Dentsply Ih Ab
HELIUMGATAN 1, MOLNDAL Vastra Gotaland, SE
Registered product codes
11 product codes
Recent MDR events
86,299 on file
- PrimeTaper EV Ø4.2 x 11mm OSJul 31, 2026Injury9612468-2026-03784
- PrimeTaper EV Ø3.6 x 9mm OSJul 31, 2026Injury9612468-2026-03902
- PrimeTaper EV Ø4.2 x 9mm OSJul 31, 2026Injury9612468-2026-03903
- PrimeTaper EV Ø5.4 x 9mm OSJul 31, 2026Injury9612468-2026-03904
- PrimeTaper EV Ø3.6 x 11mm OSJul 31, 2026Injury9612468-2026-03905
- PrimeTaper EV Ø4.8 x 8mm OSJul 31, 2026Injury9612468-2026-03906
- PrimeTaper EV Ø3.6 x 13mm OSJul 31, 2026Injury9612468-2026-03907
- PrimeTaper EV Ø3.6 x 15mm OSJul 31, 2026Injury9612468-2026-03908
- PrimeTaper EV Ø4.8 x 9mm OSJul 31, 2026Injury9612468-2026-03909
- S Atlantis Abutment Zr 20Jul 31, 2026Injury9612468-2026-03910
Recalls
3 on file
- TerminatedUnknown
Wellspect Healthcare is voluntarily recalling certain LoFric Origo" urethral catheters due to a potential defect which may be present in the catheter s distal tip.
View FDA record ↗ - TerminatedUnknown
Wellspect Healthcare is voluntarily recalling certain LoFric Origo" urethral catheters due to a potential defect which may be present in the catheters distal tip.
View FDA record ↗ - TerminatedUnknown
Wellspect Healthcare is voluntarily recalling certain LoFric Origo" urethral catheters due to a potential defect which may be present in the catheters distal tip.
View FDA record ↗
Compliance history
Matched by FEI 3002806429.
FDA inspections
0 on file
No inspections on file for this FEI number.
Inspection citations
0 on file
No citations on file for this FEI number.
Compliance actions
0 on file
No warning letters or injunctions on file for this FEI number.
Import refusals
0 on file
No import refusals on file for this FEI number.