12 results
·
27ms
·
Sources: EU EUDAMED, US FDA
HOTWIRE RF GUIDEWIRE (901XXX); HOTWIRE RF GUIDEWIRE (902XXX)
FDA 510(k)
FDA Class 2
·Cardiovascular
NA
FDA UDI
Exactech, Inc.·10885862524270·TRIAL, TIBIAL INSERT, SPACER, SIZE 4, SIZE 4.5,...
BIOTECH Nitrile Examination Gloves
FDA 510(k)
FDA Class 1
·General Hospital
MAXIMUS 3.0 AND OS IMPLANTS
FDA 510(k)
FDA Class 2
·Dental
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·September 9, 2025
IMPL TAPERED SCR-V SBM 4. 7MM 4.5MM 10MM
FDA Adverse Event
Injury
·ZIMMER DENTAL·Product code DZE·November 8, 2023
AFX
FDA Adverse Event
Malfunction
·ENDOLOGIX·Product code MIH·October 29, 2015
COLLEAGUE
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·September 17, 2011
ORTHO SUMMIT SAMPLE HANDLING SYSTEM
FDA Adverse Event
Malfunction
·HAMILTON BONADUZ AG·Product code JTC·September 25, 2008
MECHANICAL (MANUAL) WHEELCHAIR
FDA Adverse Event
Malfunction
·UNKNOWN·Product code IOR·July 29, 2013
BARD Dynamic Deca Steerable, Product Number 201101; REPROCESSED ELECTROPHYSIOLOGY CATHETER
FDA Enforcement
Class II
·Ongoing·Stryker Sustainability Solutions·May 20, 2026
ACCOLADE DR SL MRI (Model L311)
FDA Enforcement
Class I
·Ongoing·Boston Scientific Corporation·October 22, 2025