14 results
·
25ms
·
Sources: EU EUDAMED, US FDA
ActivSight Intraoperative Imaging System
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
CoRoent
FDA UDI
Nuvasive, Inc.·00887517570369·CoRoent Ant TLIF Ti, 13x11x34mm 4°
BD BBL™ Sensi-Disc™ Tetracycline 30 µg
FDA UDI
BECTON, DICKINSON AND COMPANY·30382902313442·BD BBL™ Sensi-Disc™ Tetracycline 30 µg
24PW - Hanta Virus
FDA UDI
Certified Safety Manufacturing, Inc.·00766588013442·Hanta Virus - 24 Poly White
POWDER FREE YELLOW SYNTHETIC VINYL PATIENT EXAMINATION GLOVES
FDA 510(k)
FDA Class 1
·General Hospital
RANFAC GOLDENBERG SNARECOIL SOFT TISSUE BIOPSY (GSS) NEEDLE
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·August 21, 2025
FLO-GARD 6201 VOLUMETRIC INFUSION PUMP
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE (SG)·Product code FRN·November 17, 2008
3002 SECURE II
FDA Adverse Event
Malfunction
·STRYKER MEDICAL·Product code FNL·July 18, 2011
CD HORIZON SPINAL SYSTEM
FDA Adverse Event
Malfunction
·MDT SOFAMOR DANEK PUERTO RICO MFG·Product code KWP·July 17, 2013
BD BBL Sensi Disc Tetracycline 30 ug,used for semi-quantitative in vitro susceptibility testing. Catalog Number 230998 and 231344¿
FDA Enforcement
Class II
·Ongoing·Becton Dickinson & Co.·February 14, 2024
CELL-DYN 3000 CS ANALYZER
FDA Adverse Event
Malfunction
·ABBOTT DIAGNOSTICS DIVISION·Product code GKZ·April 18, 2011
BD BBL Sensi Disc Tetracycline 30 ug,used for semi-quantitative in vitro susceptibility testing. Catalog Number 230998 and 231344
FDA Recall
Open, Classified
·Becton Dickinson & Co.·Product code JTN·January 8, 2024
Revogene, Catalog no. 610210. IVD test instrument
FDA Enforcement
Class II
·Ongoing·Meridian Bioscience Inc·August 3, 2022