12 results
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20ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Elation Pulmonary Balloon Dilation Catheter
FDA 510(k)
FDA Class 2
·Ear, Nose, Throat
LANX POSTERIOR CERVICOTHORACIC SPINAL FIXATION SYSTEM (PCFS)
FDA 510(k)
FDA Class 2
·Orthopedic
VP-2000/1000
FDA 510(k)
FDA Class 2
·Cardiovascular
CLARIUS ULTRASOUND SCANNER
FDA Adverse Event
Malfunction
·CLARIUS MOBILE HEALTH CORP.·Product code IYN·October 17, 2024
URETEX SUP URETHRAL SUPPORT SYSTEM
FDA Adverse Event
Injury
·SOFRADIM PRODUCTION·Product code OTN·May 8, 2013
ASR ACETABULAR CUPS 58
FDA Adverse Event
Injury
·DEPUY INTERNATIONAL, LTD.·Product code KWA·August 12, 2011
POWERED WHEELCHAIR
FDA Adverse Event
Malfunction
·UNKNOWN·Product code ITI·October 30, 2014
ACL ELITE PRO Refurbished)-Analyzer designed specifically for clinical use in the hemostasis laboratory, for coagulation and/or fibrinolysis testing. Part Number: 0001000311R
FDA Recall
Open, Classified
·Instrumentation Laboratory·Product code KFF·February 3, 2023
ACL ELITE PRO-Analyzer designed specifically for clinical use in the hemostasis laboratory, for coagulation and/or fibrinolysis testing. Part Number: 0001000311
FDA Recall
Open, Classified
·Instrumentation Laboratory·Product code KFF·February 3, 2023
ACL ELITE Refurbished-Analyzer designed specifically for clinical use in the hemostasis laboratory, for coagulation and/or fibrinolysis testing. Part Number: 0000880311R
FDA Recall
Open, Classified
·Instrumentation Laboratory·Product code KFF·February 3, 2023
ACL ELITE- Analyzer designed specifically for clinical use in the hemostasis laboratory, for coagulation and/or fibrinolysis testing. Part Number: 0000880311
FDA Recall
Open, Classified
·Instrumentation Laboratory·Product code KFF·February 3, 2023
DRX Revolution Mobile X-Ray System
FDA Enforcement
Class II
·Ongoing·Carestream Health, Inc.·December 13, 2023