meddevicedb.com FDA Device Reference

Review Panel

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

Cleared Devices
16,323
Product Codes (page)
47
Latest Decision
1988-12-09

Clearances · page 131 of 164

K-Number Trade Name Applicant / Manufacturer Product Code Class Decision Date
K884790 QUALTEX NEUROLOK SURGICAL SPONGE Deroyal Industries, Inc. GDY Class I 1988-12-09
K884456 STERILE DISPOSABLE ENDOCULAR PROBE Biophysic Medical, Inc. GEX Class II 1988-12-09
K884473 RUBIN BONE PLANER W/REPLACEABLE BLADE Neo Contemporary Co. GAC Class I 1988-12-09
K884839 MODIFIED SAW BLADES TO THE SAGITAL SAW Dyonics, Inc. KIJ Class I 1988-12-07
K884836 UNIVERSAL GENERATOR IRRIGATOR MODEL UGI-3000 Meditron Devices, Inc. GEI Class II 1988-12-06
K882431 CONFIDENCE(TM) STERILE, DISP., LATEX SURG. GLOVES Charise Charles, Ltd. KGO Class I 1988-12-02
K881784 KLEIN NEEDLE E.L. Medico Intl., Inc. GDM Class I 1988-12-02
K881783 KLEIN HANDLE E.L. Medico Intl., Inc. GDM Class I 1988-12-02
K884431 HEXASCAN HANDPIECE FOR ARGON/DYE LASER California Laboratories, Inc. GEX Class II 1988-12-02
K883968 TENDERFOOT International Technidyne Corp. FMK Class II 1988-12-01
K884783 RANEY CLIP Alto Development Corp. FZQ Class I 1988-11-30
K882461 O2 CARE Ballard Medical Products KPJ Class II 1988-11-28
K882639 PALMA Kelso Imports KGO Class I 1988-11-25
K884656 DISPOSABLE BIPOLAR CORD AND BIPOLAR FORCEP Dermacare GEI Class II 1988-11-25
K883466 STERILE SURGICAL GLOVES Cal-American Exports, Inc. KGO Class I 1988-11-25
K884029 KTP/532 SURGICAL LASER Laserscope GEX Class II 1988-11-25
K883822 FIRST AID KIT, EYE DRESSING NSN6545-00-853-6309 Consolidated Industries of Greater Syracuse, Inc. HMP Class I 1988-11-22
K884392 KBM DENTAL MASK Kawamoto Bandage Material Co., Ltd. FXX Class II 1988-11-18
K883827 MASKS, VARIOUS TYPES OF SURGICAL MASKS Greene International Corp. FXX Class II 1988-11-17
K884558 IOP ADJUSTABLE STIRRUP Mend Technologies, Inc. BWN Class I 1988-11-17
K884514 FORCEPS, TOWEL, BACKHAUS-TSK (BRAND) TOWEL Gatewood and Associates, Ltd. GEN Class I 1988-11-17
K884512 BEAVER(R) HANDLE Bd Becton Dickinson Vacutainer Systems Preanalytic GDZ Class I 1988-11-17
K884492 MICRO SURGICAL INSTRUMENT SYSTEM Tava Surgical Instruments HSZ Class I 1988-11-16
K883738 CARBON DIOXIDE LASER SYSTEM MODEL 20-CX W/ATTACH. Directed Energy, Inc. GEX Class II 1988-11-15
K873766 STERNAL POWER AWL Bowen & Company, Inc. KIJ Class I 1988-11-14
K884553 STAMEY NEEDLE Cook Ob/Gyn GEJ Class I 1988-11-14
K883705 FACE MASK: COMAS ALSO CHOICE/CONE MASK: POLYMAS Select Sources, Inc. FXX Class II 1988-11-14
K881426 PAN-PRA AID SELF-ADHE. COLLO. COATED BANDAGE Laboratoire Pan-Pra NAD Class I 1988-11-10
K884181 MANUAL SURGICAL INSTRUMENTS (SEVERAL MODELS) Sales & Marketing Assoc. GEN Class I 1988-11-10
K881954 CONCEPT POWER SYSTEM Concept, Inc. HSZ Class I 1988-11-09
K884196 SURGICAL INSTRUMENTS (VARIOUS TYPES & SIZES) Disposable Sterile Surgical Instruments, Inc. HRQ Class I 1988-11-08
K884373 KORBER ARTERIOTOMY SCISSORS Micrins, Ltd. LRW Class I 1988-11-08
