13 results
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19ms
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Sources: EU EUDAMED, US FDA
AtriClip PRO, PRO2, and PRO V LAA Exclusion System devices with preloaded Gillinov-Cosgrove Clip
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
HALLEY ALL-POLY HIP SYSTEM
FDA UDI
Biomet Orthopedics, LLC·00880304255586·
LINK Instruments - Trial implants and size gauges
FDA UDI
WALDEMAR LINK GmbH & Co. KG·04026575399659·Femoral stem prosthesis trial - Megasystem-C Tu...
LINK Instruments - Trial implants and size gauges
FDA UDI
WALDEMAR LINK GmbH & Co. KG·04026575399604·Femoral stem prosthesis trial - Megasystem-C Tu...
MEDFUSION 4000 WIRELESS SYRINGE INFUSION PUMP
FDA Adverse Event
Malfunction
·ST PAUL·Product code FRN·February 8, 2022
NUCLISENS EASYQ ENTEROVIRUS SYSTEM
FDA 510(k)
FDA Class 2
·Microbiology
EUROIMMUN ANTI-NRNP/SM ELISA (IGG)
FDA 510(k)
FDA Class 2
·Immunology
CASSETTE MEDI RESERVOIR
FDA Adverse Event
Injury
·SMITHS MEDICAL ASD, INC.·Product code LHI·December 20, 2022
CAPSURE SP
FDA Adverse Event
Injury
·MPRI·Product code DTB·October 10, 2014
DEPUY ASR XL FEM IMP SIZE 46
FDA Adverse Event
Injury
·DEPUY INTERNATIONAL, LTD.·Product code KWA·July 8, 2011
TENSION FREE VAGINAL TAPE
FDA Adverse Event
Injury
·ETHICON, INC.·Product code OTN·June 11, 2013
Medtronic MiniMed(TM) Mio(TM) (MMT-921, 921T, 923, 923T, 925, 925T, 941, 941T, 943, 943T, 945, 945T, 961, 963, 963T, 965, 965T, 975, 975T)
FDA Enforcement
Class II
·Ongoing·Medtronic Inc.·November 29, 2017
Alaris System PC Unit Model 8000, a modular infusion pump and monitoring system
FDA Enforcement
Class I
·Terminated·CareFusion 303, Inc.·August 12, 2020