10 results
·
21ms
·
Sources: EU EUDAMED, US FDA
MICROSELECTION INTERSTITIAL REMOTE AFTERLOAD SYS
FDA 510(k)
FDA Class 2
·Radiology
NAR
FDA UDI
NORTH AMERICAN RESCUE, LLC·00842209124220·
GALANTE FIBER METAL TOTAL HIP
FDA 510(k)
FDA Class 2
·Orthopedic
AUSTIN MODIFIED TOTAL OSSICULAR REPLACE
FDA 510(k)
FDA Class 2
·Ear, Nose, Throat
KIT IMPLANTABLE SLIM TIP LEAD, 50CM
FDA Adverse Event
Injury
·ABBOTT MEDICAL·Product code PMP·February 18, 2025
VITALITY 2
FDA Adverse Event
Malfunction
·GUIDANT CRM CLONMEL IRELAND·Product code LWS·October 5, 2010
OT ULTRA2 METER
FDA Adverse Event
Injury
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·December 3, 2012
HOMECHOICE AUTOMATED PD SET WITH CASSETTE
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code FKX·June 6, 2014
Product Name: Ingenia 3.0T; Model Numbers: (1) 781342, (2) 781377, (3) 782103;
FDA Enforcement
Class II
·Ongoing·Philips North America Llc·May 28, 2025
Animas(R) 2020 Insulin Infusion Pump Product Usage: This product is indicated for continuous subcutaneous infusion of insulin for the treatment of insulin-requiring diabetes.
FDA Enforcement
Class I
·Terminated·Animas Corporation·April 10, 2013