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
2003-10-22

Clearances · page 74 of 164

K-Number Trade Name Applicant / Manufacturer Product Code Class Decision Date
K023139 ROMED LATEX SURGICAL GLOVES, POWDERED, STERILE Van Oostveen Medical B.V. KGO Class I 2003-10-22
K032565 CYNOSURE PHOTOGENICA VL Cynosure, Inc. GEX Class II 2003-10-22
K032501 MAXTER STERILE POWDER FREE SURGICAL GLOVES Maxter Glove Manufacturing Sdn Bhd KGO Class I 2003-10-17
K033179 MEDELA CLARIO HOME CARE PUMP Medela AG BTA Class II 2003-10-15
K032223 COOK VASCULAR PERFECTA ELECTROSURGICAL DISSECTION SYSTEM ERGONOMIC INTERMITTENT ACTIVATION SWITCH Cook Vascular, Inc. GEI Class II 2003-10-15
K031408 DEROYAL POLY-REINFORCED SURGICAL GOWNS (STERILE, NON-STERILE) Deroyal FYA Class II 2003-10-15
K031301 ESTEEM STERILE POLYISOPRENE SURGICAL GLOVES WITH COATING Cardinalhealth KGO Class I 2003-10-15
K032310 MINI V.A.C., V.A.C. FREEDOM, V.A.C. ATS Kinetic Concepts, Inc. OMP Class II 2003-10-10
K030539 LASERSMILE Biolase Technology, Inc. GEX Class II 2003-10-10
K032467 MAXTER STERILE POWDERED LATEX SURGICAL GLOVES Maxter Glove Manufacturing Sdn Bhd KGO Class I 2003-10-10
K032357 NOVUS TTX LASER AND DELIVERY DEVICES WITH ACCESSORIES Lumenis, Inc. GEX Class II 2003-10-09
K031125 CYNOSURE SMART FILE ND:YAG LASERS Cynosure, Inc. GEX Class II 2003-10-09
K031564 CSS Medical Scientific, Inc. GEI Class II 2003-10-07
K032180 NUVASIVE CEMENT RESTRICTOR Nuvasive, Inc. JDK Class II 2003-10-07
K032721 MODIFICATION TO: STELLARTECH COAGULATION SYSTEM (MODELS 1100C-115 & 1100C-230) Stellartech Research Corp. GEI Class II 2003-10-06
K032702 VIVATIP MICROWAVE ABLATION PROBE Vivant Medical, Inc. GEI Class II 2003-10-03
K032085 GREEN LASER PHOTOCOAGULATOR MODEL GYC-1000 Nidek, Inc. GEX Class II 2003-10-03
K032344 THE HEDROCEL TRABECULAR METAL RECONSTRUCTION SYSTEM MODEL 10-330 Implex Corp. EZX Class II 2003-10-02
K032673 IMMIX PLASTIFILM Osteobiologics, Inc. FTL Class II 2003-10-02
K031389 CYNOSURE SMART 2940D ER:YAG LASER Cynosure, Inc. GEX Class II 2003-10-01
K032023 W.O.M. LASER U100PLUS W.O.M. World of Medicine AG GEX Class II 2003-10-01
K031440 SMART CO2 (SMART US 20D, SMART CLINIC) SURGICAL LASER Cynosure, Inc. GEX Class II 2003-10-01
K032805 MODIFICATION TO VASCULAR SOLUTIONS VARI-LASE ENDOVENOUS LASER PROCEDURE KIT Vascular Solutions, Inc. GEX Class II 2003-10-01
K032701 SURGASSIST CIRCULAR STAPLER DIGITAL LOADING UNITS (CS21, CS25, CS29, CS33) Power Medical Interventions, Inc. GDW Class II 2003-09-30
