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Panels › Anesthesiology › Product code JOH · Class 2

Tube Tracheostomy And Tube Cuff

Regulation 868.5800

1510(k)s in 12 months (109 all time)
5recalls in 12 months (131 all time)
114recalls that name a 510(k)
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Top companies in JOH

Company510(k)sRecalls
Nellcor Puritan Bennett Inc. (dba Covidien LP)057
Smiths Medical Asd, Inc.526
Cook Incorporated623
Bivona Medical Technologies150
Premier Dental Products Co014
Covidien74
Mallinckrodt Medical70
Rusch Intl.50
Passy-Muir, Inc.40
Smiths Industries Medical Systems, Inc.40
Decided510(k)Device and applicantCode
Oct 13, 1989K894614BIVONA AIRE-CUF ADJUSTABLE TRACHEOSTOMY TUBE
Bivona Medical Technologies
JOH
Oct 13, 1989K894613BIVONA FOME-CUF ADJUSTABLE TRACHEOSTOMY TUBE
Bivona Medical Technologies
JOH
Aug 1, 1989K894050MODIFIED DECANNULATION STOPPER
Premier Medical
JOH
Jul 20, 1989K890194SHILEY SPECIALIZED TRACHEOSTOMY TUBE
Shiley, Inc.
JOH
Feb 27, 1989K885130MODIFIED AIRE-CUF SILICONE TRACHEOSTOMY TUBE
Bivona Medical Technologies
JOH
Feb 27, 1989K885129MODIFIED FOME-CUF SILICONE TRACHEOSTOMY TUBE
Bivona Medical Technologies
JOH
Sep 21, 1981K812163AIRE-CUF TRACHEOSTOMY TUBE
Bioana Surgical Instruments, Inc.
JOH
Sep 8, 1981K812302SHILEY FENESTRATED LOW PRESS. CUFFED
Shiley, Inc.
JOH
Sep 13, 1976K760453REGULATOR, PRESSURE, CUFF
Boehringer Laboratories
JOH

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