31 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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MODIFICATION TO MAS CARDIOLMMUNE TL; DADE CARDIAC TL
FDA 510(k)
FDA Class 1
·Clinical Chemistry
FOSTER GRANT
FDA UDI
FGX INTERNATIONAL INC.·00193033547038·
FOSTER GRANT
FDA UDI
FGX INTERNATIONAL INC.·00193033547045·
FOSTER GRANT
FDA UDI
FGX INTERNATIONAL INC.·00193033547007·
FOSTER GRANT
FDA UDI
FGX INTERNATIONAL INC.·00193033547076·
FOSTER GRANT
FDA UDI
FGX INTERNATIONAL INC.·00193033547052·
FOSTER GRANT
FDA UDI
FGX INTERNATIONAL INC.·00193033547069·
FOSTER GRANT
FDA UDI
FGX INTERNATIONAL INC.·00193033547021·
POLYMER COATED LATEX MEDICAL EXAMINATION GLOVES WITH PROTEIN CONTENT LABELING CLAIM (50 MICROGRAMS OR LESS)
FDA 510(k)
FDA Class 1
·General Hospital
SPECULITE/ORALLITE
FDA 510(k)
FDA Class 1
·Dental
DIDECO LILIPUT ECMO M PHISIO
FDA Adverse Event
Other
·SORIN GROUP ITALIA·Product code DTZ·April 20, 2012
OT PING METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·March 21, 2013
TENDRIL STS
FDA Adverse Event
Injury
·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code DTB·March 10, 2011
10 MM HEMASHIELD ARTERIAL CANNULA
FDA Adverse Event
Malfunction
·ABIOMED, INC.·Product code DSQ·March 13, 2008
HEALICOIL RSB SA 4.75MM W/1 UT & 1 UB BK-- Absorbable Suture anchor Product Number: 72203705
FDA Enforcement
Class II
·Ongoing·Smith & Nephew, Inc.·October 28, 2020
METASUL, ALPHA INSERT, II/32
FDA Adverse Event
Injury
·ZIMMER GMBH·Product code KWA·March 15, 2018
METASUL, ALPHA INSERT, II/32
FDA Adverse Event
Injury
·ZIMMER GMBH·Product code KWA·June 25, 2018
DURASUL, ALPHA INSERT, KK/36
FDA Adverse Event
Malfunction
·ZIMMER GMBH·Product code LZO·March 6, 2018
DURASUL, ALPHA INSERT, HOODED, MM/28
FDA Adverse Event
Injury
·ZIMMER GMBH·Product code JDI·May 22, 2018
DURASUL, ALPHA INSERT, HH/32
FDA Adverse Event
Malfunction
·ZIMMER GMBH·Product code LZO·June 4, 2018