10 results
·
21ms
·
Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
×
ACUTE INNOVATIONS MODULAR RIBLOC SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
ZAVATION ROD CONNECTOR
FDA UDI
Zavation LLC·00197157016166·ROD CONNECTOR, PARALLEL CLOSED 18mm OFFSET, Ø 5...
T:SLIM X2 INSULIN PUMP WITH INTEROPERABLE TECHNOLOGY
FDA Adverse Event
Malfunction
·TANDEM DIABETES CARE·Product code QFG·March 31, 2020
UNI-VENT 731 SERIES MODEL EMV+ PORTABLE CRITICAL CARE VENTILATOR
FDA 510(k)
FDA Class 2
·Anesthesiology
ACTICHROME HEPARIN (ANTI-FXA), MODEL 832
FDA 510(k)
FDA Class 2
·Hematology
*
FDA Adverse Event
Malfunction
·UNK·Product code FWM·May 6, 2013
UNKNOWN DEPUY DURALOC 48MM LINER
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDICS, INC.·Product code LPH·May 20, 2011
ITST INTERTROCHANTERIC/SUBTROCHANTERIC FIXATION INSERTER LINK
FDA Adverse Event
Malfunction
·ZIMMER, INC.·Product code LXH·August 12, 2008
V-Twin, Catalog # 6002-800, UDI # 03661540600180 Product Usage: automated chemistry analyzer intended for clinical use
FDA Enforcement
Class II
·Terminated·Vital Scientific N.V.·October 23, 2019
INLIVEN CRT-P, Model Numbers: a) V284 b) V285 c) W274 d) W275 (added 7/15/2021)
FDA Enforcement
Class I
·Ongoing·Boston Scientific Corporation·July 21, 2021