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
2009-06-10

Clearances · page 57 of 164

K-Number Trade Name Applicant / Manufacturer Product Code Class Decision Date
K090399 TRIOS SYSTEM Viora , Ltd. ONF Class II 2009-06-10
K083415 PEAK PLASMABLADE TNA TONSIL AND ADENOID TISSUE DISSECTION DEVICE Peak Surgical, Inc. GEI Class II 2009-06-05
K091323 MODIFIED INTERMEDIC DIODE LASER 980NM SYSTEM (MULTIDIODE SST 200) Intermedic Arfran, SA GEX Class II 2009-06-04
K090909 C-QUR V -PATCH MESH Atrium Medical Corp. FTL Class II 2009-06-04
K090934 PFR SLING SYSTEM, PART OF THE AMS PELVIC FLOOR REPAIR SYSTEM American Medical Systems, Inc. FTL Class II 2009-06-02
K090776 MEGAPULSE LASER SYSTEM AND FIBERS Richard Wolf Medical Instruments Corp. GEX Class II 2009-06-02
K090630 NOBEL BIOCARE ENDOSSEOUS IMPLANTS (MAXILLOFACIAL INDICATION) Nobel Biocare AB FZE Class II 2009-06-02
K083899 REVLITE Q-SWITCHED ND:YAG LASER SYSTEM Hoya Conbio, Inc. GEX Class II 2009-06-01
K090525 LOI SYSTEM Palomar Medical Products, Inc. ONG Class II 2009-06-01
K091322 CONTOUR CURVED CUTTER STAPLER AND RELOADS, MODELS: CS40B, CS40G, CR40B, CR40G Ethicon Endo-Surgery, Inc. GDW Class II 2009-06-01
K090383 SRI LEVEL II SURGICAL GOWN Sri Surgical FYA Class II 2009-05-29
K090831 TANTHERA-T35 Tanthera, Inc. LEJ Class II 2009-05-29
K090880 XYLOS POROUS SURGICAL MESH Xylos Corporation FTM Class II 2009-05-27
K091097 PROMEDICAL SURGICAL GOWN, MODELS 18-301, 18-401 AND 18-501 Promedical Products Co., Ltd. FYA Class II 2009-05-27
K091133 APLION TOPICAL CARE SYSTEM Aplion Medical,Llc NAD Class I 2009-05-20
K090094 ZELTIQ SYSTEM Zeltiq Aesthetics GEX Class II 2009-05-20
K091215 INTELLIGENT POWER UNIT, INTELLIGENT CONSOLE, INTELLIGENT DELIVERY SYSTEM, INTELLIGENT SURGICAL INSTRUMENT Power Medical Interventions, Inc. GDW Class II 2009-05-18
K083455 LIPOKIT WITH DISPOSABLE 50CC AFT SYRINGE, MODEL ZLK-100 Medi-Khan USA, Inc. MUU Class II 2009-05-18
K090066 POWDER FREE POLYMER COATED LATEX SURGICAL GLOVES, STERILE, WITH PROTEIN LABELING CLAIM OF 50 MICROGRAMS PER DM2 OF GLOVE Wear Safe (Malaysia) Sdn. Bhd. KGO Class I 2009-05-15
K083253 LOTUS II PULSED ER: YAG LASER SYSTEM Laseroptek Co., Ltd. GEX Class II 2009-05-15
K090489 ABTHERA OPEN ABDOMEN DRESSING, MODEL: M8275026 Kci USA, Inc. FTL Class II 2009-05-14
K091169 ELITE MPX LASER SYSTEM WITH CRYO C Cynosure, Inc. GEX Class II 2009-05-13
K083102 REFINE LIFT SYSTEM Alure Medical, Inc. FTL Class II 2009-05-11
K082834 ELLMAN INTERNATIONAL NON-ABLATIVE TECHNIQUE FOR SURGITRON IEC Ellman Int'L, Inc. GEI Class II 2009-05-07
