meddevicedb.com FDA Device Reference

Review Panel

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

Cleared Devices
16,323
Product Codes (page)
34
Latest Decision
1996-11-27

Clearances · page 96 of 164

K-Number Trade Name Applicant / Manufacturer Product Code Class Decision Date
K963721 SKIN SCRUB TRAY Grand Medical Products LRO Class II 1996-11-27
K964109 MICROSURGE LAPAROSCOPIC PERMACLIP CARTRIDGE WITH IMPLANTABLE CLIP Microsurge, Inc. FZP Class II 1996-11-27
K963714 GRAND MEDICAL SUTURE REMOVAL KIT Grand Medical Products MCZ Class I 1996-11-27
K963723 LACERATION TRAY Grand Medical Products LRP Class I 1996-11-27
K963020 GLOVEL GX Kenwell International , Ltd. KGO Class I 1996-11-27
K963189 ERBE APC 300 ARGON PLASMA COAGULATOR AND ACCESSORIES - ARGON PLASMA COAGULATOR AND ACCESSORIES Erbe USA, Inc. GEI Class II 1996-11-26
K962205 STERILE AND NON-STERILE O.R. TOWELS, STERILE AND NON-STERILE X-RAY DETECTABLE O.R. TOWELS, SINGLE USE Medline Industries, Inc. KKX Class II 1996-11-26
K963389 FLEX-LASE 600 SERIES ION LASER SYSTEM American Laser Medical GEX Class II 1996-11-26
K963783 MITEK ELECTROSURGICAL SYSTEM FOR ARTHROSCOPIC USE ETHICON, Inc. GEI Class II 1996-11-25
K964011 SUCTION CATHETER TRAY PRODUCT NO. 900277 Customed, Inc. LRO Class II 1996-11-25
K955749 TEX-CARE STERILE STOCKINETTE Flynt Amtex, Inc. KKX Class II 1996-11-22
K963809 COOL-ZONE Kappler USA FYA Class II 1996-11-20
K955835 FLUID BARRIER BOOT KNEE & ANKLE-HIGH Instrument Makar, Inc. FXP Class I 1996-11-19
K963226 SURGICAL FABRICS Boston Scientific Corp FTL Class II 1996-11-15
K961334 HEARTPORT HANDSWITCH ELECTROCAUTERY PROBE Heartport, Inc. GEI Class II 1996-11-15
K964073 BME BONE DRILL BITS Biomedical Ent., Inc. GEY Class I 1996-11-14
K962913 SYNTHES STERILE DRILL BITS Synthes (Usa) HWE Class I 1996-11-14
K963241 ULTRAFLEX Boston Scientific Corp JCT Class II 1996-11-14
K963682 GENIE' SINGLE CEILING AND DOUBLE CEILING Burton Medical Products Corp. FSY Class II 1996-11-13
K963193 ACCU-BEAM LASER BLOCK 301513BG385/BEAM SPLITTERS 301513BG39 Transamerican Technologies Intl. GEX Class II 1996-11-13
K962593 ELECTROSURGICAL PROBES & DEVICES Ximed/Prosure/Injectx GEI Class II 1996-11-12
K963124 PC LASER WITH SMART PLUG (PC EDO & DENTAL 200) Fisma, Inc. GEX Class II 1996-11-08
K962068 LIGHTSTIC MODEL 180 Rare Earth Medical, Inc. GEX Class II 1996-11-08
K963229 SHARPLAN MODELS 20C, 30C, AND 40C CO2 LASERS Sharplan Lasers, Inc. GEX Class II 1996-11-05
K963901 ELECTROSURGICAL PROBE Smith & Nephew Endoscopy, Inc. GEI Class II 1996-11-04
K962690 E2590 - B, ARGON ACCESSORY WITH BLADE ELECTRODE AND E2590 - N, ARGON ACCESSORY WITH NEEDLE ELECTRODE Valleylab, Inc. GEI Class II 1996-11-04
K961710 AOC MEDICAL SYSTEM MODEL PHASE II 25 SURGICAL DIODE LASER SYSTEM Applied Optronics Corp. GEX Class II 1996-11-01
K961935 SHARPLAN LASERS, INC. SILKTOUCH CO2 FLASH SCANNER Sharplan Lasers, Inc. GEX Class II 1996-11-01
K961705 AOC MEDICAL SYSTEM MODEL PHASE II 50 SURGICAL DIODE LASER SYSTEM Applied Optronics Corp. GEX Class II 1996-11-01
K962993 CYNOSURE PHOTOAPPEAL CO2 SURGICAL LASERS Cynosure, Inc. GEX Class II 1996-10-31
K963218 BANTEX SURGICAL LATEX GLOVES- TYPE 1 NATURAL RUBBER LATEX SURGICSL GLOVES, STERILE American Bantex Corp. KGO Class I 1996-10-30
K962724 STERILE LATEX SURGICAL, SOLD UNDER BRAND NAMES SAVACARE AND ROGUMED Sonnheim Medikal GmbH KGO Class I 1996-10-29
