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

Company	510(k)s	Recalls
Nellcor Puritan Bennett Inc. (dba Covidien LP)	0	57
Smiths Medical Asd, Inc.	5	26
Cook Incorporated	6	23
Bivona Medical Technologies	15	0
Premier Dental Products Co	0	14
Covidien	7	4
Mallinckrodt Medical	7	0
Rusch Intl.	5	0
Passy-Muir, Inc.	4	0
Smiths Industries Medical Systems, Inc.	4	0

Date	Firm and product	Code	Linked 510(k)
Nov 7, 2007	Smiths Medical ASD, Inc. Portex Perfit Percutaneous Tracheostomy Tube Replacement Kit, Sterile Ref: 536090 Terminated	JOH	K031057
Jan 5, 2007	Smiths Medical ASD, Inc. Bivona Adult Tracheostomy Tube, I.D. 8.5 mm, O.D 11.0 mm, Length 88 mm, TTS 11.8 mm, Mfrd by Smiths Medical Critical Care; Product code 670185. Terminated	JOH	K913859
Dec 7, 2006	Smiths Medical ASD, Inc. Custom 5.5 mm Bivona Uncuffed Hyperflex Tracheostomy Tube, I.D. 5.5 mm, O.D. 8.0 mm, length 4.75 mm, Mfrd by Smiths Medical Critical Care; REF HU05JS55NNA112S. Terminated	JOH	K923878
Oct 19, 2006	Smiths Medical ASD, Inc. Bivona Adult Tracheostomy Tube, Labeled I.D. 6.0 mm, O.D. 8.7 mm, A 7.0 mm, B 0 mm, C 53.0 mm, Mfrd by Smiths Medical Critical Care; REF 60A160. Terminated	JOH	K913859
Jan 18, 2006	Smiths Medical ASD, Inc. Bivona brand TTS Adjustable Neck Flange Hyperflex Tracheostomy Tube, I.D. 8.0 mm O.D. 11.0mm length 130 mm; REF 67HA80. Terminated	JOH	K922665
Jan 18, 2006	Smiths Medical ASD, Inc. Bivona brand Mid-Range Aire-Cuf Extra Length Fixed Hyperflex Adult Tracheostomy Tube, I.D. 8.0 mm O.D. 11.0mm length 120 mm; REF 75FHXL80. Terminated	JOH	K922665
Jan 18, 2006	Smiths Medical ASD, Inc. Bivona brand Mid-Range Aire-Cuf Adjustable Neck Flange Hyperflex Tracheostomy Tube, I.D. 6.0 mm O.D. 8.7 mm length 110 mm; REF 75HA60. Terminated	JOH	K922665
Jun 25, 2005	Smiths Medical ASD, Inc. Bivona brand Pediatric TTS Tracheostomy Tube, 3.5 mm tracheostomy tubes with a 3.5mm obturator ; product code 67P035. Terminated	JOH	K914088
Jun 4, 2005	Smiths Medical ASD, Inc. Portex Per-Fit Percutaneous Dilational Tracheostomy Kit , ID 9.0mm Product Number: 538090E Terminated	JOH	K031057
Jun 4, 2005	Smiths Medical ASD, Inc. Portex Per-Fit Percutaneous Dilational Tracheostomy Kit , ID 8.0mm Product Number: 538080E Terminated	JOH	K031057
Jun 4, 2005	Smiths Medical ASD, Inc. Portex Per-Fit Percutaneous Dilational Tracheostomy Kit , ID 7.0mm Product Number: 538070E Terminated	JOH	K031057
Jun 4, 2005	Smiths Medical ASD, Inc. Portex Per-Fit Percutaneous Dilational Tracheostomy Kit , ID 9.0mm Product Number: 535090 Terminated	JOH	K031057
Jun 4, 2005	Smiths Medical ASD, Inc. Portex Per-Fit Percutaneous Dilational Tracheostomy Kit, ID 8.0mm Product Number: 535080 Terminated	JOH	K031057
Jun 4, 2005	Smiths Medical ASD, Inc. Portex Per-Fit Percutaneous Dilational Tracheostomy Kit ,ID 7.0mm Product Number: 535070 Terminated	JOH	K031057
Sep 15, 2004	Premier Dental Products Co Laryngectomy Tubes, Air Lon Inhalation Set (Inner Cannula with 15 mm Adapter) Nylon, item number 1050200 size 8 and item number 1050202 size 10. Terminated	JOH	None listed
Sep 15, 2004	Premier Dental Products Co Laryngectomy Tubes, Air Lon Nylon, item number1050170 size 8 and item number 1050172 size 10. Terminated	JOH	None listed
Sep 15, 2004	Premier Dental Products Co Laryngectomy Tubes, Jackson Improved Stainless Steel, item number1037414 size 4, item number 1037415 size 5, item number 1037416 size 6, item number 1037417 size 7, item number 1037418 size 8, item nu Terminated	JOH	None listed
