Atlas FDA

FLG

19 FDA 510(k) clearances · Product code

89 daysmedian time to decision
329 days90th percentile
19clearances measured

FDA profile

Official device name
Cleaner, Ultrasonic, Medical Instrument
Device class
Class I (low risk)
Regulation
21 CFR 880.6150
Medical specialty
General Hospital
Adverse events (MAUDE)
2011: 8 · 2013: 9 · 2014: 9 · 2015: 17 · 2016: 9 · 2018: 12
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
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Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free

RecordFirmDate
KLENZYME (K944950)Calgon Corp.1994-12-20
ALSA-KLENZ (K944494)Calgon Vestal Div.1994-10-19
BILL EVANS-KLENZ (K944033)Calgon Vestal Div.1994-10-07
MON-KLENZ (K941163)Calgon Vestal Div.1994-05-18
NPH-KLENZ (K940263)Calgon Corp.1994-05-18
INSTRU KLENZ (K935063)Calgon Corp.1994-05-09
PDS ULTRACLEAN (K934666)Medical Polymers, Inc.1994-04-15
SURGICLEAN ENZYMATIC INSTRUMENT CLEANER (K931270)Surgicot, Inc.1994-04-13
INSTRUMENT DETERGENT CONCENTRATE (K933149)Nobelpharma USA, Inc.1994-02-16
BIOSONIC ULTRASONIC CLEANING SYSTEM (K884660)Whaledent Intl. Div. Ipco1989-03-16
RAPIDEX BIOLOGICAL SURFACTANT (K862282)Rapidex of London1987-05-11
UCS-2, ULTRASONIC CLEANING SOLUTION (K861147)Keymed, Inc.1986-06-23
WEC-WASH, CATALOG NO. 850-115 (K861592)Palmetto Chemical & Supply Co., Inc.1986-06-17
WECK INSTRUMENT CLEANER, CAT. NO. 850-103 (K861588)Palmetto Chemical & Supply Co., Inc.1986-06-17
WEC-KLEEN, CATALOG N. 850-102 (K861590)Palmetto Chemical & Supply Co., Inc.1986-06-17
WECK CONCENTRATED LIQUID CLEANER (K861587)Palmetto Chemical & Supply Co., Inc.1986-05-19
SATALEC SEPTOSONIC SC 80/SC 120 (K852527)Spelna, Inc.1986-01-03
CUSTOM ULTRASONICS-SYS 80, 81-24, 83-2 (K842754)Custom Ultrasonics1984-11-28
MICROFLATOR (K771679)Fisons Corp.1977-09-28

Track FLG automatically

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