84 results · 21ms · Sources: EU EUDAMED, US FDA

Get notified when this changes

We'll email you when new records match this search — new devices, new clearances, certificate changes, or withdrawals.

Biopsy Positioner

FDA 510(k)
FDA Class 2 ·Radiology

SINGLE USE 3-LUMEN EXTRACTION BALLOON V, MODEL V B-V233P-A,B-V233P-B,B-V433P-A,B-V433P-B, BV243Q-A, B-V243Q-B, B-V443Q-A

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

COOK GI ENDOSCOPIC INJECTION GEL KIT, GEL-S, GEL-N, GEL-H, GEL-K

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

ARCHITECT STAT HIGH SENSITIVE TROPONIN-I

FDA Adverse Event
Malfunction ·ABBOTT IRELAND DIAGNOSTICS DIVISION·Product code MMI·May 27, 2026

ARCHITECT STAT HIGH SENSITIVE TROPONIN-I

FDA Adverse Event
Malfunction ·ABBOTT IRELAND DIAGNOSTICS DIVISION·Product code MMI·May 27, 2026

NON AC-POWERED PATIENT LIFT

FDA Adverse Event
Malfunction ·INVACARE SUZHOU·Product code FSA·June 26, 2013

8800

FDA Adverse Event
Malfunction ·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·July 27, 2011

840 VENTILATOR

FDA Adverse Event
Malfunction ·PURITAN-BENNETT CORP.·Product code CBK·September 26, 2008

ARCHITECT STAT HIGH SENSITIVE TROPONIN-I

FDA Adverse Event
Malfunction ·ABBOTT IRELAND DIAGNOSTICS DIVISION·Product code MMI·May 19, 2026

ARCHITECT STAT HIGH SENSITIVE TROPONIN-I

FDA Adverse Event
Malfunction ·ABBOTT IRELAND DIAGNOSTICS DIVISION·Product code MMI·April 8, 2026

ARCHITECT STAT HIGH SENSITIVE TROPONIN-I

FDA Adverse Event
Malfunction ·ABBOTT IRELAND DIAGNOSTICS DIVISION·Product code MMI·May 27, 2026

ARCHITECT STAT HIGH SENSITIVE TROPONIN-I

FDA Adverse Event
Malfunction ·ABBOTT IRELAND DIAGNOSTICS DIVISION·Product code MMI·April 9, 2026

ARCHITECT STAT HIGH SENSITIVE TROPONIN-I

FDA Adverse Event
Malfunction ·ABBOTT IRELAND DIAGNOSTICS DIVISION·Product code MMI·May 19, 2026

ARCHITECT STAT HIGH SENSITIVE TROPONIN-I

FDA Adverse Event
Malfunction ·ABBOTT IRELAND DIAGNOSTICS DIVISION·Product code MMI·February 26, 2026

ARCHITECT STAT HIGH SENSITIVE TROPONIN-I

FDA Adverse Event
Malfunction ·ABBOTT IRELAND DIAGNOSTICS DIVISION·Product code MMI·April 3, 2026

ARCHITECT STAT HIGH SENSITIVE TROPONIN-I

FDA Adverse Event
Malfunction ·ABBOTT IRELAND DIAGNOSTICS DIVISION·Product code MMI·March 9, 2026

ARCHITECT STAT HIGH SENSITIVE TROPONIN-I

FDA Adverse Event
Malfunction ·ABBOTT IRELAND DIAGNOSTICS DIVISION·Product code MMI·February 27, 2026

ARCHITECT STAT HIGH SENSITIVE TROPONIN-I

FDA Adverse Event
Malfunction ·ABBOTT IRELAND DIAGNOSTICS DIVISION·Product code MMI·May 5, 2026

ARCHITECT STAT HIGH SENSITIVE TROPONIN-I

FDA Adverse Event
Malfunction ·ABBOTT IRELAND DIAGNOSTICS DIVISION·Product code MMI·August 19, 2025

ARCHITECT STAT HIGH SENSITIVE TROPONIN-I

FDA Adverse Event
Malfunction ·ABBOTT IRELAND DIAGNOSTICS DIVISION·Product code MMI·February 20, 2025