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GEX

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

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RecordFirmDateBuilder
LASER DELIVERY SYSTEMS, FIBEROPTICS & CONTACT TIPS (K900463)Ximed Medical Systems1990-03-22+ Add
SHARPLAN FLEXIBLE CO2 SURGICAL LASER APPLICATOR (K900076)Sharplan Lasers, Inc.1990-03-22+ Add
SHARPLAN ND:YAG DISPOSABLE FIBER DELIVERY SYSTEM (K900153)Sharplan Lasers, Inc.1990-03-19+ Add
FLEXIGUIDE(TM) CO2 LASER HOLLOW FLEXIBLE FIBER (K900066)Luxar Corp.1990-03-19+ Add
DISPOSABLE FIBER OPTIC DELIVERY SYSTEM FOR ND:YAG (K896939)Fiber Delivery Concepts, Inc.1990-03-08+ Add
MODEL JM-1 CO2 LASER (K892912)L.A.S.E.R., Inc.1990-03-06+ Add
SHARPLAN 1041 SEALED-OFF CO2 SURGICAL LASER SYSTEM (K900077)Sharplan Lasers, Inc.1990-03-06+ Add
ACCU-BEAM WAVEGUIDE (K895656)Tti Medical1990-02-22+ Add
OPTILASE YAG MODEL 1000 ACV SURGICAL LASER SYSTEM (K897157)Trimedyne, Inc.1990-02-22+ Add
SHARPLAN ND:YAG LASER FOR ARTHROSCOPY/MENISCECTOMY (K896762)Sharplan Lasers, Inc.1990-02-16+ Add
MODEL 2800 ND:YAG OPHTHALMIC LASER (K897099)Alcon Surgical, Inc.1990-02-16+ Add
LUXAR ENDOGUIDE CO2 LASER WAVEGUIDE (NEURO.) (K897040)Luxar Corp.1990-02-13+ Add
BISTAT ELECTROSURGICAL UNIT 60-5400-001 (K896838)Aspen Laboratories, Inc.1990-02-13+ Add
ILLUMINA MODELS 30, 40 & 55 CO2, MILLIWATT POWER (K896517)Heraeus Lasersonics, Inc.1990-02-09+ Add
QUARTZ FIBER CATHETERS AND SURGICAL TIPS (K900144)Pfizer Laser Systems1990-02-09+ Add
LUXAR MODEL LX-20 MINILASE CO2 LASER (K896478)Luxar Corp.1990-02-08+ Add
KTP/532 SURGICAL LASER FOR PERCUTANEOUS DISKECTOMY (K896183)Laserscope1990-02-02+ Add
GAS MIXTURES AS DEVICE COMPONENTS (K896412)Spectra Gases, Inc.1990-02-01+ Add
SHARPLAN 1030 SEALED CO2 SURGICAL LASER SYSTEM (K896847)Sharplan Lasers, Inc.1990-01-24+ Add
NIIC LASER SYSTEM (K896988)Niic U.S.A., Inc.1990-01-23+ Add
35 WATT SURGICAL CARBON DIOXIDE LASER SYSTEM (K896049)Pfizer Laser Systems1990-01-11+ Add
LUXAR ENDOGUIDE CO2 LASER WAVEGUIDE (K896595)Luxar Corp.1990-01-09+ Add
LIST DERMATOLOGY/PLASTIC SURGERY AS USE ENDOGUIDE (K896619)Luxar Corp.1990-01-09+ Add
LISTING PODIATRY AS INTENDED USE FOR ENDOGUIDE (K896711)Luxar Corp.1990-01-09+ Add
LIST GENERAL SURGERY AS INTENDED USE FOR ENDOGUIDE (K896618)Luxar Corp.1990-01-09+ Add
LISTING ENT AS INTENDED USE FOR ENDOGUIDE (K896617)Luxar Corp.1990-01-09+ Add
OPTILASE YAG MODEL 1000 (K895874)Trimedyne, Inc.1990-01-03+ Add
GYN-PROBE (K895774)Trimedyne, Inc.1990-01-03+ Add
MEDILASE SYSTEM 2010L LASER LITHOTRIPTOR (K895837)Medical Laser, Inc.1989-12-14+ Add
STERILE DISPOSABLE INFRATIP (K895918)Heraeus Lasersonics, Inc.1989-12-14+ Add
MODEL: IR205 ARTICULATED SURGICAL LASER (K895581)Niic U.S.A., Inc.1989-12-13+ Add
SITE 810E PHOTOCOAGULATOR AND ACCESSORIES (K895663)Site Microsurgical Systems, Inc.1989-12-04+ Add
