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
2003-07-01

Clearances · page 75 of 164

K-Number Trade Name Applicant / Manufacturer Product Code Class Decision Date
K024169 MACROPORE OS RECONSTRUCTION Macropore Biosurgery, Inc. EZX Class II 2003-07-01
K030559 RUSCH POLYFLEX STENT FOR THE ESOPHAGUS W/INTRODUCER/DELIVERY SYSTEM Rusch Intl. ESW Class II 2003-06-30
K031188 ORTHOMEND Tei Biosciences, Inc. FTL Class II 2003-06-27
K031130 YA MEI FIRST AID KIT Ya Mei Technology Co., Ltd. KGO Class I 2003-06-27
K030838 WARTNER PRO Wartner Medical Products GEH Class II 2003-06-27
K031680 SPECTRAPULSE Primary Technology, LLC GEX Class II 2003-06-24
K024259 PULSED LIGHT THERAPY SYSTEM, MODEL# UV-300 New Star Lasers, Inc. GEX Class II 2003-06-20
K031675 SMITH & NEPHEW DYONICS ELECTROBLADE RESECTOR Smith & Nephew, Inc. GEI Class II 2003-06-20
K024189 NLITE SYSTEM, MODEL#: A00-1025/A00-1033 Icn Photonics , Ltd. GEX Class II 2003-06-20
K031353 SOLUTION FACE MASKS A Plus International, Inc. FXX Class II 2003-06-19
K031041 FLUENCY TRACHEOBRONCHIAL STENT GRAFT Bard Peripheral Vascular JCT Class II 2003-06-19
K030897 SKINSTATION Radiancy (Israel) , Ltd. GEX Class II 2003-06-19
K024093 MODIFIED LUMENIS FAMILY OF INTENSE PULSED-LIGHT (IPL) AND COMBINATION IPL SYSTEMS AND ND:YAG LASER SYSTEMS Lumenis, Ltd. GEX Class II 2003-06-19
K023898 GYNE IDEAS MINITAPE RP DEVICE Gyne Ideas , Ltd. PAH Class II 2003-06-18
K030654 VASCULAR SOLUTIONS VARI-LASE ENDOVENOUS LASER PROCEDURE KIT Vascular Solutions, Inc. GEX Class II 2003-06-18
K030883 OMNILUX BLUE Photo Therapeutics Limited GEX Class II 2003-06-18
K024057 CURAD SCAR THERAPY Beiersdorf, Inc. MDA Class I 2003-06-18
K031233 ANDIODYNAMICS, INC. ELVS PROCEDURE KIT AngioDynamics, Inc. GEX Class II 2003-06-18
K023030 DEMETECH POLYESTER NONABSORBABLE SUTURE Demetech Corp. GAT Class II 2003-06-18
K023028 DEMETECH NYLON NONABSORBABLE SUTURE Demetech Corp. GAR Class II 2003-06-18
K031443 LSI SOLUTIONS SUTURE QUICK LOAD PRODUCTS Lsi Solutions NEW Class II 2003-06-18
K023881 PROFILE 1064 LASER SYSTEM Sciton, Inc GEX Class II 2003-06-13
K030608 OTI BONE CEMENT PLUG Osteoimplant Technology, Inc. JDK Class II 2003-06-12
K031131 KLINIDRAPE SURGICAL DRAPES Molnlycke Health Care KKX Class II 2003-06-10
K023755 WINNER EAR LOOP PROCEDURE MASK, TIE-ON SURGICAL MASK & EAR LOOP PROCEDURE MASK WITH SHIELD Winner Industries (Shenzhen) Co., Ltd. FXX Class II 2003-06-10
K030444 PRE-POWDERED LATEX ORTHOPEDIC SURGEON'S GLOVES Primus Gloves Private , Ltd. KGO Class I 2003-06-05
K030445 POWDER FREE LATEX MICROSURGERY GLOVES WITH BROWN COLOR AND PROTEIN LABELING CLAIM OF 50 MICROGRAMS OR LESS PROTEIN GRAM Primus Gloves Private , Ltd. KGO Class I 2003-06-05
K031488 CYNOSURE APOGEE-TKS II DERMATOLOGICAL LASER Cynosure, Inc. GEX Class II 2003-06-04
K030700 CERALAS D 10-60 810NM LASER SYSTEM WITH ENDO LASER VEIN SYSTEM KIT Biolitec, Inc. GEX Class II 2003-06-04
K030720 ULTRABLATOR ELECTRODE Linvatec Corp. GEI Class II 2003-06-03
K031362 LAC-MAC LIMITED INNERBLOC VARIOUS O.R. DRAPE BASED ON THE REPEL, PLUS AND GORE SURGICAL BARRIER FABRIC MATERIALS Lac Mac, Ltd. KKX Class II 2003-05-30
K030996 MSI SA ELECTRODES Medsphere International, Inc. GEI Class II 2003-05-30
