8 results
·
17ms
·
Sources: EU EUDAMED, US FDA
TRICHOMONAS DIRECT ENZYME IMMUNOASSAY
FDA 510(k)
FDA Class 1
·Microbiology
MODEL 486-01 PACING LEAD
FDA 510(k)
FDA Class 3
·Cardiovascular
LIQUI-URA TOXIC URINE CONTROL
FDA 510(k)
FDA Class 1
·Clinical Toxicology
PINN CAN BONE SCREW 6.5MMX20MM
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDICS INC US·Product code NDJ·June 16, 2014
ALARIS SYSTEM PC UNIT
FDA Adverse Event
Other
·CAREFUSION CORPORATION·Product code FRN·October 14, 2010
PARADIGM REAL-TIME INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·December 14, 2012
Azurion 7 B20; System Code: (1)722068, (2)722226, (3)722236;
FDA Enforcement
Class II
·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·April 8, 2026
Exactech Equinoxe REVERSE SHOULDER,42mm Constrained Humeral Liner, a) +0mm, Item number 320-42-10, b) +2.5mm, Item Number 320-42-13; Shoulder Arthroplasty
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·April 10, 2024