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
1981-02-04

Clearances · page 156 of 164

K-Number Trade Name Applicant / Manufacturer Product Code Class Decision Date
K802904 MICROSCOPE MODEL OM-U Jedmed Instrument Co. EPT Class I 1981-02-04
K810075 AUTOCLIX Biodynamics Corp. FMK Class II 1981-02-04
K802903 MICROSCOPE MODEL OM-P Jedmed Instrument Co. EPT Class I 1981-02-04
K802942 HITEMP. TM 2 LOOPTIP CAUTERY Medical Products Development, Inc. GEI Class II 1981-02-04
K803292 FIELD SUCTION DISSECTOR V. Mueller O.V. Baxter Healthcare Corp. GDI Class I 1981-01-29
K810101 WATER RESISTANT FOOTSWITCH W/CABLE Aspen Laboratories, Inc. GEI Class II 1981-01-29
K803189 SUNSCENE TANNING STUDIO Sunscene Tanning Studio LEJ Class II 1981-01-28
K803116 HEAVY DRAINAGE PACK American Medical Disposable, Inc. GEC Class I 1981-01-28
K770791 DEPILATOR, DERMA-I & DERMA-II Electro-Kinetic Eng/Mfg KCX Class I 1981-01-26
K810004 STERILE DISPOSABLE INSTRUMENT TRAYS Ascep, Inc. FSM Class I 1981-01-26
K810019 SURG-FLEX 15 SURGICAL LIGHT Medical Products Development, Inc. FSQ Class II 1981-01-23
K810018 SURG-FLEX 5 SURGICAL LIGHT Medical Products Development, Inc. FSQ Class II 1981-01-23
K802806 VISECERA RETAINER Adept-Med Intl., Inc. GCZ Class I 1981-01-23
K802756 SEMI-OVAL MODULAR SUNTANNING BOOTH Tannhut LEJ Class II 1981-01-22
K803090 SUNMAKER (SUN TANNING BED) Sunmaker, Inc. LEJ Class II 1981-01-22
K803156 SURGITEK MEDI-LOOPS Medical Engineering Corp. KDC Class I 1981-01-15
K803125 BONE-DRI SURGICAL SPONGE Howmedica Corp. NAB Class I 1981-01-15
K803199 SUTURE REMOVAL KIT Walpak Co. KDD Class I 1981-01-15
K802972 DUAL-TROL Cimarron Instruments, Inc. GEI Class II 1981-01-15
K803188 GAUZE SPONGES Abco Dealers, Inc. GDY Class I 1981-01-15
K802885 L.A.F. ISOLATION PACK Action Medical Systems, Inc. FYA Class II 1981-01-15
K803158 IRRADIATED BOUNDARY DEVICES The Buckeye Cellulose Corp. FYA Class II 1981-01-15
K803061 SUN TANNING DEVICES Mutzhas Corp. LEJ Class II 1981-01-13
K802850 TECNOL O.R. TOURNIQUET COVER Tecnol New Jersey Wound Care, Inc. EYR Class I 1981-01-13
K803142 CONPHAR VELCRO TOUNIGUER Conphar, Inc. GAX Class I 1981-01-13
K803284 OSTEO OSCILAIR Richard'S Medical Equip., Inc. HSZ Class I 1981-01-09
K802522 DELTA-LITE CASTING TAPE & SPLINTS Johnson & Johnson Professionals, Inc. FYH Class I 1981-01-08
K802965 AMPCO-DRESSING CHANGE TRAY-MAJOR DC 7418 Associated Medical Products Co. FSM Class I 1981-01-05
K802964 AMPCO-DRESSING CHANGE TRAY-MAJOR DC Associated Medical Products Co. FSM Class I 1981-01-05
K803119 LARGE WOUND DRESSING KIT American Medical Disposable, Inc. KDD Class I 1980-12-30
K803117 CUSTOM DRESSING TRAY WET TO DRY American Medical Disposable, Inc. KDD Class I 1980-12-23
