13 results
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24ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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IBL 5000 Tanning Booth
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
MEDI
FDA UDI
MEDI MANUFACTURING, INC.·04051526768499·GENUMEDI PSS GREEN V
DeRoyal
FDA UDI
DEROYAL INDUSTRIES, INC.·00749756669801·POST-OP SHOE
Life Instruments
FDA UDI
Life Instrument Corporation·M9307511524050·Chisel 1/4" Str 15"
STINGRAY LP
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC CORPORATION·Product code DQY·March 26, 2025
INFUSION SET FOR POWERPICC SOLO 2 CATHETER
FDA 510(k)
FDA Class 2
·General Hospital
STERLING INTERFERENC SCREW HT
FDA 510(k)
FDA Class 2
·Orthopedic
STINGRAY? LP
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC CORPORATION·Product code DQY·May 29, 2026
TRUERESULT
FDA Adverse Event
Malfunction
·NIPRO DIAGNOSTICS, INC.·Product code NBW·October 3, 2014
SPRINT QUATTRO SECURE
FDA Adverse Event
Malfunction
·MPRI·Product code NVY·June 7, 2013
COLLEAGUE PRE 1.7
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·July 7, 2011
Electrophysiology Imaging System
FDA Recall
Terminated
·Fischer Imaging Corporation·Product code JAA·April 28, 2005
Exactech Equinoxe REVERSE SHOULDER,38mm Constrained Humeral Liner: a) +0mm, Item Number 320-38-10, b) +2.5mm, Item Number 320-38-13, Shoulder Arthroplasty
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·April 10, 2024