14 results
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24ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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ILUMIEN OPTIS
FDA 510(k)
FDA Class 2
·Radiology
ECG Module(AHA)
FDA UDI
SAMSUNG MEDISON CO., LTD.·08806167712532·
Oticon
FDA UDI
Oticon A/S·05707131283009·RIA2 PRO, MINIBTE 312 WL 85 STG
CD HORIZON SPINAL SYSTEM
FDA Adverse Event
Injury
·WARSAW ORTHOPEDICS·Product code NKB·July 21, 2017
BD AUTOSHIELD PEN NEEDLE
FDA Adverse Event
Other
·BD MEDICAL - INFUSION THERAPY SYSTEMS·Product code FMI·March 20, 2009
SELF CATH CATHETER
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
ON CALL MULTI-DRUG HOME TEST CUP
FDA 510(k)
FDA Class 2
·Clinical Toxicology
CAPTURED HIP SCREW 135 DEGREE 4 HOLE PLATE
FDA Adverse Event
Malfunction
·BIOMET TRAUMA·Product code KTT·May 3, 2017
CAPTURED HIP SCREW LAG SCREW
FDA Adverse Event
Malfunction
·BIOMET TRAUMA·Product code KTT·May 3, 2017
INGENIO
FDA Adverse Event
Injury
·GUIDANT CRM CLONMEL IRELAND·Product code LWP·October 8, 2014
MECHANICAL (MANUAL) WHEELCHAIR
FDA Adverse Event
Malfunction
·INVACARE TAYLOR STREET·Product code IOR·June 6, 2013
HIP HEAD,10/12 TAPER,28MM,+0MM
FDA Adverse Event
Injury
·DEPUY INTERNATIONAL, LTD.·Product code KWY·June 29, 2011
CD HORIZON SPINAL SYSTEM
FDA Adverse Event
Injury
·WARSAW ORTHOPEDICS·Product code NKB·April 19, 2019
VERSA-FXII SC TUBE PLT 90DX16H, 95DX16H, 95DX18H, 95DX20H, 95DX22H
FDA Enforcement
Class II
·Terminated·Zimmer Biomet, Inc.·June 21, 2017