K802895 COBE CENTRY 2 VARIABLE CONCENTRATE-18- Cobe Laboratories, Inc. KDC Class I 1980-12-22
K803118 SIMPLE DRESSING TRAY #82028 American Medical Disposable, Inc. KDD Class I 1980-12-22
K802980 DISPOSABLE STERILE LAP SPONGE Anago, Inc. KKX Class II 1980-12-19
K802982 GAUZE, ABSORBABLE X-RAY DETECT. LAP SPG. Stanford Laboratories GDY Class I 1980-12-19
K802973 ISPVAC TM Innovative Surgical Products, Inc. GCY Class I 1980-12-19
K802865 SAFE T COUNT Instranetics, Inc. KDC Class I 1980-12-18
K802793 LOMATUELL OINTMENT DRESSING Secol Co. NAE Class I 1980-12-18
K802797 O.R. DRAPES Secol Co. KKX Class II 1980-12-17
K802787 METALLINE DRESSINGS Secol Co. KKX Class II 1980-12-17
K802799 EYE PADS Secol Co. HMP Class I 1980-12-17
K802783 SURGEONS CHOICE STAPLE, REMOVE/IMPLANT Hospital Products Intl. GBN Class I 1980-12-16
K802513 DPA 207 PERSONAL Hill, Farrer & Borrill KCX Class I 1980-12-16
K802798 OPRATEX ABDOMINAL PAD Secol Co. GDY Class I 1980-12-11
K802827 BOUIE ELECTROSURGICAL TIP CLEANER Sybron Corp. GEI Class II 1980-12-11
K802838 STERNUM SAW BLADE Amsco Co. GFA Class I 1980-12-11
K802641 GAMMEX SURGICAL GLOVES Ansell, Inc. KGO Class I 1980-12-11
K802304 SOLAR TONE Bloomex International, Inc. LEJ Class II 1980-12-01
K802088 AUXILIARY TRAY American Pharmaseal Div. Ahsc FSM Class I 1980-11-28
K802713 FMS-02 FLOOR-UNIT MODEL MICROSCOPE Jedmed Instrument Co. FSO Class I 1980-11-19
K802866 SHARPS CADDY MAGNETIC & SHARPS CADDY FOA Instranetics, Inc. KDC Class I 1980-11-17
K802570 A.M.P.C.O. SKIN SCRUB TRAY Associated Medical Products Co. FSM Class I 1980-11-14
K802373 SURGICAL FACE MASK Louis M. Gerson Co., Inc. FXX Class II 1980-11-12
K801908 SI-14 Kmi Medical, Inc. KDC Class I 1980-11-12
K802652 BOUNDARY SURGICAL DRAPES WITH ADHESIVE Procter & Gamble Mfg. Co. KKX Class II 1980-11-12
K802330 HI-TEMP LOOPTIP SURGICAL CAUTERY Medical Products Development, Inc. GEI Class II 1980-11-12
K802605 ELECTRO SURGICAL TIP CLEANER Concept, Inc. GEI Class II 1980-11-12
K802537 DISPOSABLE SURGICAL DRAPE Texas Medical Products, Inc. KKX Class II 1980-11-12
K802524 SURGICAL HAMMERS Midshore Welding Corp. FZY Class I 1980-11-12
K802557 EMERGENCY DEPARTMENT LACERATION KIT- Johnson & Johnson Professionals, Inc. KDD Class I 1980-11-12
K802676 ORHTOPEDIC REAMER 87 HTD Zimmer, Inc. HTD Class I 1980-11-12
K802359 DISP. FENESTRATED SURG. DRAPE SHEETS American Convertors Div., American Pharmaseal KKX Class II 1980-10-31
K802291 FLUORESCENT SUN LAMP FIXTURE Strato-Ray Co. HJE Class II 1980-10-31
K802558 SURCAN KNEE HOLDING DEVICE Bend Orthopedic & Fracture Clinic FWZ Class I 1980-10-31
K802317 COMFORT CUSHION DRY BURN PADS, STERILE American Convertors Div., American Pharmaseal KKX Class II 1980-10-31
K801921 GCS-79 Gilmore Liquid Air Co. GEH Class II 1980-10-31
