17 results · 39ms · Sources: EU EUDAMED, US FDA

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Aveir Retrieval Catheter

FDA 510(k)
FDA Class 2 ·Cardiovascular

3.75MM AND 5.0MM SPLINE TWIST IMPLANT

FDA 510(k)
FDA Class 2 ·Dental

NOBLESTITCH EL NOBLESTITCH MR NOBLESTITCH TA

FDA 510(k)
FDA Class 2 ·General, Plastic Surgery

VIDEO MEDIASTINOSCOPE

FDA Adverse Event
Injury ·KARL STORZ SE & CO. KG·Product code EWY·December 21, 2021

VIDEO MEDIASTINOSCOPE

FDA Adverse Event
Injury ·KARL STORZ SE & CO. KG·Product code EWY·December 21, 2021

VIDEO MEDIASTINOSCOPE

FDA Adverse Event
Injury ·KARL STORZ SE & CO. KG·Product code EWY·December 21, 2021

BIO-PUMP

FDA Adverse Event
Death ·MEDTRONIC BIO-MEDICUS, INC.·Product code KFM·March 5, 1997

VIDEO MEDIASTINOSCOPE

FDA Adverse Event
Injury ·KARL STORZ SE & CO. KG·Product code EWY·December 21, 2021

PRECISE PRO RX CAROTID STENT SYSTEM

FDA Adverse Event
Malfunction ·CORDIS CORPORATION·Product code NIM·October 30, 2014

COLLEAGUE

FDA Adverse Event
Malfunction ·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·August 16, 2011

UNK

FDA Adverse Event
Malfunction ·MEDTRONIC SOFAMOR DANEK·Product code KWQ·July 9, 2013

IMPL TWIST MTX 3.75 MM 10 MM

FDA Adverse Event
Injury ·ZIMMER DENTAL·Product code DZE·June 17, 2024

ACL ELITE PRO Refurbished)-Analyzer designed specifically for clinical use in the hemostasis laboratory, for coagulation and/or fibrinolysis testing. Part Number: 0001000311R

FDA Recall
Open, Classified ·Instrumentation Laboratory·Product code KFF·February 3, 2023

ACL ELITE PRO-Analyzer designed specifically for clinical use in the hemostasis laboratory, for coagulation and/or fibrinolysis testing. Part Number: 0001000311

FDA Recall
Open, Classified ·Instrumentation Laboratory·Product code KFF·February 3, 2023

ACL ELITE Refurbished-Analyzer designed specifically for clinical use in the hemostasis laboratory, for coagulation and/or fibrinolysis testing. Part Number: 0000880311R

FDA Recall
Open, Classified ·Instrumentation Laboratory·Product code KFF·February 3, 2023

ACL ELITE- Analyzer designed specifically for clinical use in the hemostasis laboratory, for coagulation and/or fibrinolysis testing. Part Number: 0000880311

FDA Recall
Open, Classified ·Instrumentation Laboratory·Product code KFF·February 3, 2023

Philips AneurysmFlow. Model Number: 001015. AneurysmFlow is a software medical device (Interventional Tool) intended to be used in combination with a Philips interventional X-ray system and 3DRA data.

FDA Enforcement
Class II ·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·April 22, 2026