meddevicedb.com FDA Device Reference

Review Panel

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

Cleared Devices
16,323
Product Codes (page)
40
Latest Decision
1992-04-21

Clearances · page 117 of 164

K-Number Trade Name Applicant / Manufacturer Product Code Class Decision Date
K920677 CLEARSITE HYDROGEL WOUND DRESSING MODIFICATION New Dimensions IN Medicine, Inc. NAE Class I 1992-04-21
K910422 MODEL RD-1200 RUBY LASER SYSTEM Spectrum Medical Technologies, Inc. GEX Class II 1992-04-21
K920516 GENERAL PURPOSE INSTRUMENT TRAY, STERILE, DISPOSAB Trinity Laboratories, Inc. KDD Class I 1992-04-16
K910152 ORION Pfizer Laser Systems GEX Class II 1992-04-15
K912611 OLSEN LAPAROSCOPIC INSTR, DISPOSABLE, SINGLE USE Olsen Electrosurgical, Inc. GEI Class II 1992-04-15
K914235 ASEP SURGEONS GOWN Baxter Interwoven Offsite FYA Class II 1992-04-14
K920584 SCULPTURED ENDOSTAT Laserscope GEX Class II 1992-04-10
K915656 CARBON DIOXIDE CO2 LASER Ion Laser Technology GEX Class II 1992-04-10
K920120 ND:YAG SURGICAL LASER Carl Zeiss, Inc. GEX Class II 1992-04-10
K914197 ALLOY SCALPEL HANDPIECES L.A.S.E.R., Inc. GEX Class II 1992-04-10
K914679 PRODIGY ND:YAG SURGICAL LASER SYSTEM Xintec Corporation GEX Class II 1992-04-07
K914761 KAY-MED SURGICAL DEAPE/DRAP ACCESSORIES Kayco Medical, Inc. KKX Class II 1992-04-06
K920052 HEALTH PAK TRAY SOX BARRIERS Healthpak, Inc. KKX Class II 1992-04-03
K913300 LAPAROSTAT(TM) Cook Ob/Gyn HAM Class II 1992-04-02
K914839 COMPEL E Standard Textile Co., Inc. FYA Class II 1992-04-02
K920110 ENDOPATH DISPOSABLE THORACIC TROCAR SLEEVE ETHICON, Inc. GEA Class I 1992-04-02
K920632 SIDE FIRING FIBERS Trimedyne, Inc. GEX Class II 1992-04-02
K920185 GENESIS ELECTROSURGICAL UNIT Conmedcorp GEI Class II 1992-04-02
K915117 MODEL 1210 OMNIPULSE HOLMIUM LASER SYSTEM Trimedyne, Inc. GEX Class II 1992-04-02
K920529 ZEISS MULTIYAG LASER Carl Zeiss, Inc. GEX Class II 1992-04-02
K915169 EXCEL MODEL XLT-TWO HOLMIUM:YAG LASER SYSTEM Excel Tech. , Ltd. GEX Class II 1992-04-02
K914518 KTP/YAG AND KTP/YAG PLUS Laserscope GEX Class II 1992-04-02
K920625 LATERALASE Trimedyne, Inc. GEX Class II 1992-04-02
K915583 CO2 LASER AND WAVEGUIDE DELIVERY SYSTEMS FOR THOR. Heraeus Lasersonics, Inc. GEX Class II 1992-03-27
K920562 UNISTIK Ulster Scientific, Inc. FMK Class II 1992-03-27
K914827 LPI ML210 HOLMIUM SURGICAL LASER, MODIFICATION Laser Photonics, Inc. GEX Class II 1992-03-27
K915536 DAVOL 100CC SILICONE CLOSED WOUND DRAINAGE EVAC Davol, Inc. GCY Class I 1992-03-26
K920553 MYRIADLASE SIDEFIRE-TIPPED OPTICAL FIBER Myriad Lase, Inc. GEX Class II 1992-03-26
K915822 MULTIPLE DRESSING, STERILE NONADDHERENT PADS Kerma Medical Products, Inc. NAB Class I 1992-03-26
K914604 MEPITEL NON-ADHERENT SILICONE DRESSING Molnlycke Clinical Products AB NAB Class I 1992-03-25
K920167 NEXTEC FIBEROPTIC ILLUMINAT 150 WATT/HALO/3500 KEL Nextec Corp. HBI Class II 1992-03-23
K915835 COATED VICRYL* II ETHICON, Inc. GAM Class II 1992-03-23
K915840 ZEISS MULTIYAG LASER Carl Zeiss, Inc. GEX Class II 1992-03-23
