13 results
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28ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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MONO-PHILE
FDA 510(k)
FDA Class 2
·Immunology
LinkSymphoKnee - Instruments
FDA UDI
WALDEMAR LINK GmbH & Co. KG·04026575309122·Knee tibia prosthesis trial - LinkSymphoKnee Sy...
LinkSymphoKnee - Instruments
FDA UDI
WALDEMAR LINK GmbH & Co. KG·04026575309269·Knee tibia prosthesis trial - LinkSymphoKnee Sy...
LinkSymphoKnee - Instruments
FDA UDI
WALDEMAR LINK GmbH & Co. KG·04026575309412·Knee tibia prosthesis trial - LinkSymphoKnee Sy...
LinkSymphoKnee - Instruments
FDA UDI
WALDEMAR LINK GmbH & Co. KG·04026575308897·Knee tibia prosthesis trial - LinkSymphoKnee Sy...
TM-400
FDA 510(k)
FDA Class 2
·Physical Medicine
Vitrea CT Brain Perfusion
FDA 510(k)
FDA Class 2
·Radiology
10MM/130 DEG TI CANN TROCH FIXATION NAIL 235MM
FDA Adverse Event
Injury
·OBERDORF SYNTHES PRODUKTIONS GMBH·Product code HSB·July 18, 2018
HYPODERMIC NEEDLE-PRO NEEDLE WITH W/ NEEDLE PROTECTION DEVICE
FDA Adverse Event
Malfunction
·SMITHS MEDICAL, INC.·Product code FMI·February 13, 2014
MANUAL ORTHOPEDIC SURGICAL INSTRUMENT
FDA Adverse Event
Malfunction
·MEDTRONIC SOFAMOR DANEK·Product code LXH·October 6, 2010
CENTRA BED
FDA Adverse Event
Malfunction
·HILL-ROM, INC.·Product code FNL·November 14, 2012
Alaris System PC Unit Model 8000, a modular infusion pump and monitoring system
FDA Enforcement
Class I
·Terminated·CareFusion 303, Inc.·August 12, 2020
Azurion 7 M20; Catalog numbers: (1) 722079, (2) 722224, (3) 722234, (4) 722282 (OUS ONLY);
FDA Enforcement
Class I
·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·February 26, 2025