K031011 LIGASURE 5MM LAPAROSCOPIC SEALER-DIVIDER, MODEL LS1500 Valleylab, Inc. GEI Class II 2003-05-29
K031286 SAFIL AND SAFIL QUICK SYNTHETIC ABSORBABLE SURGICAL SUTURE Aesculap, Inc. GAM Class II 2003-05-29
K031117 SEEDNET SYSTEM AND SEEDNETGOLD SYSTEM Galil Medical , Ltd. GEH Class II 2003-05-23
K031371 SAPHYRE BIPOLAR ABLATION PROBES Smith & Nephew, Inc. GEI Class II 2003-05-23
K023566 CODMAN ISOCOOL BIPOLAR FORCEPS Codman & Shurtleff, Inc. GEI Class II 2003-05-22
K031046 THERMACOOL TC SYSTEM Thermage, Inc. GEI Class II 2003-05-22
K031317 SMART 2940 D ER: YAG LASER Cynosure, Inc. GEX Class II 2003-05-22
K031184 COOL TOUCH 3 New Star Lasers, Inc. GEX Class II 2003-05-21
K030805 MYTHOS 500 Msq (M2) , Ltd. GEX Class II 2003-05-21
K031081 EVEREST LP BIPOLAR SCISSORS AND GYRUS LP BIPOLAR SCISSORS Gyrus Medical, Inc. GEI Class II 2003-05-21
K031082 EVEREST BIPOLAR L HOOK & PK BIPOLAR L HOOK Gyrus Medical, Inc. GEI Class II 2003-05-21
K031079 EVEREST BIPOLAR NEEDLE ELECTRODE & GYRUS BIPOLAR NEEDLE ELECTRODE Gyrus Medical, Inc. GEI Class II 2003-05-21
K030508 DEPILASE TRIO LASE LASER SYSTEM Depilase Group , Ltd. GEX Class II 2003-05-20
K030527 LUMENIS FAMILY OF IPL AND COMBINATION IPL/ND:YAG SYSTEMS Lumenis GEX Class II 2003-05-20
K031285 MEGA 2000 SOFT DUAL CORD PATIENT RETURN ELECTRODE PAD Megadyne Medical Products, Inc. GEI Class II 2003-05-19
K030631 ZIPPERE - BIOABSORBABLE/NON-ABSORBABLE POLYMER SLING & SURGICAL MESH Prosurg, Inc. FTL Class II 2003-05-19
K023908 INTERPORE CROSS CEMENT RESTRICTOR Interpore Cross Intl. JDK Class II 2003-05-16
K031080 EVEREST BIPOLAR LYONS DISSECTING FORCEPS & GYRUS BIPOLAR LYONS DISSECTING FORCEPS Gyrus Medical, Inc. GEI Class II 2003-05-16
K031078 EVEREST BIPOLAR MACRO, MICRO & MOLLY FORCEPS & GYRUS BIPOLAR MACRO, MICRO & MOLLY FORCEPS Gyrus Medical, Inc. GEI Class II 2003-05-16
K031295 BARD INNERLACE BIOURETHRAL SUPPORT SYSTEM C.R. Bard, Inc. PAG Class II 2003-05-15
K031332 BARD PELVISOFT ACELLULAR COLLAGEN BIOMESH C.R. Bard, Inc. FTM Class II 2003-05-15
K023594 TENO FIX Ortheon Medical, LLC GAQ Class II 2003-05-15
K030925 PROXIMATE HCS HEMORRHOIDAL CIRCULAR STAPLER AND ACCESSORIES, MODEL PPH01 Ethicon Endo-Surgery, Inc. GDW Class II 2003-05-15
K030947 ALVEOLUS INC., TB-STS TRACHEOBRONCHIAL STENT SYSTEM Alveolus, Inc. JCT Class II 2003-05-15
K030480 L600 HAIR REMOVAL A&M Technology GEX Class II 2003-05-14
K030510 DEPILASE TWIN YAG LASER SYSTEM Depilase Group , Ltd. GEX Class II 2003-05-14
K023733 COA-COMP/M, AUTOMATED BIPOLAR COAGULATOR Ingenjorsfirman Bjorn Bergdahl AB GEI Class II 2003-05-14
K030453 COOLTOUCH ND: YAG LASER SYSTEM New Star Lasers, Inc. GEX Class II 2003-05-12
K031224 SMARTXIDE Cynosure, Inc. GEX Class II 2003-05-09
K030506 DEPILASE YAG LASE PLUS LASER SYSTEM Depilase Group , Ltd. GEX Class II 2003-05-09
K030423 POWERLITE 600 EP SYSTEM Preswede AB GEX Class II 2003-05-09
K030786 MONO-SWIFT Cp Medical NEW Class II 2003-05-06
K030536 LAC-MAC LIMITED INNERBLOC O.R. GOWN Lac Mac, Ltd. FYA Class II 2003-05-06
K023734 ARAMIS II DERMATOLOGICAL LASER Quantel Medical GEX Class II 2003-05-06
K031257 RITA MODEL 1500X ELECTROSURGICAL RF GENERATOR Rita Medical Systems, Inc. GEI Class II 2003-05-02
