10 results
·
21ms
·
Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
×
CLS HIP PROSTHESIS
FDA 510(k)
FDA Class 2
·Orthopedic
Sklar®
FDA UDI
SKLAR CORPORATION·10649111205460·GUYON SOUNDS W/O THREAD 17FR
NAR
FDA UDI
NORTH AMERICAN RESCUE, LLC·00842209109371·
PEDICLE SCREW BALINIT TAP CANNULATED - UNDERSIZED - AT- Ø4.5 MM
FDA Adverse Event
Malfunction
·MEDACTA INTERNATIONAL SA·Product code LXH·June 23, 2023
SITE-RITE 5 ULTRASOUND SYSTEM
FDA 510(k)
FDA Class 2
·Radiology
Manual Wheelchair (SYIV100A008)
FDA 510(k)
FDA Class 1
·Physical Medicine
ANIMAS INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·June 5, 2014
RECEPTAL CANISTER 1000 ML CE
FDA Adverse Event
Malfunction
·AMSINO MEDICAL CO., LTD.·Product code GCX·November 15, 2012
NATURA STOMAHESIVE FLEXIBLE 5" X 5" WAFER
FDA Adverse Event
Injury
·CONVATEC, INC·Product code EXE·June 17, 2015
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