16 results
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35ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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ARCHITECT CYCLOSPORINE
FDA 510(k)
FDA Class 2
·Clinical Chemistry
ARCHITECT CYCLOSPORINE REAGENT KIT
FDA Adverse Event
Malfunction
·ABBOTT IRELAND DIAGNOSTICS DIVISION·Product code MKW·August 8, 2025
ARCHITECT CYCLOSPORINE REAGENT KIT
FDA Adverse Event
Malfunction
·ABBOTT IRELAND DIAGNOSTICS DIVISION·Product code MKW·September 4, 2025
ABBOTT TUBE EDTA PLH 13X75 2.0 PNK
FDA Adverse Event
Malfunction
·BECTON, DICKINSON & CO. (BROKEN BOW)·Product code JKA·August 3, 2022
ABBOTT TUBE EDTA PLH 13X75 2.0 PNK
FDA Adverse Event
Malfunction
·BECTON, DICKINSON & CO. (BROKEN BOW)·Product code JKA·September 17, 2019
ARCHITECT CYCLOSPORINE REAGENT KIT
FDA Adverse Event
Malfunction
·ABBOTT IRELAND DIAGNOSTICS DIVISION·Product code MKW·September 30, 2025
SchureMed
FDA UDI
SCHUERCH CORPORATION·00810014607283·SKYTRON 3501B 5" SOFTCARE
NA
FDA UDI
STRYKER CORPORATION·07613327056518·Insert, Peritoneal Scissors.
RHIGENE MESACUP2 TEST- SSB
FDA 510(k)
FDA Class 2
·Immunology
BPFONE, MODEL UA 767IT
FDA 510(k)
FDA Class 2
·Cardiovascular
Stablecut®
FDA UDI
ZIMMER ORTHOPAEDIC SURGICAL PRODUCTS, INC.·00889024493056·
Stablecut®
FDA UDI
ZIMMER ORTHOPAEDIC SURGICAL PRODUCTS, INC.·00889024493049·
IDUO G2
FDA Adverse Event
Malfunction
·CONFORMIS·Product code NPJ·April 9, 2013
UNICEL® DXC 600 PRO SYNCHRON® CLINICAL SYSTEMS
FDA Adverse Event
Malfunction
·BECKMAN COULTER INC.·Product code JJE·May 6, 2011
RESTORE PRIME ADVANCED
FDA Adverse Event
Injury
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code LGW·July 23, 2008
CADD-Solis VIP ambulatory Infusion Pumps, Model 2110. Indicated for the following uses: Intra-arterial, subcutaneous, intraperitoneal, in close proximity to nerves, into an intraoperative site, epidural space or subarachnoid space. Therapies that require a continuous rate of infusion, intermittent bolus, and/or with patient-controlled demand doses.
FDA Enforcement
Class I
·Ongoing·Smiths Medical ASD Inc.·August 14, 2024