19 results
·
23ms
·
Sources: EU EUDAMED, US FDA
HDL CHOLESTEROL REAGENT
FDA 510(k)
FDA Class 1
·Clinical Chemistry
PAQ.114X150X70/QT-HS/CARDIOVIT FT-1
FDA UDI
AB MEDICA GROUP, S.A.·08428763046998·
Novo Surgical
FDA UDI
NOVO SURGICAL, INC.·G5869114060·round caps, gas or steam permeable, can be used...
BEVER REINFORCED ENDOTRACHEAL TUBE WITH CUFF (ORAL/NASAL), BEVER REINFORCED ENDOTRACHEAL TUBE WITHOUT CUFF (ORAL/NASAL)
FDA 510(k)
FDA Class 2
·Anesthesiology
SPINAL MESH SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
PYRAMESH C TITANIUM MESH
FDA Adverse Event
Injury
·WARSAW ORTHOPEDIC, INC.·Product code EZX·August 12, 2011
PYRAMESH
FDA Adverse Event
Injury
·WARSAW ORTHOPEDICS·Product code EZX·September 29, 2015
ASTERX EXPANDABLE CORPECTOMY SYSTEM
FDA Adverse Event
Injury
·MSD DEGGENDORF MFG·Product code MQP·March 4, 2019
ASTERX EXPANDABLE CORPECTOMY SYSTEM
FDA Adverse Event
Injury
·MSD DEGGENDORF MFG·Product code MQP·March 4, 2019
PYRAMESH C TITANIUM MESH
FDA Adverse Event
Injury
·WARSAW ORTHOPEDICS·Product code EZX·October 26, 2019
HOVEROUND CORP
FDA Adverse Event
Injury
·HOVEROUND CORP·Product code ITI·November 24, 2010
ENDOTAK RELIANCE
FDA Adverse Event
Malfunction
·CPI - DEL CARIBE·Product code NVY·January 11, 2013
OT ULTRALINK METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·July 3, 2014
PYRAMESH C TITANIUM MESH
FDA Adverse Event
Injury
·WARSAW ORTHOPEDICS·Product code EZX·June 27, 2020
PYRAMESH C TITANIUM MESH
FDA Adverse Event
Injury
·WARSAW ORTHOPEDICS·Product code EZX·April 22, 2019
ZEVO ANTERIOR CERVICAL PLATE SYSTEM
FDA Adverse Event
Injury
·MEDTRONIC SOFAMOR DANEK·Product code KWQ·December 19, 2018
PYRAMESH® C TITANIUM MESH
FDA Adverse Event
Malfunction
·MEDTRONIC MEDICAL COSTA RICA S.R.L.·Product code EZX·May 26, 2025
HealthLink***BIOPSY PUNCHES*** Disposable manual instrument for skin biopsy.
FDA Enforcement
Class II
·Terminated·Clorox Healthcare Holdings, LLC (dba HealthLink)·July 10, 2013
TFN-ADVANCED Proximal Femoral Nailing System (TFNA); for treatment of fractures in orthopedics and trauma.
FDA Enforcement
Class II
·Terminated·Synthes, Inc.·May 20, 2015