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