meddevicedb.com FDA Device Reference

Review Panel

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

Cleared Devices
16,323
Product Codes (page)
29
Latest Decision
2007-11-08

Clearances · page 62 of 164

K-Number Trade Name Applicant / Manufacturer Product Code Class Decision Date
K072359 AEARO COMPANY SURGICAL N95 RESPIRATORS, MODELS N9508C AND N9511C Aearo Company MSH Class II 2007-11-08
K072646 UNICAPRONE United Medical Industries Co. , Ltd. GAM Class II 2007-11-07
K072644 UNICRYL QUICK United Medical Industries Co. , Ltd. GAM Class II 2007-11-07
K072645 UNIGLACTIN United Medical Industries Co. , Ltd. GAM Class II 2007-11-07
K072868 ACCOLADE II LASER Cynosure, Inc. GEX Class II 2007-11-05
K071768 ERBIUM FRACTIONAL HANDPIECE Palomar Medical Products, Inc. GEX Class II 2007-11-05
K071051 FRAXEL III SR LASER SYSTEM AND ACCESSORIES Reliant Technologies, Inc. GEX Class II 2007-11-02
K072076 CYTOPLAST PTFE SUTURE Osteogenics Biomedical, Inc. NBY Class II 2007-10-31
K072262 GENTLERAY 980 DIODE LASER SYSTEM Kavo America GEX Class II 2007-10-26
K072865 MODIFICATON TO: ARTHROCARE ARTHROWANDS Arthrocare Corp. GEI Class II 2007-10-23
K071796 CAPSEW PLICATION SYSTEM Cayenne Medical, Inc. GAT Class II 2007-10-19
K071937 BONALIVE GRANULES AND BONALIVE PLATES Vivoxid , Ltd. KKY Class II 2007-10-19
K071986 LTM-RC SURGICAL MESH Lifecell Corp. FTM Class II 2007-10-19
K072789 DISPOSABLE AEM FIXED TIP ELECTRODES AND HANDPIECES Encision, Inc. GEI Class II 2007-10-19
K070930 REPROCESSED AUTOSUTURE GIA ENDOSCOPIC STAPLERS Sterilmed, Inc. NLL Class II 2007-10-18
K070405 MODIFICATION TO SURGISIS SLR STAPLE LINE REINFORCEMENT Cook Biotech, Inc. FTM Class II 2007-10-17
K072035 RESOLVE UVB PHOTOTHERAPY SYSTEM Allux Medical FTC Class II 2007-10-16
K072767 QUASAR BLUE LIGHT THERAPY SYSTEM Silver Bay, LLC GEX Class II 2007-10-15
K070870 SKIN CARE LIGHT Transverse Industries Co. GEX Class II 2007-10-10
K071491 ARROW INTERNATIONAL, INC., SURGICAL DRAPES Arrow Intl., Inc. KKX Class II 2007-10-10
K071621 RELIANT TECHNOLOGIES C300 CHILLER SYSTEM AND ACCESSORIES Reliant Technologies, Inc. GEX Class II 2007-10-09
K072699 ALMA LASERS FAMILY OF ACCENT RADIOFREQUENCY (RF) SYSTEMS, MODELS: ACCENT, ACCENT XL Alma Lasers , Ltd. GEI Class II 2007-10-05
K072229 MONOSWIFT Cp Medical GAM Class II 2007-10-05
K072559 SUCTION COAGULATOR Megadyne Medical Products, Inc. GEI Class II 2007-10-05
K070443 INTRACEPT BI-POLAR RF PROBE, MODEL 04814 Relievant Medsystems, Inc. GEI Class II 2007-10-05
K072072 HARMONY LED-1 SURGICAL LIGHTING SYSTEM STERIS Corporation FSY Class II 2007-10-05
K072525 ZIPKNOT, MODEL 1017-3000 Medicinelodge, Inc. FZP Class II 2007-10-05
K072424 COOLTOUCH, MODEL LC215,COOLLIPO New Star Lasers, Inc. GEX Class II 2007-10-03
K070296 VISIOLITE OPHTHALMIC ER: YAG LASER SYSTEM Ace Vision Group GEX Class II 2007-10-03
K072126 HABIB VESEAL Emcision , Ltd. GEI Class II 2007-10-02
K071845 RELIEVA LUMA SINUS ILLUMINATION SYSTEM, MODEL SIS-100A Acclarent, Inc. KAM Class I 2007-09-28
K071920 AUTOSUTURE ABSORBABLE TACK AND APPLICATOR United States Surgical, A Division of Tyco Healthc GDW Class II 2007-09-28
