Atlas FDA

Ophthalmic

4,750 FDA 510(k) clearances · Medical specialty

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RecordFirmDate
EYE SURGERY INSTRUMENT (K840101)Truline Instruments, Inc.1984-03-16
EYE SPONGE OR SPEAR (K834356)Jedmed Instrument Co.1984-03-16
ERGO DIAGNOSTIC CARD (K834145)American Ergo Systems1984-03-16
ANTERIOR CAPSULECTOMY CYSTITOME (K840659)Sharpoint, Inc.1984-03-16
EYE SPEAR (K840471)Surgicot, Inc.1984-03-16
ARGON/KRYPTON ION LASER PHOTOCOAGULA (K834305)Nidek, Inc.1984-03-16
STERILIZED DISPOS. CYSTOTOME (K840442)Microsurgical Technology, Inc.1984-03-16
CATEGORY 6 OPTHALMIC DEVICES (K840310)Imm Enterprises , Ltd.1984-03-16
MICRO FORCEPS (K834355)Jedmed Instrument Co.1984-03-16
PLASTIC OPTICAL LENS M-110 (K834261)U-Molde Systems, Inc.1984-03-16
DISPOSABLE FIBER OPTIC ILLUMINATOR (K833465)CooperVision, Inc.1984-03-15
I/A PLUS PAK SURGICAL SYSTEM (K833961)Ipax, Inc.1984-03-12
KPE PLUS-PAK SURGICAL SYSTEM (K833962)Ipax, Inc.1984-03-12
DOWNING SPECTRAL ILLUMINATOR (K833446)Vision Health Technology1984-03-12
DOWING OPHTHALMIC CHAIR AC-POWERED (K833539)Vision Health Technology1984-03-05
JAKOBI SURG. INSTRUMENTS #6 50 (K834187)Imm Enterprises , Ltd.1984-03-05
DISPOS. I/A & IRRIGATION HANDPIECES (K833783)CooperVision, Inc.1984-03-05
PHAKO SYSTEMS VIA 2000 (K833642)Pharosystems, Inc.1984-03-05
DOWING OPHTHALMIC CHAIR-NON/AC POWER (K833538)Vision Health Technology1984-03-05
TEXAS BIO SCAN (K833694)Texas Bio Scan1984-03-02
DISPOSABLE I/A HANDPIECE (K833784)CooperVision, Inc.1984-02-21
OMYL -ARDE- SPECTACLE FRAME (K833401)I.J. Langleb , Ltd.1984-02-21
OCUMAP 100 AUTOPERIMETER (K832555)Shorashim1984-02-10
CROUCH CORNEAL PROTECTOR (K833256)Star Instrument Co.1984-02-08
RELIANCE OPHTHALMIC SLIT LAMP R-083 (K834060)F. & F. Koenigkramer1984-02-04
OCULASE 514 OPHTHALMIC ARGON LASER (K833532)Lasermed Corp.1984-02-04
MODEL 150K LASER COAGULATOR (K832089)Lasertek OY1984-01-30
ARGON LASER SYS-MODEL 5000 (K832703)Cooper Medical Corp.1984-01-30
LASER PHOTOCOAGULATOR 1520-A & K (K833533)Britt Corp., Inc.1984-01-30
OPHTHALMIC ARGON LASER #700A (K832316)Laser Industries , Ltd.1984-01-30
SUN BED BY VERRE ET QUARTZ UVA-FRANCE (K833229)H & M Douglas Enterprises, Inc.1984-01-27
GELENDER VACUUM FIXATION RING SYS (K832912)Miami Eye Technology, Inc.1984-01-10
STERILE OIL AND GUIDEWIRE (K833671)CooperVision, Inc.1984-01-10
IRRIGATION ASPIRATION KIT (K833405)American Medical Optics1984-01-06
MACHEMER/TANO ROTATING (K833820)Optical Micro Systems, Inc.1984-01-04
DOT VISUAL ACVITY TEST 2000 (K833956)Good-Lite Co.1984-01-04
TESTING VISUAL ACUITY (K833778)Technical Enginuities Co.1984-01-04
OSCAR COLOUR VISION TESTER (K832843)Keeler Instruments, Inc.1984-01-04
M.S.D. ASPIRATOR (K832529)Medical Surgical Designs1984-01-04
STORZ EXTRA (K833064)Storz Instrument Co.1984-01-04
BEECHER 20 GA. PROBE (K833800)Beecher Medical Diagnostic Instrumentation1984-01-04
CLERZ LUBRICATING/REWETTING SOLUTION (K833494)CooperVision, Inc.1984-01-04
DISPOSABLE OCUTOME PROBE (K833371)CooperVision, Inc.1984-01-04
LASER PROTECTIVE EYESHIELD (K833232)Stefanovsky & Assoc.1983-12-30
EXTRA PLUS TM (K833617)American Surgical Co., Inc.1983-12-28
UNIVERSAL PAC (K834161)American Surgical Co., Inc.1983-12-28
EXTRA SENSORY PAK-DISPOS. ACCESS (K833697)American Surgical Co., Inc.1983-12-28
EXTRA SENSORY PLUS (K834158)American Surgical Co., Inc.1983-12-28
ULTRAVIT (K834163)American Surgical Co., Inc.1983-12-28
PHACOTRON PLUS (K834159)American Surgical Co., Inc.1983-12-28
