29 results
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23ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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MouthLab Vital Signs Monitoring System
FDA 510(k)
FDA Class 2
·Cardiovascular
Dornier MedTech
FDA UDI
DORNIER MEDTECH AMERICA, INC.·00810116023318·600 Micron SU Thulio Performance 3m Fiber
CODMAN
FDA UDI
Cerenovus, Inc.·10886704001379·CODMAN SLIM-LINE Aneurysm Clip 30 Degree Forwar...
ABSORBENT PAPER POINTS
FDA UDI
DiaDent Group International·08806383512695·"An absorbent paper points is an endodontic pap...
Zodiac
FDA UDI
ALPHATEC SPINE, INC.·00844856063150·TI ILIAC BONE SCREW ASSY, 7.5MM X 35MM X 30°
Zodiac
FDA UDI
ALPHATEC SPINE, INC.·00844856063143·TI ILIAC BONE SCREW ASSY, 7.5MM X 35MM X 15°
KARATS MULTIPURPOSE SOLUTION
FDA 510(k)
FDA Class 2
·Ophthalmic
TD-4239 BLOOD GLUCOSE MONITORING SYSTEM AND TD-4239 MULTI BLOOD GLUCOSE MONITORING SYSTEM
FDA 510(k)
FDA Class 2
·Clinical Chemistry
FREESTYLE LITE
FDA Adverse Event
Injury
·ABBOTT DIABETES CARE INC.·Product code NBW·November 23, 2016
UNKNOWN VLOC PRODUCT
FDA Adverse Event
Injury
·COVIDIEN LP LLC NORTH HAVEN·Product code GAM·April 1, 2020
GII QA+ W #2 ORTHOCORD
FDA Adverse Event
Injury
·DEPUY MITEK·Product code JDR·October 27, 2014
COLLEAGUE PRE P1.7
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·August 11, 2011
SYNCHROMED II
FDA Adverse Event
Injury
·MDT PUERTO RICO OPERATIONS CO·Product code LKK·July 2, 2013
ADD (AKA VBR SMALL) SPINAL VERTEBRAL BODY REPLACEMENT DEVICE
FDA Adverse Event
Injury
·ULRICH MEDICAL USA·Product code MQP·May 7, 2017
GORE® VIABAHN® ENDOPROSTHESIS
FDA Adverse Event
Injury
·W.L. GORE & ASSOCIATES·Product code PFV·October 27, 2017
COOK-SWARTZ DOPPLER PROBE
FDA Adverse Event
Injury
·COOK VANDERGRIFT INC·Product code ITX·April 4, 2022
HEARTWARE VENTRICULAR ASSIST SYSTEM- PUMP
FDA Adverse Event
Injury
·HEARTWARE, INC.·Product code DSQ·February 21, 2019
HEARTWARE VENTRICULAR ASSIST SYSTEM- PUMP
FDA Adverse Event
Death
·HEARTWARE, INC.·Product code DSQ·February 21, 2019
HEARTWARE VENTRICULAR ASSIST SYSTEM
FDA Adverse Event
Injury
·HEARTWARE, INC.·Product code DSQ·August 15, 2018
RESTORE ULTRA
FDA Adverse Event
Injury
·MEDTRONIC NEUROMODULATION·Product code LGW·June 15, 2016