16 results
·
22ms
·
Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
×
Plum 360(TM) Infusion System with MedNet/ Smart Card Plug and Play Module
FDA 510(k)
FDA Class 2
·General Hospital
Oxford Partial Knee System
FDA UDI
Biomet Uk Ltd·05019279438242·Twin Peg Femoral
ACON ON CALL DIABETES MANAGEMENT SOFTWARE
FDA 510(k)
FDA Class 2
·Clinical Chemistry
STAXXSD SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
OXFORD ANATOMIC BEARING LEFT MD SIZE 3 PMA
FDA Adverse Event
Injury
·BIOMET UK LTD.·Product code NRA·November 16, 2017
OXFORD TWIN-PEG CEMENTED FEMUR MD PMA
FDA Adverse Event
Injury
·BIOMET UK LTD.·Product code NRA·November 16, 2017
OXF ANAT BRG RT MD SIZE 5 PMA
FDA Adverse Event
Injury
·BIOMET UK LTD.·Product code JWH·March 23, 2018
SINGLE LUMEN PERIPHERALLY INSERTED CENTRAL VENOUS CATHETER SET
FDA Adverse Event
Malfunction
·COOK INC·Product code LJS·December 19, 2017
PENTA
FDA Adverse Event
Injury
·ST. JUDE MEDICAL - NEUROMODULATION·Product code LGW·June 5, 2013
COLLEAGUE PRE P1.7
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·July 14, 2011
VITROS CHEMISTRY PRODUCTS VANC REAGENT
FDA Adverse Event
Malfunction
·ORTHO-CLINICAL DIAGNOSTICS·Product code LEH·September 11, 2008
OXF TWIN-PEG CMNTD FEM MD PMA
FDA Adverse Event
Injury
·BIOMET UK LTD.·Product code NRA·March 16, 2018
OXF ANAT BRG RT MD SIZE 3 PMA
FDA Adverse Event
Injury
·BIOMET UK LTD.·Product code NRA·March 16, 2018
TURBO-FLO SINGLE LUMEN CENTRAL VENOUS CATHETER SET
FDA Adverse Event
Injury
·COOK INC·Product code LJS·October 1, 2018
TURBO-FLO SINGLE LUMEN CENTRAL VENOUS CATHETER SET
FDA Adverse Event
Injury
·COOK INC·Product code LJS·October 1, 2018
RECLAIM DISTAL TAPERED, Angled Distal Stem, various sizes. Taper Protector Sleeve. RECLAIM Revision Hip System Orthopedic Manual Surgical Instrument, used to ensure the locking taper surface of the Distal Stem is protected during proximal preparation.
FDA Enforcement
Class II
·Terminated·DePuy Orthopaedics, Inc.·July 30, 2014