Panels › Anesthesiology › Product code BZT · Class 2
Stethoscope, Esophageal, With Electrical Conductors
Regulation 868.1920
1510(k)s in 12 months (46 all time)
3recalls in 12 months (4 all time)
1recalls that name a 510(k)
Top companies in BZT
| Company | 510(k)s | Recalls |
|---|---|---|
| Covidien, LLC | 1 | 3 |
| Sheridan Catheter Corp. | 4 | 0 |
| Deroyal Industries, Inc. | 3 | 0 |
| Biomedical Concepts, Inc. | 2 | 0 |
| Cincinnati Sub-Zero Products, Inc. | 1 | 1 |
| Coast Medical Corp. | 2 | 0 |
| Portex, Inc. | 2 | 0 |
| Respiratory Support Products, Inc. | 2 | 0 |
| Sensortek, Inc. | 2 | 0 |
| Starboard Medical, LLC | 2 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Dec 29, 2025 | K251025 | Mon-a-Therm Esophageal Stethoscope with Temperature Sensor 400TM (90041, 90042, 90043, 90049) Covidien, LLC | BZT |
| Apr 2, 2020 | K193027 | Esophageal Stethoscope 9 French, Esophageal Stethoscope 12 French, Esophageal Stethoscope 18 French, Esophageal Stethosc Deroyal Industries, Inc. | BZT |
| Jun 16, 2014 | K140134 | ESOPHAGEAL STETHOSCOPE WITH TEMPERATURE SENSOR (NON-STERILE),ESOPHAGEAL STETHOSCOPE TEMPERATURE WITH ATTACHED EAR PIECE Starboard Medical, LLC | BZT |
| Apr 12, 2012 | K111050 | ESOPHAGEAL / RECTAL TEMPERATURE PROBE, 9FR, 12FR, ESOPHAGEAL STETHOSCOPE WITH TEMPERATURE SENSOR, 9FR, 12FR, 18FR, 24FR Starboard Medical, LLC | BZT |
| Sep 17, 2009 | K092716 | ESOPHAGEAL STETHOSCOPE Truer Medical, Inc. | BZT |
| Dec 13, 2007 | K072621 | ESOPHAGEAL/RECTAL TEMPERATURE PROBE AND ESOPHAGEAL STETHOSCOPE WITH TEMPERATURE SENSOR Cincinnati Sub-Zero Products, Inc. | BZT |
| Sep 5, 2006 | K062020 | LIFESOUND ESOPHAGEAL STETHOSCOPE Novamed, LLC | BZT |
| Sep 1, 1998 | K982193 | ESOPHAGEAL STETHOSCOPE Shore Medical, Inc. | BZT |
| Mar 19, 1998 | K973839 | DISPOSABLE ESOPHAGEAL STETHOSCOPE Catheter Research, Inc. | BZT |
| Jun 19, 1996 | K961060 | ARISTO ESOPHAGEAL STETHOSCOPE Aristo Medical Products, Inc. | BZT |
| Nov 29, 1995 | K953793 | INTROSCOPE Polamedco, Inc. | BZT |
| Mar 17, 1995 | K930929 | ESOPHAGEAL STETHOSCOPE Coast Medical Corp. | BZT |
| Sep 8, 1994 | K943495 | DISPOSABLE ESOPHAGEAL STETHOSCOPE Coast Medical, Inc. | BZT |
| Jul 28, 1994 | K940169 | DEBUSK TEMPERATURE SYSTEMS PREMIER AND SIGNATURE SERIES MULTI-PURPOSE ESOPHAGEAL STETHOSCOPE Deroyal Industries, Inc. | BZT |
| Jul 13, 1993 | K925789 | DEBUSK TEMP. SYST. ESOPHAGEAL STETHOSCOPE Deroyal Industries, Inc. | BZT |
| Mar 29, 1993 | K930533 | BNOS MICROVENT(TM), MODEL AC AND MODEL AO Bnos Meditech, Ltd., GB | BZT |
| Nov 4, 1992 | K922007 | YSI MODEL 441A AIRWAY TEMPERATURE PROBE Yellow Springs Instrument Co., Inc. | BZT |
| Apr 26, 1991 | K904943 | TAPSCOPE ESOPHAGEAL CARDIAC RECORDING STETHOSCOPE Arzco Medical Electronics, Inc. | BZT |
