14 results · 23ms · 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.

Powder Free Nitrile Patient Examination Glove, Blue Colored, Non-Sterile, Powder Free Nitrile Patient Examination Glove, White Colored, Non-Sterile

FDA 510(k)
FDA Class 1 ·General Hospital

OsteoMed

FDA UDI
OSTEOMED LLC·00845694047029·PrimaLIF LLIF PEEK Implant, 17mm X 18mm X 50mm,...

MaxFuse,VBR, 12 (D) x 14 (W) x 31 (H)

FDA UDI
Pioneer Surgical Technology, Inc.·00846468056247·12 (D) x 14 (W) x 31 (H)

Phantom Hindfoot TTC/TC Nail System

FDA UDI
Paragon 28, Inc.·00889795135865·Phantom ActivCore Nail, 11.5 X 175mm

Phantom Hindfoot TTC/TC Nail System

FDA UDI
Paragon 28, Inc.·00889795097743·Phantom ActivCore Nail, 11.5 X 175mm

FLOR-OPAL VARNISH, MODELS UP 4500/ UP 4501/ UP 4502

FDA 510(k)
FDA Class 2 ·Dental

RPC E-Z CHEK 6.8-8.5 PH TEST STRIPS, MODEL K100-0117 AND E-Z CHEK 0-14 PH TEST STRIPS, MODEL K100-0104

FDA 510(k)
FDA Class 2 ·Gastroenterology, Urology

DRUG ELUTING PERMANENT LEFT VENTRICULAR (LV) PACEMAKER ELECTRODE

FDA Adverse Event
Injury ·RICE CREEK MFG·Product code OJX·June 7, 2013

VITALITY 2

FDA Adverse Event
Injury ·GUIDANT CRM CLONMEL IRELAND·Product code LWS·July 6, 2011

ONETOUCHPING GLUCOSEMGMTSYSTEM

FDA Adverse Event
Malfunction ·ANIMAS CORPORATION·Product code LZG·October 8, 2014

INTELLIS

FDA Adverse Event
Malfunction ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code LGW·July 28, 2025

MINIMED 770G US SYSTEM BLE CONNECT 3.0 MG/DL

FDA Adverse Event
Injury ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OZP·October 3, 2025

ELEKTA LIMITED Elekta Synergy Platform, REF MRT 8501, MRT 8511; Medical Charged-Particle Radiation Therapy System Accelerator, Linear

FDA Enforcement
Class II ·Ongoing·Elekta, Inc.·December 13, 2023

Medical Linear Accelerator

FDA Enforcement
Class II ·Terminated·Elekta, Inc.·September 14, 2016