K021563 INTRACOIL SELF-EXPANDING PERIPHERAL STENT Sulzer Intratherapeutics, Inc. JCT Class II 2002-05-31
K020673 WAVE FORM MANUFACTURING PROLASE GENERAL SHAPED FIBER Wave Form Mfg., Inc. GEX Class II 2002-05-30
K021364 MODIFICATION TO ENTEC PLASMA WANDS Arthrocare Corp. GEI Class II 2002-05-30
K020952 SURX RF SYSTEM Surx, Inc. MUK Class II 2002-05-30
K013021 LIGHTLANCE LASER SKIN PERFORATOR Innotech USA, Inc. GEX Class II 2002-05-30
K021577 MODIFICATION TO EN-BLOC BIOPSY SYSTEM Neothermia Corp. GEI Class II 2002-05-29
K020778 GYRUS ENT SOMNOPLASTY TISSUE COAGULATING ELECTRODE, MODEL 2420 Gyrus Ent LLC GEI Class II 2002-05-28
K020640 KSEA SCB MEDIA CONTROL KARL STORZ Endoscopy-America, Inc. FTA Class II 2002-05-28
K013846 ULTRAGARD IMPERVIOUS REINFORCED GOWN Precept Medical Products, Inc. FYA Class II 2002-05-22
K014283 LATEX SURGEONS GLOVE (POWDER FREE) Brightway Gloves Pvt. , Ltd. KGO Class I 2002-05-22
K020574 TISSUELINK BIPOLAR FLOATING BALL DEVICE Tissuelink Medical, Inc. GEI Class II 2002-05-20
K020902 SERRALESTER Serral, S.A. DE C.V. GAT Class II 2002-05-20
K020849 APEX 800 LASER SYSTEM, MODEL APEX 800 Iridex Corp GEX Class II 2002-05-20
K021092 PHILIPS TL 20W/01RS UV-B, PHILIPS PL-S 9W/01/2P UV, AND PHILIPS PL-L 36W/01/4P UV-B Philips Lighting Co. FTC Class II 2002-05-16
K021514 PHILIPS PLS9W/12/2P UVB Philips Lighting Co. FTC Class II 2002-05-16
K020513 EPY-50 Ddc Technologies, Inc. GEX Class II 2002-05-16
K020847 XTRAC EXCIMER LASER SYSTEM, MODEL AL7000 Photo Medex, Inc. GEX Class II 2002-05-16
K020591 BCLEAR Lumenis FTC Class II 2002-05-16
K013764 IMMIX BONE GRAFT EXTENDER Osteogenics Biomedical, Inc. KKY Class II 2002-05-16
K021107 FORTAFLEX SURGICAL SLING Organogenesis, Inc. FTM Class II 2002-05-15
K020652 HERNIAMESH T-SLING Herniamesh PAH Class II 2002-05-15
K021263 MODIFICATION TO SPARC SLING SYSTEM American Medical Systems, Inc. OTN Class II 2002-05-15
K021249 SURGASSIST FLEXSHAFT 2, MODEL FS2 14 Power Medical Interventions, Inc. GDW Class II 2002-05-15
K021368 MEDELA BASIC 30 AND DOMINANT 50 SUCTION PUMPS, MODELS 037, 057 Medela AG BTA Class II 2002-05-15
K014278 LATEX SURGEONS GLOVE (POWDERED) Brightway Gloves Pvt. , Ltd. KGO Class I 2002-05-14
K020579 AARON ARTHROSCOPY ELECTRODE, CATALOG NUMBERS AR00, AR01, AR02, AND AR03 Aaron Medical Industries GEI Class II 2002-05-13
K020719 SURGASSIST SYSTEM STRAIGHT LINEAR CUTTER DIGITAL LOADING UNIT, 55MM, 30MM WITH BLUE AND GREEN RELOAD CARTRIDGES Power Medical Interventions, Inc. GDW Class II 2002-05-10
K021105 FORTAFLEX SURGICAL MESH Organogenesis, Inc. FTM Class II 2002-05-10
K020453 PALOMAR ESTELUX PULSED LIGHT SYSTEM AND PALOMAR COOLROLLER Palomar Medical Technologies, Inc. GEX Class II 2002-05-10
K020466 HEC 1000 Metro Medical Equipment, Inc. KPJ Class II 2002-05-08
K021065 PRE-POWDERED STERILE SURGEON'S GLOVES (WITH A 50 MICROGRAM/GM PROTEIN CLAIM Primus Gloves Private , Ltd. KGO Class I 2002-05-08
K020781 WET CHAMBER Kinetic Concepts, Inc. NAD Class I 2002-05-06
K020393 MASTER & FRANK SURGICAL DRAPES (STERILE) Master & Frank Enterprses Co., Ltd. KKX Class II 2002-05-03
K020510 SMOKE EVACUATION HOSES/TUBING Dm Medical, Inc. FYD Class II 2002-05-03
K020408 SYSTEM 2000 CONTROLLER, SYSTEM 5000 CONTROLLER, FOOTSWITCH, POWER CORD, AND VISAGE WANDSFF Arthrocare Corp. GEI Class II 2002-05-02
K020344 RPX TITANIUM CEMNT RESTRICTOR Sulzer Spine-Tech JDK Class II 2002-05-02

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