14 results
·
22ms
·
Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
×
VUSION(R) OS
FDA 510(k)
FDA Class 2
·Orthopedic
IMAGER II UROLOGY TORQUE CATHETER, MODEL 40030X1, 40040X1, AND 40050X1
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
RENOVIS T 710 LARGE EXTERNAL FIXATION SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
PLEURX LOCKABLE DRAINAGE LINE SET
FDA Adverse Event
Malfunction
·CAREFUSION, INC·Product code DWM·April 2, 2026
¿ZENAPRO HYBRID HERNIA REPAIR GRAFT
FDA Adverse Event
Injury
·COOK BIOTECH·Product code FTL·September 23, 2015
FIRSTSTEP
FDA Adverse Event
Death
·KCI USA, INC.·Product code IOQ·May 18, 2007
PRECISION®
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC NEUROMODULATION·Product code LGW·June 2, 2011
TRANSTAR STRETCHER
FDA Adverse Event
Malfunction
·HILL-ROM RITTER·Product code FPO·August 11, 2008
PLEURX
FDA Adverse Event
Malfunction
·CAREFUSION, INC·Product code DWM·September 26, 2025
ZENAPRO HYBRID HERNIA REPAIR GRAFT
FDA Adverse Event
Injury
·COOK BIOTECH, INC.·Product code FTL·August 8, 2014
PLEURX
FDA Adverse Event
Malfunction
·CAREFUSION, INC·Product code DWM·June 2, 2025
¿ZENAPRO HYBRID HERNIA REPAIR GRAFT
FDA Adverse Event
Injury
·COOK BIOTECH·Product code FTL·November 30, 2015
SIEMENS SOMATOM with software syngo CT VA30A_SP4 Models: SOMATOM go.Now 11061610 & 11061618 SOMATOM go.Up 11061620 & 11061628 SOMATOM go.All 11061630 & 11061638 SOMATOM go.Top 11061640 & 11061648 SOMATOM go.Sim 11061660 & 11061668 SOMATOM go.Open Pro 11061670 & 11061678 SOMATOM X.cite 11330001 Intended Use: Computed tomography x-ray system
FDA Enforcement
Class II
·Ongoing·Siemens Medical Solutions USA, Inc·April 27, 2022
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