meddevicedb.com FDA Device Reference

Review Panel

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

Cleared Devices
16,323
Product Codes (page)
28
Latest Decision
2008-03-21

Clearances · page 61 of 164

K-Number Trade Name Applicant / Manufacturer Product Code Class Decision Date
K080680 QUILL SELF-RETAINING SYSTEM (SRS) COMPRISED OF PDO (POLYDIOXANONE Surgical Specialties Corp NEW Class II 2008-03-21
K073391 SURGISIS BIODESIGN TISSUE GRAFT Cook Biotech, Inc. FTM Class II 2008-03-21
K080482 ARTHROCARE IRRIGATION PUMP, MODEL SIP001-00, SIP001-01 Arthrocare Corp. GEI Class II 2008-03-20
K073095 TUMARK PROFESSIONAL, MODEL 271560; MR- TUMARK PROFESSIONAL, MODEL 601560 Somatex Medical Technologies GmbH NEU Class II 2008-03-19
K072891 SINUS SPACER Acclarent, Inc. KAM Class I 2008-03-19
K073450 SUTTER ELECTROSURGICAL CABLES Sutter Medizintechnik GmbH GEI Class II 2008-03-17
K073287 PREVADH MESH Sofradim Production FTL Class II 2008-03-13
K080133 MOUNTABLE ENDOSCOPIC BLADE A.M. Surgical, Inc. EMF Class I 2008-03-13
K080393 MODIFICATION TO REBOUND HRD Minnesota Medical Development, Inc. FTL Class II 2008-03-13
K073041 RELIEVA AND RELIEVA ACELLA SINUS BALLOON CATHETER Acclarent, Inc. KAM Class I 2008-03-11
K073605 ATRICURE COOLRAIL LINEAR PEN AtriCure, Inc. OCL Class II 2008-03-11
K080406 IPULSE, MODEL I400 Cyden Limited GEX Class II 2008-03-10
K073164 IVS TUNNELLER DEVICES Covidien UK Manufacturing, Ltd. FTL Class II 2008-03-05
K073659 XTRAC ULTRA 2, MODEL AL10000 Photo Medex, Inc. GEX Class II 2008-03-05
K070355 FOTONA FIDELIS III ER:YAG/ND:YAG LASER SYSTEM FAMILY Fotona D.D. GEX Class II 2008-03-04
K072793 LIPOSAT BASIC (INFILTRATION PUMP), MODEL 92-007 688 Moeller Medical GmbH & Co. KG QPB Class II 2008-03-04
K073647 MINITAPE EXTRA URETHRAL SLING Mpathy Medical Devices, Ltd. OTN Class II 2008-03-03
K072459 OMNILUX NEW-U Photo Therapeutics, Inc. OHS Class II 2008-03-03
K071343 ELLMAN NOBLE ALLOY ELECTRODES Ellman International, Inc. GEI Class II 2008-02-28
K080006 AFFIRM WITH XPL HANDPIECE AND ER:YAG LASER MODULE Cynosure, Inc. GEX Class II 2008-02-28
K080145 PRIMAEVA MEDICAL SYSTEM Primaeva Medical, Inc. GEI Class II 2008-02-28
K073549 Q-PLUS T Quanta System Spa GEX Class II 2008-02-28
K073048 PETERIO UNIVERSAL LASER SCANNING HANDPIECE Scilex, Ltd. GEX Class II 2008-02-28
K073063 15W CERALAS D 1470NM DIODE LASER Biolitec, Inc. GEX Class II 2008-02-27
K073266 WALLFLEX PARTIALLY COVERED ESOPHAGEAL STENT SYSTEM Boston Scientific Corp ESW Class II 2008-02-27
K070961 BIOMERIX SURGICAL MESH, MODEL: RCR-01 Biomerix Corporation FTL Class II 2008-02-25
K073046 ETHICON ENDO SURGERY ARTICULATING NEEDLE KNIFE, MODEL 2504 Ethicon Endo-Surgery, Inc. GEI Class II 2008-02-25
K073646 MINITAPE URETHRAL SLING Mpathy Medical Devices, Ltd. PAH Class II 2008-02-25
K071896 FOX 940, MODEL 940 Valam, Inc. GEX Class II 2008-02-22
K080367 ZIMMER MIS LIGHT Zimmer Spine, Inc. FST Class II 2008-02-22
K073322 FOX 1-980, FOX Q-1064, FOX-Q-810 A.R.C Laser GmbH GEX Class II 2008-02-22
K073466 SMITH & NEPHEW INTRADISCAL CATHETER SYSTEM Smith & Nephew, Inc. GEI Class II 2008-02-22
