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)
Top companies in JOH
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Oct 10, 1997 | K964056 | RUSCH ULTRA TRACHEOFLEX FENESTRATED KIT CUFFED,UNCUFFED/ RUSCH TRACHEOFLEX TRACHEOSTOMY KIT UNCUFFED STERILE Rusch Intl. | JOH |
| Sep 25, 1997 | K971267 | SHILEY EXTENDED LENGTH, DISPOSABLE CANNULA, TRACHEOSTOMY TUBE: CUFFED, DISTAL EXTENSION, CUFFED, PROXIMAL EXTENSION, CUF Mallinckrodt Medical | JOH |
| Jun 26, 1997 | K963732 | PERCUTANEOUS DUAL CANNULA TRACHEOSTOMY TUBE WITH LOW PRESSURE/LOW PROFILE CUFF AND DISPOSABLE INNER CANNULA Mallinckrodt Medical | JOH |
| Feb 12, 1997 | K970365 | PASSY-MUIR O2 ADAPTER; PMA2000 Passy-Muir, Inc. | JOH |
| Jan 17, 1997 | K962175 | PORTEX ADJUSTABLE FLANGE TRACHEOSTOMY TUBE Smiths Industries Medical Systems, Inc. | JOH |
| Oct 28, 1996 | K962714 | PASSY-MUIR LOW-PROFILE TRACHEOSTOMY AND VENTILATOR SPEAKING VALVE; PRODUCT NUMBER PMV 2000 OR PMTSV 2000 Passy-Muir, Inc. | JOH |
| Oct 11, 1996 | K962078 | TRACHEOSTOMY CLEANING TRAY W/SUCTION CATHETER Continental Medical Laboratories, Inc. | JOH |
| Oct 4, 1996 | K962173 | SHIKEY TRACHEOSTOMY TUBES AND ACCESSORIES Mallinckrodt Medical | JOH |
| Sep 13, 1996 | K961449 | TRACHEOSTOMY TUBES TRACOE-FLEX Tracoe Medical GmbH, DE | JOH |
| Jun 28, 1996 | K955564 | RUSCH ULTRA TRACHEOFLEX TRACHEOSTOMY SET, CUFFED, STERILE Rusch, Inc. | JOH |
| May 2, 1996 | K960429 | PER-FIT PERCUTANEOUS TRACHEOSTOMY KIT W/PORTEX TRACHEOSTMY TUBE & DISP. INNER CANNULA Smiths Industries Medical Systems, Inc. | JOH |
| Mar 13, 1996 | K955680 | SHILEY CUFFED PEDIATRIC TRACHEOSTOMY TUBE; LONG CUFFED Mallinckrodt Medical | JOH |
| Jan 24, 1996 | K954749 | MALLINCKRODT SHILEY 15MM CAP Mallinckrodt Medical | JOH |
| Jan 19, 1996 | K954661 | THE ZIPPER MEDICAL COMBINATION VENTILATOR ANTI-DISCONNCET DEVICE & TRACHEOSTOMY TUBE NECKBAND. TRACHEOSTOMY TUBE HOLDER, Zipper Medical, Inc. | JOH |
| Dec 22, 1995 | K955516 | MONTGOMERY TRACHEOSTOMY SPEAKING VALVE Boston Medical Products, Inc. | JOH |
| Oct 31, 1995 | K952700 | SUPERSLICK Bivona Medical Technologies | JOH |
| Jul 7, 1995 | K944451 | PASSY-MUIR TRACHEOSTOMY SPEAKING VALVES (ONE-WAY TRACHEOSTOMY SPEAKING VALVES) Passy-Muir, Inc. | JOH |
| Jan 13, 1995 | K945513 | MALLINCKRODT SHILEY NEONATAL, PEDIATRIC, LONG PEDIATRIC TRACHEOSTOMY TUBE Mallinckrodt Medical | JOH |
| Dec 27, 1994 | K945874 | EUROMEDICAL POLY TRACHEOTOMY TUBE Regulatory & Marketing Services, Inc. | JOH |
| Oct 27, 1994 | K944178 | BIVONA FLEXTEND PEDIATRIC & NEONATAL TRACHEOSTROMY TUBES Bivona Medical Technologies | JOH |
| Aug 30, 1994 | K936224 | REUSABLE CANNULA TRACHEOSTOMY TUBES, MODIFIED HEADS Mallinckrodt Medical Tpi, Inc. | JOH |
