meddevicedb.com FDA Device Reference

Review Panel

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

Cleared Devices
16,323
Product Codes (page)
46
Latest Decision
1990-08-31

Clearances · page 124 of 164

K-Number Trade Name Applicant / Manufacturer Product Code Class Decision Date
K903544 CAREKITS(TM) INCISION/DRAINAGE/SUTURE REMOVAL KITS J.J. Skinner, Inc. LRP Class I 1990-08-31
K903800 FIBER OPTIC LIGHT CABLE Orlux Engineering and Instrumentation FST Class II 1990-08-29
K903336 CUSTOMED HIP PACT Customed, Inc. LRO Class II 1990-08-29
K902009 ELANTEC'S SURGICAL TAPE REMOVER Elantec, Inc. KOX Class I 1990-08-29
K901016 LASER-SHIELD II(TM) Xomed, Inc. GEX Class II 1990-08-29
K903726 DRAPE, SURGICAL - UTILITY DRAPE - STERILE Graham Medical Products KKX Class II 1990-08-27
K902441 DISPOSABLE PROCEDURAL TRAYS #CK-XXXXX (VARIOUS) Currie Medical Specialties, Inc. KDD Class I 1990-08-23
K901365 LASER FORCEPS HANDPIECE Lca, Inc. GEX Class II 1990-08-21
K902000 KEVTEK(TM) LASER DRAPE/ORGAN PROTECTOR/EYE SHIELD Kevtek Medical Products, Inc. FZS Class I 1990-08-21
K903534 SURGEON'S (SURGICAL) GLOVES Straitscom KGO Class I 1990-08-17
K902677 STERI-SHIELD Biomedical Devices, Inc. FXY Class II 1990-08-17
K902307 SHAW II HEMOSTATIC SURGERY SYSTEM Hemostatic Surgery Corp. GEI Class II 1990-08-17
K902611 I.C. MEDICAL SMOKE EVACUATOR ACTIVATOR I.C Medical, Inc. FYD Class II 1990-08-17
K901205 MODELS IR103,IR107,IR104,IR205 (ADD'L APPLICATION) Niic U.S.A., Inc. GEX Class II 1990-08-14
K902283 THE NAUTILUS NASAL IMPLANT Applied Biomaterial Technologies FZE Class II 1990-08-14
K902447 CORING NEEDLE (TREPHINE, ORTHOPEDIC) Biomedtrix, Ltd. HWE Class I 1990-08-14
K892514 AHRS EPILATOR 629 American Hair Removal System Co. KCX Class I 1990-08-14
K903419 MODIFIED SURGIPORT DISPOSABLE TROCAR AND SLEEVE United States Surgical, A Division of Tyco Healthc GDH Class I 1990-08-09
K902384 ABDOMINAL OR C-SECTION DRAPE SHEET Medical Plastics, Inc. KKX Class II 1990-08-09
K895687 D'PLUME XXII PHOTOCOAGULATOR (EPILATION MACHINE) Carol Block, Ltd. KCW Class I 1990-08-09
K902828 SUTURE REMOVAL TRAY Orion Life Systems, Inc. LRW Class I 1990-08-08
K902642 CONTORNO (TM) Palex Intl. SA GEI Class II 1990-08-07
K903069 KLEARTEX LATEX SURGICAL GLOVES Transcorp KGO Class I 1990-08-07
K902502 BYRD STAINLESS STEEL DILATOR Medical Engineering and Development Institute GCC Class I 1990-08-07
K902108 HEM-O-LOK(TM) Edward Weck, Inc. FZP Class II 1990-08-06
K902430 GLUCOLET 2 AUTOMATIC LANCING DEVICE FOR OB. BLOOD Heraeus Kulzer, Inc. FMK Class II 1990-08-02
K902941 CURVILINEAR SILICONE CHIN IMPLANT Implantech Associates, Inc. FWP Class II 1990-08-02
K902735 SD SNARES Olympus Corp. GEI Class II 1990-08-02
K902232 WECK ELECTROSURGICAL GENERATOR #174200 Edward Weck, Inc. GEI Class II 1990-08-02
K902824 EXTENDED CHIN IMPLANT STYLE I Implantech Associates, Inc. FWP Class II 1990-08-01
K902076 J2 MICROSCOPE Jedmed Instrument Co. FSO Class I 1990-08-01
K902825 EXTENDED CHIN IMPLANT STYLE II Implantech Associates, Inc. FWP Class II 1990-08-01