K961341 CONVERTORS POLYOLEFIN FABRIC GOWNS Baxter Healthcare Corp FYA Class II 1996-10-28
K962948 CERALAS G ND;YAG LASER SYSTEM (CERALAS G) Ceram Optec, Inc. GEX Class II 1996-10-25
K963619 GORE-TEX SOFT TISSUE PATCH,MYCROMESHA BIOMATERIAL,DUALMESH BIOMATERIAL,DUALMESH BIOMATERIAL WITH HOLES W. L. Gore & Associates, Inc. FTL Class II 1996-10-25
K963772 SOMNUS MODEL 225 ELECTRO SURGICAL GENERATOR (MODEL 225) Somnus Medical Technologies, Inc. GEI Class II 1996-10-23
K963234 STAPLE REMOVAL KIT Continental Medical Laboratories, Inc. GDT Class I 1996-10-21
K963338 UNIMED SUCTION-IRRIGATION ELECTRODE AND SLIDING SHEATH Unimed Surgical Products, Inc. GEI Class II 1996-10-21
K963443 PROD. NO. 02-031 - LACERATION TRAY Continental Medical Laboratories, Inc. LRO Class II 1996-10-17
K963141 KUGEL HERNIA PATCH Douglas Bueschel FTL Class II 1996-10-11
K963180 VIDAMED RF GENERATOR DATA RECORDER Vidamed, Inc. GEI Class II 1996-10-10
K963253 SYNTHETIC ABSORBABLE SURGICAL SUTURE United States Surgical, A Division of Tyco Healthc GAM Class II 1996-10-08
K961647 DEROYAL INDUSTRIES, INC. ELECTROSURGICAL CAUTERY PENCIL Deroyal Industries, Inc. GEI Class II 1996-10-08
K963499 MIRROR FINISH BIPOLAR FORCEPS Johnson & Johnson Professionals, Inc. GEI Class II 1996-10-08
K963123 ARTHROCARE ARTHROSCOPIC ELETROSURGERY SYSTEM (MODEL 980) Arthrocare Corp. GEI Class II 1996-10-08
K960918 VIDAMED TUNA (TRANSURETHRAL NEEDLE ABLATION) SYSTEM Vidamed, Inc. GEI Class II 1996-10-08
K962286 2505 FACE MASK, TIE STRING / ANTI-FOG / FACE SHIELD Berkley Medical Resources, Inc. FXX Class II 1996-10-07
K963015 SURGICAL STAPLE MARKER DEVICE (MODIFY) Biopsys Medical, Inc. GDW Class II 1996-10-07
K962824 IMPLANTECH JEJ PERI-PYRIFORM IMPLANT Implantech Associates, Inc. FZE Class II 1996-10-03
K962837 NULIFE Med-Tech Rubber & Engineering Industries KGO Class I 1996-10-02
K961771 AUTO SUTURE SURGIWAND United States Surgical, A Division of Tyco Healthc GEI Class II 1996-09-25
K962043 AUTO SUTURE MODIFIED VCS CLIP APPLIER United States Surgical, A Division of Tyco Healthc FZP Class II 1996-09-23
K962592 OPHTHALAS 532 SOLID STATE PHOTOCOAGULATOR, OR EQUIVALENT LASER SYSTEMS Alcon Laboratories GEX Class II 1996-09-23
K963175 GLYCAR TISSUE REPAIR PATCH, BIO-PATCH, URO-SLING Glycar, Inc. FTM Class II 1996-09-23
K963006 SCION SAPHENOUS VEIN HARVESTING SYSTEM Scion International, Inc. GAD Class I 1996-09-20
K962986 MAXXUS POWDER FREE ORTHOPAEDIC LATEX SURGICAL GLOVES Johnson & Johnson Medical, Inc. KGO Class I 1996-09-20
K962544 MICRO DIAMOND-POINT DISSECTION NEEDLES Dsp Worldwide JOS Class II 1996-09-20
K962692 ZOMED MODEL 30-6 MULTIELECTRODE ARRAY PROBE Zomed Intl. GEI Class II 1996-09-19
K963157 ORATEC INTERVENTIONS MODEL TAC-S MONOPOLAR CAUTERY PROBE (MODIFY) Oratec Interventions, Inc. GEI Class II 1996-09-18
K962541 REFLECTION ACETABULAR REINFORCEMENT RINGS Smith & Nephew Richards, Inc. JDJ Class II 1996-09-17
K961239 DEPUY STERILE VIEW BARRIER HOOD/GOWN WITH HYTREL Depuy, Inc. FYA Class II 1996-09-17
K962826 MEDLINE RADIOLOGY-DIAGNOSTIC KITS Medline Industries, Inc. LRO Class II 1996-09-16
K962971 POLYPROPYLENE MESH (VARIOUS SIZES) Davis & Geck, Inc. FTL Class II 1996-09-16
K963088 SHEATH, ELECTROSURGICAL PENCIL Aspen Laboratories, Inc. GEI Class II 1996-09-13
