Atlas FDA

HOY

55 FDA 510(k) clearances · Product code

63 daysmedian time to decision
233 days90th percentile
55clearances measured

FDA profile

Official device name
Shield, Eye, Ophthalmic (Including Sunlamp Protective Eyewear And Post-Mydriatic Eyewear)
Device class
Class I (low risk)
Regulation
21 CFR 886.4750
Medical specialty
Ophthalmic
Flags
GMP exempt
Adverse events (MAUDE)
2001: 1 · 2002: 2 · 2004: 2 · 2005: 3 · 2006: 4 · 2007: 4
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
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RecordFirmDate
AMB101 SYSTEM, AMBLYZ, LCG SYSTEM, XPAND (K132042)X6d, Ltd.2014-04-28
LCG (LIQUIDE CRYSTAL GLASSES) SYSTEM (K050856)Ophthocare , Ltd.2005-05-31
NATIONAL MEDICAL HALTHCARE CUSTOM OPHTHALMIC KITS OR TRAYS (K971465)National Healthcare Mfg. Corp.1997-06-04
ARCTIC PREMIER SERIES (K944700)Sungold Eyewear, Inc.1994-12-22
GOGGLE SAFEGUARD (K944857)Sellstrom Mfg. Co.1994-12-15
SHIELD, EYE, OPHTHALMIC (K945351)Taiwan Eva Industrial Co., Inc.1994-12-13
MAKROLON 2405 GOGGLES (LIGHT AND DARK) (K945346)Universal Massage & Tanning, Inc.1994-11-22
AMCON SLIP IN MYDRIATIC SUNGLASSES (K942407)Amcon Laboratories, Inc.1994-06-06
SUN FILTERS/SHIELDS (K941829)Klinger Eye Shields, Inc.1994-05-17
SHAIDS PROTECTIVE GLASSES (K930347)Depuy, Inc.1994-04-29
UNIVERSAL CUSHIONED METAL EYE SHIELD (K940213)P.J. Products, Inc.1994-03-24
UNIVERSAL CUSHIONED POLYCARBONAT EYE SHIELD (K940275)P.J. Products, Inc.1994-03-24
POST-MYDS(TM) (K930840)Aukland Medical Plastics, Inc.1994-03-01
FOX EYE ALUMINUM SHIELD, OPHTHALMIC (K940095)P.J. Products, Inc.1994-03-01
GOGGLE SAFEGUARD (K931254)Sellstrom Mfg. Co.1993-11-12
MODIFICATION OF SURGICAL EYESHIELD MASK (K934085)American Threshold Industries, Inc.1993-11-12
ACTION MEDTEK/DENTEK EYEGLASSES (K925564)Action Eyewear Corp.1993-10-07
INSTRUMENT WIPE AND CORNEAL SHIELD (K912576)Katena Products, Inc.1992-01-31
PEEPERS TANNING GOGGLES (K914095)California Suncare, Inc.1991-10-30
UNIDIRECTIONAL OCCLUDER (K913230)Welch Allyn, Inc.1991-10-02
EYE BUBBLE (K912367)Aaron Medical Industries1991-10-02
OCULAR OCCLUDER (K900942)Microdynamics1990-05-25
OMNIPATCH (K900941)Eye Garter Company, Inc.1990-05-21
SOFT CORNEAL LIGHT SHIELD (K896681)Visitec Co.1990-01-11
STRAPPED EYE SHIELD (K896172)Eye Garter Company, Inc.1989-11-03
EYE PATCH (K896171)Eye Garter Company, Inc.1989-11-03
LID LOC (K895364)Spectrum Co.1989-10-31
SAFE-EDGE EYESHIELD (K894724)Trident Medical Products, Inc.1989-09-14
UNIVERSAL EYESHIELD (K894720)Trident Medical Products, Inc.1989-09-14
DIOPTICS EYESHIELDS (K885163)Dioptics1988-12-30
CLEAR EYE GARTER SHIELD (K880489)Eye Garter Company, Inc.1988-08-08
COOL EYE(TM) EYE PROTECTOR (K881135)Cool Eyes, Inc.1988-07-08
ULTRAVIOLET LIGHT PROTECTVE EYEWERE (K880666)Free Sun Intl. AB1988-06-28
BLUE PLASTIC EYE SHIELD (K880490)Eye Garter Company, Inc.1988-05-03
SURGIN EYE SHIELD (K881232)Surgeon Surgical Instrumentation, Inc.1988-04-13
EASY SHIELD ADHESIVE BANDAGE (K880675)Eye Garter Company, Inc.1988-04-01
HEALTH CARE EYE PROTECTION (K875107)Surgikos, Inc.1988-03-21
MEDICAL EYE DISPOSABLE SHIELD (K875302)Bfd, Inc.1988-03-21
WINK-EASE PERSONAL PROTECTIVE EYEWEAR (K873662)Eye Pro Medical Products, Inc.1987-10-02
TAPELESS EYE SHIELD (K872659)Precision Therapeutics, Inc.1987-07-27
EYE GARD (K872000)Treace Medical, Inc.1987-07-21
KASEY EYE SHIELD (K863474)Kasey Enterprises, Inc.1986-09-24
HESSBURG LIGHT GUARD (K853035)Visitec Co.1985-12-13
LASERSAFE EYE SHIELDS (K852404)Lasersafe, Inc.1985-10-04
SCHWARTZ/NORRIS CORNEAL LIGHT SHIELD (K844761)Medical Instrument Development Laboratories, Inc.1984-12-24
COLOR OPTIC CORNEAL EYE SHIELD (K843961)Colors IN Optics , Ltd.1984-11-28
CORNEAL LIGHT SHIELD (K840834)Gabl, Inc.1984-10-05
COLOR OPTIC CORNEAL EYE SHIELD (K840414)Diversations, Inc.1984-08-15
STORZ UNIVERSAL EYE SHIELD (K841599)Storz Instrument Co.1984-05-22
NEONATE MASK FOR BABIES (K840444)Richards Medical Co., Inc.1984-03-16
CROUCH CORNEAL PROTECTOR (K833256)Star Instrument Co.1984-02-08
PHOTOTHERAPY EYE PROTECTION FOR INFANTS (K821765)Russell Terry Co.1982-08-16
CROUCH CORNEAL PROTECTOR (K811577)Denver Biomedicals, Inc.1981-08-07
FOX EYE SHIELDS (K810098)American Hospital Supply Corp.1981-02-27
POROPLAST-EYE DRESSING (K802786)Secol Co.1980-12-17

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Every clearance here is in the API, with alerts when new ones post.