14 results
·
27ms
·
Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
×
ACTA OEM MODULE
FDA 510(k)
FDA Class 2
·Dental
artegral
FDA UDI
Merz Dental GmbH·D7091972006·posteriors; shade A1; size S; upper jaw
Cerebellar Retractor
FDA UDI
KOROS U.S.A., INC.·10840199540553·Weitlaner Cerebellar Retractors Sharp Tips 16cm...
VQ ORTHOCARE
FDA UDI
Vision Quest Industries Incorporated·00817717022511·BIONICARE ALIGN PREFAB PB L
VQ ORTHOCARE
FDA UDI
Vision Quest Industries Incorporated·00817717022528·BIONICARE ALIGN PREFAB PB HD L
DAR-9400F
FDA 510(k)
FDA Class 2
·Radiology
Alivio Ventricular Catheter and Flusher System (Alivio System)
FDA 510(k)
FDA Class 2
·Neurology
TOTAL ASR FEM IMP SIZE 47
FDA Adverse Event
Injury
·DEPUY INTERNATIONAL LTD. 8010379·Product code KXA·February 21, 2013
ATTAIN OTW
FDA Adverse Event
Death
·MEDTRONIC PUERTO RICO, INC.·Product code DTB·January 27, 2011
PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·July 31, 2014
PROSTHESIS INTERVERTEBRAL DISC
FDA Adverse Event
Injury
·SYNTHES BRANDYWINE·Product code MJO·May 18, 2015
PROSTHESIS INTERVERTEBRAL DISC
FDA Adverse Event
Injury
·SYNTHES BRANDYWINE·Product code MJO·May 18, 2015
PROSTHESIS INTERVERTEBRAL DISC
FDA Adverse Event
Injury
·SYNTHES BRANDYWINE·Product code MJO·May 18, 2015
Azurion 7 M20; System Code: (1)722079, (2)722224, (3)722234, (4)722282 (OUS only);
FDA Enforcement
Class II
·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·April 8, 2026