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

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20G x 1.25 NovaCath Secure IV Catheter System, 24G x 0.56 NovaCath Secure IV Catheter System

FDA 510(k)
FDA Class 2 ·General Hospital

Monza Cervical Plate System

FDA UDI
Altus Spine, LLC·B41711603741·74mm Cervical Plate, 3 Level

3M™ Unitek™

FDA UDI
3M UNITEK CORPORATION·00652221045249·Unitek(TM) Molar Band General Purpose Wide Regu...

REFA, PHYSIOLOGICAL AMPLIFIER

FDA 510(k)
FDA Class 2 ·Neurology

MAX PULSE SYSTEM

FDA 510(k)
FDA Class 2 ·Cardiovascular

SECURA DR

FDA Adverse Event
Injury ·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code LWS·June 10, 2013

COLLEAGUE PRE P1.7

FDA Adverse Event
Malfunction ·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·July 13, 2011

COLLEAGUE CX VOLUMETRIC INFUSION PUMP

FDA Adverse Event
Malfunction ·BAXTER HEALTHCARE PTE. LTD.·Product code FRN·September 16, 2008

GALAXY G3 MINI 2MM X 4CM

FDA Adverse Event
Injury ·MEDOS INTERNATIONAL SARL·Product code KRD·June 16, 2021

GALAXY G3 5MM X 15CM

FDA Adverse Event
Injury ·MEDOS INTERNATIONAL SARL·Product code KRD·June 16, 2021

GALAXY G3 MINI 3MM X 8CM

FDA Adverse Event
Injury ·MEDOS INTERNATIONAL SARL·Product code KRD·June 16, 2021

GALAXY G3 MINI 2MM X 3CM

FDA Adverse Event
Injury ·MEDOS INTERNATIONAL SARL·Product code KRD·June 16, 2021

OPTETRAK Comprehensive Knee System including OPTETRAK Logic RBK PS Tibial Components (Product Line: 02-012-38-XXXX). NOTE: Information reflects Exactech recall expansion initiated on 02/07/2022.

FDA Enforcement
Class II ·Ongoing·Exactech, Inc.·October 13, 2021