22 results · 21ms · Sources: EU EUDAMED, US FDA

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PROSERIES BIOIMPLANTS-PROANKLE/PROCUFF

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

8200 VALVE

FDA UDI
HANS RUDOLPH, INC.·00817136020068·8216C CO2 REB SUB W/8201 HDCRL

Millennium

FDA UDI
Avalign Technologies, Inc.·00190776389512·Coller Artery Forceps, 9 1/2", jaws angled 90°

POWDERFREE NITRILE NEOPRENE EXAMINATION GLOVES (PULPLE)

FDA 510(k)
FDA Class 1 ·General Hospital

WELL-LIFE OTC EMS SYSTEM

FDA 510(k)
FDA Class 2 ·Physical Medicine

MAINFRAME 8253001 NIM RESPONSE 3.0

FDA Adverse Event
Malfunction ·MEDTRONIC XOMED INC.·Product code ETN·February 24, 2014

PASS LP - LIGAPASS

FDA Adverse Event
Injury ·MEDICREA INTERNATIONAL·Product code JDQ·April 26, 2013

PASS LP

FDA Adverse Event
Injury ·MEDICREA INTERNATIONAL·Product code MNI·July 12, 2013

EMG TUBE 8229737 3PK NIM TRIVANTAGE 7MM

FDA Adverse Event
Injury ·MEDTRONIC XOMED, INC.·Product code ETN·November 12, 2014

MECHANICAL (MANUAL) WHEELCHAIR

FDA Adverse Event
JUMAO MEDICAL EQUIPMENT·Product code IOR·May 14, 2013

TOTALCARE

FDA Adverse Event
Malfunction ·HILL-ROM, INC.·Product code FNL·April 29, 2011

HARMONIC ACE 36CM W ERG HANDLE

FDA Adverse Event
Malfunction ·ETHICON ENDO-SURGERY, LLC·Product code LFL·August 12, 2008

NIM® EMG - ENDOTRACHEAL TUBE - TRIVANTAGE®

FDA Adverse Event
Malfunction ·MEDTRONIC XOMED INC.·Product code ETN·July 19, 2016

NIM® 3.0 MAINFRAME

FDA Adverse Event
Injury ·MEDTRONIC XOMED INC.·Product code ETN·January 14, 2015

PASS LP - LIAPASS

FDA Adverse Event
Injury ·MEDICREA TECHNOLOGIES·Product code MNI·March 29, 2013

NIM® 3.0 MAINFRAME

FDA Adverse Event
Injury ·MEDTRONIC XOMED INC.·Product code ETN·August 15, 2016

NIM® PROBE

FDA Adverse Event
Malfunction ·MEDTRONIC XOMED INC.·Product code ETN·March 23, 2018

NIM® PROBE

FDA Adverse Event
Malfunction ·MEDTRONIC XOMED INC.·Product code ETN·May 11, 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

Stolen McGRATH MAC Video Laryngoscopes, REF: 301-000-000

FDA Enforcement
Class I ·Ongoing·Covidien·November 8, 2023