K091152 VIRTUE VENTRAL URETHRAL ELEVATION SLING SYSTEM, MODEL 50020 Coloplast A/S OTM Class II 2009-05-07
K090858 PARIETEX MONOFILAMENT POLYESTER MESH Sofradim Production FTL Class II 2009-05-06
K090385 LARIAT II SUTURE DELIVERY DEVICE Sentreheart, Inc. GAT Class II 2009-05-06
K090288 ORTHADAPT PR Pegasus Biologics, Inc. FTL Class II 2009-05-05
K091139 CONMED AER DEFENSE SMOKE EVACUATOR Conmed Corporation FYD Class II 2009-05-05
K083733 LUME 2 SYSTEM, MODEL GA0005000 Lumenis, Ltd. GEX Class II 2009-05-04
K091016 COVIDIEN SPORTS SURGERY AS MENISCAL REPAIR DEVICE WITH HIGH STRENGTH SUTURE Surgical Devices, A Global Business Unit Covidien GAT Class II 2009-05-04
K091107 MODEL P8400 HEMOSTATIX THERMAL SCALPEL SYSTEM Hemostatix Medical Technologies, LLC GEI Class II 2009-05-01
K081509 MONTERIS MEDICAL AUTOLITT LASER PROBE Monteris Medical, GEX Class II 2009-05-01
K091017 CARDICA PAS-PORT PROXIMAL ANASTOMOSIS SYSTEM, MODEL FG-000001 Cardica, Inc. FZP Class II 2009-04-29
K090638 GENADYNE A4-XLR8 WOUND VACUUM SYSTEM Genadyne Biotechnologies, Inc. OMP Class II 2009-04-29
K083203 HELIOS II Q-SWITCHED ND:YAG LASER SYSTEM Laseroptek Co., Ltd. GEX Class II 2009-04-28
K090778 MTA PROTECTIVE SHEET Xylos Corporation FTM Class II 2009-04-28
K090131 DS N95 SURGICAL MASKS AND FLAT SURGICAL Shanghai Dasheng Health Products MSH Class II 2009-04-27
K082479 SKLAR SURGICAL GOWN Sklar Corp. FYA Class II 2009-04-24
K083889 FOTONA QX ND:YAG/KTP LASER SYSTEM FAMILY Fotona D.D. GEX Class II 2009-04-23
K083467 REBOUND HRDV Minnesota Medical Development, Inc. FTL Class II 2009-04-23
K091087 MODIFICATION TO V-LOC 180 ABSORBABLE WOUND CLOSURE DEVICE Surgical Devices, Tyco Healthcare Group LP GAM Class II 2009-04-22
K090070 INVUITY BRITEFIELD MCCULLOCH RETRACTOR SYSTEM Invuity, Inc. FST Class II 2009-04-22
K091011 PUREFORM EPTFE FACIAL IMPLANTS (NASAL, CHIN, MALER) Surgical Technology Laboratories, Inc ("Stl") FWP Class II 2009-04-22
K090872 MODIFICATION TO CARDICA C-PORT XA DISTAL ANASTOMOSIS SYSTEM Cardica, Inc. FZP Class II 2009-04-21
K090679 VESSELINK MICROVASCULAR ANASTOMOTIC COUPLER SYSTEM Vioptix, Inc. MVR Class II 2009-04-17
K083590 ISKRA MEDICAL GREEN IRF PRESTIGE Iskra Medical, D.O.O. GEI Class II 2009-04-17
K083848 ALMA LASERS SOPRANO XL MULTI-APPLICATION PLATFORM Alma Lasers , Ltd. GEX Class II 2009-04-14
K090618 CYNOSURE SMARTCOOL FAMILY COLD AIR DEVICE: SMARTCOOL, SMARTCOOL 6 AND CRYO C Cynosure, Inc. GEX Class II 2009-04-14
