11 results
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24ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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OptiOne Single-Head Contrast Delivery System with Pedestal; with Ceiling Suspension;Injector, OptiOne Base System
FDA 510(k)
FDA Class 2
·Cardiovascular
LINK Endo-Model EVO Knee System
FDA UDI
WALDEMAR LINK GmbH & Co. KG·04026575267989·Femoral component, cemented, CoCrMo, UHMWPE, Ti...
LINK Endo-Model EVO Knee System
FDA UDI
WALDEMAR LINK GmbH & Co. KG·04026575267996·Femoral component, cemented, CoCrMo, UHMWPE, Ti...
ZIP'R4/ ZIP'R4 XTRA SCOOTER
FDA 510(k)
FDA Class 2
·Physical Medicine
SIMULIX-EVOLUTION WITH ONCENTRA CONEBEAM
FDA 510(k)
FDA Class 2
·Radiology
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·June 13, 2025
FEMORAL NAIL, A/R T2 FEMUR ? 10X360MM
FDA Adverse Event
Injury
·STRYKER TRAUMA GMBH·Product code HSB·August 3, 2012
COLLEAGUE PRE 1.7
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·July 7, 2011
CONCERTO II CRT-D
FDA Adverse Event
Injury
·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code NIK·June 7, 2013
VERSACARE
FDA Adverse Event
Malfunction
·HILL-ROM RITTER·Product code FNL·September 10, 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