8 results
·
24ms
·
Sources: EU EUDAMED, US FDA
LEG BAG
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
MTG INSTANT CATHER (WITH AND WITHOUT KIT), MTG INSTANT CATH DELUXE (WITH AND WITHOUT KIT)
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
BIO-VENTURE Rapid Amphetamine Test Cassette for OTC Use, BIO-VENTURE Rapid Oxazepam Test Cassette for OTC Use, BIO-VENTURE Rapid Cocaine Test Cassette for OTC Use, BIO-VENTURE Rapid Methamphetamine Test Cassette for OTC Use, BIO-VENTURE Rapid Morphine Test Cassette for OTC Use, BIO-VENTURE Rapid Marijuana Test Cassette for OTC Use, BIO-VENTURE Rapid Amphetamine Test Cassette for Rx Use, BIO-VENTURE Rapid Oxazepam Test Cassette for Rx Use, BIO-VENTURE Rapid Cocaine Test Cassette for Rx
FDA 510(k)
FDA Class 2
·Clinical Toxicology
ONETOUCHPING GLUCOSEMGMTSYSTEM
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·April 30, 2014
EXTRACTOR¿ PRO DL
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC - CORK·Product code FGE·October 10, 2012
INRATIO
FDA Adverse Event
Injury
·BIOSITE INCORPORATED·Product code GJS·July 30, 2010
BARD Dynamic Tip Steerable, Product Number 200344; REPROCESSED ELECTROPHYSIOLOGY CATHETER
FDA Enforcement
Class II
·Ongoing·Stryker Sustainability Solutions·May 20, 2026
ACCOLADE SR SL MRI (Model L310)
FDA Enforcement
Class I
·Ongoing·Boston Scientific Corporation·October 22, 2025