10 results
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18ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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SOLUTION SET WITH 1.2 MICRON AIR ELIMINATING FILTER
FDA 510(k)
FDA Class 2
·General Hospital
SEE H10
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE CORPORATION·Product code FPA·January 17, 2020
APEX Revision Knee
FDA UDI
Omni Life Science, Inc.·00841690124078·Modular Offset Stem 19mm x x 75mm x 4mm
iNSitu™ Hip System
FDA UDI
NEXTSTEP ARTHROPEDIX, LLC·00816127024191·X20 HOLE COVER DRIVER, Quick Connect
Aplio i900, Aplio i800 and Aplio i700 Software V9.0 Diagnostic Ultrasound System
FDA 510(k)
FDA Class 2
·Radiology
JSZ-STAT-TREE, AND JSZ-STAT-OR, CLEANING, DISINFECTING AND STORING SOLUTIONS; JSZ-WET-TREE AND JSZ-WET-OR, WETTING,
FDA 510(k)
FDA Class 2
·Ophthalmic
SPRINT QUATTRO
FDA Adverse Event
Injury
·MPRI·Product code LWS·February 9, 2013
MECHANICAL WALKER, ROLLATOR
FDA Adverse Event
UNKNOWN·Product code ITJ·July 23, 2014
STENOSCOP
FDA Adverse Event
Malfunction
·GE MEDICAL SYSTEMS (INDIA) PRIVATE LTD·Product code JAA·January 4, 2011
Exactech Equinoxe CAGE GLENOID, CEMENTED, beta curvature, Mates with: a) 47, 50, 53 head, Medium, Item Number 314-13-13, b) 47, 50, 53 head, Large, Item Number 314-13-14, c) 47, 50, 53 head, Extra Large, Item Number 314-13-15; Shoulder Arthroplasty
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·April 10, 2024