9 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Microwave Ablation Device (Exceed S10U); Sterile Microwave Ablation Probe (Exact)
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
IdentiTi
FDA UDI
ALPHATEC SPINE, INC.·00190376382975·IdentiTI ALIF SA, Inserter, Cranial-Caudal
NEUROMUSCULAR ELECTRICAL STIMULATOR, MODEL EV-807P
FDA 510(k)
FDA Class 2
·Physical Medicine
BD VERITOR SYSTEM FOR THE RAPID DETECTION OF RSV
FDA 510(k)
FDA Class 1
·Microbiology
ALARIS SYSTEM
FDA Adverse Event
Malfunction
·CAREFUSION SD·Product code FRN·September 27, 2023
FLO-GARD 6201 VOLUMETRIC INFUSION PUMP
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE (SG)·Product code FRN·November 18, 2008
ALARIS SE ADMINISTRATION SET
FDA Adverse Event
Malfunction
·CAREFUSION CORPORATION·Product code FPA·July 20, 2011
PINNACLE MTL INS NEUT40IDX56OD
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDICS, INC. 1818910·Product code KWA·July 18, 2013
Model Number L111, ESSENTIO DR SL MRI Pacemaker
FDA Enforcement
Class I
·Ongoing·Boston Scientific Corporation·October 22, 2025