FDA inspection

Medtronic, Inc.: FDA inspection ending Aug 9, 2024

FDA inspection 1246495 · No Action Indicated (NAI) · Billerica, Massachusetts

Key facts

Inspection ID	1246495
Firm	Medtronic, Inc.
FEI number	3012520654
Address	880 Technology Park Dr
City	Billerica
State	Massachusetts
ZIP	01821
Fiscal year	2024
Inspection end date	Aug 9, 2024
Classification	No Action Indicated (NAI)
Project area	Compliance: Devices\|Compliance: Devices\|Compliance: Devices\|Compliance: Devices\|Compliance: Devices\|Compliance: Devices\|Compliance: Devices\|Compliance: Devices\|Compliance: Devices\|Compliance: Devices\|Compliance: Devices\|Compliance: Devices\|Compliance: Devices\|Compliance: Devices\|Compliance: Devices\|Compliance: Devices\|Compliance: Devices\|Compliance: Devices\|Compliance: Devices\|Compliance: Devices\|Compliance: Devices\|Compliance: Devices\|Compliance: Devices\|Compliance: Devices\|Compliance: Devices\|Compliance: Devices\|Compliance: Devices\|Compliance: Devices\|Compliance: Devices\|Compliance: Devices\|Compliance: Devices\|Compliance: Devices\|Compliance: Devices\|Compliance: Devices\|Compliance: Devices\|Compliance: Devices\|Compliance: Devices\|Compliance: Devices\|Compliance: Devices\|Compliance: Devices\|Compliance: Devices\|Compliance: Devices\|Compliance: Devices\|Compliance: Devices\|Compliance: Devices\|Compliance: Devices\|Compliance: Devices\|Compliance: Devices\|Compliance: Devices\|Compliance: Devices\|Compliance: Devices\|Compliance: Devices\|Compliance: Devices\|Compliance: Devices\|Compliance: Devices\|Compliance: Devices\|Compliance: Devices\|Compliance: Devices\|Compliance: Devices\|Compliance: Devices\|Compliance: Devices\|Compliance: Devices\|Compliance: Devices\|Compliance: Devices\|Compliance: Devices\|Compliance: Devices\|Compliance: Devices\|Compliance: Devices\|Compliance: Devices\|Compliance: Devices\|Compliance: Devices\|Compliance: Devices\|Compliance: Devices\|Compliance: Devices\|Compliance: Devices\|Compliance: Devices\|Compliance: Devices\|Compliance: Devices\|Compliance: Devices\|Compliance: Devices\|Compliance: Devices\|Compliance: Devices\|Compliance: Devices\|Compliance: Devices\|Compliance: Devices\|Compliance: Devices\|Compliance: Devices\|Compliance: Devices\|Compliance: Devices\|Compliance: Devices\|Compliance: Devices\|Compliance: Devices\|Compliance: Devices\|Compliance: Devices\|Compliance: Devices\|Compliance: Devices\|Compliance: Devices\|Compliance: Devices\|Compliance: Devices\|Compliance: Devices\|Compliance: Devices\|Compliance: Devices\|Compliance: Devices\|Compliance: Devices\|Compliance: Devices\|Compliance: Devices\|Compliance: Devices\|Compliance: Devices\|Compliance: Devices\|Compliance: Devices\|Compliance: Devices\|Compliance: Devices\|Compliance: Devices\|Compliance: Devices\|Compliance: Devices\|Compliance: Devices\|Compliance: Devices\|Compliance: Devices\|Compliance: Devices\|Compliance: Devices\|Compliance: Devices\|Compliance: Devices\|Compliance: Devices\|Compliance: Devices\|Compliance: Devices\|Compliance: Devices\|Compliance: Devices\|Compliance: Devices\|Compliance: Devices\|Compliance: Devices\|Compliance: Devices\|Compliance: Devices\|Compliance: Devices\|Compliance: Devices\|Compliance: Devices\|Compliance: Devices\|Compliance: Devices\|Compliance: Devices\|Compliance: Devices\|Compliance: Devices\|Compliance: Devices\|Compliance: Devices\|Compliance: Devices\|Compliance: Devices\|Compliance: Devices\|Compliance: Devices\|Compliance: Devices\|Compliance: