12 results
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18ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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TEMPLATE
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
ClotTriever Thrombectomy System, ClotTriever Catheter, ClotTriever Sheath
FDA 510(k)
FDA Class 2
·Cardiovascular
AVS PL PEEK SPACERS, MODELS 48351XXX AND 48353XXX
FDA 510(k)
FDA Class 2
·Orthopedic
OT PING METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·June 14, 2014
UNKNOWN DEPUY PINNACLE CUP
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDICS, INC.·Product code KWY·December 14, 2012
PLM LS PRIMARY
FDA Adverse Event
Malfunction
·HOSPIRA COSTA RICA LTD.·Product code FRN·September 20, 2010
RECIPROC BLUE FILES, 6X, STERILE
FDA Adverse Event
Malfunction
·VDW GMBH·Product code EKS·June 13, 2025
RECIPROC BLUE FILES, 6X, STERILE
FDA Adverse Event
Malfunction
·VDW GMBH·Product code EKS·June 13, 2025
RECIPROC BLUE FILES, 6X, STERILE
FDA Adverse Event
Malfunction
·VDW GMBH·Product code EKS·June 13, 2025
RECIPROC BLUE FILES, 6X, STERILE
FDA Adverse Event
Malfunction
·VDW GMBH·Product code EKS·June 13, 2025
XP-XP Tibial Tray - Interlok 63 mm Item # 195751
FDA Enforcement
Class II
·Terminated·Zimmer Biomet, Inc.·September 18, 2019
Dynamic Locking Screw System (DLS) 3.7mm & Dynamic Locking Screw (DLS) 5.0mm; intended for use in long bone fractures, the fixation of osteopenic bone, the fixation of osteotomies, and for the fixation of non-unions and malunions.
FDA Enforcement
Class II
·Terminated·Synthes (USA) Products LLC·September 30, 2015