Atlas FDA

DQF

3 FDA 510(k) clearances · Product code

FDA profile

Official device name
Actuator, Syringe, Injector Type
Device class
Class II (moderate risk)
Regulation
21 CFR 870.1670
Medical specialty
Cardiovascular
Flags
Third-party review eligible
Adverse events (MAUDE)
1994: 1 · 2004: 1
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
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RecordFirmDate
VERSA-VIAL (K920177)Bioteque America, Inc.1992-07-13
ALCON FLUID INJECTOR (K882723)Alcon Laboratories1988-11-08
MODEL TA-CS10 SPECTRAJECT CONTROL SYRINGE (K880740)Spectramed, Inc.1988-03-22

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