12 results · 36ms · 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.

CERAROOT IMPLANT SYSTEM

FDA 510(k)
FDA Class 2 ·Dental

Merit Medical®

FDA UDI
Merit Medical Systems, Inc.·00884450053188·

BURETTE-IN LINE (150 ML)

FDA 510(k)
FDA Class 2 ·General Hospital

PREMIER III PHASED ARRAY CTL SPINE COIL

FDA 510(k)
FDA Class 2 ·Radiology

DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

FDA Adverse Event
Malfunction ·DEXCOM, INC.·Product code QBJ·April 21, 2025

UNKNOWN

FDA Adverse Event
Other ·ENCORE MEDICAL, L.P.·Product code NA·April 14, 2011

LCP® DHHS(TM) INSERTER GUIDE

FDA Adverse Event
Injury ·SYNTHES BRANDYWINE·Product code FZX·May 6, 2013

EON MINI

FDA Adverse Event
Injury ·ST. JUDE MEDICAL - NEUROMODULATION·Product code GZB·September 4, 2014

INDIGO SYSTEM ASPIRATION CATHETER 7D

FDA Adverse Event
Malfunction ·PENUMBRA, INC.·Product code QEW·December 10, 2024

EDWARDS TRANSCATHETER INTRODUCER SHEATH

FDA Adverse Event
Injury ·EDWARDS LIFESCIENCES·Product code NPT·December 11, 2019

INDIGO SYSTEM ASPIRATION CATHETER 7D

FDA Adverse Event
Malfunction ·PENUMBRA, INC.·Product code QEW·January 5, 2023

Stryker MA204 Bed Model (FL25E) Beds are intended for medical purposes in both general patient care as well as critical care environments. Each uses built-in electric motors and controls which can be operated by the patient, or caregiver, to adjust the height and/or surface contour of the bed.The devices listed above also include movable and latchable side rails which can be lowered or raised to help prevent patient fall and subsequent injury. The Beds include an optional Scale (Models: FL20E, FL25E, FL28C, FL28EX) as well as an optional Bed Exit (1 Zone) or Chaperone

FDA Enforcement
Class II ·Terminated·Stryker Medical Division of Stryker Corporation·July 4, 2012