FBRClass I

Urethrometer

Gastroenterology, Urology · 21 CFR 876.5520

MDR events0All time

Recalls1All time

Registered firms1Currently listed

510(k) clearances0All time

Recent MDR events

0 adverse event reports on file

No MDR events on file for this product code.

Event type breakdown

No data available.

Most-reported manufacturers

No data available.

Recalls

1 recall events for this product code

Busse Hospital Disposables, Inc.
TerminatedUnknown
SS 4.5MM DIAMOND TIP TROCAR WITH LARGE GLOVES
Busse Convenience kits contain one or more swab/swabstick drug products, manufactured by Professional Disposables International (PDI), that are subject to a drug recall due to uncertainty of the adequacy of the validation of the test methods used to manufacture the drug products
Z-1192-2022 · View FDA record ↗

Registered firms

1 firms currently registered for this product code

Heinrich Medizintechnik Gmbh
Stuttgart Baden-Wurttemberg, DE

510(k) clearances

0 clearances for this product code

No 510(k) clearances on file for this product code.