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GEX

2,872 FDA 510(k) clearances · Product code

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RecordFirmDateBuilder
ARGON CURING LASER (K942204)Bio-Laser Technology, Inc.1994-08-26+ Add
SHARPLAN MODEL 1080S CO2 SURGICAL LASER (K933918)Sharplan Lasers, Inc.1994-08-25+ Add
SIDE-FIRING UROLOGIC REFRACTIVE FIBER (K943409)Energy Life Systems Corp.1994-08-23+ Add
LASER GAS MIXTURE (K942865)Nordan Smith Welding Supplies1994-08-23+ Add
CONBIO MEDALEX LASER SYSTEM (K935631)Continuum Biomedical, Inc.1994-08-23+ Add
PULSEMASTER S SERIES (K943693)Incisive Technologies, Inc.1994-08-22+ Add
SMARTSCAN (K941841)Laserscope1994-08-15+ Add
RIGHT ANGLE UROLOGIC LASER FIBER (K943491)Surgitek1994-08-05+ Add
PULSEJET DENTAL LASER SYSTEM (K942217)Incisive Technologies, Inc.1994-08-03+ Add
IRIS G-PROBE (K915236)Iriderm Div.1994-07-28+ Add
CANDELA Q-SWITCHED, FREQUENCY DOUBLED ND;YAG LASER SY (K942152)Candela Laser Corp.1994-07-25+ Add
ECLIPSE 3200 (K943311)Cardiogenes1994-07-22+ Add
LASEAWAY Q-SWITCHED RUBY LASER SYSTEM (K942343)Polytec Pi, Inc.1994-07-08+ Add
COHERENT VERSAPULSE 2.1U /1.06U COMPACT SURGICAL LASER, MODELS A & B (K933318)Lumenis, Inc.1994-07-08+ Add
MEGABEAM DENTAL FIBER (K942182)Ceram Optec, Inc.1994-07-06+ Add
ZEISS OPMILAS 144 SURGICAL LASERS (K942439)Zeiss Humphrey System1994-07-01+ Add
SHARPLAN SWIFTLASE 765/766/767 FLASHSCAN (K941312)Sharplan Lasers, Inc.1994-06-30+ Add
OPTILASE MODEL 1000-100 ND: YAG LASER SYSTEM (K932883)Trimedyne, Inc.1994-06-21+ Add
DISPOSABLE SPINAL INTRODUCER SHEATH (K941419)Trimedyne, Inc.1994-06-21+ Add
ALEXANTRIPTOR (K940461)Servicetrends, Inc.1994-06-02+ Add
CONBIO MEDLITE Q-SWITCHED ND:YAG LASER SYSTEM (K940636)Continuum Biomedical, Inc.1994-05-31+ Add
CONBIO MEDLITE Q-SWITCHED ND:YAG LASER SYSTEM (K940607)Continuum Biomedical, Inc.1994-05-31+ Add
MEGA BEAM LATERAL FIRE (K941909)Hogan & Hartson1994-05-23+ Add
SHARPLAN SURGICAL CO2 LASERS AND ACCESSORIES (K935563)Sharplan Lasers, Inc.1994-05-17+ Add
SHARPLAN MODEL 1120 CO2 SURGICAL LASER (K936109)Sharplan Lasers, Inc.1994-05-17+ Add
CYTOCARE DIODE LASER SYSTEM (K934211)Cytocare, Inc.1994-05-17+ Add
OMNIPULSE MODEL 1210-VHP HO:YAG LASER SYSTEM (K934865)Trimedyne, Inc.1994-05-12+ Add
ISL QC 2000 LASER (K941694)Intelligent Surgical Lasers, Inc.1994-05-12+ Add
COHERENT VERSAPULSE 2.1 HOLMIUM SURGICAL LASERS (K932981)Coherent Medical Group1994-05-02+ Add
CANDELA PLTL-1 LASER SYSTEM: PIGMENTED LESION LASER AND TATULAZR (K934706)Candela Laser Corp.1994-04-29+ Add
ULTRALINE II STERILE DISPOSABLE FIBER (K933245)Heraeus Lasersonics, Inc.1994-04-21+ Add
D'AMICO\PEYMAN FLUTED ENDOPROBE (K933211)Iriderm Div.1994-04-19+ Add
