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BV Medical · Model 80-510-214-BC-OTO-L · UDI-DI 00845821031426

FTY LRW LDE KYT ERA

510(k) clearances

436

Adverse events

Recalls

399

Facilities

Description

Combo Kit: Pink Breast Cancer Awareness Nurse Kit: 30-510-214 Gem-Scope, Adult, Pink, Latex Free, Breast Cancer Chest piece: 60-840-210-HP 2.5 V Standard Otoscope w/specula: 60-402-210-1 Penlight, Disposable, Pink, With Pupil Gauge, Single: 8-380J Fiberglass Tape Measure, BV Logo Sticker, White Case: 80-170-310 Utility scissors 5.5", stainless steel with neon pink handle: Nurse Kit Pocket Organizer, White, Latex Free: 2 Velcro Tab, Fuchsia, Latex Free: 3D Pedometer: Tracks steps, aerobic steps, distance, calories burned. With 7 day memory and clock

Recalls

Date	Firm	Reason
2015-03-05	SpineFrontier, 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
2010-10-22	Lemaitre Vascular, Inc.	Box label (Top Part). Lot and Expiration Date information were switched.
2010-10-22	Lemaitre Vascular, Inc.	Box label (Top Part). Lot and Expiration Date information were switched.
2010-10-22	Lemaitre Vascular, Inc.	Box label (Top Part). Lot and Expiration Date information were switched.
2010-10-22	Lemaitre 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.