Sep 15, 2004	Premier Dental Products Co Laryngectomy Tubes, Jackson Original Stainless Steel, item number 1037214 size 4, item number 1037215 size 5, item number 1037216 size 6, item number 1037217 size 7, item number 1037218 size 8, item n Terminated	JOH	None listed
Sep 15, 2004	Premier Dental Products Co Laryngectomy Tubes, Martin Stainless Steel, item number 1036128 size 8 and item number 1036130 size10. Terminated	JOH	None listed
Sep 15, 2004	Premier Dental Products Co Tracheostomy Tubes, Air Lon Inhalation Set (Inner Cannula with 15 mm Adapter) Nylon, item number 1050180 size 3, item number 1050182 size 4, item number 1050184 size 5, item number 1050186 size 6, ite Terminated	JOH	None listed
Sep 15, 2004	Premier Dental Products Co Tracheostomy Tubes, Air Lon Nylon, item number 1050150 size 3, item number 1050152 size 4, item number 1050154 size 5, item number 1050156 size 6, item number 1050158 size 7, and item number 1050160 s Terminated	JOH	None listed
Sep 15, 2004	Premier Dental Products Co Tracheostomy Tubes, Jackson Improved Extra Long Stainless Steel, item number 1034964 size 4, item number 1034965 size 5, item number 1034966 size 6, item number 1034967 size 7, item number 1034968 siz Terminated	JOH	None listed
Sep 15, 2004	Premier Dental Products Co Tracheostomy Tubes, Jackson Improved Short Stainless Steel with Adapter, item number 8100402 size 3,item number 8100040 size 4, item number 8100041 size 5, item number 8100229 size 6, item number 8100 Terminated	JOH	None listed
Sep 15, 2004	Premier Dental Products Co Tracheostomy Tubes, Jackson Improved Short Stainless Steel, item number 1034930 size 00, item number 1034940 size 0, item number 1034941 size 1, item number 1034942 size 2, item number 1034943 size 3, Terminated	JOH	None listed
Sep 15, 2004	Premier Dental Products Co Tracheostomy Tubes, Jackson Improved Stainless Steel with Adapter, item number 8100465 size 1, item number 8100373 size 3, item number 1034924 size 4, item number 1034925 size5, item number 1034926 si Terminated	JOH	None listed
Sep 15, 2004	Premier Dental Products Co Tracheostomy Tubes, Jackson Improved Stainless Steel, item number 1034900 size 00, item number 1034910 size 0, item number 1034911 size 1, item number 1034912 size 2, item number 1034913 size 3, item Terminated	JOH	None listed
Sep 15, 2004	Premier Dental Products Co Tracheostomy Tubes, Jackson Original Short Stainless Steel, item number 1034600 size 00, item number 1034610 size 0, item number 1034611 size 1, item number 1034612 size 2, item number 1034613 size 3, Terminated	JOH	None listed
Sep 15, 2004	Premier Dental Products Co Tracheostomy Tubes, Jackson Original Stainless Steel, item number 1034300 size 00, item number 1034310 size 0, item number 1034311 size 1, item number 1034312 size 2, item number 1034313 size 3, item Terminated	JOH	None listed
Jul 20, 2004	Smiths Medical ASD, Inc Portex Inner Cannula for Tracheostomy Tube, 8.0 mm, REF Code 566080 Terminated	JOH	K902180
Jul 20, 2004	Smiths Medical ASD, Inc Portex Inner Cannula for Tracheostomy Tube Size 7.0 mm, REF Code 566070 Terminated	JOH	K902180
Jul 20, 2004	Smiths Medical ASD, Inc. PER-FIT Percutaneous Dilational Tracheostomy Kit with Specialty Tracheostomy Tube REF # 511080 Terminated	JOH	K980466

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