K915693 PROXIMATE ABSORBABLE STAPLES ETHICON, Inc. GDW Class II 1992-03-19
K914036 MEDSURG LAPAROSCOPY TRAY Medsurg Industries, Inc. LRO Class II 1992-03-18
K915670 MICROAIRE MODEL 2600 Microaire GEF Class I 1992-03-18
K914928 BASIC SET UP TRAY Westmark Hospital Supplies GEI Class II 1992-03-16
K920107 ADL 800 ND:YAG LASER SYSTEM FOR INTRAORAL TIS. SUR Sunrise Technologies, Inc. GEX Class II 1992-03-13
K913839 OPTICA 25 ND:YAG DENTAL LASER SYSTEM Xintec Corporation GEX Class II 1992-03-13
K915788 MIS ELECTROSURGICAL ELECTRODES Beacon Laboratories, Inc. GEI Class II 1992-03-13
K920106 ADL 400 ND;YAG LASER SYSTEM FOR INTRORAL SOFT TIS. Sunrise Technologies, Inc. GEX Class II 1992-03-13
K913408 STERILE PLASTIC DRAPE Acacia Laboratories, Inc. KKX Class II 1992-03-12
K915561 ZEISS MULTIYAG LASER Carl Zeiss, Inc. GEX Class II 1992-03-11
K914455 SHARPLAN MODELS 100 SERIES C02 LASERS/ACCESSORIES Sharplan Lasers, Inc. GEX Class II 1992-03-11
K915064 DISPOSABLE CAUTERY ABRASIVE PAD American Medical Mfg., Inc. KDC Class I 1992-03-11
K915497 CONBIO MEDLITE Q-SWITCHED ND:YAG LASER SYSTEM Continuum Biomedical, Inc. GEX Class II 1992-03-06
K915426 MEDICAL SUNLAMP FOR PHOTOTHERAPY American Sunlight, Inc. FTC Class II 1992-03-04
K915774 PROLENE POLYPROPYLENE MESH PLUG W/ ONLAY PATCH ETHICON, Inc. FTM Class II 1992-03-02
K915085 DL100 C02 SURGICAL LASER SYSTEM Mnlase, Inc. GEX Class II 1992-02-28
K914960 INSTRUMENT ORGANIZER O.R. Concepts, Inc. KDC Class I 1992-02-28
K915430 SKIN STAPLE REMOVER KIT Cypress Medical Products, Ltd. GDT Class I 1992-02-28
K912618 LASER SYSTEMS FOR PERCUTANEOUS LUMBAR DISCECTOMY Heraeus Lasersonics, Inc. GEX Class II 1992-02-27
K914849 EXCEL MODEL XLT-ONE ND:YAG LASER SYSTEM Excel Tech. , Ltd. GEX Class II 1992-02-25
K915354 LATERALASE Trimedyne, Inc. GEX Class II 1992-02-24
K914244 STERILE CUSTOM SURGICAL KITS Ulti-Med Intl., Inc. KDD Class I 1992-02-24
K914174 STERILE DISPOSABLE WET SKIN SCRUB TRAY Medical Device Inspection Co., Inc. LRO Class II 1992-02-24
K912879 MODEL SLASE 210 HOLMIUM (THC:YAG) LASER SYSTEM Sunrise Technologies, Inc. GEX Class II 1992-02-21
K913290 MULTILASE 2100 A Teknomed, Inc. GEX Class II 1992-02-21
K913623 SURGICAL ELECTRICAL PENCIL Aaron Medical, Inc. GEI Class II 1992-02-21
K915285 SKYTRON INFINITY SERIES SURGICAL LIGHTS Skytron, Div. the Kmw Group, Inc. FSY Class II 1992-02-20
K915300 A & EM MEDICAL ELECTROSURGICAL PENCIL/ACCESSORIES Alto Development Corp. GEI Class II 1992-02-18
K914832 SURGICAL APPAREL W. L. Gore & Associates, Inc. FXX Class II 1992-02-14
K914118 I.C. MEDICAL AUTO INTRA-ABDOMINAL PLUME ELIMINATOR I.C Medical, Inc. FYD Class II 1992-02-12
K915158 SUREBREATH DOME, E-Z BREATHER Ipax, Inc. GAD Class I 1992-02-12
K915768 SURGI LIGHT ND:YAG LASER SYSTEM MODEL 904030 Surgical Laser Products, Inc. GEX Class II 1992-02-11
K913447 DISPOSABLE CYSTOSCOPY SPLASH DRAPE-STERILE #599 Graham Medical Products KKX Class II 1992-02-07
K915370 COPPER VAPOR LASER SYSTEM Metatech Corp. GEX Class II 1992-02-07
