21 results · 30ms · 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.

CPS AIM UNIVERSAL SLITTABLE INNER CATHETER

FDA 510(k)
FDA Class 2 ·Cardiovascular

EVONOS

FDA UDI
Gyrus ACMI, LLC·00821925012028·GUILFORD INCUDOSTAPEDIAL JOINT KNIFE 30 DEGREE ...

Surge Cardiovascular

FDA UDI
Alliant Enterprises, LLC·00817278011986·Vein graft cannula, blunt tip, free-flow (2 pack)

980 VENTILATOR

FDA Adverse Event
Malfunction ·COVIDIEN·Product code CBK·December 14, 2016

ORIA SPINAL CLIP SYSTEM EXTENDED OMNIAXIAL CONNECTORS (CO05 & CO07)

FDA 510(k)
FDA Class 2 ·Orthopedic

MASTER-VU A-SCAN, MV4500

FDA 510(k)
FDA Class 2 ·Radiology

T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY

FDA Adverse Event
Malfunction ·TANDEM DIABETES CARE·Product code QFG·May 27, 2021

AMISTEM H FEMORAL CEMENTLESS STEM SIZE 3 STD

FDA Adverse Event
Injury ·MEDACTA INTERNATIONAL SA·Product code LZO·September 25, 2015

DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

FDA Adverse Event
Malfunction ·DEXCOM, INC.·Product code QBJ·May 28, 2025

T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY

FDA Adverse Event
Malfunction ·TANDEM DIABETES CARE·Product code QFG·September 6, 2023

LAP-BAND ADJUSTABLE FASTRIC BANDING SYSTEM (UNK SIZE)

FDA Adverse Event
Malfunction ·ALLERGAN·Product code LTI·May 22, 2013

PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

FDA Adverse Event
Malfunction ·MEDTRONIC MINIMED·Product code OYC·September 18, 2014

AED PLUS

FDA Adverse Event
Malfunction ·ZOLL MEDICAL CORP·Product code MKJ·May 9, 2011

Nerve Block Tray Catalog Number: 8415

FDA Enforcement
Class II ·Terminated·Busse Hospital Disposables, Inc.·June 8, 2022

VirtuTRAX Instrument Navigator, 10 17 GA VirtuTRAX

FDA Enforcement
Class II ·Terminated·Civco Medical Instruments Co. Inc.·December 29, 2021

Syngo.via and Syngo.x ; a software solution intended to be used for viewing, manipulation, communication, and storage of medical images.

FDA Enforcement
Class II ·Terminated·Siemens Medical Solutions USA, Inc·June 10, 2015

Artis zee multi-purpose, Model Number 10094139

FDA Enforcement
Class II ·Ongoing·Siemens Medical Solutions USA, Inc·April 27, 2022

Syngo.via picture archiving and communication system Syngo via is a software solution intended to be used for viewing, manipulation, communication, and storage of medical images.

FDA Enforcement
Class II ·Terminated·Siemens Medical Solutions USA, Inc·September 28, 2016

Syngo.x picture archiving and communication system Syngo.x is a software solution intended to be used for viewing, manipulation, communication, and storage of medical images.

FDA Enforcement
Class II ·Terminated·Siemens Medical Solutions USA, Inc·September 28, 2016

Azurion 7 B12; System Code: (1)722067, (2)722225, (3)722235;

FDA Enforcement
Class II ·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·April 8, 2026