meddevicedb.com FDA Device Reference

Review Panel

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

Cleared Devices
16,323
Product Codes (page)
39
Latest Decision
1994-01-07

Clearances · page 110 of 164

K-Number Trade Name Applicant / Manufacturer Product Code Class Decision Date
K932261 ES-100 ACCESSORIES Elekta Instruments, Inc. HWE Class I 1994-01-07
K930363 POWERED SURGICAL INSTRUMENT ACCESSORY Intenn Engineering, Inc. HWE Class I 1994-01-07
K930319 OSTEON ADAPTOR/CRADLE United American Medical Co., Inc. HWE Class I 1994-01-07
K932214 SILON SILICONE GEL SHEET Bio Med Sciences, Inc. MDA Class I 1994-01-06
K934008 MEGABEAM LATERAL FIRE FIBER OPTIC DELIVERY SYST Ceram Optec, Inc. GEX Class II 1994-01-03
K932205 ERCP CATHETER, HYDROPHILIC COATED Wilson-Cook Medical, Inc. GBX Class I 1994-01-03
K931673 CARAPACE CATARACT TRAYS Carapace, Inc. LRO Class II 1993-12-30
K934428 ARGYLE TURKEL SAFETY PNEUMOTHORAX PROCEDURE TRAY Sherwood Medical Co. LRO Class II 1993-12-30
K934930 OLYMPIC AUTO-LENGTH Olympic Medical Corp. FTY Class I 1993-12-29
K933085 GOODMAN BANDAGE Megadyne Medical Products, Inc. KGY Class I 1993-12-23
K935310 MEDICAL LASER MIXTURE Acetylene Gas Co. GEX Class II 1993-12-23
K933686 LOOK INC. 316L STAINLESS STEEL SURGICAL SUTURE Look, Inc. GAQ Class II 1993-12-23
K932978 CALSSIQUE OR MYSTIQUE Dekumed, Kunststofftechnik Degler GmbH KCZ Class I 1993-12-22
K926586 REVISED LABELING FOR CHROMIC AND PLAIN GUT SUTURES Look, Inc. GAL Class II 1993-12-22
K932664 ENCORE POWDER-FREE SURGICAL GLOVES ORTHOPAEDIA Smith & Nephew Perry KGO Class I 1993-12-22
K932591 ENDO-JUDGE Synergistic Medical Technologies, Inc. GAB Class I 1993-12-22
K932665 ENCORE POWDER-FREE SURGICAL GLOVES MICROPTIC Smith & Nephew Perry KGO Class I 1993-12-22
K930942 LUKENS SILK SURGICAL SUTURE Lukens Medical Corp. GAT Class II 1993-12-17
K930517 NON-ABSORBABLE SURGICAL SUTURES Alcon Laboratories GAR Class II 1993-12-17
K931612 NYLAMID SUTURE S. Jackson, Inc. GAR Class II 1993-12-17
K930591 TI-CRON AND DACRON SUTURES Davis & Geck, Inc. GAT Class II 1993-12-17
K930941 LUKENS POLYPROPYLENE MONOFILAMENT NONABSORBABLE Lukens Medical Corp. GAW Class II 1993-12-17
K930589 PLAIN, MILD CHROMIC AND CHROMIC SURGICAL GUT SUTUR Davis & Geck, Inc. GAL Class II 1993-12-17
K931660 ULTRABRONZ SERIES 400 TANNING BED Eurocut, Ltd. LEJ Class II 1993-12-17
K930940 LUKENS STAINLESS STEEL SURGICAL SUTURE Lukens Medical Corp. GAQ Class II 1993-12-17
K930587 SURGILENE POLYPROPYLENE SUTURE Davis & Geck, Inc. GAW Class II 1993-12-17
K931613 SUPRAMID SUTURE S. Jackson, Inc. GAR Class II 1993-12-17
K931614 MOPYLEN SUTURE S. Jackson, Inc. GAW Class II 1993-12-17
K930992 FLEXON AND STAINLESS STEEL SUTURES American Cyanamid Co. GAQ Class II 1993-12-17
K930943 LUKENS NYLON SURGICAL SUTURE Lukens Medical Corp. GAR Class II 1993-12-17
K930360 SUTURES ETHICON, Inc. GAM Class II 1993-12-17
K926167 POLYVIOLENE SUTURE-REVISED LABELING Look, Inc. GAT Class II 1993-12-17
K930590 SILK SUTURES Davis & Geck, Inc. GAT Class II 1993-12-17
