10 results
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20ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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Pristina Serena 3D
FDA 510(k)
FDA Class 2
·Radiology
ELMED INCORPORATED
FDA UDI
ELMED INCORPORATED·00198506075414·Kelly Retractor, 2 x 3 Inchers 5.1cm x 7.6CM, R...
EXACTECH EQUINOX FIXED ANGLE REPLICATOR PLATE (0MM,1.5MM,4.5MM), HUMERAL HEAD-SHORT (44MM,47MM), GLENOSPHERE (38MM,42MM)
FDA 510(k)
FDA Class 2
·Orthopedic
IMMERSION HYDROBATH
FDA 510(k)
FDA Class 2
·Physical Medicine
I-STAT EC4+ CARTRIDGE
FDA Adverse Event
Malfunction
·ABBOTT POINT OF CARE·Product code JGS·July 23, 2019
I-STAT EC4+ CARTRIDGE
FDA Adverse Event
Malfunction
·ABBOTT POINT OF CARE·Product code JGS·April 17, 2019
GE OEC 2600
FDA Adverse Event
Malfunction
·GE OEC MEDICAL SYSTEMS INC.·Product code JAA·October 3, 2008
SYNCHROMED II
FDA Adverse Event
Malfunction
·MDT PUERTO RICO OPERATIONS CO·Product code LKK·June 21, 2013
PROXIMATE PPH PROCEDURE SET
FDA Adverse Event
Malfunction
·ETHICON ENDO-SURGERY, LLC.·Product code GDW·July 28, 2011
Exactech Equinoxe CAGE GLENOID,POSTERIOR AUGMENT, CEMENTED, Left, Mates with: a) 38, 41, 44, 47 head, Small, Item Number 314-13-22, b) 41, 44, 47, 50, head, Medium, Item Number 314-13-23, c) 44, 47, 50, 53 head, Large, Item Number 314-13-24, d) 44, 47, 50, 53 head, Extra Large, Item Number 314-13-25; Shoulder Arthroplasty
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·April 10, 2024