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Ambler Surgical
AMBLER SURGICAL CORP. · Model Hardy transsphenoidal curette · UDI-DI 00190660022280
HAO
Prescription
10
510(k) clearances
351
Adverse events
2
Recalls
212
Facilities
Description
Hardy transsphenoidal curette, 9 1/2'', bayonet shaft, working length 120mm, curved down 5.0mm cup, round handle
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2011-04-04 | Zimmer Inc. | A rounded or partially rounded tip on the screwdriver may not provide the required locking torque to lock the closure top to the polyaxial screw. When the hex tip of the screwdrive |
| 2010-07-02 | Integra LifeSciences Corp | Certain NeuroBalloon Catheters have the potential to improperly inflate or deflate under certain conditions. |
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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.