13 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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INNESIS PEEK CERVICAL CAGE
FDA 510(k)
FDA Class 2
·Orthopedic
Sonic
FDA UDI
Sonic Innovations, Inc.·05711583024189·BL100 IIC, BL BLISS 100
VIATRONIX V3D EXPLORER, REVISION 1.2
FDA 510(k)
FDA Class 2
·Radiology
SUNSET HEALTHCARE SOLUTIONS BACTERIAL/VIRAL HME FILTER, MODEL BHF 104
FDA 510(k)
FDA Class 2
·Anesthesiology
GMK-PRIMARY TIBIAL INSERT PS FIXED SIZE 5/14MM
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code JWH·February 17, 2023
MAXZERO NEEDLELESS CONNECTOR
FDA Adverse Event
Malfunction
·CAREFUSION·Product code FPA·January 6, 2020
OT PING METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·May 29, 2013
ZENITH FLEX AAA ENDOVASCULAR GRAFT BIFURCATED MAIN BODY
FDA Adverse Event
Injury
·COOK, INC.·Product code MIH·June 8, 2011
UNK
FDA Adverse Event
Injury
·I-FLOW CORP.·Product code MEB·August 19, 2008
MAXZERO NEEDLELESS CONNECTOR
FDA Adverse Event
Malfunction
·CAREFUSION·Product code FPA·September 2, 2020
MAXZERO NEEDLELESS CONNECTOR
FDA Adverse Event
Malfunction
·CAREFUSION·Product code FPA·May 8, 2020
MAXZERO NEEDLELESS CONNECTOR
FDA Adverse Event
Malfunction
·CAREFUSION·Product code FPA·May 8, 2020
Exactech Equinoxe GLENOID,KEELED, CEMENTED,47, 50, 53 head, beta curvature, Sizes: a) Small, Item Number 314-02-12, b) Medium, Item Number 314-02-13, c) Large, Item Number 314-02-14, d) Extra Large, Item Number 314-02-15, Shoulder Arthroplasty
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·April 10, 2024