K080282 ARTHROCARE CONTROLLERS (SYSTEM 2000,1100,1200), MODEL H2076-00, H2079-00, H3000-00, H4000-00; Arthrocare Corp. GEI Class II 2008-02-15
K062991 GENTLEWAVES CONSUMER LED PHOTOMODULATION DEVICE Light Bioscience, LLC OHS Class II 2008-02-15
K073332 V-RASER DIODE LASER SYSTEM Hoya Conbio, Inc. GEX Class II 2008-02-14
K071363 WATERLASE AND WATERLASE MD Biolase Technology, Inc. GEX Class II 2008-02-12
K073613 REPROCESSED SCISSOR TIPS Sterilmed, Inc. NUJ Class II 2008-02-12
K073149 MENISCAL CINCH Arthrex, Inc. GAT Class II 2008-02-11
K073096 ANCHORAGE CLOSURE DEVICE Epitek, Inc. GAT Class II 2008-02-07
K073533 SANARUS V2 TREATMENT SYSTEM Sanarus Medical, Inc. GEH Class II 2008-02-07
K053527 SPECTRA HAIR REMOVAL LASER Spectragenics, Inc. GEX Class II 2008-02-01
K073651 NEOTRACT ANCHOR SYSTEM Neotract, Inc. GAT Class II 2008-02-01
K080121 CYNOSURE SMARTLIPO MULTIWAVLENGTH LASER Cynosure, Inc. GEX Class II 2008-01-31
K073703 AMS MINIARC SLING SYSTEM American Medical Systems, Inc. PAH Class II 2008-01-30
K071734 WATERLASE MD DERM Biolase Technology, Inc. GEX Class II 2008-01-25
K072833 P-NAIN SYSTEM Jeisys Medical, Inc. GEX Class II 2008-01-24
K072779 CERALAS D 980NM DIODE LASER, MODELS D15 AND D25 Biolitec, Inc. GEX Class II 2008-01-24
K073503 VERSA LITE Diomedics, Inc. FTC Class II 2008-01-23
K071883 IPULSE, QUADRA Q4 PLATINUM SERIES, MODEL(S) 1200+SERIES 2, 1300 SERIES 2, Q4 SERIES 2 Cyden Limited GEX Class II 2008-01-23
K073464 ANGIODYNAMICS, INC., NEVERTOUCH II 400UM FIBER AND VENACURE PROCEDURE KIT AngioDynamics, Inc. GEX Class II 2008-01-23
K073496 OPTILITE HOLMIUM LASER FIBERS Cook Urological, Inc. GEX Class II 2008-01-23
K072906 SILK'N Home Skinovations , Ltd. GEX Class II 2008-01-23
K072219 CYTOPHIL TISSUE MARKER Cytophil, Inc. NEU Class II 2008-01-18
K072849 MODIFICATION TO THERMAGE THERMACOOL SYSTEM Thermage, Inc. GEI Class II 2008-01-18
K072124 BLACK AND BLACK ELECTROSURGICAL CUTTING AND COAGULATION FORCEPS AND ELECTRODES Black & Black Surgical, Inc. GEI Class II 2008-01-18
K073587 DERMAPAL WITH DIGITAL TIMER Daavlin Distributing Co. FTC Class II 2008-01-18
K063091 PIVIT CRM (TYRX ANTIMICROBIAL PACEMAKER POUCH), MODEL CMRM-0601 Tyrx Pharma, Inc. FTL Class II 2008-01-16
K072190 ORTHO-WRAP BIORESORBABLE SHEET Mast Biosurgery FTL Class II 2008-01-16
K072870 MICROWAVE TISSUE COAGULATION SYSTEM (MTCS) Foundry Newco X, Inc. NEY Class II 2008-01-14
K072925 CANDELA-INOLASE SERENITY PRO PSF SYSTEM Inolase, Ltd. GEX Class II 2008-01-10
K072332 VARI-LASE WIRE FIBER Vascular Solutions, Inc. GEX Class II 2008-01-10
K073687 HABIB LAPAROSCOPIC HEXABLATE Emcision , Ltd. GEI Class II 2008-01-09
K073495 TISSUELINK AQUAMANTYS MALLEABLE BIPOLAR SEALER WITH LIGHT Tissuelink Medical, Inc. GEI Class II 2008-01-09
K072067 N95 SURGICAL RESPIRATOR, TYPE AP0018 AND AP0028 Shuenn Bao Shing Corporation MSH Class II 2008-01-08
K072331 RADIANCY MISTRAL DEVICE Radiancy (Israel) , Ltd. GEX Class II 2008-01-07
K072913 SECURMARK BIOPSY SITE IDENTIFICATION SYSTEM Suros Surgical Systems, Inc. A Hologic Company NEU Class II 2008-01-04
K072751 COOLTOUCH MODELS NS 160 AND LC215 COOLIPO New Star Lasers, Inc. GEX Class II 2008-01-02
K073313 MARK III WAVEGUIDE FIBER WITH LOW PROFILE TIP Omniguide, Inc. GEX Class II 2008-01-02
