14 results
·
24ms
·
Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
×
SICAT Endo
FDA 510(k)
FDA Class 2
·Radiology
Integra® Jarit®
FDA UDI
INTEGRA LIFESCIENCES PRODUCTION CORPORATION·10381780379799·Integra® Jarit® Grooved Director - Tongue Tie, ...
HLS UNI EVOLUTION & U-KNEETEC
FDA 510(k)
FDA Class 2
·Orthopedic
SHARPS CONTAINER
FDA 510(k)
FDA Class 2
·General Hospital
T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY
FDA Adverse Event
Malfunction
·TANDEM DIABETES CARE·Product code QFG·May 25, 2021
PENTAX
FDA Adverse Event
Malfunction
·HOYA CORPORATION PENTAX TOKYO OFFICE·Product code FDS·September 3, 2021
COVIDIEN
FDA Adverse Event
Malfunction
·CARDINAL HEALTH, INC.·Product code KNT·July 24, 2024
COVIDIEN
FDA Adverse Event
Malfunction
·CARDINAL HEALTH, INC.·Product code KNT·July 24, 2024
PENTAX
FDA Adverse Event
Malfunction
·HOYA CORPORATION PENTAX TOKYO OFFICE·Product code FDS·August 20, 2021
KANGAROO
FDA Adverse Event
Malfunction
·CARDINAL HEALTH 200, LLC·Product code KNT·January 28, 2026
NUTRILINE 2 FR PICC
FDA Adverse Event
Malfunction
·VYGON GMBH·Product code LJS·October 15, 2014
SYNCHROMED II
FDA Adverse Event
Injury
·MDT PUERTO RICO OPERATIONS CO·Product code LKK·June 20, 2013
OT VERIO METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·July 27, 2011
Exactech Equinoxe CAGE GLENOID, CEMENTED, alpha curvature, Mates with: a) 38, 41, 44 head, Small, Item Number 314-13-02, b) 38, 41, 44 head, Medium, Item Number 314-13-03, c) 38, 41, 44 head, Large, Item Number 314-13-04; Shoulder Arthroplasty
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·April 10, 2024