K962425 BONOPTY COAXIAL BONE BIOPSY SYSTEM WITH ECCENTRIC DRILL(10-1072,3,4) Radi Medical Systems AB GAA Class I 1996-09-11
K962800 STRYKER UNIVERSAL DRILL ATTACHMENTS & ACCESSORIES Stryker Instruments HWE Class I 1996-09-11
K961006 MEDLITE/755 ALEXANDRITE LASER SYSTEM Continuum Biomedical, Inc. GEX Class II 1996-09-11
K962313 MODIFIED LEVEEN NEEDLE ELECTRODE Radiotherapeutics Corp. JOS Class II 1996-09-11
K960772 PHOTODERM PL. Esc Medical Systems , Ltd. GEX Class II 1996-09-11
K962354 DIOMED 15, 30, 60 SURGICAL DIODE LASER Lifestream Int'L, Inc. GEX Class II 1996-09-11
K962242 SURESCAN Clinicon Corp. GEX Class II 1996-09-03
K962401 GORE-TEX DUALMESH PLUS BIOMATERIAL WITH HOLES W. L. Gore & Associates, Inc. FTL Class II 1996-09-03
K961410 DURASIL (MODIFICATION) The S. F. Group, Inc. MDA Class I 1996-09-03
K962935 UNIMED COATED NEEDLE ELECTRODE/COATED BLADE ELECTRODE/COATED BALL ELECTRODE Unimed Surgical Products, Inc. GEI Class II 1996-09-03
K962496 SOFT TISSUE AUGMENTATION TUBE (S.T.A.T.) Tissue Technologies, Inc. FTL Class II 1996-09-03
K955586 ROBISON & SMITH SURGICAL PACKS Robison & Smith, Inc. FYA Class II 1996-08-30
K962044 VALLEYLAB COATED ELECTRODES Valleylab, Inc. GEI Class II 1996-08-30
K962371 DERMTOME BLADE Dsp Worldwide GFD Class I 1996-08-29
K961699 EQUIPMENT COVERS United States Surgical, A Division of Tyco Healthc MMP Class II 1996-08-23
K961083 OREX SURGEON'S VEST Thantex Specialties, Inc. FYA Class II 1996-08-23
K962013 MENTOR H/S SILICONE GEL SHEETING FOR SCAR MANAGEMENT Mentor Corp. MDA Class I 1996-08-22
K961843 GENIE Burton Medical Products Corp. FSY Class II 1996-08-22
K961122 STRYKER KNIFELIGHT Stryker Instruments FTD Class II 1996-08-22
K962974 SHARPLAN LASERS, INC. AF ACUSPOT MICROMANIPULATOR (713) Sharplan Lasers, Inc. GEX Class II 1996-08-21
K960636 LASERSONICS ND:YAG CYLINDRICALLY DIFFUSING STERILE DISPOSABLE FIBER Heraeus Surgical, Inc. GEX Class II 1996-08-21
K962261 IMPLANTECH WM NASAL-LABIAL IMPLANT Implantech Associates, Inc. LZK Class II 1996-08-19
K962215 CONSENSUS POSTERIOR STABILIZED KNEE-INTERCONDYLAR NOTCH ROUTER U.S. Medical Products, Inc. HWE Class I 1996-08-15
K961682 ARGON CURING LASER Premier Laser Systems, Inc. GEX Class II 1996-08-15
K962678 BIPOLAR PENCIL COAGULATOR Kirwan Surgical Products, Inc. GEI Class II 1996-08-14
K962789 SURGICAL KIT-ACUFEX MOSAICPLASTY SYSTEM Smith & Nephew Endoscopy, Inc. GEY Class I 1996-08-14
K961791 DEPUY DISPOSABLE FILTER/HOOD Depuy, Inc. LYU Class I 1996-08-09
K962328 SINGLE USE INSTRUMENT TRAY Medcare Medical Group, Inc. FSM Class I 1996-08-09
K962530 PROLENE POLYPROPYLENE MESH NONABSORBABLE SYNTHETIC SURGICAL MESH ETHICON, Inc. FTL Class II 1996-08-09
K962119 RE-NEW LAPAROSCOPIC INSTRUMENTS Microline Pentax, Inc. GEI Class II 1996-08-09
K961194 ANTIMICROBIAL MEDIASTINAL SILICONE DRAIN Sil-Med Corp. GBW Class I 1996-08-08
K961901 BONE & MARROW COLLECTION SYSTEM Biomedical Ent., Inc. GEY Class I 1996-08-06
K962022 POWERCUT GOLD SURGICAL SYSTEM Baxter Healthcare Corp HWE Class I 1996-08-05
K962480 COATED VICRYL RAPIDE (POLYGLACTIN 910) BRAIDED, SYNTHETIC ABSORBABLE SUTURE, UNDYED ETHICON, Inc. GAM Class II 1996-08-02
K962352 HYDROGEL SKIN DRESSING North American Sterilization & Packaging Co. NAE Class I 1996-08-02
K962007 PROTRUSION CAGES Depuy, Inc. JDJ Class II 1996-08-01

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