| Sep 18, 1989 | K894757 | T-SCOPE, TELEMETRIC PRECORDIAL STETHOSCOPE Louisville Laboratories, Inc. | BZT |
| Jul 20, 1989 | K893409 | YSI MODELS 4400 & 4700 ESOPHAGEAL STETHOSCOPE TEMP Yellow Springs Instrument Co., Inc. | BZT |
| Jan 30, 1989 | K885347 | VITACOMM MODEL #140/141 ESOPHAGEAL STETHOSCOPE Vitacomm, Inc. | BZT |
| Aug 2, 1988 | K882319 | TELEMETRIC STETHOSCOPE Vital Signs, Inc. | BZT |
| Jun 16, 1988 | K881293 | SHERIDAN ELECTROSURGERY PROTECTION FILTER Sheridan Catheter Corp. | BZT |
| Nov 24, 1987 | K874295 | ESOPHAGEAL STETHOSCOPE W/ELECTRICAL CONDUCTORS Sheridan Catheter Corp. | BZT |
| Oct 20, 1987 | K873344 | ESOPHAGEAL STETHOSCOPE W/THERMISTOR Medical Components, Inc. | BZT |
| Mar 26, 1987 | K870255 | MODIFIED TRACHEAL TUBE WITH SALTZMAN E.A.R.(TM) Transcor, Inc. | BZT |
| Mar 10, 1987 | K864858 | LIFESOUND(TM) ESOPHAGEAL STETHOSCOPE W/THERMISTOR Biomedical Concepts, Inc. | BZT |
| Dec 15, 1986 | K864043 | ESOPHAGEAL STETHOSCOPE W/THERMOCOUPLE TYPE T Respiratory Support Products, Inc. | BZT |
| Oct 27, 1986 | K862672 | ESOPHAGEAL STETHOSCOPE WITH THERMISTOR Inmed Corp. | BZT |
| Oct 22, 1986 | K862548 | TEMPERATURE SENSING ESOPHAGEAL TRANSDUCER Lawrence Medical Systems, Inc. | BZT |
| Jul 14, 1986 | K862131 | SALTZMAN EAR(TM) ENDOTRACHEAL ASCULTATION RECEPTOR K & S Medicorp | BZT |
| Jun 16, 1986 | K861541 | SHERIDAN - YSI/ECG SONATEMP (TM) Sheridan Catheter Corp. | BZT |
| Jan 3, 1986 | K854212 | ACOUSTASCOPE ESOPHAGEAL STETHOSCOPE W/TEMP SENSOR Respiratory Support Products, Inc. | BZT |
| Sep 3, 1985 | K852228 | ESOPHAGEAL STETHOSCOPE WITH ELECTRICAL CONDUCTORS Sensortek, Inc. | BZT |
| Oct 25, 1984 | K844055 | ESOPHAGEAL STETHO SCOPE Sensortek, Inc. | BZT |
| Aug 24, 1984 | K843071 | ESOPHAGEAL STETHOSCOPES W/ELEC CONDUCTOR Primrose Medical, Inc. | BZT |
| Jun 22, 1984 | K842309 | VITACOMM 100 ESOPHAGEAL STETHOSCOPE Vitacomm, Inc. | BZT |
| Apr 30, 1984 | K841098 | SHERIDAN YSI/SONATEMP Sheridan Catheter Corp. | BZT |
| Aug 12, 1983 | K830716 | CARDIO-ESOPHASCOPE Portex, Inc. | BZT |
| Jan 18, 1983 | K823743 | MODEL 40-80-2 DISPOS. ESOPHAGEAL STETHO Y | BZT |
| Aug 3, 1982 | K821890 | CRITIKON #817 ESOPHAGEAL MULTI-PROBE Critikon Company, LLC | BZT |
| Dec 8, 1981 | K812976 | ARGYLE ACC-U-THERM W/TEMPERATURE PROBE Sherwood Medical Co. | BZT |
| Jul 28, 1981 | K811928 | LIFESOUND ESOPHAGEAL STETHOSCOPE Biomedical Concepts, Inc. | BZT |
| Jul 10, 1981 | K811862 | HI-LO TEMP ESOPHAGEAL STETHOSCOPE Mallinckrodt Critical Care | BZT |
| Feb 5, 1981 | K810147 | ESOPHAGEAL STETHOSCOPE TEMPERATURE PROBE Portex, Inc. | BZT |
| Jul 6, 1979 | K791190 | STETHOSCOPE WITH TEMPERATURE SENSOR National Catheter Co. Div. Mallinckrodt | BZT |
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