FDA Device Intelligence
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Bausch + Lomb

Bausch & Lomb Incorporated · Model SP7-18640D · UDI-DI 00757770405237

FTY Prescription
10
510(k) clearances
436
Adverse events
5
Recalls
398
Facilities

Description

PERKINS DIS 110DEG CVD DOWN

Recalls

DateFirmReason
2015-03-05SpineFrontier, Inc.The PedFuse Pedicle Screw Rod Caliper included with the MISquito Pedicle Screw System may be used incorrectly as the Surgical Technique does not adequately convey the intended use
2010-10-22Lemaitre Vascular, Inc.Box label (Top Part). Lot and Expiration Date information were switched.
2010-10-22Lemaitre Vascular, Inc.Box label (Top Part). Lot and Expiration Date information were switched.
2010-10-22Lemaitre Vascular, Inc.Box label (Top Part). Lot and Expiration Date information were switched.
2010-10-22Lemaitre Vascular, Inc.Box label (Top Part). Lot and Expiration Date information were switched.

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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.