10 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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MONTAGE Settable, Resorbable Hemostatic Bone Putty
FDA 510(k)
FDA Unclassified
·Unknown
NA
FDA UDI
Synthes GmbH·10886982153234·5.0MM LOCKING SCREW SELF-DRILLING 18MM
AM-BIO EXTENDED RANGE SERIES DIALYZER, MODELS WET AND DRY
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
GRAM-NEGATIVE QUICKFISH BC
FDA 510(k)
FDA Class 1
·Microbiology
INRATIO PT/INR TEST STRIPS
FDA Adverse Event
Malfunction
·ALERE SAN DIEGO, INC.·Product code GJS·October 23, 2014
ASR ACETABULAR CUPS 58
FDA Adverse Event
Injury
·DEPUY INTERNATIONAL, LTD.·Product code KWA·August 12, 2011
AUTOLUBE-III
FDA Adverse Event
Malfunction
·DEPUY SYNTHES POWER TOOLS·Product code GEI·July 9, 2013
BD ULTRA-FINE¿ MINI PEN NEEDLE
FDA Adverse Event
Malfunction
·BECTON DICKINSON·Product code FMI·January 5, 2022
DRX Revolution Mobile X-Ray System
FDA Enforcement
Class II
·Ongoing·Carestream Health, Inc.·December 13, 2023
BV Pulsera with Software Release 2.3-A mobile, diagnostic X-ray image acquisition and viewing system. Model Number: 718095
FDA Enforcement
Class II
·Ongoing·Philips North America Llc·December 15, 2021