Atlas FDA

JDY

8 FDA 510(k) clearances · Product code

22 daysmedian time to decision
234 days90th percentile
8clearances measured

FDA profile

Official device name
Evacuator, Vapor, Cement Monomer
Device class
Class I (low risk)
Regulation
21 CFR 888.4220
Medical specialty
Orthopedic
Adverse events (MAUDE)
1993: 1
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
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RecordFirmDate
CONTAIN(TM) LASER PLUME FILTER (K902167)Arbor Technologies, Inc.1991-01-04
LASER TRAP 100 LASER PLUME SMOKE EVACUATION FILTER (K902056)Hollister, Inc.1990-10-30
CHARCOAL LASER SMOKE FILTER CATALOG NO. 901103-000 (K862509)Lifestream Int'L, Inc.1986-07-23
CEMENT FUME EVACUATOR TANK & FILTER (K810542)Walgen Medical Innoventions1981-03-13
BIOVAC: LFA LASER FUME (SMOKE) EVACUATIO (K790877)Stackhouse Assoc.1979-05-23
MONOMER EVACUATION SYSTEM (K780202)Medishield, Inc.1978-02-21
MASK, VAPOR, MONOMER (K770690)Howmedica Corp.1977-07-21
MONOMER VAPOR CONTAINMENT SYSTEM (K760906)Howmedica Corp.1976-11-11

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