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
1996-01-18

Clearances · page 99 of 164

K-Number Trade Name Applicant / Manufacturer Product Code Class Decision Date
K955229 WRIGHT MEDICAL TECHNOLOGY SAWBLADES Wrightmedicaltechnologyinc GFA Class I 1996-01-18
K955591 MICROAIRE SMARTDRIVE SYSTEM Microaire Surgical Instruments, Inc. HWE Class I 1996-01-18
K955084 ASPACH 65,000 (MODIFICATION) The Anspach Effort, Inc. HSZ Class I 1996-01-17
K954940 MDT STERIGRIP DISPOSABLE, SOFT COVER, LIGHT HANDLE Mdt Biologic Co. FTA Class II 1996-01-17
K954834 CERALAS G FREQUENCY DOUBLED ND;YAG LASER SYSTEM Ceram Optec, Inc. GEX Class II 1996-01-17
K955501 THE TULIP MONO POLAR ROTATABLE ALLIGATOR FORCEP The Tulip Mfg. Co. GEI Class II 1996-01-17
K955006 ECLIPSE 2100 Cardiogenes GEX Class II 1996-01-17
K955502 THE TULIP MONO POLAR ROTATABLE METZ SCISSORS The Tulip Mfg. Co. GEI Class II 1996-01-17
K953879 SURGEON'S CAP American Threshold Industries, Inc. FYF Class I 1996-01-05
K953878 BOUFFANT CAP American Threshold Industries, Inc. FYF Class I 1996-01-05
K955552 EXPRESSAIRE TORUNIQUET SYSTEM Smith & Nephew Richards, Inc. KCY Class I 1996-01-05
K953258 TITANIUM HEMOSTATIC CLIP Intramed Laboratories, Inc. FZP Class II 1996-01-05
K954031 COMPU-BLEND EPILATOR R. A. Fischer Co. Corp. KCW Class I 1996-01-05
K942709 MEDIASTINAL SILICONE DRAINS Sil-Med Corp. GBW Class I 1996-01-04
K954314 ULTRAFIT LINERS Stahmer Weston Scientific LYU Class I 1995-12-28
K953358 SURGEONS GLOVE POWDER FREE American Pro Latex, Inc. KGO Class I 1995-12-28
K951910 ODYSSEY HO:YAG SURGICAL LASER SYSTEMS & ACCESSORIES Xintec Corporation GEX Class II 1995-12-27
K955439 THE REEL THING (MODIFICATION) Biomedical Devices, Inc. GBX Class I 1995-12-26
K955322 PROTEC X-RAY DETECTABLE GAUZE SPONGE Derivados DE Gasa, S.A. DE C.V. GDY Class I 1995-12-19
K954460 ILT SURGICAL LASER Ion Laser Technology GEX Class II 1995-12-18
K954931 NEO-MED DLS-1100 Neo-Laboratories, LLC GEX Class II 1995-12-18
K955109 VL2600 HANDSWITCHING PENCIL WITH HOLSTER Valleylab, Inc. GEI Class II 1995-12-18
K954439 ORATEC INTERVENTIONS MODEL TAC 1000 MONOPOLAR CAUTERY PROBE Oratec Interventions, Inc. GEI Class II 1995-12-18
K955467 NEUROVIEW COAXIAL BIPOLAR ELECTRODE Neuro Navigational Corp. GEI Class II 1995-12-18
K954965 ZOMED MODEL 20 & 30 ELECTROSURGICAL PROBES Zomed Intl. GEI Class II 1995-12-18
K954316 AURORA SURGICAL DIODE LASER SYSTEM W/ACCESSORIES Premier Laser Systems, Inc. GEX Class II 1995-12-15
K955001 EVERSHEARS SCISSORS, BILAP PROBES, BICOAG FORCEPS Everest Medical Corp. GEI Class II 1995-12-13
K950565 DEROYAL SURGICAL INSTRUMENT DRAPE Deroyal Industries, Inc. KKX Class II 1995-12-13
K954535 ELASTYREN HYPOALLERGENIC SURGICAL GLOVES Eci Medical Technologies, Inc. KGO Class I 1995-12-11
K953102 BLOODBORNE PATHOGEN KIT Certified Safety Mfg., Inc. FXX Class II 1995-12-11
K954470 SURGIMOTOR W.O.M. World of Medicine GmbH GEY Class I 1995-12-08
K955346 VFS - 300 BIPOLAR ELECTROSURGERY SYSTEM Valley Forge Scientific Corp. GEI Class II 1995-12-08
