DeviceClearance

JOERNS HEALTHCARE, INC. FULL LENGTH TELESCOPING RAIL— 510(k) K951735

Substantially Equivalent

Joerns Healthcare, Inc.

FDA 510(k) clearance K951735 for JOERNS HEALTHCARE, INC. FULL LENGTH TELESCOPING RAIL, Substantially Equivalent on 1995-08-18. Applicant: Joerns Healthcare, Inc.. Device class: 2.

Clearance details

Applicant
Joerns Healthcare, Inc.
Product code
Code FNL
Device class
Class 2
Regulation
21 CFR 880.5100
Advisory panel
General Hospital
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Stevens Point, WI, US
Download summary PDFView on FDA.gov ↗

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Adverse events under product code FNL

product code FNL
Death
64
Injury
728
Malfunction
10,825
Other
9
Total
11,626

Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Recalls naming K951735

K-number listed on FDA's recall record

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K951735.

Data sourced from openFDA. This site is unofficial and independent of the FDA.