K931661 ULTRABRONZ SERIES 800 (ECLIPSE) TANNING BED Eurocut, Ltd. LEJ Class II 1993-12-17
K930586 DERMALON,SURGILON,OPHTHALON,& OPHTHALMIC NYLON SUT Davis & Geck, Inc. GAR Class II 1993-12-17
K926588 REVISED LABELING FOR POLYPROPYLENE SUTURE Look, Inc. GAW Class II 1993-12-17
K930945 BRAIDED POLYESTER SURGICAL SUTURE Lukens Medical Corp. GAT Class II 1993-12-17
K926168 SILK SUTURES-REVISED LABELING Look, Inc. GAR Class II 1993-12-17
K930944 LUKENS SURGICAL GUT SUTURE Lukens Medical Corp. GAL Class II 1993-12-17
K926587 REVISED LABELING FOR NYLON SUTURE (POLYAMIDE) Look, Inc. GAR Class II 1993-12-17
K932899 CLASSIQUE Hemispheres Marketing Co. , Ltd. KCZ Class I 1993-12-16
K930669 ATRIUM POLYPROPYLENE MESH Atrium Medical Corp. FTL Class II 1993-12-16
K934808 UVISOL AND UVISOL II National Biological Corp. FTC Class II 1993-12-16
K932376 ZEISS OPMILAS 144 SURGICAL LASERS Carl Zeiss, Inc. GEX Class II 1993-12-14
K935034 LASER GAS MIXTURE Tri-Gas, Inc. GEX Class II 1993-12-14
K920421 MEDSURG MARSHMALLOW TRAY Medsurg Industries, Inc. GAT Class II 1993-12-13
K931618 DUODERM HYDROCOLLOID GEL Convatec, A Division of E.R. Squibb & Sons NAE Class I 1993-12-10
K933668 ALMOST U, INC. BREAST PROSTHESIS Almost U., Inc. KCZ Class I 1993-12-10
K934970 DUET Trulife , Ltd. GBJ Class I 1993-12-10
K932846 TENCEL X-RAY DETECTABLE SPONGES/LAP PADS Courtaulds Fibers, Inc. GDY Class I 1993-12-09
K923759 FLUORESCENT T12 UVA TANNING LAMP Quality Lamp, Inc. LEJ Class II 1993-12-09
K932418 SUNBRONZE TANNING LAMPS Ess Lighting LEJ Class II 1993-12-09
K931824 CARAPACE INSTRUMLENT AND INSTRUMENT SETS Carapace, Inc. LRO Class II 1993-12-06
K934075 ISI METZENBAUM SCISSORS Innovative Surgical, Inc. GEI Class II 1993-12-01
K933866 ACU-HEMOSTATIC RING Acuderm, Inc. MDM Class I 1993-12-01
K934087 IMPLANTABLE CLIP APPLIER United States Surgical, A Division of Tyco Healthc FZP Class II 1993-12-01
K930611 TRUE FLOW(TM) VALVE Gm Engineering, Inc. GEX Class II 1993-12-01
K934035 GM MONOPOLAR/FRAZIER SUCTION PROBE Gm Engineering, Inc. GEI Class II 1993-12-01
K930058 BUFFALO FILTER REPLACEMENT FILTER #BPTU100 Buffalo Filter Co., Inc. FYD Class II 1993-11-30
K930067 BUFFALO FILTER SURGICAL MASK Buffalo Filter Co., Inc. FXX Class II 1993-11-30
K930167 REUSABLE TOWEL AND GOWN PACKS Custom Sterile Services, Inc. FYD Class II 1993-11-30
K930062 BUFFALO FILTER REPLACEMENT FILTER #BST300UL Buffalo Filter Co., Inc. FYD Class II 1993-11-30
K926478 GORE-TEK(R) SOFT TISSUE PATCH W. L. Gore & Associates, Inc. FTL Class II 1993-11-29
K932652 TRI-MED PARACENTESIS TRAY Tri-Med Specialties, Inc. LRO Class II 1993-11-24
K933887 IMPLANTABLE CLIP United States Surgical, A Division of Tyco Healthc FZP Class II 1993-11-24
K933508 REFLEX SDD SURGICAL STAPLER Richard-Allan Medical GEF Class I 1993-11-23
K934935 ECLIPSE LAZERBLADE(TM) FIBEROPTIC DELIVERY SYSTEM Cardiogenes GEX Class II 1993-11-22
K932392 PHX TECHNOLOGIES CORP ELECTROSURGICAL PROBES Phx Technologies Corp. GEI Class II 1993-11-22
