20 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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BD MAX Enteric Viral Panel
FDA 510(k)
FDA Class 2
·Microbiology
BD MAX¿ ENTERIC VIRAL PANEL
FDA Adverse Event
Malfunction
·GENEOHM SCIENCES CANADA, INC. (BD DIAGNOSTICS)·Product code PCH·February 23, 2024
TALOS° HA PEEK IBF
FDA UDI
MEDITECH SPINE, LLC·B1676220607150·
TALOS° HA PEEK IBF
FDA UDI
MEDITECH SPINE, LLC·B1676220607070·
TALOS° HA PEEK IBF
FDA UDI
MEDITECH SPINE, LLC·B1676220607000·
Bernafon
FDA UDI
Sbo Hearing A/S·05714464011421·ALIGO 5 FW 1.0.0
Zavation
FDA UDI
Zavation LLC·00842166132832·Ti3Z CIF 14mmx16mmx7mm -6 deg
Zavation
FDA UDI
Zavation LLC·00842166104921·CIF 14x16, 6 deg, -07
VEO® Lateral Interbody Fusion System
FDA UDI
Choice Spine, LP·00840996134651·LATERAL,RAKE CURETTE, ANGLED
BALFOUR CENTER BLADE
FDA UDI
SONTEC INSTRUMENTS, INC.·00192896077256·BALFOUR CENTER BLADE WIDE END
TALOS®-C HA
FDA UDI
MEDITECH SPINE, LLC·B167522206070·
SilverGlide
FDA UDI
STRYKER CORPORATION·04546540696021·ProSeries Non-stick Bipolar Electrosurgical For...
SLEEPFLO, MODEL 101501
FDA 510(k)
FDA Class 2
·Anesthesiology
LINK MobileLink® Acetabular Cup System - Dual Mobility Liners, and Shell/Insert Adapters
FDA 510(k)
FDA Class 2
·Orthopedic
Ziptight Ankle Syndesmosis Fixation Device, Titanium Implant Titanium Implant for surgical repairs of soft tissue.
FDA Enforcement
Class II
·Terminated·Zimmer Biomet, Inc.·March 7, 2018
ENDO GIA ROTICULATOR* 60-4.8 SULU
FDA Adverse Event
Injury
·COVIDIEN, FORMERLY US SURGICAL A DIVISON·Product code GDW·November 3, 2014
LEFT - NAV COMPATIBLE DUAL-OFFSET ACCOLADE RASP HA
FDA Adverse Event
Malfunction
·STRYKER ORTHOPAEDICS MAHWAH·Product code LXH·July 15, 2011
VERSACARE BED
FDA Adverse Event
Malfunction
·HILL-ROM, INC.·Product code FNL·June 24, 2013
NSK
FDA Adverse Event
Injury
·NAKANISHI INC.·Product code EGS·June 24, 2022
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