22 results
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23ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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BD MAX MRSA XT, BD MAX INSTRUMENT
FDA 510(k)
FDA Class 2
·Microbiology
Zavation
FDA UDI
Zavation LLC·00197157005382·Trial Drill Guide 12x14x5
INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT, LUMBAR
FDA Adverse Event
Injury
·MSD DEGGENDORF MFG·Product code OVD·December 18, 2019
SMARTFLOW CATHETER
FDA 510(k)
FDA Class 2
·Neurology
INOMAX DSIR (DELIVERY SYSTEM)
FDA 510(k)
FDA Class 2
·Anesthesiology
CLYDESDALE PTC SPINAL SYSTEM
FDA Adverse Event
Injury
·MSD DEGGENDORF MFG·Product code MAX·October 17, 2019
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·May 29, 2025
STAINLESS STEEL DISC ELECTRODE
FDA Adverse Event
Injury
·NATUS NEUROLOGY INCORPORATED·Product code IKT·May 24, 2013
OCTRODE PERCUTANEOUS LEAD
FDA Adverse Event
Injury
·ST. JUDE MEDICAL- NEUROMODULATION·Product code LGW·June 16, 2011
GE OEC 9800
FDA Adverse Event
Malfunction
·GE OEC MEDICAL SYSTEMS INC.·Product code JAA·August 20, 2008
ADVIA CENTAUR INTACT PTH (IPTH) ASSAY
FDA Adverse Event
Malfunction
·SIEMENS HEALTHCARE DIAGNOSTICS, INC.·Product code CEW·February 24, 2016
ADVIA CENTAUR XP INTACT PARATHYROID (IPTH) ASSAY
FDA Adverse Event
Malfunction
·SIEMENS HEALTHCARE DIAGNOSTICS, INC.·Product code CEW·January 7, 2015
ADVIA CENTAUR INTACT PTH (IPTH) ASSAY
FDA Adverse Event
Malfunction
·SIEMENS HEALTHCARE DIAGNOSTICS, INC.·Product code CEW·December 19, 2014
ADVIA CENTAUR XP INTACT PARATHYROID HORMONE (IPTH) ASSAY
FDA Adverse Event
Malfunction
·SIEMENS HEALTHCARE DIAGNOSTICS, INC.·Product code CEW·November 1, 2016
ADVIA CENTAUR XP INTACT PARATHYROID (IPTH) ASSAY
FDA Adverse Event
Malfunction
·SIEMENS HEALTHCARE DIAGNOSTICS, INC.·Product code CEW·February 29, 2016
ADVIA CENTAUR XP INTACT PARATHYROID (IPTH) ASSAY
FDA Adverse Event
Malfunction
·SIEMENS HEALTHCARE DIAGNOSTICS, INC.·Product code CEW·June 15, 2016
CD HORIZON SPINAL SYSTEM
FDA Adverse Event
Injury
·WARSAW ORTHOPEDICS·Product code NKB·April 19, 2019
ADVIA CENTAUR XP INTACT PARATHYROID (IPTH) ASSAY
FDA Adverse Event
Malfunction
·SIEMENS HEALTHCARE DIAGNOSTICS, INC.·Product code CEW·August 30, 2016
Depuy P.F.C. Modular Knee System, curved tibial insert (CVD); polyethylene tibial insert, Sz 4, 8.0 mm; Ref 98-4152.
