16 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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DIMENSION-HA HIP PROSTHESIS
FDA 510(k)
FDA Class 2
·Orthopedic
Votion®
FDA UDI
Ortho Organizers, Inc.·00190707114442·Votion .018 R UL 4/5 G/O -7T 0A 2DO (10PK)
Pinnacle
FDA UDI
ORTHO TECHNOLOGY, INC.·00190730010575·Pinnacle .018 R UL 4/5 G/O -7T 0A 2DO (10PK)
Votion
FDA UDI
ORTHO TECHNOLOGY, INC.·00190730008749·Votion .018 R UL 4/5 G/O -7T 0A 2DO (10PK)
Pinnacle®
FDA UDI
Ortho Organizers, Inc.·00190707112516·Pinnacle .018 R UL 4/5 G/O -7T 0A 2DO (10PK)
Gentuity HF-OCT Imaging System with Vis-Rx Micro-Imaging Catheter
FDA 510(k)
FDA Class 2
·Radiology
ULTRAFLEX EV HEMOSTASIS INTRODUCER
FDA 510(k)
FDA Class 2
·Cardiovascular
LC4200 PCA PLUS AUST
FDA Adverse Event
Malfunction
·HOSPIRA COSTA RICA LTD.·Product code FPA·March 8, 2012
LC4200 PCA AUST
FDA Adverse Event
Malfunction
·HOSPIRA, INC.·Product code MEA·October 20, 2010
PCA PUMP (AUZ)
FDA Adverse Event
Malfunction
·HOSPIRA COSTA RICA LTD.·Product code MEA·March 13, 2012
LC4200 PCA PLUS AUST
FDA Adverse Event
Injury
·HOSPIRA COSTA RICA LTD.·Product code MEA·March 1, 2012
PCA PUMP (AUZ)
FDA Adverse Event
Malfunction
·HOSPIRA, INC.·Product code MEA·June 2, 2010
7 EXTENSION SET WITH BIONECTOR
FDA Adverse Event
Malfunction
·VYGON MFG·Product code FPA·May 14, 2014
HYDRELLE
FDA Adverse Event
Other
·ANIKA THERAPEUTICS, INC.·Product code LMH·November 11, 2010
COBE REVOLUTION
FDA Adverse Event
Other
·SORIN GROUP ITALIA·Product code KFM·December 19, 2012
Exactech Equinoxe GLENOID,KEELED, CEMENTED, mates with 47, 50, 53 head, beta curvature, Sizes: a) Small, Item Number 314-01-12, b) Medium, Item Number 314-01-13, c) Large, Item Number 314-01-14, Shoulder Arthroplasty
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·April 10, 2024