Atlas FDA

FEX

2 FDA 510(k) clearances · Product code

FDA profile

Official device name
Instrument, Catheter, Punch
Device class
Class I (low risk)
Regulation
21 CFR 876.5090
Medical specialty
Gastroenterology, Urology
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RecordFirmDate
PHOTCOAGULATOR KR-568 LASER SPECTRUM ELITE K1 (K911104)Hgm Medical Laser Systems, Inc.1991-06-11
BIOSP. TOTAL OSSICULAR REPLACE. PROSTHE. (K771725)Xomed, Inc.1977-09-26

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