12 results
·
28ms
·
Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
×
MANAN INTRODUCER SHEALTH/NEEDLE
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
C-STEM
FDA UDI
DEPUY (IRELAND)·10603295235873·C-STEM VOID CENTRALISER 16mm
SYNCHRON URIC ACID
FDA Adverse Event
BECKMAN COULTER INC.·Product code KNK·June 10, 2011
Immunalysis SEFRIA Fentanyl Urine Enzyme Immunoassay, Immunalysis Fentanyl Urine Calibrators
FDA 510(k)
FDA Class 2
·Clinical Toxicology
USGI TRANSPORT ENDOSCOPIC GUIDE
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
CELL-DYN EMERALD
FDA Adverse Event
Malfunction
·ABBOTT DIAGNOSTICS DIVISION·Product code GKZ·February 14, 2013
OUTBACK RE-ENTRY CATHETER
FDA Adverse Event
Malfunction
·CORDIS DE MEXICO·Product code DQY·January 14, 2011
OCTRODE
FDA Adverse Event
Injury
·ST. JUDE MEDICAL - NEUROMODULATION·Product code GZB·July 15, 2014
DHS®/DCS® LAG SCREW 12.7MM THREAD/110MM
FDA Adverse Event
Malfunction
·OBERDORF SYNTHES PRODUKTIONS GMBH·Product code KTT·July 18, 2018
Medtronic INTREPID Spinal System SPACER, 32X23, 12 DEG, Size: 10MM, Part Number: REF 7961210; 12MM, REF 7961212; 14MM, REF 7961214; 16MM, REF 7961216; 18MM, REF 7961218; 20MM, REF 7961220; Rx only, STERILE R The INTREPID Spinal System is indicated for use with autogenous bone graft in patients with degenerative disc disease.
FDA Recall
Terminated
·Medtronic Sofamor Danek USA Inc·Product code MAX·February 6, 2009
ALLURA Xper FD10; System Code: (1) 722003, (2)722010, (3)722026;
FDA Enforcement
Class II
·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·April 8, 2026
Allura Xper FD10; Model Numbers: (1) 722003, (2) 722010, (3) 722026; Associated 510(k)s: K102005, K130638, K130842, K133292, K141979, K162859, K161563;
FDA Enforcement
Class II
·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·October 8, 2025