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MEDRAD® PRO-TEKT Endorectal Balloon

BAYER MEDICAL CARE INC. · Model PROT 50 · UDI-DI 00616258005706

EXX Prescription
0
510(k) clearances
10
Adverse events
1
Recalls
41
Facilities

Description

MEDRAD PRO-TEKT Endorectal Balloon (PRO-TEKT Endorectal Balloon, PROT50) (60729377)

Recalls

DateFirmReason
2009-04-09Marina Medical Instruments Inc.Marina Medical, Sunrise, FL initiated recall of 46 different 350 series devices and 47 different 270 series products because the material used to manufacture the products was not p

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

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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.