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
1986-10-30

Clearances · page 139 of 164

K-Number Trade Name Applicant / Manufacturer Product Code Class Decision Date
K864111 STERILE FIELD #605 FENESTRATED STERILE FIELD #606 Graham Medical Products KKX Class II 1986-10-30
K864026 NONCONDUCTIVE SHOE COVER Kimberly-Clark Corp. FXP Class I 1986-10-30
K864064 LATEX SURGICAL GLOVES Futuremed Div. of Future Impex Corp. KGO Class I 1986-10-30
K864101 COOK (R) VEIN GRAFT RING MARKERS Cook, Inc. KPK Class II 1986-10-30
K864019 NEEDLE NOSE PLIERS Med-Tool, Inc. HTC Class I 1986-10-30
K863323 SENGEWALD CATALOG NUMBER 55 66 01 Sengewald/USA, Inc. KKX Class II 1986-10-29
K861044 MODEL 2100 ND:YAG SURGICAL LASER NEUROSURGICAL IND Sharplan Industries, Inc. GEX Class II 1986-10-28
K863942 POREX(TM) NOSE PROSTHESIS Porex Medical FZE Class II 1986-10-24
K862863 MODEL 10-C W/LC-10A/U FOR OPHTHALMIC & ORBITAL USE Directed Energy, Inc. GEX Class II 1986-10-24
K863982 VAS-CATH PERICARDIOCENTESIS CATHETER, SET & TRAY Vas-Cath of Canada , Ltd. JCY Class I 1986-10-24
K863951 P.S.I.-DISPOSABLE SCALPEL SURGEONS HANDLE Precision Surgical Industries, Inc. GDZ Class I 1986-10-24
K863939 POREX(TM) EAR PROSTHESIS Porex Medical FZD Class II 1986-10-24
K863885 SABLE BLADES Sable Industries GES Class I 1986-10-24
K863752 VALTRAC (BAR) REMOVER DEVICE Davis & Geck, Inc. EMF Class I 1986-10-24
K863950 P.S.I.-DISPOSABLE METAL HANDLE SURGEONS SCALPEL Precision Surgical Industries, Inc. GDX Class I 1986-10-24
K863941 POREX(TM) PROSTHESIS, CHIN, INTERNAL Porex Medical FWP Class II 1986-10-24
K863183 ND:YAG LASER, MODEL 6000 FOR NEUROSURGERY Cooper Lasersonics, Inc. GEX Class II 1986-10-24
K863871 OPERATING ROOM TOWELS - STERILE/NON STERILE Med-Tex, Inc. KKX Class II 1986-10-24
K863595 COATED SUTURE NEEDLE Sharpoint, Inc. GAB Class I 1986-10-24
K862408 MODEL 8-B CO2 LASER FOR OPTHALMIC & ORBITAL SURG Directed Energy, Inc. GEX Class II 1986-10-24
K862864 MODEL 20-C W/FL-20A/U FOR SURGERY & DERMATOLOGY Directed Energy, Inc. GEX Class II 1986-10-24
K863867 DEXTRA DISPOSABLE BLADES Storz Instrument Co. GES Class I 1986-10-24
K863732 SURGICAL DRAPE & DRAPE ACCESSORIES Intera Corp. KKX Class II 1986-10-23
K863731 ROTARY* POWERED SCALPEL Self Sharpening Surgical Steel, Inc. GEI Class II 1986-10-17
K863808 THE S. CORDERO STYLUS S. Cordero Co. GDZ Class I 1986-10-14
K863800 ENDOSCOPIC VIDEO CAMERA Technology For Imaging, Inc. KQM Class I 1986-10-14
K863701 MODEL 709 BIPOLAR MICRO COAGULATOR Bergen Mfg. GEI Class II 1986-10-14
K863482 DRAINOVAC COMPLETE CLOSED WOUND DRAINAGE DEVICE Cardio Metrics, Inc. GCY Class I 1986-10-14
K863089 DISPOSABLE LASER SPONGE SURGIMEDICS, 902001-000 Lifestream Int'L, Inc. GDY Class I 1986-10-14
K863848 MANAN BREST TUMOR LOCALIZATION NEEDLE Manan Manufacturing Co., Inc. GAA Class I 1986-10-14
K863788 SAWBLADE Tava Surgical Instruments GFA Class I 1986-10-14
