FDA Device Intelligence
HomeFALCK MEDICAL INC › FMAT1 Prism B

FMAT1 Prism B

FALCK MEDICAL INC · Model Prism B · UDI-DI 00867009000215

HKY Prescription
10
510(k) clearances
11
Adverse events
2
Recalls
64
Facilities

Description

Disposable single use prism for FMAT1 Device

Recalls

DateFirmReason
2014-09-08Instrumed International, Inc.The reason these devices are being withdrawn from the market by Instrumed is that Instrumed did not market these devices prior to September 26, 1976, and therefore, does not meet a
2014-09-08Instrumed International, Inc.The reason these devices are being withdrawn from the market by Instrumed is that Instrumed did not market these devices prior to September 26, 1976, and therefore, does not meet a

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.