10 results
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17ms
·
Sources: EU EUDAMED, US FDA
ODONTIT AUTOGENOUS BONE COLLECTION DEVICE
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
Ortho Organizers
FDA UDI
Ortho Organizers, Inc.·00190707105426·.036 LINGUAL SHEATHS - HORIZONTAL HOOK - UPPER ...
SHAVE PREP TRAY
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
MODIFICATION TO ACUSON X300 ULTRASOUND SYSTEM
FDA 510(k)
FDA Class 2
·Radiology
SPIROPERFECT
FDA Adverse Event
Malfunction
·MEDIKRO OY·Product code BZG·August 11, 2023
VACUETTE BLOOD COLLECTION TUBE 3ML K2E K2EDTA
FDA Adverse Event
Malfunction
·GREINER BIO-ONE NA INC.·Product code JKA·November 2, 2020
EON PATIENT PROGRAMMER
FDA Adverse Event
Injury
·ST. JUDE MEDICAL - NEUROMODULATION·Product code LGW·February 15, 2013
MR TWINSPEED
FDA Adverse Event
Malfunction
·GE MEDICAL SYSTEMS, LLC·Product code LNH·January 6, 2011
GRANUFLO
FDA Adverse Event
Injury
·FRESENIUS MEDICAL CARE NORTH AMERICA·Product code KPO·July 8, 2014
Exactech Equinoxe GLENOID,KEELED, CEMENTED, mates with 47, 50, 53 head, beta curvature, Sizes: a) Small, Item Number 314-01-12, b) Medium, Item Number 314-01-13, c) Large, Item Number 314-01-14, Shoulder Arthroplasty
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·April 10, 2024