31 results · 23ms · Sources: EU EUDAMED, US FDA

Get notified when this changes

We'll email you when new records match this search — new devices, new clearances, certificate changes, or withdrawals.

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