14 results
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25ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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PERMANENT PACING LEAD
FDA 510(k)
FDA Class 3
·Cardiovascular
FLI Twin
FDA UDI
Rmo, Inc.·00885797527769·FLI(R) TWIN ROTH .018 WITHOUT HOOK 5-5 20 BRACKETS
VIDAS® LYME IGG
FDA Adverse Event
Malfunction
·BIOMERIEUX SA·Product code LSR·January 3, 2019
Portex
FDA UDI
ICU MEDICAL, INC.·15019315061066·
VIDAS® LYME IGG
FDA Adverse Event
Malfunction
·BIOMERIEUX SA·Product code LSR·December 19, 2018
Pneupac
FDA UDI
ICU MEDICAL, INC.·15019517159127·
LYTENING 2Z LYTENING SYSTEM 31
FDA 510(k)
FDA Class 2
·Clinical Chemistry
BIOPSY FORCEPS
FDA 510(k)
FDA Class 2
·Cardiovascular
KOALA EXTERNAL
FDA Adverse Event
Injury
·MVF DISPOSABLES/CLINICAL INNOVATIONS, LLC·Product code HFN·March 12, 2024
COMPREHENSIVE SEGMENTAL REVISION SYSTEM - 12MM X 75 MM MODULAR STEM
FDA Adverse Event
Injury
·BIOMET ORTHOPEDICS·Product code KWT·January 4, 2017
KOALA INTRAUTERINE PRESSURE CATHETER
FDA Adverse Event
Injury
·CLINICAL INNOVATIONS, LLC·Product code HFN·May 2, 2024
CE INTERMATE SV 200, 48 PACK,50125
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - IRVINE·Product code FRN·November 22, 2010
TENDRIL ST
FDA Adverse Event
Injury
·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code NVN·January 9, 2013
INGENIO
FDA Adverse Event
Injury
·GUIDANT CRM CLONMEL IRELAND·Product code LWP·July 1, 2014