10 results
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18ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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FORDER RETRACTOR
FDA 510(k)
FDA Class 1
·Gastroenterology, Urology
Medtronic Model 5392 External Pulse Generator (EPG)
FDA 510(k)
FDA Class 2
·Cardiovascular
VAGINAL CT / MR MULTI CHANNEL APPLICATOR SET
FDA 510(k)
FDA Class 2
·Radiology
50MM RIGHT STANDARD MANDIBLE
FDA Adverse Event
Injury
·BIOMET MICROFIXATION·Product code LZD·May 15, 2014
CAPSUREFIX NOVUS
FDA Adverse Event
Injury
·MEDTRONIC PUERTO RICO, INC.·Product code DTB·October 31, 2012
PUMP MMT-523NAB PRDGM INSULIN BLUE
FDA Adverse Event
Injury
·MEDTRONIC PUERTO RICO OPERATIONS MED-REL·Product code LZG·August 17, 2010
G7 ACETABULAR LINER
FDA Adverse Event
Injury
·BIOMET ORTHOPEDICS·Product code PBI·June 2, 2017
G7 ACETABULAR SHELL
FDA Adverse Event
Injury
·BIOMET ORTHOPEDICS·Product code PBI·June 2, 2017
G7 SCREW
FDA Adverse Event
Injury
·BIOMET ORTHOPEDICS·Product code PBI·June 2, 2017
Exactech Equinoxe CAGE GLENOID, CEMENTED, alpha curvature, Mates with: a) 38, 41, 44 head, Small, Item Number 314-13-02, b) 38, 41, 44 head, Medium, Item Number 314-13-03, c) 38, 41, 44 head, Large, Item Number 314-13-04; Shoulder Arthroplasty
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·April 10, 2024