K090297 BLUESHINE GOLD SERIES Blueshine Srl GEX Class II 2009-04-14
K083519 AUTOSUTURE ENDO GIA STAPLERS WITH ENDO GIA SINGLE USE LOADING UNITS Covidien Lp, Formerly Registered AS United States GDW Class II 2009-04-10
K083215 INCISIVE FAMILY OF INPULSE ND:YAG LASERS Incisive, LLC GEX Class II 2009-04-08
K090130 ATMOS S041 WOUND Atmos, Inc. OMP Class II 2009-04-02
K090759 BIODRAIN STREAMWAY FLUID MANAGEMENT SYSTEM Biodrain Medical, Inc. JCX Class II 2009-04-01
K083307 SYNTHASOME X-REPAIR Synthasome, Inc. FTL Class II 2009-03-27
K090410 COOLTOUCH THERMAL SENSING HANDPIECE ACCESSORY New Star Lasers, Inc. GEX Class II 2009-03-27
K083266 GORE BIO-A FISTULA PLUG W. L. Gore & Associates, Inc. FTL Class II 2009-03-27
K082662 V-LOC 180 ABSORBABLE WOUND CLOSURE DEVICE Surgical Devices, Tyco Healthcare Group LP GAM Class II 2009-03-26
K083234 KIMBERLY-CLARK KC100 SURGICAL DRAPES, MODEL KC 100, KIMBERLY-CLARK KC100 SURGICAL EQUIPMENT COVERS, MODEL KC 100 Kimberly-Clark Corp. KKX Class II 2009-03-25
K082819 DERMATOLOGIC TREATMENT SYSTEM (DTS) G2 Miramar Labs, Inc. NEY Class II 2009-03-20
K090136 STERIS CMAX XLT SURGICAL TABLE STERIS Corporation FQO Class I 2009-03-20
K082039 SYNCHRO HP PLATFORM El.En Electronic Engineering Spa GEX Class II 2009-03-20
K083493 MYOSCIENCE CRYO-TOUCH Myoscience, Inc. GEH Class II 2009-03-20
K090128 TAC-TITE (TM) Core Essence Orthopaedics, Inc. GAT Class II 2009-03-19
K081424 AFFIRM CO2 AND AFFIRM CO2 HP Cynosure, Inc. GEX Class II 2009-03-19
K083823 SECURIAN TISSUE REINFORCEMENT MATRIX Xylos Corporation FTM Class II 2009-03-18
K090547 ULTRACLIP II US WING AND COIL, MODELS: 862017U, 864017U C.R. Bard, Inc. NEU Class II 2009-03-18
K083478 SMOOTHLIPO Eleme Medical, Inc. GEX Class II 2009-03-17
K090235 ELITE MPX LASER SYSTEM WITH XPL HANDPIECE Cynosure, Inc. GEX Class II 2009-03-17
K083142 PICASSO LASER SYSTEM Amd Lasers, LLC GEX Class II 2009-03-13
K083625 AERO DV TRACHEOBRONCHIAL STENT SYSTEM Alveolus, Inc. JCT Class II 2009-03-11
K090084 ELATION ENDOVENOUS LASER PROCEDURE KIT UNIVERSAL FLUID DISPENSING SYRINGE Merit Medical Systems, Inc. GEX Class II 2009-03-06
K083320 DUKAL SURGICAL DRAPE; FENESTRATED DUKAL SURGICAL DRAPE Dukal Corp. KKX Class II 2009-03-06
K090501 BIOPSY SCIENCES HYDROMARK BREAST BIOPSY SITE MARKER, MODELS 4005-02-15-T1, 4005-02-15-S1, 4005-03-15-T1, 4005-03-15-S1 Biopsy Sciences, LLC NEU Class II 2009-03-05
K083357 OPEN ABDOMEN NEGATIVE PRESSURE THERAPY SYSTEM, MODEL 370502, CANISTER, MODEL 370510 Kci USA, Inc. OMP Class II 2009-03-04
