15 results · 22ms · 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.

LifeSPARC System

FDA 510(k)
FDA Class 2 ·Cardiovascular

CVS Health

FDA UDI
WOONSOCKET PRESCRIPTION CENTER, INCORPORATED·00050428639290·Flexible Fabric Antibacterial Bandages, assorte...

NA

FDA UDI
Synthes GmbH·10886982151636·2.4MM CANNULATED SCREW LONG THREAD 30MM

Meridian

FDA UDI
Seaspine Orthopedics Corporation·10889981247133·No-Profile Interbody, 35mm x 27mm x 18mm, 30 Deg

Medical Facets NC

FDA UDI
MEDICAL FACETS NC LLC·M933MDF2118300·2.4mm Cannulated Screw, Long Thread, 30mm

Diamond Orthopedic, LLC

FDA UDI
DIAMOND ORTHOPEDIC, LLC·B551DMD2118300·2.4mm, Cannulated Screw, Long Thd., 30mm

TRI-FIX SPINAL FIXATION SYSTEM

FDA 510(k)
FDA Class 2 ·Orthopedic

FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR MODEL KD-7902BTJ, FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR MO

FDA 510(k)
FDA Class 2 ·Cardiovascular

I-STAT EC8+ CARTRIDGE

FDA Adverse Event
Malfunction ·ABBOTT POINT OF CARE·Product code CHL·October 13, 2021

VISIAN ICL (IMPLANTABLE COLLAMER LENS)

FDA Adverse Event
Malfunction ·STAAR SURGICAL COMPANY·Product code MTA·October 29, 2014

ASR UNI FEMORAL IMPL SIZE 47

FDA Adverse Event
Injury ·DEPUY INTERNATIONAL, LTD.·Product code KWA·August 10, 2011

M2A-MAGNUM PF CUP 50ODX44ID

FDA Adverse Event
Injury ·BIOMET ORTHOPEDICS·Product code KWA·July 8, 2013

MAKO Integrated Cutting System (MICS) HANDPIECE, Catalog Number 209063

FDA Enforcement
Class II ·Ongoing·Howmedica Osteonics Corp.·October 16, 2024

Model Number L211 PROPONENT DR SL MRI Pacemaker

FDA Enforcement
Class I ·Ongoing·Boston Scientific Corporation·October 22, 2025

PROPONENT DR Pacemaker, SL (Model Number L201), (VDD) SL (Model Number L209), SL MRI (Model Number L211), EL (Model Number L221), and EL MRI (Model Number L231).

FDA Enforcement
Class I ·Ongoing·Boston Scientific Corporation·January 22, 2025