83 results
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19ms
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Sources: EU EUDAMED, US FDA
Enhanced External Counter Pulsation Device Plus Omay-A
FDA 510(k)
FDA Class 2
·Cardiovascular
Oticon
FDA UDI
Oticon A/S·05707131340061·SIYA 2, KIT 312 2.4G NFM 90 PB R C001
Sklar®
FDA UDI
SKLAR CORPORATION·10649111251115·LANE TISSUE FCP 1X2 5 1/2"
IN-OVATION® Mini
FDA UDI
DENTSPLY SIRONA ORTHODONTICS INC.·D807K19105514R1·IN-OVATION® mini Rhodium Base Rx 018 UL/5-5 CS ...
IN-OVATION® Mini
FDA UDI
DENTSPLY SIRONA ORTHODONTICS INC.·D807K191055241·IN-OVATION® mini Base Rx 022 UL/5-5 CS BC HK
IN-OVATION® Mini
FDA UDI
DENTSPLY SIRONA ORTHODONTICS INC.·D807K19105523P1·IN-OVATION®mini Base Rx 022 UL/5-5 CS HK PSV
IN-OVATION® Mini
FDA UDI
DENTSPLY SIRONA ORTHODONTICS INC.·D807K191055131·IN-OVATION® mini Base Rx 018 UL/5-5 CS HK
IN-OVATION® Mini
FDA UDI
DENTSPLY SIRONA ORTHODONTICS INC.·D807K19105523R1·IN-OVATION®mini Rhodium Base Rx 022 UL/5-5 CS HK
IN-OVATION® Mini
FDA UDI
DENTSPLY SIRONA ORTHODONTICS INC.·D807K191055231·IN-OVATION®mini Base Rx 022 UL/5-5 CS HK
IN-OVATION® Mini
FDA UDI
DENTSPLY SIRONA ORTHODONTICS INC.·D807K19105524R1·IN-OVATION®mini Rhodium Base Rx 022 UL/5-5 CS B...
ST JUDE MEDICAL MEDIGUIDE ENABLED LIVEWIRE STEERABLE ELECTROPHYSIOLOGY CATHETER, MODEL D402058
FDA 510(k)
FDA Class 2
·Cardiovascular
STRYKER SONICPIN SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
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·May 27, 2026
ACCENT DR RF
FDA Adverse Event
Malfunction
·ST. JUDE MEDICAL, INC., CRMD·Product code DXY·January 13, 2014
ON-Q C-BLOC SAF/PCA, 400 X 1-7 +5ML/60MIN
FDA Adverse Event
Malfunction
·I-FLOW CORP.·Product code MEB·July 22, 2011
OT VERIO PRO METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·June 27, 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