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BV Medical · Model 28-443-164-OTO-L · UDI-DI 00845821029584
10
510(k) clearances
438
Adverse events
5
Recalls
403
Facilities
Description
Combo Kit: Black and Pink Bling Fanny Pack: 38-402-164 Dual Head Stethoscope, Deluxe-Lite, Adult, Magenta, Latex Free: 60-840-210-HP 2.5V Standard Otoscope w/specula: 60-402-210-1 Pink Penlight: 8-380J Fiberglass Tape Measure, BV Logo Sticker, White Case: 80-500-999 Taylor Percussion Hammer, Stealth: 80-150-070 Lister bandage scissors 5.5", stainless steel with fuchsia handle
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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Get your free API keyRead the docsData 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.