meddevicedb.com FDA Device Reference

Review Panel

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

Cleared Devices
16,323
Product Codes (page)
33
Latest Decision
1995-05-05

Clearances · page 102 of 164

K-Number Trade Name Applicant / Manufacturer Product Code Class Decision Date
K931490 SLT MULTIDIMENSIONAL CONTACT LASER SYSTEM FAMILY Surgical Laser Technologies, Inc. GEX Class II 1995-05-05
K932031 AMBU PORTABLE SUCTION UNIT Ambu, Inc. BTA Class II 1995-05-05
K950013 CONSENSUS(TM) ORTHOPEDIC DRILL BIT U.S. Medical Products, Inc. HWE Class I 1995-05-05
K951589 MANUAL SURGICAL INSRUMENT United States Surgical, A Division of Tyco Healthc GEI Class II 1995-05-03
K950830 STA-PUT NON-MAGNETIC INSTRUMENT DRAPE CATALOG #100-187-00 (16X20), 100-186-00 (16X10), 100-183-00 W/DEXTER WRAP Avail-Southwest Division KKX Class II 1995-05-03
K941802 OR TOWEL Hermitage Hospital Products, Inc. KKX Class II 1995-05-03
K944558 ELLMAN VAPOR-VAC II North American Technical Services Corp. GEX Class II 1995-04-28
K946060 REMINGTON MEDICAL DISPOSABLE FLUORO/EQUIPMENT COVER MODEL RMI8 Remington Medical, Inc. KKX Class II 1995-04-27
K945371 COMPEL 3000 SURGICAL GOWN, COMPEL 2G SURGICAL GOWNS Standard Textile Co., Inc. FYA Class II 1995-04-27
K944992 ELECTRODES Linvatec Corp. JOS Class II 1995-04-27
K951328 LMI MEDICAL, ELECTRODE, ELECTROSURGICAL, DISPOSABLE DISPERSIVE ELECTRODE WITH CORD Labeltape Meditect, Inc. GEI Class II 1995-04-25
K950468 POWDER FREE STERILE LATEX SURGEONS GLOVES Intl. Trade Management Co. KGO Class I 1995-04-25
K950504 PERVAL SURGICAL GOWN (MARKETING NAME) Standard Textile Co., Inc. FYA Class II 1995-04-25
K945223 OREX ISOLATION GOWN Thantex Specialties, Inc. FYC Class II 1995-04-25
K944053 NATURAL RUBBER LATEX SURGEONS GLOVE Arent Fox KGO Class I 1995-04-25
K943411 ACCUCURE 3000 Lasermed GEX Class II 1995-04-25
K950754 MACRO SUCTION TUBE MODEL NO 10061 Dlp, Inc. GCY Class I 1995-04-25
K951475 NAVARRE UNIVERSAL DRAINAGE CATHETER Navarre Biomedical , Ltd. GBX Class I 1995-04-24
K946107 GORE-TEX MYCROMESH PLUS BIOMATERIAL W. L. Gore & Associates, Inc. FTL Class II 1995-04-24
K951269 DISPOSABLE & REUSABLE MONOPOLAR HANDSWITHC PENCIL Boston Surgical Products, Inc. GEI Class II 1995-04-24
K946106 GORE-TEX DUALMESH PLUS BIOMATERIAL W. L. Gore & Associates, Inc. FTL Class II 1995-04-24
K945758 HI-TIP HIGH TEMPERATURE REPLACEMENT TIP Aaron Medical Industries GEI Class II 1995-04-21
K950295 WOUND CLOSURE/LACERATION TRAY Customed, Inc. LRO Class II 1995-04-18
K951215 LASERSONICS ULTRALINE III STERILE DISPOSABLE FIBER Heraeus Surgical, Inc. GEX Class II 1995-04-18
K951423 ASPIRATOR, CONTINUOUS & PROGRAMMABLE INTERMITTENT Impact Instrumentation, Inc. BTA Class II 1995-04-18
K950776 BIPOLAR SNARE Cook Urological, Inc. GAE Class I 1995-04-18
K950819 SLT SIDEFIRING REFRACTIVE FIBER (HIGH POWER DENSITY FIBER) Surgical Laser Technologies, Inc. GEX Class II 1995-04-18
K950372 ULTRACELL ORTHOPEDIC SPONGES Ultracell Medical Technologies, Inc. GDY Class I 1995-04-17
K950373 ULTRACELL ORTHOPEDIC SPONGES Ultracell Medical Technologies, Inc. GDY Class I 1995-04-17
K950370 ULTRACELL ORTHOPEDIC SPONGES Ultracell Medical Technologies, Inc. GDY Class I 1995-04-17
K950406 DEVICE, ELECTROSURGICAL, CUTTING AND COAGULATION & ACCESSORIES Aaron Medical Industries GEI Class II 1995-04-13
