27 results
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22ms
·
Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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THORACIC VCAR
FDA 510(k)
FDA Class 2
·Radiology
Zethon
FDA UDI
ZETHON LIMITED·05060528013482·C-C10 - ADULT CRANIOTOME ATTACHMENT
IMMCO DIAGNOSTICS
FDA UDI
IMMCO DIAGNOSTICS, INC.·00845714000898·Hep-2 Cells -Anti-Nuclear Antibody IFA Kit
BIOFIND
FDA 510(k)
FDA Class 2
·Neurology
COBE SMARXT OPTIMIN SURFACE MODIFIED HOLLOW FIBER MEMBRANE OXYGENATOR
FDA 510(k)
FDA Class 2
·Cardiovascular
UNKNOWN
FDA Adverse Event
Injury
·BIOMET ORTHOPEDICS·Product code LPH·April 30, 2014
SELEX/MAGNUM MODULAR HEAD 40MM +3
FDA Adverse Event
Injury
·BIOMET ORTHOPEDICS·Product code JDI·January 30, 2014
VISIAN ICL (IMPLANTABLE COLLAMER LENS)
FDA Adverse Event
Malfunction
·STAAR SURGICAL COMPANY·Product code MTA·May 9, 2013
PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·MEDTRONIC MINIMED·Product code OYC·September 19, 2014
COLLEAGUE PRE P1.7
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·May 26, 2011
ARCOMXL 40MM RINGLOC LINER HW SZ26
FDA Adverse Event
Injury
·BIOMET ORTHOPEDICS·Product code JDI·January 30, 2014
Illumina MiSeqDx Cystic Fibrosis Clinical Sequencing Assay in vitro diagnostic system for use on the Illumina MiSeqDx Platform.
FDA Enforcement
Class III
·Terminated·Illumina Inc·December 31, 2014
Daig Livewire Steerable, Product Number 401581; REPROCESSED ELECTROPHYSIOLOGY CATHETER
FDA Enforcement
Class II
·Ongoing·Stryker Sustainability Solutions·May 20, 2026
MICRUSFRAME10 5MM X 17CM
FDA Adverse Event
Injury
·MEDOS INTERNATIONAL SARL·Product code KRD·December 15, 2022
GALAXY G3 XSFT 4MM X 10CM
FDA Adverse Event
Injury
·MEDOS INTERNATIONAL SARL·Product code KRD·December 15, 2022
GALAXY G3 XSFT 4MM X 10CM
FDA Adverse Event
Injury
·MEDOS INTERNATIONAL SARL·Product code KRD·December 15, 2022
GALAXY G3 XSFT 2.5MM X 3.5CM
FDA Adverse Event
Injury
·MEDOS INTERNATIONAL SARL·Product code KRD·December 15, 2022
GALAXY G3 XSFT 3MM X 8CM
FDA Adverse Event
Injury
·MEDOS INTERNATIONAL SARL·Product code KRD·December 15, 2022
SOLARICE RX
FDA Adverse Event
Malfunction
·MEDTRONIC MEXICO·Product code LOX·August 26, 2019
MICRUSFRAME10 6MM X 11.9CM
FDA Adverse Event
Injury
·MEDOS INTERNATIONAL SARL·Product code KRD·December 7, 2022