10 results
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23ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Sterile Triplex Surgical Gown (S, M, L, XL, XXL, XXXL)
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
MILLENNIUM
FDA UDI
Avalign Technologies, Inc.·00190776325893·Punch Biopsy Forcep,
PROVEN MODULAR TIBIAL TRAY
FDA 510(k)
FDA Class 2
·Orthopedic
AZUR PUSHABLE 18 & 35 SYSTEM
FDA 510(k)
FDA Class 2
·Cardiovascular
ILLINOIS (TJ) NEEDLE ASPIRATION 15GA
FDA Adverse Event
Malfunction
·CAREFUSION, INC·Product code LWE·November 4, 2019
FLO-GARD 6201 VOLUMETRIC INFUSION PUMP
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE·Product code FRN·November 17, 2008
SWIFT
FDA Adverse Event
Injury
·SORIN BIOMEDICA·Product code MRM·August 12, 2011
IMMERSION HYDROBATH
FDA Adverse Event
Malfunction
·INVACARE CLEVELAND STREET·Product code ILJ·July 16, 2013
BioGX SARS-CoV-2 Reagents for BD MAX System-IVD PCR test intended for the qualitative detection of nucleic acid from the SARS-CoV-2 in nasopharyngeal specimens Catalog Number: 444213
FDA Enforcement
Class II
·Terminated·Becton Dickinson & Co.·April 21, 2021
CODMAN Disposable Perforator, 14mm. Cranial perforator.
FDA Enforcement
Class I
·Ongoing·Integra LifeSciences Corp. (NeuroSciences)·May 14, 2025