16 results · 35ms · Sources: EU EUDAMED, 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