FDA Device Intelligence
HomeEast Coast Surgical Inc. › East Coast Surgical Instruments

East Coast Surgical Instruments

East Coast Surgical Inc. · Model 14-8205 · UDI-DI 00850837007150

KNF
10
510(k) clearances
404
Adverse events
5
Recalls
50
Facilities

Description

"J" Hook Electrode 32cm

Recalls

DateFirmReason
2013-02-12Integra 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
2012-05-23Integra LimitedThe Integra(TM) Jarit(R) Take-Apart Laparoscopic Instrument shafts were released with internal component out of specification.
2009-12-01LINA Medical ApSPotential for the LiNA Loop to break during operating procedure.
2009-12-01LINA Medical ApSPotential for the LiNA Loop to break during operating procedure.
2009-12-01LINA Medical ApSPotential for the LiNA Loop to break during operating procedure.

Query this across every FDA database — by API.

Linked GUDID · 510(k)/PMA · MAUDE · recalls · establishments. Free tier, no card required.

Get your free API keyRead the docs
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.