K030365 DEROYAL DRAPES, STERILE, NON-STERILE Deroyal Industries, Inc. KKX Class II 2003-04-29
K030303 FREEZOR XTRA SURGICAL CARDIAC CRYOABLATION DEVICE AND CCT.2 CARDIAC CARDIAC CRYOABLATION CRYOCONSOLE Cryocath Technologies, Inc. GEH Class II 2003-04-29
K030364 DEROYAL GOWNS, STERILE, NON-STERILE Deroyal Industries, Inc. FYA Class II 2003-04-28
K030959 BARE LASER FIBER MODELS DBLF-40, DBLF-60, DBLF-60-1, DCLF-600B, DSLF-60, DBLF-100 Laser Peripherals, LLC GEX Class II 2003-04-25
K030879 VERITAS COLLAGEN MATRIX Synovis Surgical Innovations OXE Class II 2003-04-24
K030235 F1 DIODE LASER SYSTEM Opus Medical, Inc. GEX Class II 2003-04-23
K030906 AXCEL SURGICAL LIGHT Alm FSY Class II 2003-04-23
K024117 INSORB ABSORBABLE STAPLES, MODEL SP-B20 Incisive Surgical, Inc. GDW Class II 2003-04-22
K030967 RITA STARBURST SDE ELECTROSURGICAL DEVICE Rita Medical Systems GEI Class II 2003-04-21
K030782 SEAMGUARD BIOABSORBABLE STAPLE LINE REINFORCEMENT MATERIAL W. L. Gore & Associates, Inc. FTM Class II 2003-04-21
K030181 INTERNATIONAL BIOPHYSICS CORPORATION (IBC) LASER PEEL SYSTEM International Biophysics Corp. GEX Class II 2003-04-17
K030954 ARTHROCARE PERCD SPINEWAND Arthrocare Corp. GEI Class II 2003-04-16
K030147 LUMENIS FAMILY OF ULTRAPULSE SURGITOUCH CO2 SURGICAL LASERS Lumenis, Ltd. GEX Class II 2003-04-15
K023547 DIOLASE 980 D LASER SYSTEM American Dental Technologies, Inc. GEX Class II 2003-04-15
K024170 L1 SYSTEM Pelikan Technologies, Inc. FMK Class II 2003-04-14
K030186 POLRIS LV Syneron Medical, Ltd. GEX Class II 2003-04-14
K030362 SKINTACT COOL CONTACT ELECTROSURGICAL GROUNDING PLATES Leonhard Lang GmbH GEI Class II 2003-04-14
K023311 LOOP MICROWAVE ABLATION PROBE Vivant Medical, Inc. GEI Class II 2003-04-09
K030697 RADIONICS SINGLE USE GROUND PAD (DGP-HP) Radionics, Inc. GEI Class II 2003-04-04
K030890 SWITCHBLADE Snowden Pencer, Inc. GEI Class II 2003-04-04
K023288 COBRA BIPOLAR CLAMP, MODEL 15902 Boston Scientific EP Technologies GEI Class II 2003-04-02
K030721 QUICK-TAP PARACENTESIS TRAY, KIT & NEEDLE Ballard Medical Products LRO Class II 2003-03-31
K024371 CANDELA GENTLE LASE FAMILY OF LASER SYSTEM Candela Corp. GEX Class II 2003-03-31
K030653 SURGASSIST STRAIGHT LINEAR STAPLER AND STRAIGHT LINEAR 4 ROW NO KNIFE DIGITAL LOADING UNITS WITH RELOADS Power Medical Interventions, Inc. GDW Class II 2003-03-31
K030351 STAINLESS STEEL SURGICAL SUTURE, NON-ABSORBABLE Cp Medical GAQ Class II 2003-03-28
K023257 ENDOSCOPIC LASER DELIVERY SYSTEM-LASERTX Prosurg, Inc. GEX Class II 2003-03-28
K030212 MONODEK SYNTHETIC ABSORBABLE SURGICAL SUTURE Genzyme Biosurgery NEW Class II 2003-03-27
K023969 REACTIVE SKIN DECONTAMINATION LOTION Dept. of the Army MAC Class I 2003-03-25
K030567 MODIFICATION TO VASCULAR ARCHITECTS ASPIRE COVERED STENT AND CONTRILLED EXPANSION DELIVERY SYSTEM Vascular Architects, Inc. JCT Class II 2003-03-24
K024132 CHROMOPHARE X 65 Berchtold Holding GmbH FSY Class II 2003-03-21
K024260 CANDELA GENTLELASE FAMILY OF LASER SYSTEMS Candela Corp. GEX Class II 2003-03-21
K022873 POWDER-FREE RADIATION ATTENUATING NEOPRENE SURGICAL GLOVE (BLACK) International Biomedical, Inc. KGO Class I 2003-03-21
K030269 GENICON CLIP APPLIER Genicon, LC FZP Class II 2003-03-20

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