Atlas FDA

HPN

5 FDA 510(k) clearances · Product code

36 daysmedian time to decision
90 days90th percentile
5clearances measured

FDA profile

Official device name
Magnet, Permanent
Device class
Class I (low risk)
Regulation
21 CFR 886.4445
Medical specialty
Ophthalmic
Flags
GMP exempt
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RecordFirmDate
EYE SEE INSTRUMENT (K905237)King Tool, Inc.1991-02-14
H200 HANNA SUCTION TREPHINE SYSTEM FOR CORNEAL SUR (K896473)Emory University School of Medicine1990-02-09
PAREL RARE EARTH MAGNET, I.O.M., INTRAOCULAR MAG (K880855)Richard James, Inc.1988-04-01
RARE EARTH INTRA-OCULAR MAGNET (K860960)Ameritek, Inc.1986-03-31
RARE-EARTH INTRA-OCULAR MAGNET (K831702)Miami Eye Technology, Inc.1983-06-30

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