COHERENT HOLMIUM:YAG SURGICAL LASER (K895518)Lumenis, Inc.1989-11-30+ Add
HERAEUS LASERSONICS ND:YAG LASER, MODEL LUXUS 100 (K895430)Heraeus Lasersonics, Inc.1989-11-28+ Add
MODEL IR103 SURGICAL LASER SYSTEM (K895247)Niic U.S.A., Inc.1989-11-16+ Add
MODEL NUMBER: IR204 CO2 SURGICAL LASER SYSTEM (K892359)Niic U.S.A., Inc.1989-11-16+ Add
MODEL IR107 50-WATT CARBON-DIOXIDE SURGICAL LASER (K895239)Niic U.S.A., Inc.1989-11-16+ Add
SURGIPROBES AND SURGISCALPES IN HEAD/NECK SURGERY (K894471)Surgilase, Inc.1989-11-14+ Add
LASERMATIC COMBOLASER MODEL 5050 (K895279)Lasermatic OY1989-11-08+ Add
ENDOGUIDE PRODUCT LINE: EX0120, EX0300 AND EX0400 (K895786)Luxar Corp.1989-10-27+ Add
LASERMEDIC 1200 RUBY LASER SYSTEM (K895299)Lasermetrics, Inc.1989-10-24+ Add
MODIFIED ENDOGUIDE (K895559)Luxar Corp.1989-10-20+ Add
ILLUMINA MODEL 25, 40 AND 55 CO2 LASER SYSTEMS (K895263)Heraeus Lasersonics, Inc.1989-10-20+ Add
MICRORUPTOR III SYSTEM, CW ARGON LASER COMPONENT (K895348)Lasag Medical Lasers1989-10-20+ Add
SLT CONTACT LASER SYSTEMS FOR PHOTOCOAGULATION (K895029)Surgical Laser Technologies, Inc.1989-10-16+ Add
OPTILASE YAG MODEL 1000 SURGICAL LASER SYSTEM (K894977)Trimedyne, Inc.1989-10-10+ Add
GYNEGUIDE (K894591)Marlo Surgical Technology1989-10-10+ Add
POW-IR TIP (K895073)Living Technology, Inc.1989-10-10+ Add
SHARPLAN MODEL 710 MICROSPOT (K895746)Sharplan Lasers, Inc.1989-10-05+ Add
IRIS OCULIGHT(TM) SL (K894841)Iriderm Div.1989-10-05+ Add
NIDEK MODEL ADC-8000 (K894709)Nidek, Inc.1989-10-04+ Add
CO2 LASER BRONCHOSCOPE COUPLER (K894962)Cuda Products Co.1989-09-28+ Add
SHARPLAN CO2 LASERS FOR ARTHROSCOPIC SURGERY (K895042)Sharplan Lasers, Inc.1989-09-27+ Add
COHERENT XA-50, X30/CW, XA30/SP SURGICAL LASERS (K895143)Lumenis, Inc.1989-09-25+ Add
SLT CONTACT LASER SYSTEMS (K895093)Surgical Laser Technologies, Inc.1989-09-18+ Add
SURGIFLEX LASER CONTACT TIPS (K894186)Cabot Medical Corp.1989-09-12+ Add
MODELS 4000,4900,6000,8000,8900 ND YAG 1700ND (K894164)Heraeus Lasersonics, Inc.1989-08-29+ Add
CO2 SURGICAL LASER SYSTEM (K894074)Niic U.S.A., Inc.1989-08-24+ Add
EAGLE LASER, SURGICAL, NEODYMIUM DOPED YTTRIUM (K893956)Living Technology, Inc.1989-08-10+ Add
SHARPLAN SERIES 2900 SYNTHETIC CONTACT TIPS (K894211)Sharplan Lasers, Inc.1989-08-10+ Add
SHARPLAN SERIES 2900 SYNTHETIC CONTACT TIPS (K894210)Sharplan Lasers, Inc.1989-08-10+ Add
SHARPLAN CO2 LAPAROSCOPIC PROBE MODEL 792 TO 792BX (K894066)Sharplan Lasers, Inc.1989-08-10+ Add
CO2 LASER SYSTEMS & ARTHROGUIDE CO2 LASER FIBER (K893832)Heraeus Lasersonics, Inc.1989-08-09+ Add
SURGILASE 25, 40, 45, 55, 60, 80, 100 LASER (K894396)Surgilase, Inc.1989-08-07+ Add
OPMILAS CO2-L (K894393)Carl Zeiss, Inc.1989-07-27+ Add
MODIFIED ENDOGUIDE (K893642)Luxar Corp.1989-07-14+ Add
INFRALASE-LASERGUIDE DELIVERY SYSTEM (K892933)Ximed Medical Systems1989-06-22+ Add
SLT CONTACT LASER SYSTEM (K893701)Surgical Laser Technologies, Inc.1989-06-21+ Add
