11 results
·
22ms
·
Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
×
ER-REBOA PLUS Catheter
FDA 510(k)
FDA Class 2
·Cardiovascular
PIVOX™ Oblique Lateral Spinal System
FDA UDI
MEDTRONIC SOFAMOR DANEK, INC.·00643169599376·TRIAL 2193440 O25 IB 27MM 18 DEG 14X40
Best Medical International
FDA UDI
BEST MEDICAL INTERNATIONAL, INC.·00841365116339·
EVEREST SPINAL SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
HIGH FIVE
FDA 510(k)
FDA Class 1
·General Hospital
2.7MM TI VA LCKNG SCR SLF-TPNG WITH T8 STARDRIVE RECESS 18MM
FDA Adverse Event
Malfunction
·SYNTHES SELZACH·Product code HRS·March 13, 2017
RESTORE RECHARGABLE NEUROSTIMULATOR
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code LGW·October 7, 2008
CYLOS VR COATED
FDA Adverse Event
Malfunction
·BIOTRONIK SE & CO. KG·Product code DXY·June 27, 2013
PRECISION®
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC NEUROMODULATION·Product code LGW·August 5, 2011
Dimension EXL with LM, Dimension EXL 200, Dimension RxL, Dimension RxL HM, Dimension RxL Max, Dimension RxL Max HM, Dimension Xpand, Dimension Xpand HM, Dimension Xpand Plus, Dimension Xpand Plus HM. The Dimension EXL clinical chemistry system is a discrete, random-access, microprocessor-controlled, integrated instrument/chemistry system that measures a variety of analytes, including enzyme activities, in body fluids for in vitro diagnostic use.
FDA Enforcement
Class II
·Terminated·Siemens Healthcare Diagnostics, Inc.·May 20, 2015
Exactech Equinoxe CAGE GLENOID, CEMENTED, beta curvature, Mates with: a) 47, 50, 53 head, Medium, Item Number 314-13-13, b) 47, 50, 53 head, Large, Item Number 314-13-14, c) 47, 50, 53 head, Extra Large, Item Number 314-13-15; Shoulder Arthroplasty
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·April 10, 2024