K863726 INSTRUMENT STERILIZATION TRAY Medical Technology Development Corp. FSM Class I 1986-10-14
K863653 SUCTION-OFF B&B Medical Technologies, Inc. HXD Class I 1986-10-07
K863621 PALS West Lake Marketing FMK Class II 1986-10-06
K862753 TANDEM SUCTION CAUTERY Celebration Designs, Inc. GEI Class II 1986-10-03
K861688 XANAR CO2 SURGICAL LASER SYSTEM MODEL XAP-15 Xanar, Inc. GEX Class II 1986-10-03
K862669 ACTIVATED PARTIAL THROMBOPLASTIN TIME TEST U. S. Diagnostics, Inc. GFD Class I 1986-10-03
K863518 WEINGART MODEL 1000 SUNLAMP PRODUCT Weingart, Inc. FTC Class II 1986-10-02
K863413 BIPOLFORCEPS Treace Medical, Inc. GEI Class II 1986-10-02
K863555 BREMI BEAUTY BRONZE Handelsonderneming Bremi B.V. FTC Class II 1986-10-02
K863598 VIDEO CAMERA SYSTEM American Edwards Laboratories FWF Class I 1986-10-02
K863412 BIPOL CABLE Treace Medical, Inc. GEI Class II 1986-10-02
K862422 MODEL 20-B CO2 LASER FOR GENERAL & PLASTIC SURGERY Directed Energy, Inc. GEX Class II 1986-10-02
K860831 MODEL LS-870 CO2 SURGICAL LASER SYSTEM (MODIFIED) Cooper Lasersonics, Inc. GEX Class II 1986-10-02
K863376 MODEL MC-1 SURGICAL VIDEO CAMERA Biometric Products, Inc. FWF Class I 1986-10-02
K863549 REUSABLE/DISPOSABLE AUTOPSY KNIFE SET Surgipath Medical Industries, Inc. EMF Class I 1986-09-30
K863034 SHARPOINT STAINLESS STEEL SUTURE Chathamborough Research Group, Inc. GAO Class II 1986-09-30
K863512 DRAPE STERICOVER Sterimed, Inc. KKX Class II 1986-09-30
K863447 STRYKER ORTHOPOWER 90 & ORTHOPOWER 90 SYSTEM II Stryker Corp. GET Class I 1986-09-29
K863560 URESIL STD FLAT/ROUND & FLAT/ROUND SPLIT. SILI/DRA Uresil Corp. GBS Class I 1986-09-29
K863562 URESIL 150CC BELLOWS RESERVOIR Uresil Corp. GCY Class I 1986-09-29
K863570 LE VEEN WOUND SPLINT Tek-Aid, Inc. KGS Class I 1986-09-29
K862805 ANGIOMED VAC-U-CUT BIOPSY NEEDLE Angiomed U.S., Inc. GDM Class I 1986-09-29
K863359 BOUFFANT-STYLE SURGICAL CAP Kimberly-Clark Corp. FYF Class I 1986-09-29
K863409 KUNDIN WOUND GAUGE Jane I. Kundin FTY Class I 1986-09-29
K863379 DERMATEC BURN PADS Dermatec, Inc. NAD Class I 1986-09-26
K863446 ANGIOMED HIGH PRESSURE CONNECTORS Angiomed U.S., Inc. GCD Class I 1986-09-23
K862862 MODEL 10-C W/FL-10A/U FOR SURGERY AND DERMATOLOGY Directed Energy, Inc. GEX Class II 1986-09-19
K863397 BYRON SILICONE CHIN IMPLANTS Byron Medical FWP Class II 1986-09-18
K863505 URESIL CLOSED DRAINAGE RESERVOIR Uresil Corp. GCY Class I 1986-09-18
K863398 BYRON NASAL SEPTAL BUTTON Byron Medical FZE Class II 1986-09-17
K863414 MICROBIPOLATOR Treace Medical, Inc. GEI Class II 1986-09-17
K863430 BYRON BIVALVE NASAL SPLINTS Byron Medical FZE Class II 1986-09-17
K863433 MODEL 8900 ND:YAG LASER Cooper Lasersonics, Inc. GEX Class II 1986-09-17
K863399 BYRON DORSAL COLUMELLA IMPLANT Byron Medical FZE Class II 1986-09-17
K863400 BYRON EXTENDED MALAR AND BYRON CONTOURED MALAR Byron Medical LZK Class II 1986-09-17
K863326 BONE MARROW TRAY Packaging Technologies, Inc. GAA Class I 1986-09-16