K950185 TACTYLON(TM) POWDER FREE SURGEONS GLOVE Tactyl Technologies, Inc. KGO Class I 1995-04-13
K950659 ULTRACELL RETRACTOR COVERS Ultracell Medical Technologies, Inc. GDY Class I 1995-04-13
K951034 AURA LASER SYSTEM Laserscope GEX Class II 1995-04-13
K950540 IMPLANTABLE CLIP United States Surgical, A Division of Tyco Healthc FZP Class II 1995-04-13
K941435 BIPOLAR U-SHAPE HANDLE, PRONGS, AND CORD New Eder Corp. GEI Class II 1995-04-11
K944763 CUT-TEC OR WELLS LAMONT POLYESTER/WIRE CUT-RESISTANT GLOVE LINER WELLS-TEC, SCEPTER Wells Lamont Corp. LYU Class I 1995-04-10
K951035 BIPOLAR FORCEPS Megadyne Medical Products, Inc. GEI Class II 1995-04-07
K950725 SHARPLAN MODEL 1015 CO2 LASER Sharplan Lasers, Inc. GEX Class II 1995-04-06
K951032 FINESS I (DERMATOLOGIC APPLICATION) Utah Medical Products, Inc. GEI Class II 1995-04-06
K951149 SINGLE USE INSTRUMENT TRAY Medcare Custom Packaging, Inc. LRO Class II 1995-04-06
K951353 HYBRID SURGICAL DEVICES, MODIFICIATION Laser Centers of America, Inc. GEI Class II 1995-04-06
K946105 ELECTROSURGICAL CUTTING & COAGULATION DEVICE & ACCESSORIES Endoscopic Technologies, Inc. GEI Class II 1995-04-06
K946197 CONSENSUS(TM) PATELLA REAMER U.S. Medical Products, Inc. HWE Class I 1995-04-05
K951066 RAINS FRONTAL SINUS STENT Smith & Nephew Richards, Inc. KAM Class I 1995-04-04
K946104 SMOKIEVAC ELECTROSURGICAL PENCIL Aspen Laboratories, Inc. GEI Class II 1995-04-03
K950192 SKYTRON SKYBOOM SERIES Skytron, Div. the Kmw Group, Inc. FQO Class I 1995-04-03
K950019 THERMOLASE LT-100 ND:YAG LASER HAIR REMOVAL SYSTEM; THERMOLASE LT-100;LT-100 Thermolase Corp. GEX Class II 1995-04-03
K951045 LASER GAS MIXTURE Liquid Carbonic Industrial Gases GEX Class II 1995-03-31
K945656 THE COUPLER/DRAPE(TM), VIDEO CAMERA STERILE DRAPE Micro-Medical Devices, Inc. KKX Class II 1995-03-28
K946377 ELECTROPROBE SINGLE USE ELECTROSURGICAL PROBES Ximed Medical Systems GEI Class II 1995-03-24
K942622 LASEAWAY Q-SWITCHED ND:YAG LASER SYSTEM Mdi, Inc. GEX Class II 1995-03-24
K950412 CURAGEL HYDROGEL WOUND DRESSING Kendall Healthcare Products Co. Div.Of Tyco Health NAE Class I 1995-03-24
K946386 CANDELA RUBY LAZE Q-SWITCHED RUBY LASER Candela Laser Corp. GEX Class II 1995-03-24
K950313 KAPLAN PENDULASER 115 - A 15W CO2 SURGICAL LASER Optomedic Medical Technologies , Ltd. GEX Class II 1995-03-24
K950351 CL-5500 (UNMODIFIED DEVICE) PRECISION CURING UNIT (PCU) (MODIFIED OPTION) Ion Laser Technology GEX Class II 1995-03-24
K945658 INTERWOVEN(TM) REUSABLE SURGICAL GOWN Baxter Healthcare Corp FYA Class II 1995-03-22
K946343 INTEC EXTENDED EYE SHIELD WITH MASK Intec Industries, Inc. FXX Class II 1995-03-22
K946267 GORE-TEX SAM FACIAL IMPLANT W. L. Gore & Associates, Inc. FWP Class II 1995-03-22
K945228 125MM HANDPIECE Plc Medical Systems, Inc. GEX Class II 1995-03-20
K950006 SURGICAL STAPLE MARKER Biopsys Medical, Inc. GDW Class II 1995-03-15
K950932 BIPOLAP HOOK ELECTRODE Berchtold Holding GmbH GEI Class II 1995-03-15
K946304 COHERENT FAMILY OF CO2 SURGICAL LASER SCANNER HANDPIECES Lumenis, Inc. GEX Class II 1995-03-15
K950007 SURGICAL INSTRUMENT GUIDE United States Surgical, A Division of Tyco Healthc GDF Class I 1995-03-15
