Atlas FDA

EPT

18 FDA 510(k) clearances · Product code

43 daysmedian time to decision
101 days90th percentile
18clearances measured

FDA profile

Official device name
Microscope, Surgical
Device class
Class I (low risk)
Regulation
21 CFR 878.4700
Medical specialty
General, Plastic Surgery
Adverse events (MAUDE)
2018: 13 · 2019: 15 · 2021: 31 · 2022: 42 · 2023: 44 · 2024: 16
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
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RecordFirmDate
MKM (MULTIPLE COORDINATE MANIPULATOR) SYSTEM (K942233)Carl Zeiss, Inc.1994-07-01
MICRODYNE OFFICE SURGICAL MICROSCOPE (K931284)Microdyne, Inc.1993-11-18
MICRINS CONTRAST BACKGROUND MATERIAL (K933310)Micrins Surgical, Inc.1993-08-19
STORZ MODEL M705 AND/OR M706 CEILING MOUNTED MICR. (K903412)Storz Instrument Co.1990-09-20
OPMI CS (K883581)Carl Zeiss, Inc.1988-09-13
STORZ DIAGNOSTIC MICROSCOPE SYSTEM (K882269)Storz Instrument Co.1988-06-23
ZEISS VOICE CONTROL SYSTEM FOR OPMI'S (K860811)Carl Zeiss, Inc.1986-04-30
STORZ/URBAN SURGICAL MICROSCOPE SYSTEM (K844858)Storz Instrument Co.1985-03-25
ELECTRONIC UNIT (K832887)Surgi-Quip Inc.U1983-10-04
VC III (K823011)Teknar, Inc.1982-11-08
MICROSCOPE (K822561)Treace Medical, Inc.1982-09-14
NAGASHIMA SU-A CEILING MOUNT UNIT FOR (K822014)Kelleher Corp.1982-08-06
BINOCULAR OPERATING MICROSCOPES & (K822009)Kelleher Corp.1982-07-30
LEBANON MICROSCOPE (K821689)The Lebanon Corp.1982-07-09
STORZ/OLYMPUS MICROSCOPE SYSTEM (K812234)Storz Instrument Co.1981-09-11
MICROSCOPE MODEL OM-U (K802904)Jedmed Instrument Co.1981-02-04
MICROSCOPE MODEL OM-P (K802903)Jedmed Instrument Co.1981-02-04
REMOTE CONTROL SYSTEM FOR MICROSCOPE (K760696)Alcon Laboratories1976-12-16

Track EPT automatically

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