19 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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Reusable Blood Pressure Cuff
FDA 510(k)
FDA Class 2
·Cardiovascular
KMEDIC
FDA UDI
TELEFLEX INCORPORATED·24026704294293·
DECOMPRESSION OF CHOICE AND NEURO DECOMPRESSION DEVICE
FDA 510(k)
FDA Class 2
·Physical Medicine
DATEX-OHMEDA S/5 CRITICAL CARE MONITOR WITH L-ICU05 AND L-ICU05A SOFTWARE
FDA 510(k)
FDA Class 2
·Cardiovascular
FILLER, RECOMBINANT HUMAN BONE MORPHOGENETIC P
FDA Adverse Event
Injury
·MEDTRONIC SOFAMOR DANEK USA, INC.·Product code NEK·April 2, 2020
IMP,TSV,MCOL MG,4.7MM,10M
FDA Adverse Event
Injury
·ZIMMER DENTAL·Product code DZE·May 21, 2024
IMP,TSV,MCOL MG,4.7MM,11.5MML
FDA Adverse Event
Injury
·ZIMMER DENTAL·Product code DZE·May 21, 2024
IMP,TSV,MCOL MG,4.7MM,11.5MML
FDA Adverse Event
Injury
·ZIMMER DENTAL·Product code DZE·June 12, 2024
IMP,TSV,MCOL MG,3.7MM,11.5MML
FDA Adverse Event
Injury
·ZIMMER DENTAL·Product code DZE·July 23, 2024
IMP,TSV,MCOL MG,4.7MM,11.5MML
FDA Adverse Event
Injury
·ZIMMER DENTAL·Product code DZE·August 1, 2023
SYMBIQ SINGLE CHANNE
FDA Adverse Event
Malfunction
·HOSPIRA COSTA RICA LTD.·Product code FRN·June 7, 2013
VOYAGER NC CORONARY DILATATION CATHETER
FDA Adverse Event
Malfunction
·AV-TEMECULA-CT·Product code LOX·July 22, 2011
OT VERIO IQ METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·October 15, 2014
IMP,TSV,MCOL MG,4.7MM,11.5MML
FDA Adverse Event
Malfunction
·ZIMMER DENTAL·Product code DZE·June 16, 2022
IMP,TSV,MCOL MG,4.7MM,10M
FDA Adverse Event
Injury
·ZIMMER DENTAL·Product code DZE·September 9, 2025
IMP,TSV,MCOL MG,4.7MM,11.5MML
FDA Adverse Event
Injury
·ZIMMER DENTAL·Product code DZE·December 27, 2024
IMP,TSV,MCOL MG,4.7MM,13M
FDA Adverse Event
Injury
·ZIMMER DENTAL·Product code DZE·July 20, 2023
IMP,TSV,MCOL MG,4.7MM,10M
FDA Adverse Event
Malfunction
·BIOMET 3I·Product code DZE·February 13, 2019
Ingenia 3.0T-a Magnetic Resonance Medical Electrical Systems indicated for use as a diagnostic device. The system can produce cross-sectional images, spectroscopic images and/or spectra in any orientation of the internal structure of the head, body, or extremities Models: 781342 781377
FDA Enforcement
Class II
·Completed·Philips North America Llc·September 15, 2021