Panels › Anesthesiology › Product code BTR · Class 2
Tube, Tracheal (W/Wo Connector)
Regulation 868.5730
2510(k)s in 12 months (242 all time)
1recalls in 12 months (227 all time)
203recalls that name a 510(k)
Top companies in BTR
| Company | 510(k)s | Recalls |
|---|---|---|
| Teleflex Incorporated | 1 | 127 |
| Teleflex Medical | 2 | 48 |
| Smiths Medical | 0 | 17 |
| Smiths Medical Asd, Inc. | 2 | 10 |
| Sheridan Catheter Corp. | 11 | 0 |
| Mallinckrodt Critical Care | 10 | 0 |
| Rusch, Inc. | 10 | 0 |
| Bivona Medical Technologies | 8 | 0 |
| Covidien | 6 | 1 |
| Polamedco, Inc. | 7 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Dec 8, 1995 | K954754 | WIRE REINFORCED SILICONE ENDOTRACHEAL TUBE Unomedical Sdn Bhd, MY | BTR |
| Dec 8, 1995 | K954753 | PEDIATRIC SILICONE ENDOTRACHEAL TUBE Unomedical Sdn Bhd, MY | BTR |
| Dec 8, 1995 | K954751 | SILICONE ENDOTRACHEAL TUBE Unomedical Sdn Bhd, MY | BTR |
| Dec 8, 1995 | K954750 | PEDIATRIC WIRE REINFORCED SILICONE ENDOTRACHEAL TUBE Unomedical Sdn Bhd, MY | BTR |
| Sep 18, 1995 | K953368 | LUER, JACKSON TRACHEA TUBES, LUER SPEAKING TRACHEA TUBES Karl Storz Endoskop GmbH | BTR |
| May 23, 1995 | K935842 | RUSCH LASERTUBUS/RUSCH LASER RESISTANT CUFFED WITH MURPHY EYE Rusch, Inc. | BTR |
| May 22, 1995 | K952013 | PRIMA GUEDEL AIRWAYS Prima, Inc. | BTR |
| May 22, 1995 | K951697 | PEDIATRIC ENDOTRACHEAL TUBE Unomedical Sdn Bhd, MY | BTR |
| May 22, 1995 | K951696 | ENDOTRACHEAL TUBE Unomedical Sdn Bhd, MY | BTR |
| Mar 28, 1995 | K924997 | EDD Arc Medical, Inc. | BTR |
| Jan 13, 1995 | K945816 | QUICK-LOCK B&B Medical Technologies, Inc. | BTR |
| Dec 23, 1994 | K945455 | GENERAL ANESTHESIA SYSTEM Vital Signs, Inc. | BTR |
| Dec 7, 1994 | K945745 | ESOPHAGEAL INTUBATION DETECTOR ADAPTER - (EID-ADAPTER) Wolfe Tory Medical, Inc. | BTR |
| Nov 4, 1994 | K944324 | SURE-LOCK VENTILATOR TUBING HOLDER B&B Medical Technologies, Inc. | BTR |
| Aug 18, 1994 | K942628 | ESOPHAGEAL INTUBATION DETECTOR BULB Wolfe Tory Medical, Inc. | BTR |
| Jul 27, 1994 | K940041 | COLIBRI Icor AB, SE | BTR |
| Jun 22, 1994 | K941969 | ENDOPLUS Wembley Rubber Products (M) Sdn Bhd, MY | BTR |
| Apr 11, 1994 | K941246 | RAE II TRACHEAL TUBE Mallinckrodt Medical | BTR |
| Jan 14, 1994 | K934465 | DIC TRACHEOSTOMY TUBE AND PORTEX BLUE LINE Smiths Industries Medical Systems, Inc. | BTR |
| Nov 2, 1993 | K932647 | WIRE REINFORCED ENDOTRACHEAL TUBE Vitaid, Ltd. | BTR |
| Oct 25, 1993 | K934117 | STABILTUBE Garrett Medical Products | BTR |
| Oct 6, 1993 | K933398 | BIVONA ILLUMINATED ENDOTRACHEAL TUBE Bivona Medical Technologies | BTR |
