Atlas FDA

MOE

19 FDA 510(k) clearances · Product code

87 daysmedian time to decision
296 days90th percentile
19clearances measured

FDA profile

Official device name
Collagen Corneal Shield
Device class
Class I (low risk)
Regulation
21 CFR 886.4750
Medical specialty
Ophthalmic
Flags
GMP exempt
Adverse events (MAUDE)
1996: 4 · 2001: 4
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
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RecordFirmDate
BIO-COR COLLAGEN CORNEAL SHIELD (K944872)Bausch & Lomb Healthcare and Optics Worldwide1995-07-26
MEDILENS-CS CORNEAL SHIELD (K915861)Chiron Ophthalmics1992-03-06
SOFTSHIELD(TM) 12, 24, 72 COLLAGEN CORNEAL SHIELDS (K914529)Oasis Medical, Inc.1991-11-13
COLLAGEN SHIELD FOR ACUTE CARE (K913148)Vitaphore Corp.1991-10-15
COLLAGEN SHIELD, VARIOUS MODELS (K905825)Chiron Ophthalmics1991-06-10
COLLAGEN SHIELD FOR ACUTE CARE (K902558)Vitaphore Corp.1990-08-17
MEDILENS(TM) CORNEAL SHIELD (K901880)Chiron Ophthalmics1990-07-02
IM COLLAGEN SHIELD (K896449)Intermedical, Inc.1990-05-24
ADDIT. INDICATIONS FOR BIO-COR EXT COLLAGEN CORNEA (K884962)Bausch & Lomb Pharmaceutical, Inc.1990-02-09
COI 72 HR COLLAGEN SHIELD (K885015)Chiron Ophthalmics1989-06-23
ADDIT. INDICATION FOR FYODOROV COLLAGEN CORNEAL (K884960)Bausch & Lomb Pharmaceutical, Inc.1989-02-13
ADDIT. INDICATIONS FOR BIO-COR II COLLAGEN CORNEAL (K884961)Bausch & Lomb Pharmaceutical, Inc.1989-02-13
COI 24 HR COLLAGEN SHIELD (K885016)Chiron Ophthalmics1989-02-01
LABELING CHANGES TO BIO-COR EXT COLLANGEN CORNEAL (K884364)Bausch & Lomb Pharmaceutical, Inc.1988-11-29
LABELING CHANGES TO BIO-COR II COLLANGEN CORNEAL (K884363)Bausch & Lomb Pharmaceutical, Inc.1988-11-29
COLLAGEN SHIELD (K882762)Chiron Ophthalmics1988-09-12
BIO-COR II COLLAGEN CORNEAL SHIELD (K874224)Bausch & Lomb, Inc.1988-01-22
BIO-COR EXT COLLAGEN CORNEAL SHIELD (K874225)Bausch & Lomb, Inc.1988-01-22
FYODOROV COLLAGEN CORNEAL SHIELD (K862315)Medical Technology Development Corp.1987-01-07

Track MOE automatically

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