K902827 ANATOMICAL MANDIBULAR IMPLANT STYLE II Implantech Associates, Inc. FWP Class II 1990-08-01
K901856 CUSTOM WOUND MANAGEMENT KITS AND TRAYS Medcare Custom Packaging, Inc. LRO Class II 1990-08-01
K903212 LATEX SURGICAL STERILE GLOVES Mirage Medical & Chemical, Inc. KGO Class I 1990-08-01
K902826 ANATOMICAL MANDIBULAR IMPLANT STYLE I Implantech Associates, Inc. FWP Class II 1990-08-01
K902416 SURELITE AND SURELITE XL BLOOD LANCET Gainor Medical Europe, Ltd. FMK Class II 1990-08-01
K902633 CUT RESISTANT GLOVE LINER Biomet, Inc. LYU Class I 1990-07-27
K902470 COHERENT XA30/SP AND XA50 SURGICAL LASERS Lumenis, Inc. GEX Class II 1990-07-26
K902293 ANGIOGRAPHY DRAPE PACK Biocor Medical, Inc. LRO Class II 1990-07-19
K902035 FLEXIBLE EXTENDER Beacon Laboratories, Inc. GEI Class II 1990-07-19
K901723 MDL-2000 LASERTRIPTER Candela Laser Corp. LNK Class II 1990-07-13
K902030 CUSTOMED LAP PACK III Customed, Inc. KKX Class II 1990-07-12
K902241 SLT CONTACT LASER SYSTEMS (UROLOGY) Surgical Laser Technologies, Inc. GEX Class II 1990-07-12
K902031 CUSTOMED LAP PACK IV Customed, Inc. KKX Class II 1990-07-12
K902029 CUSTOMED LAP PACK I Customed, Inc. KKX Class II 1990-07-12
K902359 SURGICAL VIDEO CAMERA, MODEL 9500 Seitz Technical Products, Inc. FWB Class I 1990-07-12
K900837 LPI YAG MODEL 1003 SURGICAL LASER SYSTEM Laser Photonics, Inc. GEX Class II 1990-07-12
K901221 PHYSICIAN BARRIER GLOVE, SURGICAL Dynamic Marketing Ent. LYU Class I 1990-07-10
K902148 MODELS 4000,4900,6000,8000,8900,LUXUS 60,100,1700 Heraeus Lasersonics, Inc. GEX Class II 1990-07-10
K902061 MODELS 4000,4900,6000,8000,8900,LUXUS 60,100&1700 Heraeus Lasersonics, Inc. GEX Class II 1990-07-10
K902831 TACTYLON TM SURGICAL GLOVE Tactyl Technologies, Inc. KGO Class I 1990-07-10
K901995 PLEURA BIOPSY DEVICE Mill-Rose Laboratory GDM Class I 1990-07-10
K895579 POLYSORB SYNTHETIC ABSORBABLE SUTURE United States Surgical, A Division of Tyco Healthc GAN Class II 1990-07-05
K900198 DEXON II ABSORBABLE SURGICAL SUTURE, U.S.P. American Cyanamid Co. GAN Class II 1990-07-05
K900531 NONABSORBABLE NYLON SURGICAL SUTURE* United States Surgical, A Division of Tyco Healthc GAR Class II 1990-07-05
K900587 SEMPERMED SURGEON'S GLOVES Semperit Industrial Products KGO Class I 1990-07-03
K902063 NIIC MODEL 15 CARBON-DIOXIDE SURGICAL LASER SYSTEM Niic U.S.A., Inc. GEX Class II 1990-06-29
K902211 SURGILASE YAG 100 SURGICAL LASER SYSTEM Surgilase, Inc. GEX Class II 1990-06-29
K902058 ADD'L USE OF THE KTP/YAG SURGICAL LASER Laserscope GEX Class II 1990-06-29
K902636 LIPOGEN RHEUMELISA DSDNA ASSAY Lipogen, Inc. LRY Class I 1990-06-28
K901876 INTRASITE CAVITY WOUND DRESSING (LABEL REVISION) Smith & Nephew United, Inc. KOZ Class I 1990-06-28
K901714 LIFESTYLE HOME TANNING UNITS Life Products, Inc. LEJ Class II 1990-06-27
K900298 GAMASHIELD Formtex Medical Sdn. Bhd. KGO Class I 1990-06-27
K901786 LASEGUIDE CAT # CLF-600D & CLF-1000D Laser Peripherals, LLC GEX Class II 1990-06-27