FDA Recall
Terminated
·Depuy Orthopaedics, Inc.·Product code JWH·May 26, 2005
Pipeline Embolization Device (Pipeline Classic) The device is indicated for the endovascular treatment of adults (22 year of age or older) with large or giant widenecked intracranial aneurysms (lAs) in the internal carotid artery from the petrous to the superior hypophyseal segements. Catalog No. FA-71300-25V09 FA-71350-25V16 FA-71400-25V10 FA-71425-35V13 FA-71475-30V16 FA-71300-25V12 FA-71350-25V17 FA-71400-25V11 FA-71425-35V15 FA-71475-30V18 FA-71300-25V13 FA-71350-25V18 FA-71400-25V12 FA-71425-35V18 FA-71475-35V09 FA-71300-25V15 FA-71350-25V19 FA-71400-25V13 FA-71450-25V09 FA-71475-35V10 FA-71300-25V16 FA-71350-30V09 FA-71400-25V15 FA-71450-25V10 FA-71475-35V11 FA-71300-25V17 FA-71350-30V10 FA-71400-25V16 FA-71450-25V11 FA-71475-35V12 FA-71300-25V18 FA-71350-30V12 FA-71400-25V18 FA-71450-25V12 FA-71475-35V13 FA-71300-25V19 FA-71350-30V13 FA-71400-25V19 FA-71450-25V13 FA-71475-35V15 FA-71300-30V09 FA-71350-30V15 FA-71400-30V09 FA-71450-25V15 FA-71475-35V18 FA-71300-30V12 FA-71350-30V16 FA-71400-30V10 FA-71450-25V16 FA-71475-35V19 FA-71300-30V13 FA-71350-30V18 FA-71400-30V11 FA-71450-25V18 FA-71500-25V09 FA-71300-30V15 FA-71350-35V09 FA-71400-30V12 FA-71450-25V19 FA-71500-25V10 FA-71300-30V16 FA-71350-35V10 FA-71400-30V13 FA-71450-30V09 FA-71500-25V11 FA-71300-30V19 FA-71350-35V12 FA-71400-30V15 FA-71450-30V10 FA-71500-25V12 FA-71300-35V09 FA-71350-35V13 FA-71400-30V16 FA-71450-30V11 FA-71500-25V13 FA-71300-35V12 FA-71350-35V15 FA-71400-30V18 FA-71450-30V12 FA-71500-25V15 FA-71300-35V13 FA-71350-35V18 FA-71400-35V09 FA-71450-30V13 FA-71500-25V16 FA-71300-35V15 FA-71375-25V09 FA-71400-35V13 FA-71450-30V15 FA-71500-25V18 FA-71325-25V09 FA-71375-25V10 FA-71400-35V15 FA-71450-30V16 FA-71500-25V19 FA-71325-25V10 FA-71375-25V11 FA-71400-35V18 FA-71450-30V18 FA-71500-30V09 FA-71325-25V12 FA-71375-25V12 FA-71425-25V09 FA-71450-30V19 FA-71500-30V10 FA-71325-25V13 FA-71375-25V13 FA-71425-25V10 FA-71450-35V09 FA-71500-30V11 FA-71325-25V15 FA-71375-25V15 FA-71425-25V11 FA-71450-35V10 FA-71500-30V12 FA-71325-25V18 FA-71375-25V16 FA-71425-25V12 FA-71450-35V12 FA-71500-30V13 FA-71325-25V19 FA-71375-25V17 FA-71425-25V13 FA-71450-35V13 FA-71500-30V15 FA-71325-30V09 FA-71375-25V18 FA-71425-25V15 FA-71450-35V15 FA-71500-30V16 FA-71325-30V10 FA-71375-25V19 FA-71425-25V16 FA-71450-35V16 FA-71500-30V17 FA-71325-30V12 FA-71375-30V09 FA-71425-25V18 FA-71475-25V09 FA-71500-30V18 FA-71325-30V13 FA-71375-30V10 FA-71425-25V19 FA-71475-25V10 FA-71500-35V09 FA-71325-30V15 FA-71375-30V12 FA-71425-30V09 FA-71475-25V11 FA-71500-35V10 FA-71325-30V16 FA-71375-30V13 FA-71425-30V10 FA-71475-25V12 FA-71500-35V11 FA-71325-30V18 FA-71375-30V15 FA-71425-30V11 FA-71475-25V13 FA-71500-35V12 FA-71325-30V19 FA-71375-30V16 FA-71425-30V12 FA-71475-25V15 FA-71500-35V13 FA-71325-35V09 FA-71375-30V18 FA-71425-30V13 FA-71475-25V16 FA-71500-35V15 FA-71325-35V12 FA-71325-35V13 FA-71325-35V15 FA-71350-25V09 FA-71350-25V10 FA-71350-25V13 FA-71350-25V15 FA-77250-10V13 FA-77250-10V19 FA-77250-12V11 FA-77250-12V12 FA-77250-12V13 FA-77250-12V18 FA-77250-14V12 FA-77250-14V13 FA-77250-14V15 FA-77250-14V18 FA-77250-14V19 FA-77250-16V11 FA-77250-16V12 FA-77250-16V13 FA-77250-16V15 FA-77250-16V16 FA-77250-16V19 FA-77250-18V09 FA-77250-18V10 FA-77250-18V11 FA-77250-18V12 FA-77250-18V13 FA-77250-18V16 FA-77250-18V18 FA-77250-18V19 FA-77250-20V10 FA-77250-20V11 FA-71375-35V09 FA-71375-35V12 FA-71375-35V13 FA-71375-35V15 FA-71375-35V16 FA-71375-35V18 FA-71400-25V09 FA-77275-14V11 FA-77275-14V12 FA-77275-14V13 FA-77275-14V17 FA-77275-14V18 FA-77275-14V19 FA-77275-16V12 FA-77275-16V13 FA-77275-16V16 FA-77275-16V18 FA-77275-16V19 FA-772
FDA Enforcement
Class I
·Terminated·Micro Therapeutics Inc, Dba Ev3 Neurovascular·November 16, 2016