27 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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INDIRECT FLUORESCENT ASSAY FOR (EBV-VCA) IGG ANTI.
FDA 510(k)
FDA Class 1
·Microbiology
SCANLAN® Dilators
FDA UDI
SCANLAN INTERNATIONAL INC·00846159010671·Garrett Vascular Dilator
SPECTRUM TURBO-JECT PICC SET
FDA 510(k)
FDA Class 2
·General Hospital
FOWLER ENDOCURETTE, MODEL CUR-XXX
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
INTERSTIM II
FDA Adverse Event
Injury
·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code EZW·September 18, 2013
INTERSTIM II
FDA Adverse Event
Malfunction
·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code EZW·July 6, 2012
INTERSTIM II
FDA Adverse Event
Malfunction
·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code EZW·June 1, 2012
Torcon NB Advantage Catheters - Product Usage: Intended for use in the peripheral and coronary vascular system, including the carotid arteries, in giographic procedures by physicians trained and experienced in angiographic techniques.
FDA Enforcement
Class II
·Terminated·Cook Inc.·November 27, 2019
HOYER PRESENCE LIFT
FDA Adverse Event
Injury
·APEX HEALTHCARE MFG INC·Product code FNG·June 16, 2014
ANGIO PACK
FDA Adverse Event
Malfunction
·DEROYAL·Product code GDY·November 11, 2010
9900
FDA Adverse Event
Malfunction
·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·December 13, 2012
SPECTRUM TURBO-JECT ANTIBIOTIC POWER INJECTABLE PICC
FDA Adverse Event
Injury
·COOK INC·Product code FOZ·April 2, 2019
SPECTRUM TURBO-JECT ANTIBIOTIC POWER INJECTABLE PICC
FDA Adverse Event
Malfunction
·COOK INC·Product code FOZ·March 14, 2018
LJS TURBO-JECT PERIPHERALLY INSERTED CENTRAL VENOUS CATHETER
FDA Adverse Event
Injury
·COOK INC·Product code LJS·May 11, 2018
SPECTRUM TURBO-JECT ANTIBIOTIC POWER INJECTABLE PICC
FDA Adverse Event
Malfunction
·COOK INC·Product code FOZ·February 15, 2018
SPECTRUM TURBO-JECT ANTIBIOTIC POWER INJECTABLE PICC
FDA Adverse Event
Malfunction
·COOK INC·Product code FOZ·February 15, 2018
LJS TURBO-JECT PERIPHERALLY INSERTED CENTRAL VENOUS CATHETER
FDA Adverse Event
Injury
·COOK INC·Product code LJS·May 11, 2018
SPECTRUM TURBO-JECT ANTIBIOTIC POWER INJECTABLE PICC
FDA Adverse Event
Injury
·COOK INC·Product code LJS·June 26, 2017
LJS TURBO-JECT PERIPHERALLY INSERTED CENTRAL VENOUS CATHETER
FDA Adverse Event
Injury
·COOK INC·Product code LJS·May 11, 2018
SPECTRUM TURBO-JECT ANTIBIOTIC POWER INJECTABLE PICC
FDA Adverse Event
Injury
·COOK INC·Product code LJS·July 1, 2017