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