meddevicedb.com FDA Device Reference

Review Panel

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

Cleared Devices
16,323
Product Codes (page)
50
Latest Decision
1986-01-13

Clearances · page 142 of 164

K-Number Trade Name Applicant / Manufacturer Product Code Class Decision Date
K854814 SURGICAL CAUTERIES MODELS 775-11,12,13,31,32 & 33 Birtcher Corp. GEI Class II 1986-01-13
K854760 CHURCHHILL LANCET Churchill Corp. FMK Class II 1986-01-03
K854262 MEADOX SURGIMED BREAST LOCALIZATION WIRE SET/ONLY Meadox Surgimed, Inc. FZX Class I 1985-12-24
K854857 SCALPEL, ONE-PIECE, DISPOSABLE Medelec Intl. Corp. GDX Class I 1985-12-24
K854864 BI-POLAR FORCEPS Birtcher Corp. GEI Class II 1985-12-24
K854888 RANDALL CURETTE Euro-Med Intl. FZS Class I 1985-12-24
K854859 BLADES, SCALPEL STAINLESS STEEL Medelec Intl. Corp. GES Class I 1985-12-24
K854892 RULER Euro-Med Intl. FTY Class I 1985-12-24
K854899 NOVAK CURETTE Euro-Med Intl. FZS Class I 1985-12-24
K854860 BLADES, SCALPEL CARBON STEET Medelec Intl. Corp. GES Class I 1985-12-24
K854858 SCALPEL HANDLE Medelec Intl. Corp. GDZ Class I 1985-12-24
K853588 FIBRELIGHT NASAL SPECULA Downs Surgical , Ltd. EPY Class I 1985-12-18
K854620 SURGICAL BLADES Niraj Industries GES Class I 1985-12-17
K854579 HYPODERMIC NEEDLE AND STYLET Berkley and Co. GAA Class I 1985-12-17
K854746 SURGICAL INSTRUMENT TRAY Zbi, Inc. FSM Class I 1985-12-17
K854541 TIP OFF FORCEPS Keller Instruments, Inc. GEN Class I 1985-12-17
K854714 X-RAY DETECTABLE COTTON BALLS American Silk Sutures, Inc. GDY Class I 1985-12-17
K854592 MALIS MICRO BIPOLAR COAGULATOR Valley Forge Scientific Corp. GEI Class II 1985-12-17
K854440 MODIFIED CLINICAL WIDEFIELD SPECULAR MICROSCOPE 50 Keeler Instruments, Inc. HRM Class I 1985-12-16
K851560 PORTASPIR II Roseburg SA BTA Class II 1985-12-13
K854232 PHARMASEAL SCRUB CARE-SURGICAL SCRUB BRUSH SPONGES American Pharmaseal Div. Ahsc GEC Class I 1985-12-10
K854005 DEDO SUCTION CANNULA Dedo Manufacturer, Inc. GEA Class I 1985-12-06
K854027 LASERSCOPE OMNI PLUS PHOTOSURGICAL SYSTEM Laserscope LNK Class II 1985-12-02
K854413 MALIS IRRIGATION SYSTEM Valley Forge Scientific Corp. GEI Class II 1985-12-02
K854561 BLADE, SCALPEL Medelec Intl. Corp. GES Class I 1985-12-02
K854568 V. MUELLER PNEUMO-INTESTINAL 15 VASCULAR & 30 STAP American V. Mueller GEF Class I 1985-12-02
K854292 MEDSURG ARTHROGRAM TRAY Medsurg Industries, Inc. LRO Class II 1985-11-26
K854095 BIOPSY TRAY I & II North Coast Medi-Tek LRO Class II 1985-11-25
K854515 SHAW SUN SYSTEMS 1000, 2000 & 3200 Shaw Sun Systems FTC Class II 1985-11-25
K853917 EGNELL COMPACT SUCTION PUMP Egnell, Inc. BTA Class II 1985-11-25
K853909 EGNELL UNIVERSAL SUCTION PUMP Egnell, Inc. BTA Class II 1985-11-25
K854498 SPECTRA 724 Daavlin Co. FTC Class II 1985-11-25
K854420 MEADOX SURGIMED A/S THREE PIECE SCREW BIOPSY NEEDL Meadox Surgimed, Inc. GDM Class I 1985-11-22