K953696 COAGULATING CANNULA DEVICE Dorsal Orthopedic Corp. GEI Class II 1995-12-08
K953637 CMS ACCUPROBE 550/530 Cryomedical Sciences, Inc. GEH Class II 1995-12-04
K951231 ORTHOPEDIC PACKS Sterile Concepts, Inc. GAN Class II 1995-12-01
K953908 DAVIS & GECK LIGATING CLIP REMOVER Davis & Geck, Inc. FZP Class II 1995-11-30
K953800 MLT 20 Medical Laser Technology, Inc. GEX Class II 1995-11-29
K950826 AM RUBY American Lasers, Inc. GEX Class II 1995-11-29
K954264 ACI SINGLE LUMEN BIOPSY NEEDLE Advanced Cytometrix, Inc. BTA Class II 1995-11-29
K951760 OPTILITE VIII LASER SURGERY ACCESSORIES Xintec Corporation GEX Class II 1995-11-29
K954287 ACI FINE NEEDLE ASPIRATION BIOPSY KIT Advanced Cytometrix, Inc. BTA Class II 1995-11-29
K954286 ACI PULSATING VACUUM PUMP SYSTEM Advanced Cytometrix, Inc. BTA Class II 1995-11-29
K955035 VIDAMED SERIES 7205 ELECTROSURGICAL GENERATOR Vidamed, Inc. GEI Class II 1995-11-29
K954413 KELOCOTE Allied Biomedical Corp. MDA Class I 1995-11-29
K953961 OSTEONICS INSIGHT KNEE POSITIONING & ALIGNMENT SYSTEM Osteonics Corp. FWW Class I 1995-11-29
K952470 ACTI-FLEX LOW, MEDIUM, RESCARE I, RESCARE II. R-Group Intl. GCD Class I 1995-11-28
K954599 CONMED TROGARD ELECTRONIC TROCAR SYSTEM Conmedcorp GEA Class I 1995-11-27
K952612 DURASIL The S. F. Group, Inc. MDA Class I 1995-11-22
K952231 EMC MODEL STATOME 200 Emc Industries GEI Class II 1995-11-21
K954229 ARGON ACCESSORY WITH BLADE & NEEDLE ELECTRODE, ADAPTER BOX Valleylab, Inc. GEI Class II 1995-11-20
K953980 KREUZER CEILING MOUNTED SUPPORT SYSTEMS, KLINOPORT Kreuzer Corp. FQO Class I 1995-11-16
K952277 SHARPLAN MODEL 2040 PULSED CTH:YAG SURGICAL LASER SYSTEM Sharplan Lasers, Inc. GEX Class II 1995-11-16
K954025 SIME SURGICAL POWDERFREE Sime Health, Ltd. KGO Class I 1995-11-15
K954851 BIOPOLAR FORCEPS LINE Johnson & Johnson Professionals, Inc. GEI Class II 1995-11-14
K952898 GORE-TEX SAM FACIAL IMPLANT WITH INTRODUCER W. L. Gore & Associates, Inc. FTL Class II 1995-11-14
K953794 SHARPLAN LASERS, INC. SURGICAL DIODE LASER Sharplan Lasers, Inc. GEX Class II 1995-11-14
K952682 LOKKI DT Lokki GEX Class II 1995-11-14
K954201 BUONAFEDE PNEUMATIC SLEEVE Promedic, Inc. KCY Class I 1995-11-09
K954871 LAPAROSCOPIC INSTRUMENT GROUNDING SYSTEM Conmedcorp GEI Class II 1995-11-02
K954253 STORZ S2060-C & DP9040 BIPOLAR CCORD ADAPTORS Storz Instrument Co. GEI Class II 1995-11-01
K954103 TOURNI-COMP Scandinavian Medical JW AB KCY Class I 1995-11-01
K954544 LASER GAS MIXTURE Liquid Technology Corp. GEX Class II 1995-10-30
K953081 BEAMER PLUS Aspen Laboratories, Inc. GEI Class II 1995-10-30
K942987 NUCLEOTOME L KIT Surgical Dynamics, Inc. GET Class I 1995-10-30
K943872 COMMANDER MARK II HAIR REMOVAL SYSTEM The Helene Edgar Corp. KCX Class I 1995-10-26
K951773 PODOSPRAY DRILL SYSTEM Darco Intl., Inc. GEY Class I 1995-10-26
K953917 LASESONICS LOW POWER CO2 LASER SYSTEM Heraeus Surgical, Inc. GEX Class II 1995-10-26
K952806 MEDI PUMP ASPIRATOR MODELS 1130 AND 1135 Thomas Industries BTA Class II 1995-10-26