PF404/409/410/411/416/418 W/PF319:0/319:1/319:2 (K935495)Perimed, Inc.1994-04-18+ Add
SLT REFLECTING PROBE (K934209)Surgical Laser Technologies, Inc.1994-04-08+ Add
SHARPLAN CO2 SURGICAL LASER (K933362)Laser Industries , Ltd.1994-04-07+ Add
COOL LASER OPTICS (CLO) UNIT (K934486)Cyruschess1994-03-24+ Add
OPHTHALAS 532 SOLID STATE PHOTOCOAGULATOR (K932062)Alcon Laboratories1994-03-18+ Add
CYNOSURE PHOTOTOME SURGICAL DIODE LASER (K935305)Cynosure, Inc.1994-03-18+ Add
CANDELA SPTL PULSED DYE LASERS (K931762)Candela Laser Corp.1994-03-15+ Add
PEGASUS (K925178)Premier Laser Systems, Inc.1994-03-14+ Add
SHARPLAN ND:YAG SURGICAL LASER, MODEL 3060 SHARPLASER 60 (K926543)Sharplan Lasers, Inc.1994-03-09+ Add
MEGABEAM RADIAL EMIT SHAPE FIBER OPTIC DELIV SYST (K924258)Ceram Optec, Inc.1994-03-09+ Add
RQM-1005 INTEGULASER RUBY MEDICAL LASER SYSTEM (K933140)Laser Photonics, Inc.1994-03-02+ Add
OPTILASE ND:YAG MODELS 1000/4000 SURG LASER SYSTEM (K922497)Trimedyne, Inc.1994-03-01+ Add
TRIMEDYNE MODEL 1210 OMNIPULSE HOLMIUM LASER SYST (K922496)Trimedyne, Inc.1994-03-01+ Add
INFINITECH OTOPROBE (K931264)Infinitech, Inc.1994-03-01+ Add
TRIMEDYNE MODEL 1210 OMNIPULSE HOLMIUM LASE SYST (K925124)Trimedyne, Inc.1994-03-01+ Add
LASERSONICS CLEARPULSE MODELS 50, 70 & 100 CO2 SURGICAL LASER SYSTEMS (K935775)Heraeus Surgical, Inc.1994-03-01+ Add
LATERALASE CATHETER (K925414)Trimedyne, Inc.1994-03-01+ Add
DIOMED 25 25W SURGICAL DIODE LASER (K933525)Dio-Med Corp.1994-03-01+ Add
EXCEL'S EST-30 HO:YAG LASER SYSTEM (K932730)Excel Tech. , Ltd.1994-03-01+ Add
SL SERIES SURGICAL LASER SYSTEMS (K933880)Laserscope1994-02-25+ Add
MODIFIED SHARPLAN 1041 (K923605)Sharplan Lasers, Inc.1994-02-23+ Add
CANDELA PLTL-1 LASER SYSTEM (K933016)Candela Laser Corp.1994-02-09+ Add
BIO QUANTUM TECHNOLOGIES, INC. HAND-HELD CO2 LASER SYSTEM MODEL HH-550S (K934089)Bio Quantum Technologies, Inc.1994-02-03+ Add
UROTEK LASER CATHETER (K934389)Energy Life Systems Corp.1994-02-03+ Add
CONBIO CUB-D10 COPPER LASER SYSTEM (K932723)Buckman Co., Inc.1994-02-03+ Add
HYBRID SURGICAL DEVICE MODIFICATION (K935258)Lca, Inc.1994-01-13+ Add
SLASE 210 & SLASE 210 PLUS HOLMIUM LASER SYSTEMS (K933007)Sunrise Technologies, Inc.1994-01-10+ Add
ECLIPSE 3200 FOR USE IN UROLOGY APPLICATIONS (K931305)Cardiogenes1994-01-07+ Add
MEGABEAM LATERAL FIRE FIBER OPTIC DELIVERY SYST (K934008)Ceram Optec, Inc.1994-01-03+ Add
MEDICAL LASER MIXTURE (K935310)Acetylene Gas Co.1993-12-23+ Add
ZEISS OPMILAS 144 SURGICAL LASERS (K932376)Carl Zeiss, Inc.1993-12-14+ Add
LASER GAS MIXTURE (K935034)Tri-Gas, Inc.1993-12-14+ Add
TRUE FLOW(TM) VALVE (K930611)Gm Engineering, Inc.1993-12-01+ Add