| Sep 2, 1993 | K925508 | RUSCH SAFETY CLEAR PLUS CUFFED W/MAGILL TIP Rusch, Inc. | BTR |
| Sep 2, 1993 | K925507 | RUSCH SAFETY CLEAR UNCUFFED WITH MAGILL TIP Rusch, Inc. | BTR |
| Sep 2, 1993 | K925505 | RUSCH SAFETY CLEAR PLUS CUFFED W/MURPHY EYE Rusch, Inc. | BTR |
| Aug 10, 1993 | K931749 | BIVONA(R) ICU ENDOTRACHEAL TUBE Bivona Medical Technologies | BTR |
| Aug 7, 1993 | K930741 | ESOPHAGEAL INTUBATION DETECTOR Wolfe-Carney Medical | BTR |
| Aug 2, 1993 | K925506 | RUSCH SAFETY CLEAR UNCUFFED WITH MURPHY EYE Rusch, Inc. | BTR |
| Jul 23, 1993 | K932711 | PRECISION MED PRODUCTS LTD GUEDEL AIRWAYS Precision Med Products, Ltd. | BTR |
| Jul 22, 1993 | K932561 | GUEDEL AIRWAYS Life Shield Healthcare Products, Inc. | BTR |
| Jul 8, 1993 | K932280 | RAE(R) II TRACHEAL TUBE Mallinckrodt Medical | BTR |
| Jun 23, 1993 | K931164 | RUSCH AGT PVC PREFORM NASAL TRACH TUB/CUF W/MUR EY Rusch, Inc. | BTR |
| Jun 23, 1993 | K931163 | RUSCH AGT PVC PREFORM ORAL TRACH TUB/CUF W/MUR EYE Rusch, Inc. | BTR |
| Jun 22, 1993 | K931166 | RUSCH AGT PVC PREF ORAL TRACH TUBE, UNCUF W/MUR EY Rusch, Inc. | BTR |
| Jun 22, 1993 | K931165 | RUSCH AGT PVC PREF NASAL TRACH TUB/UNCUF W/MUR EYE Rusch, Inc. | BTR |
| May 18, 1993 | K931735 | BLUE LINE(R) PDT(TM) PORTEX DIRECTIONAL TUBE Smiths Industries Medical Systems, Inc. | BTR |
| May 7, 1993 | K922894 | LAZER-TRACH TRACHEAL TUBE Sheridan Catheter Corp. | BTR |
| Apr 19, 1993 | K925781 | DISPOSABLE CUFFED ENDOTRACHEAL TUBE Coast Medical Corp. | BTR |
| Apr 15, 1993 | K922880 | XOMED TREACE JET VENTILATION TUBE Xomed-Treace, Inc. | BTR |
| Apr 7, 1993 | K926498 | ENDOGRIP Biomedix, Inc. | BTR |
| Mar 19, 1993 | K930114 | TRACHEOSTOMY T-TUBE Invotec International, Inc. | BTR |
| Mar 16, 1993 | K923591 | PALA-NATE Gesco Intl., Inc. | BTR |
| Mar 3, 1993 | K930179 | TRACHEAL TUBE FIXATION DEVICE Garrett Medical Products | BTR |
| Feb 18, 1993 | K925855 | DISPOSABLE UNCUFFED ENDOTRACHEAL TUBE Coast Medical Corp. | BTR |
| Feb 12, 1993 | K930150 | SAFE-T-TUBE RADIOPAQUE Boston Medical Products, Inc. | BTR |
| Jan 6, 1993 | K914370 | MECONIUM SUCTION DEVICE (MSD) Vital Signs, Inc. | BTR |
| Aug 25, 1992 | K921077 | DISPOSABLE INTUBATION KITS Coast Medical Corp. | BTR |
| Apr 6, 1992 | K910463 | MEROCEL(R) LASER-GUARD(TM) Merocel Corp. | BTR |
| Mar 20, 1992 | K915277 | ENDOTRACHEAL CPAP SET Vital Signs, Inc. | BTR |
| Mar 18, 1992 | K920900 | POLAMEDCO TRACHEAL AND NASOTRACHEAL TUBES Polamedco, Inc. | BTR |
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