13 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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17HK700G-W
FDA 510(k)
FDA Class 2
·Radiology
IN-OVATION® C
FDA UDI
DENTSPLY SIRONA ORTHODONTICS INC.·D807K100332601·IN-OVATION® C Roncone 022 UL/3-3 CS HK
IN-OVATION® C
FDA UDI
DENTSPLY SIRONA ORTHODONTICS INC.·D807K100332101·IN-OVATION® C Base Rx 022 UL/3-3 CS HK
RZ Medizintechnik GmbH
FDA UDI
RZ-Medizintechnik GmbH·04049197080804·CRILE-WOOD needle holder,straight
20 cm,...
RZ Medizintechnik GmbH
FDA UDI
RZ-Medizintechnik GmbH·04049197080798·CRILE-WOOD needle holder, straight
18 cm,...
RZ Medizintechnik GmbH
FDA UDI
RZ-Medizintechnik GmbH·04049197385336·CRILE-WOOD needle holder,straight
15 cm,...
POLYFLEX STENT SYSTEM WITH DELIVERY SYSTEM, MODEL M00514270, M00514280, 00514290, 00514300, 00514310, 00514320, 00514330
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
CLEARCANVAS RIS / PACS
FDA 510(k)
FDA Class 2
·Radiology
EQUINOXE
FDA Adverse Event
Injury
·EXACTECH, INC.·Product code KWT·April 26, 2022
SYNCHROMED II
FDA Adverse Event
Injury
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code LKK·October 17, 2014
OT ULTRASMART METER
FDA Adverse Event
Injury
·LIFESCAN INC.·Product code NBW·July 27, 2011
OBTRYX SYSTEM
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC - MARLBOROUGH·Product code FTL·June 20, 2013
Lyra SARS-CoV-2 Assay (M120) in vitro diagnostic test reagent
FDA Enforcement
Class I
·Terminated·Quidel Corporation·July 7, 2021