Tracheotome

FDA product code LJW · Class I (low risk) · 21 CFR 874.4420 · Ear, Nose, Throat

2510(k) clearances
0PMA approvals
1recalls

Manufacturers

510(k) clearances

510(k)DeviceApplicantDecision
K933570Resolution(Tm) Hip StemLJW · Traditional Wrightmedicaltechnologyinc03/07/1994SN
K822618Emergency Tracheostomy Instrument SetLJW · Traditional Kelleher Corp.01/28/1983SE

Recalls

RecallProductFirmInitiated
Z-1137-2017 Class IICelerity ECG Cable Accessory Pack, STERILE, Rx ONLY - distributed under the following…The Celerity ECG Cable Accessory Pack has the potential to contain an ECG Clip Cable that was not properly… Angiodynamics Inc. (Navilyst Medical Inc.)09/07/2016Terminated