14 results · 20ms · Sources: EU EUDAMED, US FDA

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Saranas Early Bird Bleed Monitoring System

FDA 510(k)
FDA Class 2 ·Cardiovascular

Oticon

FDA UDI
Sbo Hearing A/S·05714464029181·OTICON MORE 1 MINIRITE T C079

Ophthalmic Cannula

FDA UDI
KATENA PRODUCTS, INC.·00841668114261·CHAMBER MAINTAINER 23GA (PK/10)

Intrigue

FDA UDI
LANCER ORTHODONTICS, INC.·00817573020645·INTRG WHISP-Z MBT 2BIC-17T 0A 018 L0

devemed

FDA UDI
devemed GmbH·04061644024728·Anatomical tweezers, micro TC, 1.3 mm, angled F...

GLOVETEX LATEX EXAMINATION GLOVES, POWDERED, BLUE, NON STERILE

FDA 510(k)
FDA Class 1 ·General Hospital

PANPAC VAGINAL DILATORS

FDA 510(k)
FDA Class 2 ·Obstetrics/Gynecology

TRUMETRXGO

FDA Adverse Event
Malfunction ·TRIVIDIA HEALTH, INC.·Product code NBW·April 16, 2019

RSP

FDA Adverse Event
Other ·ENCORE MEDICAL, L.P.·Product code HSD·November 7, 2008

UNICEL ® DXC600I SYNCHRON ® ACCESS ® CLINICAL SYSTEM

FDA Adverse Event
Malfunction ·BECKMAN COULTER INC.·Product code JJE·September 1, 2011

DEPUY ASR XL FEM IMP SIZE 41

FDA Adverse Event
Injury ·DEPUY INTERNATIONAL LTD - 8010379·Product code KXA·July 16, 2013

i-STAT CG8+ cartridge. List Number: 03P88-25. 510(k) numbers: K894914, K940918, K223710, K230275, K230285, K230300

FDA Enforcement
Class II ·Ongoing·Abbott Point Of Care Inc.·September 24, 2025

i-STAT CG8+ cartridge. List Number: 03P88-25. 510(k) numbers: K894914, K940918, K223710, K230275, K230285, K230300

FDA Recall
Open, Classified ·Abbott Point Of Care Inc.·Product code CHL·August 21, 2025

Model Number L111, ESSENTIO DR SL MRI Pacemaker

FDA Enforcement
Class I ·Ongoing·Boston Scientific Corporation·October 22, 2025