| Jun 15, 1994 | K921733 | TRACHEOSTOMY CARE TRAY Medikmark, Inc. | JOH |
| Mar 23, 1994 | K936133 | PERCUTANEOUS TRACHEOSTOMY KIT Smiths Industries Medical Systems, Inc. | JOH |
| Nov 3, 1993 | K932016 | TRACHEOSTOMY CARE TRAY Clinipad Corp. | JOH |
| Oct 1, 1993 | K933412 | SALINE SOLUTION-STERILE Trinity Laboratories, Inc. | JOH |
| Aug 27, 1993 | K931611 | PERCUTANEOUS TRACHEOSTOMY TUBE KIT Crandall Medical Devices | JOH |
| Aug 27, 1993 | K925288 | TRACHEOSTOMY KIT Ajs Medical Co., Inc. | JOH |
| Aug 18, 1993 | K923156 | TRACHEOSTOMY CARE TRAY Orion Life Systems, Inc. | JOH |
| Jul 7, 1993 | K925020 | TRACHEOSTOMY CARE KIT (STERILE) Customed, Inc. | JOH |
| Jul 2, 1993 | K930895 | SHILEY FENESTRATED REUSABLE INNER CANNULA, MODIF Mallinckrodt Medical Tpi, Inc. | JOH |
| Jun 16, 1993 | K924243 | TRACHEOSTOMY CARE KIT Transidyne General Corp. | JOH |
| Feb 17, 1993 | K925438 | COMBINATION TRACH TIE & VENTILATOR ANTIDISCONNECT Aga Medical Products, Inc. | JOH |
| Jan 7, 1993 | K922665 | BIVONA HYPERFLEX TRACHEOSTOMY TUBE Bivona Medical Technologies | JOH |
| Dec 29, 1992 | K923878 | BIVONA CUSTOMIZED TRACHEOSTOMY TUBES Bivona Medical Technologies | JOH |
| Dec 11, 1992 | K924660 | TRACHEOSTOMY TUBE AND TUBE CUFF Applied Medical Resources | JOH |
| Jun 29, 1992 | K914471 | NEEDLECRIC Ajs Medical Co., Inc. | JOH |
| Jan 30, 1992 | K913859 | BIVONA FOME-CUF(R) & AIR CUF(R), MODIFICATION Bivona Medical Technologies | JOH |
| Oct 23, 1991 | K914183 | BIVONA CUFF MAINTENANCE DEVICE (CMD) Bivona Medical Technologies | JOH |
| Oct 23, 1991 | K914088 | BIVONA AIRE-CUF(R) PEDIATRIC TRACHEOSTOMY TUBE Bivona Medical Technologies | JOH |
| Aug 9, 1991 | K913270 | BIVONA FOME-CUF(R) PEDIATRIC TRACHEOSTOMY TUBE Bivona Medical Technologies | JOH |
| Jul 17, 1991 | K912967 | BIVONA AIRE-CUF TRACHEOSTOMY TUBE W/TALK ATTACH. Bivona Medical Technologies | JOH |
| May 20, 1991 | K911080 | HYGIENA-TRACH Apdyne Medical Co. | JOH |
| Apr 8, 1991 | K910362 | TRACHEOSTOMY CARE KIT Megadyne Medical Products, Inc. | JOH |
| Oct 2, 1990 | K903435 | SHILEY SPECIALIZED TRACHEOSTOMY TUBE Shiley, Inc. | JOH |
| Sep 4, 1990 | K903699 | PASSY-MUIR TRACHEOSTOMY SPEAKING VALVE 15MM / 22MM Passy & Passy, Inc. | JOH |
| Apr 23, 1990 | K897102 | HYDRASORB(TM) Avitar, Inc. | JOH |
| Mar 16, 1990 | K897005 | BLOM-SINGER(R) SILICONE LARYNGECTOMY TUBE Helix Medical, Inc. | JOH |
| Mar 12, 1990 | K897059 | HOOD SPEAKING VALVE Hood Laboratories | JOH |
| Jan 22, 1990 | K896548 | MODIFIED AIRE-CUF SILICONE TRACHEOSTOMY TUBE Bivona Medical Technologies | JOH |
| Jan 22, 1990 | K896547 | MODIFIED FOME-CUF SILICONE TRACHEOSTOMY TUBE Bivona Medical Technologies | JOH |
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