Laerdal Medical Corp.

FDA Regulatory Profile

Summary

Total Recalls
0
510(k) Clearances
20
Inspections
3
Compliance Actions
0

Recent 510(k) Clearances

K-NumberDeviceDate
K251631The BAG manual resuscitator and accessoriesNovember 24, 2025
K232111NeoBeat, NeoBeat MiniJune 25, 2024
K183348Reusable Silicone Cover CPRmeter 2December 17, 2018
K173886CPRmeter 2 CPR Feedback DeviceMarch 23, 2018
K151702Reusable Full Silicone CoverAugust 13, 2015
K132172NEONATALIE RESUSCITATORJanuary 15, 2015
K122050CPRMETER CPR FEEDBACK DEVICEOctober 22, 2012
K023805LAERDAL PAEDIATRIC POCKET MASK, MODEL 820050February 11, 2003
K001742RESUSCI INFLATE-A-SHIELD CPR BARRIEROctober 6, 2000
K993668LAERDAL SUCTION UNIT,(4000) MODEL 78 00 20December 20, 1999
K962361TRACHLIGHT STYLET AND TRACHEAL LIGHTWANDSeptember 5, 1996
K954771TRACHLIGHT STYLET & TRACHEAL LIGHTWAND (ORIGINAL APPLICATION NAME: STYLETT & TRACHEAL LIGHTWAND)May 9, 1996
K954609HEARTSTART 911January 4, 1996
K950698LSU 2000 PORTABLE SUCTION UNITMay 9, 1995
K933048LAERDAL(TM) POCKET MASK, MODIFICATIONDecember 2, 1993
K896919HEARTSTART 3000May 3, 1990
K880450RESUSCI PATIENT FACE SHIELDMarch 4, 1988
K861401LAERDAL POCKET MASKMay 21, 1986
K840110LAERDAL SUCTION UNITMarch 12, 1984
K822356MODULAIDE EMERG. CARDIAC LIFE SUPP. KTAugust 20, 1982