9 results
·
25ms
·
Sources: EU EUDAMED, US FDA
ARCOLITH 2100-CARDIAC PULSE GENERATOR
FDA 510(k)
FDA Class 3
·Cardiovascular
APEX Knee System
FDA UDI
Omni Life Science, Inc.·00841690198543·AK3 Ultra Insert Trial Size 2, 16mm
LEONE SPA
FDA UDI
LEONE SPA·08033707077756·WIRES BETA MEMORIA STRAIGHT 16x22
PORT-A-BOUT 240
FDA 510(k)
FDA Class 1
·Anesthesiology
Invacare AVIVA FX Power Wheelchair, Model: IFX-20MP
FDA 510(k)
FDA Class 2
·Physical Medicine
OT PING METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·May 6, 2014
INFINITI VISION SYSTEM OZIL
FDA Adverse Event
Injury
·ALCON - IRVINE TECHNOLOGY CENTER·Product code HQC·October 12, 2012
OT PING METER
FDA Adverse Event
Malfunction
·LIFESCAN, INC.·Product code MDS·August 10, 2010
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