K854424 BARD PARKER 150CC BELLOWS RESERVOIR Bd Becton Dickinson Vacutainer Systems Preanalytic GCY Class I 1985-11-20
K854390 WIRE CUTTING PLIERS OR LINEMAN'S PLIERS Med-Tool, Inc. HTC Class I 1985-11-19
K854418 ROUND SUCTION DRAIN Sil-Med Corp. GBS Class I 1985-11-19
K854159 ELLIPTI-PUNCH Alcon Laboratories FZI Class II 1985-11-15
K854020 G-T 1000 G-T Products FTC Class II 1985-11-15
K854254 TENSION-ISOMETER Medmetric Corp. LXI Class I 1985-11-15
K853968 DIATEMP ELECTROSURGICAL PEN Ndm Corp. GEI Class II 1985-11-14
K854146 SURGICAL & DENTAL INSTRUMENT Baort, Inc. GEN Class I 1985-11-13
K853376 MORGAN SUTURE-DRILL Bowen & Company, Inc. HWE Class I 1985-11-13
K853778 THE DEXTRA PRECISION POWER UNIT Storz Instrument Co. GEY Class I 1985-11-13
K854238 NEEDLE W/STYLET FOR IMPLANTATION Microvasive GAA Class I 1985-11-13
K854327 SUBCUTANEOUS TUNNELING NEEDLES & HANDLES Concord Laboratories, Inc. GCB Class I 1985-11-13
K852470 SURGILASE 40S Surgilase, Inc. GEX Class II 1985-11-13
K854192 ANADIAS NASAL SAW BLADES Anadias, Inc. GFA Class I 1985-11-13
K843628 HOTIP HEMOSTATIC PROBE Trimedyne, Inc. LNK Class II 1985-11-12
K852534 ULTRAVIOLET TREATMENT LAMPS UV-8 & UV-9 R. A. Fischer Co. Corp. FTC Class II 1985-11-08
K854170 I.S.M. PRODUCT FAMILY MODEL R3600C Intl. Solarium Manufacturer, Inc. FTC Class II 1985-11-08
K854224 GOLDEN RULE SUN TANNING BEDS Golden Rule Tanning Co., Inc. FTC Class II 1985-11-08
K854131 PHASE V-MODEL 1500 RUVA Apollo'S Suntanning Supplies FTC Class II 1985-11-08
K854111 EXPRESS TAN SUN CANOPY Sunmaker Tanning Systems, Ltd. FTC Class II 1985-11-08
K854154 FOX BED MODEL 2001 Ace Mfg. FTC Class II 1985-11-08
K854171 I.S.M. PRODUCT FAMILY MODEL P2400C,A & ABC Intl. Solarium Manufacturer, Inc. FTC Class II 1985-11-06
K854004 FLUORESCENT T12 UVA TANNING LAMP Light Sources, Inc. FTC Class II 1985-10-29
K853846 SUN TANNING BED Tan America Mfg. FTC Class II 1985-10-29
K853904 ENDO-LASE CD40 FOR UROLOGY Endo Lase, Inc. GEX Class II 1985-10-25
K853874 ENDO-LASE CD-100 CO2 LASER FOR EXTERNAL GENITALIA- Endo Lase, Inc. GEX Class II 1985-10-25
K853833 TOP SUN MODELS 100,101,103 &139, 139-1, 139-3 Top Sun America, Inc. FTC Class II 1985-10-24
K853752 SUN KING American Chase Company, Inc. FTC Class II 1985-10-21
K853911 UV-A SUNTANNING EQUIPMENT Eurotan Intl. FTC Class II 1985-10-21
K853980 EROSA DISPOSABLE HYPODERMIC NEEDLE Rose KG GAA Class I 1985-10-18
K844178 MODEL TT25RF Inframed, Inc. GEX Class II 1985-10-18
K853720 MOBILE OPERATING TABLE FOR ORL MICROSURGERY Carl Zeiss, Inc. GDC Class I 1985-10-18
K853945 CUI RHINOPLASTY IMPLANTS Cox-Uphuff Intl. FZE Class II 1985-10-18
K854003 STERILE SOFT TISSUE BIOPSY NEEDLE Co-Medical, Inc. GEE Class I 1985-10-18
K853948 MINNESOTA SCIENTIFIC, INC. OMNI-BEAM Minnesota Scientific, Inc. HBI Class II 1985-10-16