K071695 KENSEY NASH MACROPORE SHIELD Kensey Nash Corp. FTL Class II 2007-12-31
K073436 SPECTRA VRMII 1-SWITCHED ND:YAG LASER SYSTEM Lutronic Corporation GEX Class II 2007-12-28
K072937 OLSEN MEDICAL INTEGRATED IRRIGATION TUBING AND BIPOLAR CORD SET Olsen Medical GEI Class II 2007-12-28
K072484 CYNOSURE YAG FAMILY LASER Cynosure, Inc. GEX Class II 2007-12-27
K072159 SMART CO2 (SMARTXIDE, SMART US20D) WITH DOT SCANNER El.En Electronic Engineering Spa GEX Class II 2007-12-27
K072261 FINESSE SYSTEM Primaeva Medical, Inc. GEI Class II 2007-12-26
K073066 308 DERMATOLOGICAL EXCIMER SYSTEM Quantel Medical, Inc. FTC Class II 2007-12-26
K073304 CARDICA C-PORT X-CHANGE ANASTOMOSIS SYSTEM AND HANDLE AND XA X-CHANGE SUBASSEMBLIES Cardica, Inc. FZP Class II 2007-12-20
K073360 PROPLATE Bio Protech, Inc. GEI Class II 2007-12-19
K072478 BAYLIS PAIN MANAGEMENT GENERATOR-TD, MODELS: PMG-115-TD AND PMG-230-TD Baylis Medical Co., Inc. GEI Class II 2007-12-19
K072995 TWINWAVE DENTAL LASER, TIDALWAVE 810 DENTAL LASER, TIDALWAVE 980 DENTAL LASER Lumen Development and Manufacturing, Inc. GEX Class II 2007-12-18
K070356 MEDWAVES MICROWAVE COAGULATION/ABLATION SYSTEM Medwaves Incorporated NEY Class II 2007-12-18
K073001 IDRIVES, IDRIVEC, IDRIVEF Power Medical Interventions, Inc. GDW Class II 2007-12-18
K073409 OMNIGUIDE STERILE WAVEGUIDE ADAPTER SYSTEM Omniguide, Inc. GEX Class II 2007-12-14
K071746 DERMA PRENE PI OR ISOTOUCH GREEN STERILE POWDER-FREE SYNTHETIC POLYISOPRENE SURGICAL GLOVES Ansell Healthcare Products, LLC KGO Class I 2007-12-13
K072911 ION MEDICAL BIPOLAR COAGULATION PEN Ion Medical, LLC GEI Class II 2007-12-13
K073394 SMARTLIPO LASER Cynosure, Inc. GEX Class II 2007-12-12
K072587 CYTORI AFT SYSTEM Cytori Therapeutics, Inc. MUU Class II 2007-12-10
K072883 ICE-SENSE Arbel Medical , Ltd. GEH Class II 2007-12-10
K073148 IDRIVES, IDRIVEC, IDRIVEF WITH VASCULAR INDICATIONS Power Medical Interventions, Inc. GDW Class II 2007-12-07
K072651 CRYOSPRAY ABLATION SYSTEM, MODEL CC2-NAM CSA Medical, Inc. GEH Class II 2007-12-07
K073123 CARDICA C-PORT FLEX-A DISTAL ANASTOMOSIS SYSTEM, MODEL FG-000150 Cardica, Inc. FZP Class II 2007-12-06
K073300 MILESMAN PREMIUM Milesman S.L. GEX Class II 2007-12-04
K072344 APL MEDICAL SYSTEM Bios S.R.L. GEX Class II 2007-12-03
K072453 CRY-AC TRACKER, MODEL(S) B-700T, AND B-800T Brymill Corp. GEH Class II 2007-12-03
K073017 STRYKER STRI-SHIELD FLYTE TOGAS Stryker Instruments, Instruments Div. FYA Class II 2007-11-30
K072520 TEPHAFLEX SURGICAL FILM Tepha, Inc. FTL Class II 2007-11-29
K071815 NOVEON, MODEL LS1100-01-0968 Nomir Medical Technologies, Inc. GEX Class II 2007-11-28
K063245 ELUTIA COATED CLOSED SURGICAL WOUND DRAIN Bacterin International, Inc. OEI Class II 2007-11-28
K071406 AUTOSUTURE ENDO CLIP III 5 MM CLIP APPLIER United States Surgical, A Division of Tyco Healthc FZP Class II 2007-11-21
K072470 BIOELAST 5-0 SUTURE, MODEL 500100 Entrigue Surgical, Inc. NWJ Class II 2007-11-16
K072216 KAPP BARI-RING ENDOSCOPIC MARKER, MODEL K-9536 Kapp Surgical Instrument, Inc. NEU Class II 2007-11-09

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