Devices\|Compliance: Devices\|Compliance: Devices\|Compliance: Devices\|Compliance: Devices\|Compliance: Devices\|Compliance: Medical Devices\|Postmarket Assurance: Devices\|Postmarket Assurance: Medical Devices\|Product Evaluation: Medical Devices\|Postmarket Assurance: Devices\|Compliance: Medical Devices\|Postmarket Assurance: Devices\|Postmarket Assurance: Medical Devices\|Product Evaluation: Medical Devices\|Compliance: Medical Devices\|Postmarket Assurance: Devices\|Postmarket Assurance: Medical Devices\|Product Evaluation: Medical Devices\|Compliance: Medical Devices\|Postmarket Assurance: Devices\|Postmarket Assurance: Medical Devices\|Product Evaluation: Medical Devices\|Compliance: Medical Devices\|Postmarket Assurance: Devices\|Postmarket Assurance: Medical Devices\|Product Evaluation: Medical Devices\|Compliance: Medical Devices\|Postmarket Assurance: Devices\|Postmarket Assurance: Medical Devices\|Product Evaluation: Medical Devices\|Compliance: Medical Devices\|Postmarket Assurance: Devices\|Postmarket Assurance: Medical Devices\|Product Evaluation: Medical Devices\|Compliance: Medical Devices\|Postmarket Assurance: Devices\|Postmarket Assurance: Medical Devices\|Product Evaluation: Medical Devices\|Compliance: Medical Devices\|Postmarket Assurance: Devices\|Postmarket Assurance: Medical Devices\|Product Evaluation: Medical Devices\|Compliance: Medical Devices\|Postmarket Assurance: Devices\|Postmarket Assurance: Medical Devices\|Product Evaluation: Medical Devices\|Compliance: Medical Devices\|Postmarket Assurance: Devices\|Postmarket Assurance: Medical Devices\|Product Evaluation: Medical Devices\|Compliance: Medical Devices\|Postmarket Assurance: Devices\|Postmarket Assurance: Medical Devices\|Product Evaluation: Medical Devices\|Compliance: Medical Devices\|Postmarket Assurance: Devices\|Postmarket Assurance: Medical Devices\|Product Evaluation: Medical Devices\|Compliance: Medical Devices\|Postmarket Assurance: Devices\|Postmarket Assurance: Medical Devices\|Product Evaluation: Medical Devices\|Compliance: Medical Devices\|Postmarket Assurance: Devices\|Postmarket Assurance: Medical Devices\|Product Evaluation: Medical Devices\|Compliance: Medical Devices\|Postmarket Assurance: Devices\|Postmarket Assurance: Medical Devices\|Product Evaluation: Medical Devices\|Compliance: Medical Devices\|Postmarket Assurance: Devices\|Postmarket Assurance: Medical Devices\|Product Evaluation: Medical Devices\|Compliance: Medical Devices\|Postmarket Assurance: Devices\|Postmarket Assurance: Medical Devices\|Product Evaluation: Medical Devices\|Compliance: Medical Devices\|Postmarket Assurance: Devices\|Postmarket Assurance: Medical Devices\|Product Evaluation: Medical Devices\|Compliance: Medical Devices\|Postmarket Assurance: Devices\|Postmarket Assurance: Medical Devices\|Product Evaluation: Medical Devices\|Compliance: Medical Devices\|Postmarket Assurance: Devices\|Postmarket Assurance: Medical Devices\|Product Evaluation: Medical Devices\|Compliance: Medical Devices\|Postmarket Assurance: Devices\|Postmarket Assurance: Medical Devices\|Product Evaluation: Medical Devices\|Compliance: Medical Devices\|Postmarket Assurance: Devices\|Postmarket Assurance: Medical Devices\|Product Evaluation: Medical Devices\|Compliance: Medical Devices\|Postmarket Assurance: Devices\|Postmarket Assurance: Medical Devices\|Product Evaluation: Medical Devices\|Compliance: Medical Devices\|Postmarket Assurance: Devices\|Postmarket Assurance: Medical Devices\|Product