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ELMED

ELMED INCORPORATED · Model EL-CH13144 · UDI-DI 00842180178700

GDG Prescription
10
510(k) clearances
277
Adverse events
7
Recalls
313
Facilities

Description

Clamp applying forceps. Offers the ability to open approximator clamps individually or simultaneously. For clamps used on vessel diameter from 0.4mm to 2.25mm. Without lock. Angled. Overall length 5-7/8in (15cm).

Recalls

DateFirmReason
2024-12-03Sklar InstrumentsReports of various packaging issues that may result in a breach of the sterile barrier.
2024-11-12MEDLINE INDUSTRIES, LP - NorthfieldWeak seals may result in a breach of sterility, which may not be detectable to the user. This can lead to increased risk of contamination and infection.
2024-02-23MEDLINE INDUSTRIES, LP - NorthfieldProduct may have a weak seal which may result in a breach of sterility of the contents if the seal fails. The weak seal may not be detectable by all users.
2011-12-06Teleflex MedicalTeleflex Medical received complaints that the elastic bands are breaking, cracking and /or deteriorating prior to their expiration date. If the elastic bands break during use there
2011-12-06Teleflex MedicalTeleflex Medical received complaints that the elastic bands are breaking, cracking and /or deteriorating prior to their expiration date. If the elastic bands break during use there
2008-05-12Telefelx MedicalThe bands are breaking within the sealed packaging or in use prior to the expiration dates.
2008-05-12Telefelx MedicalThe bands are breaking within the sealed packaging or in use prior to the expiration dates.

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Data 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.