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Ambler Surgical

AMBLER SURGICAL CORP. · Model 44-340 · UDI-DI 00190660029562

DWP Prescription
1
510(k) clearances
171
Adverse events
1
Recalls
44
Facilities

Description

Cooley coronary dilator set, 5", includes 6 sizes - 0.5mm, 1.0mm, 1.5mm, 2.0mm, 2.5mm and 3.0mm, aluminum round handle (44-341, 44-342, 44-343, 44-344, 44-345 and 44-346)

Recalls

DateFirmReason
2023-12-06Baxter Healthcare CorporationCardiovascular Surgery marketing brochure (US-AS46-220001) that was distributed for the products listed below contains inaccurate content that does not align with some of the produ

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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.