9 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Site~Rite 8 Ultrasound System with Cue Needle Tracking System and Pinpoint GT Needle Tech
FDA 510(k)
FDA Class 2
·Radiology
THERMAL MASSAGE BED, MODEL 2D-GX
FDA 510(k)
FDA Class 2
·Physical Medicine
GLIDERXTREME PTA BALLON CATHETER (OVER THE WIRE) 0.018 GUIDE WIRE 6100-XXXXX, 6100CB-XXXX
FDA 510(k)
FDA Class 2
·Cardiovascular
TENDRIL STS
FDA Adverse Event
Injury
·ST. JUDE MEDICAL, INC. CRMD·Product code DTB·January 13, 2014
ENDOPATH** XCEL* STABILITY SLEEVE
FDA Adverse Event
Malfunction
·ETHICON ENDO-SURGERY, LLC.·Product code GCJ·June 21, 2013
UNKNOWN MESH
FDA Adverse Event
Injury
·UNK·Product code FTL·July 23, 2011
URETERAL BRUSH BIOPSY SET
FDA Adverse Event
Malfunction
·COOK INC·Product code FDX·November 15, 2023
URETERAL BRUSH BIOPSY SET
FDA Adverse Event
Malfunction
·COOK INC·Product code FDX·January 7, 2022
R-F IM NAIL 10MMDX48CM LG, 11MMDX42CM, 11MMDX44CM, 11MMDX46CM LG, 11MMDX48CM LG, 12MMDX46CM LG, 12MMDX48CM LG, 13MMDX40CM, 13MMDX42CM, 13MMDX44CM, 13MMDX46CM LG, 13MMDX48CM LG, 14MMDX34CM, 14MMDX36CM, 14MMDX38CM, 14MMDX40CM, 14MMDX42CM, 14MMDX44CM, 14MMDX46CM LG, 14MMDX48CM LG
FDA Enforcement
Class II
·Terminated·Zimmer Biomet, Inc.·June 21, 2017