ALLOY SCALPEL HANDPIECES, MODIFICATION (K925726)Lca, Inc.1993-11-22+ Add
ZEISS VISULAS YAG II LASER (K926452)Carl Zeiss, Inc.1993-11-22+ Add
BOSTON SCIENTIFIC CORPORATION SIDE FIRING LASER GUIDE (K933715)Boston Scientific Corp1993-11-22+ Add
ECLIPSE LAZERBLADE(TM) FIBEROPTIC DELIVERY SYSTEM (K934935)Cardiogenes1993-11-22+ Add
ORION YAG LASER SYSTEM OPHTHALMOLOGY (K910826)Pfizer Laser Systems1993-11-16+ Add
ORION (K911288)Pfizer Laser Systems1993-11-16+ Add
SHARPLAN SHARPLASE LATERAL ND:YAG FIBER (K930582)Sharplan Lasers, Inc.1993-11-02+ Add
DIOMED 25 25W SURGICAL DIODE LASER (K931776)Dio-Med Corp.1993-10-19+ Add
MULTILINE; DLY-1 (K932156)Derma-Lase Co.1993-10-15+ Add
ZEISS OPMILAS 144 SURGICAL LASERS (K933322)Carl Zeiss, Inc.1993-10-15+ Add
SURGILASE/OP 15, 20, 25, 30, 40, 50 CO2 SURG. LASE (K932421)Surgilase, Inc.1993-10-15+ Add
CLOSED END/ELECTROCAUTERY FIBEROPT LASER DELIV SYS (K932272)Lc Ent.1993-10-12+ Add
VISIDISC KITS, SPINESCOPE (K924720)Laserscope1993-10-08+ Add
CLOSED END FIBEROPTIC LASER DELIVERY SYSTEM (K931070)Lca, Inc.1993-10-05+ Add
COHERENT VERSAPLUSE 2.1 HOLMIUM SURG. LASERS (K923575)Coherent Medical Group1993-09-29+ Add
SHARPLASE SHORT FIBER ND:YAG DELIVERY SYSTEM (K931978)Sharplan Lasers, Inc.1993-09-23+ Add
DIOMED 25 25W SURGICAL DIODE LASER (K931212)Dio-Med Corp.1993-09-23+ Add
HGM SCANMAN PLUS (K933333)Hgm, Inc.1993-09-23+ Add
NOVUS MULTIWAVELENGTH (K932468)Coherent Medical Group1993-09-22+ Add
DIOMED 25 SURGICAL DIODE LASER, GYNECOLOGY APPLIC (K914519)Dio-Med Corp.1993-09-16+ Add
ZEISS DIODE-PUMPED SOLID STATE LASER (K925642)Carl Zeiss, Inc.1993-09-13+ Add
ECLIPSE 2100(TM) MODEL 32, MODIFICATION (K931101)Cardiogenes1993-08-25+ Add
MULTILINE; DLY-1 (K930793)Derma-Lase Co.1993-08-19+ Add
DERMA-LASE DLA-1 LASER (K930975)Derma-Lase Co.1993-08-19+ Add
Q-11 OPHTHALMIC LASER (K931499)Hgm, Inc.1993-08-19+ Add
SHARPLAN 2100,3000,SHARPLASER 65, 40 (K920865)Sharplan Lasers, Inc.1993-08-02+ Add
ECLIPSE 3200 (K926210)Cardiogenes1993-07-28+ Add
LASER HANDPIECE SHROUD (K930099)I.C Medical, Inc.1993-07-28+ Add
ACCULITE(TM) OTOPROBE (K930981)Coherent Medical Group1993-07-28+ Add
SPECULUM SMOKE EVACUATOR TUBING (K930098)I.C Medical, Inc.1993-07-28+ Add
MODEL 5030 SUCTION HANDPIECE SYSTEM (K933017)Sunrise Technologies, Inc.1993-07-26+ Add
ECLIPSE 3200 FOR USE IN ORTHO SURG/ARTH APPL JOINT (K931306)Cardiogenes1993-07-23+ Add
UPGRADED PACKAGE FOR DLASE 300 PULSED DENTAL LASER (K931774)Sunrise Technologies, Inc.1993-07-22+ Add
DLASE 300 UPGRADE (K932065)Incirt Tech., Inc.1993-07-22+ Add
DIOMEDICS SURGI LIGHT/LIGHT TOUCH OPTICAL FIBERS (K926224)Diomedics, Inc.1993-07-22+ Add
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