9 results
·
27ms
·
Sources: EU EUDAMED, US FDA
GASTROSCOPE AND COLONOSCOPE NOZZLE REPLACEMENT KITS
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
artegral
FDA UDI
Merz Dental GmbH·D7091970372·anteriors; shade C4; mould UBM
SpiralTech Dental Implant System
FDA 510(k)
FDA Class 2
·Dental
GOPHER 2F SUPPORT CATHETER, MODEL 5600 AND GOPHER 3F SUPPORT CATHETER, MODEL 5610
FDA 510(k)
FDA Class 2
·Cardiovascular
MINIMED QUICK-SET
FDA Adverse Event
Malfunction
·UNOMEDICAL A/S·Product code FPA·June 27, 2024
HOMECHOICE AUTOMATED PD SET WITH CASSETTE
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code FKX·February 20, 2013
CORE IMPACTION DRILL
FDA Adverse Event
Malfunction
·STRYKER INSTRUMENTS KALAMAZOO·Product code DZJ·January 18, 2011
HOMECHOICE AUTOMATED PD SET WITH CASSETTE
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code FKX·July 31, 2014
GXL acetabular liners, orthopedic hip implant component. Product Line Numbers: a. GXL NEUTRAL LINER, G0 28MM ID, 130-28-50; b. GXL NEUTRAL LINER, G00 22MM ID, 130-22-70; c. NOVATION GXL LIPPED LINER, G0 28MM ID, 132-28-50; d. NOVATION GXL LIPPED LINER, G00 22MM ID, 132-22-70;
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·September 21, 2022