K071708 I45, I45S, I60, AND I60S Power Medical Interventions, Inc. GDW Class II 2007-09-27
K072493 ENSEAL TISSUE SEALING DEVICE Surgrx, Inc. GEI Class II 2007-09-27
K071732 MARROWMINER Stemcor Systems, Inc. GDM Class I 2007-09-24
K070432 GENERAL SURGERY DRAPES Welmed, Inc. KKX Class II 2007-09-24
K072514 VISULAS TRION Carl Zeiss Meditec, AG GEX Class II 2007-09-21
K072034 DIODE MEDICAL LASER FAMILY, MODELS 4, 6, 30 Quanta System Spa GEX Class II 2007-09-20
K071859 STRYKER CROSSFIRE SYSTEM Stryker Endoscopy GEI Class II 2007-09-20
K071604 ALVEOLUS AERO DV TRACHEOBRONCHIAL STENT SYSTEM Alveolus, Inc. JCT Class II 2007-09-19
K071823 PERMA FACIAL IMPLANTS Surgisil ODU Class II 2007-09-19
K072322 ULTRA FAST-FIX AND ULTRA FAST-FIX AB MENISCAL REPAIR SYSTEMS Smith & Nephew, Inc. GAT Class II 2007-09-18
K071887 SPORTMESH OR ARTELON TISSUE REINFORCEMENT Artimplant AB FTL Class II 2007-09-18
K070812 DISPOSABLE LAPAROSCOPIC INSTRUMENT Modern Medical Equipment Mfg., Ltd. GEI Class II 2007-09-14
K062736 SIASCOPE V Astron Clinica Limited PSN Class II 2007-09-14
K072023 ELLIPSE JUVIA, MODEL 9EJU7465 Ellipse A/S GEX Class II 2007-09-12
K072394 PORTRAIT STAND-OFF Rhytec Incorporated GEI Class II 2007-09-12
K070859 REPROCESSED ETHICON ETS ENDOSCOPIC LINEAR CUTTERS Sterilmed, Inc. NLL Class II 2007-09-12
K071465 BIOGEL ORTHOPAEDIC SURGICAL GLOVE WITH NON-PRYOGENIC STATEMENT Molnlycke Health Care Us, LLC KGO Class I 2007-09-11
K071700 BIOGEL SENSOR SURGEON'S GLOVE WITH NON-PYROGENIC STATEMENT Molnlycke Health Care Us, LLC KGO Class I 2007-09-11
K071414 BIOGEL ECLIPSE, LATEX, POWDER FREE, INDICATOR UNDERGLOVE WITH PROTEIN CONTENT LABELING CLAIM (50 MICROGRAMS OR LESS) Molnlycke Health Care Us, LLC KGO Class I 2007-09-10
K071565 BIOGEL INDICATOR UNDERGLOVE WITH NON-PYROGENIC STATEMENT Molnlycke Health Care Us, LLC KGO Class I 2007-09-10
K071976 VECTEC DISPOSABLE TROCARS AND LAPAROSCOPIC ACCESSORIES Vectec GEI Class II 2007-09-06
K072177 ENSEAL VESSEL SEALING AND HEMOSTASIS SYSTEM Surgrx, Inc. GEI Class II 2007-09-05
K071016 DEPUY RESTORE ORTHOBIOLOGIC SOFT TISSUE IMPLANT DePuy Orthopaedics, Inc. FTM Class II 2007-09-04
K071080 ELECTROSURGICAL INFANT PATIENT RETURN ELECTRODE, DUAL PLATE WITH CORD, MODEL EP 211M E Surgical, LLC GEI Class II 2007-08-31
K071328 VISUALASE THERMAL THERAPY SYSTEM Biotex, Inc. GEX Class II 2007-08-31
K071470 IMPLANTECH EPTFE SHEETING, MODEL EPTFE-XXX Implantech Associates, Inc. FTL Class II 2007-08-31
K072106 150W CERALAS D 980NM DIODE LASER Biolitec, Inc. GEX Class II 2007-08-30
K071902 AMS MINIARC SLING SYSTEM American Medical Systems, Inc. PAH Class II 2007-08-24
K071872 VELASHAPE Syneron Medical, Ltd. NUV Class II 2007-08-22
K070918 4DDOME Cousin Biotech FTL Class II 2007-08-22
K070185 TANDA SKINCARE SYSTEM, PLC-001, TANDA BLUE, 414-001, TANDA RED, 660-001 Pharos Life Corporation GEX Class II 2007-08-21
K072089 ARTHROCARE SPINEWAND Arthrocare Corp. GEI Class II 2007-08-17
K063671 REBOUND HRD Minnesota Medical Development, Inc. FTL Class II 2007-08-16
K070023 MICROSURGEON MICROWAVE TISSUE ABLATION DEVICE, MODEL MTAD-100 Microsurgeon, Inc. NEY Class II 2007-08-15