K031225 TIMESH ALSO KNOWN AS TIMESH-TC, MODELS 6000001 & 6000004 Gfe Medizintechnik GmbH FTL Class II 2003-09-29
K031960 INTRALASE FS LASER Intra Lase Corp. GEX Class II 2003-09-29
K032838 CELON ENT SYSTEM Celon AG Medical Instruments GEI Class II 2003-09-26
K031669 STERILE POWDER FREE SYNTHETIC SURGICAL GLOVE WITH POLYMER COATING P.T. Saptindo Surgica KGO Class I 2003-09-23
K031670 STERILE POWDER FREE LATEX SURGICAL GLOVE WITH POLYMER COATING P.T. Saptindo Surgica KGO Class I 2003-09-23
K032242 PERSONNA PLUS SAFETY SCALPEL SYSTEM Omi Manufacturing Pty., Ltd. GES Class I 2003-09-23
K032468 SUTURTEK FASTCLOSE STERNUM CLOSURE DEVICE Suturtek Incorporated GAQ Class II 2003-09-23
K031531 S&T MICROSURGICAL SUTURE S & T AG GAR Class II 2003-09-23
K031955 MACROPORE SURGI-WRAP MAST BIORESORBABLE SHEET Macropore Biosurgery, Inc. FTL Class II 2003-09-22
K031889 ALEXIS WOUND RETRACTOR Applied Medical Resources Corp. KKX Class II 2003-09-22
K032065 MEDLINE BAND BAGS AND EQUIPMENT COVERS Medline Industries, Inc. MMP Class II 2003-09-22
K032584 RUBICOR ENCAPSULE BREAST BIOPSY DEVICE, MODEL 30629 Rubicor Medical, Inc. GEI Class II 2003-09-17
K031925 PROCEED TRILAMINATE SURGICAL MESH ETHICON, Inc. FTL Class II 2003-09-17
K031933 MEDLINE REUSABLE SURGICAL GOWNS (100X) Medline Industries, Inc. FYA Class II 2003-09-16
K030846 CANDELA SMOOTHBEAM LASER SYSTEM Candela Corp. GEX Class II 2003-09-16
K031951 TRANSDISCAL SYSTEM (TRANSDISCAL PROBE), MODEL TDP-17-150-6 Baylis Medical Co., Inc. GEI Class II 2003-09-11
K031287 STERI-DRAPE SURGICAL DRAPES 3M Company KKX Class II 2003-09-10
K031800 SOLARC/SOLRX 500 SERIES ULTRAVIOLET PHOTOTHERAPY LAMP UNIT FAMILY A NEW MEDICAL DEVICE FAMILY CONSISTING OF 5 MODELS: Solarc Systems, Inc. FTC Class II 2003-09-10
K032271 WARTNER WART REMOVAL SYSTEM, MODEL 66715 82000 (PRODUCT CODE NUMBER 52E022) Wartner USA B.V. GEH Class II 2003-09-10
K032149 RITA MODEL 1500X ELECTROSURGICAL RF GENERATOR Rita Medical Systems, Inc. GEI Class II 2003-09-09
K032238 TWISTER SUPERELASTIC LIGATING CLIP AND APPLIER Neurosel (Medical) Limited FZP Class II 2003-09-09
K031805 BLU-U, MODEL 4170 Dusa Pharmaceuticals, Inc. GEX Class II 2003-09-09
K031938 GEL MARK III BIOPSY SITE MARKER Senorx, Inc. NEU Class II 2003-09-05
K031697 DR. SCHOLL'S FREEZE AWAY WART REMOVER, MODEL 40226 Schering-Plough Healthcare Products, Inc. GEH Class II 2003-08-29
K031318 TRAXIS CEMENT RESTRICTOR Spinal Concepts, Inc. JDK Class II 2003-08-22
K032464 ALOETOUCH POWDER FREE LATEX SURGICAL GLOVES, STERILE, COATED WITH ALOE VERA AND WITH PROTEIN CONTENT LABELING CLAIM (50 Wrp Asia Pacific Sdn. Bhd. KGO Class I 2003-08-22
