18 results
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29ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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ACMI AUTOCLAVABLE URETEROSCOPE, MODELS MR-6A AND MR-6AL
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
N.A.
FDA UDI
Forestadent Bernhard Förster GmbH·EFOR20520441·Titanol S Spee-arches max. .017"x.025"
JOBST forMen
FDA UDI
BSN MEDICAL, INC.·04042809849257·FOR MEN 15-20 MM HG KNEE HIGH CLOSED TOE LARGE ...
EXPLANT™
FDA UDI
ZIMMER TRABECULAR METAL TECHNOLOGY INC.·00889024311817·
MAGNA FORTIS OPHTHALMOSCOPE DIAGNOSTIC KIT
FDA 510(k)
FDA Class 2
·Ophthalmic
BI-PHASIC INFILTRATOR
FDA 510(k)
FDA Class 2
·General Hospital
COLORADO 2 SPINAL SYSTEM
FDA Adverse Event
Malfunction
·WARSAW ORTHOPEDIC INC.·Product code KWP·January 22, 2009
COLORADO 2 SPINAL SYSTEM
FDA Adverse Event
Injury
·WARSAW ORTHOPEDIC, INC.·Product code KWP·February 23, 2012
M2A-MAGNUM MODULAR HEAD SZ 52MM
FDA Adverse Event
Injury
·BIOMET ORTHOPEDICS·Product code KWA·April 11, 2013
DAILY ACTIVITY ASSIST DEVICES
FDA Adverse Event
Malfunction
·AQUATEC OPERATIONS GMBH·Product code ILS·September 2, 2014
ACCU-CHEK AVIVA TEST STRIPS
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS·Product code LFR·May 21, 2008
FLEXOR RADIAL ACCESS SET
FDA Adverse Event
Malfunction
·COOK INC·Product code DYB·December 12, 2017
FLEXOR RADIAL ACCESS SET
FDA Adverse Event
Malfunction
·COOK INC·Product code DYB·December 27, 2016
INFUSE BONE GRAFT/LT-CAGE
FDA Adverse Event
Injury
·MEDTRONIC·Product code NEK·November 12, 2013
FLEXOR RADIAL ACCESS SET
FDA Adverse Event
Malfunction
·COOK INC·Product code DYB·March 10, 2017
FLEXOR RADIAL ACCESS SET
FDA Adverse Event
Malfunction
·COOK INC·Product code DYB·March 10, 2017
TSRH SPINAL SYSTEM
FDA Adverse Event
Injury
·MEDTRONIC SOFAMOR DANEK·Product code KWP·May 24, 2016
FFR Link-FFR Signal Processing Module, Material Number H7495551000 It is intended to condition physiological signals from measuring devices (BSC Pressure Guidewire or an external pressure transducer), transmit and receive via radiofrequency, and recondition the signals so they can be displayed on and/or recorded in a receiving device (iLab POLARIS Multi-Modality Guidance System or other monitoring device). The physiological signals can also be distributed by cable
FDA Enforcement
Class II
·Terminated·Boston Scientific Corporation·September 20, 2017