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MINOP

Aesculap AG · Model FH635R · UDI-DI 04046963888862

GZX Prescription

510(k) clearances

Adverse events (1 deaths)

Recalls

137

Facilities

Description

MINOP INVENT Micro scissors, complete instrument, w/o HF connection, straight, working length: 10 1/2", (265 mm), diam. 2 mm, serrated (one blade), sharp/sharp, with tubular shaft, rotatable, ring handle, double action, consisting of FF433R, FF435R, FH633R, detachable, non-sterile, reusable, to be used with: FH620R

Recalls

Date	Firm	Reason
2007-01-22	Medtronic Xomed, Inc.	A labeling discrepancy was internally identified for the surface electrode component of REF 8263210 AccuGuide EMG Injection Needle, 30G X 25MM. The outside box label correctly ind

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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.