17 results · 31ms · Sources: EU EUDAMED, US FDA

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MEDOJECT fine Pen Needles

FDA 510(k)
FDA Class 2 ·General Hospital

10PW - Amazon Delivery Van Mexico - 10PW

FDA UDI
Certified Safety Manufacturing, Inc.·00766588206141·10PW - Amazon Delivery Van Mexico - 10PW

APEX PS Knee

FDA UDI
Omni Life Science, Inc.·00841690113386·PS Insert, Size 6 x 14mm

TALOS° HA PEEK IBF

FDA UDI
MEDITECH SPINE, LLC·B1676220614000·

TALOS° HA PEEK IBF

FDA UDI
MEDITECH SPINE, LLC·B1676220614150·

TALOS° HA PEEK IBF

FDA UDI
MEDITECH SPINE, LLC·B1676220614070·

IRRIGATING CANNULA

FDA 510(k)
FDA Class 2 ·Gastroenterology, Urology

FiteBac Antimicrobial Cavity Cleanser

FDA 510(k)
FDA Class 2 ·Dental

VERSACROSS CONNECT LAAC ACCESS SOLUTION

FDA Adverse Event
Injury ·BAYLIS MEDICAL COMPANY INC.·Product code DRE·April 6, 2023

BARRIGEL INJECTABLE GEL

FDA Adverse Event
Malfunction ·PALETTE LIFE SCIENCES·Product code OVB·June 24, 2024

ONETOUCHPING GLUCOSEMGMTSYSTEM

FDA Adverse Event
Malfunction ·ANIMAS CORPORATION·Product code LZG·November 3, 2014

LIFEVEST WCD 4000 SYSTEM

FDA Adverse Event
Malfunction ·ZOLL LIFECOR CORP·Product code MVK·July 15, 2011

IMPAX CV REPORTING

FDA Adverse Event
Malfunction ·AGFA HEALTHCARE CORPORATION·Product code LLZ·July 8, 2013

SINGLE USE 8MM SCRAPER PROBE - 80MM - STERILE

FDA Adverse Event
Injury ·ORTHOFIX SRL·Product code JDX·May 27, 2024

VERSACROSS CONNECT LAAC ACCESS SOLUTION

FDA Adverse Event
Injury ·BAYLIS MEDICAL COMPANY INC.·Product code DXF·April 25, 2023

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

Allura Exper FD Series. System codes 722003 722010 722022 722005 722011 722019 722001 722002 722006 722012 722008 722013 722020 722025 722015 722023 722038 889006 889016 889009 722005 The device is an X-Ray Generator.

FDA Enforcement
Class II ·Terminated·Philips North America, LLC·March 25, 2020