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AESCULAP
Aesculap AG · Model PO118R · UDI-DI 04038653284702
KNF
Prescription
10
510(k) clearances
410
Adverse events
5
Recalls
50
Facilities
Description
DE BAKEY ADTEC MONOPOLAR Atraumatic Vascular Clamp, complete instrument, straight, (370 mm), diam. 10 mm, toothing De Bakey, (50 mm), double action, consisting of PM977R, PO624R, PO959R, reusable
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2013-02-12 | Integra LifeSciences Corp. | Addendum to the Instructions for Use. The addendum emphasizes the warnings and precautions already contained in the device's IFU and also provides additional warnings and precautio |
| 2012-05-23 | Integra Limited | The Integra(TM) Jarit(R) Take-Apart Laparoscopic Instrument shafts were released with internal component out of specification. |
| 2009-12-01 | LINA Medical ApS | Potential for the LiNA Loop to break during operating procedure. |
| 2009-12-01 | LINA Medical ApS | Potential for the LiNA Loop to break during operating procedure. |
| 2009-12-01 | LINA Medical ApS | Potential for the LiNA Loop to break during operating procedure. |
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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.