SHARPLAN 1075 CO2 LASER (K893206)Sharplan Lasers, Inc.1989-06-21+ Add
CANDELA PLDL-1 PULSED DYE LASER (K892516)Candela Laser Corp.1989-06-15+ Add
COMBOLASER MODEL 5050 (K893529)Lasermatic, Inc.1989-06-08+ Add
LASERCOMP MODEL: 10 STAR 10 (K885170)Laser-West1989-06-05+ Add
EAGLE - NEODYUMIUM DOPED YTTRIUM ALUMINUM GARNET (K885257)Living Technology, Inc.1989-06-05+ Add
PEGASUS (K885060)Pfizer Laser Systems1989-06-02+ Add
LIGHT-TOUCH/GS 905250 ND:YAG LASER MICRO PRO ENDOS (K891909)Lifestream Int'L, Inc.1989-05-26+ Add
LUXAR ENDOGUIDE CO2 LASER WAVEGUIDE (K893013)Luxar Medical Laser Instruments1989-05-23+ Add
LIGHT-TOUCH LAPAROSCOPIC MODEL 905200 FIBEROPTIC (K891130)Lifestream Int'L, Inc.1989-05-23+ Add
HERAEUS LASERSONIC INC. STERILE DISPOSABLE FIBERS (K892211)Heraeus Lasersonics, Inc.1989-05-19+ Add
ACCU-BEAM YAG FIBER (K890922)Tti Medical1989-05-15+ Add
SLT CONTACT LASER SYSTEMS (GYNECOLOGY) (K892346)Surgical Laser Technologies, Inc.1989-05-01+ Add
SLT CONTACT LASER SYSTEMS (NEUROSURGERY) (K892345)Surgical Laser Technologies, Inc.1989-04-27+ Add
INFRALASE - LASERGUIDE DELIVERY SYSTEM (K890775)Ximed Medical Systems1989-04-21+ Add
SHARPLAN MODEL 1050 SEALED-OFF CO2 SURGICAL LASER (K890287)Sharplan Lasers, Inc.1989-04-12+ Add
SURGILASE YAG 100 SURGICAL ND:YAG LASER/GEN SURG (K891461)Surgilase, Inc.1989-04-06+ Add
SLT CONTACT LASER SYSTEM (ORTHOPEDICS) (K890321)Surgical Laser Technologies, Inc.1989-04-05+ Add
SHARPLAN MODEL 750 REMOTE CONTROL UNIT (RCU) (K890286)Sharplan Lasers, Inc.1989-04-05+ Add
SLT CONTACT LASER SYSTEM (ENT, HEAD & NECK SURG.) (K890322)Surgical Laser Technologies, Inc.1989-04-05+ Add
HEXASCAN SCANNER HANDPIECE (K890865)Metatech Corp.1989-03-24+ Add
MODIFIED LABELING PACKAGING SHARPLAN 2100 STERILE (K891088)Sharplan Lasers, Inc.1989-03-17+ Add
MICROLASE CO2 LASER MICROMANIPULATOR (K891126)Ximed Medical Systems1989-03-17+ Add
SHARPLAN MODEL 2106 (K891016)Sharplan Lasers, Inc.1989-03-13+ Add
MODIFIED LABELING & PACKAGING OF SHARPLAN 2100 (K890040)Sharplan Lasers, Inc.1989-02-14+ Add
MODIFIED MODEL 1000 OPTILASE(TM) ND:YAG LASER (K890279)Trimedyne, Inc.1989-02-07+ Add
SHARPLAN COMBINED CO2/ND:YAG LASER MICRO. #749 (K890059)Sharplan Lasers, Inc.1989-02-06+ Add
MODEL 20-CH CARBON DIOXIDE LASER W/ACCESSORIES (K885291)Pfizer Laser Systems1989-02-03+ Add
SLT CLMD CONTACT LASER SYSTEM (ADDIT. INDICATION) (K890174)Surgical Laser Technologies, Inc.1989-01-26+ Add
SURGILASE YAG 100 SURGIPROBES & SURGISCALPEL (K884182)Surgilase, Inc.1989-01-24+ Add
MODELS 4000/4900/6000/8000/8900 ND:YAG & 1700 CO2 (K883379)Heraeus Lasersonics, Inc.1989-01-24+ Add
(HLI) CARBON DIOXIDE SYSTEMS W/INFRAGUIDE CO2 (K885181)Heraeus Lasersonics, Inc.1989-01-10+ Add
LIVING TECHNOLOGY LASER CONTACT TIPS (K884682)Living Technology, Inc.1989-01-05+ Add
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