K090281 ACCUTECH FAMILY OF POWERFLEX LASER DELIVERY DEVICES Accutech Medical Technologies, Inc. GEX Class II 2009-03-04
K083471 GMD UNIVERSAL SLING, MODEL PRODUCT CODE 1010 AND 1020 Generic Medical Device, Inc. OTN Class II 2009-03-03
K082074 ATRICURE CRYO1 CRYO-ABLATION PROBE AtriCure, Inc. GEH Class II 2009-03-02
K082682 SURGISIS BIODESIGN ENTEROCUTANEOUS FISTULA PLUG Cook Biotech, Inc. FTM Class II 2009-02-27
K083900 ERBIUM FRACTIONAL HANDPIECE Palomar Medical Products, Inc. GEX Class II 2009-02-27
K090445 ATMOS C361/C451 SUCTION PUMP Atmos, Inc. BTA Class II 2009-02-27
K090097 LH-75T PHOTOTHERAPY SYSTEM Lerner Medical Devices, Inc. FTC Class II 2009-02-26
K083424 BUSSE SURGICAL DRAPE Busse Hosipital Disposables KKX Class II 2009-02-26
DEN070002 QMT NIMBUS ANTIMICROBIAL BARRIER GAUZE DRESSING Quick-Med Technologies, Inc. NYS Class II 2009-02-25
K083281 EL LIGHTWAVE SUCTION ABLATOR, MODEL EL-2000-S, LIGHTWAVE SUCTION ABLATOR, MODEL IA-2000-S, LIGHTWAVE ABLATOR, MODEL IA- Linvatec Corp. GEI Class II 2009-02-25
K083375 RENASYS GO NEGATIVE PRESSURE WOUND THERAPY Smith & Nephew, Inc. OMP Class II 2009-02-25
K081541 DERMABLATE EFFECT Asclepion Laser Technologies GmbH GEX Class II 2009-02-23
K083710 RETRACTOR LITE Thomas Surgical Instruments, Inc. FST Class II 2009-02-23
K090378 CHROMOPHARE E 668 Berchtold GmbH & Co. KG FSY Class II 2009-02-23
K083629 SMOOTHSHAPES Eleme Medical, Inc. NUV Class II 2009-02-19
K082992 AXXION LIGHT GUIDE Spinal Elements, Inc. FST Class II 2009-02-18
K090202 NUMERIS GUIDED COAGULATION SYSTEM WITH VISITRAX, MODELS CSK-121, -122, -123 AND -125 Ncontact Surgical, Inc. OCL Class II 2009-02-17
K083165 PALOMAR ASPIRE LASER PLATFORM Palomar Medical Products, Inc. GEX Class II 2009-02-13
K083500 MEDILAS D FAMILY LASERS, INCLUDING MEDILAS D LITEBEAM, LITEBEAM +, UROBEAM, MULTIBEAM, FLEXIPULSE AND MAGNAPULSE Dornier Medtech America, Inc. GEX Class II 2009-02-12
K083531 LIQUIBAND ULTIMA, MODEL LB0004 Medlogic Global , Ltd. MPN Class II 2009-02-12
K082565 MICROSURGEON MICROWAVE TISSUE ABLATION DEVICE, MODEL MTAD-200 Microsurgeon, Inc. NEY Class II 2009-02-12
K090181 WATERLASE MD Biolase Technology, Inc. GEX Class II 2009-02-11
K083737 HALO ABLATION CATHETER Barrx Medical, Incorporated GEI Class II 2009-02-10
K083006 BIOPSY SCIENCES, INC., HYDROMARK BREAST BIOPSY SITE MARKER Biopsy Sciences, LLC NEU Class II 2009-02-09
K090159 INSORB ABSORBABLE STAPLE, MODEL 1020, 1025, AND OTHER PRODUCT FAMILIES Incisive Surgical, Inc. GDW Class II 2009-02-06

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