K882715 STERILE SURGICAL LATEX GLOVES Plastic Materials of Puerto Rico, Inc. KGO Class I 1988-11-08
K884030 ERGO II, SURGICAL LATEX GLOVES Ergo Intl., Ent., Inc. KGO Class I 1988-11-07
K883541 METALASER VASCULASE Metatech Corp. GEX Class II 1988-11-04
K884060 MEDITEC QL-15 ND:YAG LASER Storz Ophthalmics, Inc. GEX Class II 1988-11-04
K884204 COHERENT EXCELITE CO2 AIR FIBER Coherent Medical Lasers GEX Class II 1988-11-03
K882952 CO2 SURGICAL LASER SYSTEM MODEL #IR106 Niic U.S.A., Inc. GEX Class II 1988-11-02
K882951 CO2 SURGICAL LASER SYSTEM MODEL #IR105 Niic U.S.A., Inc. GEX Class II 1988-11-02
K884343 SONY COLOR VIDEO CAMERAS AND ACCESSORIES Sony Corp. of America FWB Class I 1988-11-01
K884313 MODEL SL45 SURGILASE CO2 SURGICAL LASER SYSTEMS Surgilase, Inc. GEX Class II 1988-10-27
K884311 MODEL SL60 SURGILASE CO2 SURGICAL LASER SYSTEMS Surgilase, Inc. GEX Class II 1988-10-27
K883658 I-SPOSE EYE SHIELD Products For Medicine FXX Class II 1988-10-25
K884171 #875 DISPOSABLE BIOPOLAR CABLE Olsen Electrosurgical, Inc. HAM Class II 1988-10-24
K884173 #920 DISPOSABLE TUR CABLE Olsen Electrosurgical, Inc. HAM Class II 1988-10-24
K884172 MODIFIED OLSEN #770 DISPOSABLE HOLSTER Olsen Electrosurgical, Inc. HAM Class II 1988-10-24
K884195 GENERAL SURGICAL INSTRUMENTS (VARIOUS TYPES) Mumtaz I. Malik GEN Class I 1988-10-24
K884175 #820/821 BIPOLAR FORCEPS Olsen Electrosurgical, Inc. HAM Class II 1988-10-24
K884174 MODIFIED OLSEN 755/756 SWITCHPENS Olsen Electrosurgical, Inc. HAM Class II 1988-10-24
K883892 BALLET STERILE DISPOSABLE ELECTROLYSIS Synoptic Products KCW Class I 1988-10-20
K883642 CODMAN NEUROLASE LASER SYSTEM I.L. Med, Inc. GEX Class II 1988-10-20
K884057 ELAN-E DISPOSABLE DRAPE Aesculap Instruments Corp. KKX Class II 1988-10-19
K884093 STERILE DISPOSABLE SURGICAL PACKS Bolden Surgical Products LRO Class II 1988-10-19
K884095 SCISSORS, WIRE CUTTING Magnatrade Corp. LRW Class I 1988-10-19
K883957 ARTERIAL ANCHOR BANDAGE Guidelines, Inc. FMK Class II 1988-10-18
K883472 CLOSED WOUND SUCTION DEVICE Westmark, Sterile Packing Systems, Inc. (Sps) GCY Class I 1988-10-18
K884019 ALM OPERATING TABLES Alm Surgical Equipment, Inc. FWX Class I 1988-10-13
K883654 STERI-TAG(TM) STERILE LABEL SETS Acacia Laboratories, Inc. LYV Class I 1988-10-13
K884039 MEDICAL DYNAMICS SOLID STATE VIDEO CAMERA 5940 Medical Dynamics, Inc. FWH Class I 1988-10-13
K884092 SURGILASE CO2 SURGICAL LASER SYSTEM MODEL SL80 Surgilase, Inc. GEX Class II 1988-10-13
K884055 SURGI-TAG(TM) STERILE LABEL SETS Acacia Laboratories, Inc. LYV Class I 1988-10-13
K884112 CARETEX OR TOWEL James River Corp. KKX Class II 1988-10-13
K883824 STERILE SURGICAL LATEX GLOVES Intl. Trading Ventures, Inc. KGO Class I 1988-10-13
K883736 STERILE SURGEONS GLOVES Medical Manufacturers Marketing Co. KGO Class I 1988-10-12
K880440 PROTECT-AIDS AUTOPSY UNDERGLOVE Medical Armor Corp. LYU Class I 1988-10-11
K880439 PROTECT-AIDS UNDERGLOVE Medical Armor Corp. LYU Class I 1988-10-11
K884076 SUREBREATH DOME Ipax, Inc. GAD Class I 1988-10-07