K913448 DISPOSABLE TURP FLUID CONTAINMENT DRAPE - STERILE Graham Medical Products KKX Class II 1992-02-07
K915068 PLASTIC DISPOSABLE SURGICAL LIGHT HANDLE COVER American Medical Mfg., Inc. FTA Class II 1992-02-06
K913486 QUALTEX SURGICAL DRAPE, MODIFICATION Deroyal Industries, Inc. KKX Class II 1992-02-05
K915139 MODEL 2250-000 ZIMMER STYLE SAGITTAL SAW MODULE Micro Surgical Instruments Corp. HSZ Class I 1992-02-05
K914956 KEELER KONAN SPECULAR MICROSCOPE SP5500 Keeler Instruments, Inc. HRM Class I 1992-02-03
K915445 MAALEABLE FACIAL IMPLANT Biomet Ussc Orthopedics KKY Class II 1992-02-03
K920100 GSU HANDPIECE ADAPTER Beacon Laboratories, Inc. HAM Class II 1992-02-03
K915089 MITEK QUICKANCHOR(TM), MODIFICATION Mitek Surgical Products, Inc. GAS Class II 1992-02-03
K915572 BECTON DICKINSON MODIFIED MENGHINI NEEDLE Bd Becton Dickinson Vacutainer Systems Preanalytic GDM Class I 1992-02-03
K915056 FINGGUARD Allied Signal, Inc. LYU Class I 1992-02-03
K915489 AUTO SUTURE ABSORABLE SUBCUTICULAR CLOSURE STAPLE United States Surgical, A Division of Tyco Healthc GDW Class II 1992-01-31
K914929 LACERATION TRAY Westmark Hospital Supplies KKX Class II 1992-01-31
K914935 HEART PACK II Westmark Hospital Supplies LRO Class II 1992-01-31
K914701 SIL-K Degania Silicone , Ltd. MDA Class I 1992-01-31
K915081 MITEK SNAP PAK(TM), MODIFICATION Mitek Surgical Products, Inc. GAS Class II 1992-01-31
K915000 ACU-GUARD Acuderm, Inc. GEX Class II 1992-01-27
K913799 LM-90 ESU Keisegang Medical, Inc. GEI Class II 1992-01-27
K915274 METAL HALIDE LIGHT SOURCE MODEL LM 250 Pentax Precision Instrument Corp. FST Class II 1992-01-23
K915223 METAL ENCLOSED SIDE FIRING FIBERS Trimedyne, Inc. GEX Class II 1992-01-23
K913256 DERMA-LASE RUBY LASER - MODEL DLR-1 Derma-Lase Co. GEX Class II 1992-01-22
K913539 THORACIC CATHTER STYLET Intl. Medical Devices , Ltd. GBX Class I 1992-01-21
K913542 THORACIC CATHETER WITH GUIDE Intl. Medical Devices , Ltd. GBX Class I 1992-01-21
K914824 HYPOALLERGENIC SURGEON'S GLOVES - STERILE Wembley Rubber Products (M) Sdn Bhd KGO Class I 1992-01-17
K914694 STERILE VIEW(TM) HI EFFIC HELMET/BACK PK SUP/EXHAU Depuy, Inc. JCX Class II 1992-01-16
K914605 MULTIPLE STERILE SURGICAL DRAPE PACK Assured Surgical Products, Inc. KKX Class II 1992-01-15
K914591 L.C.S. 2000 SYSTEM Stiefel Research Institute, Inc. GEH Class II 1992-01-14
K915382 AMOENA AFFINITY MODEL #802 Coloplast Corp. KCZ Class I 1992-01-14
K915417 KOPAN'S TARGET Medical Device Technologies, Inc. GAA Class I 1992-01-14
K914845 M170 PNEUMATICALLY OPERATED OSCILLATING SAW Desutter Medical , Ltd. HSZ Class I 1992-01-13
K915151 AUTO SUTURE MODIFIED POLYMER SKIN GRAFT STAPLE United States Surgical, A Division of Tyco Healthc FZP Class II 1992-01-13
K914563 STERILE SUGICAL GOWN PACK Assured Surgical Products, Inc. FYA Class II 1992-01-10
K912803 MSI STERILE BACK SURGICAL GOWN PACK HAND TOWEL Medical Sterilization, Inc. FYA Class II 1992-01-10
K914608 BREAST LES LOCAL WIRE ST. 48219/49220/48119/48120 Dlp, Inc. GAA Class I 1992-01-09

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