K953412 CANDELA MODEL PLTL-1 LASER SYSTEM Candela Laser Corp. GEX Class II 1995-10-24
K952895 CMS URETHRAL WARMER Cryomedical Sciences, Inc. GEH Class II 1995-10-24
K954435 WILOMAT STERILIZABLE CLIP FORCEPS W/INTERCHANGABLE MAGAZINES Wilo Medizintechnik Lothar Wilberg GmbH FZP Class II 1995-10-23
K952937 NIOMED NON-SKID SHOE COVERS Amerasia Corp. FXP Class I 1995-10-23
K952897 NIOMED SHOE COVERS Amerasia Corp. FXP Class I 1995-10-23
K953992 LUMITROL CONTROLLER, LUMITROL HAND-CONTROLLED ELECTROSURGICAL PENCIL WITH BLADE ELECTRODE Lmi Lightwave Medical Industries , Ltd. GEI Class II 1995-10-23
K954633 CONMED ELECTROSURGICAL GROUNDING PAD Conmedcorp GEI Class II 1995-10-23
K954212 CONTAMINATION CONTAINMENT DRAPE Engineering Controls For Medicine KKX Class II 1995-10-23
K952117 EPILATOR Burke Neutech, Inc. KCX Class I 1995-10-19
K952611 STEREX STERILE DISPOSALE ELECTROLYSIS NEEDLE FOR USE IN EPILATION Sterex Electrolysis Intl., Ltd. KCW Class I 1995-10-18
K954263 XE-LITE Ophthalmic Technologies, Inc. FTD Class II 1995-10-18
K953889 AMERICAN BIOSURGICAL ELECTROSURGICAL BIPOLAR CABLE/CORD American Biosurgical, Inc. GEI Class II 1995-10-18
K953869 POLYSORB II COATED SYNTHETIC ABSORBABLE SUTURE United States Surgical, A Division of Tyco Healthc GAM Class II 1995-10-18
K953294 CANDELA CRYOSYSTEM CS-5 Candela Laser Corp. GEH Class II 1995-10-18
K954076 MIDAS REX DRILL ATTACHMENTS & TWIST DRILLS Midas Rex Pneumatic Tools, Inc. GET Class I 1995-10-18
K951117 LIHTAN 532 LASER Buckman Co., Inc. GEX Class II 1995-10-18
K953738 ERBOTOM ICC 300 Erbe Electromedizin GmbH GEI Class II 1995-10-16
K953089 I-SPOUSE Products For Medicine LYU Class I 1995-10-16
K954080 SODEM HIGH SPEED SYSTEM Sodem Diffusion SA HSZ Class I 1995-10-16
K953593 RUSCH TRACHEAL BRONCHIAL Y STENT Rusch, Inc. NYT Class II 1995-10-13
K954321 ENDOCARE MONOPOLAR ELECTRODES (MODIFICATION) Cytocare, Inc. GEI Class II 1995-10-13
K954462 POLYKOTE POWDER FREE STERILE LATEX SURGEONS GLOVES Intl. Trade Management Co. KGO Class I 1995-10-13
K951913 OVAL SURGICAL FACE MASK Oval Industries, Ltd. FXX Class II 1995-10-12
K953479 BIPOLAR FORCEPS Megadyne Medical Products, Inc. GEI Class II 1995-10-12
K953639 NEUTRALON BROWN LATEX SURGICAL GLOVES Johnson & Johnson Medical, Inc. KGO Class I 1995-10-12
K953712 DERRICK SURESHIELD M.P.S. Pharm'L Int'L KGO Class I 1995-10-12
K951700 GORE-TEX SOFT TISSUE PATCH W. L. Gore & Associates, Inc. FTL Class II 1995-10-07
K951676 GORE-TEX DUALMESH BIOMATERIAL W. L. Gore & Associates, Inc. FTL Class II 1995-10-07
K951675 GORE-TEX MYCROMESH BIOMATERIAL W. L. Gore & Associates, Inc. FTL Class II 1995-10-07
K952661 SLT THERMALITE DIODE LASER SERIES, DIODE 980, 810, 940 Surgical Laser Technologies, Inc. GEX Class II 1995-10-06
K954049 MICRO-TOUCH* LATEX SURGICAL GLOVES Johnson & Johnson Medical, Inc. KGO Class I 1995-10-05
K952072 ZOMED MODEL 500 ELECTROSURGICAL GENERATOR MODEL 200 ELECTROSURGICAL PROBE Zomed Intl. GEI Class II 1995-10-04

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