Evaluation: Medical Devices\|Compliance: Medical Devices\|Postmarket Assurance: Devices\|Postmarket Assurance: Medical Devices\|Product Evaluation: Medical Devices\|Compliance: Medical Devices\|Postmarket Assurance: Devices\|Postmarket Assurance: Medical Devices\|Product Evaluation: Medical Devices\|Compliance: Medical Devices\|Postmarket Assurance: Devices\|Postmarket Assurance: Medical Devices\|Product Evaluation: Medical Devices\|Compliance: Medical Devices\|Postmarket Assurance: Devices\|Postmarket Assurance: Medical Devices\|Product Evaluation: Medical Devices\|Compliance: Medical Devices\|Postmarket Assurance: Devices\|Postmarket Assurance: Medical Devices\|Product Evaluation: Medical Devices\|Compliance: Medical Devices\|Postmarket Assurance: Devices\|Postmarket Assurance: Medical Devices\|Product Evaluation: Medical Devices\|Compliance: Medical Devices\|Postmarket Assurance: Devices\|Postmarket Assurance: Medical Devices\|Product Evaluation: Medical Devices\|Compliance: Medical Devices\|Postmarket Assurance: Devices\|Postmarket Assurance: Medical Devices\|Product Evaluation: Medical Devices\|Compliance: Medical Devices\|Postmarket Assurance: Devices\|Postmarket Assurance: Medical Devices\|Product Evaluation: Medical Devices\|Compliance: Medical Devices\|Postmarket Assurance: Devices\|Postmarket Assurance: Medical Devices\|Product Evaluation: Medical Devices\|Compliance: Medical Devices\|Postmarket Assurance: Devices\|Postmarket Assurance: Medical Devices\|Product Evaluation: Medical Devices\|Compliance: Medical Devices\|Postmarket Assurance: Devices\|Postmarket Assurance: Medical Devices\|Product Evaluation: Medical Devices\|Compliance: Medical Devices\|Postmarket Assurance: Devices\|Postmarket Assurance: Medical Devices\|Product Evaluation: Medical Devices\|Compliance: Medical Devices\|Postmarket Assurance: Devices\|Postmarket Assurance: Medical Devices\|Product Evaluation: Medical Devices\|Compliance: Medical Devices\|Postmarket Assurance: Devices\|Postmarket Assurance: Medical Devices\|Product Evaluation: Medical Devices\|Compliance: Medical Devices\|Postmarket Assurance: Devices\|Postmarket Assurance: Medical Devices\|Product Evaluation: Medical Devices\|Compliance: Medical Devices\|Postmarket Assurance: Devices\|Postmarket Assurance: Medical Devices\|Product Evaluation: Medical Devices\|Compliance: Medical Devices\|Postmarket Assurance: Devices\|Postmarket Assurance: Medical Devices\|Product Evaluation: Medical Devices\|Compliance: Medical Devices\|Postmarket Assurance: Devices\|Postmarket Assurance: Medical Devices\|Product Evaluation: Medical Devices\|Compliance: Medical Devices\|Postmarket Assurance: Devices\|Postmarket Assurance: Medical Devices\|Product Evaluation: Medical Devices\|Compliance: Medical Devices\|Postmarket Assurance: Devices\|Postmarket Assurance: Medical Devices\|Product Evaluation: Medical Devices\|Compliance: Medical Devices\|Postmarket Assurance: Devices\|Postmarket Assurance: Medical Devices\|Product Evaluation: Medical Devices\|Compliance: Medical Devices\|Postmarket Assurance: Devices\|Postmarket Assurance: Medical Devices\|Product Evaluation: Medical Devices\|Compliance: Medical Devices\|Postmarket Assurance: Devices\|Postmarket Assurance: Medical Devices\|Product Evaluation: Medical Devices\|Compliance: Medical Devices\|Postmarket Assurance: Devices\|Postmarket Assurance: Medical Devices\|Product Evaluation: Medical Devices\|Compliance: Medical Devices\|Postmarket Assurance: Devices\|Postmarket