17 results
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23ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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CONCORDE LIFT
FDA 510(k)
FDA Class 2
·Orthopedic
OVUM ASPIRATION NEEDLE SINGLE LUMEN
FDA Adverse Event
Injury
·WILLIAM A. COOK AUSTRALIA, PTY LTD·Product code MQE·April 19, 2018
OVUM ASPIRATION NEEDLE SINGLE LUMEN
FDA Adverse Event
Injury
·WILLIAM A. COOK AUSTRALIA, PTY LTD·Product code MQE·April 22, 2018
UNITE BIOMATRIX
FDA 510(k)
FDA Unclassified
·Unknown
MICROSCAN DRIED GRAM-NEGATIVE MIC/COMBO PANEL, B1017 PANEL SERIES
FDA 510(k)
FDA Class 2
·Microbiology
OVUM ASPIRATION NEEDLE SINGLE LUMEN
FDA Adverse Event
Injury
·WILLIAM A. COOK AUSTRALIA, PTY LTD·Product code MQE·April 18, 2018
OVUM ASPIRATION NEEDLE SINGLE LUMEN
FDA Adverse Event
Injury
·WILLIAM A. COOK AUSTRALIA, PTY LTD·Product code MQE·April 19, 2018
OVUM ASPIRATION NEEDLE SINGLE LUMEN
FDA Adverse Event
Injury
·WILLIAM A. COOK AUSTRALIA, PTY LTD·Product code MQE·April 22, 2018
CART 9733856 S7 STAFF ASSEMBLED 110V
FDA Adverse Event
Malfunction
·MEDTRONIC NAVIGATION, INC·Product code HAW·June 4, 2019
OT VERIO IQ METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·June 15, 2013
HUDSON MICRO MIST NEBULIZER W/TEE, MOUTHPIECE
FDA Adverse Event
Malfunction
·TELEFLEX MEDICAL·Product code CAF·June 29, 2011
ACCU-CHEK AVIVA TEST STRIPS
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS·Product code LFR·September 17, 2008
STEALTHSTATION® S7´
FDA Adverse Event
Malfunction
·MEDTRONIC NAVIGATION, INC·Product code HAW·June 20, 2019
CART 9733856 S7 STAFF ASSEMBLED 110V
FDA Adverse Event
Malfunction
·MEDTRONIC NAVIGATION, INC·Product code HAW·June 17, 2019
ZYSTON IMPLANT, UNKNOWN SIZE OR TYPE
FDA Adverse Event
Injury
·ZIMMER BIOMET SPINE INC.·Product code MAX·August 22, 2020
ZYSTON IMPLANT, UNKNOWN SIZE OR TYPE
FDA Adverse Event
Injury
·ZIMMER BIOMET SPINE INC.·Product code MAX·August 22, 2020
CADD-Solis VIP ambulatory infusion pump, Model Numbers: a. 21-2120-0105-02L b. 21-2120-0105-03L c. 21-2120-0105-06L d. 21-2120-0105-07L e. 21-2120-0105-08L f. 21-2120-0105-12L g. 21-2120-0105-13L h. 21-2120-0105-14L i. 21-2120-0105-15L j. 21-2120-0105-17L k. 21-2120-0105-50L l. 21-2127-0105-02L m. 21-2127-0105-06L n. 21-2127-0105-50L
FDA Enforcement
Class I
·Terminated·Smiths Medical ASD Inc.·October 27, 2021