K071469 INOLASE SERENITY PSF ( PNEUMATIC SKIN FLATTENING) SYSTEM Candela Corp. GEX Class II 2007-08-15
K071943 SERENITY PRO PSF SYSTEM Inolase 2002, Ltd. GEX Class II 2007-08-10
K071963 MODIFICATION TO: ARTHROCARE ARTHROWANDS Arthrocare Corp. GEI Class II 2007-08-07
K071775 DASH Ezsurgical GAD Class I 2007-08-07
K071709 ARTHROCARE SYSTEM 12000 Arthrocare Corp. GEI Class II 2007-08-07
K071807 ORTHOMEND SOFT TISSUE MATRIX Tei Biosciences, Inc. FTM Class II 2007-08-06
K071989 QUILL SELF-RETAINING SYSTEM (SRS) SYNTHETIC ABSORBABLE SURGICAL SUTURE MATERIAL Surgical Specialties Corp NEW Class II 2007-08-06
K072028 QUILL SELF-RETAINING SYSTEM (SRS) COMPRISED OF MONODERM Surgical Specialties Corp GAM Class II 2007-08-03
K071959 ANGIODYNAMICS, INC.NEVERTOUCH 600UM FIBER AND VENACURE PROCEDURE KIT AngioDynamics, Inc. GEX Class II 2007-08-01
K071451 TATTOOSTAR Y Asclepion Laser Technologies GmbH GEX Class II 2007-08-01
K070625 PELVIMESH / HERMESH 7 Marketing Solutions, Inc. FTL Class II 2007-08-01
K070406 ENDODRAPE Vortek Surgical, LLC KKX Class II 2007-07-30
K063757 MOTEX POWDER-FREE SURGICAL GLOVES AND LIGHTLY POWDERED SURGICAL GLOVES Shanghai Motex Healthcare Co., Ltd. KGO Class I 2007-07-27
K070092 MODIFICATION TO VELASMOOTH, SHAPER Syneron Medical, Ltd. NUV Class II 2007-07-27
K071819 NCONTACT VISITRAX GUIDED COAGULATION SYSTEM KIT, MODELS CSK-212 AND CSK-515 Ncontact Surgical, Inc. OCL Class II 2007-07-26
K071786 PORTRAIT PSR Rhytec Incorporated GEI Class II 2007-07-26
K063427 LUMINA INTENSE PULSED LIGHT (& LASER) SYSTEM Lynton Lasers Limited GEX Class II 2007-07-25
K061934 XTAC Osteogenics, Inc. FTL Class II 2007-07-17
K071111 NON-ABSORBABLE SILK SUTURE Arrow Intl., Inc. GAP Class II 2007-07-17
K070392 MOSAIC LASER SYSTEM Lutronic Corporation GEX Class II 2007-07-13
K071728 MODIFICATION TO: ENSEAL PTC TISSUE SEALING DEVICE Surgrx, Inc. GEI Class II 2007-07-13
K070805 ULTRAWAVE II EX 1320 Quanta System Spa GEX Class II 2007-07-11
K070253 AXYA SUTURE WELDING SYSTEM AND KIT Axya Medical, Inc. GAT Class II 2007-07-11
K063154 FACIAL RECONSTRUCTIVE MESH (FRM) Evera Medical, Inc. FTL Class II 2007-07-10
K071629 PARIETEX POLYESTER MESH WITH INTRODUCER Sofradim Production FTL Class II 2007-07-10
K071698 AURORA LED SERIES SURGICAL LIGHTS Skytron, Div. the Kmw Group, Inc. FSY Class II 2007-07-06
K043579 ATRICURE BIPOLAR SYSTEM AtriCure, Inc. OCL Class II 2007-07-05
K071622 ARTHREX FIBERWIRE Arthrex, Inc. GAT Class II 2007-07-03
K070298 MODIFICATION TO PALOMAR LUXIR HANDPIECE Palomar Medical Technologies, Inc. GEX Class II 2007-07-03
K070846 MINISLING ADJUSTABLE POLYMER SLING & SURGICAL MESH WITH SELF-ANCHORING SYSTEM Prosurg, Inc. FTL Class II 2007-07-02
K071543 HALO360' COAGULATION CATHETER Barrx Medical, Incorporated GEI Class II 2007-06-29
K070426 SILHOUETTE, MODEL 1000.01 Aranz Medical Limited FXN Class I 2007-06-29
K071103 HABIB HEXABLATE Emcision , Ltd. GEI Class II 2007-06-27
K070619 POWDER FREE POLYMER COATED BROWN LATEX SURGICAL GLOVES, STERILE, COATED WITH ALOE VERA AND WITH PROTEIN CONTENT LABELING Wrp Asia Pacific Sdn. Bhd. KGO Class I 2007-06-27

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