9 results
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20ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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ImmuLisa Enhanced SS-A (Ro) Antibody ELISA, ImmuLisa Enhanced SS-B (La) Antibody ELISA, ImmuLisa Enhanced Sm Antibody ELISA, ImmuLisa Enhanced RNP Antibody ELISA
FDA 510(k)
FDA Class 2
·Immunology
IPACS CARDIO
FDA 510(k)
FDA Class 2
·Radiology
RESECTION BUTTON ELECTRODE FOR PLASMA VAPORIZATION, HF-RESECTION ELECTRODE ROLLERS AND NEEDLES, LOOPS AND BANDS
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·June 6, 2025
PINNACLE MTL INS NEUT36IDX52OD
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDICS, INC. 1818910·Product code KWA·June 3, 2013
MODEL NOT SPECIFIED
FDA Adverse Event
Injury
·MEDTRONIC MINIMED·Product code LZG·August 27, 2008
PINN MAR +4 NEUT 32IDX50OD
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDICS, INC.·Product code LPH·June 23, 2011
XIA TITANIUM 4.5 BLOCKER
FDA Adverse Event
Malfunction
·STRYKER SPINE-US·Product code NKB·September 3, 2020
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