Medical Device Manufacturer · US , Mchenry , IL

Laerdal Medical Corp.

11 submissions · 11 cleared · Since 1982
11
Total
11
Cleared
0
Denied

Laerdal Medical Corp. — FDA 510(k) Submissions

Laerdal Medical Corp. has submitted 11 FDA 510(k) premarket notifications since 1982, of which 11 received clearance as substantially equivalent to a predicate device.

The company's most frequent device categories include Ventilator, Emergency, Manual (resuscitator), Automated External Defibrillators (non-wearable), Stylet, Tracheal Tube, Valve, Non-rebreathing, Pump, Portable, Aspiration (manual Or Powered) . Use the specialty filter in the sidebar to narrow results.

11 devices
1–11 of 11
RESUSCI INFLATE-A-SHIELD CPR BARRIER
K001742 · CBP Valve, Non-rebreathing · Anesthesiology
Oct 2000 120d
TRACHLIGHT STYLET AND TRACHEAL LIGHTWAND
K962361 · BSR Stylet, Tracheal Tube · Anesthesiology
Sep 1996 78d
TRACHLIGHT STYLET & TRACHEAL LIGHTWAND (ORIGINAL APPLICATION NAME: STYLETT & TRACHEAL LIGHTWAND)
K954771 · BSR Stylet, Tracheal Tube · Anesthesiology
May 1996 205d
HEARTSTART 911
K954609 · MKJ Automated External... · Cardiovascular
Jan 1996 92d
LSU 2000 PORTABLE SUCTION UNIT
K950698 · JCX Apparatus, Suction, Ward... · General & Plastic Surgery
May 1995 88d
LAERDAL(TM) POCKET MASK, MODIFICATION
K933048 · KGB Mask, Oxygen,... · Anesthesiology
Dec 1993 205d
HEARTSTART 3000
K896919 · MKJ Automated External... · Cardiovascular
May 1990 142d
RESUSCI PATIENT FACE SHIELD
K880450 · BTM Ventilator, Emergency,... · Anesthesiology
Mar 1988 31d
LAERDAL POCKET MASK
K861401 · CBP Valve, Non-rebreathing · Anesthesiology
May 1986 36d
LAERDAL SUCTION UNIT
K840110 · BTA Pump, Portable,... · General & Plastic Surgery
Mar 1984 62d
MODULAIDE EMERG. CARDIAC LIFE SUPP. KT
K822356 · BTM Ventilator, Emergency,... · Anesthesiology
Aug 1982 14d
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