15 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Steripath Micro Blood Collection System
FDA 510(k)
FDA Class 2
·Clinical Chemistry
Sonic
FDA UDI
Sonic Innovations, Inc.·05714464010806·SONIC RADIANT 80 MNR T R TP
HEALIX ADVANCE ORTHOCORD
FDA UDI
Medos International Sàrl·10886705021352·HEALIX ADVANCE BR ANCHOR w/ORTHOCORD AND NEEDLE...
5.5 HEALIX ADVANCE BR ANCHOR W/ ORTHOCORD AND NEEDLES
FDA Adverse Event
Malfunction
·DEPUY MITEK LLC US·Product code MAI·May 10, 2018
4.5 HEALIX ADVANCE BR ANCHOR WITH ORTHOCORD
FDA Adverse Event
Malfunction
·DEPUY MITEK LLC US·Product code MAI·May 10, 2018
5.5 HEALIX ADVANCE BR W/OC&ND
FDA Adverse Event
Malfunction
·DEPUY MITEK LLC US·Product code MAI·January 23, 2019
TRILUX, Z-TONE, ACRY ROCK
FDA 510(k)
FDA Class 2
·Dental
SPIDER SURGICAL INSTRUMENTS, FLEXIBLE MONOPOLAR GRASPER WAVY RATCHETED, SPIDER SURGICAL INSTRUMENTS, FLEXIBLE MONOPOLAR
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
ASR ACETABULAR CUPS 60
FDA Adverse Event
Injury
·DEPUY INTERNATIONAL LTD.-8010379·Product code KWA·November 3, 2014
SEE H-10
FDA Adverse Event
Malfunction
·STAAR SURGICAL COMPANY·Product code HQL·August 24, 2011
ROTALINK? PLUS
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC - CORK·Product code MCX·July 12, 2013
5.5 HEALIX ADVANCE BR W/OC&ND
FDA Adverse Event
Malfunction
·DEPUY MITEK LLC US·Product code MAI·January 23, 2019
5.5 HEALIX ADVANCE BR W/OC&ND
FDA Adverse Event
Malfunction
·DEPUY MITEK LLC US·Product code MAI·January 22, 2019
Model Number L111, ESSENTIO DR SL MRI Pacemaker
FDA Enforcement
Class I
·Ongoing·Boston Scientific Corporation·October 22, 2025
The Merlin PCS 3650 programmer Model 3330 The Merlin PCS programmer model 3650 is a portable, dedicated programming system which operates using the Merlin PCS Model 3330 software and is designed to interrogate, program, display data from, and test Abbott Medical implantable devices and leads.
FDA Enforcement
Class II
·Ongoing·Abbott Medical·January 1, 2025