8 results
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19ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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SURGIC II IMPLANT CONTROL UNIT
FDA 510(k)
FDA Class 1
·Dental
GentleCath Intermittent Urinary Catheter
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
PARAGON 8500 CARDIO-PULMONARY BED
FDA 510(k)
FDA Class 2
·General Hospital
TBD
FDA Adverse Event
Malfunction
·Product code KOD·April 5, 2018
INTERMATE
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - IRVINE·Product code FRN·February 21, 2013
M2A-MAGNUM MOD HD SZ 46MM
FDA Adverse Event
Injury
·BIOMET ORTHOPEDICS·Product code KWA·August 1, 2014
ONE TOUCH PING GLUCOSE MANAGEMENT SYSTEM
FDA Adverse Event
Malfunction
·ANIMAS CORP.·Product code LZG·January 19, 2011
BARD Dynamic Deca Steerable, Product Number 201101; REPROCESSED ELECTROPHYSIOLOGY CATHETER
FDA Enforcement
Class II
·Ongoing·Stryker Sustainability Solutions·May 20, 2026