K925726 ALLOY SCALPEL HANDPIECES, MODIFICATION Lca, Inc. GEX Class II 1993-11-22
K933715 BOSTON SCIENTIFIC CORPORATION SIDE FIRING LASER GUIDE Boston Scientific Corp GEX Class II 1993-11-22
K926452 ZEISS VISULAS YAG II LASER Carl Zeiss, Inc. GEX Class II 1993-11-22
K924071 INTEGRON SURGICAL GLOVES Bd Becton Dickinson Vacutainer Systems Preanalytic KGO Class I 1993-11-18
K931210 INTERMEDICS ORTHOPEDICS SAW BLADE Intermedics Orthopedics GFA Class I 1993-11-18
K934337 CUDA PRODUCTS CORP. MODEL MX2-300 LIGHTSOURCE Cuda Products Co. FSW Class II 1993-11-18
K931284 MICRODYNE OFFICE SURGICAL MICROSCOPE Microdyne, Inc. EPT Class I 1993-11-18
K930746 SYNTHETIC ABSORBABLE SURGICAL SUTURE United States Surgical, A Division of Tyco Healthc GAM Class II 1993-11-17
K932061 MIRACLE GLOVE UNDER THE GLOVE GLOVING CREAM Advanced Chemical Technology, Inc. KGO Class I 1993-11-16
K911288 ORION Pfizer Laser Systems GEX Class II 1993-11-16
K910826 ORION YAG LASER SYSTEM OPHTHALMOLOGY Pfizer Laser Systems GEX Class II 1993-11-16
K930434 PLUMEMASTER SMOKE EVACUATION SYSTEM Sorenson Laboratories, Inc. FYD Class II 1993-11-16
K932217 MAJOR, MINOR, BASIN TRAYS (PACKS) Associated Medical Products Co. LRO Class II 1993-11-15
K932051 TOTE-L-VAC Aeros Instruments, Inc. BTA Class II 1993-11-12
K930066 BUFFALO FILTER REPLACEMENT FILTER #BCCHAR Buffalo Filter Co., Inc. FYD Class II 1993-11-12
K932451 HANAULUX 2005 SURGICAL LIGHT Heraeus Instruments GmbH FTD Class II 1993-11-12
K930064 BUFFALO FILTER REPLACEMENT FILTER #BCR0030 Buffalo Filter Co., Inc. FYD Class II 1993-11-12
K930063 BUFFALO FILTER REPLACEMENT FILTER #BCULPA Buffalo Filter Co., Inc. FYD Class II 1993-11-12
K930060 BUFF. FILTER REPLACEMENT FILTER #BST312CO,BST306CO Buffalo Filter Co., Inc. FYD Class II 1993-11-12
K920689 DEEMED MSS -- MICROSCOPE SUPPORT SYSTEM Deemed, Inc. FSO Class I 1993-11-12
K930065 BUFFALO FILTER REPLACEMENT FILTER #BCR0043 Buffalo Filter Co., Inc. FYD Class II 1993-11-12
K926477 BIFURCATED SUCTION/IRRIGAT TUBING SET W/PUSH BUTTO Core Dynamics, Inc. GBW Class I 1993-11-12
K930675 MITEK CONE WASHER Mitek Surgical Products, Inc. KGS Class I 1993-11-09
K925653 DERMAPUNCH DISPOSABLE SKIN BIOPSY PUNCH Dermatopathology Laboratory MDM Class I 1993-11-08
K934367 PC-MINI GE Medical Systems JYD Class I 1993-11-08
K931597 CARAPACE INCISION AND DRAINAGE TRAYS Carapace, Inc. MCZ Class I 1993-11-05
K930041 VICROSAFE 6 AND VICROSAFE 12 Buffalo Filter Co., Inc. FYD Class II 1993-11-03
K930061 BUFFALO FILTER REPLACEMENT FILTER BST312PF Buffalo Filter Co., Inc. FYD Class II 1993-11-02
K930040 BUFFALO FILTER REPLACEMENT #BLFS-101/103 Buffalo Filter Co., Inc. FYD Class II 1993-11-02
K930582 SHARPLAN SHARPLASE LATERAL ND:YAG FIBER Sharplan Lasers, Inc. GEX Class II 1993-11-02
K933181 VALLEYLAB FORCE GSU HANDSET ADAPTER MODEL #E0500 Valleylab, Inc. GFI Class I 1993-11-02
K930059 BUFFALO FILTER REPLACEMENT FILTER #BSTM300 Buffalo Filter Co., Inc. FYD Class II 1993-10-29

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