Assurance: Medical Devices\|Product Evaluation: Medical Devices\|Compliance: Medical Devices\|Postmarket Assurance: Devices\|Postmarket Assurance: Medical Devices\|Product Evaluation: Medical Devices\|Compliance: Medical Devices\|Postmarket Assurance: Devices\|Postmarket Assurance: Medical Devices\|Product Evaluation: Medical Devices\|Compliance: Medical Devices\|Postmarket Assurance: Devices\|Postmarket Assurance: Medical Devices\|Product Evaluation: Medical Devices\|Compliance: Medical Devices\|Postmarket Assurance: Devices\|Postmarket Assurance: Medical Devices\|Product Evaluation: Medical Devices\|Compliance: Medical Devices\|Postmarket Assurance: Devices\|Postmarket Assurance: Medical Devices\|Product Evaluation: Medical Devices\|Postmarket Assurance: Devices\|Compliance: Medical Devices\|Postmarket Assurance: Devices\|Postmarket Assurance: Medical Devices\|Product Evaluation: Medical Devices\|Compliance: Medical Devices\|Postmarket Assurance: Devices\|Postmarket Assurance: Medical Devices\|Product Evaluation: Medical Devices\|Compliance: Medical Devices\|Postmarket Assurance: Devices\|Postmarket Assurance: Medical Devices\|Product Evaluation: Medical Devices\|Compliance: Medical Devices\|Postmarket Assurance: Devices\|Postmarket Assurance: Medical Devices\|Product Evaluation: Medical Devices\|Compliance: Medical Devices\|Postmarket Assurance: Devices\|Postmarket Assurance: Medical Devices\|Product Evaluation: Medical Devices\|Compliance: Medical Devices\|Postmarket Assurance: Devices\|Postmarket Assurance: Medical Devices\|Product Evaluation: Medical Devices\|Compliance: Medical Devices\|Postmarket Assurance: Devices\|Postmarket Assurance: Medical Devices\|Product Evaluation: Medical Devices\|Compliance: Medical Devices\|Postmarket Assurance: Devices\|Postmarket Assurance: Medical Devices\|Product Evaluation: Medical Devices\|Compliance: Medical Devices\|Postmarket Assurance: Devices\|Postmarket Assurance: Medical Devices\|Product Evaluation: Medical Devices\|Compliance: Medical Devices\|Postmarket Assurance: Devices\|Postmarket Assurance: Medical Devices\|Product Evaluation: Medical Devices\|Compliance: Medical Devices\|Postmarket Assurance: Devices\|Postmarket Assurance: Medical Devices\|Product Evaluation: Medical Devices\|Compliance: Medical Devices\|Postmarket Assurance: Devices\|Postmarket Assurance: Medical Devices\|Product Evaluation: Medical Devices\|Compliance: Medical Devices\|Postmarket Assurance: Devices\|Postmarket Assurance: Medical Devices\|Product Evaluation: Medical Devices\|Compliance: Medical Devices\|Postmarket Assurance: Devices\|Postmarket Assurance: Medical Devices\|Product Evaluation: Medical Devices\|Compliance: Medical Devices\|Postmarket Assurance: Devices\|Postmarket Assurance: Medical Devices\|Product Evaluation: Medical Devices\|Compliance: Medical Devices\|Postmarket Assurance: Devices\|Postmarket Assurance: Medical Devices\|Product Evaluation: Medical Devices\|Compliance: Medical Devices\|Postmarket Assurance: Devices\|Postmarket Assurance: Medical Devices\|Product Evaluation: Medical Devices\|Compliance: Medical Devices\|Postmarket Assurance: Devices\|Postmarket Assurance: Medical Devices\|Product Evaluation: Medical Devices\|Compliance: Medical Devices\|Postmarket Assurance: Devices\|Postmarket Assurance: Medical Devices\|Product Evaluation: Medical Devices\|Compliance: Medical Devices\|Postmarket Assurance: Devices\|Postmarket Assurance: Medical Devices\|Product Evaluation: Medical Devices\|Compliance: