31 results
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23ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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ARTHREX BIO-PIN
FDA 510(k)
FDA Class 2
·Orthopedic
Merit Medical®
FDA UDI
Merit Medical Systems, Inc.·00884450139981·
Merit Medical®
FDA UDI
Merit Medical Systems, Inc.·00884450279885·
MEDIFACE PACS
FDA 510(k)
FDA Class 2
·Radiology
HARDYDISK, CEFTAZIDIME, 30MCG
FDA 510(k)
FDA Class 2
·Microbiology
BIPAP AUTO M-SERIES
FDA Adverse Event
Death
·RESPIRONICS, INC·Product code BZD·July 11, 2012
BIPAP AUTO SERIES
FDA Adverse Event
Malfunction
·RESPIRONICS, INC.·Product code BZD·March 9, 2022
RD SET GE - 12
FDA Adverse Event
Malfunction
·Product code DQA·August 13, 2021
BIPAP AUTO SERIES
FDA Adverse Event
Malfunction
·RESPIRONICS, INC.·Product code BZD·March 14, 2022
BIPAP AUTO BIFLEX
FDA Adverse Event
Malfunction
·RESPIRONICS, INC.·Product code BZD·March 14, 2022
BIPAP AUTO SERIES ASSY
FDA Adverse Event
Malfunction
·RESPIRONICS, INC.·Product code BZD·March 31, 2022
BIPAP AUTO SERIES
FDA Adverse Event
Malfunction
·RESPIRONICS, INC.·Product code BZD·March 14, 2022
BIPAP AUTO SERIES ASSY
FDA Adverse Event
Malfunction
·RESPIRONICS, INC·Product code BZD·March 31, 2022
BIPAP AUTO SERIES
FDA Adverse Event
Malfunction
·RESPIRONICS, INC.·Product code BZD·March 9, 2022
BIPAP AUTO SERIES
FDA Adverse Event
Malfunction
·RESPIRONICS, INC.·Product code BZD·March 9, 2022
BIPAP AUTO SERIES
FDA Adverse Event
Malfunction
·RESPIRONICS, INC.·Product code BZD·March 9, 2022
Access-9 Large Bore Hemostasis Valves, Catalog Code: 580775001, IN8112/C, K05-00053H, K05-00109G, K05-00137K, K05-00410G, K05-00438G, K05-00502F, K05-00587D, K05-01052, K05-01706C, K05-01880K, K05-02130, K05-02595, K09-12599A, K10-05487P, K12-00264, MAP111/F, MAP112/B, MAP112/F, K08-YP085A, K08-YS017B, K08-YS055A, K09-YS029A, K09-YS040F, K12-YP002A, K12-YP030A, K12-YP060A, K12-YP061A, K12-YP063C, K12-YP072, K12-YS018A, K12-YS019A, K12-YS026A, K05-01140D, K05-01706C***, K05-02595, MAP112, K05-00564L, K12-YP002A,
FDA Enforcement
Class II
·Ongoing·Merit Medical Systems, Inc.·April 20, 2022
BIPAP AUTO SERIES
FDA Adverse Event
Malfunction
·RESPIRONICS, INC.·Product code BZD·March 31, 2022
SETROX S 53
FDA Adverse Event
Injury
·BIOTRONIK SE & CO. KG·Product code NVN·April 10, 2013
NUCLEUS 24 CHANNEL COCHLEAR IMPLANT SYSTEM
FDA Adverse Event
Injury
·COCHLEAR LTD.·Product code MCM·May 22, 2008