20 results · 24ms · Sources: EU EUDAMED, US FDA

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Dental Cone-beam Computed Tomography

FDA 510(k)
FDA Class 2 ·Radiology

Ophthalmic Knife

FDA UDI
KATENA PRODUCTS, INC.·00841668101186·GILL CORNEAL KNIFE CURVED

Tecomet

FDA UDI
TECOMET INC.·00841435121133·RONGEUR LARGE JAW STR

Vu a-POD™

FDA UDI
Seaspine Orthopedics Corporation·10889981041779·27x21mm Trial Rasp 10mm 8 deg

CLOSED SYSTEM INTERMITTENT CATHETERIZATION KIT

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

Disposable Medical Face Mask

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

IMP,TSV,4.1MM,DUAL SEL,HA

FDA Adverse Event
Malfunction ·ZIMMER DENTAL·Product code DZE·June 15, 2021

840 VENTILATOR

FDA Adverse Event
Malfunction ·PURITAN-BENNETT CORP.·Product code CBK·November 14, 2008

PINNACLE MTL INS NEUT28IDX48OD

FDA Adverse Event
Malfunction ·DEPUY ORTHOPAEDICS, INC. 1818910·Product code KWA·August 18, 2011

ZEPHIR ANTERIOR CERVICAL SYSTEM

FDA Adverse Event
Malfunction ·MEDTRONIC SOFAMOR DANEK·Product code KWQ·July 18, 2013

COMP LK SCR 3.5HEX 4.75X20 ST

FDA Adverse Event
Injury ·ZIMMER BIOMET, INC.·Product code PHX·November 5, 2024

COMP RVRS 25MM BSPLT HA+ADPTR

FDA Adverse Event
Injury ·ZIMMER BIOMET, INC.·Product code PHX·November 5, 2024

COMP RVS CNTRL 6.5X30MM ST/RST

FDA Adverse Event
Injury ·ZIMMER BIOMET, INC.·Product code PHX·November 5, 2024

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

SPECIFIC DEVICE NOT REPORTED

FDA Adverse Event
Injury ·EXACTECH, INC.·Product code KWS·January 14, 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

IMP,TSV,4.1MM,DUAL SEL,HA

FDA Adverse Event
Malfunction ·ZIMMER DENTAL·Product code DZE·October 21, 2023

COMP NLK SCR 3.5HEX 4.75X30 ST

FDA Adverse Event
Injury ·ZIMMER BIOMET, INC.·Product code PHX·November 5, 2024

COMP NLK SCR 3.5HEX 4.75X15 ST

FDA Adverse Event
Injury ·ZIMMER BIOMET, INC.·Product code PHX·November 5, 2024

Model Number L111, ESSENTIO DR SL MRI Pacemaker

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