Medical Devices\|Postmarket Assurance: Devices\|Postmarket Assurance: Medical Devices\|Product Evaluation: Medical Devices\|Compliance: Medical Devices\|Postmarket Assurance: Devices\|Postmarket Assurance: Medical Devices\|Product Evaluation: Medical Devices\|Compliance: Medical Devices\|Postmarket Assurance: Devices\|Postmarket Assurance: Medical Devices\|Product Evaluation: Medical Devices\|Compliance: Medical Devices\|Postmarket Assurance: Devices\|Postmarket Assurance: Medical Devices\|Product Evaluation: Medical Devices\|Postmarket Assurance: Devices\|Compliance: Medical Devices\|Postmarket Assurance: Devices\|Postmarket Assurance: Medical Devices\|Product Evaluation: Medical Devices\|Compliance: Medical Devices\|Postmarket Assurance: Devices\|Postmarket Assurance: Medical Devices\|Product Evaluation: Medical Devices\|Compliance: Medical Devices\|Postmarket Assurance: Devices\|Postmarket Assurance: Medical Devices\|Product Evaluation: Medical Devices\|Compliance: Medical Devices\|Postmarket Assurance: Devices\|Postmarket Assurance: Medical Devices\|Product Evaluation: Medical Devices\|Compliance: Medical Devices\|Postmarket Assurance: Devices\|Postmarket Assurance: Medical Devices\|Product Evaluation: Medical Devices\|Compliance: Medical Devices\|Postmarket Assurance: Devices\|Postmarket Assurance: Medical Devices\|Product Evaluation: Medical Devices\|Compliance: Medical Devices\|Postmarket Assurance: Devices\|Postmarket Assurance: Medical Devices\|Product Evaluation: Medical Devices\|Compliance: Medical Devices\|Postmarket Assurance: Devices\|Postmarket Assurance: Medical Devices\|Product Evaluation: Medical Devices\|Compliance: Medical Devices\|Postmarket Assurance: Devices\|Postmarket Assurance: Medical Devices\|Product Evaluation: Medical Devices\|Compliance: Medical Devices\|Postmarket Assurance: Devices\|Postmarket Assurance: Medical Devices\|Product Evaluation: Medical Devices\|Compliance: Medical Devices\|Postmarket Assurance: Devices\|Postmarket Assurance: Medical Devices\|Product Evaluation: Medical Devices\|Compliance: Medical Devices\|Postmarket Assurance: Devices\|Postmarket Assurance: Medical Devices\|Product Evaluation: Medical Devices\|Compliance: Medical Devices\|Postmarket Assurance: Devices\|Postmarket Assurance: Medical Devices\|Product Evaluation: Medical Devices\|Compliance: Medical Devices\|Postmarket Assurance: Devices\|Postmarket Assurance: Medical Devices\|Product Evaluation: Medical Devices\|Compliance: Medical Devices\|Postmarket Assurance: Devices\|Postmarket Assurance: Medical Devices\|Product Evaluation: Medical Devices\|Compliance: Medical Devices\|Postmarket Assurance: Devices\|Postmarket Assurance: Medical Devices\|Product Evaluation: Medical Devices\|Compliance: Medical Devices\|Postmarket Assurance: Devices\|Postmarket Assurance: Medical Devices\|Product Evaluation: Medical Devices\|Compliance: Medical Devices\|Postmarket Assurance: Devices\|Postmarket Assurance: Medical Devices\|Product Evaluation: Medical Devices\|Compliance: Medical Devices\|Postmarket Assurance: Devices\|Postmarket Assurance: Medical Devices\|Product Evaluation: Medical Devices\|Compliance: Medical Devices\|Postmarket Assurance: Devices\|Postmarket Assurance: Medical Devices\|Product Evaluation: Medical Devices\|Compliance: Medical Devices\|Postmarket Assurance: Devices\|Postmarket Assurance: Medical Devices\|Product Evaluation: Medical Devices\|Compliance: Medical Devices\|Postmarket Assurance: Devices\|Postmarket Assurance: Medical