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AMT Balloon Measuring Device
APPLIED MEDICAL TECHNOLOGY, INC. · Model E1904 · UDI-DI 00842071152956
FTY
Prescription
10
510(k) clearances
436
Adverse events
5
Recalls
399
Facilities
Description
Guidewire Compatible Balloon Measuring Device (Pouched), MDR
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.