K901638 MODIFIED COMBOLASER 5050 & NEW MODEL 5050 VER. 33 Lasermatic, Inc. GEX Class II 1990-06-27
K901520 WURTZ CHOLEY CLIP (TM) Cd Medical, Inc. GBZ Class I 1990-06-26
K901340 MODEL MC 2100 ND:YAG SURGICAL LASER SYSTEM Klinger Medical GEX Class II 1990-06-26
K902332 HALL MODULAR ACETABULAR REAMER SYSTEM Zimmer, Inc. HWE Class I 1990-06-25
K901217 TRIA-SONIC ULTRA SOUND TRANSMISSION GEL H & P Industries, Inc. JOT Class II 1990-06-22
K901636 DIAMOND ND:YAG OPHTHALMIC LASER Biovision, Inc. GEX Class II 1990-06-22
K902562 REVISED LABELING FOR MODEL CL-0PE ND:YAG LASER Lca, Inc. GEX Class II 1990-06-20
K901481 MODEL YC-1200/PHOTOCOAGULATOR OPHTHALMIC LASER Nidek, Inc. GEX Class II 1990-06-20
K902380 TRIFLEX ORTHOPEDIC STERILE SURGEON'S GLOVE Baxter Healthcare Corp KGO Class I 1990-06-18
K901491 CUDA SURGICAL LIGHT Cuda Products Co. FST Class II 1990-06-18
K894241 MODEL 20-CH W/ AR-10A/U OPTICAL ATTACHMENT Directed Energy, Inc. GEX Class II 1990-06-18
K901165 MODULAR FLEXIBLE DRILLING SYSTEM Dalton Technology, Inc. HWE Class I 1990-06-13
K901378 TENSOPLUS LITE Smith & Nephew United, Inc. NAD Class I 1990-06-12
K901465 ABSORBABLE GAUZE DRAPE Ulti-Med Intl., Inc. KKX Class II 1990-06-12
K896630 SINOVENT MAXILLARY SINUS DRAINAGE SYSTEM Atos Medical AB KAM Class I 1990-06-06
K901302 BIPOLARD POLYPECTOMY SYSTEM (TM) Medical Devices, Inc. GEI Class II 1990-06-06
K901128 LASERCOMP MODEL STAR 10 FOR ORAL,GYNECOLOGY SURG. Lasercomp GEX Class II 1990-06-05
K900430 IRRIGATION AND SUCTION APPARATUS Acorn Group, Inc. JCX Class II 1990-06-05
K901204 EXPANDED MARKETING OF MODELS IR104 & IR205 LASERS Niic U.S.A., Inc. GEX Class II 1990-06-05
K896998 ATRAUCLIP (TANTALUM HEMOSTATIC CLIP) S.P.K. Technology, Inc. MCH Class II 1990-06-01
K896554 GUT SUTURES Look, Inc. GAL Class II 1990-05-31
K901943 KTP/532 (TM) SURGICAL LASER Laserscope GEX Class II 1990-05-29
K901718 KLEIN LAMPREY-CANNULA(TM) Jeff Klein Surgical, Inc. GEA Class I 1990-05-24
K901438 SURE-STOP TRANSBRONCHIAL ASPIRATION NEEDLE Telemed Systems, Inc. GAA Class I 1990-05-24
K901717 KLEIN MICRO-CANNULA(TM) Jeff Klein Surgical, Inc. GEA Class I 1990-05-24
K901830 CHICK III SURGICAL LIGHTING SYSTEM Chick Medical Products FSY Class II 1990-05-24
K901719 KLEIN MICRO-CANNULA HANDLE(TM) Jeff Klein Surgical, Inc. GEA Class I 1990-05-22
K902016 MODIFIED AOR-SULLIVAN PROTECTIVE OVERGLOVE Aor-Sullivan LYU Class I 1990-05-16
K901398 LATEX SURGEON GLOVES Sinochem (Usa), Inc. KGO Class I 1990-05-16
K901455 THE KIRSCHNER UNIVERSAL POWER TOOL SYSTEM Kirschner Medical Corp. HSZ Class I 1990-05-14
K900665 DRESSING CHANGE KIT Healthdyne Cardiovascular, Inc. FXX Class II 1990-05-14
K901716 KLEIN CONNECTOR(TM) Jeff Klein Surgical, Inc. GCE Class I 1990-05-11
K901715 KLEIN CORK(TM) Jeff Klein Surgical, Inc. GCE Class I 1990-05-11
K896314 ENDOSCOPIC USES OF THE ARGON LASER IN GENERAL SURG Hgm Medical Laser Systems, Inc. GEX Class II 1990-05-10
K902001 SURGICAL RETENTION BAR Acufex Microsurgical, Inc. KGS Class I 1990-05-09

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