Atlas FDA

FWY

4 FDA 510(k) clearances · Product code

FDA profile

Official device name
Table, Operating-Room, Non-Electrical
Device class
Class I (low risk)
Regulation
21 CFR 878.4950
Medical specialty
General, Plastic Surgery
Adverse events (MAUDE)
2003: 4 · 2008: 5
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
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RecordFirmDate
ASST-3000 SPINAL SURGERY TABLE (K883457)Orthopedic Systems, Inc.1988-08-26
SKYTRON MODEL 130 SURGICAL TABLE (K873478)Skytron, Div. the Kmw Group, Inc.1987-09-24
CHEMONUCLEOLYSIS TABLE (K833509)Stryker Corp.1983-11-28
CHICK SURGICAL TABLE (K800118)Warner-Lambert Co.1980-02-05

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