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MEDTRONIC, INC. · Model 8529 · UDI-DI 00613994997937

KMN PJS Prescription

510(k) clearances

131

Adverse events (3 deaths)

Recalls

188

Facilities

Description

MAGNET 8529 PHYS PROGRMR 8840 US 60601

Recalls

Date	Firm	Reason
2021-05-12	Stryker Medical Division of Stryker Corporation	Medical devices intended for use in a healthcare facility were distributed to residential customers and may be in use in a home environment. The product s labeling accurately iden
2021-05-12	Stryker Medical Division of Stryker Corporation	Medical devices intended for use in a healthcare facility were distributed to residential customers and may be in use in a home environment. The product s labeling accurately iden
2012-08-06	Invacare Corporation	On August 6, 2012, Invacare voluntarily recalled the Invacare I-Fit" Shower Chair (Models 9780, 9781, 9781-1) based on the return, quality and adverse event data received.

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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.