18 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Electric Scooter (Model: S3312)
FDA 510(k)
FDA Class 2
·Physical Medicine
ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
FDA UDI
FX SOLUTIONS·03701037318102·TRIAL HUMERAL CUP ECCENTRIC SYMMETRIC MOBILITY ...
Signature ONE System
FDA 510(k)
FDA Class 2
·Orthopedic
INFINITY EXPLORER
FDA 510(k)
FDA Class 2
·Cardiovascular
ENDEAVOR SPRINT RX CORONARY STENT SYSTEM
FDA Adverse Event
Injury
·MEDTRONIC IRELAND·Product code NIQ·August 11, 2011
SYSTEM, PERITONEAL, AUTOMATIC DELIVERY
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code FKX·November 6, 2014
COULTER® LH 780 HEMATOLOGY ANALYZER
FDA Adverse Event
Malfunction
·BECKMAN COULTER·Product code GKZ·July 16, 2013
VITEK® REVEAL¿ SENSOR PANEL
FDA Adverse Event
Malfunction
·BIOMERIEUX, INC.·Product code LON·June 23, 2025
7" (18 CM) APPX 0.45 ML, PRESSURE INFUSION (400PSIG) EXT SET W/ MICROCLAVE® CLEA
FDA Adverse Event
Malfunction
·ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V.·Product code FPA·January 31, 2024
VITEK® REVEAL¿ SENSOR PANEL
FDA Adverse Event
Malfunction
·BIOMERIEUX, INC.·Product code LON·June 24, 2025
VITEK® REVEAL¿ SENSOR PANEL
FDA Adverse Event
Malfunction
·BIOMERIEUX, INC.·Product code LON·June 23, 2025
VITEK® REVEAL¿ SENSOR PANEL
FDA Adverse Event
Malfunction
·BIOMERIEUX, INC.·Product code LON·June 24, 2025
VITEK® REVEAL¿ SENSOR PANEL
FDA Adverse Event
Malfunction
·BIOMERIEUX, INC.·Product code LON·June 24, 2025
Medline Gown Poly W/Breath Sleeves XL AAMIK Level 4 (Eclipse gown), REF SPT-2208CS, 100/pack, Non-Sterile.
FDA Enforcement
Class II
·Ongoing·MEDLINE INDUSTRIES, LP - Northfield·January 17, 2024
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
Vue Motion V12. Product Number: 1017979.
FDA Enforcement
Class II
·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·April 8, 2026
CODMAN Disposable Perforator, 14mm. Cranial perforator.
FDA Enforcement
Class I
·Ongoing·Integra LifeSciences Corp. (NeuroSciences)·May 14, 2025
Transseptal Needle, Trocar. RPN TSNC-18-71.0, TSNC-19-56.0. GPN G02364, G02365. Product consists of a transseptal needle and obturator.
FDA Enforcement
Class II
·Terminated·Cook Inc.·November 24, 2021