15 results · 21ms · 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.

CYTETTE(TM) CYTOLOGY BRUSH

FDA 510(k)
FDA Class 2 ·Obstetrics/Gynecology

Millennium

FDA UDI
Avalign Technologies, Inc.·00190776178758·Gwilliam Clamp curved teeth, longitudinal ser...

ALLthread Titanium

FDA UDI
Biomet Orthopedics, LLC·00880304444263·

COBE SMARXT VVR 4000 FILTERED HARDSHELL VENOUS RESERVOIR

FDA 510(k)
FDA Class 2 ·Cardiovascular

ORTHOPANTOMOGRAPH OP30

FDA 510(k)
FDA Class 2 ·Dental

5.0 ALLTHREAD TI 2#2 MB

FDA Adverse Event
Injury ·ZIMMER BIOMET, INC.·Product code MBI·July 12, 2023

LOCKING SCREW, FULLY THREADED T2 TIBIA Ø5X45 MM

FDA Adverse Event
Malfunction ·STRYKER TRAUMA KIEL·Product code HSB·June 30, 2014

ATLAS II HF CRT-D

FDA Adverse Event
Malfunction ·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code NIK·January 8, 2013

FG6301 DUAL CHNL VOL INFUSIONPUMP,2M8064 RECONDND

FDA Adverse Event
Malfunction ·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·November 18, 2010

980 VENTILATOR

FDA Adverse Event
Malfunction ·COVIDIEN·Product code CBK·September 13, 2024

980 VENTILATOR

FDA Adverse Event
Malfunction ·COVIDIEN·Product code CBK·January 2, 2024

980 VENTILATOR

FDA Adverse Event
Malfunction ·COVIDIEN·Product code CBK·January 2, 2024

QUATTRO LINK SP KNOTLESS ANCHOR 4.5MM PEEK ANCHOR WITH TITANIUM TIP

FDA Adverse Event
Malfunction ·CAYENNE MEDICAL·Product code MBI·May 1, 2024

UniCel DxI 600 Access Immunoassay Analyzer, Part Number A30260

FDA Enforcement
Class II ·Ongoing·Beckman Coulter, Inc.·August 13, 2025

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