K883876 WILLIAMS-FRITTS PLEURAL BIOPSY NEEDLE E.G. Dick & Assoc. GDM Class I 1988-10-07
K883823 BERNSCO ELECTROSURGICAL SHIELD Bernsco Surgical Supply, Inc. GEI Class II 1988-10-04
K884079 MODEL CBX EPILATOR R. A. Fischer Co. Corp. KCW Class I 1988-10-04
K883774 BERNSCO NEEDLE ADAPTER Bernsco Surgical Supply, Inc. GEI Class II 1988-10-04
K883680 MEDALIST EXAMINATION TABLE Hamilton Industries, Inc. LGX Class I 1988-10-04
K882595 MEDICAL GLOVES STERILE LATEX SURGEONS DIGIFORM Marathon Management Co. KGO Class I 1988-10-04
K883828 CONE MASKS, VARIOUS TYPES OF SURGICAL CONE MASKS Greene International Corp. FXX Class II 1988-10-03
K882115 A-SORB Howard Medical Co. NAB Class I 1988-10-03
K883582 VARIDYNE MODEL 250 SUCTION DRAINAGE SYSTEM Surgidyne, Inc. BTA Class II 1988-10-03
K883929 TANNING BED Dallas Tan, Inc. FTC Class II 1988-10-03
K883857 FIBEROPTIC WIRE PICK LIGHTPIPE Advanced Surgical Products, Inc. HBI Class II 1988-09-29
K883856 FIBEROPTIC BLUNT INTEGRAL PICK LIGHTPIPE Advanced Surgical Products, Inc. HBI Class II 1988-09-29
K883858 FIBEROPTIC SHARP INTEGRAL PICK LIGHTPIPE Advanced Surgical Products, Inc. HBI Class II 1988-09-29
K883760 STORZ MODEL 62 ENT CAMERA SYSTEM Storz Instrument Co. FWL Class I 1988-09-28
K883943 CCM-1 VIDEO CAMERA SYSTEM Medical Concepts, Inc. FTS Class I 1988-09-28
K883944 MEC-1 VIDEO COMBO SYSTEM Medical Concepts, Inc. FTS Class I 1988-09-28
K883952 U. V. SUNLAMP 95UF-11 Light Sources, Inc. FTC Class II 1988-09-28
K883429 LINDSTROM CORDLESS EPILATOR A Place of Health & Beauty KCW Class I 1988-09-28
K883089 4000/4900/6000/8000/8900 ND:YAG/1700 ND:YAG C02 Heraeus Lasersonics, Inc. GEX Class II 1988-09-28
K883762 BARD EMS SYSTEMS 3400 & 4400 & DUAL PAD ELECTRODE Bard Electro Medical Systems, Inc. GEI Class II 1988-09-27
K883563 SHARPLAN 2100 ND:YAG LASER, SERIES 2900 SYN. TIPS Sharplan Lasers, Inc. GEX Class II 1988-09-27
K882568 130 CRYO UNIT & ASSOC. CRYOPROBES & SPRAY Spembly Medical , Ltd. GEH Class II 1988-09-27
K883201 VITAL-VUE ILLUMINATION, SUCTION & IRRIGATION SYS Vital Metrics, Inc. HBI Class II 1988-09-26
K880416 WCCS 800 WALLACH CARDIAC CRYOSURGICAL SYSTEM Wallach Surgical Devices, Inc. GEH Class II 1988-09-26
K882654 PHYSIOTRON(TM) MICROSURGICAL MOTOR & COOLING SYS. Surgical Innovators of America, Inc. GEY Class I 1988-09-20
K883613 OPER. TABLE FOR PERCUTAN. TRANS. CORONARY ANGIO. Stierlen-Maquet AG GDC Class I 1988-09-15
K883657 SKID RESISTANT, LONG LASTING SHOE COVERS James River Corp. FXP Class I 1988-09-15
K883255 KOMET SURGICAL BUR Komet Medical, Div. of Brasseler USA I, L.P. GFF Class I 1988-09-15
K883578 S 21 INSTRUMENT STAND Carl Zeiss, Inc. FSH Class I 1988-09-13
K883581 OPMI CS Carl Zeiss, Inc. EPT Class I 1988-09-13
K883396 HANDSWITCHING MONOPOLAR PENCIL New England Surgical Instrument Corp. GEI Class II 1988-09-13
K883485 STRYKER PRESSURE MONITOR SYSTEM Stryker Corp. FTY Class I 1988-09-13
K883474 THORACIC CATHETERS Westmark, Sterile Packing Systems, Inc. (Sps) GBX Class I 1988-09-13

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