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BV Medical

BV Medical · Model 20-480-194-L · UDI-DI 00845821023377

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10
510(k) clearances
436
Adverse events
5
Recalls
403
Facilities

Description

Combo Kit: Orange Fanny Pack: Latex Aneroid Sphygmomanometer: 38-416-194 Sprague Rappaport-Type, Adult, Orange, Latex Free: 60-403-020 Penlight, Reusable, With Pupil Gauge, Chrome: 80-153-000 Lister bandage scissors, with clip, stainless steel, 5.5 ": Fiberglass Tape Measure (White Case)

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.