Devices\|Product Evaluation: Medical Devices\|Compliance: Medical Devices\|Postmarket Assurance: Devices\|Postmarket Assurance: Medical Devices\|Product Evaluation: Medical Devices\|Compliance: Medical Devices\|Postmarket Assurance: Devices\|Postmarket Assurance: Medical Devices\|Product Evaluation: Medical Devices\|Compliance: Medical Devices\|Postmarket Assurance: Devices\|Postmarket Assurance: Medical Devices\|Product Evaluation: Medical Devices\|Compliance: Medical Devices\|Postmarket Assurance: Devices\|Postmarket Assurance: Medical Devices\|Product Evaluation: Medical Devices\|Compliance: Medical Devices\|Postmarket Assurance: Devices\|Postmarket Assurance: Medical Devices\|Product Evaluation: Medical Devices\|Compliance: Medical Devices\|Postmarket Assurance: Devices\|Postmarket Assurance: Medical Devices\|Product Evaluation: Medical Devices\|Compliance: Medical Devices\|Postmarket Assurance: Devices\|Postmarket Assurance: Medical Devices\|Product Evaluation: Medical Devices\|Compliance: Medical Devices\|Postmarket Assurance: Devices\|Postmarket Assurance: Medical Devices\|Product Evaluation: Medical Devices\|Compliance: Medical Devices\|Postmarket Assurance: Devices\|Postmarket Assurance: Medical Devices\|Product Evaluation: Medical Devices\|Compliance: Medical Devices\|Postmarket Assurance: Devices\|Postmarket Assurance: Medical Devices\|Product Evaluation: Medical Devices\|Compliance: Medical Devices\|Postmarket Assurance: Devices\|Postmarket Assurance: Medical Devices\|Product Evaluation: Medical Devices\|Compliance: Medical Devices\|Postmarket Assurance: Devices\|Postmarket Assurance: Medical Devices\|Product Evaluation: Medical Devices\|Compliance: Medical Devices\|Postmarket Assurance: Devices\|Postmarket Assurance: Medical Devices\|Product Evaluation: Medical Devices\|Compliance: Medical Devices\|Postmarket Assurance: Devices\|Postmarket Assurance: Medical Devices\|Product Evaluation: Medical Devices\|Compliance: Medical Devices\|Postmarket Assurance: Devices\|Postmarket Assurance: Medical Devices\|Product Evaluation: Medical Devices\|Compliance: Medical Devices\|Postmarket Assurance: Devices\|Postmarket Assurance: Medical Devices\|Product Evaluation: Medical Devices\|Compliance: Medical Devices\|Postmarket Assurance: Devices\|Postmarket Assurance: Medical Devices\|Product Evaluation: Medical Devices\|Compliance: Medical Devices\|Postmarket Assurance: Devices\|Postmarket Assurance: Medical Devices\|Product Evaluation: Medical Devices\|Compliance: Medical Devices\|Postmarket Assurance: Devices\|Postmarket Assurance: Medical Devices\|Product Evaluation: Medical Devices\|Compliance: Medical Devices\|Postmarket Assurance: Devices\|Postmarket Assurance: Medical Devices\|Product Evaluation: Medical Devices\|Compliance: Medical Devices\|Postmarket Assurance: Devices\|Postmarket Assurance: Medical Devices\|Product Evaluation: Medical Devices\|Compliance: Medical Devices\|Postmarket Assurance: Devices\|Postmarket Assurance: Medical Devices\|Product Evaluation: Medical Devices\|Compliance: Medical Devices\|Postmarket Assurance: Devices\|Postmarket Assurance: Medical Devices\|Product Evaluation: Medical Devices\|Compliance: Medical Devices\|Postmarket Assurance: Devices\|Postmarket Assurance: Medical Devices\|Product Evaluation: Medical Devices\|Compliance: Medical Devices\|Postmarket Assurance: Devices\|Postmarket Assurance: Medical Devices\|Product Evaluation: Medical Devices\|Compliance: Medical Devices\|Postmarket Assurance: Devices\|Postmarket