K853436 H-H HUNTER PASSIVE TENDON IMPLANT Holter-Hausner Intl. HXR Class I 1985-10-16
K853947 OMNI-TRACT CHEST WALL & LUNA RETRACTOR Minnesota Scientific, Inc. GAD Class I 1985-10-16
K853855 XTAL X-150 OPERATING MICROSCOPE Xtal Corp. HRM Class I 1985-10-15
K852942 WORLD PORTABLE CAUTERY Sturgeon Engineering Co. GEI Class II 1985-10-10
K853472 FINGER TOURNIQUETTE Joseph B. Marogil GAX Class I 1985-10-10
K852935 ESCHMANN ELECTROSURGICAL UNIT, MODEL TD411 Eschmann Bros. & Walsh , Ltd. GEI Class II 1985-10-10
K853291 GP-100 ADULT ELECTROSURGICAL GROUND PAD/200 & 300 Bio-Detek, Inc. HAM Class II 1985-10-10
K853910 SUTURE REMOVAL KIT Scientific & Medical Care Co. KDD Class I 1985-10-08
K853742 GAUZE SPONGE South Mountain Medical GDY Class I 1985-10-08
K851405 TRIMEDYNE MEDICAL ARGON LASER SYSTEM MODEL 700 Trimedyne, Inc. GEX Class II 1985-10-07
K853802 ATS 500 TOURNIQUET Aspen Laboratories, Inc. KCY Class I 1985-10-07
K853796 RAYLOR RETRACTORS Cedar Surgical, Inc. GAD Class I 1985-10-07
K852860 MODEL 920 ARGON/DYE LASER-FOR DERMATOLOGICAL/USE Coherent Medical Group GEX Class II 1985-10-07
K853762 ISOMETRIC ACL DRILL GUIDE Orthopedic Systems, Inc. GEY Class I 1985-10-07
K853761 DRILLING TEMPLATE Orthopedic Systems, Inc. GEY Class I 1985-10-07
K853545 FLOURESCENT T12 UVA TANNING LAMP Light Sources, Inc. FTC Class II 1985-10-01
K853692 SUN TANNING BED MODEL EC-3RF Mottek Intl. Corp. FTC Class II 1985-10-01
K853679 SUNJET MODELS 240/280 Sunjet Manufacturer, Inc. FTC Class II 1985-10-01
K853587 UVATAN INDUS. UVATAN 900C, 900B/800 & 600C Uvatan Industries , Ltd. FTC Class II 1985-10-01
K853489 DEXTRA PRECISION POWER SYSTEM Chattanooga Group, Inc. HWE Class I 1985-09-30
K853822 AMOENA BREAST FORMS Coloplast Corp. GBI Class I 1985-09-30
K853678 KAMBIN SPINAL INSTRUMENT SET Pilling Co. HTZ Class I 1985-09-24
K853658 BURS FOR MICRO SURGICAL DRILL SYSTEM Acumed Instruments Corp. GFF Class I 1985-09-24
K853528 STAINLESS STEEL & CARBON STEEL STERILE BLADES Abco Dealers, Inc. GES Class I 1985-09-24
K853186 SILASTIC INFLATABLE BONE PLUG H.P. Dow Corning Corp. Healthcare Industries Materials LZN Class II 1985-09-24
K853597 INSTRUMENT MAKAR DISPOSALBE LOOP Instrument Makar, Inc. KDC Class I 1985-09-23
K853319 MINI-HALO(HAND-HELD) CO2 LASER SYSTEM Directed Energy, Inc. GEX Class II 1985-09-19
K852696 FOR USE IN GENERAL & PLASTIC SURGERY & DERMATOLOGY Minnesota Laser Corp. GEX Class II 1985-09-19
K853600 INFLATABLE AIR SPLINTS Hospitak, Inc. FZF Class I 1985-09-19
K853650 AUTO SUTURE TITANIUM HEMOSTATIC CLIP United States Surgical, A Division of Tyco Healthc FZP Class II 1985-09-19
K850946 SURGICAL ASPIRATOR Medicalex BTA Class II 1985-09-16
K853583 MODERN MEDICAL PRODUCTS TOWEL CLAMP Modern Medical Products GDJ Class I 1985-09-16

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