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ELMED
ELMED INCORPORATED · Model 31-4000-30 · UDI-DI 00842180171978
KOA
Prescription
10
510(k) clearances
37
Adverse events
6
Recalls
114
Facilities
Description
Goodwin Style Dilation Sounds- shaft with curved tip with flat distal end for curve directional identification and ergonomic sure grip round handle, 30Fr. Autoclavable Medical Grade Stainless Steel.
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2020-04-01 | Aesculap Implant Systems LLC | Endoscopic graspers may become separated at the weld from handle to the shaft of the device. |
| 2020-04-01 | Aesculap Implant Systems LLC | Endoscopic graspers may become separated at the weld from handle to the shaft of the device. |
| 2019-04-10 | Uromedica Inc. | Potential issue with the manufacture and inspection of U-channel sheaths in Implantation Instruments Sets. Affected U-channel sheaths may be more likely to cause damage to ProACT i |
| 2017-05-01 | Cook Inc. | COOK Medical is initiating a voluntary recall of multiple products because the reprocessing instructions do not provide sufficient detailed information for the cleaning, disinfecti |
| 2017-05-01 | Cook Inc. | COOK Medical is initiating a voluntary recall of multiple products because the reprocessing instructions do not provide sufficient detailed information for the cleaning, disinfecti |
| 2017-05-01 | Cook Inc. | COOK Medical is initiating a voluntary recall of multiple products because the reprocessing instructions do not provide sufficient detailed information for the cleaning, disinfecti |
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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.