DERMATOLOGY HANDPIECE-OPHTH LASER (K833274)Synemed, Inc.1983-12-03
SURGICAL IOP MONITOR (K832996)Miami Eye Technology, Inc.1983-11-28
CATAREX DIAP. EXTRACAPSULAR CATARACT (K832446)Calliope Corp.1983-10-19
VXTRA OCUTOME KIT (K832980)Vxtra Corp.1983-10-19
KARICKHOFF FLYING CORPUSCLE VIEWER (K831829)Surgidev Corp.1983-10-19
SCIENTRONICS 10K EYE MAGNET (K832950)Scientific Manufacturer1983-10-19
I-GLIDE IOL IMPLANTATION AID (K832939)I For M, Inc.1983-10-04
SIAS IRRIGATION/ASPIRATION SYSTEM (K832413)Clark Pool & Assoc.1983-10-04
EPA AUTOMATED INFUSION POLE (K832997)Miami Eye Technology, Inc.1983-10-04
ELECATH HEPARIN COATED THERMAL DILUTION (K832787)Electro-Catheter Corp.1983-10-04
ABBOTT GLOBE HOLDER (K832911)Miami Eye Technology, Inc.1983-09-29
AUTOMATIC TANGENT SCREEN 50 (K832800)CooperVision, Inc.1983-09-29
DISPOSABLE VITRECTOMY HANDPIECE (K832235)Innovative Surgical Products, Inc.1983-09-29
RUBY KNIVES FOR OPHTH. SURGERY (K832844)Keeler Instruments, Inc.1983-09-29
OCUCARE FREEDOM PACK (K832559)Ocular Innovations, Inc.1983-09-29
MILLER/NADLER GLARE TESTER (K832762)Titmus Optical, Inc.1983-09-29
SCLERAL BUCKLING IMPLANTS DIF/TYPES (K832481)Storz Instrument Co.1983-09-20
ENVISION G21 I/A ENPAK (K832423)Envision, Inc.1983-09-12
DISCO SUNGLASSES/HEADBAND SUNGLASSES (K832564)E-Tay Industrial Co. , Ltd.1983-09-12
ENVISION G31 P.E. PAK (K832424)Envision, Inc.1983-09-12
LEADING EDGE OPHTHALMIC KNIFE (K831975)Surgidev Corp.1983-08-31
MEDIC LUX DIAGNOSTIC SETS (K832437)Keeler Instruments, Inc.1983-08-16
DIGILAB 350 THE KRAKAU PERIMETER (K832175)Bio-Rad1983-08-16
MAI HYDROSEAL IMPLANT FOR SCLERAL BUCK (K831773)Bcd Products, Inc.1983-08-16
SNO STRIPS STERILE TEARFLOW TEST STRIP (K832181)Smith & Nephew, Inc.1983-08-12
ELECTRIC INSTRUMENT TABLE (K832073)CooperVision, Inc.1983-08-12
BAILEY ASPIRATOR/IRRIGATOR (K831584)Medical Instrument Development Laboratories, Inc.1983-08-12
CAVITRON/KELMAN PHACO-EMULSIFIER ASPIRA (K832074)CooperVision, Inc.1983-08-01
DICON GLAUCOMA DIAG. CENTER 2000 SERIES (K832142)CooperVision, Inc.1983-08-01
LACIMAL INTUBATION SETS (K831901)Visitec Co.1983-07-12
DISPOSABLE CYSTOTOME (K831916)CooperVision, Inc.1983-07-12
OCULAR IRRIGATING CANNULA (K831532)Dey Laboratories, Inc.1983-07-12
UNIVERSAL PACK (K831701)Atlantic Optical Systems, Inc.1983-07-12
MICRO SURGICAL HANDLE (K831996)Visitec Co.1983-07-12
INFUSION CANNULA (K831192)Medical Instrument Development Laboratories, Inc.1983-06-30
SCLERAL PLUG (K831193)Medical Instrument Development Laboratories, Inc.1983-06-30
SUN PHOTO-KERATOSCOPE (K831084)Nidek, Inc.1983-06-30
RARE-EARTH INTRA-OCULAR MAGNET (K831702)Miami Eye Technology, Inc.1983-06-30
EPSILON ULTRASONIC TIP (K831836)CooperVision, Inc.1983-06-30
MICROSURGICAL KNIFE (K831266)Vxtra Corp.1983-06-10
LENSERT CONTACT LENS CLEANING & INSERT (K830738)Jermyn Specialties of California1983-06-10
AUTO REFRACTOMETER (K831083)Nidek, Inc.1983-06-10
EYELID SPECULUM (K830430)Douglas C. Mckee & Co.1983-06-10
ULTRAKIT (K831172)Staar Surgical Co.1983-06-08
ALPHAMEDIX I/A HAND-PIECE, 500-001 (K830812)Alphamedix, Inc.1983-06-08
SURGICAL/LID MARGIN COVER & EYELASH- (K831285)Richard R. Anthony, M.D.1983-06-03
PHAKOSYSTEMS MODEL 1000/OMNI PACKS IRRIGATION/ASPIRATION (K830871)Phakosystems, Inc.1983-06-02
GLASS FRAMES & COMPONENT PARTS (K831388)Anamar1983-06-02
LED GOGGLES (K831231)Cadwell Laboratories, Inc.1983-05-16
OCUCARE PACK (K830902)Ocular Innovations, Inc.1983-05-16
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