K950953 KARL STORZ PEDIATRIC VANCAILLIE TAKE-APART BIPOLAR MICRO-FORCEPS, MANHES TAKE-APART BIPOLAR FORCEPS, VBIPOLAR COAGULATEE KARL STORZ Endoscopy-America, Inc. GEI Class II 1995-03-14
K944437 DISPOSABLE LASER SWEEP TIP Reliant Technologies, Inc. GEX Class II 1995-03-14
K950439 INSYTE SIDEHOLDED DRAINAGE CATHETER Becton Dickinson Vascular Access, Inc. GBX Class I 1995-03-14
K945062 VACPLUS Kinetic Concepts, Inc. JCX Class II 1995-03-14
K943716 LASERSONICS SURGICAL LASER SYSTEMS AND ACCESSORIES Heraeus Surgical, Inc. GEX Class II 1995-03-14
K950437 ANGIOCATH SIDEHOLDER DRAINAGE CATHETER Becton Dickinson Vascular Access, Inc. GBX Class I 1995-03-14
K950661 CANDELA 10MM CIRCULAR SPOT LASER HANDPIECE Candela Laser Corp. GEX Class II 1995-03-10
K934336 SPINALPLANE Synvasive Technology, Inc. HSZ Class I 1995-03-10
K950662 DERMASTAT, MICRONSPOT, MACROSPOT, FOCALSTAT Laserscope GEX Class II 1995-03-10
K950710 MICROQUARTZ MEDICAL SIDE-FIRING LASER FIBER Microquartz Medical, Inc. GEX Class II 1995-03-10
K943292 CANDELA SPTL VARIABLE PULSE/TUNABLE PULSED DYE LASERS Candela Laser Corp. GEX Class II 1995-03-09
K945156 SLASE 210 PLUS HOLMIUM LASER SYSTEM New Star Lasers, Inc. GEX Class II 1995-03-09
K950877 REUSABLE MONOPOLAR FORCEPS Boston Surgical Products, Inc. GEI Class II 1995-03-09
K946246 SURGI-LINK BIPOLAR MICRO FORCEPS Unimed Surgical Products, Inc. GEI Class II 1995-03-07
K945363 MEDI PLUS SURGEON'S GLOVES P.T. Saptindo Surgica KGO Class I 1995-03-07
K943254 SCIPOTEX POWDER FREE SURGICAL GLOVES (BEADED) Wembley Rubber Products (M) Sdn Bhd KGO Class I 1995-03-07
K943255 SCIPOTEX POWDER FREE SURGICAL GLOVES (UNBEADED) Wembley Rubber Products (M) Sdn Bhd KGO Class I 1995-03-07
K950507 NEZHAT-DORSEY LAPAROSCOPIC HAND INSTRUMENTS American Hydro-Surgical Instruments, Inc. GEI Class II 1995-03-06
K943638 USDL MODEL SELECT 1000 FREQUENCY DOUBLED ND:YAG LASER SYSTEM United States Dental Laser, Inc. GEX Class II 1995-03-06
K945892 SILON(R) SILICONE THERMOPLASTIC SHEETING Bio Med Sciences, Inc. MDA Class I 1995-03-03
K945494 WALLSTENT(R) TRACHEOBRONCHIAL ENDOPROSTHESIS Boston Scientific Scimed, Inc. JCT Class II 1995-03-03
K945060 HERNIA MESH INTRODUCTION SYSTEM Gerard Medical, Inc. FTL Class II 1995-03-02
K941961 605 VACU-MAX Medical Industries America, Inc. BTA Class II 1995-03-02
K944488 S & S ORTHOPEDIC WIRE DRIVER 701 S & S Orthopedic , Ltd. KIJ Class I 1995-03-02
K950449 SURGICAL BUR Transidyne General Corp. GFF Class I 1995-03-01
K945861 BERGEN 710 ESU Bergen Mfg. HAM Class II 1995-03-01
K943968 TUNNELER Denver Biomedicals, Inc. MDM Class I 1995-03-01
K945832 BRADY MEDICAL PRODUCTS TRANSCORBENT AND THINSITE TOPICAL BORDER WOUND DRESSINGS Brady Medical Products Co. NAE Class I 1995-03-01
K944827 OREX SURGEON'S GOWN Thantex Specialties, Inc. FYA Class II 1995-02-28
K945486 SPLATTER CONTROL SHIELD Taut, Inc. KKX Class II 1995-02-28
K944859 OREX SURGICAL DRAPES Thantex Specialties, Inc. KKX Class II 1995-02-28
K943201 CLEAN AIR Wallach Surgical Devices, Inc. GEX Class II 1995-02-28
K945098 OP-D-OP II Op-D-Op Visor Shields, Inc. LYU Class I 1995-02-28
K944863 COMPEL SURGICALDRAPES Standard Textile Co., Inc. KKX Class II 1995-02-28
K946015 IVALON EXTERNAL SPONGE Ivalon NAB Class I 1995-02-27
K950248 LASERSPRAY(TM) Biolase Technology, Inc. GEX Class II 1995-02-24

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