BZW
13 FDA 510(k) clearances · Product code
38 daysmedian time to decision
88 days90th percentile
13clearances measured
FDA profile
- Official device name
- Stethoscope, Esophageal
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 868.1910
- Medical specialty
- Anesthesiology
- Adverse events (MAUDE)
- 1999: 1 · 2000: 2 · 2001: 1 · 2005: 1 · 2006: 2 · 2008: 2
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free
| Record | Firm | Date |
|---|---|---|
| MODIFIED ESOPHAGEAL STETHOSCOPE/TEMPERATURE SENSOR (K874519) | Mon-A-Therm, Inc. | 1988-01-29 |
| ESOPHAGEAL STETHOSCOPE (K860558) | Sharn, Inc. | 1986-04-01 |
| ESOPHAGEAL STETHOSCOPE (K844444) | Medical Parameters, Inc. | 1985-01-10 |
| ESOPHAGEAL STETHOSCOPES (K843070) | Primrose Medical, Inc. | 1984-08-24 |
| ESOPHAGEAL STETHOSCOPE (K842865) | Inmed Corp. | 1984-08-15 |
| QUAZAR ESOPHAGEAL STETHOSCOPE (K841574) | Axiom Medical, Inc. | 1984-08-15 |
| ESOPHAGEAL STETHOSCOPE (K830329) | Science Development Corp. | 1983-03-11 |
| SHERIDAN/ESOPHAGEAL STETHOSCOPE (K830218) | Sheridan Catheter Corp. | 1983-03-09 |
| ESOPHAGEAL STETHOSCOPE (K823703) | Rsp, Inc. | 1983-01-07 |
| MODEL SA-1 STETHOSCOPE AUDIO AMPLIFIER (K823126) | Electromedics, Inc. | 1982-11-16 |
| ESOPHAGEAL STETHESCOPE (K800463) | Medical Components, Inc. | 1980-03-10 |
| ARGYLE ESOPHAGEAL STETHOSCOPE (K790523) | Sherwood Medical Industries | 1979-03-27 |
| ESOPHAGEAL STETH. TEMP. SENSOR (K771411) | Labarge, Inc. | 1977-09-23 |
Track BZW automatically
Every clearance here is in the API, with alerts when new ones post.