K031954 COOLTOUCH INCORPORATED MODELCT3 ND:YAG SURGICAL LASER SYSTEMS New Star Lasers, Inc. GEX Class II 2003-08-21
K032301 NEOGEN ONE, CLOSED WOUND DRAIN SYSTEM, PART NUMBER: NG9900 Neogen Technologies, Inc. OMP Class II 2003-08-21
K032347 BIOMARC TISSUE MARKER Carbon Medical Technologies, Inc. GDW Class II 2003-08-21
K032282 MODIFICATION TO HEDROCEL TRABECULAR METAL RECONSTRUCTION SYSTEM Implex Corp. EZX Class II 2003-08-21
K032217 14G CORMARK BIOPSY SITE IDENTIFIER Artemis Medical, Inc. FZP Class II 2003-08-21
K032452 MODIFICATION TO: STELLARTECH COAGULATION SYSTEM, MODELS 1100C-115 & 100C-230 Stellartech Research Corp. GEI Class II 2003-08-21
K032504 ARTHROCARE SYSTEM Arthrocare Corp. GEI Class II 2003-08-21
K032207 COBRA COOLED SURGICAL PROBE, MODEL M004159670 Boston Scientific Corp GEI Class II 2003-08-20
K032191 OMNILIGHT FLUORESCENT PULSED LIGHT SYSTEM Luxsano AB GEX Class II 2003-08-20
K032204 MODIFICATION TO VASCULAR SOLUTIONS VARI-LASE ENDOVENOUS LASER PROCEDURE KIT Vascular Solutions, Inc. GEX Class II 2003-08-20
K032132 TISSUELINK FLOATING BALL MODEL 23-201-1 Tissuelink Medical, Inc. GEI Class II 2003-08-20
K031489 PITANGA Syneron Medical, Ltd. GEX Class II 2003-08-19
K032168 GORE-TEX DUALMESH EMERGE PLUS BIOMATERIAL W. L. Gore & Associates, Inc. FTL Class II 2003-08-15
K032333 CRYOCARE CS SURGICAL SYSTEM Endocare, Inc. GEH Class II 2003-08-12
K031068 STRYKER VISUM SURGICAL LIGHTING SYSTEM Stryker Endoscopy FSY Class II 2003-08-12
K030908 DEROYAL SURGICAL DRAPES BACKTABLE COVER Deroyal KKX Class II 2003-08-11
K032095 INTERPORE CROSS CEMENT RESTRICTOR Interpore Cross Intl. JDK Class II 2003-08-08
K032047 TRI-LOOP MICROWAVE ABLATION PROBE Vivant Medical, Inc. GEI Class II 2003-08-06
K031641 VASCULAR ARCHITECTS ASPIRE COVERED STENT AND 718 DELIVERY SYSTEM Vascular Architects, Inc. JCT Class II 2003-08-01
K031988 AURORA DS Syneron Medical, Ltd. GEX Class II 2003-08-01
K032088 MODIFICATION TO THERMACOOL TC SYSTEM Thermage, Inc. GEI Class II 2003-08-01
K031993 AURORA SR Syneron Medical, Ltd. GEX Class II 2003-08-01
K031451 XTRACXL PLUS EXCIMER LASER SYSTEM, MODEL AL7000 Photo Medex, Inc. GEX Class II 2003-08-01
K032062 STELLARTECH COAGULATION SYSTEM, MODELS (1100C-115 & 1100C-230) Stellartech Research Corp. GEI Class II 2003-07-29
K031881 AIRBRUSH LIPOSCULPTOR SYSTEM Biosculpture Technology, Inc. QPB Class II 2003-07-28
K031969 DEPUY RESTORE ORTHOBIOLOGIC SOFT TISSUE IMPLANT DePuy Orthopaedics, Inc. FTM Class II 2003-07-28
