81 results
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21ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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CalprestNG, EasyCal
FDA 510(k)
FDA Class 2
·Immunology
Audina
FDA UDI
Bernafon AG·05711584086469·CAPTO 5 MNR, 2.4G NFM PB SABE/MAC AUDIN DEMO
Orthos
FDA UDI
ORMCO CORPORATION·00889989030198·ORTHOS CM SST ARCH 20 DIA UPLG PK10
IN-OVATION® Mini
FDA UDI
DENTSPLY SIRONA ORTHODONTICS INC.·D807K191552811·IN-OVATION® mini EURO 022/5-5 CS HK
IN-OVATION® Mini
FDA UDI
DENTSPLY SIRONA ORTHODONTICS INC.·D807K191552821·IN-OVATION® mini EURO 022/5-5 CBC HK
ERASE HAND- HELD CONTROLLER; ERASE SINGLE USE ELECTRIC CATRIDGE SYSTEM
FDA 510(k)
FDA Class 2
·Neurology
YOULASER CO2 LASER SYSTEM
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
PARTIAL ARTICULAR SURFACE
FDA Adverse Event
Malfunction
·ZIMMER BIOMET, INC.·Product code HSX·April 20, 2023
ARCHITECT STAT HIGH SENSITIVE TROPONIN-I
FDA Adverse Event
Malfunction
·ABBOTT IRELAND DIAGNOSTICS DIVISION·Product code MMI·May 27, 2026
PARTIAL ARTICULAR SURFACE
FDA Adverse Event
Malfunction
·ZIMMER BIOMET, INC.·Product code HSX·July 25, 2022
ARCHITECT STAT HIGH SENSITIVE TROPONIN-I
FDA Adverse Event
Malfunction
·ABBOTT IRELAND DIAGNOSTICS DIVISION·Product code MMI·May 27, 2026
OT VERIO IQ METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·October 22, 2014
BIPOLAR LEAD MODEL 300
FDA Adverse Event
Malfunction
·CYBERONICS, INC.·Product code LYJ·July 20, 2011
PORTABLE AIR COMPRESSOR FOR MEDICAL PURPOSES
FDA Adverse Event
MEDEL S.P.A.·Product code BTI·June 26, 2013
ARCHITECT STAT HIGH SENSITIVE TROPONIN-I
FDA Adverse Event
Malfunction
·ABBOTT IRELAND DIAGNOSTICS DIVISION·Product code MMI·May 19, 2026
ARCHITECT STAT HIGH SENSITIVE TROPONIN-I
FDA Adverse Event
Malfunction
·ABBOTT IRELAND DIAGNOSTICS DIVISION·Product code MMI·April 8, 2026
ARCHITECT STAT HIGH SENSITIVE TROPONIN-I
FDA Adverse Event
Malfunction
·ABBOTT IRELAND DIAGNOSTICS DIVISION·Product code MMI·May 27, 2026
ARCHITECT STAT HIGH SENSITIVE TROPONIN-I
FDA Adverse Event
Malfunction
·ABBOTT IRELAND DIAGNOSTICS DIVISION·Product code MMI·April 9, 2026
ARCHITECT STAT HIGH SENSITIVE TROPONIN-I
FDA Adverse Event
Malfunction
·ABBOTT IRELAND DIAGNOSTICS DIVISION·Product code MMI·May 19, 2026
ARCHITECT STAT HIGH SENSITIVE TROPONIN-I
FDA Adverse Event
Malfunction
·ABBOTT IRELAND DIAGNOSTICS DIVISION·Product code MMI·February 26, 2026