27 results · 30ms · Sources: EU EUDAMED, US FDA

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TNL-ULTRA ASSAY FOR THE ADVIA CENTAUR SYSTEM

FDA 510(k)
FDA Class 2 ·Clinical Chemistry

ADVIA CENTAUR CKMB AND TROPONIN ULTRA ASSAY

FDA Adverse Event
Other ·SIEMENS HEALTHCARE DIAGNOSTICS INC.·Product code JHX·July 29, 2010

REF H10

FDA Adverse Event
Malfunction ·SIEMENS HEALTHCARE DIAGNOSTICS, INC.·Product code MMI·August 9, 2016

ATELLICA IM HIGH-SENSITIVITY TROPONIN I (TNIH)

FDA Adverse Event
Malfunction ·SIEMENS HEALTHCARE DIAGNOSTICS, INC.·Product code MMI·December 10, 2020

ADVANCE®

FDA UDI
Microport Orthopedics Inc.·M684K00530201·

JOBST forMen

FDA UDI
BSN MEDICAL, INC.·04042809845051·FOR MEN 20-30 MM HG KNEE HIGH OPEN TOE SMALL BR...

MicroAire®

FDA UDI
Microaire Surgical Instruments LLC·00847399005120·SST TWIST DRILL, JACOBS, 2mm DIA. X 27mm

Shannon Recta X-Large, quick coupling

FDA UDI
Gebr. Brasseler GmbH & Co. KG·14053613293041·

FJ2000 System

FDA UDI
Paragon 28, Inc.·00889795133106·Shannon-style Corta Bone Burr, 3.0 x 20 x 100, ...

CARDIAC FUNCTION LABORATORY; PRESSURE INTERFACE; PRESSURE / VOLUME CATHETER

FDA 510(k)
FDA Class 2 ·Cardiovascular

AGFA MAMORAY MAMMOGRAPHIC CASSETTE, AGFA METAL-BODIED CAWO CASSETTE, AGFA CURIX AND LIGHTWEIGHT CASSETTE

FDA 510(k)
FDA Class 2 ·Radiology

VERTEX RECONSTRUCTION SYSTEM

FDA Adverse Event
Injury ·MEDTRONIC SOFAMOR DANEK·Product code KWP·November 15, 2013

VERTEX RECONSTRUCTION SYSTEM

FDA Adverse Event
Malfunction ·MEDTRONIC SOFAMOR DANEK·Product code KWP·November 15, 2013

VERTEX RECONSTRUCTION SYSTEM

FDA Adverse Event
Injury ·MEDTRONIC SOFAMOR DANEK·Product code KWP·February 17, 2014

VERTEX RECONSTRUCTION SYSTEM

FDA Adverse Event
Injury ·MEDTRONIC SOFAMOR DANEK·Product code KWP·February 17, 2014

VERTEX RECONSTRUCTION SYSTEM

FDA Adverse Event
Injury ·MEDTRONIC SOFAMOR DANEK·Product code KWP·February 17, 2014

VERTEX RECONSTRUCTION SYSTEM

FDA Adverse Event
Injury ·MEDTRONIC SOFAMOR DANEK·Product code KWP·February 17, 2014

EDWARDS SAPIEN TRANSCATHETER HEART VALVE

FDA Adverse Event
Injury ·EDWARDS LIFESCIENCES·Product code NPT·April 11, 2013

FOUNDATION SHOULDER SYSTEM

FDA Adverse Event
Other ·ENCORE MEDICAL, L.P.·Product code KWS·May 27, 2008

FINELINE II

FDA Adverse Event
Malfunction ·CPI - DEL CARIBE·Product code NVN·April 13, 2011