Assurance: Medical Devices\|Product Evaluation: Medical Devices\|Compliance: Medical Devices\|Postmarket Assurance: Devices\|Postmarket Assurance: Medical Devices\|Product Evaluation: Medical Devices\|Compliance: Medical Devices\|Postmarket Assurance: Devices\|Postmarket Assurance: Medical Devices\|Product Evaluation: Medical Devices\|Compliance: Medical Devices\|Postmarket Assurance: Devices\|Postmarket Assurance: Medical Devices\|Product Evaluation: Medical Devices\|Compliance: Medical Devices\|Postmarket Assurance: Devices\|Postmarket Assurance: Medical Devices\|Product Evaluation: Medical Devices\|Compliance: Medical Devices\|Postmarket Assurance: Devices\|Postmarket Assurance: Medical Devices\|Product Evaluation: Medical Devices\|Compliance: Medical Devices\|Postmarket Assurance: Devices\|Postmarket Assurance: Medical Devices\|Product Evaluation: Medical Devices\|Compliance: Medical Devices\|Postmarket Assurance: Devices\|Postmarket Assurance: Medical Devices\|Product Evaluation: Medical Devices\|Compliance: Medical Devices\|Postmarket Assurance: Devices\|Postmarket Assurance: Medical Devices\|Product Evaluation: Medical Devices\|Compliance: Medical Devices\|Postmarket Assurance: Devices\|Postmarket Assurance: Medical Devices\|Product Evaluation: Medical Devices\|Compliance: Medical Devices\|Postmarket Assurance: Devices\|Postmarket Assurance: Medical Devices\|Product Evaluation: Medical Devices\|Compliance: Medical Devices\|Postmarket Assurance: Devices\|Postmarket Assurance: Medical Devices\|Product Evaluation: Medical Devices\|Compliance: Medical Devices\|Postmarket Assurance: Devices\|Postmarket Assurance: Medical Devices\|Product Evaluation: Medical Devices\|Compliance: Medical Devices\|Postmarket Assurance: Devices\|Postmarket Assurance: Medical Devices\|Product Evaluation: Medical Devices\|Compliance: Medical Devices\|Postmarket Assurance: Devices\|Postmarket Assurance: Medical Devices\|Product Evaluation: Medical Devices\|Compliance: Medical Devices\|Postmarket Assurance: Devices\|Postmarket Assurance: Medical Devices\|Product Evaluation: Medical Devices\|Compliance: Medical Devices\|Postmarket Assurance: Devices\|Postmarket Assurance: Medical Devices\|Product Evaluation: Medical Devices\|Compliance: Medical Devices\|Postmarket Assurance: Devices\|Postmarket Assurance: Medical Devices\|Product Evaluation: Medical Devices\|Compliance: Medical Devices\|Postmarket Assurance: Devices\|Postmarket Assurance: Medical Devices\|Product Evaluation: Medical Devices\|Compliance: Medical Devices\|Postmarket Assurance: Devices\|Postmarket Assurance: Medical Devices\|Product Evaluation: Medical Devices\|Compliance: Medical Devices\|Postmarket Assurance: Devices\|Postmarket Assurance: Medical Devices\|Product Evaluation: Medical Devices\|Compliance: Medical Devices\|Postmarket Assurance: Devices\|Postmarket Assurance: Medical Devices\|Product Evaluation: Medical Devices\|Compliance: Medical Devices\|Postmarket Assurance: Devices\|Postmarket Assurance: Medical Devices\|Product Evaluation: Medical Devices
Product type	Devices

At a glance

None Citations
None Posted citations
No Warning letter followed
Yes Form FDA 483 issued
No Establishment inspection report (EIR) exists
1–9 Inspections at this FEI

Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.

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Source: U.S. Food and Drug Administration (FDA), inspection classification data

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