K862749 LS9000 SUCTION BIOPSY NEEDLE Engineering, Inc. GDM Class I 1986-09-15
K862423 MODEL 8-B CO2 LASER FOR GENERAL & PLASTIC SURGERY Directed Energy, Inc. GEX Class II 1986-09-15
K863360 NEOMED NON GEL-R TOTAL ADHESIVE CONDUCT. ELECTRODE Richards Medical Co., Inc. GEI Class II 1986-09-12
K862221 E-Z CLEAN American Medical Products, Inc. GEI Class II 1986-09-12
K862472 QUARTZ RODS TITANIUM RODS Quali-Med, Inc. GEX Class II 1986-09-12
K863280 DERMAMARKER Dermacare Products, Inc. FZZ Class I 1986-09-09
K863293 DISPOSABLE SUCTION CANNULA NO. 902008-000 Lifestream Int'L, Inc. GEA Class I 1986-09-09
K863161 TABLE, OPERATING ROOM, HYDRAULIC Kamiya Tsusan Kaisha, Ltd. FWW Class I 1986-09-05
K863150 BOWEN CANNULA Bowen & Company, Inc. GEA Class I 1986-09-05
K863211 KEISEI SURGICAL BLADES (STERILE & NON-STERILE) Keisei Medical Industrial Co., Ltd. GES Class I 1986-09-02
K863212 KEISEI HANDLES FOR SURGICAL BLADES Keisei Medical Industrial Co., Ltd. GDZ Class I 1986-09-02
K863213 KEISEI SCALPEL (STERILE AND NON-STERILE) Keisei Medical Industrial Co., Ltd. GDX Class I 1986-09-02
K863214 KEISEI MICRO-BLADES (STERILE AND NON-STERILE) Keisei Medical Industrial Co., Ltd. GES Class I 1986-09-02
K863247 AXIOM TROCAR THORACIC CATHETER Axiom Medical, Inc. GBS Class I 1986-08-29
K863142 THORACIC CATHETER (CHEST DRAINAGE TUBE) Sheridan Catheter Corp. GBS Class I 1986-08-29
K863201 NEW USE FOR ACUVAC SUCTION RESERVOIR 400CC Allergan, Inc. GCY Class I 1986-08-29
K863090 PERCU GUIDE I (LOOP TYPE) E-Z-Em, Inc. GDF Class I 1986-08-29
K863091 BICORD BY QMED Qmed, Inc. HAM Class II 1986-08-29
K862935 WOUND MANAGER(TM) - STERILE Convatec, A Division of E.R. Squibb & Sons NAD Class I 1986-08-20
K862564 A.C.L. GUIDE KIT Aspen Laboratories, Inc. FZX Class I 1986-08-18
K862936 NEWMAN CANNULAE SYSTEM (NCS) Byron Medical GEA Class I 1986-08-14
K861955 CONTACT TIPS Cooper Lasersonics, Inc. LNK Class II 1986-08-14
K862569 HEAVY DUTY (HD) SUCTION UNITS (W/CANNULAS) Jedmed Instrument Co. BTA Class II 1986-08-14
K862584 OSTEOTOMY DRAINAGE TUBE Treace Medical, Inc. GBS Class I 1986-08-12
K853117 COOPER LASER SONICS ND: YAG LASER, MODEL 8008 Cooper Lasersonics, Inc. GEX Class II 1986-08-12
K862852 MICRO-AIRE REPLACE OTOLOGY BURS/ZIM HALL SUR INSTR Micro-Aire Surgical Instruments, Inc. GFF Class I 1986-08-11
K860083 DERMASCAN LASER SURGICAL HANDPIECE Medical Laser Research & Development Corp. GEX Class II 1986-08-07
K862801 SPUNGUARD PLUS SURGICAL DRAPE Kimberly-Clark Corp. KKX Class II 1986-08-07
K862767 SILICONE SUMP DRAIN Sil-Med Corp. GBS Class I 1986-08-07
K861331 ENDOSCOPIC ELECTROSURGICAL FIBEROPTIC PROBE Trimedyne, Inc. LNK Class II 1986-08-07
K862608 SPERTILITE PHOTOTHERAPY LAMP Cooper-Hewitt Electric Co. FTC Class II 1986-08-06
K862751 USA ASPIRATOR U. S. A. Medical Corp. BTA Class II 1986-08-04
K862726 DISPOSABLE SHOE COVERS AND NURSES CAPS Abco Dealers, Inc. FXP Class I 1986-08-01

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