65 results · 23ms · Sources: EU EUDAMED, US FDA

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InMode VLaze

FDA 510(k)
FDA Class 2 ·General, Plastic Surgery

SCANSCOPE XT SYSTEM

FDA 510(k)
FDA Class 2 ·Hematology

M7/M7T DIAGNOSTIC ULTRASOUND SYSTEM

FDA 510(k)
FDA Class 2 ·Radiology

TARGET DEVICE GAMMA3 300X160MM

FDA Adverse Event
Malfunction ·STRYKER OSTEOSYNTHESIS KIEL·Product code LXH·November 13, 2012

ACUSNARE POLYPECTOMY SNARE

FDA Adverse Event
Malfunction ·WILSON-COOK MEDICAL INC·Product code FDI·March 29, 2024

ACUSNARE POLYPECTOMY SNARE

FDA Adverse Event
Malfunction ·WILSON-COOK MEDICAL INC·Product code FDI·March 29, 2024

ANALYTICAL E MODULE

FDA Adverse Event
Malfunction ·ROCHE DIAGNOSTICS·Product code JJE·April 23, 2014

PARADIGM REAL-TIME INSULIN INFUSION PUMP

FDA Adverse Event
Malfunction ·MEDTRONIC MINIMED·Product code OYC·October 15, 2014

NX3

FDA Adverse Event
Injury ·KERR CORPORATION·Product code EMA·June 17, 2013

FLEXTEND II

FDA Adverse Event
Injury ·CPI - DEL CARIBE·Product code NVN·July 23, 2011

ELECSYS 2010 RACK

FDA Adverse Event
Malfunction ·ROCHE DIAGNOSTICS·Product code JJE·December 20, 2013

MAGNETOM Vida (DE). Model Number: 11060815. 510(k): K170396, K173617, K181433, K183254, K192924, K203443, K213693, K213805, K220425, K231560.

FDA Recall
Open, Classified ·Siemens Medical Solutions USA, Inc·Product code LNH·August 28, 2025

MAGNETOM Vida (DE). Model Number: 11060815. 510(k): K170396, K173617, K181433, K183254, K192924, K203443, K213693, K213805, K220425, K231560.

FDA Enforcement
Class I ·Ongoing·Siemens Medical Solutions USA, Inc·October 8, 2025

COBAS 6000 E601 MODULE

FDA Adverse Event
Malfunction ·ROCHE DIAGNOSTICS·Product code JJE·August 29, 2014

ACUSNARE POLYPECTOMY SNARE

FDA Adverse Event
Malfunction ·WILSON-COOK MEDICAL INC·Product code FDI·June 25, 2024

ACUSNARE POLYPECTOMY SNARE SOFT

FDA Adverse Event
Malfunction ·WILSON-COOK MEDICAL INC·Product code FDI·September 3, 2024

ACUSNARE POLYPECTOMY SNARE SOFT

FDA Adverse Event
Malfunction ·WILSON-COOK MEDICAL INC·Product code FDI·September 3, 2024

ACUSNARE POLYPECTOMY SNARE

FDA Adverse Event
Malfunction ·WILSON-COOK MEDICAL INC·Product code FDI·July 26, 2024

ACUSNARE POLYPECTOMY SNARE SOFT

FDA Adverse Event
Malfunction ·WILSON-COOK MEDICAL INC·Product code FDI·April 8, 2024

ACUSNARE POLYPECTOMY SNARE

FDA Adverse Event
Malfunction ·WILSON-COOK MEDICAL INC·Product code FDI·June 7, 2024