K031979 CONMED INTEGRATED SYSTEMS NURSES ASSISTANT Conmed Integrated Systems (Cmis) FSY Class II 2003-07-25
K031837 MODIFICATION TO FORTITUDE CEMENT RESTRICTOR Spinal Concepts, Inc. JDK Class II 2003-07-24
K030239 MEGATECH SCIENTIFIC FACE MASK Megatech Scientific Pte, Ltd. FXX Class II 2003-07-24
K031173 NEEDLETECH GUIDEWIRE INTRODUCER NEEDLE, MODELS 40021, 40069, 40053, 40042 & 40013 Needle Tech Products, Inc. GDF Class I 2003-07-23
K031846 CARDIOVATIONS OPTICAL BIPOLAR DEVICE ETHICON, Inc. GEI Class II 2003-07-21
K031085 GYRUS PLASMAKINETIC SUPERPULSE SYSTEM (GENERATOR, ACCESSORIES) Gyrus Medical, Inc. GEI Class II 2003-07-21
K030177 ORLON NONABSORABLE SURGICAL SUTURE USP Sri Orion Pharmaceuticals & Sutures GAR Class II 2003-07-21
K030033 LUMENIS FAMILY OF DISPOSABLE CONTACT TIP DELIVERY DEVICES Lumenis, Ltd. GEX Class II 2003-07-21
K030926 FAST THROW STAINLESS STEEL SURGICAL SUTURE Advanced Surgical Products, Inc. FZP Class II 2003-07-21
K030158 UNIT, CAUTERY, TEHRMAL,BATTERY-POWERED Walsh Medical Devices, Inc. GEI Class II 2003-07-17
K031926 RITA MODEL 1500X ELECTROSURGICAL RF GENERATOR AND ACCESSORIES (E.G., RITA THERMO PAD AND CABLE ADAPTER) Rita Medical Systems, Inc. GEI Class II 2003-07-17
K030342 LUMENIS FAMILY OF IPL SYSTEMS AND COMBINATION IPL/ND:YAG SYSTEMS Lumenis, Ltd. GEX Class II 2003-07-17
K031950 BAYLIS PAIN MANAGEMENT GENERATOR, MODELS PMG-115-TD AND PMG-230-TD Baylis Medical Co., Inc. GEI Class II 2003-07-17
K031828 NATURALASE LP ND:YAG LASER Focus Medical, LLC GEN Class I 2003-07-17
K030426 OMNILUX RED Photo Therapeutics Limited GEX Class II 2003-07-17
K031216 MONOPLUS POLY-P-DIOXANONE MONOFILAMENT ABSORBABLE SURGICAL SUTURE Aesculap NEW Class II 2003-07-17
K031767 MENTOR OBTAPE TRANS-OBTURATOR TAPE Mentor Corp. OTN Class II 2003-07-17
K031247 CARDIOBLATE BIPOLAR RADIOFREQUENCY SURGICAL ABLATION SYSTEM Medtronic Vascular GEI Class II 2003-07-17
K030769 ULTRAFLEX PRECISION COLONIC STENT Boston Scientific Corp MQR Class II 2003-07-14
K031258 CYNOSURE PHOTOLIGHT PL Cynosure, Inc. GEX Class II 2003-07-08
K031690 CYNOSURE YAG FAMILY LASER (PHOTOGENICA YAG AND ACCLAIM) Cynosure, Inc. GEX Class II 2003-07-08
K024204 FOTONA FIDELIS PLUS ND:YAG LASER SYSTEM Fotona D.D. GEX Class II 2003-07-07
K031623 MODIFICATION TO COALESCENT SURGICAL U-CLIP AND ACCESSORIES Coalescent Surgical FZP Class II 2003-07-03
K031133 SURGRX ENSEAL VESSEL SEALING AND HEMOSTASIS SYSTEM INCLUDING THE ENSEAL CONTROLLER ADAPTER, ENSEAL OPEN AND LAPAROSCOPIS Surgrx, Inc. GEI Class II 2003-07-03

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