122 results
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26ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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TREFOIL System
FDA 510(k)
FDA Class 2
·Dental
RUSCH
FDA UDI
TELEFLEX INCORPORATED·14026704647030·
Oticon
FDA UDI
Oticon A/S·05707131318626·G50, MRITE 312 2.4G NFM PB C090 REVEAL
Pulsar-18 T3
FDA UDI
Biotronik AG·07640130447035·
Pulsar-18
FDA UDI
Biotronik AG·07640130436671·
Pulsar-18 T3
FDA UDI
Biotronik AG·07640130446830·
Pulsar-18
FDA UDI
Biotronik AG·07640130436473·
Pulsar-18 T3
FDA UDI
Biotronik AG·07640130447134·
Pulsar-18
FDA UDI
Biotronik AG·07640130436770·
Pulsar-18
FDA UDI
Biotronik AG·07640130436572·
Pulsar-18 T3
FDA UDI
Biotronik AG·07640130446939·
PULSAR-18 T3 5/150/135
FDA Adverse Event
Malfunction
·BIOTRONIK AG·Product code NIP·April 28, 2026
GDS-DC12
FDA 510(k)
FDA Class 2
·Cardiovascular
VITRIFREEZE MEDIUM; VITRITHAW MEDIUM
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
SENSOR ENLITE MMT-7008B
FDA Adverse Event
Malfunction
·MEDTRONIC MINIMED·Product code OZO·October 14, 2014
OMNIPOD INSULIN PUMP
FDA Adverse Event
Injury
·INSULET CORPORATION·Product code LZG·June 6, 2013
ANGIOJET RHEOLYTIC THROMBECTOMY SYSTEM
FDA Adverse Event
Other
·MEDRAD INTERVENTIONAL / POSSIS·Product code DXE·June 22, 2011
DUODERM
FDA Adverse Event
Malfunction
·CONVATEC DOMINICAN REPUBLIC INC·Product code NAD·May 2, 2025
Slick Set Uncuffed Endotracheal Tube and Stylet Set, oral/nasal, REF 170135
FDA Recall
Open, Classified
·TELEFLEX LLC·Product code BTR·May 25, 2023
Slick Set Uncuffed Endotracheal Tube and Stylet Set, oral/nasal, REF 170135
FDA Enforcement
Class I
·Ongoing·TELEFLEX LLC·July 5, 2023