K802599 ARTHROSCOPIC FAT PAD RETRACTOR The Anspach Effort, Inc. GAD Class I 1980-10-31
K802134 JK INT'L, INC. SOLTRON UVA TANNING BED Mottek Intl. Corp. LEJ Class II 1980-10-23
K802367 ARROW CATHETER CLAMP Arrow Intl., Inc. KGZ Class I 1980-10-23
K802214 COS-UPHOFF INT'L DS-5 DRAINAGE SYSTEM Cox-Uphuff Intl. GCY Class I 1980-10-23
K801914 TEMP STERNUM SAW Temp Medical Products, Inc. DWI Class I 1980-10-23
K802286 ARGLE LATEX PENROSE TUBING Sherwood Medical Co. KGZ Class I 1980-10-23
K801675 U.I. OCTOSON Ausonics Pty , Ltd. LEJ Class II 1980-10-23
K802271 THE IMMOBILIZER FOR OPEN & ARTHROSCOPIC The Anspach Effort, Inc. BWN Class I 1980-10-23
K802318 ARGYLE SILICONE THORACIC CATHETER Sherwood Medical Co. GBS Class I 1980-10-23
K802017 DRESSING CHANGE SET CAT.#910-930 Pollak (Intl.), Ltd. KDD Class I 1980-10-10
K802213 WHITE KNIGHT BOVIE CORD/SUCTION TUBE G.D. Searle and Co. KKX Class II 1980-10-10
K802280 WHITE KNIGHT DRAPE SEAL G.D. Searle and Co. KKX Class II 1980-10-10
K801965 CUSTOM UNIVERSAL CUTDOWN PREP TRAY American Pharmaseal Div. Ahsc FSM Class I 1980-10-10
K802060 STERILE TONSIL SPONGES Medspec Corp. GDY Class I 1980-10-10
K802027 VIALON SURGEON'S GLOVES Rivefain Corp. KGO Class I 1980-10-10
K801964 CUSTOM LYMPHANGIOGRAM ACCES. PACK-STERI American Pharmaseal Div. Ahsc FSM Class I 1980-10-10
K801925 CABANNA TAN SUNLAMP The Marketing Exchange, Inc. LEJ Class II 1980-10-03
K801585 HESSBURG-BFRRON TREPHINE Precision Instruments, Inc. EMF Class I 1980-10-03
K802192 BOUNDARY SINGLE-USE DRAPES Procter & Gamble Mfg. Co. KKX Class II 1980-09-26
K801976 SCANLAN STERNUM NEEDLE-SUTURE Scanlan Intl., Inc. GAB Class I 1980-09-26
K802025 BALLOON RETENTION CHEST CATHETER Loseff Medical Designers, Ltd. GBA Class I 1980-09-26
K802186 DISPOSABLE NURSES CAP Anago, Inc. FYF Class I 1980-09-26
K802225 TENDER-SORB DRAIN SPONGES Kendall Research Center NAB Class I 1980-09-26
K802093 GABBAY-FRATER SUTURE GUIDE Howmedica Corp. FZX Class I 1980-09-26
K802248 DISARP ORIGINAL Unoplast A/S GAO Class II 1980-09-26
K802247 BOUNDARY SINGLE-USE DRAPES Procter & Gamble Mfg. Co. KKX Class II 1980-09-26
K801699 ETHICON RETRACTION TAPE ETHICON, Inc. GAD Class I 1980-09-26
K802148 BOUNDARY SINGLE-USE DRAPE Procter & Gamble Mfg. Co. KKX Class II 1980-09-26
K801939 RHYTIDOMETER Aztec Medical Products, Inc. FTY Class I 1980-09-26
K802001 LAP SPONGES CAT.#801-850 Pollak (Intl.), Ltd. KKX Class II 1980-09-16
K802050 TACKMER INCISE DRAPE American Convertors Div., American Pharmaseal KKX Class II 1980-09-16
K802019 SUTURE REMOVAL SET CAT.#906 Pollak (Intl.), Ltd. KDD Class I 1980-09-16
K801674 SUN ROOM TANNING BOOTH Sun Tan Enterprises, Inc. LEJ Class II 1980-09-16
K802105 C-BLADE Cutter Laboratories, Inc. HWE Class I 1980-09-16

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