FDA Device Intelligence
Home › B BRAUN INTERVENTIONAL SYSTEMS, INC › Z-MED™

Z-MED™

B BRAUN INTERVENTIONAL SYSTEMS, INC · Model 610446 · UDI-DI 04046964328541

OZTLIT Prescription
10
510(k) clearances
367
Adverse events (35 deaths)
2
Recalls
24
Facilities

Description

PDZ355 SPECIAL Z-MED 17X6X100

Recalls

DateFirmReason
2014-03-14InterValve IncLeak issues were discovered through accelerated age testing.
2013-03-18Loma Vista MedicalSlow deflation time: Slower than normal balloon deflation time of greater than 10 seconds. The balloon normally deflates in less than 5 seconds. The device performance specificat

Query this across every FDA database — by API.

Linked GUDID · 510(k)/PMA · MAUDE · recalls · establishments. Free tier, no card required.

Get your free API keyRead the docs
Data compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.