16 results · 21ms · Sources: EU EUDAMED, 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