14 results · 22ms · Sources: EU EUDAMED, US FDA

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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