14 results
·
23ms
·
Sources: EU EUDAMED, US FDA
Quidel Triage® TOX Drug Screen, 94600
FDA 510(k)
FDA Class 2
·Clinical Toxicology
SW
FDA UDI
SW SAFETY SOLUTIONS INC.·00616489201939·PowerForm Nitirle Exam Gloves, Medium
Sonoma™
FDA UDI
Seaspine Orthopedics Corporation·10889981050931·Sonoma Anterior Cervical Plate 3 Level Plate, 63mm
DESS dental smart solutions
FDA UDI
TERRATS MEDICAL SL.·08435457200772·Conic OSS
Manta Ray™
FDA UDI
Seaspine Orthopedics Corporation·10889981057213·Plate - 3 Level - 63 mm
MODIFICATION TO ZEUS SCIENTIFIC, INC., THYROGLOBULIN IGG ELISA TEST SYSTEM
FDA 510(k)
FDA Class 2
·Immunology
GREAT GLOVE LATEX EXAMINATION POWDERFREE GLOVES WITH PROTEIN LABELLING CLAIMS (50 MICROGRAMS OR LESS)
FDA 510(k)
FDA Class 1
·General Hospital
ANIMAS INSULIN CARTRIDGE
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·January 28, 2017
1.5X5MM SD HT X-DRIVE SCREW
FDA Adverse Event
Other
·BIOMET MICROFIXATION·Product code HWC·October 9, 2008
SUPERDIMENSION INREACH SYSTEM
FDA Adverse Event
Injury
·SUPERDIMENSION INC.·Product code JAK·August 11, 2011
MECHANICAL WALKER, ROLLATOR
FDA Adverse Event
CONSMA·Product code ITJ·July 1, 2013
ANIMAS ONE TOUCH PING INSULIN PUMP
FDA Adverse Event
Injury
·ANIMAS / JOHNSON & JOHNSON·Product code LZG·May 9, 2017
AUTOSOFT XC
FDA Adverse Event
Malfunction
·UNOMEDICAL A/S·Product code FPA·July 1, 2024
Medrad Continuum MR Infusion system- non-wireless system The MEDRAD Continuum MR Infusion System is designed for patients who require medications and other fluids during an MR procedure. It is intended to provide infusion therapy directly prior to, during and immediately after the MR procedure functioning while either stationary or mobile. It is not intended to provide long-term patient care outside the MR environment. The system is to be used by trained medical staff, primarily critical care, emergency room and radiology nursing staff.
FDA Enforcement
Class II
·Terminated·Bayer Corp·June 11, 2014