14 results · 28ms · 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.

I.V. ADDITIVE CAP

FDA 510(k)
FDA Class 2 ·General Hospital

CODMAN®

FDA UDI
INTEGRA LIFESCIENCES PRODUCTION CORPORATION·10381780516866·CODMAN® IRIS Bipolar Forceps Curved Non Stick M...

CODMAN

FDA UDI
Cerenovus, Inc.·10886704039259·CODMAN IRIS Bipolar Forceps Curved Non Stick Mi...

PB560 VENTILATOR

FDA Adverse Event
Malfunction ·COVIDIEN·Product code CBK·August 22, 2011

OCU-FLEX-49 SPHERICAL, TORIC, ASPHERICAL AND TORIC ASPHERICAL (HIOXIFILCON B) SOFT CONTACT LENSES FOR DAILY WEAR

FDA 510(k)
FDA Class 2 ·Ophthalmic

PB 540 VENTILATOR

FDA 510(k)
FDA Class 2 ·Anesthesiology

PB560 VENTILATOR X1

FDA Adverse Event
Malfunction ·NELLCOR PURITAN BENNETT·Product code CBK·April 20, 2011

ESSURE

FDA Adverse Event
Other ·BAYER PHARMA AG·Product code HHS·May 6, 2014

FREESTYLE

FDA Adverse Event
Malfunction ·ABBOTT DIABETES CARE INC, USA·Product code NBW·October 1, 2007

CONSTELLATION VISION SYSTEM

FDA Adverse Event
Malfunction ·ALCON - IRVINE TECHNOLOGY CENTER·Product code HQC·October 19, 2012

RX PERMANENT PACING LEAD

FDA Adverse Event
Injury ·OSCOR INC.·Product code DTB·November 19, 2021

ACUSON Sequoia Ultrasound Imaging System with Software Version VA25A/B

FDA Enforcement
Class II ·Ongoing·Siemens Medical Solutions USA, Inc.·February 9, 2022

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

Exactech Equinoxe GLENOID,KEELED, CEMENTED, mates with 47, 50, 53 head, beta curvature, Sizes: a) Small, Item Number 314-02-02, b) Medium, Item Number 314-02-03, c) Large, Item Number 314-02-04, Shoulder Arthroplasty

FDA Enforcement
Class II ·Ongoing·Exactech, Inc.·April 10, 2024