15 results
·
21ms
·
Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
×
Custom Legacy and Custom InterActive Titanium Abutments
FDA 510(k)
FDA Class 2
·Dental
APEX Knee System
FDA UDI
Omni Life Science, Inc.·00841690198550·AK3 Ultra Insert Trial Size 2, 18mm
Aspida
FDA UDI
ALPHATEC SPINE, INC.·00840967191027·SACRAL DTS GUIDE 18MM
Responsive Orthopedics Total Knee Arthroplasty System
FDA UDI
RESPONSIVE ORTHOPEDICS, LLC·00841973108016·TRIAL 90-SRK-192218 POLY-MPCS 2X18 LEFT
FLEXICARE BREATHING FILTERS
FDA 510(k)
FDA Class 2
·Anesthesiology
COMPACT PIEZO P2K, POWERCARE
FDA 510(k)
FDA Class 2
·Dental
T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY
FDA Adverse Event
Malfunction
·TANDEM DIABETES CARE·Product code QFG·June 27, 2023
OT VERIO IQ METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·April 28, 2015
PEN NDL 32G 4MM PRO 100 BOX 1200 CA
FDA Adverse Event
Malfunction
·EMBECTA PENEL LIMITED - DUN LAOGHAIRE, IRELAND·Product code FMI·June 21, 2024
PEN NDL 32G 4MM PRO 100 BOX 1200 CA
FDA Adverse Event
Malfunction
·EMBECTA PENEL LIMITED - DUN LAOGHAIRE, IRELAND·Product code FMI·July 22, 2024
PEN NDL 32G 4MM PRO 100 BOX 1200 CA
FDA Adverse Event
Malfunction
·EMBECTA PENEL LIMITED - DUN LAOGHAIRE, IRELAND·Product code FMI·July 24, 2024
ZEPHYR XL DR
FDA Adverse Event
Malfunction
·ST. JUDE MEDICAL, INC., CRMD·Product code LWP·January 13, 2014
8800
FDA Adverse Event
Malfunction
·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·June 20, 2013
ONETOUCHPING GLUCOSEMGMTSYSTEM
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·August 4, 2011
Azurion 7 M12; System Code: (1)722078, (2)722223, (3)722233;
FDA Enforcement
Class II
·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·April 8, 2026