31 results · 21ms · Sources: EU EUDAMED, 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